On October 14, 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 the Co-PSMA (NCT06907641)1 Investigator-Initiated Trial (IIT), led by Prof Louise Emmett at St Vincent’s Hospital Sydney, has achieved its primary endpoint with a statistically significant higher number of prostate-specific membrane antigen (PSMA)-positive prostate cancer lesions detected using 64Cu-SAR-bisPSMA compared to standard-of-care (SOC) 68Ga-PSMA-11 positron emission tomography/computed tomography (PET/CT) in patients with low prostate-specific antigen (PSA) levels.

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Co-PSMA’s official study title is "Comparative performance of 64Copper [64Cu]-SAR-bisPSMA vs. 68Ga-PSMA-11 PET CT for the detection of prostate cancer recurrence in the setting of biochemical failure following radical prostatectomy". This Phase II IIT is evaluating the performance of Clarity’s diagnostic product, 64Cu-SAR-bisPSMA, in comparison to SOC 68Ga-PSMA-11 in 50 patients with low PSA who are candidates for curative salvage therapy. Eligible patients were required to have had radical prostatectomy with no salvage therapy and a PSA level between 0.2 and 0.75 ng/mL.

The Co-PSMA trial has successfully met its primary endpoint, demonstrating that 64Cu-SAR-bisPSMA PET/CT detects significantly more lesions per patient than the SOC, 68Ga-PSMA-11 PET/CT. This result supports the hypothesis that 64Cu-SAR-bisPSMA can improve early detection of recurrence and staging of prostate cancer in patients with low PSA who are candidates for curative salvage therapy. Full analysis of all data generated in the Co-PSMA trial is underway, and results of this study will be presented at an upcoming international conference.

The Co-PSMA topline results corroborate findings from the COBRA trial2, which investigated the diagnostic performance of 64Cu-SAR-bisPSMA in patients with biochemical recurrence (BCR) of prostate cancer who had a negative or equivocal SOC scan at study entry. In the COBRA study, a subset of participants underwent follow-up SOC PSMA PET imaging. Only 60% of these participants had a positive SOC PSMA PET, while 70% of participants had a positive 64Cu-SAR-bisPSMA PET on same-day imaging and 90% on next-day imaging. The number of lesions across all participants (average sum of lesions across all readers) identified by 64Cu-SAR-bisPSMA was also higher (26.3 lesions on same-day imaging, 52.6 on next-day imaging) than that detected by SOC PET agents (20 lesions). The COBRA trial results showed that 64Cu-SAR-bisPSMA was able to identify lesions more than 6 months earlier than SOC PSMA PET agents, with 6 months being the last follow-up visit for that trial.

The Co-PSMA trial further builds on the growing body of evidence of the enhanced diagnostic performance of 64Cu-SAR-bisPSMA compared to SOC PSMA PET agents, which are known to have low sensitivity, especially in patients with low PSA levels3,4. Improvements in sensitivity, as with all diagnostic agents, play a pivotal role in guiding more informed treatment decisions, enabling earlier and more accurate detection of prostate cancer recurrence and ultimately improving patient outcomes.

Dr Alan Taylor, Executive Chairperson of Clarity Pharmaceuticals, commented: "Achieving the primary endpoint in the Co-PSMA trial, which was a head-to-head trial against a SOC competing product, is yet another important step in the development of 64Cu-SAR-bisPSMA as we look to further validate this agent as best-in-class through two registrational trials with two Fast Track Designations (FTDs) under our belt for diagnostic applications and a strong focus on commercialisation.

"We look forward to Prof Emmett releasing the full Co-PSMA trial data at world-leading congresses as we continue to adhere to the highest standards of clinical research in our aspirations to bring a best-in-class diagnostic option to men with prostate cancer with clear evidence of superiority. We have already seen in the first-in-human PROPELLER trial an improved diagnostic performance of 64Cu-SAR-bisPSMA compared to 68Ga-PSMA-11 on same-day imaging, including a higher number of lesions identified and 2-3 times higher tumour uptake and tumour-to-background ratio5. We then showed in the COBRA trial that approximately twice the amount of lesions was identified on 64Cu-SAR-bisPSMA PET on next-day vs. same-day imaging, and vs. SOC PSMA PET2. 64Cu-SAR-bisPSMA also allowed for the identification of lesions in the 2-mm range, something that SOC PSMA PET agents often fail to achieve2, 6-9. This improvement was driven by a substantially increased tumour-to-background ratio and lesion uptake over time with next-day imaging2.

"The current market for PSMA PET imaging in the US alone is around US$2 billion per year, and this is expected to further grow to over US$3 billion by 2029. However, this entire market is currently served by products that have low sensitivity, while the development pipeline of new products, excluding 64Cu-SAR-bisPSMA, offers no differentiation from the existing agents, with some new entrants commercialising the unpatented 68Ga-PSMA-11 agent, which has been capitalised on by three separate groups already. We believe that with the clinical and logistical benefits offered by 64Cu-SAR-bisPSMA we could not only become the new SOC in PSMA PET but grow the market opportunity further by diagnosing prostate cancer earlier, while lesions are still very small.

"We look forward to continuing to work with Prof Emmett, a world-renowned thought leader in the radiopharmaceutical space, in our home city of Sydney on progressing clinical development of the 64Cu-SAR-bisPSMA product, including our CLARIFY and AMPLIFY Phase III trials. This partnership will ensure we continue to generate the highest quality of data supporting our New Drug Applications (NDAs) to the US Food and Drug Administration (FDA) as the next step towards our mutual goal of improving treatment outcomes for men with prostate cancer."

(Press release, Clarity Pharmaceuticals, OCT 14, 2025, View Source [SID1234656623])

On October 14, 2025 Nusano, a physics company transforming the production of radioisotopes, and Ariceum Therapeutics (Ariceum), a targeted radiotherapeutics company dedicated to setting new standards in cancer care, reported the signing of a multi-isotope supply agreement to support Ariceum’s novel radiotherapeutic pipeline.

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The agreement gives Ariceum access to Nusano-produced radioisotopes, including actinium-225 (Ac-225) and lutetium-177 (Lu-177).

"Radiotherapeutics have the potential to redefine the standard of care in oncology," said Manuel Sturzbecher-Höhne, Chief Technology Officer of Ariceum Therapeutics. "This agreement further strengthens our ability to advance 225Ac-SSO110, which is currently being investigated in a Phase 1/2 trial in patients with extensive-stage small cell lung cancer and Merkel cell carcinoma. Reliable access to actinium-225 ensures we can deliver on our commitment to developing transformative therapies for patients facing these aggressive and underserved cancers."

The Nusano radioisotope production platform combines time-proven technology from universities and world-class research centers with the company’s patented particle acceleration technology. The result is the first significant advancement in radioisotope production in decades – a platform that’s smaller and more efficient than existing methods, and capable of the simultaneous manufacturing of up to 12 different radioisotopes.

"Nusano’s production capabilities are designed to stabilize supply chains and enable innovation," said Chris Lowe, CEO of Nusano. "Our scalable production allows us to work with drug developers from the earliest stages through commercial drug availability. We look forward to working with Ariceum on their current and future therapeutic candidates."

(Press release, Nusano, OCT 14, 2025, View Source [SID1234656644])

On October 14, 2025 Synnovation Therapeutics, a precision medicine company focused on the discovery and development of best-in-class targeted medicines, reported that it will be presenting the initial results from a Phase 1 Trial of SNV1521, a next-generation, CNS-penetrant PARP1-selective inhibitor, at the 2025 Annual Meeting of the European Society for Medical Oncology in Berlin, Germany.

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"We look forward to sharing the first clinical dataset for our PARP-1 selective inhibitor, SNV1521, with the scientific community in Berlin," said Kevin O’Hayer, M.D., Ph.D., Senior Vice President, Head of Clinical Development at Synnovation. "We have generated encouraging anti-tumor activity and a differentiated safety and PK profile that supports best-in-class potential and further development as a monotherapy and in combination with novel targeted and cytotoxic agents."

Patricia LoRusso, D.O, Ph.D, Associate Center Director for Innovative Medicine at Yale Cancer Center, will present the initial results on Friday, October 17, 2025. The details of the presentation are below:

Oral Presentation:

Title:

First results from a phase 1 trial of SNV1521, a next generation, CNS-penetrant, PARP1-selective inhibitor in patients (pts) with molecularly selected advanced solid tumors (Abstract #923MO)

Presenter:

Patricia LoRusso, DO, PhD

Details:

Developmental Therapeutics Mini Oral Session

Friday, October 17, 2025; Heidelberg Auditorium

10:25 – 10:30 AM EST (4:25 – 4:30 PM CET)

"PARP1 selective agents offer the promise of delivering effective PARP inhibition while mitigating the hematologic and GI toxicity associated with first generation PARP inhibitors," said Patricia LoRusso, D.O., Ph.D., Associated Center Director for Innovative Medicine at Yale Cancer Center. "By optimizing PARP1 selectivity and potency, SNV1521 has the potential to emerge as a best-in-class agent with a differentiated safety profile compared to standard of care and PARP inhibitors in development."

Synnovation also announced a clinical collaboration with DualityBio to evaluate the combination of SNV1521 with Duality’s HER3-directed antibody-drug conjugate (ADC), DB-1310. DB-1310 is a novel ADC targeting HER3 developed using DualityBio’s proprietary DITAC platform. In June 2025, Dr. Aaron E. Lisberg from the University of California, Los Angeles (UCLA) presented the first-in-human Phase I/IIa clinical trial data (NCT05785741) of DB-1310 in an oral session at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The results demonstrated encouraging efficacy and a manageable safety profile in patients with advanced solid tumors who had failed standard therapies.

"The combination of cytotoxic agents with PARP inhibitors has shown clear preclinical synergy, however, overlapping hematologic toxicity has so far hindered the successful co-development." said Wenqing Yao, Ph.D., CEO and Co-Founder at Synnovation. "This collaboration provides an exciting opportunity to evaluate the combination of two potentially best-in-class therapies—a heme-sparing, PARP1-selective inhibitor, SNV1521, and the HER3-targeting ADC, DB-1310—with the aim of demonstrating synergistic efficacy and improving patient outcomes".

(Press release, Synnovation Therapeutics, OCT 14, 2025, View Source [SID1234656659])

On October 14, 2025 AB Science SA (Euronext – FR0010557264 – AB) reported an update on the Phase 1 study of the molecule AB8939 and, in particular, on the initial clinical data for the combination of AB8939 + Venetoclax in the first three patients with acute myeloid leukemia (AML) associated with a very unfavorable genetic profile.

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AB8939 is a drug candidate that jointly targets cancer cells by destabilizing microtubules, which are essential for cell division, and also targeting cancer stem cells by inhibiting enzymes (ALDH1A1 and ALDH2) that are essential for maintaining their physiological state and survival.

AB8939 is currently being evaluated in a Phase 1 clinical trial (study AB18001, NCT05211570) in patients with refractory and relapsed AML.

The Phase 1 clinical trial of AB8939 has completed its first two stages, which consisted of determining the maximum tolerated dose (MTD) after 3 and 14 consecutive days of monotherapy, respectively. In both cases, the MTD was 21.3 mg/m².

The third stage, currently underway, involves evaluating the combination of AB8939 + Venetoclax. Three patients were evaluated at the first dose level (AB8939 14 days at a dose of 16 mg/m² + Venetoclax 14 days).

Nicholas J. Short, MD, Associate Professor and Co-Lead of Section of Developmental Therapeutics, Department of Leukemia, MD Anderson Cancer Center, said, "The results observed in these high-risk AML patients are impressive, particularly in the two patients whose leukemia had progressed on venetoclax. These initial results are very encouraging and justify the continuation of patient treatment with additional cycles, particularly in view of the mechanism of AB8939 on cancerous hematopoietic stem cells."

At the end of this third stage, an AB8939 + venetoclax expansion phase will be initiated in a group of about 15 patients with a more homogeneous profile than in the previous stages of phase 1, namely patients in their second- or third-line of treatment and with a poor prognosis (TP53 mutant, MECOM, NRAS mutant) in order to confirm the initial promising clinical data before initiating a registration clinical trial.

Virtual conference

AB Science will hold a virtual conference on Thursday, October 16, 2025, from 2pm to 3pm CET.

ZOOM link to the conference (audio + presentation): Access to the conference.

The purpose of this virtual conference will be to present in more detail the initial clinical data on the combination of AB8939 + venetoclax in the first three patients with refractory and relapsed AML associated with a very unfavorable genetic profile.

The following individuals will participate in the virtual conference:

Nicholas J. Short, MD, Associate Professor and Co-Lead of Section of Developmental Therapeutics, Department of Leukemia, MD Anderson Cancer Center

Professor Short is a clinical and translational investigator in adult acute leukemias, with a particular emphasis on the development of phase I and II investigator-initiated clinical trials of novel agents and combinations for patients with acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). His major contributions to leukemia research include: developing new immunotherapy-based frontline regimens in Philadelphia chromosome-negative B-cell ALL, developing chemotherapy-free regimens in Philadelphia chromosome-positive ALL, establishing the clinical utility of high-sensitivity next-generation sequencing-based MRD assays in ALL, developing novel MRD-directed therapies in AML and ALL, and developing novel regimens for older adults with FLT3-mutated AML. He serves as principal investigator or co-principal investigator on over a dozen phase I and II clinical trials and has authored over 250 peer-reviewed manuscripts in the field of leukemia. For his clinical and translational accomplishments in the field of leukemia, he has been awarded the ASCO (Free ASCO Whitepaper) Young Investigator Award and the ASH (Free ASH Whitepaper) Junior Faculty Scholar in Clinical Research.

Olivier Hermine, MD, PhD, Head of the Hematology Department at Necker-Enfants Malades Hospital, Paris, France

Olivier Hermine is Professor of Hematology at Paris Descartes University, Head of the Hematology Department at Necker-Enfants Malades Hospital, member of LYSA, and Director of the CALYM team "Cellular and Molecular Mechanisms of Hematological Disorders and Therapeutic Implications" at the IMAGINE Inserm U 116 CNRS ERL 8654 institute. He is also coordinator of the Reference Center for Mastocytosis (CeReMast), co-founder and director of the scientific committee of AB Science.

His research topics include lymphoproliferative disorders linked to the hepatitis C virus, mantle cell lymphomas, and the regulation of erythropoiesis. He is the author or co-author of more than 900 scientific publications.

Christian Auclair, PharmD, PhD, Emeritus Professor

Professor Auclair holds a doctorate in pharmaceutical sciences. He is co-founder and former director of the doctoral school of oncology at the Faculty of Medicine of Paris-Saclay University. He is former director of the biology department at the École Normale Supérieure de Cachan (now ENS Paris-Saclay) and director of UMR 8113 at the CNRS. He was also deputy scientific director of the CNRS’s life sciences department. He is the author of more than 120 publications in the field of antitumor pharmacology and virology. He is co-founder and scientific advisor to AB Science.

Orphan Drug Status

In April 2025, AB Science announced that the molecule AB8939 had been granted orphan drug designation by the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) for the treatment of acute myeloid leukemia (AML).

The molecule AB8939 had already obtained orphan drug designation from the US Food and Drug Administration (FDA) for AML.

About AB8939
AB8939 is a new synthetic molecule which jointly targets cancer cells, by destabilizing the microtubules essential for cell division, and cancer stem cells, by inhibiting enzymes (ALDH1A1 and ALDH2) essential for maintaining their physiological state and survival. The molecule ‘1-{4-[2-(5-ethoxymethyl-2-methylphenylamino)-oxazol-5-yl]phenyl}imidazolidin-2-one’ is the chemical name of AB8939. The intellectual property of AB8939 is 100% owned by AB Science.

(Press release, AB Science, OCT 14, 2025, View Source [SID1234656628])

On October 14, 2025 Privo Technologies, Inc. a leader in localized cancer therapies, reported the completion of enrollment in Arm 1 of the Phase 2 run-in portion of its ongoing Phase 2/3 clinical trial (CLN-004) evaluating PRV111, a nano-engineered chemotherapy patch designed to treat oral cavity cancers across distinct stages of disease (Press release, Privo Technologies, OCT 14, 2025, View Source [SID1234656645]).

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The Phase 2 run-in data are currently being analyzed for submission to the U.S. Food and Drug Administration (FDA) prior to continuing enrollment in the Phase 3 portion of the study.While detailed results remain under review, initial observations from the Phase 2 run-in are highly encouraging with respect to both safety and local tumor response with no evidence of systemic toxicity and among patients who demonstrated a favorable local response. Investigators determined that planned surgical procedures could be cancelled based on the absence of visible or measurable disease following PRV111 treatment. These findings suggest that PRV111 has the potential to offer a localized, tissue-sparing approach for early-stage oral lesions, subject to further clinical evaluation and regulatory review.

These early results support Privo’s mission to advance targeted, localized cancer therapies aimed at reducing the need for invasive procedures and improving patients’ quality of life.

Privo extends its gratitude to the investigators, clinical staff, and patients who made this milestone possible.

About the CLN-004 Phase 2/3 Clinical Trial

CLN-004 is an adaptive, open-label Phase 2/3 clinical study evaluating the safety, tolerability, and preliminary efficacy of PRV111 for the localized treatment of oral cavity lesions.

In the Phase 2 run-in (Arm 1), enrolled patients were treated with PRV111 as a stand-alone, non-surgical topical therapy for oral carcinoma in situ (CIS)/ high-grade oral dysplasia (HGD). The goal of this stage is to determine whether localized delivery of PRV111 can safely and effectively eliminate pre-cancerous and early-stage cancerous lesions while minimizing the need for surgery.

Completion of the Phase 2 enrollment marks an important milestone in Privo’s mission to develop therapies that spare patients from invasive surgery and potentially reduce recurrence risk.

"Completing enrollment in the Phase 2 portion of the CLN-004 study is a pivotal achievement for Privo and our clinical partners," said Dr. Manijeh Goldberg, Chief Executive Officer of Privo Technologies. "The initial observations are encouraging, and we look forward to sharing the full dataset with the FDA as we prepare for the Phase 3 evaluation. PRV111 reflects our vision to transform oral cancer treatment through precise, localized therapies designed to preserve function and quality of life."

Transforming Oral Cancer Treatment Through Localized Delivery

PRV111 is part of Privo’s proprietary PRV platform, a family of nano-engineered drug-delivery systems designed to deliver high concentrations of chemotherapy directly to tumor tissue while minimizing systemic exposure.

PRV111 is a topical, transmucosal patch that adheres directly to oral lesions, enabling the delivery of cisplatin nanoparticles through the mucosa to achieve targeted, localized drug penetration. Each PRV111 application is customized to the size and shape of the patient’s tumor, allowing precise coverage of the affected area and consistent drug delivery across complex anatomical surfaces.

This non-invasive, localized approach is intended to reduce systemic toxicity compared to conventional chemotherapy and to preserve surrounding healthy tissue. By potentially avoiding extensive surgical excision, PRV111 aims to help patients maintain normal speech, swallowing, and appearance—functions often affected by standard treatment options.

The CLN-004 study builds upon Privo’s earlier clinical experience with PRV111 (CLN-001), which showed promising local tumor responses with no systemic toxicity in a first-in-human setting. The results of that earlier trial were published in Nature Communications and highlighted by Forbes for their innovative approach to localized cancer drug delivery.

Looking Ahead

With Phase 2 enrollment complete, Privo Technologies is preparing to submit the CLN-004 dataset to the U.S. FDA. The data from this phase will help inform the design of the pivotal Phase 3 trial, which is planned to further evaluate PRV111 as a localized, non-surgical treatment approach.

"This milestone moves us another step toward providing patients with treatments designed to minimize the life-altering consequences of major surgery," said Dr. Manijeh Goldberg, Chief Executive Officer of Privo Technologies. "Our platform continues to demonstrate the promise of localized, patient-focused cancer care that aims to improve outcomes while preserving quality of life."