Lutetium (177 Lu) Vipivotide Tetraxetan

- Phase I Follow-Up Data Showed an Overall Survival of 29.8 Months with the Addition of CONV01-α to 177Lu-PSMA-I&T in Advanced Prostate Cancer CAMBRIDGE, Mass., Feb. 10, 2025 /PRNewswire/ -- Convergent Therapeutics Inc., a clinical-stage biotechnology company focused on the development of next-generation radiopharmaceuticals for the treatment of cancer, today announced clinical trial updates for its lead asset, CONV01-α (225Ac-J591), a prostate-specific membrane antigen (PSMA)-targeted monoclonal antibody linked to actinium-225 (225Ac). Data will be presented at the American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium, which will take place February 13-15, 2025, in San Francisco, California. The first presentation, titled "Mature phase 1 follow up of alpha emitter 225Ac-J591 with 177Lu-PSMA-I&T in advanced prostate cancer," reported clinical follow-up of a Phase I dose-escalation trial exploring the addition of CONV01-α to 177Lu-PSMA-I&T, a PSMA-targeted beta emitting small molecule for the treatment of advanced prostate cancer. The study population presented included 18 patients (six at each dose level of CONV01-α) with progressive metastatic castration-resistant prostate cancer (mCRPC). Relatively low doses of CONV01-α were used. Data showed that the median overall survival was 29.8 months, with 10 patients still alive at the time of submission. Five patients were free from PSA progression at one year including one patient progression-free at 34 months on no active therapy. A decline in prostate-specific antigen (PSA) levels was seen in 94% of patients, 64% of patients achieved a PSA50 and 28% achieved a PSA90 response. Additionally, circulating tumor cell count changes were seen, with 80% of evaluable patients converting from "unfavorable" to "favorable." High grade adverse events were rare. "The impressive clinical activity is consistent with our pre-clinical data demonstrating that the antibody/ligand combination delivers a synergistic dose to tumor. Importantly, the synergistic tumor dose is achieved in the absence of additive toxicity due to the non-overlapping normal organ biodistribution of the ligand and antibody. This was also confirmed by the benign safety profile in the trial. The dosimetry and safety profile suggest the potential for additional cycles beyond the two cycles used in this trial. That the overall survival in this trial was double that of the Phase III VISION trial of 177Lu PSMA-617 further increases our enthusiasm for future trials of this combination," said Neil Bander, MD, Convergent's Co-Founder and Chief Scientific Officer and Professor Emeritus of Urology at Weill Cornell Medicine. The second presentation, titled "CONVERGE-01: Dosimetry, randomized dose optimization, dose escalation, and efficacy of Ac-225 rosopatamab tetraxetan in participants with PSMA-positive castration-resistant prostate cancer," is a "Trials in Progress" presentation of the three-part company sponsored Phase II trial evaluating the safety and efficacy of CONV01-α (225Ac-J591) monotherapy in patients with castration-resistant prostate cancer. Philip Kantoff, MD, Co-Founder and CEO said, "CONVERGE-01 is intended to confirm the high response rate and durability of CONV01-a monotherapy and solidify the path forward to our pivotal trial." About CONV01-α CONV01-α, Convergent's alpha-emitting radioantibody, combines the precision and pharmacokinetics of antibodies with the tumor-killing potential of alpha-emitting radionuclides. Specifically, CONV01-α uses a humanized monoclonal antibody targeted at prostate-specific membrane antigen (PSMA), which is highly overexpressed in prostate cancer cells. Since PSMA is a validated target, several therapeutics are directed at this antigen, and CONV01-α is differentiated by its use of both an antibody and alpha emitter. CONV01-α is linked to a powerful radionuclide called Ac-225, which releases alpha particles that kill cancer cells through DNA double-strand breaks. Unlike other radioactive sources, alpha particles deliver high-energy radiation over very short distances, thereby minimizing radiation exposure to healthy neighboring cells and tissues. Pairing highly selective antibodies with such a powerful, yet precise, payload offers the ideal combination to treat many types of cancers. Convergent Therapeutics is currently enrolling into the CONVERGE-01 Phase II monotherapy trial to confirm the high response rate, durability and safety of CONV01-a pre and post radioligand beta. About Convergent Therapeutics, Inc. Convergent Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing tumor-selective alpha radioantibodies to target cancer. The company was founded by world-renowned experts in clinical care and research, drug development, and cancer biology and its proprietary platform is licensed from Cornell University. In harnessing the selectivity of antibodies and tumor-destructive potential of alpha radioisotopes, Convergent's radioantibodies precisely target cancer cells with potent, localized radiation. For more information, please visit and follow us on X and LinkedIn. Media Relations: Bryan Blatstein Spectrum Science 917-714-2609 [email protected] SOURCE Convergent Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Lilly gained a connection to AdvanCell when it bought Point Biopharma. \n Eli Lilly has begun the week with a bang. Early Monday morning, AdvanCell and OliX Pharmaceuticals put out news that the Big Pharma is coughing up cash to work with them on radiopharmaceuticals and metabolic-associated steatohepatitis (MASH), respectively.The deal with OliX gives Lilly global rights to OLX75016, a siRNA candidate that targets the expression of the MARC1 enzyme. OliX selected the target after looking at genomic variants linked to MASH and other liver diseases. The Korean biotech is running a phase 1 trial of the candidate in healthy volunteers, and Lilly will pay for OliX to complete the study.Striking the global licensing agreement moves Lilly deeper into siRNA and MASH. The drugmaker showed its interest in siRNA and related modalities last year by opening a $700 million nucleic acid R&D center in the Boston Seaport.Tirzepatide, the GLP-1 drug in Mounjaro and Zepbound, is Lilly’s highest-profile MASH candidate. Lilly reported phase 2 MASH data in June and later outlined its attempts to find biomarkers that can support accelerated FDA approvals in the liver disease. The company’s early-phase pipeline, which includes siRNA inhibitors of SCAP and PNPLA3, could benefit from the investments. Lilly gained a connection to AdvanCell, an Australian radiopharmaceutical company when it bought Point Biopharma for $1.4 billion in 2023. Point partnered with AdvanCell earlier that year, securing a chance to collaborate on the development of lead-212-labeled radioligands. The new deal builds on the existing pact to support the development of an expanded portfolio of lead-212 targeted alpha therapies.AdvanCell’s star has risen since it began working with Point in 2023. Last week, the biotech disclosed a $112 million series C that was co-led by SV Health Investors, Sanofi Ventures, Abingworth and SymBiosis. AdvanCell’s pipeline is led by a would-be challenger to Novartis’ prostate cancer drug Pluvicto.