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 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
13:00 – 14:15 am EDT / 10:00 – 11:15 am PDT

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.

On June 17, 2025 SunRock Biopharma and Escugen reported to have joined forces in a strategic partnership to co-develop SRB123, a First-in-Class antibody-drug conjugate (ADC) targeting C-C motif chemokine receptor 9 (CCR9), a tumor-associated antigen overexpressed in multiple solid tumors, including pancreatic, ovarian and lung cancer (Press release, SunRock Biopharma, JUN 17, 2025, View Source [SID1234653964]).

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The collaboration combines SunRock’s proprietary SRB1 antibody, selected for its high binding affinity and efficient tumor cell internalization, with Escugen’s EZWi-Fit linker-payload platform, a next-generation ADC technology optimized for the linker stability and selective tumor release of the potent payload. The result is a highly differentiated therapeutic candidate designed exclusively for solid tumors with high CCR9 expression and internalization rates.

Under the agreement, both companies will share development responsibilities, file joint patents, and hold reciprocal licensing option rights. The primary goal is to generate robust preclinical proof-of-concept data to support early clinical entry in the near term.

"Combining our deep antibody engineering expertise with Escugen’s innovative conjugation platform enables us to deliver a precision oncology candidate with First-in-Class potential," said Dr. Laureano Simón, CEO of SunRock. "CCR9 remains an underexploited but clinically validated target. This program addresses real unmet needs in aggressive tumors with poor prognosis."

Dr. Qing Zhou, Co-Founder and CEO of Escugen, stated, "This strategic collaboration with SunRock Biopharma aligns with our vision of developing First-in-Class precision oncology candidates through technological innovation. It further highlights the unique advantages of our EZWi-Fit platform technology in next-generation ADC development. The platform’s strong anti-tumor activity and favorable tolerability provide a solid foundation for targeting high CCR9-expressing solid tumors. We are confident that combining our expertise will accelerate SRB123’s progress and bring new hope to patients."

CCR9 has been associated with metastatic potential and chemoresistance, particularly in pancreatic and ovarian cancers. SRB1, the unconjugated antibody from SunRock, has already demonstrated strong preclinical efficacy in these models. The ADC format (SRB123) leverages this targeting while enhancing tumor cell killing via Escugen’s payload delivery system.

The partnership will be showcased during the BIO International Convention 2025, where both companies will engage with potential development and commercialization partners.

On June 17, 2025 Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company outpacing cancer to help patients outlive their disease, reported positive data from its ongoing Phase 2a clinical trial evaluating atebimetinib (IMM-1-104), an oral, once-daily novel MEK inhibitor, in combination with modified gemcitabine/nab-paclitaxel (mGnP) in first-line pancreatic cancer patients (Press release, Immuneering, JUN 17, 2025, View Source [SID1234653948]).

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"These exceptional data demonstrate the potential of atebimetinib plus mGnP to dramatically extend the lives of patients with advanced pancreatic cancer," said Ben Zeskind, Ph.D., Co-founder and Chief Executive Officer of Immuneering. "94% overall survival at 6 months is remarkable in first-line pancreatic cancer patients. Atebimetinib was designed to deliver exceptional durability and tolerability to a broad range of patients with different cancers, and it is deeply gratifying to see evidence of that playing out first in one of the most aggressive and deadly types of cancer. Our ultimate goal is to help cancer patients outlive their disease, and today’s announcement represents an important milestone on that journey."

Durability and Tolerability of Atebimetinib + mGnP Demonstrated in Phase 2a Data

94% overall survival (OS) was observed at 6 months in first-line (1L) pancreatic cancer patients treated with atebimetinib + mGnP at the 320 mg once-daily dose of atebimetinib (N=34). The benchmark 6-month OS for the standard of care treatment in this population (full dose and schedule GnP) is 67%.1 The median OS was not yet reached at the data cutoff date.
72% progression-free survival (PFS) was observed at 6 months in first-line (1L) pancreatic cancer patients treated with atebimetinib + mGnP at the 320 mg dose level (N=34). The benchmark 6-month PFS for the standard of care treatment in this population (full dose and schedule GnP) is 44%.1 The median PFS was not yet reached at the data cutoff date.
An overall response rate (ORR) of 39% and a disease control rate (DCR) of 81% were observed in response evaluable patients at both the 240 and 320 mg dose levels of atebimetinib + mGnP (N=36), including many patients with deepening, durable regressions and multiple examples of individual lesions rendered undetectable.
Atebimetinib continued to demonstrate a markedly favorable tolerability profile in combination with mGnP. No Grade 3+ events were observed in a majority of the adverse event categories commonly observed with standard of care chemotherapy in first line pancreatic cancer.
Based on these data, the Company has increased target enrollment in the 1L pancreatic cancer atebimetinib + mGnP combination arm to approximately 50 patients.
All results are reported using a data cutoff date of May 26, 2025.

"The encouraging clinical data reported thus far for atebimetinib (IMM-1-104) represent a potential new and significantly more durable treatment option for pancreatic cancer patients, for whom limited therapeutic options are currently available," said Vincent Chung, M.D., F.A.C.P., Professor, Department of Medical Oncology and Therapeutics Research at City of Hope, and principal investigator of the Phase 2a clinical trial. "I have treated pancreatic cancer patients with atebimetinib who have experienced exceptional durability. Current standard of care therapies in pancreatic cancer can be associated with limited durability and severe side effects, leading to poor patient outcomes. We have not seen significant improvement in standard of care for decades, and there is an urgent need for more durable and better tolerated new treatments that help patients live longer."

"These data clearly establish atebimetinib’s potential as a more durable and better tolerated MEK inhibitor positioned to help patients both live longer and live better, with exciting potential opportunities in pancreatic cancer and a variety of other cancers," said Igor Matushansky, M.D. Ph.D., Chief Medical Officer of Immuneering. "We look forward to advancing atebimetinib to a pivotal trial as rapidly as possible."

Dr. Chung is a paid advisory board member of Immuneering.

Near-Term Milestone Expectations

Building on these new Phase 2a clinical data, Immuneering is planning for several additional milestones related to atebimetinib, including:

Regulatory feedback on pivotal study plans in 4Q 2025
Data from additional patients in Phase 2a trial in 4Q 2025
Initiation of pivotal, randomized trial of atebimetinib in combination with mGnP in first-line pancreatic cancer in 2026
Initiation of additional atebimetinib clinical trial combination arms in 2026
Conference Call

Immuneering will host a conference call and live webcast at 8:00 a.m. ET / 5:00 a.m. PT on June 17, 2025, to discuss the data and provide a business update. Individuals interested in listening to the live conference call may do so by dialing (800) 715-9871 for U.S callers and (646) 307-1963 for other locations and reference conference ID 5641694, or from the webcast link in the "investors" section of the company’s website at www.immuneering.com. A webcast replay will be available in the investor relations section on the company’s website for 90 days following the completion of the call.