3-Aminobenzamide

AstraZeneca developed the Duo-O regimen hoping Imfinzi could help Lynparza reach a broader population of patients with ovarian cancer. More than two years after a positive top-line readout, AstraZeneca has to face the reality that a lack of an overall survival (OS) showing for its combo of Imfinzi and Lynparza could prohibit a broader FDA approval in ovarian cancer.At the final analysis of the phase 3 Duo-O trial, AZ’s addition of Imfinzi and Merck & Co.-partnered Lynparza to chemotherapy and bevacizumab failed to prove it can extend lives in newly diagnosed patients with advanced ovarian cancer without tumor BRCA mutations, according to results presented at the 2025 European Society for Medical Oncology (ESMO) Congress in Berlin.The proposed regimen would add Imfinzi to chemo and bevacizumab during induction and then add Imfinzi and Lynparza to bevacizumab during the maintenance phase of treatment. With a median follow-up of about 56 months, the new combo numerically reduced the risk of death versus chemo-bevacizumab by 8%, which didn’t meet the statistical significance bar.The regimen’s poor OS result comes in stark contrast to its 38% improvement in progression-free survival (PFS), the trial's primary endpoint.A separate trial arm testing Imfinzi—but without Lynparza—performed worse than the combo, with a nonsignificant 3% OS advantage and a 16% improvement on PFS.AZ designed the trial hoping Imfinzi could help Lynparza reach a broader population of patients with ovarian cancer. Lynparza is only approved for the first-line maintenance treatment of ovarian cancer, either by itself in BRCA-mutated disease or with bevacizumab in homologous recombination deficiency (HRD)-positive disease. BRCA mutations are a major type of HRD.When Duo-O initially reported positive results on its primary endpoint, PFS, for the Lynparza-Imfinzi combo in 2023, AZ said it would need longer-term data to convince the FDA. An OS benefit is important for this setting, Susan Galbraith, Ph.D., AZ’s head of oncology R&D, said in an interview with Fierce Pharma. The lack of it “represents a challenge from a regulatory perspective, in this context, given the other choices that patients have at this point,” she said.Getting into the other half of the ovarian cancer field marked by HRD-negative tumors has proven challenging for PARP inhibitors like Lynparza.In June, the FDA limited the previously all-inclusive first-line maintenance ovarian cancer label for GSK’s Zejula to only cover HRD-positive disease. The agency made the decision after receiving the final OS analysis of the phase 3 Prima trial. While the study originally supported a broad label for Zejula, the FDA’s analysis suggested a potential trend toward harm in OS in the HRD-negative/not determined subgroup. Combined with a very small PFS improvement, plus several long-term toxicities, the FDA determined that the overall risk-benefit analysis for Zejula was not favorable in the HRD-negative population. In the Duo-O trial, the Imfinzi-Lynparza arm’s performance was slightly better in the non-BRCA HRD-positive subgroup, with a nonsignificant 20% improvement on OS and 51% advantage on PFS. But, as Galbraith noted, these are only hypothesis-generating analyses that don’t confirm efficacy.Still, the subgroup takeaways may give AZ a chance to “think about opportunities for other agents within the portfolio in these different settings,” she said.In AZ’s pipeline, there’s a folate receptor α (FRα)-targeted antibody-drug conjugate, coded AZD5335, that the British pharma is developing for ovarian cancer. The company reported first-in-human data for the agent Saturday at ESMO.

A transaction with RF Acquisition Corp II, which is due to close by the second quarter of 2026, gives Nanyang Biologics an equity value of $1.5 billion.\n An artificial-intelligence-driven drug discovery platform will receive a step up onto the Nasdaq via a reverse merger with a blank check company.Nanyang Biologics has been snapped up by Nasdaq-listed RF Acquisition Corp II, a special purpose acquisition company set up to find a suitable business in the Asian technology, AI or biotech sectors. In Nanyang, RFA has found a target that hits two—if not three—of those goals.Both RFA and NYB are based in Singapore, with the drug development company having set up a laboratory with Nanyang Technological University Singapore in order to develop an AI engine that will explore “the therapeutic potential of natural compounds to accelerate discovery across small molecules, biologics, and other large-molecule modalities,” according to an Oct. 2 release.The transaction, which is due to close by the second quarter of 2026, gives NYB an equity value of $1.5 billion.The company is aiming to create the “world\'s largest AI-curated natural compound libraries” and has secured support from the likes of Hewlett Packard Enterprise and data center provider Equinix.The drug developer’s pipeline of five preclinical molecules is led by NYH002, an ILF2-targeting asset that is being aimed at HRD-positive, chemo-resistant cancers.“By inducing synthetic lethality in HRD cancers, including BRCA-mutated and BRCAness tumors, we believe NB-A002 offers a superior alternative to PARP inhibitors with potential treatments across ovarian, breast, lung and other solid tumors,” NYB explained in the release.The molecules in the pipeline are all derived from tropical medicinal plants and also include NB-C201 for cardiovascular health and NB-C301 for mental health conditions. “Our proprietary DTIGN platform has mapped vast numbers of natural compounds and identified promising candidates, strengthening the feasibility of a new era of drug development,” NYB’s group chairman Roland Ong, Ph.D., said in a statement.“On top of that, our lead molecule NB-A002 introduces a novel approach to treating solid tumors, and we are honored to have received a clinical trial invitation from the head of oncology at one of the world\'s top universities,” Ong said.RF CEO Tse Meng Ng praised NYB for having “built a truly differentiated AI-powered drug discovery platform, combining world-class research capabilities with a strong pipeline of therapeutic candidates.”“We believe NYB is uniquely positioned to transform the future of medicine by addressing areas of high unmet medical need,” the SPAC’s CEO added.SPAC deals have become a rare sight in recent years, despite a number of high-profile announcements as recently as 2022. So far, 2025 has brought a few other examples of biotechs planning to use this route to go public, including German antibody biotech Veraxa and BridgeBio Oncology Therapeutics.