Accession Therapeutics doses first patient in Phase 1 clinical trial of TROCEPT-01 (ATTR-01), a novel cancer immunotherapy

On November 17, 2025 Accession Therapeutics Limited, a biopharmaceutical company developing next generation cancer immunotherapies, reported it has dosed the first patient in its Phase I clinical trial evaluating TROCEPT-01 (ATTR-01), the company’s lead drug candidate from its proprietary TROCEPT platform technology. The patient has now completed the cycle of treatment. This milestone marks a major step forward in the development of a potentially transformative treatment for solid tumours.

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TROCEPT-01 (ATTR-01) is a first-in-class, tumour-activated viral immunotherapy that, following systemic delivery, is designed to selectively generate a clinically validated checkpoint inhibitor within tumours. This approach, targeting αvβ6 integrin on epithelial tumours, optimises efficacy while minimising damage to healthy tissue. Preclinical studies have demonstrated strong anti-tumour activity across multiple solid tumour models, supporting its potential as a targeted therapy for aggressive cancers.

The ATTEST trial is an open label, dose-escalation and dose expansion study (View Source) designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of TROCEPT-01 (ATTR-01) in patients with advanced carcinomas who have had at least one prior treatment course. The trial is being conducted at leading clinical sites across the UK. Additional trial sites will be activated as the study progresses, including in Spain where there is established expertise in the treatment of solid tumours.

Professor Adel Samson, Professor of Cancer Medicine and Immunotherapy at Leeds University School of Medicine and lead Investigator in the ATTEST study, said:
"As a clinician, I am very excited about the potential of TROCEPT-01 (ATTR-01) and the TROCEPT platform to increase clinical response rates through high tumour-localised production of anti-cancer drugs. This program is targeted at solid tumours where there is significant need for better treatment outcomes".

Bent Jakobsen, PhD FMedSci, CEO of Accession Therapeutics, said:
"Dosing the first patient in our TROCEPT-01 clinical trial is a pivotal moment for Accession Therapeutics and a testament to the dedication of our team and collaborators. In TROCEPT, we have created a unique, highly versatile platform that enables novel drugs to be made inside cancer cells. The platform gives us multiple opportunities to generate valuable products to transform outcomes for cancer patients. TROCEPT-01 (ATTR-01) has the potential to expand the indications where checkpoint inhibitors have been successful."

Professor Hardev Pandha, FRCP, FRACP, PhD, Medical Director of Accession Therapeutics, added:
"TROCEPT-01 (ATTR-01) represents a novel approach to target hard-to-treat cancers, and we are excited to advance this promising therapy into clinical development. We anticipate the clinical data will show that the virus gets to the tumours when given systemically, and that the drug is produced within the tumours. Our goal in the ATTEST study is to establish a strong safety profile while identifying early signals of efficacy to benefit patients with limited treatment options."

(Press release, Accession Therapeutics, NOV 17, 2025, View Source [SID1234660037])

Cogent Biosciences Announces Participation in the Jefferies Global Healthcare Conference

On November 14, 2025 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported its participation in the Jefferies Global Healthcare Conference in London on Wednesday, November 19, 2025 at 11:30 a.m. GMT (6:30 a.m. ET).

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A live webcast will be available on the Investors & Media page of Cogent’s website at investors.cogentbio.com. A replay of the webcast will be available approximately two hours after the completion of the event and will be archived for up to 30 days.

(Press release, Cogent Biosciences, NOV 14, 2025, View Source [SID1234659966])

PRISM BioLab Achieved Initial Milestone and Receives the Milestone Payment in Drug Discovery Collaboration with Ono Pharmaceutical Co., Ltd.

On November 14, 2025 PRISM BioLab, Co. Ltd. ("PRISM") announces that today, PRISM and Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka; President and COO: Toichi Takino; hereinafter "Ono") reported to have achieved the initial milestone in the drug discovery collaboration and PRISM has confirmed receipt of the milestone payment.

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PRISM and Ono have entered into a "Joint Research and Licensing Agreement" on April 25, 2024, (hereinafter "the Agreement") for drug discovery in the oncology field. Under this Agreement, PRISM received an upfront payment and joint research fees, launched a joint research project (hereinafter "the Project") to discover clinical candidate compounds against targets proposed by Ono, utilizing PRISM’s proprietary peptide-mimetic technology "PepMetics". PepMetics is a technology based on small molecules targeting protein-protein interactions (PPIs).

The Project has progressed as planned under the collaboration of both companies, and has achieved the milestone defined in the Agreement for the drug discovery research stage. PRISM will receive the milestone payment and joint research fees from Ono. The milestone payment will be recorded as business revenue in the first quarter of PRISM’s fiscal year ending September 2026 (October 1, 2025 – September 30, 2026). The joint research funding will be allocated proportionally throughout the period of the next phase of the joint research. While the specific amounts of the milestone payment and joint research funding are not disclosed under the terms of the Agreement, the total amount corresponds to approximately 80% of our net sales for the previous fiscal year (FY ended September 2025), as stated in our "Financial Results for the Fiscal Year Ended September 2025 (JGAAP) " released today.

The Project will accelerate the search for clinical candidate compounds through collaborative research with Ono, and leveraging PRISM’s expertise in structural biology and computational chemistry. The Agreement stipulates multiple milestones, and PRISM will receive milestone payments according to the progress of drug discovery research and subsequent stages, including clinical development conducted by Ono. Furthermore, if clinical candidate compounds lead to the commercialization of new drug, PRISM will receive royalties based on product sales.

"We are delighted to have achieved the first milestone in drug discovery research targeting previously challenging targets identified by Ono.", said Dai Takehara, President & CEO of PRISM. "This first step toward creating innovative new drugs is the achievement of the collaborative efforts of researchers from both companies, and we are grateful for this opportunity. We will continue dedicating our full effort to this project to achieve research outcomes in the next stage."

PRISM will maintain its strong relationship with Ono, further advance the joint research project, and strive for the creation of groundbreaking new drugs in the oncology field. This achievement demonstrates the potential of PRISM’s PepMetics technology and is expected to contribute to the company’s long-term growth and enhancement of corporate value.

(Press release, PRISM Pharma, NOV 14, 2025, View Source [SID1234659996])

Curis to Present at Upcoming 30th Annual SNO Meeting

On November 14, 2025 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 inhibitor, reported that Curis will report emavusertib and BTKi clinical data in Primary CNS Lymphoma (PCNSL) and Secondary CNS Lymphoma (SCNSL) in three presentations and preclinical data on emavusertib in an oral presentation at the 30th Annual Meeting of the Society for Neuro-Oncology (SNO) on November 19-23:

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November 21, 2025 – 4:30 PM ET (11:30 AM HT)

Format:

Poster Presentation

Presenter:

Dr. Christian Grommes, Memorial Sloan Kettering Cancer Center, NY, NY

Title:

Analysis of Genetic Mutation Profile and CNS Pharmacokinetics in Relapsed/Refractory Primary CNS Lymphoma Patients Responding to Novel Emavusertib (IRAK4i) and BTKi Combination

Format:

Poster Presentation

Presenter:

Dr. Lakshmi Nayak, Dana-Farber Cancer Institute, Boston, MA

Title:

Preliminary Safety and Efficacy of Emavusertib (CA-4948) in Combination with Ibrutinib in Relapsed/Refractory Primary Central Nervous System Lymphoma Patients

November 22, 2025 – 4:45 PM ET (11:45 AM HT)

Format:

Rapid Oral Presentation

Presenter:

Dr. Christian Grommes, Memorial Sloan Kettering Cancer Center, NY, NY

Title:

Analysis of Genetic Mutation Profile and CNS Pharmacokinetics in Relapsed/Refractory Primary CNS Lymphoma Patients Responding to Novel Emavusertib (IRAK4i) and BTKi Combination

Format:

Poster Presentation

Presenter:

Cecilia A. Merrigan, APRN, CNP, DNP, Mayo Clinic, Rochester, MN

Title:

Promising Efficacy Signal in Secondary CNS Lymphoma Patients Treated with Emavusertib and Ibrutinib

November 23, 2025 – 3:24 PM ET (10:24 AM HT)

Format:

Oral Presentation

Presenter:

Christina von Roemeling, Ph.D., University of Florida, Gainesville, FL

Title:

Targeting Myddosome Signaling to Improve Immunotherapy in Melanoma Brain Metastases

(Press release, Curis, NOV 14, 2025, View Source [SID1234659967])

Nuvalent Announces Timing of Topline Pivotal Data for TKI Pre-treated Patients with Advanced ALK-positive NSCLC from ALKOVE-1 Clinical Trial of Neladalkib

On November 14, 2025 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported that the company will host a webcast and conference call on Monday, November 17, 2025 at 8:00 a.m. ET, to discuss topline pivotal data for neladalkib, an investigational ALK-selective inhibitor, in TKI pre-treated patients with advanced ALK-positive non-small cell lung cancer from the global ALKOVE-1 Phase 1/2 clinical trial.

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Webcast and Conference Call Information

To access the call, please dial +1 (800) 836-8184 (domestic) or +1 (646) 357-8785 (international) at least 10 minutes prior to the start time and ask to be joined to the Nuvalent call.

Accompanying slides and a live video webcast will be available in the Investors section of the Nuvalent website at https://investors.nuvalent.com/events. A replay and accompanying slides will be archived on the Nuvalent website for 30 days.

About Neladalkib and the ALKOVE-1 Phase 1/2 Clinical Trial

Neladalkib is an investigational brain-penetrant ALK-selective inhibitor created with the aim to overcome limitations observed with currently available ALK inhibitors. Neladalkib is designed to remain active in tumors that have developed resistance to first-, second-, and third-generation ALK inhibitors, including tumors with single or compound treatment-emergent ALK mutations such as G1202R. In addition, neladalkib is designed for central nervous system (CNS) penetrance to improve treatment options for patients with brain metastases, and to avoid inhibition of the structurally related tropomyosin receptor kinase (TRK) family. Together, these characteristics have the potential to avoid TRK-related CNS adverse events seen with dual TRK/ALK inhibitors and to drive deep, durable responses for patients across all lines of therapy. Neladalkib has received U.S. Food and Drug Administration (FDA) breakthrough therapy designation for the treatment of patients with locally advanced or metastatic ALK-positive non-small cell lung cancer (NSCLC) who have been previously treated with 2 or more ALK tyrosine kinase inhibitors and orphan drug designation for ALK-positive NSCLC.

The ALKOVE-1 trial (NCT05384626) is a first-in-human Phase 1/2 clinical trial for patients with advanced ALK-positive NSCLC and other solid tumors. The completed Phase 1 portion enrolled ALK-positive NSCLC patients who previously received at least one ALK TKI, or patients with other ALK-positive solid tumors who had been previously treated or for whom no satisfactory standard of care exists. The Phase 1 portion of the trial was designed to evaluate the overall safety and tolerability of neladalkib, with additional objectives including determination of the recommended Phase 2 dose (RP2D), characterization of the pharmacokinetic profile, and evaluation of preliminary anti-tumor activity. The global, single arm, open label Phase 2 portion is designed with registrational intent for TKI pre-treated patients with advanced ALK-positive NSCLC. Global enrollment in ALKOVE-1 remains ongoing for adult and adolescent patients with ALK-positive solid tumors outside of NSCLC, and adolescent patients with ALK-positive NSCLC.

(Press release, Nuvalent, NOV 14, 2025, View Source [SID1234659997])