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."

On September 13, 2022 The University of Texas MD Anderson Cancer Center (‘MD Anderson’) and Radiopharm Theranostics Limited (‘Radiopharm’)(ASX: RAD) reported the launch of Radiopharm Ventures, LLC, a joint venture company created to develop novel radiopharmaceutical therapeutic products for cancer (Press release, MD Anderson, SEP 13, 2022, View Source [SID1234619516]).

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Radiopharm Ventures brings together MD Anderson’s innovative and proprietary technologies in antigen discovery and molecular imaging with Radiopharm’s expertise in developing radiopharmaceutical products. The joint venture will focus initially on developing at least four therapeutic products based on MD Anderson intellectual property.

"Radiopharmaceuticals continue to be rapidly developed as a highly promising therapeutic frontier in oncology," said Riccardo Canevari, chief executive officer at Radiopharm. "We are pleased to have this opportunity to collaborate with MD Anderson and its tremendous scientists as we work to make significant in-roads into cancer therapy for the benefit of patients."

Radiopharmaceuticals are designed to deliver small doses of radiation to specifically targeted cells for either therapeutic or diagnostic purposes. Effective cancer radiopharmaceuticals require tumor-specific targets not found in healthy tissue. MD Anderson researchers have established novel platforms to discover and validate tumor specific antigens, offering promising candidates for the development of new radiopharmaceuticals.

The first potential therapeutic candidate is a humanized immunoglobulin G (IgG) antibody against the tumor-specific antigen B7-H3, also known as CD276, which is highly expressed in several common tumors but not in healthy cells. The antibody was developed in the laboratory of David Piwnica-Worms, M.D., Ph.D., chair of Cancer Systems Imaging at MD Anderson. Pre-clinical studies suggest the candidate radiotherapeutic antibody is effective in eliminating resistant colorectal cancers in laboratory models.

"Based on our early pre-clinical data, B7-H3 represents a promising radiotherapeutic target, and we look forward to having the opportunity to work with the team at Radiopharm with the goal of advancing our therapeutic candidate toward future clinical studies," Piwnica-Worms said.

In addition, the work of Samir Hanash, M.D., Ph.D., professor of Clinical Cancer Prevention at MD Anderson, has resulted in extensive characterization of the cancer surfaceome ­- the catalogue of proteins found specifically on the surface of cancer cells across cancer types – resulting in novel targets with cancer-restricted expression. Radiopharm Ventures has an opportunity to select additional targets from this dataset and plans to prioritize selection based on unmet needs in oncology.

"The cancer surfaceome holds a wealth of information about antigens restricted to cancer," Hanash said. "Mining the data, generated at the petabyte level, has uncovered many compelling targets that have not previously been explored, and we are pleased for the opportunity to collaborate with Radiopharm in developing innovative new treatment options for some targets."

Once targets have been selected, Radiopharm will collaborate with Hanash and Piwnica-Worms at MD Anderson to advance preclinical development of potential therapeutic candidates.

On September 13, 2022 Syros Pharmaceuticals, Inc. (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to SY-5609 for the treatment of pancreatic cancer (Press release, Syros Pharmaceuticals, SEP 13, 2022, View Source [SID1234619515]). SY-5609, a highly selective and potent oral cyclin-dependent kinase 7 (CDK7) inhibitor, is currently being evaluated in combination with chemotherapy for the treatment of patients with relapsed metastatic pancreatic cancer.

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"This orphan drug designation underscores the urgency of our efforts to develop SY-5609 for patients with pancreatic cancer, one of the most devastating and difficult to treat malignancies," said David A. Roth, M.D., Chief Medical Officer of Syros. "Based on the early data we reported last year, which demonstrated single-agent activity in heavily pre-treated patients, as well as compelling preclinical data and a strong mechanistic rationale, we believe SY-5609 could deliver meaningful benefit to people with pancreatic cancer, whose tumors have otherwise eluded therapeutic intervention. We look forward to sharing initial data from the safety lead-in portion of our ongoing Phase 1 study later this year."

The FDA’s Office of Orphan Drug Products grants orphan status to support development of medicines for the treatment of rare diseases that affect fewer than 200,000 people in the United States. Orphan drug designation may provide certain benefits, including a seven-year period of market exclusivity if the drug is approved, tax credits for qualified clinical trials and an exemption from FDA application fees.

Syros’ ongoing Phase 1 trial is evaluating SY-5609 in combination with chemotherapy in pancreatic cancer patients who have progressed following treatment with FOLFIRINOX. Patients were randomized to receive either SY-5609 in combination with gemcitabine, or SY-5609 in combination with gemcitabine and nab-paclitaxel, at the approved doses of the combination agents. The study is assessing safety and tolerability, as well as efficacy measures such as disease control rate and progression free survival. Safety and clinical activity data from the safety lead-in portion of the trial are expected in the second half of 2022.

Under an existing clinical supply agreement with Roche, Syros is also supplying SY-5609 for a combination dosing cohort in Roche’s ongoing Phase 1/1b INTRINSIC trial. This cohort is evaluating the combination of SY-5609 and atezolizumab in patients with BRAF-mutant colorectal cancer. Roche is the sponsor of the INTRINSIC trial.