On July 28, 2025 oNKo-innate reported that it has grown from a pioneering NK cell biology startup into a fully integrated biotechnology company with global ambitions. Today, we are proud to introduce our new name: Audax Biosciences.

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Audax captures the spirit that has driven our founders from day one. Inspired by a passion for long distance endurance cycling, the name symbolises persistence, discipline, and the unwavering commitment required to create medicines that make a meaningful difference. Just as an audax ride tests skill and endurance, advancing breakthrough therapies demands resilience, precision, and long term vision.

Audax Biosciences reflects both our heritage and our ambition – a company built to endure, innovate, and deliver impactful medicines for patients worldwide.

(Press release, Audax Biosciences, JUL 28, 2025, View Source [SID1234665871])

On July 28, 2025 Adaptimmune Therapeutics plc (NASDAQ: ADAP), a company redefining the treatment of solid tumor cancers with cell therapy, reported its entry into a definitive agreement for the sale of TECELRA, lete-cel, afami-cel, and uza-cel cell therapies to US WorldMeds (Press release, Adaptimmune, JUL 28, 2025, View Source [SID1234654566]). Consummation of the sale is expected to occur before the end of the week.

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Adrian Rawcliffe, Adaptimmune’s Chief Executive Officer: "Adaptimmune has been at the forefront of solid tumor cell therapy and delivering groundbreaking treatments to patients for more than a decade. We were the first company to obtain a marketing authorization for an engineered TCR T-cell therapy, TECELRA, and we have a second cell therapy, lete-cel, with approval anticipated in 2026. However, given the financial situation of the Company, it is clear that securing the right strategic option was critical to maximize value for all of our stakeholders and importantly ensure our patients continue to receive TECELRA. After an extensive review of all strategic alternatives available to Adaptimmune we are convinced that this transaction represents the best path forward for Adaptimmune, our patients and stakeholders."

Breck Jones, US WorldMeds Chief Executive Officer: "Anchored by a first-in-class commercial therapy and a promising pipeline, this acquisition is a meaningful step forward in our mission to bring hope and innovation to patients who need it most. US WorldMeds deeply respects the strong foundation Adaptimmune has built in the cell therapy space and is committed to carrying that work forward – advancing and delivering these important therapies to the people and families who are counting on them."

Under the terms of the asset purchase agreement, US WorldMeds will purchase the TECELRA, uza-cel, afami-cel and lete-cel cell therapy assets of Adaptimmune (the "Assigned Assets") and all intellectual property rights exclusively relating to such Assigned Assets. In return, Adaptimmune will receive $55 million in cash upon consummation of the sale. In addition, US WorldMeds has agreed to make future payments of up to $30 million to Adaptimmune upon the achievement of certain milestones. Adaptimmune and US WorldMeds will also enter into a license agreement pursuant to which, among other things, US WorldMeds will be exclusively licensed residual intellectual property rights necessary for the manufacture and commercialization of the Assigned Assets and non-exclusively licensed intellectual property rights in Adaptimmune’s vector manufacturing process. Adaptimmune will also provide certain transition services to US WorldMeds pursuant to a transition services agreement on terms specified therein.

US employees involved in the development and commercialization of the Assigned Assets will be offered employment with US WorldMeds to ensure the ongoing success and ability to supply those Assigned Assets. Following the transaction Adaptimmune intends to restructure to support the continued development by US WorldMeds of lete-cel, TECELRA and uza-cel and to maximise value from its remaining assets including its PRAME and CD70 directed T-cell therapies.

TD Cowen acted as financial advisor, and Ropes & Gray LLP provided legal counsel, to Adaptimmune.

Gibson, Dunn & Crutcher LLP provided legal counsel to US WorldMeds.

The transaction will be financed by debt financing led by funds managed by Oaktree Capital Management, L.P. ("Oaktree"), with participation from funds managed by Athyrium Capital Management, LP ("Athyrium").

On July 28, 2025 Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in predictive computational drug target discovery powered by AI/ML, reported that it will present a pooled analysis of data from three Phase 1 trials evaluating COM701 as monotherapy and combination therapy in heavily pretreated platinum resistant ovarian cancer patients at ESMO (Free ESMO Whitepaper) 2025, being held on October 17-21, 2025, in Berlin, Germany (Press release, Compugen, JUL 28, 2025, View Source [SID1234654583]).

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Poster details:
Title: COM701 in Ovarian Cancer: A Pooled Analysis of 3 Phase 1 Clinical Trials
Speaker: Dr. Oladapo Yeku, Massachusetts General Hospital, Boston, MA, U.S.
Poster presentation number: 1196P
Date of poster presentation: Saturday, October 18; 12:00-12:45 CEST

The poster will be available in the publications section of Compugen’s website, www.cgen.com

On July 28, 2025 CStone Pharmaceuticals reported it will announce the latest clinical data from its 2.0 blockbuster product, CS2009 (a PD-1/VEGF/CTLA-4 trispecific antibody), as well as the design of the global, multicenter Phase Ib study for CS5001 (a ROR1 ADC) at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper), one of the world’s most influential oncology conferences, will be held in Berlin, Germany from October 17 to 21, 2025 (Press release, CStone Pharmaceauticals, JUL 28, 2025, View Source [SID1234656217]).

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CS2009 is a potential first-in-class/best-in-class trispecific antibody. Its global multicenter Phase I dose escalation and dose expansion study is actively recruiting patients in Australia and China, and plans to expand to the United States for Phase II enrollment. CStone Pharmaceuticals will announce the Phase Ia clinical study data of CS2009 at the ESMO (Free ESMO Whitepaper) Congress , which will also become the first globalClinical data report of PD-1/VEGF/CTLA-4 trispecific antibody.
CS5001 is the first known ROR1 ADC to demonstrate clinical efficacy in both lymphoma and solid tumors, and its clinical development progress ranks among the top two globally. Currently, a global, multicenter Phase Ib clinical trial of CS5001 is progressing simultaneously in the United States, Australia, and China. CStone Pharmaceuticals will unveil the design of the ongoing Phase Ib study at the ESMO (Free ESMO Whitepaper) Congress.

The following are the key messages presented by the company at the ESMO (Free ESMO Whitepaper) conference:

CS2009, a novel PD-1/VEGF/CTLA-4 trispecific antibody, in patients with advanced solid tumors: an open-label, multicenter, phase I first-in-human study

【Category】 Investigational immunotherapy

【Format】 Poster

【Exhibition Number】 1545P

A phase Ib trial of CS5001 (ROR1-ADC) as a single agent and in combination with systemic therapies in patients with advanced solid tumours and lymphomas

【Category】 Haematological malignancies

【Format】 Electronic poster

【Exhibition Number】 1316eTiP

About CS2009 (PD-1/VEGF/CTLA-4 trispecific antibody)

CS2009 is a novel trispecific antibody targeting PD-1, VEGFA, and CTLA-4, independently developed by CStone Pharmaceuticals from the molecular design perspective. It achieves multi-dimensional anti-tumor effects through synergistic action and holds first-in-class/best-in-class potential. CS2009’s differentiated molecular design combines three clinically validated targets, enabling the reactivation of near-exhausted tumor-infiltrating T cells and demonstrating comparable VEGF neutralization to existing anti-VEGF antibodies. It targets a broad range of diseases, including but not limited to non-small cell lung cancer, liver cancer, gastric cancer, endometrial cancer, ovarian cancer, renal cell carcinoma, and cervical cancer.

About the CS5001 (ROR1 ADC)

CS5001 is an antibody-drug conjugate (ADC) targeting receptor tyrosine kinase-like orphan receptor 1 (ROR1). The drug utilizes a unique design, combining a tumor-specifically activated pyrrolobenzodiazepine (PBD) protoxin payload and a linker. This "dual-control" mechanism of linker plus protoxin effectively mitigates the toxicity issues associated with traditional PBD payloads and significantly extends the safety window. CS5001 has demonstrated complete tumor inhibition in multiple preclinical cancer models and exhibited favorable serum half-life and pharmacokinetic properties, demonstrating its significant clinical development potential and broad application prospects in the treatment of various solid and hematological tumors. Furthermore, CS5001 utilizes targeted conjugation technology to achieve a precise drug-to-antibody ratio (DAR), ensuring homogeneous production and large-scale manufacturing.

In October 2020, CStone Pharmaceuticals and LigaChem Biosciences, Inc. (LCB) entered into a licensing agreement for the development and commercialization of CS5001. CS5001 was originally co-synthesized by LCB and ABL bio, two leading Korean biotech companies. Under the terms of the agreement, CStone Pharmaceuticals obtained exclusive development and commercialization rights for CS5001 worldwide, excluding Korea.

On July 28, 2025 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported positive data in a mid-year update from the ongoing Phase 2 clinical study evaluating AIM’s drug Ampligen (rintatolimod) combined with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab) in the treatment of metastatic pancreatic cancer patients with stable disease post-FOLFIRINOX (the "DURIPANC" study) (See: ClinicalTrials.gov NCT05927142) (Press release, AIM ImmunoTech, JUL 28, 2025, View Source [SID1234654567]).

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The DURIPANC study – which is a joint collaboration with AstraZeneca and Erasmus Medical Center ("Erasmus MC") in the Netherlands – is an investigator-initiated, exploratory, open-label, single-center study expected to enroll up to 25 subjects in the Phase 2 portion. A total of 14 subjects have been enrolled in DURIPANC as of the mid-year report. The primary objective of the study is the clinical benefit rate of the combination therapy; the secondary/exploratory objectives include assessing overall survival (OS), progression-free survival (PFS) and initiating immune-monitoring using available tissue biopsies and peripheral immune profiling.

Prof. Casper van Eijck, MD, PhD, of Erasmus MC, stated: "Our preliminary data suggests that the combination of Ampligen and durvalumab is well-tolerated in post-FOLFIRINOX pancreatic cancer patients, with encouraging preliminary survival data, especially given the historical difficulty of improving outcomes in this setting. Immunologic correlatives and further follow-up are essential to determine the biological activity and the durability of response. In addition, it will be important to identify which patients are most likely to benefit from the combination treatment, thereby personalizing therapy better and maximizing clinical outcomes."

See: DURIPANC, Mid-Year Interim Clinical Progress Update.

Pancreatic cancer has limited immunotherapy responsiveness, particularly in unselected populations. Following FOLFIRINOX, maintenance or second-line immunotherapies have historically shown limited survival benefit in comparison trials. Compared to these data, the DURIPANC study mid-year report shows continuing promising early signs of both no significant toxicity and superior PFS and OS:

No significant toxicity, an encouraging safety profile for a post-chemo setting;
~21% of patients have PFS >6 months (3/14), with an additional 21% not yet progressed; and
OS >6 months in the majority (64%) of eligible patients-better than expected in this setting.
AIM ImmunoTech CEO Thomas K. Equels stated: "Data from Ampligen as a maintenance monotherapy was extremely positive when compared to existing therapeutic approaches. DURIPANC builds on that foundation and these results suggest a clear path forward and identify a promising potential benefit of combining the selective innate immune activation of Ampligen with the checkpoint inhibition of durvalumab in pancreatic cancer maintenance therapy. I am hopeful that pending immune-monitoring data analysis by Prof. van Eijck and the team at Erasmus Medical Center will identify additional mechanistic insights or predictive biomarkers in this potentially groundbreaking clinical trial, bringing hope for a future therapy for this highly lethal and clearly unmet medical need that kills more than 100,000 people in the American and European Union markets each year, and more than 500,000 worldwide."

AIM’S Pancreatic Cancer Profile

The DURIPANC study is the culmination of several years of focus by AIM on the development of Ampligen for the treatment of pancreatic cancer. Since 2017, more than 50 pancreatic cancer patients received treatment with Ampligen as an immuno-oncology mono-therapy under a Dutch government-approved Compassionate Use/Early Access Program at Erasmus MC. Prof. van Eijck was the lead investigator and the EAP has produced a number of detailed analyses in both abstracts and peer-reviewed medical research publications:

Rintatolimod (Ampligen) Enhances Numbers of Peripheral B Cells and Is Associated with Longer Survival in Patients with Locally Advanced and Metastasized Pancreatic Cancer Pre-Treated with FOLFIRINOX: A Single-Center Named Patient Program
Treating Pancreatic Ductal Adenocarcinoma Patients with Rintatolimod: Hitting Two Targets with One Arrow?
Rintatolimod in Advanced Pancreatic Cancer Enhances Antitumor Immunity through Dendritic Cell-Mediated T-Cell Responses
Based on these strong results suggesting Ampligen’s potential effectiveness as a pancreatic cancer monotherapy, in January 2023 the Company entered into Clinical Agreements with AstraZeneca and Erasmus MC for the investigator-initiated DURIPANC clinical trial to study the potential combination therapy of Ampligen and Durvalumab, a PD-L1 checkpoint inhibitor.

In order to protect what has the potential to be a valuable long-term benefit for stockholders, AIM has developed an intellectual property plan specific to pancreatic cancer that includes a recently issued U.S. patent for Ampligen as an oncology treatment in combination with an anti-PD-L1, extending protection to August 9, 2039, as well as orphan drug designations in pancreatic cancer in both the United States and the European Union granting years of market exclusivity to AIM for Ampligen post-commercial approval.