Bicara Therapeutics to Present Preclinical Data from Clinical-Stage Bifunctional Antibody Program, BCA101, at AACR Annual Meeting 2023

On April 4, 2023 Bicara Therapeutics, a clinical-stage biotechnology company developing dual-action biologics to elicit a potent and durable immune response, reported that it will present preclinical data supporting the ongoing clinical development of the lead investigational candidate BCA101, a bifunctional antibody designed to sequester the immunosuppressive TGF-β in the tumor microenvironment (TME) of EGFR+ tumors, at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023, being held April 14-19, 2023 in Orlando, Florida (Press release, Bicara Therapeutics, APR 4, 2023, View Source;utm_medium=rss&utm_campaign=bicara-therapeutics-to-present-preclinical-data-from-clinical-stage-bifunctional-antibody-program-bca101-at-aacr-annual-meeting-2023 [SID1234629787]).

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"The preclinical data that will be presented at AACR (Free AACR Whitepaper) supports the mechanism of action (MOA) of BCA101, which has demonstrated promising efficacy and a positive safety profile in an ongoing Phase 1/1b clinical trial. Data from in vitro and in vivo studies provides further evidence of BCA101’s potential, as a monotherapy and in combination with anti-PD-1, to induce durable anti-tumor responses in various tumor types, including head and neck cancer, our lead indication," said Rachel Salazar, SVP of R&D Strategy and Operations of Bicara Therapeutics. "We are also pleased to highlight our collaboration with researchers at the Belfer Center for Applied Cancer Science at Dana-Farber Cancer Institute to elucidate the effects of BCA101 on the tumor microenvironment of patients enrolled in the ongoing Ph1/1b clinical trial and highlight the important role of TGF-b neutralization in creating the conditions for an enhanced immune response."

Details of the presentations are as follows:

Title: BCA101, a novel tumor-targeted bifunctional fusion antibody simultaneously inhibiting EGFR and TGF-β signaling with potential for durable tumor growth inhibition
Presenter: Pradip Nair, Associate Research Director, Syngene International
Presentation Type: Poster
Session Category: Anticancer Immunotherapeutics
Date/Time: Wednesday, April 19, 2023, 9:00 a.m. to 12:30 p.m. ET
Location: Section 22; Abstract #6339

Title: Preliminary immune correlatives from BCA101 trial show favorable modulation of tumor immune microenvironment
Presenter: Patrick H. Lizotte, Lead Scientist, Dana-Farber Cancer Institute, Belfer Center for Applied Cancer Science
Presentation Type: Poster
Session Category: Immune Monitoring and Responses to Therapy
Date/Time: Wednesday, April 19, 2023, 9:00 a.m. to 12:30 p.m. ET
Location: Section 39; Abstract #6677

Title: An improved trispecific antibody (TsAb) platform for optimally engaging T cells for the treatment of solid tumor malignancies
Presenter: Avanish K. Varshney, Director of Antibody Discovery and Engineering, Bicara Therapeutics
Presentation Type: Poster
Session Category: Therapeutic Antibodies 1
Date/Time: Monday, April 17, 2023, 9:00 a.m. to 12:30 p.m. ET
Location: Section 25; Abstract #1864

All presentations described here will be made available on the Bicara website following the conference.

Termination of a Material Definitive Agreement

On April 4, 2023, in connection with the consummation of the Merger, the Company paid in full all outstanding obligations under, and terminated, the Loan and Security Agreement, dated as of December 21, 2021 (as amended, extended, supplemented or otherwise modified from time to time, the "Loan Agreement"), by and among Innovatus Life Sciences Lending Fund I, LP as collateral agent, the lenders listed on Schedule 1.1 thereto, and the Company and certain of the Company’s subsidiaries, as co-borrowers (Filing, 8-K, Apollo Endosurgery, APR 4, 2023, View Source [SID1234629786]). Upon such termination, all rights, obligations, liabilities and security interests under the Loan Agreement were fully and unconditionally released and discharged.

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AbbVie to Host First-Quarter 2023 Earnings Conference Call

On April 4, 2023 AbbVie (NYSE: ABBV) reported that it will announce its first-quarter 2023 financial results on Thursday, April 27, 2023, before the market opens (Press release, AbbVie, APR 4, 2023, View Source [SID1234629785]). 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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Alphamab Oncology Reports Full Year 2022 Financial Results and Business Highlights

On April 3, 2023 Alphamab Oncology (stock code: 9966.HK) reported financial results for the full year ended December 31, 2022 and highlighted recent progress and upcoming milestones (Press release, Alphamab, APR 3, 2023, View Source [SID1234632918]).

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Gossamer Bio Inc. announces FDA has placed a partial clinical hold on all trials of GB5121 in response to serious adverse events

On April 3, 2023 Gossamer Bio, Inc. (the "Company") reported that the U.S. Food and Drug Administration (the "FDA") has placed a partial clinical hold on all trials of GB5121, in response to serious adverse events that have been observed in the Phase 1b/2 STAR-CNS study, including atrial fibrillation, a sudden death event and a fatal intracranial hemorrhage (Press release, Gossamer Bio, APR 3, 2023, View Source [SID1234631618]). The Company previously announced on March 17, 2023 that it had paused enrollment of the Phase 1b/2 STAR-CNS Study based on the benefit / risk profile observed to date and a prioritization of resources to support the Company’s seralutinib program. Based on the foregoing factors, the Company has decided to terminate all ongoing studies and discontinue development of GB5121.

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