Respiratory vaccines specialist Vicebio Ltd. is to be acquired by Sanofi SA in a $1.6 billion deal, of which $1.15 billion will be paid up front. The acquisition rests on an ongoing phase I trial of the lead asset, VXB-241, a bivalent vaccine that is intended to provide protection against both respiratory syncytial virus and metapneumovirus. The interim analysis of the study showed a favorable safety and tolerability profile in adults, ages 60 and older, and validated the underlying vaccine technology, which is applicable to a wide range of respiratory viruses.

Replimune says it didn’t see this CRL coming

There are a raft of problems the U.S. FDA wants resolved before Replimune Group Inc.’s BLA for RP1 (vusolimogene oderparepvec) with nivolumab to treat advanced melanoma goes any further, all of which the company said are a surprise. Replimune received a complete response letter stating the Ignyte study was neither adequate nor well controlled enough to show evidence of efficacy, the study couldn’t be properly interpreted because of the participants’ heterogeneity, and there is a problem with the confirmatory study’s design. The BLA had a July 22 PDUFA date. Replimune’s stock (NASDAQ:REPL) was taking it on the chin at midday, with shares losing 75% of their value, putting them at $3 each.

Avalyn secures $100M to advance inhaled versions of oral pulmonary fibrosis meds

Following up on the $175 million it raised in September 2023, Avalyn Pharma Inc. secured an additional $100 million in an oversubscribed phase D financing round to support development of its inhaled treatments for pulmonary fibrosis. The capital will be used to support development of Avalyn’s lead program, AP-01, an inhaled version of pirfenidone that’s sold as an oral pill by Genentech Inc. under the brand name Esbriet, and AP-02, an inhaled version of nintedanib, the active ingredient in the oral medication Ofev that’s sold by Boehringer Ingelheim GmbH, as well as a combination product called AP-03, which contains both active ingredients

Livzon’s IL-17A/F meets phase III endpoints in plaque psoriasis

Livzon Mabpharm Inc.’s anti-IL-17A/F monoclonal antibody, LZM-012, met the primary endpoint in a phase III trial in moderate to severe plaque psoriasis. Conducted at Fudan University’s Huashan Hospital, the phase III multicenter, randomized, double-blind, active-controlled (secukinumab) trial enrolled 926 patients with moderate to severe plaque psoriasis. The primary endpoint was the proportion of subjects achieving a Psoriasis Area and Severity Index (PASI) 100 response (showing a 100% response rate) at week 12. At 12 weeks, 49.5% of patients receiving 160 mg of injectable LZM-012 achieved a PASI 100 score compared to 40.2% for the secukinumab control group, indicating that LZM-012 was superior to secukinumab.

Coinfections and diversity paint the many shades of HIV cure

We all look different to HIV, a virus that destroys the immune system. The defensive cells record every interaction with foreign agents, infections from viruses and bacteria, but also with mechanisms occurring within the body, such as microbiome metabolism, the effects of aging, or the development of diseases. This record history leaves a unique mark on everyone that must be considered when searching for an HIV cure, because antigens contribute to the persistence of the reservoir and drive immune activation and inflammation. In the preconference session, “Impact of bacterial and fungal co-infections on the reservoir” at the IAS Conference on HIV Science 2025, held in Kigali, Rwanda July 13-17, 2025, scientists explained the interactions of different microorganisms with HIV.

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