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).

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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])

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.

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

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

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.

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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])

On January 15, 2026 ImmunityBio, Inc. (NASDAQ: IBRX), a vertically-integrated commercial stage biotechnology company, reported preliminary select operational results for the fiscal quarter and full year ending December 31, 2025. ImmunityBio reported preliminary net product revenue of approximately $38.3 million during the three-month period ending December 31, 2025, which represented an increase of 20% over the $31.8 million of net product revenue earned during the third quarter of 2025 and a 431% increase over the three-month period ended December 31, 2024. ImmunityBio continues to see increased sales momentum supporting a trend of increases quarter-over-quarter with a 54% quarter over quarter unit volume growth rate during FY 2025.

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The Company ended the quarter with an estimated $242.8 million in cash, cash equivalents and marketable securities as of December 31, 2025.

"We delivered strong quarter-over-quarter revenue growth, reflecting accelerating adoption of ANKTIVA and the continued execution of our commercial strategy," said Richard Adcock, President and CEO of ImmunityBio. "This momentum is further reinforced by the approval of ANKTIVA plus BCG in Saudi Arabia, building on existing approvals in the U.S. and U.K, as well as conditional approval in the EU."

These amounts reflect the Company’s preliminary estimates based solely upon information available to it as of the date of this press release, and the amounts reported are not a comprehensive statement of its operating results or financial position as of December 31, 2025. Any actual amounts that the Company reports in its Annual Report on Form 10-K for the year ended December 31, 2025 will be subject to its financial closing procedures and any final adjustments that may be made prior to the time its operating results and financial position for the fiscal quarter ended December 31, 2025 are finalized. As a result, these preliminary estimates may differ materially from the actual results that will be reflected in the Company’s consolidated financial statements for the fiscal year ended December 31, 2025 when they are completed and publicly disclosed in its Annual Report on Form 10-K.

"The SFDA’s landmark approval of ANKTIVA in combination with a checkpoint inhibitor for non-small cell lung cancer marks the world’s first approval of an IL-15 superagonist used in combination with checkpoint therapy," said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. "This approval also represents the first authorization for subcutaneous administration of ANKTIVA. Together with the continued advancement of our first-line NMIBC program, these milestones underscore the strength of our platform and position ImmunityBio for sustained growth as we work to redefine the standard of care across multiple cancers."

(Press release, ImmunityBio, JAN 15, 2026, View Source [SID1234662056])

On January 15, 2026 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, reported a number of updates on the SECuRE trial following an SRC meeting. The SRC has recommended that the trial continue with the Cohort Expansion Phase (Phase II) as planned with no modifications to the protocol. The interim results assessed by the SRC were collected from nine participants enrolled in the cohort that had evaluable data by the cut-off date of the 25th of November 2025 and continue to show promising efficacy and a favourable safety profile of 67Cu-SAR-bisPSMA.

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The majority of the nine participants had bone metastasis at enrolment (66.7%) and received multiple lines of previous treatments (more than 5 previous anti-cancer regimens, 55.6%). Median PSA prior to 67Cu-SAR-bisPSMA treatment was 18.9 ng/mL (range 1.5-30.2 ng/mL). Six out of these nine participants received at least 2 cycles of 8 GBq of 67Cu-SAR-bisPSMA each, with two of them also receiving concomitant enzalutamide.

Of the nine participants included in this SRC analysis, six had at least two PSA results following their 67Cu-SAR-bisPSMA treatment by the data cut-off date. Of these six participants, thus far four (66.7%) showed reductions in PSA of 50% or more (PSA50) and two (33.3%) showed reductions of 80% or more (PSA80).

The safety profile of 67Cu-SAR-bisPSMA remains favourable in the Cohort Expansion, with the majority of related AEs being Grade 1 or 2. The most common related AEs were nausea and lymphopenia (observed in three out of nine participants [33.3%], for each AE). The only AE that was Grade 3 or above was lymphopenia observed in three participants, some of whom had bone metastasis at baseline and/or had received multiple lines of therapy, including taxane and an investigational agent, prior to enrolment in the SECuRE study. There have been no overall renal toxicity or electrocardiogram (ECG) changes observed in these participants. In the combination enzalutamide arm, no new AEs (or worsening of AEs) related to 67Cu-SAR-bisPSMA have been observed to date.

Trial participant with no detectable disease after 3 cycles of 67Cu-SAR-bisPSMA

One of the participants in the Cohort Expansion was a 64-year-old man with bone metastases and baseline PSA of 5.4 ng/mL prior to entering the SECuRE study. Following his first cycle of 67Cu-SAR-bisPSMA, this participant showed a dramatic 95.2% reduction in PSA. He went on to receive 2 more cycles of 67Cu-SAR-bisPSMA and achieved undetectable PSA levels. In a follow-up bone scan and CT no metastatic disease was observed. This participant only exhibited mild (Grade 1) related AEs, most of which were gastrointestinal events, with no haematological or renal AEs observed. The participant reported having excellent quality of life following the treatment.

The interim data from this Phase II continues to confirm the favourable safety profile and promising efficacy seen in previous cohorts of the SECuRE trial1 and supports the continuation of the trial with the aim to progress to a registrational Phase III study.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "SAR-bisPSMA continues generating world-class data in both theranostic and diagnostic trials. The combination of the optimised dimer "bis" structure with the benefits of copper isotopes, enabled by the proprietary sarcophagine technology, is proving to have created a product that is here to challenge the current treatment and diagnostic paradigms in radiopharmaceuticals.

"We have already seen a glimpse of the effects of 67Cu-SAR-bisPSMA through our Dose Escalation cohorts with additional and similar data being generated in the Cohort Expansion phase, demonstrating once again excellent efficacy and safety results of 67Cu-SAR-bisPSMA.

"All of the participants with evaluable data treated in the Phase II to date have shown declines in PSA, with the majority showing PSA decreases of more than 50% and mostly having only mild or moderate AEs. Most of these patients have been treated with more than 5 systemic treatment regiments and had bone metastasis prior to entering the SECuRE study. Although the number of participants with evaluable data to date is small, it is incredible to see yet another extraordinary case where a patient who had bone metastasis prior to entering the study achieved undetectable PSA following 67Cu-SAR-bisPSMA treatment, with no disease observed by anatomical and molecular imaging at the last assessments. This participant only experienced mild, transient AEs, most being gastrointestinal, and has reported having excellent quality of life following the treatment.

"Importantly, the work we have undertaken during the Dose Escalation Phase is now continuing to provide a strong foundation for us as we look ahead at protocol development and dosing for our Phase III clinical trial and commercialisation. As the participant numbers continue to increase with the trial enrollment, we continue to see very promising responses over and over again, giving us more confidence about the future of this product and its potential for commercialisation in metastatic castration-resistant prostate cancer (mCRPC). With three Fast Track Designations for the SAR-bisPSMA product and positive interactions with the US Food and Drug Administration (FDA) to date, we are working towards bringing this agent to clinicians and their patients around the world through the entirety of the prostate cancer journey, from first diagnosis to late-stage disease. All of these indications, being imaging in pre-definitive therapy and biochemical recurrence, as well as therapy in mCRPC, are blockbuster markets individually for prostate-specific membrane antigen (PSMA) targeted products, with an estimated combined market value of approximately US$10-15 billion by 2030. We are committed to continuing the development of this product, aiming to bring improved diagnostic and treatment options for prostate cancer in various stages of their disease."

About the SECuRE trial
The SECuRE trial (NCT04868604)2 is a Phase I/IIa theranostic trial for identification and treatment of participants with PSMA-expressing mCRPC using 64Cu/67Cu-SAR-bisPSMA. 64Cu-SAR-bisPSMA is used to visualise PSMA-expressing lesions and select candidates for subsequent 67Cu-SAR-bisPSMA therapy. The trial is a multi-centre, single arm, dose escalation study with a cohort expansion involving approximately 54 participants in the US. The overall aim of the trial is to determine the safety and efficacy of 67Cu-SAR-bisPSMA for the treatment of prostate cancer.

The SECuRE trial consists of the Dose Escalation (Phase I) and Cohort Expansion (Phase II) Phases. Based on the data from the Dose Escalation Phase, which demonstrated a favourable safety profile and efficacy of 67Cu-SAR-bisPSMA, the SECuRE trial progressed to the Cohort Expansion (Phase II) at an 8 GBq dose level as per the SRC recommendation (up to 6 cycles per patient in total)3.

Cohort 2 of the Dose Escalation phase of the trial, where participants were dosed with 8 GBq of 67Cu-SAR-bisPSMA, demonstrated a very low rate of related AEs while all three participants achieved PSA declines of 80% or more (PSA80)1. The Dose Escalation Phase also showed high PSA response rates of the mCRPC in the pre-chemotherapy setting with a favourable safety profile: 92% of pre-chemotherapy participants (12/13) demonstrated PSA drops greater than 35%, PSA reductions greater than 50% were reached in 61.5% (8/13) of participants, and reductions of 80% or more were achieved in 46.2% (6/13) of participants1. These results supported the progress of the trial to its Cohort Expansion Phase using 8 GBq multi-dose in participants who had not received chemotherapy in the mCRPC setting.

Recruitment is currently ongoing into the Cohort Expansion Phase which will include 24 participants. A subset of participants will be treated with the combination of 8 GBq of 67Cu-SAR-bisPSMA with enzalutamide (androgen receptor pathway inhibitor [ARPI]), in line with the positive results from the Enza-p trial4 and previous discussions with and advice from key global medical experts in the field of prostate cancer, including the Company’s Clinical Advisory Board members, Prof Louise Emmett and Prof Oliver Sartor, as well as the SRC.

About SAR-bisPSMA
SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two PSMA-targeting agents to Clarity’s proprietary sarcophagine (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.

About Prostate Cancer
Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death in men worldwide5. Prostate cancer is the second-leading causes of cancer death in American men. The American Cancer Institute estimates in 2025 there will be about 313,780 new cases of prostate cancer in the US and around 35,770 deaths from the disease.

(Press release, Clarity Pharmaceuticals, JAN 15, 2026, View Source [SID1234662039])