On November 7, 2025 Akeso, Inc. (HKEX: 9926.HK) reported that the final Overall Survival (OS) analysis results from the HARMONi-A study, a Phase III study evaluating ivonescimab combined with chemotherapy for the treatment of EGFR-mutated non-squamous non-small cell lung cancer (nsq-NSCLC) following EGFR-TKI progression, were selected as a "Late-Breaking Abstract" (LBA) for the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), held in National Harbor, Maryland, USA. Professor Xiuning Le from MD Anderson Cancer Center presented these findings to a global audience during an oral presentation session.

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HARMONi-A is the first global Phase III clinical trial of an immunotherapy in the EGFR-TKI resistant, EGFR-mutated nsq-NSCLC setting to demonstrate clinically meaningful and statistically significant benefits in both Progression-Free Survival (PFS) and Overall Survival (OS). This final OS analysis, the first from a Phase III trial of ivonescimab, confirms the breakthrough value of ivonescimab-based therapy in improving both PFS and OS. Historically, cancer immunotherapies have largely failed to demonstrate significant breakthroughs in this specific indication. Prior Phase III trials involving other regimens—such as PD-1 inhibitors combined with chemotherapy or immunotherapies combined with anti-angiogenic therapy, failed to show significant OS benefits. The significant positive outcomes in both PFS and OS in the HARMONi-A study underscore the substantial clinical benefit improvement of ivonescimab over PD-1 inhibitors.

Previously, the HARMONi-A study had already met its primary endpoint, demonstrating a statistically significant improvement in PFS at the interim analysis (PFS HR 0.46, P < 0.001). Previously, during the regulatory review for the approval of ivonescimab in first-line PD-L1-positive NSCLC in China, a descriptive analysis of OS from the HARMONi-A study was conducted in May 2024 at the request of the regulatory authorities. The final OS analysis results presented at SITC (Free SITC Whitepaper) 2025 represent the final and only pre-specified formal OS analysis for the HARMONi-A study, performed as a sequential test according to the pre-specified statistical analysis plan (SAP).

The final OS analysis, with a median follow-up period of 32.5 months, showed that the ivonescimab plus chemotherapy regimen provided a clinically meaningful and statistically significant improvement in OS compared to chemotherapy alone:

The median OS was 16.8 months in the ivonescimab treatment group compared to 14.1 months in the control group (OS HR=0.74, P=0.019), achieving statistical significance. The OS benefit increased with extended follow-up.
The ivonescimab combination regimen consistently demonstrated OS benefit over the control group across all subgroups:
In patients with brain metastases, OS HR=0.61;
In patients without brain metastases, OS HR=0.77;
In patients with EGFR 19Del mutations, OS HR=0.83;
In patients with EGFR L858R mutations, OS HR=0.60.
With a median follow-up of 32.5 months, the long-term safety profile of the ivonescimab combination therapy remained favorable, with no new safety signals identified. The incidence of common treatment-related adverse events (TRAEs) showed no significant difference between the two groups.

Based on the positive clinical data from the HARMONi-A study, ivonescimab received approval from the China National Medical Products Administration in May 2024 for this indication. In November 2024, Akeso announced that ivonescimab was successfully added to China’s National Reimbursement Drug List, effective January 1, 2025, ensuring widespread patient access to this life-saving treatment.

Additionally, Summit Therapeutics, Akeso’s global partner for ivonescimab, announced in October 2025 that it plans to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2025, seeking approval for ivonescimab in combination with chemotherapy for the treatment of EGFR-mutant, third-generation EGFR-TKI-resistant, non-squamous NSCLC.

(Press release, Akeso Biopharma, NOV 7, 2025, View Source;302608764.html [SID1234659652])

On November 7, 2025 Trained Therapeutix Discovery, Inc., a biotech company training immunity at its origin with nanomedicines, reported preclinical data on RIDE-001, a nanomedicine designed to program myeloid progenitor cells for an anticancer innate immune response, were presented in a poster at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. The data demonstrated that RIDE-001 effectively induced trained immunity in vitro in primary human immune cells, induced anti-tumor immunity in mouse tumor models of melanoma and colorectal cancer, and safely induced innate immune responses in rats and non-human primates. RIDE-001 showed therapeutic activity against solid tumors as a single agent, and it also exhibited synergy in combination with immune checkpoint inhibition.

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"Myeloid cells can promote cancer by suppressing anti-tumor immune responses, enhancing tumor angiogenesis and facilitating metastasis, but due to their plasticity in the tumor microenvironment, they have been considered an unattractive therapeutic target," said Willem Mulder, PhD, Chief Scientific Officer of Trained Therapeutix Discovery. "Our approach with RIDE-001 is a breakthrough in immune-oncology, as it targets myeloid progenitor cells before they differentiate into immune cells. By programing myeloid cells at their naissance, we can deploy the power of the innate immune response against cancer. Based on these promising data demonstrating consistent myeloid cell training and antitumor activity across species, in addition to RIDE-001’s favorable safety profile, we have initiated GMP manufacturing in anticipation of the first clinical studies in patients with solid tumors."

RIDE-001 was developed using Trained Therapeutix Discovery’s proprietary ApoA1-based nanomedicines platform to target the bone marrow where it activates the intracellular pattern recognition receptor NOD2. This triggers epigenetic changes in myeloid progenitor cells, inducing the production of trained myeloid cells to generate durable, anti-tumor responses.

RIDE-001 preclinical data showed:

A dose-dependent rise in NOD2 activation;
Trained immunity as assessed by peripheral blood mononuclear cells (PBMCs);
Trained myeloid cells in rats demonstrating a shift in monocyte phenotype and increased blood neutrophil counts;
Trained myeloid cells in non-human primates with a consistent increase in intermediate monocytes in both males and females following each administered dose;
Single-agent anti-tumor efficacy in the highly immunosuppressive B16F10 melanoma mouse model;
Synergy with a subtherapeutic dose of anti-PD1 in the MC38 colorectal cancer mouse model;
And a favorable safety profile.
A copy of the poster titled "RIDE-001: A well-tolerated innate immunotherapy to treat cancer by targeting and reprogramming bone marrow progenitor cells" (abstract number 1178) is available on the company’s website.

(Press release, Trained Therapeutix Discovery, NOV 7, 2025, View Source [SID1234660997])

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 Akeso, Inc. (HKEX: 9926.HK) reported the preclinical research data for its novel antagonistic monoclonal antibody targeting IL-1RAP, AK135, at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) held in National Harbor, Maryland.

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The results demonstrated that AK135 effectively targets IL-1RAP and blocks three key pro-inflammatory signaling pathways—IL-1, IL-33, and IL-36 at their source, thereby halting the transmission of inflammatory signals. In preclinical models, AK135 provided significant pain relief in neuropathy, exhibiting dose-dependent efficacy, while also showing good tolerability and safety profiles.

In vitro Results:

ELISA, Fortebio molecular interaction technology, and flow cytometry (FACS) results demonstrated that AK135 has high affinity for IL-1RAP, with binding activity comparable to or superior to that of the control antibody CAN04.
Reporter gene assays further confirmed that AK135 effectively inhibits the activation of IL-1, IL-33, and IL-36 signaling pathways, showing excellent half-maximal inhibitory concentration (IC50) values in each of the pathways.
In tumor cell models, AK135 significantly reduced the secretion of pro-inflammatory cytokines (such as IL-6 and IL-8) induced by IL-1, IL-33, and IL-36.
In vivo Results:

The in vitro experiments confirmed the high affinity and potent neutralizing activity of AK135. To further evaluate its in vivo efficacy, the research team established a Chemotherapy-induced peripheral neuropathy (CIPN) mouse model and assessed the pharmacological effects of AK135 through intermittent low-dose paclitaxel administration.
Following AK135 treatment, the paw withdrawal threshold (PWT) in the CIPN model was significantly increased, indicating that AK135 effectively alleviated mechanical allodynia, with a dose-dependent efficacy.
Throughout the treatment period, mice in all dose groups maintained stable body weight, with no significant signs of toxicity, demonstrating good tolerance.
CIPN is a prevalent and dose-limiting side effect of chemotherapy, affecting 50-90% of treated patients, of which 30-40% progressing to chronic neuropathic pain. Despite its clinical significance, effective treatment options remain limited, and the underlying mechanisms are not fully understood. Emerging evidence suggests that pro-inflammatory cytokines released by the damaged neurons play a key role in CIPN pathogenesis. IL-1 receptor accessory protein (IL-1RAP/IL-1RAcP) is a critical mediator of inflammatory signaling, amplifying responses through the interleukin-1 (IL-1), interleukin-33 (IL-33), and interleukin-36 (IL-36) pathways. Akeso developed AK135, a novel antagonistic monoclonal antibody targeting IL-1RAP, to alleviate the peripheral neuralgia by inhibiting these proinflammatory signaling pathways.

About AK135 (IL-1RAP Targeting Antibody)
AK135 is a novel antagonistic antibody targeting IL-1RAP, internally developed by Akeso, aimed at treating chemotherapy-induced peripheral neuropathy (CIPN). By precisely blocking IL-1RAP, this product simultaneously inhibits the three core inflammatory signaling pathways—IL-1, IL-33, and IL-36, providing relief from neuroinflammatory responses at their source. Preclinical studies have shown that AK135 significantly alleviates neuropathic pain in a dose-dependent manner, while also demonstrating good tolerance. Currently, AK135 is in Phase I clinical trials for the treatment of CIPN.

(Press release, Akeso Biopharma, NOV 7, 2025, View Source [SID1234659653])

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])