Boehringer Ingelheim and OSE Immunotherapeutics Announce First Patient Dosed in a Phase 1 Expansion Trial of SIRPα Antagonist Monoclonal Antibody BI 765063, Targeting Myeloid Cells in Immuno-Oncology

On May 3, 2022 Boehringer Ingelheim and OSE Immunotherapeutics reported a new step achieved through their global collaboration and license agreement under which Boehringer Ingelheim obtained exclusive rights to BI 765063, a first-in-class SIRPα inhibitor on the SIRPα/ CD47 myeloid pathway (Press release, OSE Immunotherapeutics, MAY 3, 2022, View Source [SID1234646964]). In particular, a milestone has been achieved upon the first patient dosed in the Phase 1 expansion trial conducted by Boehringer Ingelheim in difficult to treat advanced cancers.

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This international Phase 1 aims at evaluating BI 765063 in patients with recurrent/metastatic hepatocellular carcinoma (HCC) or head and neck squamous cell carcinoma (HNSCC)*.

Dominique Costantini, Chief Executive Officer of OSE Immunotherapeutics, comments: "We thank Boehringer Ingelheim for this important new step which demonstrates their commitment and strong belief in the potential of BI 765063 targeting myeloid cells. Through our partnership, the product is now being explored in two additional oncology indications and debilitating tumor types, the advanced HCC and H&N cancer. The associated milestone payment will strengthen OSE’s cash position to advance the development of our first-in-class portfolio."

BI 765063 is being evaluated in parallel in Europe in combination with Ezabenlimab in a Phase 1 expansion clinical trial in patients with microsatellite stable (MSS) advanced colorectal cancer and MSS advanced endometrium cancer whose disease relapsed after standard of care and who received no prior anti-PD-L1 inhibitors. The study is being conducted by OSE Immunotherapeutics.

Pfizer reports First-Quarter 2022 results

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10-Q – Quarterly report [Sections 13 or 15(d)]

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

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Oncotelic Appoints Fatih Uckun, M.D., Ph.D., as Chief Medical Officer

On May 3, 2022 Oncotelic Therapeutics, Inc. ("Oncotelic" or the "Company" or "We") (OTCQB:OTLC), reported the appointment of Dr. Fatih Uckun as its Chief Medical Officer. Dr. Uckun will be responsible for execution of internal company led registrational trials (Press release, Mateon Therapeutics, MAY 3, 2022, View Source [SID1234613789]).

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"The addition of Dr. Uckun to our executive team, comes at a critical time for Oncotelic. We have made significant inroads toward our goal of developing OT-101 as treatment for difficult to treat cancers," said Dr. Vuong Trieu, CEO and Chairman. "Dr. Uckun is one of the highest caliber physician scientists. His deep knowledge in clinical oncology and vast experience in translational research for successful applications of immunotherapy in oncology, especially for difficult to treat cancer subtypes will be invaluable, as we further advance OT-101 and the rest of our product portfolio."

"With the completion of the joint venture with Dragon Overseas Capital Limited for OT-101, we will be initiating OT-101 registration trials against difficult to treat cancers such as DIPG and pancreatic cancers", said Dr. Fatih Uckun, CMO. "I look forward to engaging the global oncology community in bringing OT-101 to these patients."

About Dr. Uckun

Dr. Uckun is an elected Member of the American Society for Clinical Investigation (ASCI), an honor society for physician-scientists, and an active member of several professional organizations. He received numerous awards for his work on monoclonal antibodies, recombinant cytokines and fusion proteins, radiation sensitizers, kinase inhibitors and targeted therapeutics for difficult-to-treat cancers, including the Stohlman Memorial Award of the Leukemia Society of America, the highest honor given to a Leukemia Society Scholar.

Prior to joining Oncotelic, Dr. Uckun served as Chief Medical Officer and Chief Scientific Officer of Reven Pharmaceuticals (from 2020 to 2022), Chief Medical Officer of Ares Pharmaceuticals (from 2017 to 2022), Chief Clinical Advisor of Aptevo Therapeutics (2021), Vice President and Clinical Strategy Lead, Oncology-Hematology of Worldwide Clinical Trials (2020), Chief Medical Officer of Mateon and Oncotelic (2019-2020), and Executive Medical Director and Strategy Lead in Global Oncology and Hematology at Syneos Health (from 2017 to 2018). Prior to this, he was Vice President of Research and Clinical Development at Nantkwest, Chief Scientific Officer of Jupiter Research Institute and, before that, held senior-level scientific and research positions at Parker Hughes Institute and its cancer center, Paradigm Pharmaceuticals, and the Children’s Cancer Study Group.

Dr. Uckun earned his doctoral degrees at the University of Heidelberg, Germany where he also served as an active member of the autologous bone marrow transplant and peripheral stem cell transplant clinical research teams of the Tumor Center. Dr. Uckun completed his residency training in pediatrics, clinical fellowship training in Hematology/Oncology/Blood and Bone Marrow Stem Cell Transplantation as well as postdoctoral research training in immunology at the University of Minnesota. Dr. Uckun has more than 30 years of professional experience in developmental therapeutics with a special emphasis on targeted therapeutics/precision medicines and biopharmaceuticals. He has published more than 500 peer-reviewed papers, authored numerous review articles and book chapters and and is an inventor on numerous patents.

Dr. Uckun worked as a Professor of Therapeutic Radiology-Radiation Oncology, Pharmacology, and Pediatrics as well as Director of the Biotherapy Institute at the University of Minnesota (1986-1997), where he became the first recipient of the Endowed Hughes Chair in Biotherapy, and as a Professor of Pediatrics and Head of Translational Research in Leukemia and Lymphoma of the Children’s Center for Cancer and Blood Diseases at the University of Southern California (2009-2015). From 2012-2015, Dr. Uckun served as chair of the Biotargeting Working Group and a Member of the Coordination and Governance Committee of the NCI Alliance for Nanotechnology in Cancer.

Distributors Agree to Opioid Settlement With Washington State

On May 3, 2022 AmerisourceBergen (NYSE: ABC), Cardinal Health (NYSE: CAH) and McKesson (NYSE: MCK) reported that they have reached an agreement with the Washington Attorney General, under which the distributors will pay up to $518 million to the State of Washington and its participating subdivisions to resolve opioid-related claims (Press release, Cardinal Health, MAY 3, 2022, View Source [SID1234613639]). This amount is consistent with Washington’s allocation under the previously announced comprehensive agreement to settle the vast majority of the opioid lawsuits filed by state and local governmental entities, as well as certain attorneys’ fees and costs.

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Upon effectiveness of the settlement, the State of Washington will dismiss the lawsuit that is currently being tried. The agreement is subject to certain contingencies, including the rate of subdivision participation. The terms of the agreement with the State of Washington are consistent with the comprehensive settlement agreement, which became effective on April 2, 2022.

While the companies strongly dispute the allegations made in the plaintiffs’ complaints and during trial, they believe that resolving all of the litigation filed by the State of Washington and its political subdivisions will further the companies’ goal of achieving broad resolution of governmental opioid claims while delivering meaningful relief to communities across the United States that have been impacted by the opioid epidemic.