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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.