On September 13, 2024 Marengo Therapeutics, Inc., a clinical-stage biotech company pioneering a new way to activate T cells targeting the Vβ chain of the T cell receptor to select the optimal T cell subsets against cancer, reported that it has entered into a clinical study collaboration and supply agreement with Gilead Sciences, Inc. to study the combination of STAR0602 (Invikafusp alfa) with Trodelvy (sacituzumab govitecan-hziy), a Trop-2-directed antibody-drug conjugate (ADC), as a potential treatment for adult patients with metastatic hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer and metastatic triple-negative breast cancer (TNBC) (Press release, Marengo Therapeutics, SEP 13, 2024, View Source;breast-cancers-302247091.html [SID1234646582]).

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The planned combination trial, sponsored by Marengo, is expected to commence soon. This study will evaluate the safety, tolerability, and preliminary efficacy of STAR0602 (Invikafusp alfa) in combination with Trodelvy in patients with metastatic TNBC or metastatic HR+/HER2- breast cancer, aiming to explore a novel therapeutic strategy that could offer new treatment options for patients.

"We are excited about the clinical potential of combining our novel selective dual T cell activator with Gilead’s antibody-drug conjugate, Trodelvy," said Kevin Chin, M.D., Chief Medical Officer of Marengo Therapeutics. "This innovative approach leverages the strengths of two unique modalities to target and potentially eradicate cancer cells more effectively. With the possibility to deliver target cytotoxic agents directly to tumors, which release more tumor antigens for selectively activated and expanded Vβ6/10 T cells to recognize and build long-term immune memory, we believe this combination may have the potential to improve cancer patient outcomes."

Under the clinical study collaboration and supply agreement, Gilead will provide Trodelvy to Marengo, who will conduct and sponsor the combination study. Marengo and Gilead will retain all development and commercial rights to their respective compounds, including as monotherapy or as combination therapies.

The combination of invikafusp alfa and sacituzumab govitecan-hziy is investigational and not approved by any health authority globally. The safety and efficacy of this combination has not been established.

On September 13, 2024 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company, reported the Company will share new data from Module 1 of its ongoing Phase 1/2 TRESR clinical trial during an oral presentation on September 14 at the European Society for Medical Oncology Congress (ESMO) (Free ESMO Whitepaper), held in Barcelona, Spain (Press release, Repare Therapeutics, SEP 13, 2024, View Source [SID1234646598]).

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TRESR (NCT04497116) is a first-in-human, multi-center, open-label Phase 1/2 dose-escalation and expansion study designed to establish the recommended Phase 2 dose (RP2D) and schedule. The study evaluated safety, pharmacokinetics and identify preliminary anti-tumor activity associated with camonsertib monotherapy in patients with solid tumors (Module 1).

Oral Presentation Details:

Title: Camonsertib (cam) monotherapy in patients (pts) with advanced cancers harboring ATM loss-of-function (LoF)
Presenter: Benedito A. Carneiro, MD, Legorreta Cancer Center, Division of Hematology/Oncology, The Warren Alpert Medical School, Brown University, Providence, RI
Presentation number: 619MO
Session: Mini Oral Session: Developmental Therapeutics
Session date and time: Saturday, September 14 | 8:45 a.m. – 10:15 a.m. ET
Session location: Oviedo Auditorium, Hall 3

On September 13, 2024  CorMedix Inc., a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases, reported that management will be participating in a fireside chat and investor meetings at the 2024 Cantor Healthcare Conference, being held in New York, NY on September 17 – 19, 2024 (Press release, CorMedix, SEP 13, 2024, View Source [SID1234646565]).

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Cantor Global Healthcare Conference
Date: Thursday, September 19, 2024
Time: 10:55AM EDT
Format: Fireside Chat and 1×1 Meetings
Webcast: Click Link

A replay of the fireside chat will also be available in the "Events and Presentations" page on the investor relations portion of the Company’s website at: www.cormedix.com

On September 13, 2024 Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, reported that it will present a poster with updated results from the RINGSIDE Phase 2 clinical trial of AL102 for the treatment of desmoid tumors at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, being held in Barcelona from 13-17 September 2024 (Press release, Immunome, SEP 13, 2024, View Source [SID1234646599]).

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Enrollment in the Phase 3 portion of RINGSIDE was completed in February 2024, and Immunome expects to report topline data from that trial in the second half of 2025.

Following the presentation, a copy of the poster will be made available in the "Events & Presentations" portion of Immunome’s website.

Poster Presentation Details:

Title: Updated Results of the RINGSIDE Phase 2 Trial and Open-Label Extension of AL102 for the Treatment of Desmoid Tumors (Abstract #1766P)

Presenter: Bernd Kasper, MD, PhD, Mannheim Cancer Center at the Mannheim University Medical Center,

Date: September 14, 2024

On September 13, 2024 CDR-Life reported significant clinical progress in its M-gager portfolio for solid tumors, marking important milestones in the company’s mission to deliver innovative, antibody-fragment based immunotherapies for difficult-to-treat cancers (Press release, CDR-Life, SEP 13, 2024, View Source [SID1234646600]).

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First patient dosed with CDR404
The first patient was dosed with CDR404, a novel, bispecific and bivalent antibody fragment-based T cell engager (TCE) targeting MAGE-A4, an intracellular cancer-specific protein that is cleaved into smaller peptide fragments and presented on HLA-A*02:01 molecules at the surface of cancer cells.

The Phase 1 study (NCT06402201) is enrolling HLA-A *02:01+ patients with MAGE-A4+ solid cancers in the U.S. and Europe. The trial is evaluating the safety, tolerability and preliminary anti-tumor activity of CDR404 in several common cancers including squamous cell carcinomas in which MAGE-A4 is highly enriched.

New clinical candidate targeting PRAME
Preferentially Expressed Antigen in Melanoma (PRAME) is a tumor-specific therapeutic target that is expressed in a wide range of solid tumors including lung, ovarian, melanoma, and endometrial cancers, while exhibiting only minimal expression in healthy tissues.

CDR-Life has identified and characterized an antibody fragment-based TCE as a clinical candidate targeting PRAME called CDR813. This TCE binds potently and bivalently to an HLA-A*02-restricted PRAME peptide on the surface of cancer cells. Pre-clinical studies have shown that CDR813 has very favorable pharmacological and manufacturability properties with best-in-class potential for the clinic.

A poster will be presented at the 2024 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, in Barcelona, Spain.

Poster Presentation Details
Title: Highly potent and specific bivalent T cell engager (TCE) targeting PRAME on HLA-A*02:01
Date and Time: Saturday, September 14, 2024, 12 – 1 pm CET
Abstract Number: 5132, Poster 1020P

"The clinical advancement of CDR404 and the excellent progress we have made in advancing CDR813 into a clinically viable drug are significant milestones in our quest to develop life-changing, antibody fragment-based cancer medicines for patients with the HLA-A*02:01 genotype, the most prevalent HLA genotype in the U.S. and Europe, using our proprietary M-gager technology," said Swethajit Biswas, Chief Medical Officer of CDR-Life. "This current suite of T cell engagers targeting cancer-specific peptides presented on HLA underscores our ambitions in solid tumor oncology to create an innovative pipeline of highly specific and potent antibody fragment-based molecules targeting a wide range of cancer-specific antigens including challenging cell surface resident proteins, which are known to be directly involved in tumor growth."