ME THERAPEUTICS GRANTED LICENCE FOR CD22 NANOBODY ASSET TO EXPAND NEXT-GEN IN VIVO CAR CELL THERAPY PROGRAM

On October 16, 2025 ME Therapeutics Holdings Inc. ("ME Therapeutics" or the "Company") (CSE: METX) (FSE: Q9T), a publicly listed biotechnology company working on novel cancer-fighting drugs in the field of immuno-oncology, reported its subsidiary, ME Therapeutics Inc., has entered into a technology license agreement dated October 15, 2025 (the "License Agreement") with the National Research Council of Canada (NRC) to license the NRC’s proprietary nanobody-based CD22 binder pursuant to the terms and conditions of the License Agreement (the "License").

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The licence gives ME Therapeutics exclusive commercial rights to the nanobody-based CD22 binder for use in Chimeric Antigen Receptor (CAR) therapy, including in vivo CAR-T and myeloid CAR (CAR-M) approaches.

"As a Canadian-owned company, we are honoured to advance this home-grown nanobody asset as part of our in vivo CAR cell therapy program," said Salim Dhanji, CEO of ME Therapeutics. "This milestone strengthens our commitment to develop innovative immuno-oncology candidates, including next-generation CAR therapies that can reprogram immune cells in the tumour microenvironment using advanced nanobody technology. We look forward to working with partners to bring these potentially life-saving treatments to cancer patients with currently limited options."

CD22 expression is often maintained in relapsed B-cell cancers following CD19 CAR-T therapy. By leveraging nanobody technology, the NRC’s CD22 binder offers potential advantages in stability, synthesis, and design flexibility compared to traditional antibody formats. Through in vivo CAR-M and CAR-T approaches, the binder provides an opportunity for novel approaches to treat patients with relapsed/refractory disease or as part of a first-line treatment.

"We are pleased to license this Canadian-made, publicly-owned nanobody-based CD22 binder to a Canadian company for use in next-generation CAR applications," says Sue Twine, Director General of the NRC’s Human Health Therapeutics Research Centre. "This technology was developed through years of dedicated NRC research, with support from our Cell and Gene Therapy Challenge program. It is a compelling example of publicly funded research enabling innovative next generation tools that can support development of affordable, cutting-edge treatments for Canadian patients."

The nanobody-based CD22 binder is currently being evaluated as part of an autologous CAR-T therapy in an investigator-driven Phase 1 clinical trial (NCT06208735) to assess safety and efficacy in pediatric and adult patients.

The Licence has been granted to the Company pursuant to the terms of the Licence Agreement in Australia, Brazil, Canada, China, Europe, India, Israel, Japan, New Zealand, Singapore, South Korea, and the United States (collectively the "Territory") for applications of the technology in these regions within the authorized field of use, which is CAR therapy. The rights granted to the Company are exclusive within the field of use for autologous CAR cell therapy products in the Territory (except in Canada) and exclusive in all jurisdictions of the Territory for any CAR cell therapies other than autologous CAR cell therapy products. The Licence Agreement provides, among other things, that the Company may sub-license its rights under the License Agreement. In consideration for the grant of the Licence, the Company shall pay the NRC an upfront licence fee within 12 months of entry into the License Agreement, and shall pay the NRC the certain royalties as more particularly described in the License Agreement relating to the sale of autologous CAR cell therapy products and sales revenue from the sale of allogeneic or in-vivo CAR cell therapy products, in all cases subject to a minimum yearly royalty subject to the terms and conditions of the License Agreement. In addition, the Company has agreed to make certain milestone payments to the NRC for each product on initiation of dosing in Phase 1 Trials, on initiation of dosing in Phase 2 clinical trials, on initiation of dosing in a registration trial, and on six months after the first regulatory approval of the first product anywhere in the Territory. The Licence shall expire upon the expiry of the last claim of the last patent pursuant to the terms of the License Agreement.

(Press release, ME Therapeutics, OCT 16, 2025, View Source [SID1234656705])

Merck Announces Phase 3 KEYNOTE-B96 Trial Met Secondary Endpoint of Overall Survival (OS) in All Comers Population of Patients With Platinum-Resistant Recurrent Ovarian Cancer

On October 16, 2025 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that the Phase 3 KEYNOTE-B96 trial, also known as ENGOT-ov65, met its secondary endpoint of overall survival (OS) for the treatment of patients with platinum-resistant recurrent ovarian cancer in all comers. The trial studied KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with chemotherapy (paclitaxel) with or without bevacizumab for these patients. As previously announced, KEYNOTE-B96 met its primary endpoint of progression-free survival (PFS) in patients with platinum-resistant recurrent ovarian cancer whose tumors express PD-L1 and in all comers, as well as its secondary endpoint of OS for patients whose tumors express PD-L1, at previous interim analyses. Findings from these prior analyses will be presented in a Presidential Symposium at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025.

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At the final analysis of the trial, the KEYTRUDA-based regimen demonstrated a statistically significant and clinically meaningful improvement in OS in all comers compared to placebo plus chemotherapy with or without bevacizumab. The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies; no new safety signals were identified. Results from this final analysis will be presented at an upcoming medical meeting.

"The results from the KEYNOTE-B96 trial mark the first time ever that an immune checkpoint inhibitor-based regimen has demonstrated the potential to help all patients with platinum-resistant recurrent ovarian cancer," said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories. "These women face a very poor prognosis with limited options for treatment, and this impactful news is a testament to our tireless commitment to exploring new options for patients with gynecologic cancers who face a critical unmet need."

KEYTRUDA is not approved to treat ovarian cancer (see selected KEYTRUDA indications in the U.S. below). LYNPARZA (olaparib), which is being jointly developed and commercialized by AstraZeneca and Merck, has three approved ovarian cancer indications in the U.S.: in first-line maintenance treatment of BRCA-mutated advanced ovarian cancer, following complete or partial response to first-line platinum-based chemotherapy; in first-line maintenance treatment of HRD-positive advanced ovarian cancer in combination with bevacizumab, following complete or partial response to first-line platinum-based chemotherapy; and in maintenance treatment of BRCA-mutated recurrent ovarian cancer, following complete or partial response to platinum-based chemotherapy. For each of these indications, patients are selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA (see indications for LYNPARZA below).

As announced, data from the REJOICE-Ovarian01 trial in collaboration with Daiichi Sankyo evaluating raludotatug deruxtecan (R-DXd) in patients with platinum-resistant, high-grade ovarian primary peritoneal or fallopian tube cancer will be presented at the ESMO (Free ESMO Whitepaper) Congress 2025. R-DXd was recently granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with platinum-resistant epithelial ovarian, primary peritoneal or fallopian tube cancers expressing CDH6 who have received prior treatment with bevacizumab, based in part on data from the REJOICE-Ovarian01 trial. R-DXd was discovered by Daiichi Sankyo and is being jointly developed by Daiichi Sankyo and Merck.

About KEYNOTE-B96/ENGOT-ov65
KEYNOTE-B96, also known as ENGOT-ov65, is a randomized, double-blind Phase 3 trial (ClinicalTrials.gov, NCT05116189) sponsored by Merck and conducted in collaboration with the European Network for Gynecologic Oncology Trial (ENGOT) groups investigating KEYTRUDA in combination with chemotherapy (paclitaxel) with or without bevacizumab compared to placebo plus chemotherapy with or without bevacizumab for the treatment of platinum-resistant recurrent ovarian cancer. The primary endpoint is PFS, and OS is a key secondary endpoint. The trial enrolled approximately 643 patients who were randomized to receive either KEYTRUDA (400 mg intravenously every six weeks for approximately two years) plus paclitaxel with or without bevacizumab, or placebo plus paclitaxel with or without bevacizumab.

About platinum-resistant ovarian cancer
Ovarian cancer often begins in the fallopian tubes or on the outer surface of the ovaries. It is the eighth most commonly diagnosed cancer and the eighth leading cause of cancer death among women worldwide. Globally, there were more than 324,000 patients diagnosed with ovarian cancer and almost 207,000 deaths from the disease in 2022. In many regions, its incidence has been increasing, with estimates projecting a 42% increase in new cases worldwide by 2040. In the U.S., it is estimated there will be approximately 20,890 patients diagnosed with ovarian cancer and about 12,730 deaths from the disease in 2025.

The primary aim of first-line treatment is to delay disease progression for as long as possible with the intent to achieve long-term remission. Between 70% and 80% of patients diagnosed with advanced ovarian cancer will experience disease progression following standard treatment with platinum-based chemotherapy regimens. Approximately 25% of these patients develop resistance within six months of completing first-line platinum-based chemotherapy, and this is defined as primary platinum-resistant ovarian cancer. Prognosis is particularly poor for these patients and treatment options are limited.

(Press release, Merck & Co, OCT 16, 2025, View Source [SID1234656706])

Rakovina Therapeutics to Present New Data Highlighting Novel ATR Inhibitor with CNS Penetration at the AACR-NCI-EORTC International Conference

On October 16, 2025 Rakovina Therapeutics Inc. ("Rakovina" or the "Company") (TSX-V: RKV, FSE: 7JO0), a biopharmaceutical company advancing cancer therapies through AI-enabled drug discovery, reported that new preclinical data from its ATR inhibitor program will be presented in a poster session at the upcoming AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), held October 22-26 at the Hynes Convention Center Boston, Massachusetts.

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DNA damage repair (DDR) enzymes, including Ataxia telangiectasia and Rad3-related protein serine/threonine kinase (ATR), are crucial for maintaining stability in cells. Inhibition of DDR enzymes has proven to be a compelling therapeutic option for numerous cancer indications. However, they lack the ability to effectively penetrate through the blood-brain barrier into the central nervous system (CNS), making them suboptimal for the treatment of brain tumors and metastases.

Rakovina’s presentation will highlight the Company’s ATR inhibitor program developed in collaboration with Variational AI and their Enki generative AI platform. This platform was used to create a shortlist of compounds with properties to selectively target ATR. The most promising molecules from this list were synthesized and characterized in vitro and in vivo. Data on the potency, selectivity, CNS penetrance and metabolic stability of select inhibitors will be presented and members of the team will be available for discussion with potential collaborators.

"The data to be presented at AACR (Free AACR Whitepaper)-NCI-EORTC reflects the continued progress of our AI-driven drug discovery pipeline and the importance of our collaboration with Variational AI," said Prof. Mads Daugaard, President and Chief Scientific Officer of Rakovina Therapeutics. "Our ATR inhibitor drug candidates show strong efficacy and blood-brain barrier permeability, a critical unmet need in current cancer therapies."

Presentation Details:

Title: Novel ATR inhibitors with CNS penetrance developed by artificial intelligence
Presentation Date: Poster session C, Saturday, October 25, 12:30 – 4 pm ET

(Press release, Rakovina Therapeutics, OCT 16, 2025, View Source;utm_medium=rss&utm_campaign=rakovina-therapeutics-to-present-new-data-highlighting-novel-atr-inhibitor-with-cns-penetration-at-the-aacr-nci-eortc-international-conference [SID1234656707])

Agenus to Host October Stakeholder Briefing Showcasing BOT/BAL Global Momentum and Post-ESMO Insights

On October 16, 2025 Agenus Inc. ("Agenus") (Nasdaq: AGEN), a leader in immuno-oncology, reported it will host a virtual Stakeholder Briefing on Tuesday, October 21, 2025, at 4:00 p.m. ET. The webcast will feature updates from leading experts on recent clinical progress and expanding international access for its immunotherapy combination botensilimab (BOT) and balstilimab (BAL). The session will be moderated by Garo Armen, PhD, Founder, Chairman, and CEO, and conclude with a live Q&A.

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Featured Topics and Speakers

Expanding Immunotherapy’s Reach: ESMO (Free ESMO Whitepaper) 2025 Highlights
Michael S. Gordon, MD, HonorHealth Research Institute

Dr. Gordon will discuss results from his oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, featuring data from over 400 patients treated with BOT/BAL across multiple refractory solid tumors.

Access Beyond Borders: France’s Autorisation d’Accès Compassionnel (AAC) Program and BOT/BAL’s Inclusion
Alexander M.M. Eggermont, MD, PhD, world-renowned immuno-oncologist and former Director General of the Gustave Roussy Cancer Center in France

Professor Eggermont will provide perspective on the French AAC program and its implications for oncologists and patients living with refractory MSS colorectal cancer.
Stakeholder Briefing Details:

Webcast Link | View Source
Pre-registration is not required.

This session marks the second in Agenus’ 2025 Stakeholder Briefing Series, following the August event highlighting corporate strategy, clinical milestones, and the launch of the global Phase 3 BATTMAN trial. A third session will follow in November, continuing the dialogue on BOT/BAL’s progress and corporate milestones.

(Press release, Agenus, OCT 16, 2025, View Source [SID1234656709])

OmniAb to Participate in Three Investor Conferences in November

On October 16, 2025 OmniAb, Inc. (NASDAQ: OABI) reported that management will be participating in three investor conferences during the month of November.

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2025 Truist Securities BioPharma Symposium, November 6 at the Lotte New York Palace Hotel. Matt Foehr, Chief Executive Officer, will participate in one-on-one meetings with investors on Thursday, November 6 th.
Stifel 2025 Healthcare Conference, November 11-13 at the Lotte New York Palace Hotel. Kurt Gustafson, Chief Financial Officer, will participate in one-on-one meetings with investors on Wednesday, November 12 th.
Jefferies Global Healthcare Conference – London, November 17-20 at the Waldorf Hilton. Matt Foehr, Chief Executive Officer, will present a corporate overview on Wednesday, November 19 th at 8:00 a.m. GMT and will hold one-on-one and small-group meetings with investors on November 18-19.

(Press release, OmniAb, OCT 16, 2025, View Source [SID1234656710])