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).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

Ensoma to Present New Preclinical Data at the Society for Immunotherapy of Cancer Annual Meeting

On October 3, 2025 Ensoma, an in vivo hematopoietic stem cell (HSC) engineering company with a mission to advance the future of medicine through one-time therapies, reported it will present new data from the company’s in vivo HSC engineering platform in two poster sessions at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 40th Annual Meeting, hosted November 5-9 in National Harbor, Md (Press release, Ensoma, OCT 3, 2025, View Source [SID1234656432]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Poster Presentations at SITC (Free SITC Whitepaper) 40th Annual Meeting:

Title: Discovery of lineage specific regulatory elements for development of in vivo CAR immune cell therapy via hematopoietic stem cell engineering
Abstract Number: 1019
Poster Presentation Time/Date: Friday, November 7, 5:10-6:35 pm EST
Location: Gaylord National Resort and Convention Center – Lower Level Atrium – Prince George’s ABC
Presenter: Alvin Pratama, Ph.D., Ensoma
Title: In vivo HSC engineering with VLPs generates lineage-restricted, multiplexed CAR-M, NK, and T cells to cooperatively mediate robust and durable solid tumor control in pre-clinical models
Abstract Number: 302
Poster Presentation Time/Date: Saturday, November 8, 5:10-6:35 pm EST
Location: Gaylord National Resort and Convention Center – Lower Level Atrium – Prince George’s ABC
Presenter: Yiwen Zhao, Ph.D., Ensoma

Kazia Therapeutics Announces 86% Reduction in Tumor Burden in Expanded-Access Case of Metastatic TNBC Patient Treated with Paxalisib-Immunotherapy Regimen

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.