On October 1, 2025 Bolt Biotherapeutics (Nasdaq: BOLT), a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer, reported an update on the ongoing Phase 1 dose escalation study of BDC-4182, a next-generation Boltbody ISAC clinical candidate targeting claudin 18.2, a clinically validated target in oncology (Press release, Bolt Biotherapeutics, OCT 1, 2025, View Source [SID1234656398]). A strong immune response was observed at the initial dose levels and the Company is in the process of modifying the clinical trial protocol to allow for step-up dosing, which has been successfully used commercially for T-cell engagers. BDC-4182 preclinical data supports this approach.

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As a result of the update to the clinical trial protocol for BDC-4182, Bolt now expects to report initial clinical data in the third quarter of 2026. To conserve capital and maintain long-term shareholder value, the Company is implementing a workforce reduction of approximately 50%, extending its cash runway into 2027.

"I want to sincerely thank all of our colleagues impacted by this decision. Their commitment and valuable contributions have been essential in developing our novel BoltbodyTM ISAC technology and these potential new treatment options for patients with cancer," said Willie Quinn, President and Chief Executive Officer. "Amid challenging market conditions, our strategic imperative is the clinical advancement of BDC-4182 and the support of our ISAC collaborations to increase shareholder value. We look forward continuing our mission and to providing updates on BDC-4182 later next year."

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 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 Ensem Therapeutics, Inc. (ENSEM) reported the U.S. Food and Drug Administration (FDA) granted Fast Track designation to its clinical stage pan mutant-specific allosteric PI3Kα inhibitor and degrader, ETX-636, for the treatment of adult patients with PIK3CA-mutant, hormone receptor positive (HR+)/human epidermal growth factor negative (HER2-) advanced breast cancer (Press release, ENSEM Therapeutics, OCT 1, 2025, View Source [SID1234656387]).

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ETX-636 was designed using ENSEM’s unique Kinetic Ensemble platform to optimally fit into a specific allosteric binding site in p110α, the catalytic subunit of PI3Kα and can selectively inhibit multiple activating mutant forms of PI3Kα, while sparing wildtype PI3Kα. The selectivity of ETX-636 for mutant PI3Kα greatly reduces the risk for hyperglycemia and other wildtype PI3Kα-related adverse events compared to non-mutant selective PI3Kα inhibitors. In addition, ETX-636 also leads to proteasome-dependent degradation of mutant PI3Kα, while sparing wildtype protein (a feature not seen with other pan-mutant allosteric inhibitors).

Activating mutations or alterations of the PI3Kα pathway are known to promote cancer cell growth and survival in a variety of tumor types, including breast cancer. In HR+/HER2- breast cancer (approximately 70% of all breast cancers), PIK3CA mutations are particularly prevalent, occurring in up to 40% of the cases.

"Patients with advanced HR+/HER2- breast cancer harboring PIK3CA mutations have poor prognosis, and there is an unmet need for therapies targeting this population that are safer and more efficacious than the current FDA approved non-mutant selective treatments," said Dr. Shengfang Jin, CEO and Co-Founder of ENSEM. "We are appreciative that the FDA has recognized ETX-636 as a potentially important treatment for this indication and we remain laser-focused on demonstrating its benefit to patients in our current clinical trials."

ETX-636 is currently being studied in an initial first-in-human, Phase 1/2 study which is evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of ETX-636 in participants with advanced solid tumors harboring a PIK3CA mutation. ETX-636 will be administered alone or in combination with fulvestrant, a selective estrogen receptor degrader approved for the treatment of advanced hormone receptor HR+/HER2- breast cancer NCT06993844.

Fast Track designation is a program provided by the FDA to expedite the development and review of drugs and biologics that treat serious conditions with unmet medical needs. It provides the opportunity for frequent and early communication and collaboration with the FDA, as well as the potential for accelerated approval and priority review eligibility to allow faster access to promising treatment to patients.

On October 1, 2025 Humanetics Corporation, an advanced clinical-stage specialty pharmaceutical company pioneering novel approaches to tissue protection in oncology-related radiation exposure and mitigating the inflammatory response in pulmonary disease, reported that the Company will be hosting a virtual panel on October 08, 2025, 1:30 pm EDT, entitled "Mitigating Tissue Damage in Radiation Oncology and Inflammation in Pulmonary Disease: Targeting Pathways of Tissue Injury and Inflammatory Response (Press release, Humanetics, OCT 1, 2025, View Source [SID1234656386])."

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Panel members include:

Rany Condos, MD, Director, Interstitial Lung Disease Program and Post-COVID Program, NYU Langone
Pranshu Mohindra, MD, MMM, Professor and Vice Chair of Operations and Quality for the Department of Radiation Oncology and Director of the University Hospitals Proton Therapy Center, University Hospitals Cleveland Medical Center
Colin G. Chinn, MD, MHS, FACP, RADM MC USN (Ret), Chief Medical Officer, Humanetics
Michael D. Kaytor, PhD, Vice President, Research & Development, Humanetics
Hannah Olson, PhD, Research & Development Scientist, Humanetics
This panel will explore advances in addressing unmet medical needs related to oncology and radiation exposure, as well as pulmonary disease and inflammation. Leading oncology and pulmonary medicine clinicians, together with researchers, will share perspectives on emerging data, trial design, clinical practice challenges, and insights into potential therapeutic targets.

A live Q&A session will follow the panel discussion.

Humanetics convened an expert panel on August 12, 2025, that explored its Medical Countermeasure development program. As discussed, protecting Warfighters from tissue damage due to accidental or intentional ionizing radiation exposure remains a priority for the United States as well as its allies and partners. Likewise, safeguarding emergency medical personnel, first responders, and civilian populations is among the domestic imperatives for Strategic National Stockpile decision makers. Access to the video recording of the August 12 session is available on the Humanetics Corporation website under "News & Events."