The U.S. government on June 17 announced plans for a multi-faceted $3.2 billion investment in the development and manufacture of new antivirals for preventing serious COVID-19 illness and death.
Just days after Hifibio Therapeutics Inc. closed a $75 million series D financing, Fibrogen Inc. has agreed to pay the antibody specialist $25 million up front and as much as $1.1 billion in milestones for rights to multiple preclinical programs for autoimmune diseases and cancer. The deal includes exclusive rights to Galectin-9 programs, in which the lead asset is expected to enter clinical development in the first quarter of 2023, and options to license all assets in Hifibio's CXCR5 and CCR8 programs.
New phase III data on Celltrion Inc.'s COVID-19 therapy, regdanvimab, showed it reduced the risk of hospitalization or death related to the disease for high-risk patients to 3.1% vs. 11.1% for placebo by day 28 of the study. The treatment also proved beneficial to participants across all risk categories, reducing their risk of hospitalization or death to 2.4% vs. 8% for placebo at the same time point.
Umoja Biopharma Inc. has raised $210 million in a series B financing that will help it advance a pipeline of in vivo engineered CAR T-cell immunotherapies to the clinic, as well as build its internal manufacturing capabilities, it said. The Seattle-based company is focused on the treatment of solid tumors and hematologic malignancies. Softbank Vision Fund 2 and Cormorant Asset Management led the financing, the third largest series B round this year, according to BioWorld data. It follows a $53 million series A round the company announced in November 2020.
New phase III data on Celltrion Inc.'s COVID-19 therapy, regdanvimab, showed it reduced the risk of hospitalization or death related to the disease for high-risk patients to 3.1% vs. 11.1% for placebo by day 28 of the study. The treatment also proved beneficial to participants across all risk categories, reducing their risk of hospitalization or death to 2.4% vs. 8% for placebo at the same time point.
New phase III data on Novan Inc.'s molluscum contagiosum candidate showed it cleared all lesions associated with the highly contagious viral skin infection in 32.4% of trial participants who received it vs. 19.7% provided a placebo. Paired with what company President and CEO Paula Brown Stafford called "strong safety," the result gives the company's team confidence as it moves toward an NDA submission for the topical antiviral, SB-206, she said.
Phase III stakes are always high. But for Merck & Co. Inc., results of a late-stage test of its SARS-CoV-2 antiviral, molnupiravir, stand to determine not just the fate of a desired emergency use authorization (EUA), but also a $1.2 billion purchase agreement with the U.S. government pending the EUA. The RNA polymerase inhibitor, invented at Emory University and developed with Ridgeback Biotherapeutics LP, is being evaluated in a phase III study for the treatment of non-hospitalized patients with mild to moderate COVID-19. An earlier study found it unlikely to deliver clinical benefit for hospitalized patients.
Following years of testing against a lengthy roster of viral foes, Chimerix Inc.'s Tembexa (brincidofovir) has finally won FDA approval as a medical countermeasure against smallpox.
Shares of Cullinan Oncology Inc. (NASDAQ:CGEM) rose 11.3% to close at $33.11 on June 4 as an update on its EGFR inhibitor, CLN-081, suggested it may prove competitive with Johnson & Johnson's recently approved treatment, Rybrevant (amivantamab), for adults with non-small-cell lung cancer (NSCLC) whose tumors bear EGFR exon 20 insertion mutations.
Following a priority review, Scynexis Inc.'s oral antifungal, Brexafemme (ibrexafungerp), has won FDA approval for the treatment of vaginal yeast infections, also known as vulvovaginal candidiasis. The one-day oral treatment, which kills a broad range of Candida species, including azole-resistant strains, represents the first approved drug in a new antifungal class in more than 20 years as well as being Scynexis’ first commercial product.
