On January 6, 2023 Purple biotech presented its corporate presentation (Presentation, Purple Biotech, JAN 6, 2023, View Source [SID1234625978]).

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On January 6, 2023 Precision BioSciences (Nasdaq: DTIL), a clinical stage gene editing company developing ARCUS-based ex vivo allogeneic CAR T and in vivo gene editing therapies, reported that the U.S. Food and Drug Administration (FDA) provided supportive Type C feedback on the Company’s CMC processes and analytical methods for azercabtagene zapreleucel (azer-cel; PBCAR0191) (Press release, Precision Biosciences, JAN 6, 2023, View Source [SID1234625977]). Azer-cel is Precision BioSciences lead allogeneic CAR T candidate being evaluated for relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL) in subjects who have relapsed following autologous CAR T treatment.

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"We are pleased with the FDA feedback on key components of our planned CMC package to support azer-cel ongoing development. The responses to questions regarding our analytical methods, proposed potency assays, and manufacturing processes are aligned with our expectations and help guide our plans," said Karl Whitney, Vice President and Head of Regulatory Affairs at Precision BioSciences. "We appreciate the FDA’s input and look forward to continuing regulatory engagement at critical points along our development horizon."

"We look forward to continuing enrollment in the ongoing Phase 1/2a trial and working closely with the FDA as we pursue development of azer-cel. Azer-cel has the potential to become the first allogeneic CAR T therapy to reach the market," said Alan List, M.D., Chief Medical Officer at Precision BioSciences. "There are currently no FDA-approved allogeneic CAR T products to address the high unmet need of the CAR T relapsed or refractory patient population. While autologous CAR T therapy is a promising treatment option for hematological malignancies, up to 60% of high-grade NHL patients relapse after treatment and up to 20% of intended auto-CAR T patients never receive treatment due to inability to manufacture the CAR T product. An effective off-the-shelf allogeneic CAR T treatment has the potential to offer clinical benefit to this growing population of lymphoma patients."

On January 6, 2023 Portage Biotech presented its corporate presentation (Presentation, Portage Biotech, JAN 6, 2023, View Source [SID1234625976]).

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On January 6, 2023 Phio Pharmaceuticals (Nasdaq: PHIO), a clinical stage biotechnology company whose proprietary INTASYL RNAi platform technology is designed to make immune cells more effective in killing tumor cells, reported that its Principal Executive Officer and Executive Chairman, Robert Bitterman, will be a featured speaker at the Entrepreneurial Showcase at the Dermatology Summit in San Francisco on January 8th (Press release, Phio Pharmaceuticals, JAN 6, 2023, View Source [SID1234625974]). The Dermatology Summit is taking place at the Hyatt Regency, alongside the annual JPMorgan Healthcare Conference.

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Mr. Bitterman will discuss innovations in dermatological cancers, highlighting Phio’s proprietary INASTYL platform. INTASYL is the only self-delivering RNAi technology focused on immuno-oncology therapeutics.

Mr. Bitterman was recently appointed to his leadership role at Phio. He previously led Cutanea and Dermik in the development and commercialization of small molecule dermatological products.

On January 6, 2023 Phio Pharmaceuticals Corp. (Nasdaq: PHIO) reported their clinical development partner, AgonOx, Inc. has received confirmation from the FDA that their planned Phase 1 clinical trial in patients with advanced solid tumors may proceed (Press release, Phio Pharmaceuticals, JAN 6, 2023, View Source [SID1234625973]). The initial Phase 1 clinical trial is designed to assess safety and to study the potential for an enhanced therapeutic benefit from the administration of Phio’s PH-762 treated "double positive" (DP) CD8 tumor infiltrating lymphocyte (TIL) in patients with melanoma and other advanced solid tumors.

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Phio is a clinical stage biotechnology company whose proprietary INTASYL RNAi technology is designed to make immune cells more effective in killing tumor cells. Phio’s PH-762 is an INTASYL compound that reduces the expression of PD-1, a protein that inhibits T cells’ ability to kill cancer cells. By decreasing PD-1 expression, the T cells have increased capacity to kill cancer cells.

AgonOx, in collaboration with the Earle A. Chiles Research Institute, a division of Providence Cancer Institute of Oregon, has shown that DP CD8 T cells sorted from human solid tumors (AGX148) are highly enriched for tumor-reactivity leading to increased tumor killing when compared to the other CD8 tumor infiltrating lymphocyte (TIL) subsets.

Preclinical data from in-vitro studies using autologous human tumor cells demonstrated that treating AGX148 with Phio’s PH-762 increased by two-fold their tumor killing activity. The trial will be conducted at Providence under the leadership of Dr. Weinberg and Principal Investigator Brendan Curti, MD, Medical Oncologist and Robert W. Franz Endowed Chair for Clinical Research.

"We’re pleased to have reached this important milestone in our collaboration with AgonOx and Providence Cancer Institute to develop improved cell therapies for cancer patients," said Robert Bitterman, Phio’s Principal Executive Officer and Executive Chairman.

"This bench to bedside research has the potential to help patients with solid malignancies and this is the first step to bringing this therapy to patients," said Andrew Weinberg, PhD, Founder and Chief Scientific Officer at AgonOx, Inc. and Research Scientist/Judy Hartmann Endowed Chair at Providence.