AC-101

Plus, news about Accro Bioscience, Hansa Biopharma, Shanghai Best-Link Bioscience and UCB. Full-Life Technologies gets $150M: The radiotherapy company has raised $110 million in a Series D round and another $40 million in debt financing. The company plans to use the Series D to fund its clinical stage assets, including its 225Ac-FL-020 for prostate cancer and its 225Ac-FL-261 candidate for multiple solid tumor indications.  Full-Life will also use the funds to start manufacturing the radioisotope actinium-225 at its factory in Belgium. The financing was led by Vivo Capital, along with SK, Chengwei Capital, HSG, Junson Capital, Yunion, Plaisance, Sky9 Capital, TSG Capital and others. — Anna Brown Quince finds a new life: Public biotech Quince Therapeutics reverse-merged with private drug developer Orphai Therapeutics in a deal that includes $115 million upfront and up to $72 million additionally down the road. Well-known life sciences investors took part, including Cormorant, Foresite and others. In conjunction with the deal, Orphai disclosed Phase 2a data for its inhaled version of rapamycin in pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. Quince had failed a Phase 3 in January, prompting the company to look for alternatives. — Kyle LaHucik China biotech gets $50M: Suzhou-based Accro Bioscience secured a Series C from OrbiMed, TCG Crossover, Lilly Asia Ventures, Shenzhen Capital Group and others. The company is working on regulated cell death and will use the money for a Phase 2b of its RIPK2 inhibitor, dubbed AC-101, in ulcerative colitis. Another biotech in that target space, Massachusetts and Michigan startup Odyssey Therapeutics, raised a $279 million IPO earlier this month. — Kyle LaHucik SERB Pharmaceuticals buys rights to Hansa Biopharma drug: The Belgian specialty pharma company will acquire the development and commercialization rights to Hansa’s Idefirix for €115 million ($127 million). The rights pertain to the EU, UK, Switzerland, Norway, Liechtenstein, Iceland and the Middle East and North Africa region. The drug still needs to be filed with the European Medicines Agency, and Hansa will support SERB with that process. — Kyle LaHucik Best-Link Bioscience raises Series C: The Shanghai biotech collected a 400 million yuan ($58 million) funding round just five months after disclosing a 200 million yuan ($29 million) Series B. The five-year-old biotech is in Phase 2a in the US, China and Australia with a treatment candidate called BL0020 for small cell lung cancer. It also has a protein degrader named BL0175 in Phase 1 for breast cancer. — Kyle LaHucik UCB’s Bimzelx beats Skyrizi: The drugmaker said its medicine had superior joint outcomes at week 16 compared to AbbVie’s Skyrizi in adults with psoriatic arthritis. UCB said it was the first approved biologic to show statistically significant superiority on that measurement in a head-to-head trial in that indication. The data come after UCB made two acquisition announcements in recent weeks. — Kyle LaHucik

TrumpRx welcomes 600 generic medicines BioMarin's $270M Inozyme bet faltersChinese firms Full-Life, Accro raise fresh capitalHansa out-licenses Idefirix in key ex-US marketsTrumpRx welcomes 600 generic medicines More than 600 generic products were added to the Trump administration's direct-to-consumer drug purchasing portal on Monday. The TrumpRx site initially launched in February with cash-pay coupons for about 40 brand-name drugs, many of which have cheaper generic alternatives.Now, the government-run website appears to segment branded products under a section labelled "Presidential deals," while the generic drugs — including cholesterol treatment atorvastatin, the blood thinner clopidogrel, blood pressure medication lisinopril and diabetes drug metformin — are listed under a "Standard prices" tab. By clicking on a generic product, patients can compare out-of-pocket costs at their local pharmacy with delivery options from private pharmacy companies like Mark Cuban's Cost Plus Drugs, Amazon Pharmacy and GoodRx. -Elizabeth EatonBioMarin's $270M Inozyme bet faltersA pivotal Phase III study of BioMarin Pharmaceutical's enzyme replacement therapy BMN 401 in children aged 1-12 with the rare genetic condition ENPP1 deficiency met only one of two co-primary endpoints. "We are actively evaluating these data to determine the appropriate next steps," said Greg Friberg, the firm's chief R&D officer.The ENERGY 3 trial showed that treatment with BMN 401 resulted in statistically significant increases in plasma inorganic pyrophosphate through week 52 compared to conventional therapy. However, the other main goal of improvement in Radiographic Global Impression of Change scores was missed, while there were no positive trends for secondary endpoints, including Rickets Severity Score and growth Z-score.BioMarin gained BMN 401 via last year's $270-million purchase of Inozyme Pharma, with the therapy at the centre of the deal.-Matt DennisChinese firms Full-Life, Accro raise fresh capitalTwo Chinese companies, radiotherapeutics firm Full-Life Technologies and clinical-stage biotech Accro Bioscience, respectively closed a $110-million series D and a $50-million series C.Full-Life will deploy the fresh funds to advance [225Ac]-FL-020, a radioligand therapy for prostate cancer, and [225Ac]-FL-261, a candidate targeting multiple solid tumours. The proceeds will also support 225Ac manufacturing at the company's Belgian facility to secure isotope supply ahead of clinical trials.The latest financing — led by Vivo Capital and joined by SK Biopharmaceuticals, Chengwei Capital, HSG, Junson Capital, Yunion, Plaisance, Sky9 Capital and TSG Capital — brings Full-Life's total funding since its 2021 inception to nearly $350 million. Meanwhile, Accro Bioscience's fundraise will help fund a Phase IIb trial of AC-101, a selective RIPK2 inhibitor targeting the NOD signalling pathway in moderate-to-severe ulcerative colitis. AC-101 previously cleared a Phase Ib/IIa proof-of-concept trial in Chinese patients. Accro's C round was fronted by OrbiMed, with participation from TCG Crossover, LAV, Cenova Capital, and existing backers Shenzhen Capital Group and Oriza Holdings.-Pavan KamatHansa out-licenses Idefirix in key ex-US marketsHansa Biopharma granted SERB Pharmaceuticals an exclusive licence to develop and commercialise Idefirix (imlifidase) across the EU, UK, Switzerland, Norway, Liechtenstein, Iceland, and Middle East and North Africa (MENA) regions in a deal worth up to €115 million ($134 million).Idefirix is conditionally approved in the EU for highly sensitised kidney transplant recipients; in the US, where it's supported by a separate pivotal trial, the desensitisation therapy is currently under FDA review with a target action date of December 19.Hansa will receive €110 million upfront and a further €5 million upon EMA acceptance of the full approval filing for Idefirix. SERB will take charge of an ongoing paediatric trial and long-term follow-up studies.-Pavan Kamat