On October 1, 2025 MiraDx, a molecular diagnostics company focused on genetic testing to personalize cancer treatment, reported that its PROSTOX ultra test is now available for ordering in the United States (Press release, MiraDx, OCT 1, 2025, View Source [SID1234656388]). The test, which helps identify localized prostate cancer patients at increased risk of developing side effects from stereotactic body radiation therapy (SBRT), has already helped over 3,500 patients as part of an Early Access Program involving select academic centers and private practices.

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PROSTOX ultra is a clinically validated genetic test that identifies patients with localized prostate cancer at higher risk of developing late genitourinary toxicity—urinary side effects such as urgency, leakage, or discomfort that may occur after treatment—with SBRT. SBRT delivers high doses of radiation over a short period of time, typically within 5-7 treatments. While SBRT is effective for treatment of prostate cancer, a subset of patients experience these side effects that present months or even years after treatment and can persist. By identifying patients with increased sensitivity to SBRT, PROSTOX ultra helps doctors and patients make more informed treatment decisions and consider alternative options when needed.

"Initial data from the PROSTOX Early Access Program in patients identified as having a high risk of toxicity to SBRT found that results from the test changed the course of treatment for 77% of these patients, helping them avoid potential complications from SBRT," said Melissa Stoppler, MD, Executive Vice President of Medical Affairs at MiraDx. "Extending access to this test to a broader range of clinicians and clinical settings will enable more prostate cancer patients to benefit from testing for these novel biomarkers of toxicity to radiation treatments."

PROSTOX ultra is a new and innovative test, and as such, coverage may vary depending on insurance plans. To ensure access, MiraDx is offering a Financial Assistance Program for patients, which provides reduced pricing based on household income.

On October 1, 2025 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") reported that it will present ten abstracts from our portfolio and advancing pipeline at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) congress taking place from 17-21 October 2025, including new data for PADCEV (enfortumab vedotin) plus pembrolizumab in muscle-invasive bladder cancer (MIBC) which will be presented in an ESMO (Free ESMO Whitepaper) Presidential Symposium on 18 October (Press release, Astellas, OCT 1, 2025, View Source [SID1234656373]). In prostate cancer, we are sharing final best-in-class overall survival data for XTANDI (enzalutamide) in high-risk, biochemically recurrent non-metastatic hormone sensitive disease, plus encouraging data for our next-generation bispecific T cell engager ASP2138 in solid tumors, demonstrating continued leadership in CLDN18.2-targeted precision medicine.

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Moitreyee Chatterjee-Kishore, Ph.D., M.B.A., Head of Oncology Development, Astellas
"Astellas focuses on some of the most complex and devastating cancers. These ESMO (Free ESMO Whitepaper) data demonstrate our ‘bench to bedside’ approach in action – from deep disease biology to measurable improvements in patient outcomes. We’re proud to share breakthrough new survival data in muscle-invasive bladder cancer and overall survival data in hormone sensitive prostate cancer, which reflect potentially practice-changing advances that could transform outcomes for patients who need them most. We also continue to advance innovation in gastric and gastroesophageal junction cancer with new clinical data for our next-generation investigational bispecific T cell engager."

Highlights from Astellas at ESMO (Free ESMO Whitepaper) 2025 will include:

Data from the Phase 3 EV-303 (also known as KEYNOTE-905) clinical trial which will be featured in an ESMO (Free ESMO Whitepaper) Presidential Symposium, evaluating enfortumab vedotin in combination with pembrolizumab as neoadjuvant and adjuvant treatment (before and after surgery) versus surgery alone, the current standard of care, in patients with MIBC who are not eligible for or declined cisplatin-based chemotherapy.
Long-term follow-up data from the EV-302 clinical trial exploring the utility of enfortumab vedotin in combination with pembrolizumab for patients with challenging baseline characteristics, including older patients with locally advanced or metastatic urothelial cancer and those with comorbidities such as diabetes and chronic kidney disease.
Final data from the Phase 3 EMBARK trial assessing overall survival with enzalutamide in combination with leuprolide and as monotherapy in patients with non-metastatic hormone-sensitive prostate cancer (nmHSPC; also known as non-metastatic castration-sensitive prostate cancer or nmCSPC) with high-risk biochemical recurrence.
First clinical data from Astellas’ investigational CLDN18.2-targeted, next-generation bispecific CD3 T cell engager ASP2138, both as a monotherapy and in combination with standard of care therapy.
Astellas Presentations at ESMO (Free ESMO Whitepaper) Congress 2025

Enfortumab vedotin

Presentation Title

Presenter

Presentation Details

Perioperative enfortumab vedotin plus pembrolizumab in participants with muscle-invasive bladder cancer who are cisplatin-ineligible: The phase 3 KEYNOTE-905 study

C. Vulsteke

Type: Presidential Symposium 1

Abstract Number: LBA2

Date: October 18,
16:52 – 17:04 CEST

Enfortumab vedotin and pembrolizumab in previously untreated locally advanced or metastatic urothelial cancer: An exploratory analysis in older patients and those with comorbidities from EV-302

N. Mar

Type: Poster

Abstract Number: 3073P

Date: October 18,
12:00-12:45 CEST

Enfortumab vedotin plus pembrolizumab as first-line treatment in recurrent or metastatic head and neck squamous cell carcinoma: Results from a cohort of the EV-202 trial

P.L. Swiecicki

Type: Mini oral

Abstract Number: 1329 MO

Date: October 19,
17:38-17:43 CEST

EV-103 Cohort K: Efficacy and safety of enfortumab vedotin with or without pembrolizumab in cisplatin-ineligible pts with previously untreated locally advanced or metastatic urothelial cancer with a median follow-up of ≈3.5 y

T.W. Friedlander

Type: Poster

Abstract Number: 3074P

Date: October 18,
12:00-12:45 CEST

Real-world use of enfortumab vedotin in patients with locally advanced or metastatic urothelial cancer previously treated with chemotherapy and immunotherapy in France

A. Fléchon

Type: ePoster

Abstract Number: 3111eP

Date: October 18, 12:00-12:45 CEST

Enzalutamide

Presentation Title

Presenter

Presentation Details

Overall survival in EMBARK, a phase 3 randomised trial of enzalutamide or placebo plus leuprolide and enzalutamide monotherapy in patients with nonmetastatic hormone-sensitive prostate cancer with biochemical recurrence at high risk for metastasis

S.J. Freedland

Type: Proffered Paper

Abstract Number: LBA87

Date: October 19,
10:55-11:05 CEST

Baseline features and metastasis-free survival by prior definitive treatment in patients with high-risk biochemically recurrent prostate cancer: EMBARK post hoc analysis

N.D. Shore

Type: Poster

Abstract Number: 2461P

Date: October 18,
12:00-12:45 CEST

Pipeline

Presentation Title

Presenter

Presentation Details

ASP2138 monotherapy in patients with (CLDN18.2)+, advanced solid tumors: Phase 1/1b trial

K. Shitara

Type: Poster

Abstract Number: 2137P

Date: October 19,
12:00-12:45 CEST

ASP2138 monotherapy or in combination with pembrolizumab and mFOLFOX6 or with ramucirumab and paclitaxel in (CLDN18.2)+ locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma: Phase 1/1b trial

F. Dayyani

Type: Poster

Abstract Number: 2136P

Date: October 19,
12:00-12:45 CEST

Phase 1 trial of ASP5541 (PRL-02), a long-acting intramuscular depot injection of abiraterone decanoate, in patients with advanced prostate cancer

J. Avitia

Type: Poster

Abstract Number: 2443P

Date: October 18,
12:00-12:45 CEST

On October 1, 2025 KaliVir Immunotherapeutics, Inc., a clinical-stage biotechnology company developing cutting-edge, multi-mechanistic oncolytic immunotherapy programs, reported the successful completion of the first cohort in the intravenous (IV) infusion arm of its STEALTH-001 (NCT06444815) clinical study, a Phase 1/1b clinical trial of VET3-TGI for patients with incurable, advanced solid tumors (Press release, KaliVir Immunotherapeutics, OCT 1, 2025, View Source [SID1234656389]).

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Patients received VET3-TGI, the Company’s lead oncolytic immunotherapy candidate, which is designed to selectively kill tumor cells and remodel the tumor microenvironment by delivering a potent immuno-stimulatory transgene payload composed of interleukin-12 (IL-12) and a TGFbeta inhibitor.

"The dosing of patients in the IV arm marks a significant advancement for the STEALTH-001 study and the broader field of systemic oncolytic viral immunotherapy," said Dr. Yana Najjar, MD, Associate Professor in the Department of Medicine at the University of Pittsburgh and Director of the Clinical and Translational Research Center at UPMC Hillman Cancer Center. "Delivering VET3-TGI intravenously opens the door to using oncolytic virotherapy to treat patients with tumors that are not easily accessible for direct injection, expanding the potential reach of this therapeutic approach."

The continuation of IV dosing complements continued enrollment in the intratumoral (IT) arm of the Phase 1/1b trial, where patients are now being treated in cohort 3, and supports plans for combining VET3-TGI with checkpoint inhibitor therapy. The STEALTH-001 trial is evaluating VET3-TGI as both a monotherapy and in combination with a checkpoint inhibitor in patients with advanced, unresectable, or metastatic solid tumors.

"Systemic delivery of VET3-TGI is essential to realizing its full therapeutic potential, and this first IV dose brings us closer to that goal," said James Burke, MD, Chief Medical Officer of KaliVir Immunotherapeutics. "VET3-TGI was engineered to selectively infect tumor cells and deliver a potent combination of IL-12 and a TGFbeta inhibitor, stimulate a strong immune response and overcome tumor-driven immunosuppression. This milestone supports our broader goal of developing multi-mechanistic oncolytic immunotherapies that can address a wide range of solid tumors."

About VET3-TGI and the STEALTH-001 Study
VET3-TGI is a novel oncolytic virus developed using KaliVir’s proprietary VET platform. It is designed to selectively replicate in tumor cells, stimulate local immune responses, and remodel the immunosuppressive tumor microenvironment through the expression of IL-12 and a TGFβ inhibitor. The STEALTH-001 study is a first-in-human, open-label, dose escalation and expansion Phase 1/1b trial assessing both intratumoral and intravenous administration of VET3-TGI.VE

The STEALTH-001 trial is a dose escalation and expansion study evaluating VET3-TGI administered through direct IT injection and IV infusion. The trial is evaluating VET3-TGI as a monotherapy and in combination with a checkpoint inhibitor in patients with pathologically confirmed, advanced, unresectable or metastatic solid tumors. The study continues to progress as planned through its dose escalation phase.

On September 30, 2025 Star Therapeutics, a clinical stage biotechnology company discovering and developing best-in-class antibodies for bleeding disorders and other diseases, reported an oversubscribed $125 million Series D financing (Press release, Star Therapeutics, SEP 30, 2025, View Source [SID1234656350]). The financing round was co-led by Sanofi Ventures and Viking Global Investors with participation from both existing and other new investors, including Janus Henderson Investors, Frazier Life Sciences and GordonMD Global Investments. Existing investors include Agent Capital, Blue Owl Capital, Catalio Capital Management, Cormorant Asset Management, New Leaf Venture Partners, NYBC Ventures, OrbiMed, Qatar Investment Authority (QIA), RA Capital Management, Redmile Group, Sofinnova Investments, Soleus Capital and Westlake BioPartners.

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Proceeds from the Series D financing will support the continued advancement of Star’s pipeline including its lead program, VGA039, a first-in-class monoclonal antibody that targets Protein S to restore balance in blood clotting. VGA039 is being developed as a universal hemostatic therapy for multiple bleeding disorders, starting with von Willebrand disease (VWD). Star has initiated a pivotal Phase 3 clinical trial of VGA039 in patients with all types of VWD, designed to evaluate VGA039 administered once monthly via subcutaneous injection.

"We’re making significant progress across our pipeline, highlighted by the recent initiation of our Phase 3 trial of VGA039 to prevent bleeding in people with all types of VWD, the most common inherited bleeding disorder, with more than 50,000 patients diagnosed and treated in the U.S.," said Adam Rosenthal, Ph.D., CEO and Founder of Star Therapeutics. "VGA039 has the potential to be transformative for VWD patients and could meaningfully reduce the treatment burden, given its once monthly subcutaneous dosing regimen, in comparison to factor replacement prophylaxis which requires two to three IV infusions per week. This new funding from leading life sciences investors reinforces the urgency and impact of our mission: to bring life-changing therapies to people living with serious bleeding disorders and other diseases in hematology and immunology."

In conjunction with the financing, Jason Hafler, Ph.D., from Sanofi Ventures will join Star’s board of directors, and Maneka Mirchandaney of Viking Global Investors will join as a board observer.

"At Sanofi Ventures, we’re proud to bring meaningful experience in supporting innovative therapies for bleeding disorders and remain deeply committed to exploring best-in-class therapies to better meet the needs of patients. VWD represents a compelling opportunity, with a sizable patient population and significant unmet need," said Jason Hafler, Ph.D., Managing Director at Sanofi Ventures. "With VGA039 advancing into Phase 3 for VWD, Star is well-positioned to deliver both substantial patient impact and long-term value. We’re proud to support a team with a strong track record and a bold vision for transforming care in VWD and beyond."

About VGA039
VGA039 is a monoclonal antibody therapy with a novel mechanism of action that targets Protein S, thereby restoring balance to the blood clotting process. VGA039 has potential to be a universal hemostatic therapy that can treat numerous bleeding disorders, starting with VWD. As a subcutaneously self-administered antibody therapy with a convenient once monthly dosing regimen, VGA039 has the potential to dramatically reduce treatment burden for patients. VGA039 has received Fast Track and orphan drug designations from the United States Food and Drug Administration (FDA).

Interim positive data from VIVID-2, a Phase 1 single ascending dose study of VGA039 in patients with VWD, were previously reported at the Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in December 2024. A Phase 1/2 multidose study, VIVID-3, is ongoing (NCT05776069). VGA039 has advanced into a Phase 3 study, VIVID-6 (NCT07115004), a global single arm cross-over study designed to investigate the safety and efficacy of subcutaneous administration of VGA039 as prophylaxis for bleeding in patients with every type of VWD. For additional information on VIVID-6, including how to enroll, please visit the website here.

About von Willebrand disease
Von Willebrand disease (VWD) is the most common inherited bleeding disorder in which the blood does not clot properly, caused by absent or defective von Willebrand factor (VWF). VWD patients may experience excessive bleeding with variability in severity and frequency, negatively impacting their daily lives. Current therapies for VWD prophylaxis include factor replacement therapies requiring multiple intravenous (IV) infusions every week. More than 50,000 people in the United States are estimated to be receiving treatment for VWD.

On September 30, 2025 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported that it will host a virtual R&D Day on Wednesday, October 29, 2025 at 10:00 AM ET featuring key opinion leaders (KOLs), alongside company management, to discuss the unmet medical need and evolving treatment landscape for acute myeloid leukemia (AML) (Press release, Sellas Life Sciences, SEP 30, 2025, View Source [SID1234656352]).

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The event will feature an overview of the ongoing Phase 3 REGAL trial of GPS (results expected by year-end) and a discussion of the unmet needs of AML patients in complete second remission (CR2). SELLAS will also present an update of SLS009, its highly selective cyclin-dependent kinase 9 (CDK9) inhibitor, highlighting recently reported Phase 2 data and plans for a newly diagnosed and frontline AML study anticipated to begin in the first quarter of 2026.

A live Q&A session will follow the formal presentations.

About Omer Jamy, MD
Omer Jamy, MD is Assistant Professor of Medicine at the University of Alabama (UAB) in the Division of Hematology and Oncology and Associate Scientist, Experimental Therapeutics at the O’Neal Comprehensive Cancer Center. He serves as principal investigator of the Phase 3 REGAL study at UAB, one of the trial’s highest enrolling sites, and leads several clinical trials in addition to REGAL, focusing on AML, chronic myelogenous leukemia, and allogeneic stem cell transplantation. Dr. Jamy completed his internal medicine residency at the University of Tennessee in Memphis followed by fellowship training at UAB in hematology/oncology, bone marrow transplantation and cellular therapy.

About Panagiotis Tsirigotis, MD, PhD
Panagiotis Tsirigotis, MD, PhD is Professor of Hematology at the National and Kapodistrian University of Athens, School of Medicine in Athens, Greece, and Scientific Director of the Transplantation Program of the Hematology Unit since 2010. He is an investigator in the Phase 3 REGAL trial and has enrolled the highest number of patients in the study. His clinical work focuses on AML with particular emphasis on cellular therapies and hematopoietic cell transplantation. Dr. Tsirigotis’ research focuses on the application of immunotherapy methods to prevent leukemia relapse after allogeneic transplantation, such as the administration of donor lymphocytes, as well as on mechanisms of immune escape in hematologic malignancies. He is the president of Acute Leukemia Working Party of the Hellenic Society of Hematology, and Vice President of the Hellenic Transplant Organization.

About Philip Amrein, MD
Philip Amrein, MD is Assistant Professor of Medicine at Harvard Medical School and a physician at the Massachusetts General Hospital (MGH), where he is part of the Cancer Center, Leukemia, Cellular Immunotherapy, and Hematology/Oncology departments. Dr. Amrein specializes in treating adults with acute and chronic leukemias, myelodysplasia, and myeloproliferative neoplasms, and leads numerous clinical trials exploring novel treatment approaches. Dr. Amrein has conducted research with SLS009 and is an expert in cyclin-dependent kinases (CDK).

About Sharif Khan, MD
Sharif Khan, MD is a hematologist at Bon Secours Health System in Greenville, SC. He is a highly rated specialist in indications such as AML, myeloproliferative neoplasms, multiple myeloma, non-Hodgkin lymphoma, and bone marrow transplantation. In addition to clinical care, Dr. Khan is a researcher for cutting-edge, breakthrough therapies and started a CAR T-Cell program at Bon Secours Health System. Dr. Khan serves as an investigator in both the REGAL trial of GPS and the SLS009 clinical program.