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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.

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).

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.

Candel Therapeutics to Present at the SITC 2025 Annual Meeting

On October 3, 2025 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, reported the Company will present insights from its enLIGHTEN Discovery Platform, and additional data from the CAN-2409 (aglatimagene besadenovec) program in non-small cell lung cancer (NSCLC), through two accepted poster presentations at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 40th Anniversary Annual Meeting, taking place November 5-9, 2025 in National Harbor, Maryland (Press release, Candel Therapeutics, OCT 3, 2025, View Source [SID1234656449]).

Dr. Paul Peter Tak, M.D., Ph.D., FMedSci, will also present Candel’s positive phase 3 clinical trial data of CAN-2409 in patients with intermediate-to-high-risk localized prostate cancer as part of an invited faculty presentation and panel discussion on the state of the cancer "and beyond" immunotherapy field, including both opportunities and obstacles for developing the next wave of breakthrough therapeutics.

Details are as follows:

Poster Presentations

Title: Integrative discovery of a multimodal cancer immunotherapy using machine learning and viral vector engineering
Presenter: Anne Diers, Ph.D., Vice President, Research, Candel Therapeutics
Abstract Number: 893
Session Date: Friday, Nov. 7, 2025
Location: Prince George ABC Exhibit Halls – Gaylord National Resort and Convention

Title: Advanced analytics identify a differential immune response to CAN-2409+valacyclovir in non-squamous vs squamous NSCLC, linked to improved survival in patients with progressive ICI-refractory NSCLC
Presenter: Daniel H. Sterman, M.D., Thomas and Suzanne Murphy Professor and Director, Multidisciplinary Pulmonary Oncology Program, NYU Langone Medical Center
Abstract Number: 513
Session Date: Friday, Nov. 7, 2025
Location: Prince George ABC Exhibit Halls – Gaylord National Resort and Convention

Invited Faculty Presentation and Panel Discussion

Title: Phase 3, Randomized, Placebo-Controlled Clinical Trial of CAN-2409 + Prodrug in Combination with Standard of Care Radiation Therapy for Newly Diagnosed, Localized Prostate Cancer with Curative Intent
Presenter: Paul Peter Tak, M.D., Ph.D., FMedSci, President and CEO of Candel Therapeutics
Session: The Next Wave: Viruses, Cells and Next-gen PD-1 Bispecifics
Date/Time: Friday, Nov. 7, 2025, 3:55 – 5:35 p.m.
Location: Potomac Ballroom – Gaylord National Resort and Convention

Transgene to Present New Immunological Data from Phase I Trial of Individualized Therapeutic Cancer Vaccine, TG4050, at SITC 2025

On October 3, 2025 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported it will present a poster highlighting in-depth analysis of the neoantigen-specific T cell response from the randomized Phase I trial of its individualized therapeutic cancer vaccine, TG4050, at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (Press release, Transgene, OCT 3, 2025, View Source [SID1234656448]). SITC (Free SITC Whitepaper) will take place November 5 to 9, 2025, in National Harbor, Maryland, USA.

Poster details

Title: "Profiling of the neoantigen-specific T cell response after adjuvant TG4050 individualized therapeutic vaccination in a randomized Phase 1 trial for locally advanced resected HPV negative HNSCC".

Poster and abstract number: 502
Date: November 8, 2025
Author: C. Le Tourneau
The abstract will be available on the SITC (Free SITC Whitepaper) website on November 4, 2025, at 9 a.m. ET.

TG4050 is an individualized immunotherapy being developed for solid tumors that is based on Transgene’s myvac technology and powered by NEC’s longstanding artificial intelligence (AI) expertise. TG4050 is being evaluated in a randomized multicenter Phase I/II clinical trial as a single agent in the adjuvant treatment of HPV-negative head and neck cancers (NCT04183166).

Transgene previously presented in a rapid oral presentation at the ASCO (Free ASCO Whitepaper) conference in June 2025, that all patients from Phase I who received TG4050 remained disease-free after a minimum of 2-year follow-up, comparing favorably to the observational arm which saw 3 out of 16 patients relapse during the same time period.

Transgene and NEC are continuing the joint development of TG4050 in this indication with a Phase II extension of the trial, which is currently enrolling patients.

Ironfist Therapeutics Announces Preclinical Proof of Concept for Novel Nanomedicine Radiopharmaceutical, Tamrada™

On October 3, 2025 Ironfist Therapeutics ("Ironfist"), a preclinical-stage company developing a nanomedicine radiopharmaceutical (Tamrada) that selectively targets tumor associated macrophages without a targeting ligand, reported the company will be presenting positive preclinical proof of concept results in anti-PD-1 resistant triple negative breast (TNB) cancer models using 177Lu-Tamrada at the 38th Annual Congress of the European Association of Nuclear Medicine (EANM) (Press release, Ironfist Therapeutics, OCT 3, 2025, View Source [SID1234656446]).

"These preclinical results coupled with our other 7 studies in a range of tumor types clearly demonstrate the therapeutic potential of targeting TAMs," said Jeffrey L Cleland, PhD, Chief Executive Officer of Ironfist Therapeutics.

TNB cancer is aggressive and unresponsive to anti-PD-1 antibody therapy in humans and preclinical models. Previous studies in the TNB cancer (4T1) mouse model presented at the Society for Nuclear Medicine and Molecular Imaging (SNMMI 2025) indicated a maximum 64Cu-Tamrada uptake of 41% ID/g in tumors. In this follow-up study, xenograft and orthotopic TNB cancer models were treated with the 177Lu-Tamrada at different radiation doses and regimens with and without anti-PD-1 antibody.

Key findings include:

Tamrada was tuned to optimize selectivity for TAMs and retention of 177Lu to maximize in vivo delivery to tumors
177Lu-Tamrada was retained in TAMs for over 10 days from a single administration (SPECT/CT)
177Lu-Tamrada alone caused tumor inhibition in both xenograft and orthotopic 4T1 mouse models
30 MBq 177Lu-Tamarada alone as a single or fractionated equivalent total dose (2x or 3x/week) caused significant (p < 0.05) tumor growth inhibition in orthotopic 4T1 tumor bearing mice compared to vehicle and anti-PD-1 treated mice.
At equivalent total radiation doses, fractionated doses were better tolerated and caused greater tumor accumulation than single doses.
"These preclinical results coupled with our other 7 studies in a range of tumor types clearly demonstrate the therapeutic potential of targeting TAMs," said Jeffrey L Cleland, PhD, Chief Executive Officer of Ironfist Therapeutics. "With this theragnostic approach, 64Cu/177Lu-Tamrada has the potential to precisely treat a wide range of tumors, kill tumor cells through bystander effects, and unlock the immune system. We look forward to sharing our compelling efficacy results in a PSMA negative mouse model at a subsequent meeting in 2026."

Unlike other radiopharmaceutical approaches, Tamrada is tumor agnostic because it is directly targeting TAMs. TAMs protect the tumor from the immune system, stimulate angiogenesis, and generate metastases. The hydroxyl dendrimer core of Tamrada was tuned specifically for selective uptake by TAMs without off target uptake in other macrophages. Once taken up by TAMs, Tamrada is not metabolized and is retained within the cells for up to one month providing a persistent source of radiation in the tumor with systemic clearance within 2-3 days.

Presentation Details:

Selective Killing of Tumor Associated Macrophages with a [177Lu]Lu-Nanomedicine Unlocks Checkpoint Inhibition

Presentation Number:

OP-025

Session Number:

204

Session Title:

M2M Track – TROP Session – Radiopharmaceutical Sciences + Translational
Molecular Imaging & Therapy Committee: New Targets in

Session Date:

Sunday, October 5, 2025

Session Presentation Time:

9:20:00 AM

Session Hall:

Room 114

About Tamrada

Tumors often enlist tumor-associated macrophages (TAMs) as protectors, shielding them from the immune system. Tamrada changes the story — reprogramming or removing these suppressive cells so the immune system can see the tumor clearly and strike with full force. Tamrada is designed from the novel nanomedicine technology of hydroxyl dendrimers invented at Johns Hopkins University. The nanomedicine component of Tamrada is comparable in size to an antibody fragment, does not leave the vasculature except in tumors, and has renal and biliary clearance without metabolism. 64Cu/177Lu-Tamrada enables precision dosing of cancer patients using a theragnostic approach. 177Lu-Tamrada provides an additional benefit of a bystander effect by killing adjacent tumor cells. The nanomedicine in Tamrada is amendable to modifications to create a pipeline of radiopharmaceuticals with different radioisotopes.