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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On October 4, 2022 SyntheX, Inc., an emerging growth biotechnology company innovating next-generation functional drug discovery engines, reported a research collaboration and license agreement with Bristol Myers Squibb to discover, develop and commercialize novel small molecules using SyntheX’s ToRNeDO platform for protein degradation (Press release, SyntheX, OCT 4, 2022, View Source [SID1234621666]).

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The collaboration will focus on discovering molecular glue degraders. Under the terms of the agreement, SyntheX will receive a combined upfront of cash and an investment and is eligible for up to $550 million in performance-based milestone payments, as well as royalties on global net sales of products.

SyntheX has developed proprietary platforms that leverage the power of synthetic biology to build next generation drug discovery engines. Using genetic engineering, SyntheX’s platform technologies rely on functional intracellular drug selection as opposed to in vitro screening, which allows the company to discover functional molecular glues using a pre-specified E3 ligase and a neosubstrate of interest. The platform is versatile and can exploit many human E3 ligases.

"Bristol Myers Squibb is a globally recognized pharmaceutical leader, and we are excited to work with them in targeted protein degradation (TPD), an extremely exciting scientific field with vast drug development opportunities," said Maria Soloveychik, Ph.D., Co-Founder and Chief Executive Officer of SyntheX. "We look forward to combining our ToRNeDO platform with Bristol Myers Squibb’s clinical development expertise as we work to discover and deliver the next-generation of TPD therapies for patients in need."