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 Harbour BioMed ("HBM" or the "Company"; HKEX: 02142), a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology and oncology, and Evinova, a global health-tech company accelerating the delivery of better health outcomes by propelling the life sciences sector forward in digital health, reported a strategic collaboration in artificial intelligence (AI).

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Under the terms of the collaboration, Harbour BioMed and Evinova China will jointly apply AI and digital technologies to enhance the efficiency of innovative biologics development. Building on their own strengths, the two companies aim to build an open ecosystem for AI-driven drug R&D.

Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed, stated, "We are pleased to collaborate with Evinova to advance the application of AI in biotherapeutic development. Harbour BioMed has built a robust and differentiated product pipeline based on our industry-leading Harbour Mice technology platform. Through this collaboration, we look forward to applying AI to improving clinical study efficiency and accelerating the delivery of innovative therapies to patients around the world."

Nate Zhang, General Manager of Evinova China, stated, "Evinova leverages the digital transformation insights of top global pharmaceutical companies to design our AI-powered clinical development solutions and digital strategy consulting services, so that we can accelerate the delivery of better health outcomes. To realize our mission, Evinova China needs to partner with innovative companies like Harbour BioMed, which are rooted in China while harboring global ambitions. Together, through our world-class AI technology platforms and deep therapeutic expertise, we can help take China-originated breakthrough assets from the laboratory to the world."

(Press release, Harbour BioMed, NOV 7, 2025, View Source [SID1234659655])

On November 7, 2025 SciBase Holding AB ("SciBase") (STO: SCIB), a leading developer of AI-based diagnostic solutions for skin disorders, reported that SciBase and Castle Biosciences ("Castle") (NASDAQ: CSTL) have expanded their collaboration and license agreement and entered into a separate loan agreement. The two companies first entered into the collaboration and license agreement in June 2025. The expanded agreement includes providing Castle increased autonomy over the manufacturing process. Under the separate loan agreement, Castle will provide SEK 20 million to SciBase.

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The goal of the first joint clinical study is to develop a test that predicts flares in patients diagnosed with atopic dermatitis (AD), with additional indications to potentially follow. The loan is based on market terms with a potential for Castle to request conversion of the loan into new shares.

"Our collaboration with Castle Biosciences is moving ahead at full speed," said Pia Renaudin, CEO of SciBase. "With this loan, we secure the resources needed to smoothly ramp up production and maintain uninterrupted growth. We expect the resulting improvements in product margins will create value across all markets and indications. This collaboration will also help us accelerate the adoption of Nevisense in skin barrier health and continue driving strong sales growth in skin cancer diagnostics."

The loan agreement is a five-year loan amounting to SEK 20 million. The interest rate on the loan amounts to STIBOR plus two (2) per cent per annum and shall be paid quarterly. However, the first interest payment date shall be 31 March 2026, and the final interest payment date shall be on the repayment date of the loan. The loan shall be repaid in cash no later than five years following the signing of the loan agreement or, if demanded by Castle, by way of conversion of the loan amount into new shares in SciBase. In case of conversion, the conversion price per share shall correspond to the volume weighted average price of the shares in SciBase during the 30 trading days preceding the repayment date. For the avoidance of doubt, repayment of the loan may be made in a combination of cash repayment and conversion repayment. The loan is secured by a share pledge over SciBase’s shares in SciBase AB.

This information is information that SciBase Holding AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below, at 08.00 CEST on November 7, 2025.

(Press release, Castle Biosciences, NOV 7, 2025, View Source [SID1234659654])

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 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])