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 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 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, reported the expansion of FLAMINGO-01 clinical trial to Belgium (Press release, Greenwich LifeSciences, OCT 2, 2025, View Source [SID1234656401]).

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The Company’s application to European regulators has been formally approved, adding Belgium as an approved country in FLAMINGO-01 in addition to Spain, France, Germany, Italy, Poland, Romania, Ireland, Portugal, and the US.

According to the latest data collected by the European Cancer Information System (click here), a total of 11,366 new cases of breast cancer were diagnosed in Belgium in 2022, which is the most common cancer diagnosed in women, representing approximately 33% of all cancers in women. Breast cancer is the leading cause of death from cancer in women in Belgium with 2,324 deaths in 2022.

The Company is collaborating with Patrick Neven, MD, PhD, at UZ Leuven, who will be serving as the national principal investigator in Belgium for FLAMINGO-01. Dr Neven is Full Professor at the Department of Gynecological Oncology, University Hospitals Leuven, and is a staff member of the Multidisciplinary Breast Centre. His research focuses on breast oncology, particularly endocrine therapy and quality of life. He has served as principal investigator in multiple clinical trials, published over 300 peer-reviewed papers, and lectured widely at international meetings. He is president of the Belgian Society of Senology, active in several scientific societies, and has mentored numerous doctors and PhD students in breast cancer care.

CEO Snehal Patel commented, "We thank our steering committee for introducing us to Dr. Neven and look forward to working with him and his colleagues. We are planning start-up activities in Leuven in the coming month. Leuven is centrally located in Belgium and is an ideal location to cover large parts of the country, including Brussels and Antwerp."

About FLAMINGO-01 and GLSI-100

FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients will be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types will be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.

For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the "Contacts and Locations" section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: [email protected]

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

On October 2, 2025 Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, reported a substantial reduction in tumor burden from a single-patient expanded access case in triple-negative breast cancer (TNBC) treated with a combination regimen that included the Company’s investigational pan-PI3K/mTOR inhibitor, paxalisib (Press release, Kazia Therapeutics, OCT 2, 2025, View Source [SID1234656402]). After three weeks of combination immunotherapy/chemotherapy plus paxalisib, imaging performed at the treating institution showed an 86% reduction in overall tumor burden.

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The patient is a 40+ year old female initially diagnosed with TNBC in April 2023. She received neoadjuvant chemotherapy and immunotherapy, followed by bilateral mastectomy six weeks post-treatment with no residual cancer detected, followed by radiation therapy. Approximately two years later, the patient was diagnosed with metastatic disease to bone and lungs. She was then treated under a single-patient expanded-access protocol with an immunotherapy/chemotherapy regimen plus paxalisib. After three weeks of therapy, imaging demonstrated an 86% overall tumor reduction. The patient’s profile and treatment approach are highly similar to the inclusion and combination strategy being evaluated in Kazia’s Phase 1b TNBC study, which is assessing paxalisib in combination with Keytruda (pembrolizumab) and chemotherapy.

"Although this is a single-patient expanded-access case, the speed and magnitude of tumor regression are highly encouraging and align with our scientific rationale for combining paxalisib with immune checkpoint blockade," said Dr. John Friend, M.D., Chief Executive Officer of Kazia Therapeutics. "This experience reinforces our commitment to our ongoing, company sponsored Phase 1b trial in advanced breast cancer, and it echoes the recent ex-vivo findings showing disruption of circulating tumor cell clusters with paxalisib."

About the ongoing Phase 1b TNBC trial

Kazia is conducting a company-sponsored multi-centered Phase 1b study in Australia evaluating paxalisib in combination with Keytruda and chemotherapy for advanced breast cancer, including TNBC. The study is designed to assess safety, preliminary anti-tumor activity, and translational biomarkers, including effects on circulating tumor cells and cluster dynamics to better understand how paxalisib may enhance immunotherapy responsiveness in this population.

On October 2, 2025 Phost’in Therapeutics, a clinical-stage biotechnology company focused on the development of N-glycosylation inhibitors and the Fondazione Gianni Bonadonna, which provides scientific contribution and independent support, reported that it will jointly present a poster on interim clinical data from the PhAST trial at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress 2025, held October 17–21 in Berlin, Germany (Press release, Phost’in, OCT 2, 2025, View Source [SID1234656403]).

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