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BriaCell to Present Positive Clinical Biomarker Data of Phase 3 Study at ESMO 2025

On October 13, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported it will be presenting positive clinical biomarker data of its ongoing pivotal Phase 3 study of Bria-IMT plus an immune check point inhibitor (CPI) in metastatic breast cancer at its poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025 Annual Meeting taking place October 17 – 21 in Berlin, Germany.

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The details of the poster presentation is listed below.

#3928: Feasibility and Biomarker Validation of an International Randomized Phase 3 Trial of Bria-IMT Cell Therapy in Late Stage MBC (BRIA-ABC)
Presentation Number: 570P
Speaker: Dr. Giuseppe Del Priore
Date and Time: Oct 20, 2025, at 12:00 – 1:00 pm CET
Presentation venue: Messe Berlin, Messedamm 22, 14055 Berlin, Germany, Hall 25

Abstract Summary
In BriaCell’s pivotal Phase 3 study of Bria-IMT plus an immune check point inhibitor (CPI) in metastatic breast cancer, patients are randomized 1:1:1 to Bria-IMT + CPI, Physician’s Choice, or Bria-IMT monotherapy. As of the time of the abstract submission, data in 68 evaluable patients, with a median of 6 prior lines of treatment (2–13), was available. Additional data will be presented at the ESMO (Free ESMO Whitepaper) conference.

Clinical efficacy data: Treatment arm agnostic biomarker positive subgroups showed significant improvement in progression free survival in patients who developed an immune response to Bria-IMT (as measured by delayed type hypersensitivity) (p=0.0002).

Tolerability profile: Bria-IMT was well tolerated with no treatment-related discontinuations due to adverse events (AEs). Most common AEs include fatigue 22.8%, anemia 22.8%, and nausea 21.5%.

About BriaCell’s Pivotal Phase 3 Clinical Study of Bria-IMT Combination Regimen in MBC patients

BriaCell’s pivotal Phase 3 study of Bria-IMT plus an immune check point inhibitor (CPI) in metastatic breast cancer is ongoing.

Interim data will be analyzed once 144 patient events (deaths) occur, comparing the overall survival (OS) in patients treated with the Bria-IMT combination regimen versus those treated with physician’s choice as the primary endpoint. Positive results of the pivotal Phase 3 study could result in full approval and marketing authorization for Bria-IMT in MBC patients. BriaCell reported positive Phase 2 survival data in a similar MBC patient population treated with the same Bria-IMT combination regimen . The Bria-IMT combination regimen has received FDA Fast Track designation.

For additional information on BriaCell’s pivotal Phase 3 study of Bria-IMT and an immune check point inhibitor in metastatic breast cancer, please visit ClinicalTrials.gov NCT06072612 .

Following the presentations, copies of the presentations will be posted on View Source

(Press release, BriaCell Therapeutics, OCT 13, 2025, View Source [SID1234656935])

Repare Therapeutics to Present Initial Data from Phase 1 LIONS Clinical Trial at 37th AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

On October 13, 2025 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a clinical-stage precision oncology company, reported it will share initial topline safety, tolerability and early efficacy data from the Phase 1 LIONS trial in a poster presentation at the 37th AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), being held October 22-26, 2025 in Boston, MA.

The LIONS clinical trial (NCT06232408) is a first-in-human, multicenter, open-label Phase 1 study to investigate safety, pharmacokinetics, pharmacodynamics and the preliminary efficacy of RP-1664, a potential first-in-class, highly selective, oral PLK4 inhibitor, for the monotherapy treatment of adult and adolescent patients with TRIM37-high solid tumors.

Poster Presentation Details:

Title: Preliminary safety and antitumor activity of RP-1664, a first-in-class PLK4 inhibitor, as monotherapy in advanced solid tumors with and without TRIM37 amplification
Presenter: Benjamin Herzberg, MD, Columbia University
Abstract Number: LB-C002
Session: Poster Session C
Session Date and Time: Saturday, October 25 | 12:30 p.m. – 4:00 p.m. ET
Session Location: Level 2, Exhibit Hall D

A copy of the poster presentation will be available on the Scientific Resources page of the Repare Therapeutics website at the start of the poster presentation session.

About RP-1664

RP-1664 is a potential first-in-class, highly selective, oral PLK4 inhibitor designed to harness the synthetic lethal relationship with TRIM37 amplification or overexpression in solid tumors. Tumors rely on PLK4 for centriole biogenesis in S-phase of the cell cycle when TRIM37, an E3 ligase that reduces pericentriolar material, is high. Preclinical studies demonstrate that RP-1664 selectively inhibits PLK4 and drives potent synthetic lethality in TRIM37-high tumor models, both in vitro and in vivo. Elevated TRIM37 is a feature found across a range of solid tumors and in approximately 80% of all high-grade neuroblastomas. RP-1664 is the only selective PLK4 inhibitor known to be in the clinic.

(Press release, Repare Therapeutics, OCT 13, 2025, View Source [SID1234656900])

Immutep Announces Successful Completion of FDA Project Optimus Requirements

On October 13, 2025 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a late-stage immunotherapy company targeting cancer and autoimmune diseases, reported that positive and straightforward feedback has been received from the US Food and Drug Administration ("FDA") regarding the successful completion of Project Optimus requirements and agreement on 30mg as the optimal biological dose for eftilagimod alfa (efti).

Immutep’s Chief Development Officer, Christian Mueller, said, "We are very thankful for the FDA’s positive feedback and productive discussions over the past few years. The alignment on efti’s optimal biologic dose has strategic relevance to our efti oncology programs and is a major de-risking event and building block towards future BLA filings. We are excited to successfully conclude this chapter of efti’s clinical development and are intently focused on bringing this novel immunotherapy to market to help address the needs of cancer patients worldwide."

The agreement with the FDA on efti’s optimal biological dosing carries strategic importance in the ongoing and future clinical development of this first-in-class immunotherapy, including the global TACTI-004 (KEYNOTE-F91) Phase III trial evaluating efti in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA (pembrolizumab), and chemotherapy as first-line treatment for advanced or metastatic non-small cell lung cancer (1L NSCLC), regardless of PD-L1 expression. With the conclusion of Project Optimus, this registrational study is now in process of opening sites in the United States.

About Eftilagimod Alfa (Efti)

Efti is a novel immunotherapy that directly activates antigen-presenting cells or APCs (e.g. dendritic cells, monocytes) via the MHC Class II pathway to fight cancer. As an MHC Class II agonist, its activation of APCs engages the adaptive and innate immune system to initiate a broad anti-cancer immune response. This includes priming and activating cytotoxic T cells as well as generating important co-stimulatory signals & cytokines that further boost the immune system’s ability to combat cancer.

Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC) in a pivotal Phase III trial called TACTI-004 (KEYNOTE-F91), as well as head and neck squamous cell carcinoma (HNSCC), soft tissue sarcoma, and breast cancer. Its favourable safety profile enables various combinations like with anti-PD-[L]1 immunotherapy, radiotherapy, and/or chemotherapy. Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA).

(Press release, Immutep, OCT 13, 2025, View Source [SID1234656640])

Evaxion to present a breadth of data from phase 2 trial with AI-designed personalized cancer vaccine EVX-01 at the ESMO Congress 2025

On October 13, 2025 Evaxion A/S (NASDAQ: EVAX) ("Evaxion"), a clinical-stage TechBio company specializing in developing AI-Immunology powered vaccines, reported it will present a wide range of data from its phase 2 trial with lead compound EVX-01 at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025 to be held in Berlin, Germany, from October 17-21, 2025.

The data, which will be presented at an oral session, will include two-year clinical efficacy, immunogenicity and safety data. More specifically, data will be presented on best overall response, deepened response/conversion rates and durability of response. Furthermore, the presentation will include data on the breadth, magnitude and duration of T-cell response upon booster immunization as well as data on the vaccine’s safety profile.

"We are eagerly anticipating the presentation of the data and the subsequent discussions with medical and scientific colleagues as well as potential partner companies. We are excited to have been selected for oral presentation at an event as important as the ESMO (Free ESMO Whitepaper) Congress, one of the most prestigious medical oncology conferences in the world. This is a testament to the interest in EVX-01 and the field of personalized cancer vaccines in general," says Birgitte Rønø, CSO and interim CEO of Evaxion.

Evaxion will be present and available for discussions at a booth (#3035) throughout the conference to allow for interactions and discussions of the data with all interested stakeholders.

Convincing data
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). The trial has yielded numerous convincing data already, including interim one-year data presented at the ESMO (Free ESMO Whitepaper) Congress last year.

Data demonstrated a 69% Overall Response Rate, reduction in tumor target lesions in 15 out of 16 patients, and a positive correlation between the AI-Immunology platform predictions and immune responses induced by the individual neoantigens in the EVX-01 vaccine (p=0.00013). Further, the most recent immune data demonstrates that 80% of EVX-01 vaccine targets triggered a tumor-specific immune response.

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.

Presentation details
Abstract Title: EVX-01, a personalized cancer vaccine, induces potent T-cell responses and durable disease control in advanced melanoma: 2-year follow-up
Abstract#: #6308
Presentation#: 1516MO
Track: Mini oral session: Investigational immunotherapy
Location: Nuremberg Auditorium – Hall 5.2
Booth: n#3035
Date/Time: October 17 at 14:10 – 14:15 CEST
Presenter: Dr. Muhammad Adnan Khattak, Director, Oncology, One Clinical Research, Hollywood Private Hospital & Edith Cowan University, Perth, WA, Australia

Webinar on October 22, 2025

Evaxion will be hosting an online webinar featuring key opinion leader and trial investigator, Dr. Muhammad Adnan Khattak, on October 22, 2025, at 16.30 CEST/10.30am EDT.

The webinar can be attended through registration via this link.

In the webinar, Dr. Khattak will present the two-year phase 2 data and discuss challenges in the medical treatment of advanced melanoma. In the end, a Q&A session will be held, and participants are encouraged to present questions.

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 a personalized therapy 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 the completed phase 1/2a clinical trial (NCT03715985), assessing EVX-01 in combination with a PD-1 inhibitor, eight of twelve metastatic melanoma patients (67%) had objective clinical responses, with two complete and six partial responses.

In addition, vaccine-induced T cells were detected in all patients and a significant correlation between clinical response and the AI-Immunology predictions was observed, underlining the predictive power of the platform.

(Press release, Evaxion Biotech, OCT 13, 2025, View Source [SID1234656637])

Children’s Hospital Los Angeles Researchers Discover Possible Cell of Origin for Ewing Sarcoma

On October 13, 2025 Children’s Hospital Los Angeles reported a groundbreaking study led by researchers that offers critical insights into Ewing Sarcoma, a rare and aggressive bone and soft tissue cancer that primarily affects children and adolescents (Press release, Children’s Hospital Los Angeles, OCT 13, 2025, View Source [SID1234656607]).

The study, a close collaboration with the Keck School of Medicine of USC, provides the first in vivo genetic evidence that Ewing sarcoma may originate from neural crest cells—flexible embryonic cells that normally give rise to neurons, glial cells, and pigment cells.

For decades, scientists have been puzzled by two enduring mysteries around Ewing sarcoma. Why does this aggressive bone and soft tissue cancer mainly affect children and adolescents? And why do its tumor cells appear so primitive, showing features of multiple different cell types?

The team showed that a common mutation in this cancer—the EWSR1::FLI1 fusion oncogene—can reprogram neural crest cells into a mesoderm-like state, adopting features of bone- and muscle-forming cells. Results were published in Cell Reports.

"This is an exciting step forward in Ewing sarcoma research," says James Amatruda, MD, PhD, Director of the Cancer and Blood Disease Institute at Children’s Hospital Los Angeles and senior author of the study. "By understanding where and how this disease begins, we open the door to developing more effective and less-toxic treatments."

Scientists have known for more than 30 years that the EWSR1::FLI1 fusion is the driver of Ewing sarcoma. But they didn’t know which specific cells it could transform into cancer, and they lacked reliable research models of the disease. Those gaps have stalled progress in finding new and better therapies.

To study this cancer’s earliest steps, Dr. Amatruda’s lab published the first genetic zebrafish model of Ewing sarcoma in 2022. Zebrafish embryos are transparent and develop outside the mother, allowing the team to characterize the earliest stages of Ewing sarcoma and track fluorescently tagged tumor cells in real time.

In this latest study, researchers used the zebrafish model to switch on the EWSR1::FLI1 fusion in different cell types. Most cells died. But neural crest cells were the exception. They not only survived, but they were reprogrammed into a mesoderm-like state, setting the stage for tumor initiation.

The work was the result of a collaboration between Dr. Amatruda’s team at CHLA and the laboratory of Gage Crump, PhD, Professor and Vice Chair of Stem Cell Biology and Regenerative Medicine at USC. Elena Vasileva, PhD, a postdoctoral fellow at CHLA, was the study’s first author.

The team found that the oncogene doesn’t just push cells down the wrong path—it co-opts the same signaling pathways the cells use in normal development. This forces the neural crest cells into an "in-between" state that fuels uncontrolled growth.

"It was remarkable to see how these pre-tumor cells changed their behavior and characteristics, contributing to tumor development later on," Dr. Vasileva says. "Even more surprising was that the reprogrammed cells appeared to hijack normal developmental programs, such as those responsible for limb development."

Because neural crest cells are only present during early development, the findings help explain why Ewing sarcoma affects children and adolescents, but not older adults. The cells’ reprogramming may also account for the puzzling mixed appearance of Ewing sarcoma cells under the microscope.

"The precancer cells seem to be caught at a crossroads of multiple potential cell fate decisions," Dr. Vasileva explains. "By understanding these reprogramming trajectories, we may be able to uncover new vulnerabilities of cancer cells and identify new therapeutic targets."

Next steps for Ewing sarcoma research

By pinpointing a likely cell of origin for Ewing sarcoma, the researchers can now explore new questions: How do these reprogrammed cells fuel tumor growth? What signals do they hijack to spread? And how might those processes be stopped?

The zebrafish model gives the team a powerful tool to study how tumor cells evade the immune system and why they metastasize so aggressively. Researchers are also investigating how these cancer cells interact with their surrounding microenvironment—the network of cells and proteins that tumors hijack to survive.

"The more we understand about how Ewing sarcoma begins, the better models we can build to accurately mimic the disease," Dr. Amatruda says. "The ultimate goal is to find new and less-toxic treatments for this cancer—and improve outcomes for children."