Bristol-Myers Squibb has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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On October 27, 2021 Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, reported that the Company will host a virtual event on Thursday, November 4, 2021 at 11:00 AM ET to provide an update on the progress for its clinical pipeline (Press release, Precigen, OCT 27, 2021, View Source [SID1234592124]).

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The event will showcase data from several of the Company’s most advanced clinical programs, such as PRGN-3005 UltraCAR-T, PRGN-3006 UltraCAR-T, PRGN-2009 OTS AdenoVerse Immunotherapy and PRGN-2012 OTS AdenoVerse Immunotherapy. Precigen executives and key opinion leaders will participate in the event, including:

Helen Sabzevari, PhD, President and CEO of Precigen
Mary L. (Nora) Disis, MD, University of Washington (UW) Professor of Medicine, Director of UW Center for Translational Medicine, Professor in the Clinical Research Division at Fred Hutch and a lead investigator for the PRGN-3005 clinical study
David Sallman, MD, Assistant Member in the Department of Malignant Hematology at the H. Lee Moffitt Cancer Center & Research Institute and a lead investigator for the PRGN-3006 clinical study
James L. Gulley, MD, PhD, Branch Chief and Director of the Medical Oncology Service at the National Institutes of Health (NIH) and a lead investigator for the PRGN-2009 clinical study
Clint T. Allen, MD, Principal Investigator with the Section on Translational Tumor Immunology at the NIH and a lead investigator for the PRGN-2012 clinical study
Participants may register and access the live webcast through Precigen’s investor relations website in the Press & Events section. An archived recording will be posted to the investor relations website following the event.

On October 27, 2021 Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reported that the IND application submitted by its partner in China, Angel Pharmaceuticals Ltd. (Angel Pharma), has been approved by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) to initiate a Phase 1/1b clinical trial of Corvus’ small molecule ITK inhibitor CPI-818 for the treatment of relapsed/refractory T-cell lymphomas (TCL) in China (Press release, Corvus Pharmaceuticals, OCT 27, 2021, View Source [SID1234592123]).

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Corvus co-founded Angel Pharma to develop its pipeline in greater China and currently holds an equity stake of 49.7% in the company. Angel Pharma licensed the rights from Corvus to develop, manufacture and commercialize CPI-818 in greater China and is responsible for all expenses related to its development in China.

"Our strategy to partner with Angel Pharma to accelerate global development of our products is advancing," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "There is a higher incidence and prevalence of T-cell lymphomas in China, and a significant need for new treatment options. The Angel Pharma team has been efficiently moving the development process forward and has partnered with top lymphoma clinical experts. CPI-818 is the only clinical stage ITK-inhibitor in China, and is positioned to become a potential novel therapy for T-cell lymphoma and more broadly for autoimmune diseases, which we plan to explore over time."

CPI-818 is an investigational, orally bioavailable, covalent inhibitor of ITK designed to have low nanomolar affinity. In vitro studies have shown that it potently inhibited T cell receptor signal transduction. Corvus is studying CPI-818 in a Phase 1/1b clinical trial that was designed to select the optimal dose of CPI-818 and evaluate its safety, pharmacokinetics (PK), target occupancy, biomarkers and efficacy. Interim data from the Phase 1/1b clinical trial of CPI-818 for T cell lymphoma demonstrated tumor responses in very advanced, refractory, difficult to treat T cell malignancies. As reported in December 2020 at the American Society of Hematology (ASH) (Free ASH Whitepaper), of seven patients with peripheral T cell lymphoma, there has been one complete response lasting over 15 months and one partial response lasting for over five months.

On October 27, 2021 CohBar, Inc. (NASDAQ: CWBR) (the "Company"), a clinical stage biotechnology company developing mitochondria based therapeutics to treat chronic diseases and extend healthy lifespan, reported a proposed underwritten public offering of shares of the Company’s common stock and accompanying warrants to purchase common stock (Press release, CohBar, OCT 27, 2021, View Source [SID1234592122]). Each warrant will be exercisable for 5 years from the closing date of the offering. All of the securities to be sold in the offering are being offered by the Company. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Cantor Fitzgerald & Co. is acting as sole book-running manager for the offering, and Brookline Capital Markets, a division of Arcadia Securities, LLC, is acting as co-manager.

CohBar intends to use the net proceeds from the offering, together with its existing cash resources, for general corporate purposes, which may include funding preclinical and clinical development of its peptides, increasing working capital, operating expenses and capital expenditures.

The securities will be issued pursuant to an effective shelf registration statement filed with the Securities and Exchange Commission (SEC) on August 24, 2020. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the prospectus supplement, together with the accompanying prospectus, can be obtained at the SEC’s website at www.sec.gov or from Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Ave., 4th Floor, New York, New York 10022, or by e-mail at [email protected].

This press release does not and shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction. Any offer, if at all, will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.

On October 27, 2021 Biomica Ltd., an emerging biopharmaceutical company developing innovative microbiome-based therapeutics and a subsidiary of Evogene Ltd. (NASDAQ: EVGN, TASE: EVGN), and Rambam Health Care Campus reported the signing of a clinical trial agreement (CTA) for initiating a first in-human proof-of-concept (POC) for BMC128, Biomica’s drug candidate (Press release, Evogene, OCT 27, 2021, View Source [SID1234592097]).

The study is titled, "A Phase 1, Open-Label Study to Evaluate the Safety and Tolerability of BMC128 in Combination with anti-PD-1 in Patients with Non-small Cell Lung Cancer (NSCLC), Melanoma or Renal Cell Carcinoma (RCC)." The study is designed primarily to evaluate the safety and tolerability of Biomica’s microbiome-based immuno-oncology drug candidate, BMC128, in combination with immune checkpoint inhibitor (ICI) immunotherapy (an anti PD-1 agent).

The initiation of this study is pending approval by the Israeli Ministry of Health (MoH).

Dr. Elran Haber, CEO of Biomica, stated: "We are very excited to work with one of Israel’s leading healthcare institutions, the Rambam Health Care Campus, and we look forward to initiating our first in-human POC study for BMC128, for the treatment of refractory cancer patients. Based on the compelling preclinical results achieved to-date, we are thrilled to take this next step in advancing BMC128 through the clinical development process. We hope that this important collaboration will be followed by further partnerships with additional leading medical institutions."

Dr. Ruth Perets, Head of Rambam’s Oncology Phase 1 Clinical Trials, stated: "We are thrilled to lead this clinical trial, aiming to target the important issue of ICI resistance. ICIs have revolutionized the field of oncology, providing prolonged survival in many malignancies. However, resistance to ICI eventually occurs in most patients, and evidence suggests that the gut microbiota plays a role in ICI resistance. We are excited to the test the ability of BMC128 to overcome ICI resistance and help provide patients meaningful and long responses to treatment."

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As previously reported, treatment with BMC128 in combination with ICI immunotherapy, significantly enhanced anti-tumor activity in various preclinical models. This resulted in an increased response of tumors to anti-PD1, as demonstrated in an improved Objective Response Rate (ORR) and Percent Tumor Growth Inhibition (%TGI). Response to BMC128 was correlated with a desired anti-tumor immunological profile. BMC128 changed the course of response to ICI, leading to stimulation of the immune system which shifted cold-tumors into hot-tumors.

Biomica’s immuno-oncology program is based on the premise that the gut microbiome affects the efficacy of cancer immunotherapy, specifically that of the ICI involving the blockade of PD-1 or PD-L1 and CTLA-4 as suggested in scientific literature1,2. Fecal microbial transplantation has been recently reported to increase response in patients resistant to immune-checkpoint therapy3,4. However, the specific microbial entities driving this response are currently unknown.

BMC128 is a rationally designed microbial consortium identified and selected through a detailed functional microbiome analysis using PRISM, a proprietary high-resolution microbiome analysis platform powered by Evogene’s MicroBoost AI platform.

About BMC128:

Developed as a Live Bacterial Product (LBP), BMC128 is a rationally-designed LBP consortium comprised of four unique bacterial strains, natural inhabitants of the human intestinal tract, that harbor specific functional capabilities with the potential to enhance immunological therapeutic responses and facilitate anti-tumor immune activity through multiple biological processes.

Rationally-designed consortia are multi-strain products designed to restore diversity and specific functionality to a host’s microbial community with individually selected, cultured bacteria.

1 Zitvogel et al. 2018, Science 359 (6382)
2 Thompson J, et al. Microbiome & immunotherapy: Antibiotic use is associated with inferior survival for lung cancer patients receiving PD-1 inhibitors. J Thorac Oncol 12(suppl 2):S1998, 2017
3 Baruch E, et al. 2021. Fecal microbiota transplant promotes response in immunotherapy-refractory melanoma patients. Science, 371 (6529)
4 Davar D, et al. 2021. Fecal microbiota transplant overcomes resistance to anti–PD-1 therapy in melanoma patients. Science, 371 (6529)