On November 7, 2025 Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, reported that biomarker data and updated clinical data from the IGNYTE clinical trial of RP1 plus nivolumab was presented as a late-breaking abstract during an oral session at the 40th Annual Meeting of the Society for the Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2025) in National Harbor, Maryland. Two additional posters on RP1 are also being presented.

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"These data are important because they demonstrate that RP1 plus nivolumab can potentially reprogram the tumor microenvironment and reverse mechanisms of resistance to immune checkpoint blockade," said Kostas Xynos, M.D., Ph.D., Chief Medical Officer of Replimune. "Low T cell levels in tumors, tumor PD-L1 expression, T-cell activation and IFNy gene signature expression, as well as the loss of antigen presentation machinery are well known mechanisms of resistance to immune checkpoint blockade."

Data from the late-breaking abstract (#1327) presented by Trisha Wise-Draper, M.D., Ph.D., show:

Pharmacodynamic changes that were not achieved during prolonged prior anti–PD-1 therapy demonstrate that the addition of RP1 reverses multiple resistance mechanisms to PD-1 blockade and highlights the contribution of RP1 in melanoma patients who previously failed such treatment.
Treatment with RP1 plus nivolumab led to upregulation of gene signatures associated with responsiveness to PD-1 blockade.
With additional follow-up (7 months), RP1 combined with nivolumab continues to demonstrate a clinically meaningful response rate (ORR: 33.6%) and durability (median duration of response: 24.8 months).
Consistent duration of response was observed across PD-L1–positive and negative tumors, as well as in both primary and secondary resistance settings. Median duration of response for PD-L1-negative patients was 24.8 months and for patients with primary resistance was 22.6 months.
Additional posters being presented at the meeting include:

Abstract 611: RP1 plus nivolumab in patients with and without prior BRAF-directed therapy: A subgroup analysis of patients with anti-PD-1 failed BRAF-mutant melanoma from the IGNYTE clinical trial (Katy Tsai, M.D.)
RP1 plus nivolumab demonstrated comparable efficacy in BRAF-mutant and BRAF–wild-type advanced melanoma.
Greater activity was observed in BRAF-naïve patients – similar to findings from the SECOMBIT and DREAMseq trials.
Abstract 600: Retreatment with RP1 in combination with nivolumab in patients with advanced anti-PD-1- failed melanoma (Gino K. In, M.D.)
Extended RP1 treatment beyond 8 doses was well tolerated providing clinical benefit in a majority of patients.
About IGNYTE
The IGNYTE phase 2 cohort enrolled 140 patients with stage IIIB-IV cutaneous melanoma and confirmed progression on anti-PD1- based therapy for > 8 weeks as the last prior treatment. RP1 was administered intratumorally into superficial and/or deep/visceral tumors once every 2 weeks for up to 8 doses (≤10 mL per cycle) with intravenous nivolumab (240 mg); nivolumab was then given alone (240 mg every 2 weeks or 480 mg every 4 weeks) for up to 2 years, with further RP1 allowed if indicated.

About RP1
RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF, intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.

(Press release, Replimune, NOV 7, 2025, View Source [SID1234659640])

On November 7, 2025 Onchilles Pharma, a private biotech company pioneering next-generation cytotoxic therapeutics that harness the ELANE pathway, reported the publication of foundational preclinical data in Cell Reports Medicine, the closing of a $25 million Series A1 financing to advance its lead drug candidate, N17350, through clinical proof-of-concept, and the appointment of Thomas A. Buchholz, M.D., a global leader in breast cancer clinical research, as a clinical advisor. N17350 is a tumor-directed biologic that leverages the ELANE pathway to selectively kill cancer cells, while sparing healthy tissue and activating a systemic immune response.

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N17350 Demonstrates Broad, Selective, Immune-Activating Tumor Killing via the ELANE Pathway in Preclinical Studies

The published study in Cell Reports Medicine presents the most comprehensive validation to date of the ELANE pathway as a cancer-selective immune-activating mechanism. N17350 demonstrated consistent monotherapy efficacy, immune cell sparing, and durable responses across 30 cancer cell lines and 15 in vivo models, including chemotherapy-resistant cells and immunologically "cold" tumors. The data highlight N17350’s ability to drive both direct tumor killing and CD8+ T cell–mediated immune activation, in part, by leveraging elevated histone H1 levels, a feature of many malignant cancer cells.

"This research publication is the culmination of years of rigorous translational work to understand and harness the ELANE pathway as the foundation for a new era of cancer treatment," said Lev Becker, Ph.D., Co-Founder and Chief Scientific Officer of Onchilles Pharma. "Our lead drug candidate, N17350, has demonstrated rapid, selective tumor killing and immune activation across models of breast, lung, ovarian, colon, and other cancers. We believe our next-generation cytotoxic therapeutics that harness the ELANE pathway offer a compelling new treatment breakthrough that combines cytotoxic activity with immune-preserving activity and the potential to address a broad range of solid tumors."

N17350 Enters Clinical Testing with Potential to Redefine Cytotoxic Cancer Therapy

Onchilles plans to initiate a first-in-human trial of N17350, a tumor-directed injectable, in patients in Australia early next year, with IND clearance in the United States and U.S. patient enrollment expected in mid-2026. The study will evaluate safety, monotherapy activity, and biomarkers of immune activation across multiple solid tumor types, including breast, skin, and head and neck cancers.

N17350 is designed to deliver two mechanistic waves of anti-cancer activity: direct tumor killing through mitochondrial and DNA damage and systemic immune activation through immunogenic cell death. In preclinical models, this mechanism has generated durable remissions, immune memory, and synergy with checkpoint inhibitors.

The company has completed a successful GMP manufacturing campaign with over 5,000 doses of N17350 available for clinical use and has observed a favorable safety profile in preclinical studies, supporting the transition into human trials.

Funding Secured to Deliver Clinical Proof-of-Concept for N17350 in 2026

The company also announced the close of a $25 million Series A1 financing round to fund the N17350 program through clinical proof-of-concept, bringing the total raised in Series A funding to $40 million. Onchilles is also advancing NEU-002, a systemically delivered version of the therapy, which is on track for development candidate nomination in early 2026.

"Our new data and this financing further validate the ELANE pathway as a powerful cancer-selective mechanism with broad therapeutic potential," said Court R. Turner, J.D., Co-Founder and Chief Executive Officer of Onchilles. "We are well-positioned to demonstrate clinical activity, and if that data looks anything like our preclinical results, we believe N17350 could represent a breakthrough therapeutic class with relevance across a variety of solid tumors."

The round included new investors, Invivium Capital, Kennedy Lewis Investment Management, and UCM Ventures (a venture investment vehicle of the University of Chicago Medical Center), and existing investors, LYZZ Capital Advisors and Lincoln Park Capital Fund, LLC.

Dr. Thomas Buchholz Appointed Clinical Advisor to Guide Development for N17350

Onchilles also announced the appointment of Dr. Thomas A. Buchholz as a clinical advisor. A leading authority in breast cancer clinical trial strategy and neoadjuvant therapy development, Dr. Buchholz previously served as co-chair of the NCI’s Breast Cancer Steering Committee and held multiple leadership roles at The University of Texas MD Anderson Cancer Center.

Dr. Buchholz is advising Onchilles on early clinical development strategy, including potential applications of N17350 in neoadjuvant settings such as hormone receptor–positive and triple-negative breast cancers, where early data suggest the potential to eliminate tumors prior to surgery, reduce recurrence risk, and minimize the need for long-term hormone therapy.

About Onchilles Therapeutic Programs Targeting the ELANE Pathway

At the core of this approach is the ELANE pathway, a unique cancer-selective killing mechanism that leverages a vulnerability shared by many cancer cell types: elevated histone H1 levels. By targeting the ELANE pathway and inducing immunogenic cancer cell death, N17350 (NEU-001) and NEU-002 are designed to rapidly eliminate tumors while mobilizing an adaptive immune response, offering the potential for sustained anti-tumor immunity. N17350 and NEU-002 offer a unique approach to treating cancer regardless of their genetic makeup, anatomical origin, or immune status, positioning them as potential game-changers in cancer therapy.

(Press release, Onchilles Pharma, NOV 7, 2025, View Source [SID1234659656])

On November 7, 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 that the Company is presenting evidence of strong immune system engagement and anti-cancer activity of its next generation Bria-OTS+ platform in preclinical models at a poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 40 th Anniversary Annual Meeting, to be held November 7-9, 2025, in National Harbor, MD.

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Title: Redefining Cancer Vaccines: Bria-OTS+ Integrates Trained Innate Immunity and Adaptive Memory to Overcome Immune Resistance
Abstract Number: 353
Location: Prince George ABC Exhibit Halls, Gaylord National Resort and Convention Center
Date: Friday, November. 7, 2025
Time : 12:15-1:45 PM, and 5:35-7 PM ET

"We are thrilled with the comprehensive, powerful, and long-lasting immune activation demonstrated by Bria-OTS+ in our preclinical studies, which we believe will translate into meaningful anti-cancer immune responses in the clinic," stated Miguel A. Lopez-Lago, PhD, BriaCell’s Chief Scientific Officer. "By training both the innate and adaptive arms of the immune system, Bria-OTS+ represents an important step toward developing more durable and broadly effective cancer immunotherapies."

"These findings add to the growing body of evidence supporting our Bria-OTS+ platform’s unique mechanism of action for novel personalized cancer immunotherapies. We look forward to confirming these encouraging preclinical results in planned clinical trials of Bria-BRES+ for breast cancer and Bria-PROS+ for prostate cancer," commented Dr. William V. Williams, BriaCell’s President and CEO.

Summary of Preclinical Findings

Bria-OTS+ Fast Acting and Potent Anti-Cancer Immune System Activation :
Bria-BRES+ and Bria-PROS+ rapidly activated key components of the immune system in preclinical models. The platform induced coordinated innate and adaptive immune responses, training the immune system to kill cancer cells. These findings are consistent with strong anti-tumor immune activity and support its promise as BriaCell’s next generation cancer immunotherapy platform.

Bria-OTS+ Long Lasting Anti-Cancer Response :
Both Bria-BRES+ and Bria-PROS+ produced sustained, and durable anti-cancer immune responses that may translate into prolonged clinical benefit for patients treated with the Bria-OTS+ platform of whole cell immunotherapies.

Bria-OTS+: Broad Applicability :
Positive results with lead candidates Bria-BRES+ and Bria-PROS+ reinforce the broad applicability of the Bria-OTS+ platform and support possible expansion into other solid tumor indications. These data highlight the platform’s capacity to generate broad and potent immune responses against multiple tumor types that share key immune-recognition features.

(Press release, BriaCell Therapeutics, NOV 7, 2025, View Source [SID1234660840])

On November 7, 2025 Oncolys BioPharma reported Non-consolidated Financial Results for the Nine Months Ended September 30, 2025.

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(Press release, Oncolys BioPharma, NOV 7, 2025, View Source [SID1234661725])

On November 7, 2025 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported its recent accomplishments and financial results for the quarter ended September 30, 2025.

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"We remain focused on multiple upcoming milestones before year-end, including top-line results from our Phase 2a clinical trial in mild-to-moderate psoriasis with SGX302 (synthetic hypericin) and an enrollment update for the confirmatory Phase 3 study evaluating HyBryte (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL)," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "Recently, we were pleased to announce that the first Data Monitoring Committee (DMC) meeting for the confirmatory Phase 3 study evaluating HyBryte in the treatment of CTCL had concluded that there were no safety concerns, with HyBryte demonstrating an acceptable safety profile that remains consistent with the safety data from all prior clinical studies. Looking ahead to 2026, Phase 3 enrollment remains on track with top-line results anticipated in the second half of 2026."

Dr. Schaber continued, "With approximately $10.5 million in cash at September 30, 2025, we’re focused on carefully allocating resources to hit our strategic goals and upcoming milestones. While this cash balance provides sufficient operating runway through 2026, we continue to evaluate all strategic options, including partnership, merger and acquisition, government grants, and potential financing opportunities to advance our late-stage pipeline and the Company."

Soligenix Recent Accomplishments

On October 14, 2025, the Company announced the update of its United States (U.S.) Medical Advisory Board (MAB) for CTCL to provide medical/clinical strategic guidance to the Company as it advances the Phase 3 clinical development of HyBryte. To view this press release, please click here.
On October 7, 2025, the Company announced its first DMC meeting for its confirmatory Phase 3 study evaluating HyBryte in the treatment of CTCL had concluded that there were no safety concerns and that HyBryte has an acceptable safety profile that remains consistent with the safety data from all prior clinical studies. To view this press release, please click here.
On September 30, 2025, the Company announced the expansion of its European MAB to provide additional medical/clinical strategic guidance to the Company as it advances its confirmatory Phase 3 d study evaluating the safety and efficacy of HyBryte. To view this press release, please click here.
On September 29, 2025, the Company announced the closing of its previously announced public offering with participation from existing and certain healthcare focused institutional investors. To view this press release, please click here.
On September 23, 2025, the Company announced the appointment of Tomas J. Philipson, PhD as a Strategic Advisor, given his extensive experience and relationships at the highest levels of government, including with U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services. To view this press release, please click here.
On September 4, 2025, the Company announced a publication describing the extended stability of ebolavirus vaccines using its ThermoVax platform. To view this press release, please click here.
On August 18, 2025, the Company announced that the Office of Orphan Products Development of the FDA had granted orphan drug designation to dusquetide, the active ingredient in SGX945, for "treatment of Behçet’s Disease" following review of positive Phase 2a clinical results demonstrating biological efficacy and safety in patients with Behçet’s Disease. To view this press release, please click here.
Financial Results – Quarter Ended September 30, 2025

Soligenix reported no revenue for the quarters ended September 30, 2025 and 2024.

Soligenix’s net loss was $2.5 million, or ($0.58) per share, for the quarter ended September 30, 2025, compared to $1.7 million, or ($0.78) per share, for the quarter ended September 30, 2024. This increase in net loss was primarily due to an increase in operating expenses related to ongoing clinical trials and a decrease in interest income and a CARES Act employee retention credit received during the three months ended September 30, 2024 with no corresponding employee retention credit received during the three months ended September 30, 2025.

Research and development expenses were $1.6 million for the quarter ended September 30, 2025 as compared to $1.0 million for the same period in 2024. The increase was primarily due to costs associated with the second confirmatory Phase 3 CTCL trial as well as increases in third party contract manufacturing.

General and administrative expenses were $1.0 million for the quarter ended September 30, 2025 as compared to $0.9 million for the same period in 2024. The decrease was primarily attributable to increases in professional expenses.

As of September 30, 2025, the Company’s cash position was approximately $10.5 million.

(Press release, Soligenix, NOV 7, 2025, View Source [SID1234659641])