Repare Therapeutics to Present Data from Phase 1/2 TRESR Clinical Trial Evaluating Camonsertib Monotherapy in Multiple Advanced Solid Tumors Harboring ATM Loss-of-Function at ESMO Congress 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

Massive Bio and Foundation Medicine Partner to Optimize Clinical Trial Recruitment and Enrollment to Expand Access to Precision Cancer Care

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."

OS Therapies Announces Development of Two Novel Tunable Antibody Drug Conjugate (tADC)-Based Therapeutic Candidates

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.

Tempus Announces Four Abstracts Accepted For Presentation at the European Society for Medical Oncology Congress 2024

On September 13, 2024 Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, reported four abstracts were accepted for presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024, which convenes in Barcelona, Spain, from September 13-17, 2024 (Press release, Tempus, SEP 13, 2024, View Source [SID1234646595]).

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"ESMO provides a great platform to share our recent research and advancements with the global oncology community, foster further collaboration, and drive forward the mission of improving patient outcomes," said Ezra Cohen, MD, Chief Medical Officer of Oncology at Tempus. "At Tempus, we are committed to leveraging AI and data to transform cancer care and research, and this is a great opportunity to showcase the impact of our innovative approaches to both."

This year, Tempus will share a few of its latest scientific and clinical research findings via one oral presentation and three poster presentations, including:

Oral Presentation (#CN13): Impact of AI Clinical Trial Program on Screening, Matching, and Enrollment of Patients Over 6 Months
Session Date & Time: Monday, September 16, 2024; 11:05-11:15 a.m. CEST
Location: Fira Barcelona Gran Via; Hall 7
Overview: In collaboration with Cleveland Clinic, Tempus’ TIME initiative streamlined large-scale patient screening and clinical trial matching, enhanced patient enrollment and access, and achieved an average of more than one consent per day over a six-month period. Utilizing AI for patient matching and accelerating trial activation is recommended to maximize clinical trial success.

Poster Presentation (#113P): The association of changes in circulating tumor fraction and in actionable variant allele frequencies with clinical outcomes in real world diverse cohort of advanced patients treated with Tyrosine Kinase inhibitors
Session Date & Time: Sunday, September 15, 2024; 9:00 a.m.-17:00 p.m. CEST
Location: Fira Barcelona Gran Via; Hall 6
Overview: This study evaluates the use of circulating tumor DNA (ctDNA) for monitoring treatment response in advanced solid tumor patients treated with tyrosine kinase inhibitors (TKIs). Using the Tempus xM ctDNA assay, patients were classified as molecular responders (MRs) or non-responders (nMRs) based on changes in ctDNA tumor fraction (TF). The majority of patients ( 69%) had targetable SNV/indels; 13 were MRs and 18 were nMRs. MRs had longer overall survival (no deaths during follow-up) than nMRs. Among patients with decreasing variant allele frequencies (VAF, n=21), patients that were MRs (n=12) had significantly longer survival compared to nMRs (n=9). The study suggests that ctDNA TF monitoring may be used clinically to monitor response to TKI therapy beyond targeted VAF monitoring alone and warrants further validation.

Poster Presentation (#79P): Comprehensive Genomic Profiling provides patients access to novel matched therapies in a diverse real world cohort of advanced lung cancer patients
Session Date & Time: Sunday, September 15, 2024; 9:00 a.m.-17:00 p.m. CEST
Location: Fira Barcelona Gran Via; Hall 6
Overview: This study assessed adherence with guideline-recommended targeted therapy recommendations and the time from genomic sequencing to the initiation of targeted treatment in a diverse, real-world dataset of advanced NSCLC patients. Findings show that most oncologists utilized comprehensive genomic profiling (CGP) to identify and treat patients with guideline-recommended, variant matched targeted therapy, with adherence rates varying according to the variant. Notably, even patients that received CGP results prior to FDA approval of novel therapies, received matched therapy once they were included in guidelines.

Poster Presentation (#580P): Impact of RAS and BRAFV600E mutations on tumor immune microenvironment and associated genomic alterations in patients with microsatellite instability (MSI) or DNA Mismatch Repair Deficient (dMMR) colorectal cancers
Session Date & Time: Monday, September 16, 2024; 9:00 a.m.-17:00 p.m. CEST
Location: Fira Barcelona Gran Via; Hall 6
Overview: This study aimed to understand the impact of RAS and BRAF mutations on prognosis and treatment effects in MSI/dMMR patients in both localized and metastatic settings. These data suggest that MSI/dMMR colorectal cancers (CRC) with RAS mutations are less immunogenic and exhibit a lower tumor inflammatory profile in the tumor immune microenvironment (TIME) compared to those with RAS wild-type (RASwt) or BRAF V600E mutations. Further analysis and validation are required to confirm these findings.

Moffitt Cancer Center Announces Strategic Collaboration with AstraZeneca to Accelerate Oncology Cell Therapies

On September 13, 2024 Moffitt Cancer Center reported a strategic collaboration with AstraZeneca that aims to accelerate the development of cell therapies, specifically chimeric antigen receptor T cell (CAR T) and T cell receptor (TCR T) therapies (Press release, Moffitt Cancer Ctr, SEP 13, 2024, View Source [SID1234646594]).

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Under this collaboration, AstraZeneca will have priority access to Moffitt’s leading clinical environment and forge strong connections between physician-scientists to accelerate the investigation of novel cell therapies.

Advances in cell therapy, including CAR Ts and TCR Ts, are reshaping cancer care by offering potential new treatments for cancers with limited treatment options. The field has grown exponentially since the first CAR T therapies were approved in 2017. Moffitt was pivotal in the clinical trials that led to several FDA approvals for cell therapies and continues to grow its capabilities in this field, with an extensive network of cancer centers across the United States.

The collaboration aims to address cell therapy development challenges and expand cell therapies’ reach to more patients in the United States and beyond. A key focus will be on advancing clinical studies to investigate cell therapies in solid tumors and further optimizing clinical operations to streamline and expedite the delivery of autologous cell therapies to patients.

"We are excited to collaborate with AstraZeneca to push the boundaries of what’s possible in cancer treatment. By combining our clinical expertise with AstraZeneca’s innovative pipeline of investigational cell therapies, global footprint and leadership in oncology, we aim to bring potential new cell therapies to patients faster and more efficiently," said Patrick Hwu, M.D., president and CEO of Moffitt.

"This collaboration will strengthen our connections with the Moffitt Cancer Center to accelerate the development of our autologous cell therapy pipeline as we strive to redefine cancer treatment for more people living with hematological and solid cancers," said Carsten Linnemann, Head of Oncology Cell Therapy Clinical Development, AstraZeneca.

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