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 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company developing targeted protein modulation therapies to treat cancer and immune disorders, reported the presentation of new translational data from its ongoing Phase 1 study of NX-1607, an oral, first-in-class inhibitor of Casitas B-lineage lymphoma proto-oncogene B (CBL-B), at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2025 Annual Meeting which is being held November 5–9, 2025, in National Harbor, MD.

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The poster, titled Translational Insights from a First-in-Human Study of an Oral CBL-B Inhibitor in Advanced Solid Tumors, expands upon data presented at the recent European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress from heavily pretreated patients with a variety of tumor types who were treated with NX-1607 in an ongoing Phase 1a clinical trial. The new data presented at SITC (Free SITC Whitepaper) demonstrate that treatment with NX-1607 resulted in dose dependent pharmacologic activity consistent with target engagement and downstream immune modulation. Treatment with NX-1607 led to increased peripheral T cell activation and proliferation, which were statistically significantly greater in patients with stable disease (SD) compared with those with progressive disease (PD), indicative of active T-cell receptor (TCR) engagement and immune responsiveness to treatment.

The poster also highlights a case study of a patient with metastatic castration-resistant prostate cancer (mCRPC) who achieved a best response of stable disease while receiving NX-1607. Treatment was associated with expansion of activated peripheral memory T cell subsets, an increase in CD8+ tumor infiltrating lymphocyte (TIL) density and enhanced immune activation gene signatures in paired metastatic lymph node tumor biopsies. Collectively, these findings indicate that NX-1607 induced peripheral immune activation is associated with remodeling of the tumor microenvironment (TME), linking systemic immune activation to local tumor control.

"These translational findings further support the biological rationale for CBL-B inhibition as a novel immune-oncology therapy," said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix Therapeutics. "NX-1607 has demonstrated encouraging signs of immune activation and disease control in heavily pretreated patients, supporting its potential as a novel next generation checkpoint inhibitor therapy and its continued development as a monotherapy and in combination with other anticancer agents for the treatment of advanced solid tumors."

Key Findings

Dose-dependent pharmacology and immune activation: NX-1607 demonstrated dose-dependent pharmacokinetics and pharmacodynamic modulation of the proximal biomarker pHS1, confirming target engagement and inhibition of CBL-B–mediated signaling.
Peripheral immune activation linked to clinical benefit: Patients with stable disease exhibited a greater enrichment of circulating PD-1⁺ CD8⁺ T cells expressing Ki67⁺ (proliferation) and ICOS⁺(activation) markers compared with those with progressive disease, demonstrating active TCR engagement and antitumor immune responsiveness.
Remodeling of the tumor microenvironment: In a case study of a heavily pretreated mCRPC patient (5 prior therapies), NX-1607 treatment achieved a best response of stable disease. Paired pre and post treatment metastatic lymph node tumor biopsy analyses showed an increase in CD8⁺ TIL density, upregulation of cytotoxic and interferon-response pathways, and reduced regulatory T-cell signatures, consistent with enhanced effector activity and immune activation within the TME.
Transcriptomic evidence of immune pathway engagement: RNA sequencing analyses demonstrated dose-dependent enrichment of immune signaling pathways, including interferon response, antigen presentation, and effector T cell activation, further supporting a mechanistic link between NX-1607 exposure and immune activation.
About NX-1607
NX-1607 is an investigational first-in-class oral inhibitor of the E3 ligase Casitas B-lineage lymphoma proto-oncogene B (CBL-B) being developed for immuno-oncology indications, including a range of solid tumor types. CBL-B is a cytoplasmic E3 ubiquitin ligase that negatively regulates T cell activation, making it an attractive target for immuno-oncology and offering a novel therapeutic approach to treat solid tumors. Inhibition of CBL-B in preclinical studies reverses T cell exhaustion, alleviates tumor induced immunosuppression, and may also exert direct antitumor effects. Nurix is evaluating NX-1607 in an ongoing Phase 1 trial in adults in a range of oncology indications. This study includes a thorough investigation of both dose and schedule in the Phase 1a portion. Additional information on the NX-1607 clinical trial can be accessed at www.clinicaltrials.gov (NCT05107674).

(Press release, Nurix Therapeutics, NOV 7, 2025, View Source [SID1234659639])

On November 7, 2025 Nouscom, a clinical-stage biotech company developing next-generation off-the-shelf and personalized neoantigen cancer immunotherapies, reported the presentation of new clinical and translational data on its lead candidate NOUS-209 at the 40th Annual Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Meeting.

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Following positive safety and immunogenicity data reported at AACR (Free AACR Whitepaper) 20251, these additional results from the Phase 1b/2 trial of NOUS-209 in Lynch Syndrome (LS) carriers demonstrate effective boosting of durable immune responses after retreatment as well as first evidence of clinical efficacy through the absence of advanced adenomas at end of study.

NOUS-209 is an off-the-shelf cancer immunotherapy designed to intercept cancer before it develops. It leverages Nouscom’s proprietary viral vector platform to deliver 209 shared frameshift peptide (FSP) neoantigens found in MSI tumors, training the immune system to recognize and eliminate pre-cancerous and cancerous cells. LS is the most common hereditary cancer syndrome, significantly increasing the lifetime risk of colorectal, endometrial, urothelial, and other cancers. Current preventive management is limited to intensive screening or elective organ removal surgery.

Key Highlights from SITC (Free SITC Whitepaper) 2025 Oral and Poster Presentations:

Durable and Potent Immune Responses: Annual retreatment with NOUS-209 was shown to be safe and to effectively boost long-lived, broad polytopic T cell immunity in LS carriers, with T cells capable of killing tumor cells ex vivo.
First Clinical Evidence of Cancer Interception: While 4.7% of LS participants had advanced adenomas at baseline (which were removed as part of standard of care), no new advanced adenomas were detected after treatment despite an expected annual incidence of around 4%, providing initial evidence of NOUS-209’s cancer preventive efficacy in LS carriers.
Broad Neoantigen Targeting Across Tumor Evolution: Analysis of primary and metachronous colorectal and urothelial MSI tumors confirmed that a high number of FSP neoantigens targeted by NOUS-209 are consistently present, supporting its utility in preventing both first and recurrent cancers in LS patients.

"These results are a step forward in intercepting cancer in LS carriers," said the study’s principal investigator, Eduardo Vilar-Sanchez, M.D., Ph.D., Professor of Clinical Cancer Prevention at The University of Texas MD Anderson Cancer Center. "NOUS-209-induced T cells persist, and annual retreatment was found to be safe, boosting long-term immune protection. The absence of advanced adenomas post-treatment is encouraging."

"These data highlight NOUS-209’s broad applicability beyond colorectal cancer. Its ability to target evolving neoantigens is critical for sustained protection against recurrent LS-associated malignancies," said Toni Seppälä, M.D., Ph.D., Professor of Cancer Research, and chief physician at Tampere University.

"Nouscom’s proprietary viral vector platform is uniquely positioned to deliver rapid, potent, broad and durable immune activation against a large number of shared neoantigens," said Elisa Scarselli, M.D., Chief Scientific Officer of Nouscom. "NOUS-209’s Phase 1b/2 data reinforce our confidence in its ability to safely and effectively prime the immune system for cancer interception in LS carriers."

Marina Udier, Ph.D., CEO of Nouscom concluded, "We are proud to present these compelling data at SITC (Free SITC Whitepaper) 2025 and remain deeply committed to pioneering cancer interception strategies for LS carriers, who deserve a better way to manage their cancer risk. These data, together with the recently presented results of NOUS-209 in MSI-H mCRC patients2 and FDA and EMA alignment, support our commitment to advancing NOUS-209 into a registration-enabling study for cancer interception in Lynch Syndrome carriers."

Oral Presentation Details:

Title: Final Ph1b/2 Results for NOUS-209 Monotherapy in Lynch Syndrome Carriers: Annual Revaccination Boosts T Cell Immunity Informing Future Cancer Interception Strategies

Session: Clinical Oral Abstract Session 2
Date & Time: Saturday, November 8, 2025, 1:45 PM – 3:00 PM ET
Location: Gaylord National Resort & Convention Center, Potomac Ballroom

Poster Presentations Details:

Poster #118 – NOUS-209 Mechanism of Action Validation
Title: NOUS-209 Enables Broad Targeting of Primary and Metachronous Tumors in Lynch Syndrome

Session: Poster Hall
Time: Saturday, November 8, 2025, 9:00 AM – 6:35 PM ET
Location: Prince George’s ABC

Poster #1336 – NOUS-209 Clinical Data
Title: Final Ph1b/2 Results for NOUS-209 Monotherapy in Lynch Syndrome Carriers

Session: Poster Hall
Time: Saturday, November 8, 2025, 9:00 AM – 6:35 PM ET
Location: Prince Georges’ ABC

All abstracts are available on the SITC (Free SITC Whitepaper) website: here

The clinical trial NCT05078866 was supported by the National Cancer Institute of the National Institutes of Health under Award Number UG1CA242609 (project director Dr. Eduardo Vilar-Sanchez). The trial was conducted through the iCAN-PREVENT consortium at The University of Texas MD Anderson Cancer Center, with support from the Data Management, Auditing, and Coordination Center (grant U24CA242637).

(Press release, NousCom, NOV 7, 2025, View Source;utm_medium=rss&utm_campaign=nouscom-presents-new-positive-phase-1-2b-data-of-nous-209-at-sitc-2025-supporting-plans-to-initiate-registration-enabling-study-for-cancer-interception-in-lynch-syndrome-carriers [SID1234659638])

On November 7, 2025 Nerviano Medical Sciences S.r.l. (NMS), a member of NMS Group S.p.A. and a clinical-stage biotech company discovering and developing innovative therapies for the treatment of cancer, reported its poster at the World ADC Summit 2025, highlighting its next-generation payload-linker technologies designed to overcome key limitations of current ADC modalities. The poster, titled "Next-Generation ADC Payloads: Redefining Targeted Cancer Therapy" (link to download), attracted strong interest from the ADC community.

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These payload-linker innovations represented an important step forward for ADC development, enabling an improved balance between potency and safety, activity in chemo-resistant tumors, and novel mechanisms that go beyond conventional DNA-damaging payloads.

Expanding the Therapeutic Reach of ADCs

Leveraging its proven expertise in drug development, NMS has advanced a portfolio of novel payloads designed to address the long-standing challenges in ADC design and therapeutic scope.

The NMS ADC payload portfolio includes:

Duocarmycins that demonstrated high in-vivo efficacy across multiple tumor models with a favorable safety profile, well-suited for chemo-resistant, highly heterogeneous solid tumors;
Anthracyclines engineered to achieve an improved balance between potency and safety while exhibiting unique immune-activating properties; and
Targeted payloads acting beyond DNA damage, offering strong potential for dual-payload combinations and activity across multiple oncogenic pathways.
By introducing these differentiated payload–linker technologies, NMS aims to broaden the range of targetable tumors and drive oncology toward durable, immune-mediated cancer control.

"We continue to innovate in payload-linker chemistry, enabling the design of novel ADCs that address unmet medical needs and expand treatment options for patients currently beyond the reach of existing therapies," said Tomasz Rzymski, Chief Scientific Officer, NMS ADC Business Unit. "We plan to further invest in our integrated R&D platform to accelerate the development of differentiated payload-linker classes and next-generation ADCs, while also exploring strategic collaborations to bring these therapies closer to patients."

(Press release, Nerviano Medical Sciences, NOV 7, 2025, View Source [SID1234659637])

On November 7, 2025 IMUNON, Inc. (Nasdaq: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, reported it will host an R&D Day on Monday, November 10, 2025 at 8:00 a.m. ET in New York City featuring in-depth discussions with experts including principal investigators leading the Phase 3 OVATION 3 clinical trial and Phase 2 minimal residual disease (MRD) trial of IMNN-001, a novel IL-12 immunotherapy in development for the treatment of women with advanced ovarian cancer.

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"This is an opportunity to hear directly from the investigators driving IMNN-001 clinical progress forward—physicians who see firsthand the urgent need for new ovarian cancer treatment options and the potential clinical impact of our novel IMNN-001 immunotherapy," said Stacy R. Lindborg, Ph.D., president and chief executive officer of IMUNON. "The data and insights shared will be consequential for understanding the future of ovarian cancer treatment and how we are leading the effort to bring the first advance in the standard of care that could transform frontline treatment, which has not seen innovation for about 30 years."

The event will include presentations from:

Premal H. Thaker, M.D. (Washington University School of Medicine) – Unmet need and OVATION 2 trial data including survival benefits
Amir A. Jazaeri, M.D. (MD Anderson Cancer Center) – Phase 2 MRD study results and immune activation mechanism overview
Giorgio Paulon, Ph.D. (Berry Consultants, LLC) – Phase 3 trial statistical design and path to approval
Douglas V. Faller, M.D., Ph.D. (IMUNON) – Phase 3 trial enrollment momentum and clinical milestones

(Press release, IMUNON, NOV 7, 2025, View Source [SID1234659636])