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])

On November 7, 2025 Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, reported pivotal clinical validation results from the ALTUS study (NCT: 05064553). The prospective, head-to-head trial demonstrated that the company’s Oncoguard Liver blood test delivers superior early-stage and overall sensitivity for hepatocellular carcinoma (HCC) — the most common form of liver cancer — compared to the current standard of care.1,2

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These findings will be presented as late-breaking data at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting* on November 11, 2025, underscoring the Oncoguard Liver test’s potential to transform liver cancer surveillance for at-risk populations. The company intends to submit the data for publication in a peer-reviewed journal.

"Ultrasound surveillance has been the standard for liver cancer screening for decades, but it’s limited by image quality and inconsistent follow up, resulting in low detection rates and poor adherence," said Dr. Binu John, principal investigator for the ALTUS trial, associate professor at the University of Miami Miller School of Medicine, and chief of gastroenterology and hepatology at the Miami VA. "A highly sensitive blood-based alternative like Oncoguard Liver is a game changer that could make liver cancer screening more accessible, equitable, and effective for millions of at-risk patients."

Setting the new benchmark in liver cancer surveillance

The ALTUS study is the largest prospective, real-world trial of a blood test for liver cancer surveillance in the United States. More than 3,000 participants were enrolled across community practices, Veterans Affairs, and academic centers, representing the racial and ethnic diversity of high-risk patient populations.1

The Oncoguard Liver test achieved its primary endpoint, detecting three times more cancers defined as early-stage by Milan criteria compared to ultrasound (67% vs 22%).1 Milan criteria are a set of guidelines that describe eligibility for curative liver transplant.3†

Very early-stage HCC sensitivity: 64% for Oncoguard Liver vs 9% for ultrasound 1
Early-stage HCC sensitivity: 77% for Oncoguard Liver vs 36% for ultrasound 1
These findings demonstrate a seven-fold improvement in detecting liver cancers when they are most treatable and remain eligible for potentially curative options such as resection or transplant.1-3

The Oncoguard Liver test also demonstrated a specificity of 82% in the ALTUS study,1 exceeding the threshold established by experts for clinical utility.4

"These new data from the ALTUS study show that we can reliably detect liver cancer earlier, which is key to improving outcomes," said Dr. Paul Limburg, chief medical officer, screening at Exact Sciences. "With Cologuard, we have already seen what is possible, with more than 20 million tests completed and thousands of colorectal cancers prevented through early detection. The Oncoguard Liver test builds on that success, applying the same science-driven approach to another cancer in which finding disease early can help save lives."

Transforming surveillance for a growing and underserved population

Hepatocellular carcinoma is among the fastest-growing causes of cancer-related deaths in the United States.5-7 By 2040, liver cancer is expected to become the third-leading cause of cancer death, with more than 40,000 new cases and 30,000 deaths annually.5-7 Patients diagnosed at early stages of HCC experience 12 times greater survival rates than those diagnosed with distant disease,6 yet fewer than 30% of eligible individuals participate in regular surveillance, which is recommended by AASLD for people with specific risk factors, such as chronic liver disease or cirrhosis.8

The Oncoguard Liver test is a blood-based multiomics assay developed in collaboration with Mayo Clinic. It combines DNA methylation and protein markers to detect molecular signatures associated with liver cancer, using Exact Sciences’ proprietary PCR technology designed for accuracy, scalability, and broad clinical access.

The ALTUS study confirms that the Oncoguard Liver test meets consensus thresholds for blood-based surveillance established in 2025 and overcomes key barriers associated with ultrasound imaging, particularly in populations affected by obesity or other factors that limit image quality.

(Press release, Exact Sciences, NOV 7, 2025, View Source [SID1234659635])

On November 7, 2025 Coherus Oncology, Inc. (NASDAQ: CHRS), reported new multiomic tumor and blood-based biomarker data from the dose expansion arm of its ongoing Phase 1b clinical trial evaluating CHS-114, a selective, cytolytic anti-CCR8 antibody, as monotherapy and in combination with toripalimab in patients with recurrent/metastatic HNSCC. These data are being presented at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) being held November 5-9, 2025, in National Harbor, Maryland.

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This interim analysis from the dose expansion phase demonstrates that CHS‑114-mediated immune activation is significantly enhanced and sustained with toripalimab in HNSCC study participants. In on-treatment tumor biopsies, CHS‑114 depleted CCR8+ Tregs, but not CCR8- Tregs, and increased CD8+ T cells in the tumor microenvironment (TME), indicating TME remodeling for antitumor immune activation and establishing proof of mechanism. To date, CHS‑114, as monotherapy or in combination with toripalimab has a manageable safety profile, with promising early antitumor activity in HNSCC.

"These data extend the data we presented at AACR (Free AACR Whitepaper) and are important for 3 key development aims. Firstly, showing selective depletion of CCR8+ Tregs and not CCR8- Tregs or CD8 and CD4 T cells, shows the drug does what it was intended to do. This coupled with the acceptable safety profile further supports that CCR8 is proving to be a tumor selective target that now allows the field to remove Tregs in cancer. Secondly, showing statistically significant increase in immune activation using multiple biomarker assays further supports the development plan to advance CHS-114 in combination with toripalimab or with other immune activators. Importantly, we have seen a partial response in a refractory head and neck cancer patient in the initial testing of the safety of this combination," said Theresa LaVallee, Ph.D., Coherus Oncology’s Chief Scientific and Development Officer. "And third, the data support the 2 doses of CHS-114 are pharmacologically active leading to substantial Treg depletion in tumors and immune activation. The ongoing enrollment in the dose optimization arm of the study, evaluating CHS-114 and toripalimab, sets us up to address the FDA’s Project Optimus and define a phase 2 dose."

Multiomic Clinical Biomarker Data from CHS-114 Phase 1 Dose Expansion and Safety Arms in HNSCC Participants

Immune profiling of blood from HNSCC participants from 2 pharmacologically active doses of CHS-114 monotherapy expansion arm (n=10) and in combination with toripalimab safety arm (n=6) showed:

CHS-114 demonstrated robust depletion of target CCR8+ Tregs and spared non-CCR8+ Tregs, CD4+ T cells and CD8+ T cells in PBMCs from HNSCC participants throughout the treatment cycle.

CHS-114 demonstrated significant increases in peripheral immune activation of CD8+ T cell cytotoxicity, activation and proliferation and inflammatory cytokine levels compared with pretreatment levels.

CHS‑114 with toripalimab mediated a robust and significant increase in CD8+ T cell proliferation (Ki67) and Th1 inflammatory cytokines that was sustained through the dosing cycle.
Immune profiling of pretreatment and on-treatment tumor tissue tumor tissue samples from HNSCC participants from monotherapy expansion (n=10) and combination with toripalimab (n=2) cohorts showed:

CHS-114 treatment decreased CCR8+ Treg density by 74% and total FOXP3+ Treg density by 43%, while sparing CCR8- Tregs demonstrating selective and robust depletion of target Tregs.
Furthermore, CHS-114 treatment increased CD8+ T cell density by 73% and CD8+ T cell /CCR8+ Treg ratio by 12-fold, demonstrating a remodeling of the TME.
Data confirm CHS-114 selectivity, the 2 doses evaluated are pharmacologically active and establish proof of mechanism in tumor tissue.
SITC 2025 Presentation Details
Abstract # 640: CHS-114, an anti-CCR8 cytolytic monoclonal antibody demonstrates selective intratumoral Treg depletion and favorable immune remodeling in participants with advanced solid tumors.

Date: Saturday, November 8, 2025, 10 a.m. – 6:35 p.m. ET
Location: Prince George ABC Exhibit Halls, Gaylord National Resort and Convention Center
About the CHS-114 Phase 1/1b Study

The Phase 1 study (NCT05635643) is a dose escalation, dose optimization, and expansion study evaluating CHS-114 as a monotherapy and in combination with toripalimab, a next-generation PD-1 inhibitor. Arm 1a (first-in-human dose escalation) enrolled 20 patients with advanced solid tumors including 2 patients with HNSCC and evaluated multiple dose levels (5-1200 mg) of CHS-114 monotherapy. Arm 1b evaluated two pharmacologically active doses of CHS-114 monotherapy in 13 HNSCC patients with required paired tumor biopsies. Arm 2 evaluated the safety of two pharmacologically active doses of CHS-114 with toripalimab in 7 patients. Arm 3 is evaluating two pharmacologically active doses of CHS-114 with toripalimab in 40 patients with second-line HNSCC. Primary objectives of the Phase 1 study are to optimize the CHS-114 dose(s) for expansion and evaluate the safety of CHS-114 with and without toripalimab. Secondary objectives are to evaluate the preliminary antitumor activity and the PK of CHS-114 with and without toripalimab and assess biomarkers, including changes in regulatory T cells (Tregs) and CD8+ T cells in paired tumor biopsies and other immune biomarkers.

About CHS-114

CHS-114, an afucosylated, cytolytic CCR8 monoclonal antibody, is designed to selectively target human CCR8 and preferentially kill CCR8+ Tregs within the tumor microenvironment while preserving CD8+ effector T cells and Tregs in normal tissue. In preclinical studies, CHS-114 induced antibody-dependent cellular cytotoxicity (ADCC) and/or antibody-dependent cellular phagocytosis (ADCP) to deplete tumoral CCR8+ Tregs. In addition, treatment with CHS-114 alone reduced tumor growth in murine models, and enhanced antitumor activity was observed in combination with anti-PD-1 treatment. CHS-114 is currently being evaluated in combination with toripalimab in two Phase 1b clinical trials in patients with advanced solid tumors, including head and neck cancer (NCT05635643), colorectal cancer, gastric cancer, and esophageal cancer (NCT06657144).

(Press release, Coherus Oncology, NOV 7, 2025, View Source [SID1234659632])