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."

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 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 Massive Bio, a cutting-edge AI driven clinical trial matching platform provider, and Foundation Medicine, Inc. reported a strategic collaboration to increase patient access to cutting edge clinical trials (Press release, Foundation Medicine, SEP 13, 2024, View Source [SID1234646597]). This collaboration unites Massive Bio’s patient matching technology and last-mile solutions with Foundation Medicine’s global expertise and leadership in next generation sequencing (NGS) and network of healthcare providers.

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This partnership seeks to improve the low rate of patient enrollment in oncology clinical trials, which sees only about 8% of eligible patients participating in clinical trials1. As potential new therapies increasingly address rare cancers, approximately 80% of clinical studies globally fail to enroll enough patients with a biopharmaceutical company’s desired timeline, according to a 2020 report published in Perspectives in Clinical Research2. The cornerstone of this partnership lies in integrated solutions that enhance service delivery for both Massive Bio’s and Foundation Medicine’s customers through shared data and AI analytics focused on patient matching.

"The application of real-time AI and our comprehensive data significantly boosts the speed and accuracy of clinical trial matching," said Dr. Arturo Loaiza-Bonilla, MD MSEd, Co-founder and Chief Medical Officer at Massive Bio. "This capability allows us to provide individualized treatments more quickly and accurately, enhancing patient outcomes across the globe. Joining forces with Foundation Medicine is pivotal as it will allow us to develop solutions to the cancer clinical trial enrollment paradox."

Massive Bio is building the largest global oncology/hematology network to transform patient recruitment at scale with more than 132,000 patients, 5,000 physicians, 40 pharma and CRO customers and 50 partners. Massive Bio’s real-time, AI-driven platform, Synergy-AI, can analyze and summarize extensive medical records, including biomarker data from multiple sources, to match patients with over 16,000 clinical trials instantly. Massive Bio’s predictive analytics maximizes trial enrollment potential and significantly reduces screen failures.

Through this partnership, Massive Bio and Foundation Medicine hope to increase clinical trial enrollment with their extensive networks and capabilities across the healthcare landscape, employing advanced AI techniques and a robust digital health platform to refine clinical trial processes and enhance precision oncology.

"Beyond providing high quality genomic profiling to support informed decision making, Foundation Medicine is committed to empowering practitioners to act on those decisions by identifying personalized treatment options including clinical trials," said Heather Jorajuria, Senior Vice President, Clinical & Scientific Operations at Foundation Medicine. "Through this partnership with Massive Bio, we have the patient at the forefront, leveraging our combined assets and expertise to improve access to clinical trials for patients."

On September 13, 2024 OS Therapies, a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, reported the development and in vitro concept data for two novel ADC therapeutic candidates leveraging the Company’s proprietary SiLinker technology (Press release, OS Therapies, SEP 13, 2024, View Source;Based-Therapeutic-Candidates [SID1234646596]). The Company has completed target engagement tests for both therapeutic candidates and confirmed their therapeutic potential. These new constructs will target Breast, Lung and Gastric Cancer; and Ovarian, Fallopian Tube and Primary Peritoneal Cancer, respectively.

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The Company is advancing its tADC platform through successive product development de-risking milestones and intends to out-license certain therapeutic candidates and components that are strategic to potential partners’ pipelines – particularly the ph-sensitive SiLinker. The Company’s first tADC asset OST-tADC-FRα-H has achieved proof of concept in animal models of ovarian cancer. With the additional two constructs now added to the pipeline, the Company is positioning itself to become a key provider of intellectual property for new therapeutic product development to partners. All while continuing to focus its internal resources on bringing to market the OST-HER2 off-the-shelf immunotherapy cancer vaccine platform for canines with osteosarcoma, and for humans with osteosarcoma and other HER2 positive cancers such as breast cancer and colorectal cancer.