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EORTC and EMA, jointly with international stakeholders, have published a multistakeholder roadmap to accelerate treatment optimisation in oncology

On January 16, 2026 EORTC, together with the European Medicines Agency (EMA), and in collaboration with key stakeholders reported to have published a multistakeholder roadmap outlining strategic actions to advance treatment optimisation research in oncology. The recommendations were developed within the Cancer Medicines Forum (CMF)1 and are presented in a new article titled "Accelerating cancer treatment optimisation: a multistakeholder roadmap from the Cancer Medicines Forum" published in the Journal of Cancer Policy.

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Treatment optimisation research focuses on determining how anticancer therapies can be used most effectively in clinical practice, addressing questions related to dose, duration, schedule, sequence, and combinations. While current regulatory trials support marketing authorisation, many of these questions remain unanswered at approval, creating challenges for clinicians, patients, and healthcare systems.

The roadmap is based on a multidisciplinary workshop held in April 2024 within the CMF, which brought together multiple international stakeholders, including regulators, health technology assessment bodies, clinicians, patient representatives, academic researchers, industry, public health organisations. The discussions align with ongoing EORTC initiatives to support treatment optimisation, including a recent event held in the European Parliament focused on the challenges and opportunities in this area. Participants identified key barriers, including limited incentives, funding constraints, regulatory hurdles, and challenges in implementing optimisation findings, and proposed coordinated solutions.

"Recognising treatment optimisation as a public health priority is essential to ensuring that cancer therapies are used as effectively and sustainably as possible," said Dr Denis Lacombe, EORTC CEO. "Strengthening collaboration and creating the right conditions for pragmatic clinical trials will be key to making this happen."

The roadmap also emphasises the importance of aligning evidence requirements across regulators and HTA bodies to ensure that optimisation results can inform regulatory approvals, clinical practice and reimbursement decisions.

EORTC remains committed to supporting independent, practice-informing research and to strengthening evidence generation throughout the lifecycle of cancer medicines.

(Press release, EORTC, JAN 16, 2026, View Source [SID1234662067])

BriaCell Therapeutics Announces Closing of US$30 million Public Offering

On January 15, 2026 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXL) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported the closing of its previously announced best-efforts public offering of 5,366,726 units. Each unit consists of one common share (or one pre-funded warrant ("Pre-Funded Warrant") in lieu thereof) and one warrant (the "Warrants"). Each unit was sold to the public at a price of US$5.59 per unit (inclusive of the Pre-Funded Warrant exercise price) for gross proceeds of approximately US$30 million, before deducting placement agent fees and offering expenses. The Warrants included in the units have been approved for listing on the Nasdaq Capital Market and commenced trading under the symbol "BCTXL" on January 14, 2026. Each Warrant is immediately exercisable, entitles the holder to purchase one common share at an exercise price of US$6.93 per share and expires five years from the date of issuance. The common shares (or Pre-Funded Warrants) and Warrants were purchased together in the offering but were issued separately.

The Company relied upon the exemption set forth in Section 602.1 of the TSX Company Manual, which provides that the TSX will not apply its standards to certain transactions involving eligible interlisted issuers on a recognized exchange, such as Nasdaq.

The Company intends to use the net proceeds from the offering to fund working capital requirements, general corporate purposes and the advancement of the Company’s business objectives.

ThinkEquity acted as the sole placement agent for the offering.

A registration statement on Form S-1 (File No. 333-292388) relating to the securities was filed with the Securities and Exchange Commission ("SEC") on December 23, 2025, and became effective on January 13, 2026, and a related registration statement was filed pursuant to Rule 462(b) under the Securities Act of 1933, as amended, on January 13, 2026. This offering was made only by means of a prospectus. Copies of the final prospectus may be obtained from ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004. The final prospectus has been filed with the SEC and is available on the SEC’s website located at View Source

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

(Press release, BriaCell Therapeutics, JAN 15, 2026, View Source [SID1234662207])

Agenus Announces Closing of $141M Strategic Collaboration with Zydus Lifesciences to Advance BOT+BAL and Strengthen U.S. Manufacturing Readiness

On January 15, 2026 Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, reported the closing of its previously disclosed strategic collaboration with Zydus Lifesciences Ltd. The agreement is designed to accelerate global development and potential commercialization of Agenus’ botensilimab and balstilimab (BOT+BAL) immunotherapy combination program.

The collaboration provides Agenus with strategic capital and committed, long-term biologics manufacturing capacity in the United States to support BOT+BAL clinical development, authorized early access pathways, and commercial supply preparation.

As part of the collaboration, Agenus has granted Zydus exclusive rights to develop and commercialize BOT and BAL in India and Sri Lanka, with Agenus eligible to receive royalties on net sales in those territories.

The collaboration, first announced on June 3, 2025, included the following key financial terms:

Upfront Consideration: $75 million cash payment to Agenus for transfer of biologics manufacturing facilities in Emeryville and Berkeley, California
Equity Investment: $16 million purchase by Zydus of Agenus (AGEN) common stock (~2.1 million shares at $7.50 per share)
Contingent Milestone Payments: Up to $50 million payable to Agenus, triggered by BOT+BAL production orders
Exclusive License: Zydus obtains exclusive rights to develop and commercialize BOT and BAL in India and Sri Lanka, with Agenus eligible to receive a 5% royalty on net sales in those territories
"Closing this collaboration with Zydus strengthens our balance sheet and, critically, secures dedicated U.S. manufacturing capacity at a pivotal moment for Agenus," said Dr. Garo Armen Ph.D., Chairman and Chief Executive Officer of Agenus. "With these foundations in place, our focus in 2026 is disciplined execution—advancing our Phase 3 program, broadening paid patient access through authorized pathways, and progressing toward regulatory submission supported by one of the most substantial clinical datasets generated in MSS colorectal cancer."

In 2025, the BOT+BAL combination demonstrated a two-year overall survival rate of 42% and a now-mature median overall survival of 21 months in an expanded cohort of 123 patients with third-line or later microsatellite-stable (MSS) metastatic colorectal cancer (mCRC) without active liver metastases. Building on these results, Agenus, in collaboration with Canadian Cancer Trials Group (CCTG) has initiated the global BATTMAN Phase 3 trial, with sites activated and prepared to enroll patients.

Following the closing, the Emeryville and Berkeley, California biologics manufacturing facilities will be transferred to Zydus and housed under a newly formed subsidiary named Zylidac Bio LLC. Agenus has secured committed manufacturing capacity at these U.S. sites to support BOT+BAL supply needs for their clinical trials, global access programs and future commercialization.

This transaction further positions Agenus to execute on its near- and long-term strategy as interest in BOT+BAL continues to grow globally.

Commenting on the finalization of the deal, Dr. Sharvil P. Patel, Managing Director of Zydus Lifesciences Limited., stated, "With this deal, Zylidac Bio LLC will now provide biologicals manufacturing sites offering CDMO services to biopharmaceutical companies globally. This supports the evolving landscape of biological product manufacturing in the U.S., which prioritizes secure, domestic, and high-quality supply chains for advanced therapies. Zylidac Bio LLC offers a critical, compliant solution for global innovators and allows for a localized supply chain. It reinforces our ability to serve the international biopharmaceutical industry with reliability and innovation."

Advisors

As part of this effort, Agenus was advised by Porrima Ltd and Biotech Value Advisors (BVA), who provided guidance on partner selection, transaction structure, and negotiations.

(Press release, Agenus, JAN 15, 2026, View Source [SID1234662065])

Ono Shares Replay Information for 44th Annual J.P. Morgan Healthcare Conference Presentation

On January 15, 2026 Ono Pharmaceutical Co., Ltd. (TSE:4528), reported that Toichi Takino, President and COO, presented at the 44th Annual J.P. Morgan Healthcare Conference on Wednesday, January 14, 2026, at 11:15 a.m. PST / 2:15 p.m. EST.

An audio recording of the event is available here and accessible until February 15, 2026.

(Press release, Ono, JAN 15, 2026, View Source [SID1234662064])

First Patients in the UK Receive Doses of Blue Earth Therapeutics’ Investigational Radiopharmaceutical Therapy Lutetium (177Lu) rhPSMA-10.1 Injection for Metastatic Castrate Resistant Prostate Cancer

On January 15, 2026 Blue Earth Therapeutics reported that the first patients in the UK have been administered with the investigational radiopharmaceutical therapy Lutetium (177Lu) rhPSMA-10.1 Injection in an ongoing Phase 2 clinical trial (NCT05413850) at St Bartholomew’s Hospital and The James Cook University Hospital. This milestone marks continued expansion of the clinical development programme for the company’s radiohybrid, lutetium-labelled, PSMA-targeted investigational radiopharmaceutical therapy in men with metastatic castration-resistant prostate cancer (mCRPC).

Dr Kenrick Ng, Medical Oncology Consultant, St Bartholomew’s Hospital, London, said: "Dosing one of the first patients in the UK in this Phase 2 study is an important milestone as we work to advance new therapeutic options for men with metastatic castration-resistant prostate cancer. Radiopharmaceuticals represent a promising area of investigation in this difficult-to-treat setting, and the team at our hospital is pleased to contribute to the generation of the clinical evidence needed to understand the potential of this investigational treatment."

Dr Darren Leaning, Consultant Clinical Oncologist, The James Cook University Hospital, Middlesbrough, said: "Bringing this study to the UK is an important step in expanding access to complex radiopharmaceutical trials. Delivering studies of this kind requires close collaboration across clinical, research, and nuclear medicine teams, we at the James Cook Cancer Institute pride ourselves on bringing studies like this to our Teesside patients and we are pleased to be working with colleagues at other NHS trusts and the radiopharmaceutical industry to support the generation of high-quality clinical data for patients with advanced prostate cancer."

The milestone of administering the first doses to patients in the UK highlights growing momentum for the Lutetium (177Lu) rhPSMA-10.1 Injection clinical programme. Other sites in the UK are actively screening patients for this study. Activation of UK clinical sites broadens the study’s international footprint and supports the generation of high-quality evidence across multiple healthcare settings. The expansion supports ongoing efforts to evaluate novel dosing strategies and contributes to the future global development of this PSMA-targeted radioligand therapy.

David Gauden, CEO of Blue Earth Therapeutics, said: "Dosing the first patients in the UK marks a pivotal step in our mission to advance radiopharmaceutical treatments for prostate cancer. With our company being headquartered in the UK, this milestone reflects our commitment to the UK’s life sciences vision to accelerate clinical research and translate innovation into meaningful patient benefit. We are proud to work in partnership with UK investigators, the NHS and patients to help strengthen the UK’s position as a global leader in life sciences excellence."

The Phase 2 is evaluating multiple strategies to optimise dosing by delivering higher radiation doses during the early treatment cycles when tumour burden is typically greatest. This approach differs from earlier pivotal studies of radioligand therapies where fixed dosing was applied uniformly across all cycles(2). The study design aligns with the US FDA’s Project Optimus initiative, which encourages dose optimisation early in development to support a favourable benefit–risk profile.

Front loading of radioactivity in Phase 2 will be achieved either by (a) giving higher radioactivity injections in the first two cycles or (b) shortening the interval between the first three injections of radioactivity from six weeks to three weeks. The study also evaluates the potential clinical benefit of delivering higher cumulative administered radioactivity, up to 60 GBq. As part of the study design, the primary measure of efficacy will be the proportion of patients achieving a ≥50% reduction in prostate-specific antigen (PSA) levels alongside a detailed assessment of safety and capturing radiation dosimetry data for all patients.

About metastatic prostate cancer

In 2025 it is estimated that there will be 50,055 new cases of metastatic prostate cancer in the United States (de novo diagnoses plus recurrence from earlier stage diagnoses).(3) Five-year survival for newly diagnosed metastatic prostate cancer is low, 36.6%.(4) While death rates from prostate cancer have declined over the past three decades(4), there is still considerable room to improve patient outcomes.

About Radiohybrid Prostate‐Specific Membrane Antigen (rhPSMA)

rhPSMA compounds are referred to as radiohybrid ("rh"), as each molecule possesses four distinct domains. The first consists of a Prostate‐Specific Membrane Antigen‐targeted receptor ligand. It is attached to two labelling moieties which may be radiolabelled with diagnostic isotopes such as 18F or 68Ga for PET imaging, or with therapeutic isotopes such as 177Lu or 225Ac for radioligand therapy, all of which are joined together by a modifiable linker which can be used to modulate important pharmacokinetic characteristics. Radiohybrid PSMA offers the potential for targeted treatment for men with prostate cancer and originated at the Technical University of Munich, Germany. Blue Earth Diagnostics acquired exclusive worldwide rights to rhPSMA diagnostic imaging technology from Scintomics GmbH in 2018, and therapeutic rights in 2020, and has sublicensed the therapeutic application to its sister company Blue Earth Therapeutics.

(Press release, Blue Earth Therapeutics, JAN 15, 2026, View Source [SID1234662063])