On October 3, 2025 Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through development of its lead immune-activating antibody therapeutic, reported the presentation of updated Phase 2 data from its ongoing study of imneskibart (AU-007) in patients with checkpoint inhibitor (CPI)-refractory melanoma and non-small cell lung cancer (NSCLC) (Press release, Aulos Bioscience, OCT 3, 2025, View Source [SID1234656422]). The data will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 40th Annual Meeting, being held virtually and in National Harbor, Maryland, from November 5-9, 2025.

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Details of the poster presentation are as follows:

Poster Title: Imneskibart, a human monoclonal antibody (mAb) that binds IL-2 and prevents CD25 binding, + low-dose subcutaneous IL-2: Phase 2 update on CPI-refractory melanoma and non-small cell lung cancer (NSCLC)
Abstract: 651
Date and Time: Friday, November 7, 2025, 10:00 a.m.-7:00 p.m. EST

The poster will be presented in the Prince George ABC Exhibit Halls at the Gaylord National Resort and Convention Center. An electronic version will also be available on the SITC (Free SITC Whitepaper) 2025 virtual meeting platform.

About Imneskibart
Imneskibart (AU-007) is a human IgG1 monoclonal antibody designed by leveraging artificial intelligence that is highly selective to the CD25-binding portion of IL-2. With a mechanism of action unlike any other IL-2 therapeutic in development, imneskibart redirects IL-2 to reinforce anti-tumor immune effects. This is achieved by preventing IL-2, either exogenous or secreted by effector T cells, from binding to trimeric receptors on regulatory T cells while still allowing IL-2 to bind and expand effector T cells and NK cells. This prevents the negative feedback loop caused by other IL-2-based treatments and biases the immune system toward activation over suppression. Imneskibart also prevents IL-2 from binding to CD25-containing receptors on eosinophils, as well as vasculature and pulmonary endothelium, which may significantly reduce the vascular leak syndrome and pulmonary edema associated with high-dose IL-2 therapy.

To learn more about the imneskibart Phase 1/2 clinical trial program, including study locations in the United States and Australia, please visit ClinicalTrials.gov (identifier: NCT05267626), www.solidtumorstudy.com (U.S.) and www.solidtumourstudy.com (Australia).

On October 3, 2025 ALX Oncology Holdings Inc., ("ALX Oncology" or "the Company") (Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, reported updated data from its Phase 2 ASPEN-06 (NCT05002127) trial will be presented during a poster session at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 40th Annual Meeting taking place November 5–9, 2025, in National Harbor, Maryland (Press release, ALX Oncology, OCT 3, 2025, View Source [SID1234656421]). The Phase 2 trial evaluated evorpacept, the Company’s lead therapeutic candidate, in combination with HERCEPTIN (trastuzumab), CYRAMZA (ramucirumab) and paclitaxel, for patients with previously treated HER2-positive advanced gastric cancer (GC) and gastroesophageal junction (GEJ) cancer.

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Details for the poster presentation at SITC (Free SITC Whitepaper) 2025 are as follows:
Title: CD47 expression as a predictive biomarker for evorpacept in HER2-positive gastric/gastroesophageal cancer from the Phase 2 randomized ASPEN-06 trial
First Author: Zev A. Wainberg, M.D., Professor of Medicine and Co-Director of GI Oncology Program, University of California, Los Angeles
Abstract: 496
Date and Time: Saturday, November 8, 2025, 10:00 a.m. – 6:35 p.m. ET
Location: Poster Hall (Exhibit Halls AB)

About ASPEN-06

ASPEN-06 is a randomized Phase 2 (open-label)/3 (blinded), international, multi-center study, evaluating evorpacept in combination with HERCEPTIN (trastuzumab), CYRAMZA (ramucirumab) and paclitaxel, for patients with metastatic second- or third-line HER2 overexpressing gastric/GEJ adenocarcinoma that has progressed on or after prior HER2-directed therapy and fluoropyrimidine- or platinum-containing chemotherapy and are suitable for chemotherapy. One hundred twenty-seven adult patients were enrolled in the Phase 2 portion of the study.

On October 2, 2025 Genialis, the RNA biomarker company, reported a collaboration with Cleveland Clinic, one of the world’s leading academic medical centers, to develop AI-powered tools that help doctors identify the most effective treatment options for patients with pancreatic ductal adenocarcinoma (PDAC), the most common and deadliest form of pancreatic cancer (Press release, Cleveland Clinic , OCT 2, 2025, View Source [SID1234656417]).

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The collaboration leverages the Genialis Supermodel, a foundation model built from one of the world’s largest and most diverse RNA-sequencing datasets to create predictive biomarker algorithms. These tools aim to help clinicians identify the most effective therapies for individual PDAC patients, optimize treatment selection, and accelerate access to novel drug strategies.

Addressing an Urgent Need

PDAC is one of the most aggressive and lethal cancers, responsible for more than 90 percent, or over 50,000, of pancreatic cancer deaths annually in the United States alone1. Despite improved survivorship in some common cancers, the Cancer Research Institute cites2 that the PDAC five-year relative survival rate remains around 9 percent, among the lowest across all cancer types.

Together, Genialis and Cleveland Clinic will work on testing Genialis Supermodel predictions across a range of therapies and combinations in the hospital’s patient-derived organoid center to quickly validate and iterate on predictive algorithms.

"For clinicians, time is critical. While standard therapies exist, we lack validated biomarkers to identify which patients are most likely to benefit from various treatment options," said Wen Wee Ma, MD, Director, Novel Cancer Therapeutics Center, Enterprise Vice Chair, Research Cleveland Clinic Cancer Institute. "Emerging therapies, including KRAS inhibitors, offer new hope but require precise patient selection to achieve meaningful outcomes. Our goal is to bring practical, data-driven tools into the clinic that help us choose the best treatment paths for patients who currently have very few effective options." Dr. Ma will serve in an advisory capacity and may receive research funding and royalties.

The majority of PDAC cases harbors a KRAS mutation.3

"Through our work on biomarker algorithms for KRAS inhibitors, Genialis has already made a major investment in understanding the drivers of PDAC," said Rafael Rosengarten, Ph.D., CEO of Genialis. "Our collaboration with Cleveland Clinic aims to extend these insights to give doctors and patients better tools to combat the disease. This is an important step toward truly data-driven, personalized care in one of the most pressing areas of unmet need."

Genialis krasID, powered by the Genialis Supermodel, is the first biomarker algorithm that can predict patient response and clinical benefit to KRAS inhibitors (KRASi) across tissue histology and mutation type. Genialis krasID can help guide drug development from early preclinical phases (e.g., compound/MOA differentiation and selection), to clinical trials (e.g., patient selection for clinical trials and identification of combination therapies), to market access and clinical care (e.g., development of CDx and as a clinical decision tool).

On October 2, 2025 Cartography Biosciences, Inc., an oncology company advancing an innovative pipeline of T-cell engaging bispecific and multi-specific antibody therapeutics that target novel and highly specific tumor antigens, reported the close of a $67 million Series B financing (Press release, Cartography Biosciences, OCT 2, 2025, View Source [SID1234656416]). The funding will help support the advancement of Cartography’s lead program, CBI-1214, into the clinic and the continued acceleration of additional, highly differentiated oncology programs generated from its ATLAS and SUMMIT drug discovery platforms.

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The Series B was led by new investor Pfizer Ventures and was joined by additional new investors LG Corp, Amgen Ventures, Finchley H.V., Global BioAccess Fund, and Lotte Holdings CVC, as well as existing investors Andreessen Horowitz (a16z) Bio + Health, 8VC, Wing Venture Capital, Catalio Capital Management, AME Cloud Ventures, ARTIS Ventures, and Gaingels. As part of the financing, Michael Baran, MBA, Ph.D., Partner at Pfizer Ventures, has joined Cartography’s Board of Directors. Additionally, Troy E. Wilson, Ph.D., J.D., who had previously joined as an Independent Director, has been elected as Chairman of the Board.

"Cartography is uniquely positioned to lead the potential next generation of T-cell engagers with a novel late preclinical program for colorectal cancer," said Michael Baran. "With a strong discovery platform and a growing pipeline, Cartography is quickly emerging as a leader in antibody therapeutics, and Pfizer Ventures is excited to support their progress in bringing potential new treatments to patients."

Cartography’s lead program CBI-1214 is a T-cell engager molecule that targets LY6G6D, an emerging and highly specific tumor antigen for treating colorectal cancer (CRC) patients. The target, which has minimal expression on healthy cells, is uniquely expressed within the microsatellite stable (MSS) and microsatellite instability-low (MSI-L) subtypes of CRC, which represent the vast majority of CRC patients and remains a major area of unmet medical need. CBI-1214 has protein engineering features that are specifically designed to optimize anti-tumor activity.

Kevin Parker, Ph.D., CEO of Cartography Biosciences said, "Combining insights from thousands of patient tissue samples, our ATLAS and SUMMIT platforms have identified several novel targets and target pairs that we have engineered new T-cell engagers against. CBI-1214, our first announced program, has the potential to be a first- and best-in-class molecule targeting CRC and positions Cartography as an emerging leader in new targeted therapies. We are grateful for the support of Pfizer Ventures and a world-class roster of strategic and financial investors as we move forward with CBI-1214, which is on track for an investigational new drug application later this year and trial enrollment in early 2026."

On October 2, 2025 Ataraxis AI, a frontier laboratory developing artificial intelligence (AI)–powered prognostic tools for oncology, and MEDSIR (Medica Scientia Innovation Research), a global leader in oncology research, reported a strategic collaboration to integrate artificial intelligence into multiple major international trials (Press release, MedSIR, OCT 2, 2025, View Source [SID1234656415]). These studies, involving data from more than 1,000 patients across randomized clinical trials, aim to identify biomarkers that can optimize treatment strategies for breast cancer, including therapies with CDK4/6 inhibitors and antibody-drug conjugates (ADCs).

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MEDSIR has been a key contributor to oncology clinical trials, helping support the advancement of transformative therapies into standard practice. These efforts have expanded access to novel treatment options and improved outcomes for patients worldwide. The introduction of new therapeutics creates an opportunity but also a challenge to select the right drug for every patient. Ataraxis addresses this critical need with Ataraxis Breast, the first AI-native platform in breast cancer developed to predict patient outcomes and treatment effects. By integrating insights from standard digital pathology slides with clinical data, the platform provides a new evidence-based layer to support treatment decisions and personalize care.

Building upon Ataraxis’ previous positive clinical validation results showing efficacy across major breast cancer subtypes, the research collaboration between MEDSIR and Ataraxis AI will focus on leveraging artificial intelligence to predict outcomes across key breast cancer subtypes—including HR+ and HER2+ cohorts—encompassing patients in early-stage and metastatic settings. The goal is to enhance clinical decision-making by integrating AI-driven insights into routine oncology workflows.

"Breast cancer treatment continues to improve, with new therapies becoming available every year. However, this creates a challenge in selecting the right drug at the right time. At Ataraxis, we are developing AI-native tools to accurately predict patient outcomes and treatment response for all cancer patients. We are proud to partner with MEDSIR to validate our breast cancer platform using data from practice-changing clinical trials," said Jan Witowski, Chief Executive Officer and Co-Founder of Ataraxis AI.

"At MEDSIR, we are committed to accelerating innovation in oncology through collaborative research that brings real value to patients and clinicians," said Alicia García, Scientific Director at MEDSIR. "Partnering with Ataraxis AI allows us to integrate cutting-edge artificial intelligence into clinical trials, generating evidence that can transform treatment decision-making in breast cancer. This collaboration represents an important step toward a future where precision oncology is not just a concept, but a standard of care."

This announcement demonstrates the commitment to building global collaborative networks for both MEDSIR and Ataraxis AI. With strategic headquarters in Europe and the United States, MEDSIR has built an extensive global network of more than 600 researchers and has conducted 65 clinical trials across more than 200 sites in 14 countries. Ataraxis AI has partnerships with over 40 institutions on the development, validation, and deployment of AI-based tools for treatment selection. Additionally, this collaboration marks a milestone in building clinical evidence for Ataraxis Breast moving beyond retrospective observational studies and into prospective trials investigating new therapies.