Orionis Biosciences Inc. is sticking with Genentech Inc. in a second deal to discover small-molecule monovalent glue therapies for treating cancer. Privately held Orionis is getting $105 million up front and could earn more than $2 billion in R&D, development, commercial and net sales milestones, plus royalties. Orionis will handle discovery and optimization of molecular glues with Genentech in charge of later-stage preclinical and clinical development, regulatory filing and commercialization of any small molecules the partnership produces. The first deal between the two came in September 2023, with Orionis discovering small-molecule molecular glues for targets in major disease areas including oncology and neurodegeneration.
Adcom splits on Urogen bladder cancer drug
More telling than the U.S. FDA’s Oncologic Drugs Advisory Committee’s 4-5 vote today on the overall benefit-risk of Urogen Pharma Inc.’s UGN-102 (mitomycin) is that the panel’s urology specialists and the patient representative all voted yes, saying the drug would be an important alternative to what is often a continuing cycle of surgery for patients with low-grade intermediate-risk non-muscle invasive bladder cancer. In light of the “relatively split vote,” Richard Pazdur, director of the FDA’s Oncology Center of Excellence, said agency staff will meet with the sponsor to determine what’s next. Although the FDA asked to discuss whether randomized trials should be required for future treatments in the novel space, Pazdur made it clear that the question was future-looking and not aimed at Urogen’s 505(b)(2) application.
Repronovo’s $65M series A gives new life to nolasiban
A drug that failed in a phase III trial in 2019 is being brought back to the clinic by Repronovo SA, a fertility and women’s health startup that has raised $65 million in a series A. The money will fund a phase II study of nolasiban in improving success rates in assisted reproductive technology, the same indication as the previous phase III failure. The oxytocin receptor antagonist also will be tested in a new indication of adenomyosis, an overgrowth of endometrial tissue into the wall of the uterus, a condition that has similar symptoms, but is distinct from endometriosis. In addition, the series A also will fund phase II development of Repronovo’s second product, leflutrozole, in treating infertility in men with low serum testosterone.
AP Bio heads to phase II with bispecific for HER2-resistant tumors
Although HER2-targeted therapies have become a mainstay in cancer treatment, some tumors evade them by stripping away the portion of the HER2 receptor that most therapies are built to recognize and bind to, but Taiwan’s AP Biosciences Inc. is developing bispecific antibody AP-402 to address treatment-resistant HER2+ cancers. “AP-402 targets p95HER2, a truncated form of HER2 present in 30% to 40% of HER2-positive cancers, which is associated with exceptionally poor prognosis and not addressable by conventional anti-HER2 therapies,” AP Biosciences founder and CEO Jeng Her told BioWorld. “AP-402 represents the only T-cell engager in human trials that bridges activated T cells and p95HER2-expressing cancer cells in the tumor, a differentiated mechanism that could deliver a powerful immune response while minimizing systemic toxicity.”
Juvenescence's $76M+ to advance CD38, ketone drugs to clinic
Anti-aging specialist Juvenescence Ltd. reached the first close of its series B-1 at $76 million and said it is on course to close the round at $150 million in the third quarter of 2025. As things stand, Juvenescence has five programs in the inhouse pipeline, of which one is in the clinic, and interests in seven portfolio companies working on a diverse range of products targeted at chronic diseases and aging. With the series B-1 due to close later this year, there are plans to advance two to three more programs into clinical development within the next year. Two of these are being developed in a partnership with the Buck Institute for Research on Aging in Novato, Calif., an oral small-molecule CD38 inhibitor for rheumatoid arthritis and an oral formulation of ketone for heart failure.
Cancer drug specialist Immuneoncia raises $24M in Kosdaq listing
Immuneoncia Therapeutics Inc. raised ₩33.9 billion (US$24 million) from its Kosdaq listing May 19. Shares closed at ₩7,500 – 108% higher than its offering price of ₩3,600 per share. Immuneoncia, a joint venture founded in 2016 between Seoul, South Korea-based Yuhan Corp. and San Diego-based Sorrento Therapeutics Inc., noted that the funds will support R&D operations until 2026. Its lead immune checkpoint inhibitors include IMC-001, a phase II-stage, PD-L1 monoclonal antibody (MAb) and IMC-002, a phase Ib-staged CD47-IgG4 MAb. The company also plans to expand into bispecific antibody development, based on its experience with monoclonal antibodies.