Nascent Begins Enrollment of Final Patient Cohort to Complete Phase One Clinical Research

On October 4, 2022 Nascent Biotech, Inc. (OTCQB:NBIO) ("Nascent Biotech", "Nascent", or the "Company"), a clinical-stage biotechnology Company focused on the development of monoclonal antibodies targeting various cancer types, reported that the Company has enrolled the first patient of the fifth and final cohort of its Phase I clinical trial to evaluate Pritumumab ("PTB") as a treatment for Primary and Metastatic Brain Cancers (Press release, Nascent Biotech, OCT 4, 2022, https://www.nascentbiotech.com/nascent-begins-enrollment-of-final-patient-cohort-to-complete-phase-one-clinical-research/ [SID1234621677]).

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Sean Carrick, Nascent CEO, explains, "We are enthusiastically encouraging anyone interested in screening for the trial to do so in a timely manner. This cohort of patients will likely be the final one in this trial, and new patient enrollment will cease until our Phase II research gets underway."

Patient enrollment continues for Phase I and interested parties may review trial requirements at www.clinicaltrials.gov under the search term ‘Pritumumab’.

Following completion of dosing of the Fifth Cohort, the Company will prepare data for submission to the FDA in preparation for Phase II clinical research.

PTB is a natural human antibody that binds to Cell surface Vimentin (also referred to as ectodomain vimentin), a protein expressed on the surface of epithelial cancers. PTB is used as a targeted immunotherapy and seek out only cancer cells without damaging healthy cells.

October 4, 2022: MaaT Pharma Appoints Nathalie Corvaïa as Chief Scientific Officer and Strengthens its R&D activities in Immuno-Oncology

On October 4, 2022 MaaT Pharma (EURONEXT: MAAT – the "Company"), a French clinical-stage biotech and a pioneer in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to improving survival outcomes for patients with cancer, reported the appointment of Nathalie Corvaïa, Ph.D., as Chief Scientific Officer (Press release, MaaT Pharma, OCT 4, 2022, View Source [SID1234621676]). Dr. Corvaïa brings more than 20 years of experience leading drug discovery and development programs in oncology and guiding the advancement of product candidates into the clinic. She will oversee MaaT Pharma’s non-clinical research and development strategies as well as the Company’s proprietary, AI-based MET drug design and development platform, gutPrint.

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"Nathalie has an impressive depth of experience and track record in early-stage research and development of drug candidates in immune-mediated diseases. She joins us as we are generating exciting preclinical results for our first co-cultured candidate aimed at improving clinical responses in patients with solid tumors treated with immune checkpoint inhibitors," said Hervé Affagard, CEO and co-founder of MaaT Pharma. "In this context, Nathalie will be instrumental in driving and expanding our scientific innovation and preclinical drug development strategy. I welcome Nathalie to the executive team and look forward to her contributions as we pursue our mission to provide the benefits of microbiome modulation to cancer patients."

MaaT Pharma has established clinical proof of concept for its high-richness, high-diversity, native, donor-derived MET-N approach, with more than 140 patients treated in Europe to date in haemato-oncology with its drug candidates MaaT013 (for the treatment of aGvHD[1]) and MaaT033 (for the treatment of patients receiving allo-HSCT[2]), with promising safety and efficacy results. MaaT Pharma is now consolidating its second-generation drug development platform, MET-C. Leveraging its gutPrint AI[3] suite and groundbreaking ecosystem co-culture technology, MET-C allows the design and manufacturing of indication-specific, donor-independent "MaaT03X" candidates. The platform opens new opportunities for the Company to address larger, and growing markets such as solid tumors, as well as to broaden its indication focus and potentially target other immune- and inflammatory-related diseases.

Nathalie Corvaïa, Ph.D. commented on the appointment adding, "MaaT Pharma’s approach of leveraging the full microbiome ecosystem to improve cancer treatment has the potential to become a new pillar in cancer therapy. With an exciting discovery pipeline and AI-powered engine, I am thrilled to join MaaT Pharma to guide the development of its next generation of therapies, to build the company’s momentum with the immuno-oncology program and to expand its early-stage drug development in this field."

Prior to joining MaaT Pharma, Dr. Corvaïa was the Head of Immuno-oncology Research at The Pierre Fabre Immunology Center (CIPF) in France where she was responsible for the institute’s research activities in immuno-oncology from early-stage product discovery to Phase 1 entry, including GMP production of its products including biologics and live products. In her previous roles as Managing Director and Research Director, she led several diverse research teams contributing to a growing pipeline of products currently in preclinical and clinical trials in different tumor indications. Dr. Corvaïa did her postdoctoral research in cellular immunology at Novartis in Austria and obtained a PhD degree in Cellular Immunology at St. Louis Hospital in Paris, France. She has authored over 100 scientific publications and holds several issued patents and is also an active member of the American Association for Cancer Research (AACR) (Free AACR Whitepaper).

JP Morgan Annual Health Care Conference, Jan. 9-11, 2023, San Francisco, CA

On October 4, 2022 ITI reported that it will be attending The 41st Annual Health Care Conference that will take place on January 9-11, 2023 at the Westin St. Francis in San Francisco, CA (Press release, Immunomic Therapeutics, OCT 4, 2022, View Source [SID1234621675]).

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This premier conference is the largest and most informative health care investment symposium in the industry which connects global industry leaders, emerging fast-growth companies, innovative technology creators and members of the investment community.

Exelixis Expands Clinical Trial Collaboration and Supply Agreement with Bristol Myers Squibb to Include the Fixed-Dose Combination of Nivolumab and Relatlimab in Combination with XL092 in Phase 1b STELLAR-002 Trial

On October 4, 2022 Exelixis, Inc. (Nasdaq: EXEL) reported the expansion of its June 2021 Clinical Trial Collaboration and Supply Agreement with Bristol-Myers Squibb Company (NYSE: BMY) to include the use of the fixed-dose combination of nivolumab and relatlimab in the ongoing phase 1b STELLAR-002 clinical trial (NCT05176483), which is evaluating XL092 in combination with multiple immune checkpoint inhibitors (ICIs) in advanced solid tumors. Exelixis is sponsoring STELLAR-002, and Bristol Myers Squibb will provide the fixed-dose combination of nivolumab and relatlimab in addition to nivolumab and ipilimumab for use in the trial, which is divided into two parts: a dose-escalation stage and an expansion cohort stage (Press release, Exelixis, OCT 4, 2022, View Source [SID1234621673]). The novel triplet combination of XL092 and the fixed-dose combination of nivolumab and relatlimab has the potential to be used in multiple expansion cohorts.

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XL092 is Exelixis’ next-generation oral tyrosine kinase inhibitor (TKI) that targets VEGF receptors, MET, AXL, MER and other kinases implicated in cancer’s growth and spread. Bristol Myers Squibb’s relatlimab is a lymphocyte activation gene-3 (LAG-3)-blocking antibody. LAG-3 is an inhibitory immune checkpoint expressed on the surface of T cells.

"We are pleased to expand our agreement with Bristol Myers Squibb for the STELLAR-002 trial to include the novel fixed-dose combination of nivolumab and relatlimab to evaluate the potential benefit of combining XL092 with additional immune checkpoint inhibitors," said Vicki L. Goodman, M.D., Executive Vice President, Product Development & Medical Affairs, and Chief Medical Officer, Exelixis. "By studying multiple immune checkpoint combinations, we hope to identify the most promising regimens across multiple solid tumors to use in future pivotal trials."

Enrollment and dosing in the dose-escalation portion of STELLAR-002 is ongoing. The dose-escalation stage will determine the recommended dose in patients with advanced solid tumors for each of the combination therapy regimens, including XL092 and nivolumab, XL092, nivolumab and ipilimumab, and XL092 and the fixed-dose combination of nivolumab and relatlimab.

About XL092

XL092 is a next-generation oral TKI that inhibits the activity of receptor tyrosine kinases implicated in cancer growth and spread, including VEGF receptors, MET, AXL and MER. These receptor tyrosine kinases are involved in both normal cellular function and in pathologic processes such as oncogenesis, metastasis, tumor angiogenesis, and resistance to multiple therapies, including ICIs. In designing XL092, Exelixis sought to build upon its extensive experience with and the target profile of cabozantinib, the company’s flagship medicine, while improving key characteristics, including pharmacokinetic half-life. XL092 is currently being developed for the treatment of advanced solid tumors, including genitourinary cancers, as a monotherapy and in combination with ICIs. XL092 is the first internally discovered Exelixis compound to enter the clinic following the company’s reinitiation of drug-discovery activities.

BlueSphere Bio Appoints Keir Loiacono as Chief Executive Officer

On October 4, 2022 BlueSphere Bio, a T-cell receptor (TCR) T-cell therapy company developing a powerful TCR discovery platform and novel therapeutic candidates for patients with hematologic malignancies and solid tumors, reported the appointment of Keir Loiacono, Esq. to Chief Executive Officer (Press release, BlueSphere Bio, OCT 4, 2022, View Source [SID1234621672]). Mr. Loiacono has played a key role as Chief Business Officer at BlueSphere over the last year, working closely with co-founders Drs. Mark and Warren Shlomchik, Dr. Bob Keefe, Chief Development Officer, and the broader team at BlueSphere. Mr. Loiacono will lead BlueSphere into the next phase of growth, as the company continues to build out its clinical and research activities.

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BlueSphere expects to file an IND in the first quarter of 2023 for its first clinical candidate, a TCR T-cell therapy directed against the minor histocompatibility antigen HA-1 for the treatment of high-risk leukemia in the setting of allogeneic stem cell transplant. In addition, the company continues to develop additional, novel TCR-based clinical candidates through the use of its TCXpress and NEOXpress discovery platforms.

Jonathan Peacock, Chairman of BlueSphere’s Board of Directors, commented, "Under Keir’s leadership, BlueSphere will continue to build on its very strong scientific foundation and the strong financial support of UPMC Enterprises as it prepares to embark on its first clinical trial and leverages its TCXpress and NEOXpress discovery platforms to generate additional clinical candidates. I would also like to thank David Apelian, who is stepping down as CEO, for his service in leading the early development of the company over the last 3 years".

Prior to joining the company, Mr. Loiacono served as Vice President of Business Development and General Counsel of OncoSec Medical Inc., a publicly traded, clinical stage oncology company. Earlier in his career, he worked as a Senior Director for Advaxis, Inc., a late stage, publicly traded, immuno-oncology company focused on developing, manufacturing and commercializing cancer vaccines, where he oversaw various legal, transaction and compliance functions. Before Advaxis, Mr. Loiacono was an IP attorney with Lerner David Littenberg Krumholz & Mentlik, where he focused on transactions and building patent portfolios. For nearly a decade before this role, he held various commercial roles with OraPharma, a specialty pharmaceutical company that was purchased by Johnson & Johnson. Mr. Loiacono also serves on the Board of Directors for EpiAxis Therapeutics, an early-stage drug discovery company.