LaNova Medicines Initiates Pivotal Clinical Trial for LM-108 in China

On December 20, 2024 LaNova Medicines Ltd. reported the initiation of its first pivotal clinical trial for LM-108 (anti-CCR8 mAb) in China (Press release, LaNova Medicines, DEC 20, 2024, View Source [SID1234656019]).

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This clinical study (CTR20250219) is a Phase II, single-arm, multicenter, open-label trial primarily evaluating the efficacy and safety of LM-108 in combination with Toripalimab in patients with unresectable or metastatic MSI-H/dMMR advanced solid tumors who have failed prior treatment with anti-PD-1/PD-L1 therapies.

Termination of a Material Definitive Agreement.

On December 20, 2024, Kronos Bio, Inc. (the "Company") reported to have entered into a Transition Agreement and Mutual General Release (the "Transition Agreement") with Genentech, Inc. and F. Hoffmann-La Roche Ltd (together, "Genentech"), pursuant to which the Company and Genentech agreed to void and cancel all of the parties’ respective rights and obligations under the Collaboration and License Agreement between the parties dated January 6, 2023 (the "Collaboration Agreement") (Filing, Kronos Bio, DEC 20, 2024, View Source [SID1234649329]). Pursuant to the Transition Agreement, the Company will transfer and assign to Genentech all small molecule compounds, materials, data, and intellectual property generated by the Company in connection with the two discovery research programs ("Program Materials") conducted by the Company under the Collaboration Agreement, but excluding the Company’s proprietary drug discovery platform. The Company also granted to Genentech a perpetual, irrevocable, non-exclusive and fully paid up license under certain related intellectual property owned or controlled by the Company that is necessary or reasonably useful to exploit the Program Materials. The Transition Agreement has the effect of terminating the Collaboration Agreement, and provides for a general release of any actual or potential claims between the Company and Genentech relating thereto. In addition, the Transition Agreement cancels and voids any and all downstream payment obligations between the parties relating to or arising from the Collaboration Agreement or any programs or compounds arising thereunder. The Company has made a one-time payment in connection with the termination of the Collaboration Agreement, which is intended to support the transition of all activities under the Collaboration Agreement to Genentech.

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The foregoing is a summary description of certain terms of the Transition Agreement and does not purport to be complete, and is qualified in its entirety by reference to the full text of the Transition Agreement to be filed, with confidential terms redacted, as an exhibit to the Company’s Annual Report on Form 10-K for the year ending December 31, 2024.

Foresight Diagnostics to Present at 43rd Annual J.P. Morgan Healthcare Conference

On December 20, 2024 Foresight Diagnostics, Inc. ("Foresight") a leading diagnostics company specializing in the development of ultra-sensitive minimal residual disease (MRD) detection, reported that CEO, Jake Chabon, will present at the 43rd Annual J.P. Morgan Healthcare Conference on Wednesday, January 15, 2025, at 7:30am Pacific Time (Press release, Foresight Diagnostics, DEC 20, 2024, View Source [SID1234649248]).

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Foresight Diagnostics will be hosting meetings at the LifeSci Corporate Access Event from January 13-15, 2025, and will also be available for additional meetings on January 16. To schedule a meeting with the Company, please contact [email protected].

Gilead Sciences to Present at Upcoming Investor Conference

On December 20, 2024 Gilead Sciences, Inc. (Nasdaq: GILD) reported that its executives will be speaking at the following investor conference (Press release, Gilead Sciences, DEC 20, 2024, View Source [SID1234649247]):

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J.P. Morgan Healthcare Conference on Monday, January 13, 2025 beginning at 11:15 a.m. Pacific Time
The live webcast can be accessed at investors.gilead.com and the replay will be available for at least 30 days following the presentation.

Marengo Announces First Patient Dosed in Phase 2 Clinical Study for its Lead Program, Invikafusp Alfa (STAR0602) in PD-1 Resistant Tumors, Expands Study to Europe

On December 20, 2024 Marengo Therapeutics, Inc., a clinical-stage biotechnology company pioneering novel approaches for precision T cell activation, reported the dosing of the first patient in the Phase 2 portion of its STARt-001 trial. The clinical study builds on the Phase 1/2 trial evaluating invikafusp alfa as a monotherapy in biomarker-enriched patients with advanced anti-PD-1 resistant solid tumors (Press release, Marengo Therapeutics, DEC 20, 2024, View Source [SID1234649246]).

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The results of the Phase 1 portion of the STARt-001 trial were recently presented during a plenary late-breaking oral session at the SITC (Free SITC Whitepaper) Annual Meeting and an oral presentation at the 2024 ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress. The data collectively validate Marengo’s STAR platform design and demonstrate early single agent anti-tumor activity of invikafusp alfa (STAR0602), including clinical benefit in heavily pre-treated, anti-PD-1 resistant cancer patients. Invikafusp alfa exhibited a manageable safety profile consistent with its novel mechanism of action, reinforcing its potential as a treatment option across high tumor mutation burden (TMB-H) cancers or virally associated malignancies.

The Phase 2 clinical trial will treat patients with the RP2D (0.08mg/kg) and is now enrolling patients in Europe at leading oncology centers, with initial activation of sites in France and Spain.

"We are thrilled to advance invikafusp alfa into Phase 2 with the addition of premier European oncology centers," said Ke Liu, M.D., Ph.D., Chief Development Officer of Marengo Therapeutics. "The single-agent anti-tumor activity observed in Phase 1, particularly in PD-1-resistant ‘cold’ tumors like colorectal cancer, gives us confidence in our approach and fuels our hope to reach as many patients as possible. The addition of renowned European institutions expands our geographical footprint and enhances our ability to enroll more PD-1 resistant patient populations. Through our Phase 2 study, we aim to deepen our understanding of invikafusp alfa’s mechanism of action across diverse tumor types."