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Clarity enters a Commercial Manufacturing Agreement for Cu-64 SAR-bisPSMA with SpectronRx

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.

Cardiff Oncology Appoints Dr. Roger Sidhu as Chief Medical Officer and Announces Timing for the Next Update from the CRDF-004 Trial in First-Line RAS-mutated mCRC

On June 17, 2025 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, reported the company has appointed Roger Sidhu, MD, as Chief Medical Officer (Press release, Cardiff Oncology, JUN 17, 2025, View Source [SID1234653945]). Dr. Sidhu is a veteran executive and clinician with over 20 years of experience and a strong track record of success in oncology research, development, and regulatory strategy. Dr. Sidhu succeeds Dr. Fairooz Kabbinavar who will remain with the company in an advisory role. The company also announced it will share additional clinical data from its lead program in RAS-mutated mCRC on July 29, 2025.

"We are pleased to welcome Dr. Sidhu to lead the clinical program for onvansertib through the next phase of development. Dr. Sidhu is a respected clinician and seasoned executive with a proven track record of advancing innovative therapies through late-stage clinical development across multiple therapeutic areas including in first-line mCRC. As we move forward, we thank Dr. Kabbinavar for his leadership in progressing onvansertib’s clinical development across multiple tumor types," said Mark Erlander, Chief Executive Officer of Cardiff Oncology. "In addition to today’s medical leadership transition, we are announcing our plan to share an update of clinical data from the ongoing CRDF-004 trial on July 29, at which point we expect to release a substantive dataset."

"I am honored to join the executive team at Cardiff Oncology as we advance onvansertib through late-stage clinical development, and make a meaningful impact for patients living with cancer," said Roger Sidhu, MD. "With a strong foundation already in place, I’m stepping into this role at an exciting time as we prepare to share a clinical update on our lead program in RAS-mutated mCRC next month."

Dr. Sidhu was most recently the Chief Medical Officer and acting CEO at Treadwell Therapeutics. Previously, Dr. Sidhu spent nearly 10 years at Amgen in roles of increasing responsibility in the Hematology/Oncology therapeutic area where he advanced multiple therapeutic candidates. In mCRC, he led multiple phase 3 clinical trials of panitumumab (Vectibix) in monotherapy and in combination with chemotherapy leading to approvals in the U.S. and globally. Dr. Sidhu was also a leader in advancing the science of RAS biology and therapeutics in mCRC and has published work in several peer reviewed journals including the New England Journal of Medicine.

In addition, Dr. Sidhu served as Executive Vice President and Chief Medical officer at Roivant Sciences. He was also the Chief Medical Officer at Eterna Therapeutics, Inc. and Cell Design Labs, up until its acquisition by the Gilead subsidiary Kite, where he subsequently served as VP, Clinical Development.

Dr. Sidhu is a Fellow of the Royal College of Physicians and Surgeons of Canada in both internal medicine and medical oncology. He earned his medical degree from Queen’s University in Kingston, Ontario Canada and his bachelor’s degree in biochemistry from the University of Alberta in Edmonton, Alberta. Dr. Sidhu trained in internal medicine at Queen’s University and medical oncology at the British Columbia Cancer Agency in Vancouver, British Columbia and the Cross Cancer Institute in Edmonton, Alberta.

Conference Call and Webcast on Additional Clinical Data from CRDF-004 in mCRC

Cardiff Oncology will host a conference call and live webcast at 4:30 p.m. ET/1:30 p.m. PT on July 29, 2025 to share additional clinical data from the CRDF-004 trial in first-line RAS-mutated mCRC. Individuals interested in listening to the live conference call may do so by using the webcast link in the "Investors" section of the company’s website at View Source A replay will be available in the investor relations section on the company’s website following the completion of the call.

Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

In connection with Dr. Sidhu joining Cardiff Oncology, the Company’s Board of Directors approved the grant of non-qualified stock options to purchase 600,000 shares of Cardiff Oncology common stock outside of the Cardiff Oncology 2021 Omnibus Equity Incentive Plan. The stock option was granted as an inducement material to Dr. Sidhu becoming an employee of Cardiff Oncology in accordance with Nasdaq Listing Rule 5635(c)(4). The option was granted as of June 16, 2025 and has an exercise price of $3.86 per share, the closing price on the grant date. The option vests over four years with 25% vesting after 12 months and the remaining shares vesting monthly over the following 36-months, subject to Dr. Sidhu’s continued employment with Cardiff Oncology on such vesting dates.

Targeted therapy delivered

On June 17, 2025 Lisata therapeutics presented its corporate presentation (Press release, Lisata Therapeutics, JUN 17, 2025, View Source [SID1234653944]).

Ashvattha Therapeutics to Present Data on Novel Nanomedicine Radiotracers at SNMMI Annual Meeting

On June 17, 2025 Ashvattha Therapeutics ("Ashvattha"), a clinical-stage company advancing a new class of nanomedicine therapeutics that traverse tissue barriers to selectively target and reprogram activated cells in regions of inflammation, reported it will present data on two novel nanomedicine radiotracers at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting, June 21 – 24, 2025 in New Orleans, LA (Press release, Ashvattha Therapeutics, JUN 17, 2025, View Source [SID1234653943]).

The data will demonstrate the ability to tune Ashvattha’s hydroxyl dendrimer platform to achieve selective uptake in neuroinflammation in humans and in tumor-associated macrophages in cancer animal models.

The company will present findings on two novel nanomedicine radiotracers: flurimedrimer, which selectively targets activated microglia in the human brain to support its neurology pipeline, and a second radiotracer designed to selectively target tumor-associated macrophages, potentially advancing precision imaging in oncology.

SNMMI:

Poster Title: Flurimedrimer, a Novel Nanomedicine Radiotracer, Selectively Targeting Activated Microglia in Human Brain
Presentation Date/Time: Sunday, June 22, 2025; 6:30-7:00pm CDT
Session Type: Molecular Targeting Probes POPs
Presenter: Farshad Moradi, MD, Stanford University

Poster Title: A Novel Nanomedicine Radiotracer, Selectively Targeting Tumor Associated Macrophages
Presentation Date/Time: Monday, June 23, 2025; 10:30 AM-11:15am CDT
Session Type: Poster Session
Presenter: Jeff Cleland, PhD, CEO, Ashvattha Therapeutics

Alligator receives positive scientific advice from EMA on Phase 3 trial of mitazalimab

On June 17, 2025 Alligator Bioscience (Nasdaq Stockholm: ATORX), a clinical-stage biotechnology company developing tumor-directed immunotherapies, reported that the European Medicines Agency (EMA) has provided positive scientific advice supporting the overall design of the planned Phase 3 study of mitazalimab in metastatic pancreatic cancer (Press release, Alligator Bioscience, JUN 17, 2025, View Source [SID1234653942]).

The advice confirms that the proposed Phase 3 study of mitazalimab in combination with mFOLFIRINOX is appropriately designed to support future marketing authorization application. The guidance confirms that the information submitted supports mitazalimab advancement to registrational trials, and Alligator is continuing preparations for trial initiation in line with regulatory input.

This regulatory feedback represents another key milestone in the late-stage development of mitazalimab and complements the recently announced confirmation by the U.S. Food and Drug Administration (FDA) of the Phase 3 dose.

"We are very pleased with EMA’s endorsement of our Phase 3 trial design and mitazalimab’s Phase 3 readiness, confirming its path to regulatory approval in Europe," said Søren Bregenholt, CEO of Alligator Bioscience. "This advice from EMA aligns very well with previous input from FDA thus enabling a single global Phase 3 study leading to mitazalimab’s potential registration as a new treatment for patients with metastatic pancreatic cancer in these major territories."