On June 18, 2025 MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, reported its entry into a clinical master supply agreement with Roche for future studies investigating the combination of MAIA’s telomere-targeting agent ateganosine (THIO), sequenced with Roche’s checkpoint inhibitor (CPI), atezolizumab (Tecentriq), for the treatment of multiple hard-to-treat cancers (Press release, MAIA Biotechnology, JUN 18, 2025, View Source [SID1234653995]).

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"In preclinical studies, ateganosine was found to be highly synergistic and effective in combination with Roche’s anti-PD-L1 agent atezolizumab," said MAIA Chairman and CEO Vlad Vitoc, M.D. "We are pleased to partner with world-renowned Roche and we look forward to further strengthening our mission to find safe and effective cancer treatments."

About Ateganosine

Ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activate both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

On June 17, 2025 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 that it has entered into a Commercial Manufacturing Agreement with SpectronRx for Clarity’s lead diagnostic product, 64Cu-SAR-bisPSMA (Press release, Clarity Pharmaceuticals, JUN 17, 2025, View Source [SID1234653946]).

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SpectronRx’s facility in Indiana will provide on-demand commercial-scale manufacturing of both copper-64 and 64Cu-SAR-bisPSMA under one roof and enable distribution to all 50 states. It is capable of producing up to 400,000 patient-ready doses of 64Cu-SAR-bisPSMA annually from the one facility. Together with other supply and manufacturing agreements Clarity has entered to date, this Agreement substantially bolsters reliable, universal access to 64Cu-SAR-bisPSMA in the US for a commercial rollout upon successful completion of Clarity’s Phase III registrational trials with this product, CLARIFY1 and AMPLIFY2, and subsequent US Food and Drug Administration (FDA) New Drug Application (NDA) approval. The Commercial Supply Agreement with SpectronRx includes options to expand integrated 64Cu-SAR-bisPSMA manufacturing to additional locations in the US, substantially increasing overall production capacity in the number of regional hubs throughout the US, providing a multi-layered and abundant supply approach, which is unique in the radiopharmaceutical space.

John Zehner, CEO of SpectronRx, highlighted the collaboration’s potential to transform patient care, stating, "Partnering with Clarity marks a significant step forward in expanding access to radiopharmaceuticals and improving healthcare outcomes in the United States. SpectronRx’s ability to reliably produce and distribute 64Cu-SAR-bisPSMA further solidifies our position as a trusted manufacturing partner for radiopharmaceutical companies, ensuring timely access to essential diagnostic and therapeutic resources for patients and providers alike."

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "This Agreement, combined with other supply and manufacturing agreements for isotope and finished product we have secured to date, ensures that we are ready to roll out large-scale manufacturing and distribution of 64Cu-SAR-bisPSMA on day one of commercialisation. This will enable a seamless launch as soon as we have US FDA approval, allowing patients to get access to this next-generation diagnostic at any treatment facility in the US with a positron emission tomography (PET) scanner, 24 hours a day, 7 days a week.

"We look forward to fully leveraging the benefits of copper-64 and its optimal half-life of 12.7 hours to overcome the logistical issues inherent to current-generation diagnostics due to their reliance on isotopes with far shorter half-lives, namely gallium-68 and fluorine-18 (half-lives of around 1 hour and 2 hours, respectively). These short half-lives translate into short shelf-lives, constraining availability of these agents to a restricted number of locations at specific times, which often do not align to the clinical needs of the sites or the patients’ needs. The gallium-68 supply chain requires large and continued capital investment to sustain a short shelf-life product network. The isotope is made on generators, with each generator only lasting approximately six months. Since most generators are manufactured outside of the US, they have potential exposure to tariffs. The fluorine-18 market for prostate-specific membrane antigen (PSMA) competes directly with the 18F-FDG market for isotope sourcing, significantly impacting supply. These challenges with gallium-68 and fluorine-18 supply chains leave many cancer patients worldwide with limited access to radiodiagnostics and therefore affect their ability to receive timely, effective treatment.

"The production and purification of copper-64 is an easy, proven, streamlined process developed over 30 years ago3. Utilising this process, SpectronRx has built the copper-64 production in-house for large-scale commercial markets. Broad, on-demand distribution, enabled by a shelf-life of up to 48 hours, combined with ease of central manufacture and the ability to produce up to 400,000 patient-ready 64Cu-SAR-bisPSMA doses annually under one roof from SpectronRx’s facility in Indiana, is a game-changer for the radiopharmaceutical field.

"We are already actively producing 64Cu-SAR-bisPSMA for our clinical trials at SpectronRx. Given our positioning of this product as the next-generation PSMA diagnostic in the large market of prostate cancer, and our other imaging products generating exciting data and progressing through clinical development, the Commercial Supply Agreement considers options to expand manufacturing to similar sites in the US. By leveraging a proven, validated process and expanding to additional facilities, we can seamlessly move to larger commercial supply volumes to meet anticipated market demand. This option also allows us to fine-tune our commercial supply and distribution approach in the future as a multi-layered strategy, ensuring that we are able to fulfil the growing needs of clinicians and patients across the country on all levels: nationally, regionally and locally. We look forward to contributing to a change in the diagnostic paradigm for prostate cancer patients by providing a reliable, accessible and accurate diagnostic alternative to first-generation PSMA PET products."

This agreement builds on the Master Service Agreement and associated Supply Agreement for the copper-64 (Cu-64 or 64Cu) isotope with SpectronRx, as well as the Clinical Manufacturing Agreement for the production of 64Cu-SAR-bisPSMA for Clarity’s Phase III trials, CLARIFY and AMPLIFY.

The Commercial Supply Agreement is effective as of 17 June 2025 and is for an initial period of five years. Cancellation and extension provisions are aligned with industry standard rates.

Overview of Clarity’s SAR-bisPSMA clinical trial program
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.

On June 17, 2025 Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, and Noetik, a leader in AI-driven spatial and multimodal biology, reported a research collaboration to develop predictive biomarkers of response to Agenus’ lead clinical stage immuno-oncology (IO) combination, botensilimab (BOT, multifunctional Fc-enhanced anti-CTLA-4) and balstilimab (BAL, anti-PD-1) (Press release, Agenus, JUN 17, 2025, View Source [SID1234653963]). The collaboration harnesses Noetik’s proprietary virtual cell foundation models and large-scale, multimodal tumor data to uncover novel insights into the biology of tumor immunology. Together, the teams will deploy Noetik’s first-in-class foundation models directly on clinical results with the aim to enrich clinical efficacy.

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Central to this collaboration is Noetik’s OCTO virtual cell model, a 1.5 billion parameter foundation model trained on one of the largest proprietary multimodal spatial datasets. This dataset brings together spatial proteomics, spatial transcriptomics, H&E pathology, DNA genotyping, and clinical metadata from nearly 200 million tumor and immune cells collected from thousands of patients with cancers such as colorectal cancer, non-small cell lung cancer, ovarian cancers, and sarcomas. By integrating these diverse data types, Noetik’s foundation models provide a systems-level view of the tumor microenvironment in real patients, unlocking novel insights into cancer biology that can drive more precise therapeutic discovery and development.

Botensilimab, alone or in combination with BAL, has been evaluated in more than 1,200 patients across nine tumor types, including colorectal cancer, NSCLC, and sarcomas. By targeting complementary immune pathways, the BOT/BAL combination has shown deep and durable clinical responses—even in tumors considered immunotherapy "cold" or resistant to prior IO treatment. The regimen has generated growing recognition within the medical community, supported by compelling data presented in both late-line and neoadjuvant settings, multiple peer-reviewed publications, and presentations at more than a dozen major medical congresses over the past three years.

The collaboration aims to uncover clear, actionable biomarkers that can help predict which patients are most likely to respond to BOT/BAL treatment. Using OCTO virtual cell models to simulate how tumors behave in the body, Noetik will analyze complex biological data from multiple cancer types. The goal is to identify patterns that can predict treatment outcomes and help classify patient groups who may benefit most. Agenus will have exclusive rights to apply these insights in its drug development and commercialization efforts.

"Enhancing clinical efficacy is the most important problem in developing new medicines, and exactly what we’ve trained our foundation models to do. We are excited to deploy Noetik’s virtual cell foundation models on Agenus’ rich clinical data to uncover biomarkers that can enrich patient therapeutic response, improve trial outcomes, and ultimately deliver more precise therapies," said Ron Alfa, M.D., Ph.D., CEO & Co-Founder, Noetik.

"At Agenus, we are committed to transforming cancer care through scientific innovation and next-generation immunotherapies. This collaboration with Noetik enables us to harness cutting-edge AI to better understand patient biology and tailor treatments more precisely," said Dr. Garo Armen, Chairman and CEO of Agenus. "By integrating Noetik’s virtual cell models with our expansive BOT/BAL clinical dataset, we have the potential to accelerate the identification of predictive biomarkers, enhance the success of our pivotal trials, and ultimately improve outcomes for patients who currently have limited or no treatment options."

This collaboration reflects a growing momentum in oncology toward model-driven trial design and AI-enabled precision medicine—an area increasingly prioritized by the FDA under the guidance of the current U.S. administration as central to advancing more equitable, effective cancer care. By applying these technologies to real patient data, the goal is to accelerate the delivery of more personalized treatments, improve outcomes, and expand access to therapies for patients who need them most.

On June 17, 2025 eXmoor Pharma, the integrated cell and gene therapy CDMO with embedded consultancy expertise, and Signadori Bio, a French biotechnology company developing next-generation cancer therapies, reported a new collaboration to accelerate the development of gene-modified monocyte-derived macrophage cell therapy targeting solid tumours (Press release, Signadori Bio, JUN 17, 2025, View Source [SID1234656408]).

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Signadori Bio, a Sofinnova Partners-backed spin-out, is advancing a promising gene-modified monocyte therapy platform aimed at overcoming the challenges of treating solid cancers, developed at the Gustave Roussy Institute, one of the world’s leading oncology centres.

Under the agreement, eXmoor Pharma will undertake a comprehensive technology translation and development programme at its Cell & Gene Therapy Centre, supporting Signadori Bio in the critical transition from discovery through to GMP-compliant manufacturing of their lead candidate. eXmoor will also provide an interim Head of CMC to integrate into Signadori Bio’s leadership team and support a structured programme of technology translation, process development and CMC planning.

This collaborative approach is designed to guide the therapy through key development milestones, with a focus on progressing the lead candidate toward GMP-compliant manufacturing and readiness for first-in-human clinical trials.

The partners will operate under a shared decision-making framework, aligning scientific, technical and commercial planning with Signadori Bio’s investment trajectory. The programme is set to transition into full process development with a long-term view toward GMP manufacturing, leveraging eXmoor’s GMP manufacturing capabilities.

Angela Osborne, CEO of eXmoor Pharma, commented:

"We are delighted to partner with Signadori Bio on such a promising and sophisticated cell therapy programme. Their approach to targeting solid tumours with gene-modified monocytes is innovative and well-grounded in translational science. At eXmoor, we are committed to supporting cell and gene therapy pioneers through the complex journey from discovery to clinical impact. This collaboration reflects our shared belief in the potential of advanced therapies to deliver meaningful outcomes for patients."

Matthieu Coutet, CEO of Signadori Bio and Partner at Sofinnova Partners, said:

"Partnering with eXmoor is a decisive step in our mission to bring next-generation monocyte-based therapies to patients with solid tumours. Their deep expertise in early-stage process development and GMP translation is exactly what we need at this critical inflection point. I’m also very pleased to welcome Evelien Stalmeijer as interim Head of CMC. Her leadership and experience will be key as we accelerate our path toward the clinic. We’re excited to work hand-in-hand with a team that understands the complexity and urgency of advancing pioneering science into impactful therapies."

On June 17, 2025 Roche reported to have invited investors and analysts to participate in its virtual event on Monday, 23 June 2025, to highlight new results from Roche’s Hematology pipeline including Phase III (STARGLO) Columvi in R/R DLBCL 2-year data , first presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from 30 May-3 June, 2025, Phase III (SUNMO) data for Lunsumio + Polivy in R/R DLBCL primary analysis, accepted as a late breaking abstract at the International Conference on Malignant Lymphoma (ICML) from 17-21 June 2025, Phase III (POLARGO) data for Polivy in R/R DLBCL selected for Plenary presentation at both the European Hematology Association (EHA) (Free EHA Whitepaper) Congress from 12-15 June 2025 and ICML as well as Phase I/II (NXTAGE) data for NXT007 in Hemophilia A presented at the Congress of the International Society on Thrombosis and Haemostasis (ISTH) from 21-25 June 2025 (Press release, Hoffmann-La Roche, JUN 17, 2025, View Source [SID1234653947]).

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19:00 – 20:15 CEST / 18:00 – 19:15 BST
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The webinar will start with a presentation, followed by a Q&A session (live access to the speakers). The slides will be available for download at 18:00 CEST on the day of the event.