Alentis Therapeutics SA has closed a $105 million series C round which will fund simultaneous phase II and phase Ib trials of anti-Claudin-1 antibodies in the treatment of organ fibrosis and phase I development in fibrosis-associated cancers. At the same time, the company will extend the reach of its Claudin-1 biology into antibody-drug conjugates and bispecific constructs, to further exploit the role of the transmembrane protein in maintaining cellular integrity and controlling cell-to-cell signaling. The new funding follows positive results from a single ascending-dose phase I study of ALE.F02, which is in development for the treatment of advanced liver, lung and kidney fibrosis.

Aer Therapeutics’ $36M series A propels mucus-busting AER-01 to clinic for COPD

With no treatments available to effectively clear mucus, Aer Therapeutics Inc. secured $36 million in a series A financing to advance its novel inhaled small-molecule mucolytic treatment, AER-01, bringing a new sense of optimism for about 5 million Americans, a subset of those with chronic obstructive pulmonary disease (COPD). The technology could be expanded to a host of other lung diseases, too, including asthma and cystic fibrosis. “At the end of the day, mucus pathology is a big problem in most chronic severe [lung] diseases,” said John Fahy, founder of Aer and a scientist at the University of California, San Francisco. “Patients with respiratory failure, like end-stage COVID patients, often have mucus that binds up their lungs … With this pipeline-in-a-product idea, one could imagine downstream that this drug could be deployed for patients with any form of lung disease in which their imaging shows they have mucus.”

Newco news: Calida Therapeutics raises $2.17M to advance thrombo-inflammatory research

With the backing of €2 million (US$2.17 million) in seed funding from venture capital company Adbio partners, French biotech Calida Therapeutics hopes that drawing on some U.S. academic research into thrombo-inflammatory disorders will enable it to develop a series of monoclonal antibodies. In a nutshell, the three-month-old firm’s scientific approach is to disrupt the molecular link between thrombosis and inflammation by preventing the “crosstalk” between platelets and myeloid cells, thus abolishing a chain reaction which can lead to tissue damage and life-threatening events.

Entasis to face FDA adcom’s questions about hospital infections therapy

With a May 29 PDUFA date nearing, the U.S. FDA’s Antimicrobial Drugs Advisory Committee meets April 17 to discuss the merits of Entasis Therapeutics Inc.’s hospital-acquired infection therapy. Injectable Sul-Dur (sulbactam-durlobactam), a combination of beta-lactam antibiotic and broad-spectrum beta-lactamase inhibitor for treating infections caused by Acinetobacter baumannii-calcoaceticus complex, has a priority NDA. The U.S. FDA accepted the priority NDA for review in December and set the PDUFA date. In a pivotal phase III study, sulbactam-durlobactam met the primary efficacy endpoint of noninferiority for 28-day all-cause mortality in the primary analysis population. Innoviva Inc., of Burlingame, Calif., acquired Entasis on July 11, 2022.

Junshi Bioscience’s PARP inhibitor senaparib meets endpoint in phase III ovarian cancer trial

Junshi Biosciences Co. Ltd.’s PARP inhibitor, senaparib (JS-109/IMP4297), met the primary endpoint of progression-free survival in a phase III ovarian cancer study, according to a prespecified interim analysis. The randomized, double-blind, placebo-controlled, multicenter phase III Flames study investigated the PARP inhibitor as a maintenance treatment following first-line platinum-based chemotherapy in patients with stage III/IV ovarian cancer, fallopian tube cancer or primary peritoneal cancer who have achieved a complete response or partial response. “We will collaborate with our partner, Impact Therapeutics, to engage in communication with regulatory agencies and look forward to expanding our commercial cancer drug portfolio to provide more effective treatment options at a lower cost for patients with advanced ovarian cancer,” said Jianjun Zou, Junshi Biosciences’ president for global R&D.

Specialised Therapeutics obtains rights to market PD-1 inhibitor from CTTQ-Akeso in $73M deal

Specialised Therapeutics Asia Pte Ltd. has inked a $73 million deal with CTTQ-Akeso Biomed Tech. Co. Ltd. to buy the rights to commercialize the latter’s anti-PD-1 antibody in Australia and Southeast Asia. CTTQ-Akeso was jointly launched by Akeso Inc. and Chia Tai Tianqing Pharmaceutical Group Co. Ltd. to focus on the R&D and commercialization of Anniko (penpulimab). With the deal, Singapore-based Specialised obtained exclusive commercial rights to the drug in Australia, New Zealand and Papua New Guinea, as well as 11 countries in Southeast Asia, including Singapore and Malaysia. It will be responsible for all marketing, regulatory and distribution activities in these regions. CTTQ-Akeso is eligible to receive 15% royalties based on the net sales of the drug in authorized territories.

Mifepristone challenge heads to US Supreme Court

Danco Laboratories LLC’s abortion pill, Mifeprex (mifepristone), and a generic will remain on the U.S. market with tighter restrictions while a challenge to the drug’s 2000 accelerated approval and the FDA’s subsequent loosening of prescribing requirements plays out on appeal. That is unless the Supreme Court says otherwise. Citing the statute of limitations, the U.S. Court of Appeals for the Fifth Circuit late yesterday granted, in part, an emergency motion from the FDA and Department of Health and Human Services to extend a hold on last week’s nationwide order, issued by a federal judge in Texas, that would have forced the removal of the drug from the market as early as next week. However, the appellate court’s stay only applies to the approval. It leaves standing the lower court’s hold on FDA actions since 2016, which included allowing mail-order prescriptions. That part of the Fifth Circuit decision has the U.S. Department of Justice seeking emergency relief from the Supreme Court.

Also in the news

Aeglea, Akeso, Altamira, Atea, Avalyn, Biomea Fusion, Cellectis, Chinook, Covis, Dyadic, Editas, Eiger, Essa, Geneos, Ginkgo Bioworks, Imaginab, Immunebridge, Impel, Insilico, Janssen, Jasper, Junshi, Kala, Kineta, Leap, Merck, Microbiotica, Mirum, MSD, Mymd, Novaliq, Oncolyze, ONL, Panbela, Poseida, Pyramid, Regulus, Scineuro, Sirnaomics, Specialised, Tiziana, Transgene, Verrica, Xeneticw