On September 13, 2022 I-Mab (the "Company") ( Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development, and commercialization of novel biologics, reported that it has successfully completed an End-of-Phase 2 (EoP2) meeting with the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA), and has obtained approval from the CDE to initiate a Phase 3 registrational trial evaluating lemzoparlimab, a novel CD47 antibody, in combination with azacitidine (AZA) for the first-line treatment of patients with newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS) (Press release, I-Mab Biopharma, SEP 13, 2022, View Source [SID1234619521]). The outcome of the EoP2 meeting supports the advancement of lemzoparlimab into Phase 3 study for a potential biologic license application (BLA) submission. The Company is on track to initiate the study as planned.

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The EoP2 meeting was supported by encouraging results from the Phase 2 clinical trial evaluating lemzoparlimab in combination with AZA in patients with newly diagnosed HR-MDS (NCT04202003). The top-line efficacy data demonstrated that lemzoparlimab combined with AZA showed encouraging clinical response in HR-MDS patients. Results also showed that lemzoparlimab combined with AZA can be safely administered without the need of a priming dose. The full results were reported in a proffered paper presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022 on September 10, 2022.

"We are pleased by the constructive feedback from the CDE, which has given us the greenlight to initiate the Phase 3 trial with lemzoparlimab for HR-MDS, a difficult-to-treat disease with high unmet medical need in this patient population with few treatment options," said Dr. Andrew Zhu, President of I-Mab. "We look forward to initiating our Phase 3 study to support a planned BLA submission in China for lemzoparlimab with the goal of providing a novel therapeutic option for patients suffering from this disease."

About CD47 and Lemzoparlimab

CD47 is a cell surface protein over-expressed in a wide variety of cancers and can act to protect tumors by delivering a "don’t eat me" signal to otherwise tumor-engulfing macrophages. CD47 antibody blocks this signal and enables macrophages to attack tumor cells. However, development of CD47 antibody as a cancer therapy has been hampered by its hematologic side effects, such as severe anemia, caused by natural binding of CD47 antibody to red blood cells. Scientists at I-Mab discovered a novel CD47 antibody, lemzoparlimab, that is designed to target tumor cells while exerting a minimal untoward effect on red blood cells.

Multiple clinical studies of lemzoparlimab are ongoing to explore indications in treating patients with myelodysplastic syndrome (MDS), acute myelocytic leukemia (AML), non-Hodgkin’s lymphoma (NHL), and advanced solid tumors in combination with chemotherapy and immune checkpoint inhibitors.

On September 13, 2022 Strata Oncology, Inc. a next-generation precision oncology company enabling smarter and earlier cancer treatment, reported expansion of its clinical collaboration with Pfizer ( NYSE: PFE) in the Strata Precision Indications for Approved THerapies (Strata PATHTM) trial (Press release, Strata Oncology, SEP 13, 2022, View Source [SID1234619520]). Strata PATH is a prospective pan-tumor therapeutic trial designed to evaluate the efficacy and safety of multiple FDA-approved cancer therapies in new, biomarker-guided patient populations. Pfizer will provide Braftovi (encorafenib), Mektovi (binimetinib), and Lorbrena (lorlatinib) for up to six new cohorts of patients with early-stage lung, melanoma, colorectal, and other cancers who have evidence of micrometastatic disease after initial treatment. Pfizer is already providing Strata with Braftovi (encorafenib), Mektovi (binimetinib), Lorbrena (lorlatinib), Talzenna (talazoparib), and Inlyta (axitinib) for evaluation in four late-stage cohorts of the Strata PATH trial.

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"The new cohorts of Strata PATH, supported by Pfizer, afford us a very exciting opportunity to move the advances we’ve seen in late-stage cancer into earlier stages of the disease," said Dan Rhodes, Ph.D., co-founder and Chief Executive Officer, Strata Oncology. "Our goal is to deliver smarter and earlier treatment to every patient and having the support of Pfizer is a testament to the potential of the clinical trials that we are using to accelerate the impact of precision oncology."

Many of the patients for the new micrometastatic cohorts of Strata PATH will be identified through the Strata SentinelTM trial, a 100,000-patient, prospective, observational, pan-solid tumor study of Strata Oncology’s highly sensitive, tumor-informed circulating tumor DNA (ctDNA)-based MRD test. An advanced molecular therapy selection profile is created simultaneously for every patient assessed with the MRD test. This enables rapid identification of clinical trial opportunities, including Strata PATH, for patients who are positive for ctDNA.

About Strata PATH
The Strata Precision Indications for Approved THerapies (Strata PATH) trial, is a 700-patient prospective pan-tumor therapeutic trial designed to evaluate the efficacy and safety of multiple FDA-approved cancer therapies in new, biomarker-guided patient populations. Strata PATH will enroll patients with advanced cancer, as well as patients with early-stage cancer who have evidence of micrometastatic disease after initial treatment. All therapies being evaluated in Strata PATH are FDA-approved in oncology with demonstrated safety profiles in the advanced setting. Enrollment for multiple arms in Stata PATH is based on novel quantitative RNA and multivariate algorithms Strata Oncology developed using its clinical molecular database comprising DNA mutation profiles and quantitative RNA expression data from tens of thousands of patients coupled with detailed treatment history and outcomes data. A range of therapeutic classes will be evaluated in Strata PATH including targeted therapies, antibody-drug conjugates, immunotherapies, and angiogenesis inhibitors.

On September 13, 2022 TC Biopharm (Holdings) PLC ("TC Biopharm" or the "Company") (NASDAQ: TCBP) (NASDAQ: TCBPW), a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer reported that it has received approval from the UK regulatory body MHRA to apply an 18-month extrapolated shelf life to its current allogeneic cell therapy product, OmnImmune (Press release, TC Biopharm, SEP 13, 2022, View Source [SID1234619519]).

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This award enables TC BioPharm to ship and store sufficient product which can then be held cryopreserved at clinical sites to fulfill the requirements not only for its current Advanced Myeloid Leukemia trial ACHIEVE, but also for future clinical trials and eventually commercial treatment of patients. Additionally, TC BioPharm’s in-house quality control department will continue to gather data in order to extend the shelf-life of OmnImmune.

"The approval received from the MHRA for our frozen product is another very important piece of a complex jigsaw. It is indeed a further step towards the achievement of a platform to deliver truly off-the-shelf products in the cell therapy space. This milestone is a result of an incredible concerted effort from all the departments within TCB, including Product Development, Quality Control and Assurance, Production and Clinical. It is an exciting time to be working in this sector and I feel incredibly privileged and proud to be part of this amazing team at TC Biopharm."

Bryan Kobel, CEO, commented, "This MHRA approval of our freeze/thawed protocol for an 18-month shelf life is an encouraging step forward in TC BioPharm’s developmental trajectory and further validation of the continuous effort and forward thinking of our development team. We are extremely pleased to receive MHRA approval for our Freeze/Thawed product, OmnImmune, the first freeze/thawed gamma delta product in clinical trials. Being able to ship frozen gamma-delta T cells and deliver them clinics all around the world for storage and use in clinical trials as well as commercial treatment increases our economies of scale and our efficiency."

"The approval received from the MHRA for our frozen product is another very important piece of a complex jigsaw," said Emilio Cosimo, Director of Product Development at TC BioPharm. "It is indeed a further step towards the achievement of a platform to deliver truly off-the-shelf products in the cell therapy space. This milestone is a result of an incredible concerted effort from all the departments within TCB, including Product Development, Quality Control and Assurance, Production and Clinical. It is an exciting time to be working in this sector and I feel incredibly privileged and proud to be part of this amazing team at TC Biopharm. "

Kobel continued, "This approval brings OmnImmune truly to the forefront as an "off the shelf" cell therapy, with the clinician’s ability to bring product from the storage facility to the specialty pharmacy for thawing and deliver the therapeutic to the patient in a short window of time. We look forward to progressing our clinical trials in AML as well as other blood cancers and continue to evaluate partnering opportunities for our allogeneic gamma delta platform and advance our modified CAR gamma delta program."

On September 13, 2022 AnBogen Therapeutics, a clinical-stage biotech company designing and developing precision oncology therapies to improve the life of patients, reported that U.S. Food and Drug Administration (FDA) has approved an investigational new drug (IND) protocol amendment for its phase Ib/II trial of ABT-101, an orally administered, irreversible, mutant selective tyrosine kinase inhibitor targeting oncogenic mutations of HER2 Exon20 insertion expressed in non-small cell lung cancer (NSCLC) (Press release, Anbogen Therapeutics, SEP 13, 2022, https://www.prnewswire.com/news-releases/anbogen-therapeutics-receives-approval-from-us-fda-for-phase-ibii-protocol-amendment-for-abt-101-301621795.html [SID1234619518]).

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"We are pleased to receive approval from the FDA on the protocol amendment, and continue to drive ABT-101 clinical development program forward. With the mission in mind, we want to make impact to transform the treatment for patients with non-small cell lung cancer harboring exon 20 insertions (e20i) in HER2," said John Tsu-An Hsu, Ph.D, Founder and Chief Executive Officer of Anbogen Therapeutics. "We look forward to working closely with FDA and all of our investigators as we enroll and dose the patients with non-small cell lung cancer (NSCLC). ABT-101 demonstrates excellent therapeutic potential and superior safety profile compared to competitors that are under clinical development, and it meets challenges of unmet medical needs for cancer drugs targeting exon 20 insertions (e20i) in HER2."

ABT-101

ABT-101 is a potent small molecule kinase inhibitor against several oncogenic kinases including epidermal growth factor receptor (EGFR), and human epidermal growth factor receptor 2 (HER2, also known as ERBB2). Approximately 10% to 12% of EGFR mutations and about 2% to 4 % of HER2 mutations in NSCLC are present in exon 20. Importantly, 90% of HER2 mutations in NSCLC are exon 20 mutations. It is estimated that the global annual patient population is greater than 56,000 who harbor HER2 exon insertion mutation. In the pre-clinical pharmacological studies, Anbogen has demonstrated that ABT-101 has superior selectivity against HER2 e20i mutation and significantly inhibits the growth of tumor harboring HER2-e20i.

On September 13, 2022 Regen BioPharma, Inc. (OTC PINK: RGBP) and (OTC PINK: RGBPP) reported initiation of a series of phased experiments to begin the process of moving its CAR-T cell de-differentiation approach through pre-clinical validation (Press release, Regen BioPharma, SEP 13, 2022, View Source;begins-experiments-validating-its-proprietary-car-t-cell-therapy-301623585.html [SID1234619517]). CAR-T cells are T cells (the lymphoid cells of the body that kill tumors) isolated from a cancer patient that have been modified by expressing a chimeric antigen receptor (CAR) which is specific for the patient’s tumor.

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While CAR-T cells are effective at treating certain lymphomas and leukemias, solid tumors such as liver, breast and colon remain resistant to CAR-T therapies for several reasons. One reason is "T cell exhaustion", a term that means the T cells that are initially recruited to the tumor to kill it end up losing their effectiveness. The company believes that NR2F6, a checkpoint that puts the brakes on T cell activity, is a key player in the T Cell exhaustion phenomenon. Inhibiting NR2F6 is expected to prevent these T cells from becoming dysfunctional.

The Company has engaged the contract research organization, ProMab Biotechnologies, Inc. of Richmond, California, to embark on a series of experiments using the Company’s proprietary shRNA NR2F6-inhibiting technology to validate this approach.

"We are extremely excited to be using our cutting-edge genetic approach to create long-lasting CAR-T cells," says David Koos, Chairman and CEO of the Company. "By partnering with a well-qualified organization such as ProMab Biotechnologies, Inc., we expect to quickly move this program forward to the clinic."