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.

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.

On October 4, 2022 BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) reported that Jean-Jacques Bienaimé, Chairman and Chief Executive Officer of BioMarin, will host a conference call and webcast on Wednesday, October 26th, at 4:30 p.m. ET to discuss third quarter 2022 financial results and provide a general business update (Press release, BioMarin, OCT 4, 2022, View Source,-October-26,-at-4-30pm-ET [SID1234621671]).

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BioMarin to Announce 3Q22 Financial Results October 26th, 2022 After the Market Closes
Interested parties may access a live audio webcast of the conference call via the investor section of the BioMarin website, www.biomarin.com. A replay of the call will be archived on the site for one week following the call.

On October 4, 2022 Abcuro, Inc., a clinical-stage biotechnology company developing therapies for the treatment of autoimmune diseases and cancer through precise modulation of cytotoxic T and NK cells, reported initiation of a Phase 1/2 dose escalation trial to evaluate the safety, tolerability, and proof-of-concept of ABC008 in patients with T cell large granular lymphocytic leukemia (T-LGLL) who suffer from anemia and/or neutropenia (Press release, Abcuro, OCT 4, 2022, View Source [SID1234621668]). ABC008 is a first-in-class anti-KLRG1 antibody capable of selectively depleting highly cytotoxic T cells, while sparing regulatory T cells, central memory T cells, and other immune cells.

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"Initiating the Phase 1/2 clinical trial of ABC008 represents an important step toward a potential breakthrough in the treatment of T-LGLL," said Jeffrey Wilkins, MD, Chief Medical Officer of Abcuro. "This trial builds upon prior published data demonstrating the ability of ABC008 to deplete highly cytotoxic T cells, which attack and destroy muscle tissue in inclusion body myositis, an autoimmune disease."

T-LGLL is an autoimmune disorder characterized by clonally expanded CD3+ CD8+ cytotoxic T lymphocytes which attack neutrophils and red blood cell precursors, leading to neutropenia and anemia. Neutropenia can lead to frequent infections, a major cause of premature death in patients with T-LGLL, while anemia results in transfusion dependence in approximately one third of patients.

"The limited efficacy of current standard of care is reflected in an overall reduced life expectancy for T-LGLL patients," said Paul Shami, MD, Professor of Medicine in the Division of Hematology and Hematologic Malignancies at the University of Utah and Principal Investigator. "Without any approved treatment options for T-LGLL, many patients turn to off-label therapies, such as methotrexate, a non-specific immunosuppressant, which often have limited effectiveness."

About ABC008
ABC008 is a first-in-class anti-KLRG1 antibody capable of selectively depleting highly cytotoxic T cells, while sparing regulatory and central memory T cells. ABC008 has been designed to treat diseases mediated by highly cytotoxic T cells, including the autoimmune muscle disease inclusion body myositis (IBM), T cell large granular lymphocytic leukemia (T-LGLL), and mature T cell malignancies. The US Food and Drug Administration (FDA) has granted Orphan Drug Designation to ABC008 for the treatment of IBM.

On October 4, 2022 AbbVie (NYSE: ABBV) reported that it will announce its third-quarter 2022 financial results on Friday, October 28, 2022, before the market opens (Press release, AbbVie, OCT 4, 2022, View Source [SID1234621667]). AbbVie will host a live webcast of the earnings conference call at 8 a.m. CT. It will be accessible through AbbVie’s Investor Relations website investors.abbvie.com. An archived edition of the session will be available later that day.

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