On January 28, 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 children and adults with cancer, reported the acceptance of two abstracts for presentation at the ASCO (Free ASCO Whitepaper) GU 2025 Conference on Clarity’s COBRA and CLARIFY trials and an abstract on the COBRA trial at the AUA Annual Meeting 2025 (Press release, Clarity Pharmaceuticals, JAN 28, 2025, View Source [SID1234649892]). These conferences are among the world’s most prestigious in oncology and urology, and the acceptance of these abstracts is testament to the strength of Clarity’s data and the exciting prospects for the diagnostic 64Cu-SAR-bisPSMA to change the paradigm in the diagnosis and treatment of cancer.

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The abstracts on Clarity’s COBRA trial showcase the improved efficacy of 64Cu-SAR-bisPSMA at detecting lesions compared to currently approved PSMA PET agents, and the potential for this product to become a best-in-class diagnostic. 64Cu-SAR-bisPSMA was able to identify lesions prior to detection by the standard-of-care (SOC) PSMA PET products, which are known to have low sensitivity.

In a subset of participants in the COBRA study who underwent follow-up SOC PSMA PET, 70% of participants had a positive scan on same-day imaging and 90% on next-day imaging using 64Cu-SAR-bisPSMA, compared to 60% of participants using SOC PSMA PET where only same-day imaging is possible. 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). Results indicate that 64Cu-SAR-bisPSMA is able to identify lesions from 29 days to more than 6 months earlier than SOC PSMA agents. Across all participants in the study, histopathology confirmed the presence of prostate cancer in lesions identified by 64Cu-SAR-bisPSMA in up to 78% of cases in which biopsies were performed, which was considerably higher compared to less sensitive methods (e.g. SOC imaging) used to verify the 64Cu-SAR-bisPSMA PET findings. With regards to the biopsies, 100% of lesions which were located outside of the prostate bed were determined as positive, with only 2 participants showing negative results. These 2 participants had lesions located in the prostate bed and had undergone the complete removal of their prostate as part of their initial treatment. The prostate bed is an area notoriously difficult to biopsy following surgery due to anatomical changes and scarring of surrounding tissues as a result of the procedure, which may lead to negative results despite the presence of cancer. Investigators stated that they would change their intended treatment plan in approximately half (48%) of their patients due to the findings of the 64Cu-SAR-bisPSMA PET.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "Our lead product, SAR-bisPSMA, continues generating impressive results as we work with world-class experts to conduct clinical research at the highest standard, bringing us closer to improving the diagnostic paradigm for prostate cancer patients around the world. It is a huge testament to the quality and importance of our data that it continues to be accepted for presentation at some of the world’s most prominent conferences.

"64Cu-SAR-bisPSMA has shown an impeccable safety profile and impressive diagnostic performance to date compared to current SOC PSMA PET agents, which are known to have significant sensitivity limitations. Not only is our product more effective on same-day imaging due to its dual-targeting "bis" structure, but the unique property of next-day imaging, enabled by the longer half-life of copper-64 isotopes, also opens a myriad of opportunities for significantly improving the accuracy of cancer diagnosis and making more informed treatment decisions for men with prostate cancer.

"The results presented in the most recent COBRA abstracts highlight how 64Cu-SAR-bisPSMA could change the scene of prostate cancer diagnostics. With 90% of next-day scans identifying prostate cancer, in comparison to only 60% on SOC PSMA PET scans, and identifying over 2.6 times the number of lesions with 64Cu-SAR-bisPSMA over the approved diagnostics, 64Cu-SAR-bisPSMA could be the game changer. The data provides physicians crucial information to make more informed decisions about treatment, and the high response from investigators in the COBRA trial who intended to change their treatment plan is an indication of how far reaching these changes could be. This opens the door for patients to potentially receive better treatment for their cancer based on these findings, improving their outcomes and quality of their lives.

"The data from the COBRA study, as well as from our earlier PROPELLER trial in the pre-prostatectomy setting, were used to support the design of our second registrational trial with 64Cu-SAR-bisPSMA, AMPLIFY, in patients with biochemical recurrence (BCR) of prostate cancer, planned to commence in the coming months. This trial, in conjunction with the ongoing pivotal CLARIFY trial, which currently has over 20 sites actively recruiting in the U.S. and Australia, is intended to provide evidence to support the U.S. Food and Drug Administration (FDA) approval of 64Cu-SAR-bisPSMA as a novel diagnostic imaging agent for newly diagnosed prostate cancer patients as well as those in BCR of their disease, bringing us closer to achieving our ultimate goal of improving treatment outcomes for people with cancer."

Title Conference and Session details
COBRA: Assessment of the efficacy of 64Cu-SAR-bisPSMA using histopathology as reference standard in patients with biochemical recurrence of prostate cancer following definitive therapy ASCO GU
Date: Thursday, February 13, 2025

Time: 11:25 AM – 12:45 PM PT; 5:45 PM – 6:45 PM PT

Session Title: Trials in Progress Poster Session A: Prostate Cancer

Abstract #: 44

Poster Bd #: A22

CLARIFY: Positron emission tomography using 64Cu-SAR-bisPSMA in patients with high-risk prostate cancer prior to radical prostatectomy — A phase 3 diagnostic performance study ASCO GU
Date: Thursday, February 13, 2025

Time: 11:25 AM – 12:45 PM PT; 5:45 PM – 6:45 PM PT

Session Title: Trials in Progress Poster Session A: Prostate Cancer

Abstract #: TPS429

Poster Bd #: M27

COBRA: Assessment of 64Cu-SAR-bisPSMA and standard of care prostate-specific membrane antigen Positron Emission Tomography in patients with biochemical recurrence of prostate cancer following definitive therapy AUA
Date: Sunday, April 27, 2025

Time: 9:30 AM – 11:30 AM PT

Session Title: MP13: Prostate Cancer: Staging

Room: To be announced

Presentations will be available on Clarity’s website after the conferences: claritypharmaceuticals.com/pipeline/scientific_presentations

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.

64Cu-SAR-bisPSMA is an unregistered product. The safety and efficacy of 64Cu-SAR-bisPSMA has not been assessed by health authorities such as the U.S. FDA or the Therapeutic Goods Administration (TGA). There is no guarantee that this product will become commercially available. Among 82 patients who received 64Cu-SAR-bisPSMA in PROPELLER and COBRA, 2 adverse reactions were reported in 2 participants (mild occasional metallic taste and moderate worsening of type II diabetes, both resolved).

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 worldwide3. Prostate cancer is the second-leading cause 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 U.S. and around 35,770 deaths from the disease.

On January 27, 2025 Manas AI, a full-stack, AI-driven company focused on discovering and advancing next generation medicines, reported the company, Manas, launched by leveraging its proprietary AI-driven platform, its partnership with Microsoft, and a world-class team of scientists across diverse disciplines, Manas AI is uniquely positioned to disrupt the traditional model of therapeutic discovery (Press release, Manas AI, JAN 27, 2025, View Source [SID1234656926]). The company aims to significantly accelerate the process of screening, identifying, and advancing transformative medicines for cancer, autoimmune disease, and rare conditions – including some previously considered unreachable.

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Co-founded by Dr. Siddhartha Mukherjee, a pioneering oncologist, researcher, and author, and Reid Hoffman, renowned entrepreneur and investor, Manas AI integrates generative computational chemistry, advanced molecular docking, and cutting-edge biology to create a full-stack therapeutic development pipeline – from target identification to clinical trials. Manas will use Microsoft’s cloud computing platform, Microsoft Azure, as well as Microsoft’s deep domain knowledge in AI to develop novel medicines.

"Our mission is simple yet profound: to transform how we discover and develop life-saving medicines. Through the power of AI and our world-class team, we believe we can drastically reduce the time and cost it takes to bring game-changing new treatments to patients. I am particularly excited about the novel models for generative chemistry that Manas is developing. If these generative models work, we aspire to replace conventional experimental methods to create medicines," said Dr. Siddhartha Mukherjee, co-founder of Manas AI.

Disrupting Medical Discovery with AI and Compute Power
Manas AI’s proprietary approach builds on several distinctive foundations:

Proprietary AI Filters and Libraries: Manas AI generates bespoke chemical libraries and utilizes advanced AI filters to identify high-potential therapeutic candidates with paradigm-shifting speed and accuracy.
Massive Scale Compute: Through the Microsoft collaboration, Manas AI will build on top of the Azure cloud computing infrastructure, enabling molecular docking at speeds 100x faster than traditional systems.
Project Cosmos: The company’s ambitious AI-driven initiative aims to map the fundamental "rules" of drug binding, further accelerating the discovery of novel chemical entities.
"Amidst all the hype in AI-powered drug discovery today, Manas AI is poised to make truly practical, game-changing advances," said Peter Lee from Microsoft. "It’s especially exciting to integrate world-class AI capabilities with groundbreaking chemistry, biology, and wet-lab expertise as we aim to re-shape the future of medicine. Microsoft is proud to partner with Manas to help realize this critically important mission."

A Global Vision for Impact

With an initial focus on oncology, Manas AI is developing treatments for aggressive cancers such as triple-negative breast cancer, prostate cancer, and lymphoma. Eventually, the company also intends to target other important global diseases

A World-Class Team Leading a New Era of Medical Discovery

Manas AI has brought together a world-class, interdisciplinary team of leaders in the discovery of novel medicines – spanning AI, computational chemistry, biology, and clinical research. The team includes five members of the National Academy of Sciences, four members of the National Academy of Medicine, and two recipients of the Breakthrough Prize in Life Sciences. The Manas team features an unprecedented assembly of globally significant, influential contributors to scientific and medical innovation, including:

Dr. Lew Cantley (Harvard University), discoverer of PI3K and PTEN, scientific founder of Agios Pharma
Dr. Gary Gilliland (Fred Hutch), former Global Oncology Franchise Head, Merck & Co., groundbreaking researcher on the genetic underpinnings of cancer
Dr. William Jorgensen (Yale University), world leading innovator in computational chemistry whose contributions have transformed molecular simulation and drug design
Dr. Peter Kim (Stanford University), pioneering biochemist and former President of Merck Research Laboratories, where he oversaw approval of over 20 new medicines
Dr. Craig Mello (UMass Chan Medical School) co-discoverer of RNA interference and 2006 Nobel Laureate in Medicine, scientific co-founder of CRISPR tx, Atalanta tx and several others RNA focused biotechnology companies.
Dr. Matthew Shair (Harvard University), world leading organic chemist, small molecule therapeutics expert and scientific founder of Nuvalent
Dr. David Spiegel (Yale University), chemical biologist renowned for his contributions in antibody-recruiting molecules and synthetic antibody mimics for therapeutic applications
"Our interdisciplinary team is uniquely equipped to tackle the most complex challenges in drug discovery," said Dr. Mukherjee. "By combining expertise in AI and biology with best-in-class preclinical models, we can accelerate the process of discovering life-saving medicines that were once out of reach."

Backed by Leading Investors

Manas AI has raised $24.6 million in funding to accelerate its groundbreaking AI-driven drug discovery programs. The company’s financing was led by General Catalyst with participation from Greylock and other strategic investors in life sciences and technology. The capital will be used to scale its proprietary AI platform, advance its pipeline of drug candidates, and expand its global clinical programs.

"As a former CEO in the biopharma industry, I’m very familiar with the challenges of the highly complex and resource-intensive therapeutic discovery model", said Ken Frazier, chairman, health assurance initiatives, General Catalyst, and former chairman and CEO of Merck. "Manas AI has the potential to compress the timeline to discovery of effective drug candidates while increasing the likelihood of success in clinical trials. This is a unique opportunity to dramatically change the drug discovery landscape and make a positive impact on billions of people around the world."

"AI will have a lasting and positive impact on humanity, and for years I have been focused on helping realize the potential of this technology. It’s my honor to partner with Sid to build a company focused on using AI to transform drug discovery," said Reid Hoffman, co-founder and investor in Manas. "Manas AI is breaking down barriers that have slowed medical innovation for decades, which will lead to exponential positive impact in our ability to treat human disease."

On January 27, 2025 LinkedIn founder Reid Hoffman and Siddhartha Mukherjee, cancer researcher and author of the book "The Emperor of All Maladies," reported they have co-founded an AI-powered drug discovery startup, Manas AI (Press release, Manas AI, JAN 27, 2025, View Source [SID1234656925]). The company, which will initially focus on breast cancer, prostate cancer, and lymphoma, has raised $24.6 million in seed funding from Hoffman, General Catalyst, and Greylock.

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Manas AI’s capital haul pales compared with some other startups trying to use AI models to develop novel drugs. Last year, Xaira, which claimed that it was ready to start developing drugs, launched with a massive $1 billion in initial funding. Treeline Biosciences is another company that uses AI for drug discovery and raised $422 million last year, Endpts reported.

Manas AI claims it will design molecules with AI, then test them in a wet lab, Hoffman reportedly said during the presentation of his new book "Superagency." The outfit also says it will use Microsoft’s cloud computing platform, Azure, and Microsoft’s "deep domain knowledge in AI" to develop novel medicines.

Hoffman has close ties to Microsoft, which famously acquired his earlier company, LinkedIn, in a blockbuster deal in 2016.

On January 27, 2025 CStone Pharmaceuticals (stock code: 2616.HK), an innovation-driven biopharmaceutical company focused on developing oncology drugs, reported a strategic commercialization collaboration with SteinCares, a leading pharmaceutical company with deep expertise in the Latin American market (Press release, CStone Pharmaceauticals, JAN 27, 2025, View Source [SID1234656222]). Under the license and commercialization agreement, SteinCares will acquire the commercialization rights to sugemalimab in ten countries across Latin America: Brazil, Argentina, Mexico, Chile, Colombia, Costa Rica, Panama, Peru, Guatemala, and Ecuador.

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In the collaboration between the two parties, SteinCares will be responsible for the registration and commercialization-related activities of Sugemalimab in the above-mentioned regions, while CStone Pharmaceuticals will be responsible for the product supply of Sugemalimab and will receive an upfront payment, registration and sales milestone payments from SteinCares, as well as international revenue from the sales of Sugemalimab to SteinCares.

Dr. Jianxin Yang, CEO, President of R&D, and Executive Director of CStone Pharmaceuticals, said, "Following the successful expansion into dozens of countries across Switzerland, Central and Eastern Europe, the Middle East, and Africa, sugemalimab has achieved another breakthrough in global commercialization. Sugemalimab is the first PD-L1 monoclonal antibody approved in the EU and the UK for the first-line treatment of all patients with Stage IV non-small cell lung cancer . Combined with SteinCares’ extensive distribution network and extensive service experience throughout Latin America, we will expand sales channels for sugemalimab in multiple Latin American regions."

At the same time, we are promoting international collaborations in Western Europe, Southeast Asia, and Canada, and actively advancing the registration and marketing of sugemalimab for other indications. We believe that with the progress of overseas registration applications and international commercialization collaborations, sugemalimab will further demonstrate its intended application and commercial value. We also look forward to collaborating with more international partners to benefit more patients worldwide."

Mitchell Waserstein, CEO of SteinCares, said: "This collaboration is a significant step forward in our efforts to create access to safe, innovative and affordable treatments for patients in Latin America. We are committed to helping patients access safe, innovative and affordable treatment options. Leveraging our decades of experience and established sales network in Latin America, we are confident we can develop a viable and efficient commercialization path for sugemalimab to address the unmet medical needs of patients in the region."

About Sugemalimab

Sugemalimab was developed by CStone Pharmaceuticals using the OmniRat transgenic animal platform licensed from Ligand Corporation in the United States . This platform enables the one-stop production of fully human antibodies. As a fully human, full-length anti-PD-L1 monoclonal antibody, sugemalimab is the closest to the body’s natural G-type immunoglobulin 4 (IgG4) response, minimizing the potential for immunogenicity and related toxicities in patients, offering distinct advantages over similar agents. Sugemalimab’s unique molecular design equips it with a dual mechanism of action: it not only blocks the PD-1/PD-L1 interaction but also mediates the interaction between PD-L1-positive tumor cells and tumor-associated macrophages (TAMs), inducing antibody-dependent cellular phagocytosis (ADCP) while sparing effector T cells. This differentiated design has enabled sugemalimab to demonstrate competitive efficacy and safety across various tumor types.

Currently, the China National Medical Products Administration (NMPA) has approved five indications for Sugemalimab (trade name: Zegemet) :

First-line treatment in combination with chemotherapy for patients with metastatic squamous and non-squamous NSCLC;
For the treatment of patients with unresectable, stage III NSCLC who have not experienced disease progression after concurrent or sequential chemoradiotherapy;
Treatment of patients with relapsed or refractory extranodal NK/T-cell lymphoma;
Combined with fluorouracil and platinum chemotherapy drugs as the first-line treatment for patients with unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma;
In combination with fluorouracil-containing and platinum-based chemotherapy, it is used for the first-line treatment of unresectable locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma that expresses PD-L1 (combined positive score [CPS] ≥ 5).
The European Commission (EC) has approved sugemalimab (trade name: Cejemly ) in combination with platinum-based chemotherapy for the first-line treatment of patients with metastatic NSCLC who do not have EGFR-sensitive mutations or genomic tumor alterations in ALK, ROS1, or RET.

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has approved sugemalimab in combination with platinum-based chemotherapy for the first-line treatment of patients with metastatic NSCLC who do not have EGFR-sensitive mutations or genomic tumor alterations in ALK, ROS1, or RET.

On January 27, 2025 Theralase Technologies Inc. ("Theralase" or the "Company") (TSXV:TLT)(OTCQB:TLTFF), a clinical stage pharmaceutical company dedicated to the research and development of light, radiation, sound and/or drug-activated small molecules and their formulations, intended for the safe and effective destruction of various cancers, bacteria and viruses reported that its interim clinical data has been selected for presentation at the American Urological Association ("AUA") Annual Meeting (Press release, Theralase, JAN 27, 2025, View Source [SID1234649964]).

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The Program Committee of the AUA has accepted the Theralase’s abstract titled: "Interim Analysis of Light-Activated TLD-1433 in a Phase II Clinical Study of BCG-Unresponsive Non-Muscle Invasive Bladder Cancer Carcinoma In-Situ" for presentation in a Podium Session at the 2025 Annual Meeting of the American Urological Association to be held in Las Vegas, Nevada, April 26th to 29th.

The clinical data from Theralase’s international, multicenter Phase II ("BCG")-Unresponsive Non-Muscle Invasive Bladder Cancer ("NMIBC") Carcinoma In-Situ ("CIS") study will be presented by principal investigator Dr. Girish Kulkarni in an oral presentation.

Pending regulatory approval, this innovative technology represents an opportunity for a significant advancement in bladder cancer treatment, by providing a safe and effective therapy for patients who have exhausted their standard of care therapeutic options and are now facing radical cystectomy (bladder removal).

The interim clinical data supports the high safety and efficacy of the treatment with a number of patients demonstrating a duration of response of 3 years or greater with a single treatment.

These findings support the use of light-activated Ruvidar by the urology community to safely and effectively treat patients inflicted with BCG-Unresponsive NMIBC, helping to revolutionize the treatment landscape for bladder cancer.

Girish Kulkarni, MD, PhD, FRCSC, a urologic surgeon in the Department of Surgical Oncology at the Princess Margaret Cancer Centre, University Health Network and Assistant Professor at the University of Toronto, Department of Surgery stated, "We are excited that our clinical study has been accepted for podium presentation at the American Urological Association. The early data is supportive of light-activated RuvidarTM, as a treatment modality for BCG-Unresponsive CIS of the bladder, thus enabling patients to preserve their bladders and maintain their quality of life."

Arkady Mandel, MD, PhD, DSc, Chief Scientific Officer, Theralase stated, "In the interim clinical data, we have observed a strong safety and efficacy response in bladder cancer patients treated at numerous clinical study sites across Canada and the US. The data supports the use of light-activated Ruvidar in the treatment of patients with high-grade, high-risk NMIBC. In addition, the latest results demonstrate a long-lasting duration of complete response induced by this innovative technology, which is able to be completed within a few hours and is suitable for patients with CIS of the urinary bladder, who have not responded to previous therapies and who are currently facing a life-altering option, such as a radical cystectomy."

Roger DuMoulin-White, BSc, P.Eng, Pro.Dir, Chief Executive Officer, Theralase stated, "The acceptance of the Theralase abstract for podium presentation at the AUA Annual Meeting is a testament to the importance and significant impact that this clinical research could have on the lives of bladder cancer patients. We look forward to the presentation and the continued development of Ruvidar for patients in need. Patient enrollment is scheduled to be completed in 2025, with clinical data submission to Health Canada and the FDA in 2026. Pending successful regulatory approval, Theralase plans to make this technology commercially available to the entire urological community in 2027."

About the Annual Meeting of the American Urological Association

The AUA Annual Meeting is one of the world’s largest gatherings of urological professionals, bringing together leading researchers, clinicians and industry experts to share the latest advancements in urological care and research. The 2025 event in Las Vegas promises to highlight cutting-edge developments in the field, offering a platform for collaboration and innovation.

About Study II:

Study II utilizes the therapeutic dose of the patented Study II Drug ("RuvidarTM" or "TLD-1433") (0.70 mg/cm2) activated by the proprietary Study II Device (TLC-3200 Medical Laser System or "TLC-3200"). Study II is focused on enrolling and treating approximately 75 to 100 BCG-Unresponsive NMIBC CIS patients in up to 15 Clinical Study Sites ("CSS") located in Canada and the United States.

About Ruvidar

Ruvidar is a small molecule, able to be activated by light, radiation, sound and/or other drugs, designed to selectively target and destroy cancer cells, while minimizing damage to surrounding healthy tissue. It represents a novel approach in the treatment of BCG-Unresponsive NMIBC CIS. It is planned to be evaluated in various other cancers in 2025; including: brain, lung, pancreatic and muscle invasive bladder cancer.