ABSTRACTS 7518, 7509, 8009

Promising clinical results with cellular therapies for patients with blood cancers highlight advances being presented by researchers from The University of Texas MD Anderson Cancer Center at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting.

These findings include long-term outcomes of patients receiving an infusion of brexucabtagene autoleucel (KTE-X19) for mantle cell lymphoma, efficacy of gamma delta CAR T therapy for aggressive B-cell lymphoma and responses of umbilical cord blood-derived expanded natural killer cells when given together with combination therapy before stem cell transplant.

CAR T cell therapy shows durable responses after three years for patients with mantle cell lymphoma (Abstract 7518)Three-year follow-up data from the Phase II ZUMA-2 trial showed a long-term survival benefit and low disease relapse potential with one infusion of the anti-CD19 chimeric antigen receptor (CAR) T cell therapy brexucabtagene autoleucel (KTE-X19) in patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL). Principal investigator Michael Wang, M.D., professor of Lymphoma and Myeloma, presented results from the trial, and study results were published in the Journal of Clinical Oncology.

The updated results include all 68 patients treated with KTE-X19 on the trial with an additional two years of follow-up. After 35.6 months median follow-up, the overall response rate was 91%, with a 68% complete response rate. The median duration of response was 28.2 months, with 25 of 68 treated patients still in ongoing response at data cutoff.

This represents the longest follow-up of CAR T cell therapy in patients with mantle cell lymphoma to date, Wang said. It is encouraging to see this therapy induced durable long-term responses and a low relapse rate for these patients.

All patients had R/R disease after receiving up to five therapies, and all had received previous Brutons tyrosine kinase (BTK) inhibitor therapy. BTK inhibitors have greatly improved outcomes in R/R MCL, yet patients who have subsequent disease progression are likely to have poor outcomes, with median overall survival of just six to 10 months. Few patients in this category qualify to proceed to an allogeneic stem cell transplant.

Response and survival benefits were positive regardless of the prior BTK inhibitor type. Ongoing effectiveness trended lower in patients with prior acalabrutinib exposure. More investigation is needed to determine the mechanism behind these differences. The findings support future study of CD19-directed CAR T cell therapy in patients with high-risk MCL in earlier treatment lines.

The researchers also evaluated minimal residual disease (MRD) as an exploratory endpoint using next-generation sequencing on 29 patients. Of those, 24 were MRD-negative at one month, and 15 of 19 with available data were MRD-negative at six months. Circulating tumor DNA analysis of MRD at three and six months was predictive of disease relapse.

The treatment was well tolerated, as reported in previous studies with this therapy. Only 3% of treatment-emergent adverse events (AE) of interest occurred since the primary report. The most frequent Grade 3 AE was neutropenia.

The study was funded by Kite Pharma, a Gilead Company. Wang has received research support and has served on the advisory board and as a consultant for Kite Pharma. A complete list of collaborating authors can be found within the abstract here.

Allogeneic gamma delta CAR T cell therapy displayed encouraging efficacy in B-cell lymphoma (Abstract 7509)In the Phase 1 GLEAN trial of ADI-001, an anti-CD20 CAR-engineered allogeneic gamma delta T cell product, the treatment was well tolerated and showed continued efficacy in patients with R/R aggressive B-cell lymphoma. Results from the ongoing trial were presented by Sattva Neelapu, M.D., professor ofLymphoma and Myeloma.

The first-in-human trial enrolled ten patients and eight were evaluable and monitored for at least 28 days. The median age was 62 years and patients received a median of 4 prior therapies. At Day 28, the overall response rate (ORR) and complete response (CR) rate based upon PET/CT was 75%. The ORR and CR rate was 80% at dose levels two and three combined. The ORR and CR rate in CAR-T relapsed patients was 100%.

The responses to ADI-001 in this population of heavily pre-treated and refractory lymphoma patients, including in those with prior CD19 CAR T cell therapy, is very promising, Neelapu said. These results suggest the potential for off-the-shelf gamma delta CAR T cell therapy to be an effective treatment possibility for patients with B-cell lymphoma.

While autologous CD19-targeted CAR T cell therapy has been effective in R/R large B-cell lymphoma, there remains a need for alternative cell-based therapies. This study uses a subset of T cells, known as gamma delta 1 T cells, isolated from the peripheral blood of donors as the basis for CAR T cell therapy.

Gamma delta 1 T cells are desirable because they are able to combine both innate and adaptive mechanisms to recognize and kill malignant cells, and high levels of these cells in hematologic and solid tumors are associated with improved clinical outcomes. ADI-001 expresses major histocompatibility complex (MHC)-independent gamma delta T cell receptors, therefore lowering the risk of graft versus host disease (GvHD) without the need for gene editing.

The median age on the study was 62 years, and patients had received a median of 4 prior therapies. The treatment was well tolerated with most related events being grade 1 or 2. There were two cases of cytokine release syndrome and one case of immune effector cell-associated neurotoxicity syndrome. There were no reported cases of GvHD or dose-limiting toxicity.

Enrollment in the trial is ongoing and a potentially pivotal program is planned.

The study was funded by Adicet Bio, Inc. Neelapu has received research support and has served on the advisory board and as a consultant for Adicet Bio and has intellectual property related to cell therapy. A complete list of collaborating authors can be found within the abstract here.

Expanded NK cells combined with chemoimmunotherapy achieved durable responses in multiple myeloma (Abstract 8009)Results from the expansion phase of a Phase II clinical trial demonstrated that umbilical cord blood-derived expanded natural killer (NK) cells combined with chemotherapy and immunotherapies achieved durable responses in patients with multiple myeloma. Results from the completed clinical trial were presented by Samer Srour M.D., assistant professor of Stem Cell Transplantation & Cellular Therapy.

Thirty patients on the trial received NK cells plus elotuzumab (an immunotherapy monoclonal antibody), lenalidomide (an immunomodulatory drug) and high-dose melphalan chemotherapy before autologous stem cell transplant (ASCT).

At three months post-transplant, 97% of patients achieved at least a very good partial response (VGPR), including 76% with a complete response or stringent complete response, while 75% were minimal residual disease (MRD)-negative. At a median follow-up of 26 months, only four patients had progressed. At two years, the progression-free survival rate was 83% and the overall survival rate was 97%.

Patients with high-risk multiple myeloma have more options to treat their disease than previous years, but they continue to have poor outcomes, Srour said. These results indicate excellent hematologic and minimal residual disease responses and improved survival for these patients, suggesting this approach could provide an additional treatment opportunity.

NK cells are white blood cells that monitor the body for virus-infected and cancerous cells. MD Anderson researchers pioneered the approach to isolate and expand NK cells from umbilical cord blood to be used as cellular therapies. Lenalidomide enhances NK cell function and antibody-mediated cell toxicity against tumor targets. Preclinical data showed that lab-expanded NK cells demonstrated higher elotuzumab-mediated cytotoxicity against myeloma targets than non-expanded cells, and that the addition of elotuzumab to lenalidomide amplified the cord blood-NK cell antibody-dependent cellular cytotoxicity against a commonly used cell line to evaluate novel therapies for multiple myeloma (MM1.S) targets.

The study enrolled 30 patients with high-risk multiple myeloma, with a median age of 63. Twenty-nine patients (97%) had Revised Multiple Myeloma International Staging System (R-ISS) stages 2/3, 40% had 2 high-risk genetic abnormalities, and 23% had deletions or mutations of TP53. The primary endpoints were best response rate (VGPR) and MRD three months after ASCT.

Before the ASCT, stem cells are taken from the patient and stored. After treatment with the immunotherapy and chemotherapy drugs, stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.

The treatment was well tolerated, with no unexpected serious adverse effects attributable to NK cells noted. The investigators plan to launch a randomized clinical trial to further explore this treatment combination for patients with high-risk multiple myeloma.

This study was supported with funding from the High-Risk Multiple Myeloma Moon Shot, part of MD Andersons Moon Shots Program, a collaborative effort to accelerate the development of scientific discoveries into clinical advances that save patients lives. The research also was supported by Celgene, a Bristol Myers Squibb company.

Srour has no conflicts of interest. A complete list of collaborating authors can be found within the abstract here.

Original post:
MD Anderson researchers present cellular therapy advances at the 2022 ASCO Annual Meeting - EurekAlert

The bouncing orange specks could be popcorn dancing on a hot plate. But theres something odd about how they move. Individual kernels spin in tight circles. Pairs slow dance a pas de deux. A cluster performs one full rotation counter-clockwise before dispersing. Each collision sets off a new motion. They seem to bebehaving.

What look like popcorn kernels inthis short videoare in fact a swarm of microscopic xenobots: tiny living robots, assembled from frog cells.

While living robots might seem a strange concept, in fact the first robots were made of flesh, not metal. Theword was coined in 1921, in a play by Czech playwright Karel apek.Rossums Universal Robotswas a thought experiment along the lines of Mary Shelleys Frankenstein, about a scientists desire to create artificial people. Nature has found only one method of organising living matter, declares Rossum, the scientist in question. There is, however, another method, more simple, flexible and rapid which has not yet occurred to nature at all.

Imagine him sitting over a test tube and thinking how the whole tree of life would grow from him, says another character.

In the century that followed, however, robots developed as things of steel and wire, rather than living tissue. Engineering moved faster than biology, says Douglas Blackiston, a developmental biologist at Tufts University. But biology is rapidly catching up. Blackiston is one of a team of scientists designing xenobots: tiny living robots, painstakingly constructed from tissue harvested fromXenopus laevis, the African clawed frog.

Thefirst xenobotswere revealed to the world at the start of 2020: minuscule cubes formed of skin cells and propelled by two stubby legs made of heart muscle. They were designed by a computer algorithm and hand-built by researchers with the objective to make the xenobots walk. (In a pleasing coincidenceXenopus means strange foot.) These organic automatons could also work together to move particles around their environment, and unlike mechanical robots they self-healed when injured.

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'Unnatural selection': How humans are altering the evolution of other animals - Genetic Literacy Project

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Seungjae (Andy) Lee, age 13, Hong Kong International School, Tai Tam, Hong Kong: Keeping Your Pet Friend Forever: Is Cloning a Soul Possible?

Zhuocheng Li, age 16, Green Hope High School, Cary, N.C.: The Blood That Saved Countless Lives

Andrew C. Lin, age 12, Visions in Education Homeschool Academy, Carmichael, Calif.: Breaking the Speech Barrier

Andy Lu, age 16, Desert Vista High School, Phoenix: Hypersonic Flight: Can We Go Faster?

Camille: Sugar and the Body: A Bittersweet Relationship

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Lasers, Fish-Skin Bandages and Pain-Free Vaccines: The Winners of Our 3rd Annual STEM Writing Contest - The New York Times

- AUTO4: oral presentation on initial clinical experience in peripheral T cell lymphoma- AUTO1/22: oral presentation on initial experience in r/r pediatric B-cell acute lymphoblastic leukemia- obe-cel: poster presentation in r/r primary CNS lymphoma- obe-cel: poster presentation in r/r B-non-Hodgkins lymphoma and chronic lymphoblastic leukemia- Conference call to be held on June 13, 2022 at 7:30 am EST/12:30 pm BST

LONDON, May 12, 2022 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc(Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announces the online publication of four abstracts submitted to the European Hematology Association (EHA) Congress to be held June 9-12, 2022. Autolus plans to present more detail on these programs and the next steps in a conference call following the EHA presentations, on June 13, 2022, details below.

We are delighted to be presenting encouraging early clinical data from four of our pipeline programs, including important additive safety and efficacy data from our lead asset obe-cel in indications beyond adult r/r B-ALL. These data demonstrate the inherent value in both our pipeline and our technology base from which it originates, said Dr. Christian Itin, Chief Executive Officer of Autolus. With oral presentations on the early safety, tolerability, feasibility and preliminary efficacy of AUTO4 and AUTO1/22, were in a great place to evaluate the next strategic steps for these candidates and further build on the data presented here.

Abstracts to be presented:

Conference Call

Management will host a conference call and webcast on June 13, 2022 at7:30 am ET/12:30 pm BST to discuss the EHA data. To listen to the webcast and view the accompanying slide presentation, please go to the events section of Autolus website.

The call may also be accessed by dialing (866) 679-5407 for U.S. and Canada callers or (409) 217-8320 for international callers. Please reference conference ID: 6594553. After the conference call, a replay will be available for one week. To access the replay, please dial (855) 859-2056 for U.S. and Canada callers or (404) 537-3406 for international callers. Please reference conference ID: 6594553.

About Autolus Therapeutics plcAutolus is a clinical-stage biopharmaceutical company developing next-generation, programmed T cell therapies for the treatment of cancer. Using a broad suite of proprietary and modular T cell programming technologies, the Company is engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognize cancer cells, break down their defense mechanisms and eliminate these cells. Autolus has a pipeline of product candidates in development for the treatment of hematological malignancies and solid tumors. For more information, please visit http://www.autolus.com.

About obe-cel(AUTO1)Obe-cel is a CD19 CAR T cell investigational therapy designed to overcome the limitations in clinical activity and safety compared to current CD19 CAR T cell therapies.Designed to have a fast target binding off-rate to minimize excessive activation of the programmed T cells, obe-cel may reduce toxicity and be less prone to T cell exhaustion, which could enhance persistence and improve the ability of the programmed T cells to engage in serial killing of target cancer cells. In collaboration with Autolus academic partner, UCL, obe-cel is currently being evaluated in a Phase 1 clinical trials for B-NHL. Autolus has progressed obe-cel to the FELIX trial, a potential pivotal trial for adult ALL.

About obe-cel FELIX clinical trialAutolus Phase 1b/2 clinical trial of obe-cel is enrolling adult patients with relapsed / refractory B-precursor ALL. The trial had a Phase 1b component prior to proceeding to the single arm, Phase 2 clinical trial. The primary endpoint is overall response rate, and the secondary endpoints include duration of response, MRD negative CR rate and safety. The trial is designed to enroll approximately 100 patients across 30 of the leading academic and non-academic centers in the United States,United KingdomandEurope. [NCT04404660]

About AUTO1/22AUTO1/22 is a novel dual targeting CAR T cell based therapy candidate based on obe-cel. It is designed to combine the enhanced safety, robust expansion & persistence seen with the fast off rate CD19 CAR from obe-cel with a high sensitivity CD22 CAR to reduce antigen negative relapses. This product candidate is currently in a Phase 1 clinical trial called CARPALL for patients with r/r pediatric ALL. [NCT02443831]

About AUTO4AUTO4 is a programmed T cell product candidate in clinical development for T cell lymphoma, a setting where there are currently no approved programmed T cell therapies. AUTO4 is specifically designed to target TRBC1 derived cancers, which account for approximately 40% of T cell lymphomas, and is a complement to the AUTO5 T cell product candidate, which is in pre-clinical development. AUTO4 has been tested in a Phase 1 clinical trial, LibRA1 for patients with peripheral T cell Lymphoma.

Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, and in some cases can be identified by terms such as "may," "will," "could," "expects," "plans," "anticipates," and "believes." These statements include, but are not limited to, statements regarding Autolus development of the obe-cel program; the future clinical development, efficacy, safety and therapeutic potential of its product candidates, including progress, expectations as to the reporting of data, conduct and timing and potential future clinical activity and milestones; expectations regarding the initiation, design and reporting of data from clinical trials; expectations regarding regulatory approval process for any product candidates; the collaboration between Autolus and Blackstone; the discovery, development and potential commercialization of potential product candidates including obe-cel using Autolus technology and under the collaboration agreement; the therapeutic potential for Autolus in next generation product developments of obe-cel in B-cell malignancies; the potential and timing to receive milestone payments and pay royalties under the strategic collaboration; and the Companys anticipated cash runway. Any forward-looking statements are based on management's current views and assumptions and involve risks and uncertainties that could cause actual results, performance, or events to differ materially from those expressed or implied in such statements. These risks and uncertainties include, but are not limited to, the risks that Autolus preclinical or clinical programs do not advance or result in approved products on a timely or cost effective basis or at all; the results of early clinical trials are not always being predictive of future results; the cost, timing and results of clinical trials; that many product candidates do not become approved drugs on a timely or cost effective basis or at all; the ability to enroll patients in clinical trials; possible safety and efficacy concerns; and the impact of the ongoing COVID-19 pandemic on Autolus business. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Autolus actual results to differ from those contained in the forward-looking statements, see the section titled "Risk Factors" in Autolus' Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 10, 2022, as well as discussions of potential risks, uncertainties, and other important factors in Autolus' subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Autolus undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required by law.

Contact:

Olivia Manser+44 (0) 7780 471568o.manser@autolus.com

Julia Wilson+44 (0) 7818 430877j.wilson@autolus.com

Susan A. NoonanS.A. Noonan Communications+1-917-513-5303susan@sanoonan.com

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Autolus Therapeutics to Present Four Clinical Data Updates at the European Hematology Association Congress - GlobeNewswire

Autolus Limited

- AUTO4: oral presentation on initial clinical experience in peripheral T cell lymphoma- AUTO1/22: oral presentation on initial experience in r/r pediatric B-cell acute lymphoblastic leukemia- obe-cel: poster presentation in r/r primary CNS lymphoma- obe-cel: poster presentation in r/r B-non-Hodgkins lymphoma and chronic lymphoblastic leukemia- Conference call to be held on June 13, 2022 at 7:30 am EST/12:30 pm BST

LONDON, May 12, 2022 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, today announces the online publication of four abstracts submitted to the European Hematology Association (EHA) Congress to be held June 9-12, 2022. Autolus plans to present more detail on these programs and the next steps in a conference call following the EHA presentations, on June 13, 2022, details below.

We are delighted to be presenting encouraging early clinical data from four of our pipeline programs, including important additive safety and efficacy data from our lead asset obe-cel in indications beyond adult r/r B-ALL. These data demonstrate the inherent value in both our pipeline and our technology base from which it originates, said Dr. Christian Itin, Chief Executive Officer of Autolus. With oral presentations on the early safety, tolerability, feasibility and preliminary efficacy of AUTO4 and AUTO1/22, were in a great place to evaluate the next strategic steps for these candidates and further build on the data presented here.

Abstracts to be presented:

Title: Safety and preliminary efficacy findings of AUTO4, a TRBC1-targetting CAR, in relapsed/refractory TRBC1 positive selected T Cell Non-Hodgkin Lymphoma LINKSession Title: Gene therapy and cellular immunotherapy - Clinical 2Session date and time: Saturday, June 11 - 16:30 - 17:45 CESTSession room: Hall Strauss 1-2Final Abstract Code: S261Presenting Author: Kate CwynarskiSummary: Peripheral T cell lymphomas (PTCL) are typically aggressive, treatment resistant, and associated with poor prognosis. Finding the right target is challenging because there is a lack of tumor-specific antigens, and pan-T cell depletion leads to immunosuppression. T cell lymphoma is clonal, and tumor cells express either TRBC1 or TRBC2. AUTO4 targets TRBC1+ cells, which allows part of the T cell compartment to be retained. As of 9 February 2022, 9 patients screened for r/r TRBC1+ peripheral T-cell lymphoma have been treated with AUTO4. Two patients had prior stem cell transplantation. After lymphodepletion with Flu/Cy, 3 patients received 25 x 106 CAR T cells, 2 patients received 75 x 106 CAR T cells, 1 patient received 225 x 106 CAR T cells and 3 patients received 450 x 106 CAR T cells. AUTO4 demonstrated a tolerable safety profile, with no patient experiencing any dose limiting toxicities, and no neurotoxicity/immune effector cell-associated neurotoxicity (ICANS). Three patients experienced cytokine release syndrome (CRS) (1 patient with Grade 1, 1 patient with Grade 2 and 1 patient with Grade 3). Of the 9 patients treated, 5 patients had achieved complete metabolic responses (CMR) by PET-CT at Month 1, 1 patient remains with a partial response (PR) 6 months post AUTO4 infusion, and 3 patients did not respond. All 3 patients at the highest dose level achieved a CMR at Month 1.

Title: Dual antigen targeting with co-transduced CD19/22 CAR T cells for relapsed/refractory ALL (AUTO1/22) LINKSession Title: Gene therapy and cellular immunotherapy - Clinical 1Session date and time: Saturday, June 11 - 11:30 - 12:45 CESTSession room: Hall Strauss 1-2Final Abstract Code: S259Presenting Author: Sara GhorashianSummary: CD19 negative escape is a major cause of relapse after CD19 CAR T cell therapy for relapsed/refractory (r/r) pediatric ALL. To overcome this challenge, AUTO1/22 builds on the favorable safety profile and excellent persistence of obe-cel by combining it with an additional CD22 targeting CAR. As of 8 February 2022, 10 pediatric ALL patients have been treated with AUTO1/22 and 8 are evaluable with >1 month follow-up. 5 of 8 patients had relapsed post allogeneic stem cell transplant (SCT), 4 had received prior Blincyto and 3 had relapsed after prior Kymriah. CRS occurred in 7/8 patients (grade 1 n=2, grade 2 n=5), but severe CRS was not seen. 7 of 8 evaluable patients achieved MRD negative complete response (CR) at 1 month post infusion. Overall, at a median follow up of 4.8 months, 5/8 patients remain in MRD negative CR at last follow up. The study results demonstrate that dual CD19/22 targeting CAR T cells generated by co-transduction show an acceptable safety profile, with robust expansion/persistence and early efficacy in a heavily pre-treated cohort. To date with limited follow-up we have not observed antigen negative relapse but longer follow up is needed.

Title: Safety and efficacy findings of AUTO1, a fast off-rate CD19 CAR, in relapsed/refractory Primary CNS Lymphoma LINKSession Title: Poster sessionSession date and time: Friday, June 10 - 16:30 - 17:45 CESTFinal Abstract Code: P1460Presenting Author: Claire RoddieSummary: Relapsed/refractory primary central nervous system lymphoma (PCNSL) has a median overall survival of 2-8 months and few therapeutic options. obe-cel (AUTO1) has previously demonstrated high remission rates, low incidence of CRS/ICANS and long-term persistence, making it a viable treatment option for PCNSL. As of 14 February 2022, the CAROUSEL study enrolled 6 patients with r/r PCNSL where the median prior lines of treatment was 2. 5 patients were infused with IV AUTO1 and 1 patient with intraventricular AUTO1. Following CAR T infusion, Grade 1 and 2 CRS affected 1 and 3 patients respectively and any Grade ICANS was observed in 2 patients with 2 Grade 3 events. AUTO1 engraftment and response was evaluable in 4 patients at 1 month following iv infusion. 2 of 4 patients had no measurable disease at 2 and 6 months of follow up respectively. AUTO1 showed encouraging remission rates and excellent CAR T engraftment/expansion in the blood and CSF. Intraventricular administration was well-tolerated and showed that AUTO1 has activity via that route in a patient who failed IV therapy. Additional patients updated biological data and longer follow up will be presented.

Title: Safety and efficacy findings of AUTO1, a fast off-rate CD19 CAR, in relapsed/refractory B-Cell Non-Hodgkins Lymphoma (B-NHL), and chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL) LINKSession Title: Poster sessionSession date and time: Friday, June 10 - 16:30 - 17:45 CESTFinal Abstract Code: P1459Presenting Author: Claire Roddie Summary: obe-cel (AUTO1) has demonstrated an excellent safety profile in previous trials, with low levels of CRS/ICANS and long-term engraftment of CAR T cells, making it an ideal CAR T candidate to evaluate in B-NHL, CLL/SLL. As of 8 February 2022, 19 patients had been infused with AUTO1; 10 with low grade NHL, 6 with DLBCL and 3 with CLL. Patients treated had received a median of 3 prior lines of treatment. Grade 1 CRS was reported in 6/19 and Grade 2 CRS in 3/19. No ICANS was observed in the B-NHL and CLL cohorts. In the lg-NHL and DCBCL cohorts, 10/10 and 4/5 evaluable patients respectively were in CMR post-treatment. Responses were ongoing in 9/10 lg-NHL at 12 months and in 4/4 DLBCL at months 1,3,3 and 6. In the CLL cohort, 2/3 evaluable patients achieved MRD negative remission in the bone marrow with residual small volume lymph nodes by CT at 6 and 3 months of follow up respectively. AUTO1 demonstrated a tolerable safety profile in patients with r/r B-NHL and CLL despite high disease burden. Early data shows excellent complete remission rates and CAR engraftment/expansion. Additional patients, updated data and longer follow up will be presented.

Story continues

Conference Call

Management will host a conference call and webcast on June 13, 2022 at 7:30 am ET/12:30 pm BST to discuss the EHA data. To listen to the webcast and view the accompanying slide presentation, please go to the events section of Autolus website.

The call may also be accessed by dialing (866) 679-5407 for U.S. and Canada callers or (409) 217-8320 for international callers. Please reference conference ID: 6594553. After the conference call, a replay will be available for one week. To access the replay, please dial (855) 859-2056 for U.S. and Canada callers or (404) 537-3406 for international callers. Please reference conference ID: 6594553.

About Autolus Therapeutics plcAutolus is a clinical-stage biopharmaceutical company developing next-generation, programmed T cell therapies for the treatment of cancer. Using a broad suite of proprietary and modular T cell programming technologies, the Company is engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognize cancer cells, break down their defense mechanisms and eliminate these cells. Autolus has a pipeline of product candidates in development for the treatment of hematological malignancies and solid tumors. For more information, please visit http://www.autolus.com.

About obe-cel (AUTO1)Obe-cel is a CD19 CAR T cell investigational therapy designed to overcome the limitations in clinical activity and safety compared to current CD19 CAR T cell therapies. Designed to have a fast target binding off-rate to minimize excessive activation of the programmed T cells, obe-cel may reduce toxicity and be less prone to T cell exhaustion, which could enhance persistence and improve the ability of the programmed T cells to engage in serial killing of target cancer cells. In collaboration with Autolus academic partner, UCL, obe-cel is currently being evaluated in a Phase 1 clinical trials for B-NHL. Autolus has progressed obe-cel to the FELIX trial, a potential pivotal trial for adult ALL.

About obe-cel FELIX clinical trialAutolus Phase 1b/2 clinical trial of obe-cel is enrolling adult patients with relapsed / refractory B-precursor ALL. The trial had a Phase 1b component prior to proceeding to the single arm, Phase 2 clinical trial. The primary endpoint is overall response rate, and the secondary endpoints include duration of response, MRD negative CR rate and safety. The trial is designed to enroll approximately 100 patients across 30 of the leading academic and non-academic centers in the United States, United Kingdom and Europe. [NCT04404660]

About AUTO1/22AUTO1/22 is a novel dual targeting CAR T cell based therapy candidate based on obe-cel. It is designed to combine the enhanced safety, robust expansion & persistence seen with the fast off rate CD19 CAR from obe-cel with a high sensitivity CD22 CAR to reduce antigen negative relapses. This product candidate is currently in a Phase 1 clinical trial called CARPALL for patients with r/r pediatric ALL. [NCT02443831]

About AUTO4AUTO4 is a programmed T cell product candidate in clinical development for T cell lymphoma, a setting where there are currently no approved programmed T cell therapies. AUTO4 is specifically designed to target TRBC1 derived cancers, which account for approximately 40% of T cell lymphomas, and is a complement to the AUTO5 T cell product candidate, which is in pre-clinical development. AUTO4 has been tested in a Phase 1 clinical trial, LibRA1 for patients with peripheral T cell Lymphoma.

Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, and in some cases can be identified by terms such as "may," "will," "could," "expects," "plans," "anticipates," and "believes." These statements include, but are not limited to, statements regarding Autolus development of the obe-cel program; the future clinical development, efficacy, safety and therapeutic potential of its product candidates, including progress, expectations as to the reporting of data, conduct and timing and potential future clinical activity and milestones; expectations regarding the initiation, design and reporting of data from clinical trials; expectations regarding regulatory approval process for any product candidates; the collaboration between Autolus and Blackstone; the discovery, development and potential commercialization of potential product candidates including obe-cel using Autolus technology and under the collaboration agreement; the therapeutic potential for Autolus in next generation product developments of obe-cel in B-cell malignancies; the potential and timing to receive milestone payments and pay royalties under the strategic collaboration; and the Companys anticipated cash runway. Any forward-looking statements are based on management's current views and assumptions and involve risks and uncertainties that could cause actual results, performance, or events to differ materially from those expressed or implied in such statements. These risks and uncertainties include, but are not limited to, the risks that Autolus preclinical or clinical programs do not advance or result in approved products on a timely or cost effective basis or at all; the results of early clinical trials are not always being predictive of future results; the cost, timing and results of clinical trials; that many product candidates do not become approved drugs on a timely or cost effective basis or at all; the ability to enroll patients in clinical trials; possible safety and efficacy concerns; and the impact of the ongoing COVID-19 pandemic on Autolus business. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Autolus actual results to differ from those contained in the forward-looking statements, see the section titled "Risk Factors" in Autolus' Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 10, 2022, as well as discussions of potential risks, uncertainties, and other important factors in Autolus' subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Autolus undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required by law.

Contact:

Olivia Manser+44 (0) 7780 471568o.manser@autolus.com

Julia Wilson+44 (0) 7818 430877j.wilson@autolus.com

Susan A. NoonanS.A. Noonan Communications+1-917-513-5303susan@sanoonan.com

Originally posted here:
Autolus Therapeutics to Present Four Clinical Data Updates at the European Hematology Association Congress - Yahoo Finance

Photo: Scott Strazzante/San Francisco Chronicle (AP)

Google announced Monday it will allow ads for stem cell treatments approved by the Food and Drug Administration to appear in search results starting in July. The tech giant previously banned any ads for stem cell therapies, FDA-approved or otherwise.

In an update to its policies page first spotted by Gizmodo, the company said that, starting July 11, it will permit search engine ads for stem cell therapies given the thumbs up from the FDA, a very small list of just 23 companies that treat some blood disorders and cancers, according to the FDAs website.

At the same time, Google is clarifying its policy language on stem cell therapy ads, which would allow a global cell or gene therapy company to advertise if the ads are are exclusively educational or informational in nature, regardless of regulatory approval status. Google did not clarify what would constitute educational or informational, nor did the company respond to a request for comment how it will restrict less-than-reputable products from being advertised with its technology going forward. We will update the story if we hear more.

The search engine said it banned all advertising for stem cell treatments back in 2019, proclaiming at the time it was restricting ads that have no established biomedical or scientific basis. In 2021, the company clarified that it was restricting ads for experimental treatments meant for so-called biohacking or other DIY genetic engineering, as well as any cell or gene therapies like stem cell therapy.

Despite the pledge to ban such ads or Mondays announced change, a simple Google search reveals just how easily bad actors can get around the restrictions. Searching for stem cells for neuropathy reveals several misleading ad results for stem cell treatments that are not FDA approved, though at least one maker claims it is FDA registered and another says its treatment is supported by FDA master files.

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Paul Knoepfler, a professor at the University of California Davis School of Medicine who researches stem cells and cancer, has written before about Googles problematic search engine ad policies that allow stem cell companies to easily advertise their products in spite of the tech giants rules. In an email, he told Gizmodo he is concerned How effectively the new rule for strictly educational ads would be maintained, particularly given the context of Google Search now so often highly ranking promotional clinic websites arguably presented as educational material.

Stem cells as an industry have grown rapidly in recent years and are expected to continue doing so, with MarketWatch reporting in February the $2.75 billion industry is expected to more than double to $5.72 billion by 2028.

Stem cell treatments are approved by the FDAs Cellular, Tissue and Gene Therapies Advisory Committee. Though some companies claim in advertising they have FDA approval, being listed on clinicaltrials.gov database or being registered with the FDA isnt full-on approval, according to the agencys guidelines. The fact that companies regularly run around Googles existing policies leaves even more questions on the table. Knoepfler asked whether clinical trial recruitment be allowed, when hes often seen such trials already claiming their treatment already works.

Perhaps good citizens in the regenerative medicine world want the opportunity to run such ads related to clinical trial recruitment, but even exclusively educational ads of that type with good intentions could run into ethical issues, Knoepfler added.

Shoshana Wodinsky contributed reporting.

Visit link:
Google Reverses Ban on Ads for All Stem Cell Therapies, Will Allow FDA-Approved Ones - Gizmodo

Publicize your community events, fundraisers and club meetings for free in The Stroller. Send information at least a week in advance to vndnews@triblive.com. Please include a daytime telephone number.

Planting day scheduled at Tarentum friendship garden

Volunteers are welcome to help at a summer garden day set for 10 a.m. to noon Saturday at the Greg Blythe Friendship Garden on First Avenue in Tarentum.

Bring tools and gloves.

Trivia night set at Lower Burrell VFW

Alle-Kiski Strong Chamber Trivia Night will begin at 6 p.m. May 19 in the Lower Burrell Veterans of Foreign Wars, Wildlife Lodge Road.

Teams will be made up of six to eight members. Cash prizes will be awarded to the top three teams. Cost is $20 per person and includes a pasta buffet. Sponsorship opportunities are available.

For registration or questions, call 724-224-3400 or email lynda@akstrong.com.

Participants welcome at NK-Arnold Memorial Day events

New Kensington-Arnold Joint Veterans will have wreath laying ceremonies on Memorial Day in the two cities.

Individuals and groups wishing to participate should call Greg Kurpakus at 724-467-7125 or Patsy Fraino at 724-337-3182.

Memorial Day events to be published

The Valley News Dispatch is compiling a list of Memorial Day observances to be published in the Valley News Dispatch and online at triblive.com.

If your organization or community is planning an event, please send the information in as soon as possible to: Carol Pinto-Smith, Valley News Dispatch, 210 Wood St., Tarentum, PA 15084; e-mail cpinto-smith@triblive.com or fax 724-226-4677.

Calendar

Apollo

Tuesday: Apollo Memorial Library will host a new summer reading book club for students who are 14 to 18 years old at 5 p.m. the second Tuesday of the month. Reservations required. Reservations: 724-478-4214 or apollo@armstronglibraries.org.

Wednesday: Apollo Hose Co. No. 2 will host bingo at 7 p.m. at the firehall, 325 N. Fourth St. Doors open at 5:30 p.m. Details: 724-478-4831.

Saturday: A vendor fair will be from 9 a.m. to 2 p.m. in the parish center at St. James Parish, 109 Owens View Ave. All vendors needed. Cost: $20 per table; without electricity, $15. Details: Linda, 724-882-8776.

May 17: The Graphic Novel Book Club for children age 10 to 14 at Apollo Memorial Library will meet at 5 p.m. the third Tuesday of each month at the library, 219 N. Pennsylvania Ave. Reservations required. Reservations: 724-478-1693.

Bethel

Tuesday: The Armstrong Nature Book Club will meet at 7 p.m. at the Outdoor Discovery Center at Crooked Creek, 142 Kerr Road. The selection will be, Entangled Life, by Merlin Sheldrake. Reservations and masks required. Reservations and details: armstrongcenter.org/odc-events.

May 23: The Knee High To Nature Series at the Outdoor Discovery Center at Crooked Creek will offer a free science program, Awesome Opossums, for children in elementary school at 6 p.m. May 23 at the center, 142 Kerr Road. Reservations required. Reservations: armstrongcenter.org/odc-events.

Brackenridge

Wednesday: Al-Anon will meet at 8 p.m. at Trinity United Methodist Church, 847 10th Ave. The group offers help and hope for families and friends of alcoholics.

Cheswick

Today: Springdale High School Alumni Association will meet at 7 p.m. in Cheswick Presbyterian Church, 1401 Pittsburgh St. Details: Mike, 724-275-7566.

Freeport

Wednesday: The Thrift Store Clothing Ministry at Freeport United Methodist Church, 211 Fourth St., will be open from noon to 3 p.m. Cash only. Donations of spring and summer clothing, shoes, bedding and purses welcome. Donations must be laundered and free from pet hair. Details: 724-295-3095.

Harrison

Tuesday: The Who Knew? program at Community Library of Allegheny Valley will present, Sensational Gardens of Pa., at 6 p.m. at the library and online at Zoom.us. Reservations required. Reservations: 724-226-3491 or visit the calendar tab at alleghenyvalleylibrary.org.

Wednesday: The PriorityCare program at Allegheny Valley Hospital will offer a free seminar, Say No To Stroke, at 1:30 p.m. in the Charles W. Young Conference Center at the hospital, 1301 Carlisle St., Natrona Heights. Reservations required. Reservations: 724-226-7339.

Wednesday: The Anime Club at Community Library of Allegheny County, 1522 Broadview Blvd., will meet at 5:30 p.m. at the library. Focused for adults, but teens and young adults welcome. Reservations required. Reservations: 724-226-3491 or visit the calendar section at AlleghenyValleyLibrary.org.

Wednesday: The Agape Thrift Shop at Grace United Methodist Church, 1333 Freeport Road, will be open from 1 to 4 p.m. Masks required. Clean spring and summer clothing in all sizes is needed. Bring donations on Wednesday or leave them on the front porch. Do not place donations in the blue bins behind the church.

Wednesday: Allegheny Valley Association of Churches Food Bank will be open to anyone in need from 1:30 to 5 p.m. at 1913 Freeport Road, Natrona Heights. Pull into the center parking lot and food will be placed into your vehicle. Those who are not yet registered should come from 2:30 to 4:30 p.m. Wednesday.

Thursday: The annual St. Joseph High School Latin Mass will be at 7 p.m. at Guardian Angels Parish Most Blessed Sacrament Church, Natrona Heights. Bishop Larry Kulick of the Catholic Diocese of Greensburg will be the celebrant. A reception will be afterward.

Thursday: Burtner House Restoration Society will meet at 6:30 p.m. in the Harrison Municipal Building, 1 Municipal Drive, Natrona Heights. New members welcome. Details: Jeff Jones, 724-205-8784 or BHRS1821@gmail.com.

Thursday : Community Library of Allegheny Valley will offer, Honeybees: The Perfect Pollinator, at 6 p.m. at the library, 1522 Broadview Blvd. The speaker will be Bill Kopar of Kopar Honey Farm. Reservations required. Reservations: alleghenyvalleylibrary.org.

May 18: Community Library of Allegheny Valley, 1522 Broadview Blvd. will offer a program, Gardening with Native Plants, at 5:30 p.m. at the library and online. Julie Travaglini of the Allegheny Land Trust will be the speaker. Reservations required. Reservations: alleghenyvalleylibrary.org.

May 21: Harrison Township Recreation board is seeking owners of commercial and non-commercial vehicles to participate in its third annual touch-a-truck event planned at Highlands High School, Natrona Heights. Details: Natalie Cale, 724-448-6588 or nmcajka@yahoo.com.

Jefferson

Tuesday: Saxonburg Goldenagers will meet at noon at the Veterans of Foreign Wars, Dinnerbell Road. Lunch will be served and entertainment will be afterward. New members welcome.

Kiski Township

May 21: Kiski Township Volunteer Fire Department will host a parking lot bingo at 5 p.m. at the firehall, 1037 Route 66. Gates open at 4 p.m. Cost: $15 per person, includes supplies. Only 125 spots available. Reservations: Morgan, 724-466-2812, or Megan, 724-575-2473.

Kittanning

Sundays and Thursdays Armstrong County Historical Museum, 330 N. McKean St., will be open from 1 to 3 p.m. Other hours available by appointment. Free parking available behind the museum via the North Grant Avenue entrance. Details: 724-548-5707 or achgs300@gmail.com.

Leechburg

Today: Leechburg Volunteer Fire Company will host bingo at 7 p.m. at the firehall, 268 Canal St. Doors open at 5 p.m. The kitchen will be open.

Today: Leechburg Public Library Board of Directors will meet at 6:30 p.m. at the library, 137 Market St. Public welcome.

Today: The Leechburg Area Museum and Historical Society, 118 First St., is closed and will reopen for summer on May 28. To arrange a private tour, email lamahs@windstream.net or call 724-845-8914 and leave a message.

Lower Burrell

Today: Alle-Kiski Multiple Sclerosis Support Group will meet at 7 p.m. in Faith Hall of Puckety Presbyterian Church, 1009 Puckety Church Road. Chiropractor Dr. Misty OToole will discuss stem cell therapies. New members welcome. Details: Mary, 724-337-7133, or Carol, 724-335-7136.

Saturday: Church of God is accepting space reservations for a parking lot treasures sale set for 8 a.m. to 2 p.m. at the church, 273 Chester Dr. Rain date: May 21. Reservations and details: 724-335-4422 or lbcog@hotmail.com.

Saturday: The annual Animal Protectors Hearts for Strays spring luncheon will be at 11:30 a.m. at Hill Crest Country Club. Doors open at 10 a.m. There will be a basket raffle, door prizes, card games and a 50/50 raffle. Cost: $30. Reservations: jlessig@animalprotectors.net or the events tab at animalprotectors.net.

May 28 to Oct. 8: The Lower Burrell Farmers Market is seeking vendors for the upcoming season. Markets are from 9 a.m. to 1 p.m. Saturdays at 2800 Bethel St. Setup begins at 8 a.m. Cost: $40 for the season and free electric is available. Merchandise must be home grown, homemade or hand crafted. Vendors must participate the whole season. Details: TimPamKey@yahoo.com.

Manor

Tuesday: An American Red Cross Blood community blood drive will be from 11 a.m. to 4 p.m. at Manor Township Volunteer Firehall, 167 Byron St., McGrann. Appointments: 800-733-2767 or visit redcrossblood.org and search for manortwpvfc.

Saturday : The Pa. Fish and Boat Commission will offer a Basic Boating Course from 8 a.m. to 4 p.m. at the Armstrong County Fire School, 1999 Route 66. Upon successful completion, students will be able to apply to the state with $10 and the proper paperwork for their Pa. Boating Safety Certificate with the state Fish Commission. Those attending should bring a bagged lunch, paper and pen. Reservation deadline: May 6. Reservations: email name, address and telephone number to jeburns@co.armstrong.pa.us.

McCandless

Wednesday: The Sealarks Womens Group will meet at 1 p.m. at Memorial Park Church, 8800 Peebles Road. The group provides Christian fellowship and social activity for women who are widowed, divorced or never married. Sandy Ritchey and her dog Wendell will present a program about therapy dogs. New members and guests welcome. Details and reservations: 412-487-7194.

New Kensington

Tuesday: The Community Clothes Closet, 1129 Kenneth Ave., will be open from 11 a.m. to 1 p.m. today and noon to 2 p.m. Tuesday. Note the change in days and times. Items available include clothing, shoes, purses, linens, blankets and Mary Queen of Apostles School uniforms. Donations are accepted during open hours.

Saturday : Vendor applications are being accepted by Knead Community Caf for an outdoor Mother Natures Garden Market at the caf. Items must be natural of plant-based products or garden related. No hot food vendors. Rain or shine. Details and applications: kneadcommunitycafe.org/vendorapplication.

May 17: East Kensington Community Circle is accepting orders for its Election Day beef vegetable soup sale. Cost: $8 per quart. Pickup: May 17 at the Community Circle Building, 1785 Seventh St. Road. Advance orders strongly recommended. Orders: Judy, 724-339-7887.

May 18: St. George Orthodox Church is accepting orders for a kibbee sale. Cost: $50 per dozen or six for $27. Order deadline: Wednesday. Pickup: 12:30 to 2:30 p.m. May 18 in the church hall, 1150 Leishman Ave. Orders: 724-337-3918.

North Apollo

May 21: North Apollo Volunteer Fire Department is accepting vendor applications for a crafter, vendor and food truck event planned at the firehall, 311 16th St. Applications: kingal0103@gmail.com or rachelann1975@yahoo.com.

Oakmont

Tuesdays: Taking Pounds Off Sensibly (TOPS) meets at 6 p.m. at Oakmont United Methodist Church, 419 Maryland Ave. Monthly dues: $5; first meeting is free. Details: vrevilla@pointpark.edu.

Plum

May 18: Plum Community Library will offer a free screening of the movie, Encanto, at 6 p.m. at the library, 445 Center New Texas Road. Reservations required. Reservations: visit the calendar section at plumlibrary.org.

May 19: The SOS Ministry at Holy Family Parish , 2000 Oblock Road, will offer a free program, What My Family Should Know, at 1 p.m. in the Our Lady of Joy Church hall. Attorney Jake Noble will discuss legal documents and papers you should have in place for your family. Reservations required. Reservations: 412-793-4511, ext. 107 or sos@holyfamilypgh.org.

Springdale

Wednesday and Thursday:Springdale Free Public Library will sponsor a plant exchange at 6 p.m. at the library, 331 School St. Bring your extra plants and exchange them with others. Details: 724-274-9729.

May 18: Springdale Free Public Library will offer a craft workshop to make a Memorial Day Mason jar candle at 1 p.m. at the library, 331 School St. Reservations required. Reservations: 724-274-9729.

Tarentum

Tuesday: Alcoholics Anonymous will meet from 7 to 8 p.m. at Central Presbyterian Church, 305 Allegheny St. An opportunity for silent prayer will be at 6:30 p.m.

Wednesday: The Elks will host bingo at 7 p.m. at the lodge, 219 E. Sixth Ave. The kitchen is open to the public from 5 to 8:30 p.m. Wednesdays, Thursdays and Fridays. Menu: elks644.org/elks-kitchen-1. Orders: 724-226-1644 by 8:15 p.m.

Vandergrift

Tuesday: A Board Game Night for students who are at least in fourth grade will be from 5:30 to 7:30 p.m. at the library, 128C. Washington Ave. All skill levels welcome. Details: 724-568-2212.

Tuesday: The YoYos Needles Art group at Vandergrift Public Library will meet from 5:30 to 7 p.m. in the library reading room, 128C. Washington Ave. All skill levels welcome. Details: 724-568-2212.

Wednesday : Vandergrift Public Library will have a free Toddler Time for children 4 and younger at 11 a.m. at the library, 128C Washington Ave. Reservations required. Reservations: 724-568-2212.

May 21: Vandergrift Presbyterian Church is accepting donations for a rummage sale. Hours: 9 a.m. to noon Mondays through Thursdays at the church, 195 Washington Ave. Please no televisions, furniture, computers or suitcases without wheels.

Washington Township

Wednesday: Poke Run Presbyterian Church will have a free soup luncheon at noon at the church, 1091 Poke Run Church Road. Doors open at 11:30 a.m. Details: 724-327-5563.

Wednesday: Alcoholics Anonymous will meet at 6 p.m. at Union Presbyterian Church, 656 Route 380.

West Deer

Wednesday: East Union Presbyterian Church will have a takeout spaghetti dinner from 4 to 7 p.m. at the church, 292 East Union Road. Menu: spaghetti with choice of meat, meatball or mushroom sauce, salad, rolls and dessert. Donations will be accepted. Details: 724-265-1381.

May 19: Union Presbyterian Church, 656 Route 380, is accepting orders for a hoagie sale. Cost: $8. Order deadline: Sunday. Pickup: 10:30 a.m. to 2 p.m. May 19 at the back of the church. Orders: 412-398-7603.

Read more from the original source:
The Stroller, May 9, 2022: Events in the Alle-Kiski Valley - TribLIVE

SAN DIEGO, Calif., SUZHOU and SHANGHAI, China , May 12, 2022 /PRNewswire/ -- Gracell Biotechnologies Inc. ("Gracell" or the "Company",NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, today announced the details of three abstracts that it will present at the European Hematology Association 2022 Hybrid Congress (EHA2022 Congress), being held from June 9 June 12 in Vienna, Austria. The abstracts highlight the clinical data from ongoing investigator-initiated trials (IITs) of BCMA/CD19 dual-targeting FasTCAR candidate GC012F in two indications of B-cell non-hodgkin's lymphoma (B-NHL) and relapsed/refractory multiple myeloma (RRMM), and allogeneic TruUCAR candidate GC502 in B-cell acute lymphoblastic leukemia (B-ALL).

"We are very excited to share our data for both our FasTCAR candidate GC012F in two indications of RRMM and B-NHL, and allogeneic TruUCAR candidate GC502 in B-ALL at the EHA2022 Congress," said Dr. Martina Sersch, Chief Medical Officer of Gracell. "The new data, including the expanded indication of GC012F into B-NHL, demonstrates the potential of our platforms and provides further validation. The clinical data of BCMA/CD19 dual-targeting GC012F in the treatment of B-NHL shows promising early results, along with benefits of the next-day manufacturing enabled by the FasTCAR platform. The CD19/CD7 dual-directed CAR-T therapy GC502 is our second allogeneic candidate on our TruUCAR platform, demonstrating the potential wide applicability of the TruUCAR design."

BCMA/CD19 Dual-Targeting FasTCAR-T GC012F for the Treatment of B-NHL

GC012F is an autologous CAR-T therapeutic candidate dual-targeting B cell maturation antigen (BCMA) and CD19. It is developed using Gracell's proprietary FasTCAR platform which enables next-day manufacturing, and is currently being evaluated in IITs in China including in RRMM and B-NHL. GC012F is the first BCMA/CD19 dual-targeting CAR-T in human trials for B-NHL.

Gracell will present the early results of the first-in-human phase 1 IIT in China evaluating the safety and tolerability of GC012F in B-NHL patients. Three patients who had received a median of two prior lines of therapy were enrolled, all of which presented with bulky disease. As of the February 22, 2022 data cutoff date, the enrolled patients had received one single infusion of GC012F at three different doses of 3.7x104 cells/kg and 2-3x105 cells/kg.

All three patients had achieved a complete response (CR) confirmed by PET- CT at day 28 after GC012F infusion. At 3-month follow-up, both of the two assessable patients had ongoing response. No dose-limiting toxicities were observed and no immune effector cell-associated neurotoxicity syndrome (ICANS) were observed. CRS presented as Grade 1 in two patients and Grade 3 in one patient (duration of two days) with no Grade 4 or 5 events.

Details of the presentation are as follows:

BCMA/CD19 Dual-Targeting FasTCAR-T GC012F for the Treatment of RRMM

Gracell will also present as an oral abstract presentation the updated results from the first-in-human IIT evaluating GC012F for the treatment of RRMM patients. This data is currently under embargo and will be published on the EHA2022 Hybrid Congress website on Thursday, May 26 concurrently with ASCO.

Details of the presentation are as follows:

CD19/CD7 Dual-directed Allogeneic TruUCAR-T GC502 for the Treatment of B-ALL

GC502 leverages the novel dual-directed CAR design of Gracell's proprietary TruUCAR platform, designed to generate high-quality allogeneic CAR-T cell therapies that can be administered "off-the-shelf" at lower cost and with faster patient's access. TruUCAR-enabled GC502 utilizes the dual-directed CAR design with one CAR targeting CD19 on malignant cells and a second CAR targeting CD7 to suppress host-versus-graft rejection. An enhancer molecule is embedded in the basic construct of TruUCAR to enhance proliferation of TruUCAR T cells.

Between September 2021 and January 2022, four r/r B-ALL patients were enrolled and treated in an open-label, non-randomized, prospective IIT in China in two different dose levels and with two different formulations. Patients were heavily pretreated, and all had previously received either autologous or donor derived CD19 or CD19/CD22 targeted CAR-T therapy. As of the January 28, 2022 data cutoff date, all four patients had received a single dose of GC502, including one patient at dose level 1 (DL1) 1.0x107 cells/kg and three patients at dose level 2 (DL2) 1.5x107 cells/kg. Patients received a Flu/Cy based lymphodepletion regimen prior to treatment with GC502.

Three of four patients achieved minimal residual disease negative complete response or complete response with incomplete count recovery (MRD- CR/CRi), and one patient achieved a partial response at month one and subsequently received allogeneic hematopoietic stem-cell transplantation (allo-HSCT) on day 39.

Cytokine release syndrome (CRS) presented as Grade 2 and Grade 3 with no Grade 4 or 5 events. No immune effector cell-associated neurotoxicity syndrome (ICANS) or acute graft-versus-host disease (aGvHD) were observed.

Details of the presentation are as follows:

For more information about the EHA2022 Hybrid Congress, visit http://www.ehaweb.org.

About GC012F

GC012F is a FasTCAR-enabled dual-targeting CAR-T product candidate that is currently being evaluated in IIT studies in China for the treatment of multiple myeloma and B-cell non-Hodgkin's lymphoma. GC012F simultaneously targets CD19 and BCMA to drive fast, deep and durable responses, which can potentially improve efficacy and reduce relapse in multiple myeloma and B-NHL patients.

About B-NHL

Non-Hodgkin's lymphoma (NHL) is a group of blood cancers that developed from lymphocytes, most commonly derived from B cells (B-NHL). Globally, approximately 510,000 patients are diagnosed with NHL every year with about 80,470 patients expected to be diagnosed with NHL in the United States in 2022[1]. B-NHL accounts for approximately 85% of NHL diagnoses.

[1] Data source: American Cancer Society

About GC502

GC502 is a TruUCAR-enabled CD19/CD7 dual-directed, off-the-shelf allogeneic CAR-T product candidate that is being studied in an ongoing Phase 1 IIT in China for the treatment of B-cell malignancies. GC502 is manufactured using T cells from non-human leukocyte antigen (HLA) matched healthy donors. An enhancer molecule is embedded in the basic construct of TruUCAR to enhance proliferation of TruUCAR T cells. Optimized for CD19/CD7 dual-CAR functionality and in vivo durability, GC502 has demonstrated robust anti-tumor effects with potential to suppress host versus graft (HvG) rejection in preclinical models.

About B-ALL

Acute lymphoblastic leukemia (ALL) is a type of blood cancer characterized by proliferation of immature lymphocytes in the bone marrow, which can involve either T lymphocytes (T-ALL), or B lymphocytes (B-ALL). Globally, approximately 64,000 patients are diagnosed with ALL every year with an estimated 6,660 new cases to be diagnosed in the United States in 2022[2]. B-ALL accounts for 75% of ALL diagnoses in adults.

[2] Data source: American Cancer Society

About FasTCAR

CAR-T cells manufactured on Gracell's proprietary FasTCAR platform appear younger, less exhausted and show enhanced proliferation, persistence, bone marrow migration and tumor cell clearance activities as demonstrated in preclinical studies. With next day manufacturing, FasTCAR is able to significantly improve cell production efficiency which may result in meaningful cost savings, and, together with fast turnaround time, enables enhanced accessibility of cell therapies for cancer patients.

About TruUCAR

TruUCAR is Gracell's proprietary technology platform and is designed to generate CAR-T cell therapies from high quality allogeneic T cells that can be administered "off-the-shelf" at lower cost and with improved accessibility of cell therapies for cancer patients. With differentiated design enabled by gene editing, TruUCAR is designed to control HvG as well as GvHD without the need for being co-administered with additional strong immunosuppressant after conventional lymphodepletion. The novel dual-CAR design allows tumor antigen-CAR moiety to target malignant cells, while the CD7 CAR moiety is designed to suppress rejection (HvG response) of allogeneic CAR-T cells by host T and NK cells (HvG).

About Gracell

Gracell Biotechnologies Inc.("Gracell") is a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies. Leveraging its pioneering FasTCAR and TruUCAR technology platforms and SMART CARTMtechnology module, Gracell is developing a rich clinical-stage pipeline of multiple autologous and allogeneic product candidates with the potential to overcome major industry challenges that persist with conventional CAR-T therapies, including lengthy manufacturing time, suboptimal cell quality, high therapy cost, and lack of effective CAR-T therapies for solid tumors. For more information on Gracell, please visit http://www.gracellbio.com.Follow @GracellBio on LinkedIn.

Cautionary Noted Regarding Forward-Looking Statements

Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the expected trading commencement and closing date of the offering. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including factors discussed in the section entitled "Risk Factors" in Gracell's most recent annual report on Form 20-F as well as discussions of potential risks, uncertainties, and other important factors in Gracell's subsequent filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Gracell specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Readers should not rely upon the information on this page as current or accurate after its publication date.

Media contacts

Marvin Tang[emailprotected]

Kyle Evans[emailprotected]

Investor contacts

Gracie Tong[emailprotected]

Stephanie Carrington[emailprotected]

SOURCE Gracell Biotechnologies Inc.

Continue reading here:
Gracell Biotechnologies to Present Clinical Data on BCMA/CD19 Dual-targeting CAR-T GC012F in RRMM and B-NHL and CD19/CD7 Dual-directed Allogeneic...

German medicine is associated with high quality and reliability, and this explains the desire of foreign patients to undergo examination and therapy in German hospitals, especially when it comes to the complex pathologies and receiving qualified medical help. As a consequence, one of the most sought-after areas of medical tourism is treatment in Germany.

Why go to Germany for treatment?

For people whose lives depend on the quality of medical services, Germany is an excellent option. The countrys health care and medical education systems receive huge investments. High-quality medical care is available in more than 2,500 German hospitals and approximately 1,400 rehabilitation centers. More than 145,000 doctors treat patients in Germany.

All university hospitals in the country participate in international scientific research. At the same time, German legislation clearly regulates all prices and treatment protocols. The cost of treatment, even at the highest level, is within limits defined by the government policy.

The treatment of any disease in Germany begins with an examination. Modern medicine can cure many diseases, but only if they are detected timely. Therefore, check-up programs are top-rated in German hospitals. People often come to Germany to undergo examination for suspected oncology, autoimmune conditions, neurological disorders, etc.

Feel free to visit the Booking Health website to know more about treatment in Germany.

Cancer treatment in Germany

Like no other field of medicine, oncology is developing at a rapid pace. Cancer is no longer an incurable disease and imminent death. Treatment methods are becoming more and more complex and require highly qualified doctors. Only with an accurate examination and selection of the appropriate therapy cancer can be successfully treated and, in some cases, even cured. Cancer treatment and general medical care in Germany are undeniably at the highest level and have gained worldwide recognition.

Cancer treatment in Germany is carried out by interdisciplinary tumor boards. Doctors of several specialties work together to help the patient.

First of all, comprehensive examination is performed to confirm the diagnosis, including MRI/CT/PET-CT scans, scintigraphy, blood tests for tumor markers, and biopsy.

Results are ready pretty quickly, and a further treatment scheme is developed. It may consist of the following components:

One of the essential features of surgical interventions in Germany is wide usage of minimally invasive methods. Endoscopic and robot-assisted surgeries are connected with minimal trauma of healthy tissues and short hospital stay. They arent accompanied by pain or other side effects, and are well-tolerated by patients.

Going to Germany for treatment during a lockdown

Undoubtedly, medical tourism in Germany has changed due to the COVID-19 pandemic. However, its successfully adjusted to the current requirements offering foreign patients the opportunity to undergo medical treatment in Germany during a lockdown.

The medical tourism provider Booking Health will readily assist you with examinations, consultations, and treatment by leading specialists in any medical field. Booking Health will organize treatment during a lockdown, taking upon paperwork, negotiations with hospitals, issuing a medical visa, translating your documents, providing insurance from complications and cost of treatment guarantee, etc. The company cooperates with the leading university and academic hospitals in Germany.

On the Booking Health website you will find reliable information about German medicine and the treatment of various diseases. If you want to start treatment in German hospitals, go ahead and leave a request with basic medical information so that a specialist can contact you and answer your questions.

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Principles of Treatment in Germany - 100 Mile Free Press

Abstract: Glucose metabolism has been the focus of research in order to understand pathological conditions associated with diseases such as neonatal hypoxic-ischemic-encephalopathy (HIE), cerebral palsy (CP) and cerebral infarction.

Objective:To evaluate the use of molecular imaging (SPECT and PET) for children with HIE and CP before and after cell therapy, and to propose future perspectives on the use of those modalities for assessment of brain function in children with these conditions.

Methods:PubMed search for studies using PET or SPECT scans for HIE and CP in children.

Results:We identified 18 PET and 17 SPECT studies that have been performed in cases under age of 19 over the past three decades (19912021). Six papers on PET use consisted of one with human umbilical cord derived mesenchymal stromal cells, one mobilized peripheral blood mononuclear cells, three autologous bone marrow mononuclear cells and one allogeneic umbilical cord blood. 4/6 papers reported that PET-CT scan revealed increased glucose metabolism and 1/6 showed no significant change in glucose metabolism after cell therapy. One article on SPECT reported that 2/5 cases had improvement of cerebral perfusion in the thalamus after treatment.

Discussion:SPECT in the first few weeks of life is useful and more sensitive than MRI in predicting major neurological disability. SPECT is not appropriate for neonates because of the risk of radiation, improvement of other clinical test equipment. PET studies reported high glucose metabolism in the early neonatal periods in children with mild to moderate HIE, but not in the most severe cases, including those neonates that died.We suggested that PET could be more useful tool to estimate effectiveness of stem cell therapy than SPECT.

Conclusion:PET might be a good clinical modalities to clarify mechanism of stem cell therapy for CP. We need further clinical studies to clarify more precisely.

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Molecular Imaging (PET and SPECT) for Children with Hypoxic-ischemic-encephalopathy and Cerebral Palsy before and after cell therapy - Newswise