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.

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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])

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]).

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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."

On October 13, 2025 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported that a late-breaking abstract (LBA) featuring new data from its global Phase 1 clinical trial (NCT06179069) evaluating zocilurtatug pelitecan (zoci), formerly known as ZL-1310, has been selected for an oral presentation at the 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), taking place October 22-26, 2025, in Boston, Massachusetts (Press release, Zai Laboratory, OCT 13, 2025, View Source [SID1234656606]). The presentation will include additional follow-up from patients from the ongoing trial.

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Zoci is the Company’s potential first- and best-in-class, Delta-like ligand (DLL3)-targeted antibody-drug conjugate (ADC) being developed for patients with extensive-stage small cell lung cancer (ES-SCLC). The ongoing Phase 1 study is evaluating the safety and antitumor activity of zoci at various doses in patients who have progressed after at least one prior platinum-based chemotherapy regimen. The study is being conducted across multiple global sites.

"The critical need for expanded treatment options for patients with small cell lung cancer propels our strategy to advance zoci as a novel therapeutic option as quickly as possible," said Rafael G. Amado, M.D., President, Head of Global Research and Development, Zai Lab. "We remain on track to initiate our Phase 3 registrational study in previously treated SCLC by year-end. We look forward to sharing updated results demonstrating zoci’s continued potential at the AACR (Free AACR Whitepaper)-NCI-EORTC International Conference."

Zai Lab will hold an investor conference call and webcast to highlight updated zoci data at the AACR (Free AACR Whitepaper)-NCI-EORTC International Conference and outline next steps in clinical development.

Details regarding the webcast and conference call are as follows:

Date/Time: October 24, 2025, at 11 a.m. ET / 11 p.m. HKT, please register at:
Webcast presentation (preferred): View Source
Dial-in: View Source
Presenter: Rafael G. Amado, M.D., President and Head of Global Research and Development, Zai Lab

Details regarding the zoci oral presentation are as follows:

Title: Phase 1 trial of ZL-1310, a DLL3-targeted ADC, in patients with previously treated extensive-stage small cell lung cancer
Presenter: Grace K. Dy, M.D., Roswell Park Comprehensive Cancer Center, Buffalo, NY
Session Title: Plenary Session 3: Antibody Drug Conjugates
Date/Time: Friday, October 24, 2025, 9:17 a.m. – 9:27 a.m. ET (presentation), 9:27 a.m. – 9:45 a.m. ET (panel discussion)
Location: Hynes Convention Center, Level 3, Ballroom AB

About Small Cell Lung Cancer and Zocilurtatug Pelitecan (zoci)

Small cell lung cancer (SCLC) is one of the most aggressive and lethal solid tumors, accounting for ~15% of the approximately 2.5 million patients diagnosed with lung cancer worldwide each year1,2. Additionally, two-thirds of all SCLC patients are diagnosed at extensive stage3.

DLL3 is an antigen overexpressed in many neuroendocrine tumors, such as SCLC, and is often associated with poor clinical outcomes. Zocilurtatug pelitecan (zoci), formerly known as ZL-1310, comprises a humanized anti-DLL3 monoclonal antibody connected via a cleavable linker to a novel camptothecin derivative (a topoisomerase 1 inhibitor) as its payload. The compound was designed with a novel ADC technology platform called TMALIN, which leverages the tumor microenvironment to overcome challenges associated with first-generation ADC therapies.

Zoci received an Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) in January 2025, recognizing its potential to treat patients with SCLC.

About the Webcast and Conference Call

All participants must use the link provided above to complete the online registration process in advance of the conference call. Dial-in details will be in the confirmation email which the participant will receive upon registering.

A replay will be available shortly after the call and can be accessed by visiting the Company’s website.

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 (Press release, Repare Therapeutics, OCT 13, 2025, View Source [SID1234656605]).

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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.

On October 13, 2025 Foundation Medicine, Inc., a precision medicine company transforming lives in cancer care and beyond, reported that the company and its research collaborators will present 11 abstracts demonstrating the value of high-quality biomarker tests to inform cancer care at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress from October 17-21 in Berlin, Germany (Press release, Foundation Medicine, OCT 13, 2025, View Source [SID1234656604]).

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Foundation Medicine’s research to be presented at the meeting spans seven disease areas and includes new insights from the company’s tissue-free monitoring assay FoundationOneMonitor, which will soon be available for clinical use. The abstract showcases that an early reduction of circulating tumor DNA using FoundationOne Monitor was associated with improved outcomes in patients with triple negative breast cancer.

Two additional studies spotlight data from FoundationOneRNA, a tissue-based RNA sequencing test for the detection of cancer-related fusions across 318 genes. Respectively, the results demonstrate the test’s strong concordance with results from the company’s FDA-approved tissue-based comprehensive genomic profiling test, FoundationOneCDx, as well as with IHC/FISH tests.

"At this year’s ESMO (Free ESMO Whitepaper) Congress, we’re looking forward to sharing our latest data which reinforces the value of our high-quality tests to support the best precision care for patients," says Foundation Medicine’s Vice President, Head of Clinical Development, Amaya Gascó, M.D., Ph.D. "In particular, a new study using FoundationOne Monitor demonstrates the test’s ability to inform a patient’s response to treatment and guide next steps in care. Additionally, our FoundationOne RNA studies highlight the powerful insights our RNA sequencing test can deliver as a complement to comprehensive genomic sequencing with FoundationOneCDx and other diagnostic tests, such as IHC/FISH, to provide healthcare providers with the confidence they need to make informed decisions for their patients."

To access all the abstracts being presented at the 2025 ESMO (Free ESMO Whitepaper) Congress, please visit ESMO (Free ESMO Whitepaper).com.

Follow Foundation Medicine on LinkedIn, X, Instagram and Bluesky for more updates from #ESMO25, and join us in person at Booth #3028 in Hall 3.2 for our "Booth Talk Series" where you will hear from our team of experts on the latest advancements that are driving innovation in precision diagnostics.

Complete list of Foundation Medicine’s abstracts at the 2025 ESMO (Free ESMO Whitepaper) Congress

Presentation Number

Title

Product

Saturday, October 18

Oral Presentation

2610MO

Genomic analysis of papillary renal cell carcinoma (PRCC): MET alterations are uncommon and enriched in patients of African ancestry

FoundationOneCDx

Poster Presentations

1146P

Genomic landscape of HRD signature (HRDsig), CCNE1 amplified (amp) and ERBB2 altered (alt) ovarian cancers (OC)

FoundationOneCDx

1936P

Genomic alterations (GA) in TP53 including the targetable TP53 Y220C mutation in clinically advanced non-small cell lung cancer (CANSCLC)

FoundationOneCDx

157P

Homologous recombination signature (HRDsig) in non-small cell lung cancer (NSCLC): Implications for PARP inhibitor (PARPi) treatment

FoundationOneCDx

1931P

Prevalence, co-alterations and preclinical characterization of FGFR variants of unknown significance in non-small cell lung cancer

FoundationOneCDx

Sunday, October 19

2150P

Homologous recombination deficiency signature in gastric adenocarcinoma

FoundationOneCDx

Monday, October 20

579P

Gene expression profiling by RNA sequencing accurately predicts estrogen, progesterone, and HER2 receptor status by immunohistochemistry in breast cancer

FoundationOneCDx, FoundationOneRNA

580P

Androgen receptor splice variant 7 (AR-V7) and ESR1 fusion detection in breast cancer utilizing comprehensive combined DNA and RNA sequencing

FoundationOneCDx, FoundationOneRNA

2697P

Comprehensive genomic profiling in chordoma by subtype classification

FoundationOneHeme, FoundationOne, FoundationOneCDx

2701P

Estrogen receptor and AKT pathways as potential novel targets for MDM2-amplified well-differentiated and dedifferentiated liposarcoma (WD/DD LPS)

FoundationOneHeme, FoundationOne, FoundationOneCDx

558P

Circulating tumor DNA dynamics correlate with response to carboplatin with or without nivolumab in metastatic TNBC

FoundationOneMonitor

Published Online

2525eP

RNA sequencing enhances TMPRSS2 fusion detection beyond DNA sequencing alone and reveals associations with androgen receptor (AR) biology in prostate cancer

FoundationOneCDx, FoundationOneRNA

1458eP

Ameloblastoma of the head and neck (HNAmelo): A biomarker and genomic landscape study

FoundationOneCDx

686eP

Clinical utility of DNA and RNA comprehensive genomic profiling (CGP) for the diagnostic workup of high grade gliomas (HGG)

FoundationOneCDx, FoundationOneRNA