Evaxion to present new biomarker data for AI-designed personalized cancer vaccine EVX-01 at the SITC 2025 Annual Meeting

On October 3, 2025 Evaxion A/S (NASDAQ: EVAX) ("Evaxion"), a clinical-stage TechBio company specializing in developing AI-Immunology powered vaccines, reported it will present new data for its lead asset EVX-01 at a poster session at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2025 Annual Meeting taking place in National Harbor November 5-9, 2025 (Press release, Evaxion Biotech, OCT 3, 2025, View Source [SID1234656459]). Designed with Evaxion’s AI-Immunology platform, EVX-01 is a personalized cancer vaccine currently being evaluated as a treatment for advanced melanoma (skin cancer).

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Evaxion will present new biomarker and immune data stemming from the ongoing phase 2 trial with EVX-01. The two-year clinical efficacy data from the trial will, as earlier announced, be presented in an oral presentation at the ESMO (Free ESMO Whitepaper) 2025 congress on October 17, 2025. Both datasets will add to an already strong data package for EVX-01, which includes convincing one-year interim data from the phase 2 trial.

The phase 2 trial investigates EVX-01 in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in patients with advanced melanoma (skin cancer). Each patient enrolled in the trial has received a unique vaccine designed and manufactured based on their individual biology. KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

SITC presentation details:

Abstract title: Immune correlates of clinical response following treatment with the personalized cancer vaccine EVX-01 and Pembrolizumab in advanced melanoma patients
Abstract#: 605
Poster#: 605
Session (category): Clinical trials in progress (subcategory: Skin cancers)
Location: Lower Level Atrium – Prince George’s ABC
Date/Time: Friday, November 7, 2025, 5:10–6:35 p.m. ET/23.10-00.35 CET
Presenter: Michail Angelos Pavlidis, Research Associate at Evaxion
About EVX-01

EVX-01 is a personalized peptide-based cancer vaccine intended for first-line treatment of multiple advanced solid cancers. It is Evaxion’s lead clinical asset.

EVX-01 is designed with our AI-Immunology platform and is tailored to target the unique tumor profile and immune characteristics of each patient. It engages the patient’s immune system to fight off cancer by mounting a targeted response against tumors.

In clinical trials, EVX-01 has demonstrated 69% and 67% Overall Response Rates in patients with advanced melanoma. Further, significant correlations between clinical responses and AI-Immunology predictions have been observed, underlining the predictive power of the platform.

Akari Therapeutics Announces Abstract Accepted for Oral Presentation at the 40th Annual Society for Immunotherapy of Cancer (SITC) Meeting

On October 3, 2025 Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing novel payload antibody drug conjugates (ADCs), reported its abstract has been accepted for oral presentation at the 40th Annual SITC (Free SITC Whitepaper) Meeting being held November 5-9, 2025 in National Harbor, MD (Press release, Akari Therapeutics, OCT 3, 2025, View Source [SID1234656532]).

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Details of the oral presentation are as follows:

Title: A Novel Splicing-Targeted ADC Payload Drives Immune Activation, Synergy with Checkpoint Inhibitors, and Enhanced Therapeutic Potential beyond Cytotoxicity

Presenter: Satyajit Mitra Ph.D., Executive Director, Head of Oncology at Akari Therapeutics

Abstract No: 951

Session: 302 Beyond Cytotoxic Chemotherapy: the Next Generation of ADCs for Immune Modulation

Date and Time: Sunday, November 9, 2025 at 11:05 AM ET

Location: Gaylord National Resort and Convention Center – Ballroom Level – Potomac Ballroom

Poster Presentation: Friday, November 7, 2025

Location: Prince George ABC Exhibit Halls, Gaylord National Resort and Convention Center

For more information about the SITC (Free SITC Whitepaper) Annual Meeting, please visit sitcancer.org.

Radiant Biotherapeutics to Present Next-Generation Multabody™ Approach for Cancer Immunotherapy at the Society for Immunotherapy of Cancer (SITC) 40th Annual Meeting

On October 3, 2025 Radiant Biotherapeutics, a biotechnology company committed to advancing a breakthrough antibody approach, the Multabody, to treat cancer, autoimmune and infectious diseases, reported the Company will present data on its Multabody approach at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 40th Annual Meeting taking place November 5-9, 2025 in National Harbor, MD (Press release, Radiant Biotherapeutics, OCT 3, 2025, View Source [SID1234656431]).

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Current multi-specific antibodies have shown promise as a family of targeted drugs, providing the potential for the simultaneous binding of two or more antigens or epitopes, however inherent structural limitations often prevent optimal therapeutic outcomes for complex diseases due to suboptimal binding affinity and specificity challenges. Radiant’s proprietary Multabody technology addresses these limitations by uniquely harnessing natural biological mechanisms to engage multiple disease targets with superior binding strength, precise tunability, and exceptional therapeutic breadth—all within a single engineered molecule. This breakthrough approach is particularly transformative for treating cancer, autoimmune, and infectious diseases, where the Multabody technology can direct immune cells to destroy tumors, block multiple disease pathways, or maintain therapeutic efficacy even as pathogens mutate.

Poster Presentation Details:

Title: Multabodies: A next-generation approach for cancer immunotherapy and 4-1BB agonist therapy
Abstract Number: 847
Session: Immune stimulants and immune modulators
Date/Time: Tuesday, November 4, 2025
Presenting Author: Joanne Hulme, Ph.D., Chief Scientific Officer, Radiant Biotherapeutics
The titles of the abstracts are currently available on the SITC (Free SITC Whitepaper) 2025 Abstracts webpage. All posters will be available on the virtual meeting platform beginning November 4, 2025, at 9 AM ET.

Data on Clarity’s SAR-bisFAP to be presented at the World Molecular Imaging Conference 2025

On October 2, 2025 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, reported that data on Clarity’s pan-cancer theranostic, 64/67Cu-SAR-bisFAP, will be presented at the upcoming World Molecular Imaging Conference (WMIC) 2025 from the 29th September to October 3rd in Anchorage, Alaska by Dr. Michele De Franco, a research fellow at the Memorial Sloan Kettering Cancer Center (MSK) and Clarity’s collaborator (Press release, Clarity Pharmaceuticals, OCT 2, 2025, View Source [SID1234656399]).

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Clarity is developing 64/67Cu-SAR-bisFAP as potential pan-cancer theranostics targeting fibroblast activation protein (FAP), which is expressed on cancer associated fibroblasts (CAFs), a particular cell type found in the tumour microenvironment (cancer ‘infrastructure’ called the tumour stroma). FAP is found to be highly expressed in a broad range of cancers (e.g. breast, colorectal, pancreatic, lung, brain and ovarian cancers), but only minimally in normal tissue, making it a promising pan-cancer target for both imaging and treatment of cancers1. CAFs form part of the environment surrounding the cancer cells, and they can promote cancer growth and the spread of the tumour throughout the body2. Targeting the tumour stroma is an alternative way to treat cancer whereby the architecture of the tumour mass is targeted rather than the tumour cells directly.

As part of the optimisation process, Clarity developed and assessed two versions of the FAP-targeted product, one with a singular targeting molecule, SAR-FAP, and a dimeric version of the same molecule, SAR-bisFAP. Whilst both molecules have shown high tumour-specific uptake and targeting, the dual-targeting SAR-bisFAP has shown superior tumour targeting and retention in FAP-expressing mouse models.

Comparison between the ex vivo biodistribution of 64Cu-SAR-FAP and 64Cu-SAR-bisFAP in FAP-positive U-87 MG (human glioblastoma) xenografts, showing how much product accumulated in each location, expressed as the percentage of the injected activity (%IA/g), at 1, 4, and 24 h post-injection.

Consistent with the enhanced tumour uptake observed using the dual-targeting 64Cu-SAR-bisFAP, 67Cu-SAR-bisFAP also showed improved efficacy in therapeutic mice studies, with a doubling in the median survival time of the mice who received 30 MBq of 67Cu-SAR-bisFAP compared to those who received 30 MBq of the 67Cu-SAR-FAP monomer or an industry benchmark, 177Lu-FAP-2286 (median survival time was 28.5, 14.5, and 11.5 days, respectively).

Based on this data and results from previously completed pre-clinical studies, Clarity is aiming to progress the dual-targeting SAR-bisFAP theranostic products into human clinical studies, with a focus on the diagnostic in the first instance.

Dr Alan Taylor, Executive Chairperson of Clarity Pharmaceuticals, commented: "FAP-targeted products represent an exciting new generation of radiopharmaceuticals with the potential to target a range of cancer indications with high unmet needs. Consistent with our approach to high quality research and science, we continue to explore and optimise the most promising products in the field and going the extra mile to maximise their viability and success in the clinic. Starting from the benchtop, we work with thought leaders in the field to overcome the shortcomings of the existing products in development and generate strong data to support this. As a result of this commitment to excellence, we are now excited for our colleagues at MSK to share the results of the SAR-bisFAP products at one of the leading conferences in the field as they pave the way for clinical research in the near future.

"The diagnostic products using copper-64 and the therapeutics using copper-67 have shown high tumour targeting and retention in FAP-expressing xenograft mice models of cancer, with the dual-targeting 64Cu-SAR-bisFAP showing improved retention compared to the monomer alone, and 67Cu-SAR-bisFAP displaying improved efficacy compared to both 67Cu-SAR-FAP and an industry benchmark, 177Lu-FAP-2286. We believe these benefits are enabled by the optimised "bis" structure of our FAP product as well as the advantages offered by the perfect pairing of copper-64 and copper-67, securely held by our proprietary SAR chelator.

"Based on this data, we are currently conducting product development to enable a Phase I clinical trial in 2026 with 64Cu-SAR-bisFAP, which will be followed by exploring potential treatment opportunities of cancers based on their unmet medical needs using 67Cu-SAR-bisFAP in subsequent clinical trials."

Cartography Secures $67 Million Series B Financing to Advance Differentiated Oncology Pipeline of Antibody-Based Therapies into the Clinic

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."