Challenges to ongoing efforts to provide effective aid for hospitalized patients with COVID-19 continued April 8, with two new trial failures reported. A phase III trial testing the Olumiant (baricitinib) vs. placebo, both on top of standard of care, missed its primary endpoint of progression to non-invasive ventilation, invasive mechanical ventilation or death, said drugmakers Eli Lilly and Co. and Incyte Corp. A phase II trial testing Beigene Ltd.'s Brukinsa (zanubrutinib) vs. placebo in patients hospitalized with respiratory symptoms of COVID-19 also fell short, missing its co-primary efficacy endpoints of respiratory failure-free survival or reduction in days on oxygen.
Shoreline Biosciences Inc., a San Diego-based company developing allogenic natural killer and macrophage cellular therapies for cancer and other diseases, has raised $43 million in a financing led by Boxer Capital.
Plans for a late-stage test of Valneva SE's COVID-19 vaccine candidate, clinical progress on a different vaccine from Novavax Inc. and advancement for two midstage therapies targeting the virus made clear April 6 that industry efforts to battle the pandemic remain in high gear.
Mineralys Therapeutics Inc., a Philadelphia-based company developing an aldosterone synthase inhibitor in-licensed from Mitsubishi Tanabe Pharma Corp. (MTPC), has raised $40 million in series A funding to complete a phase II proof-of-concept study in hypertension for the candidate, known as MLS-101.
Janssen Pharmaceuticals Inc. has agreed to pay up to $780 million in up-front, milestone payments and R&D funding for exclusive rights to antiviral conjugates to be developed by Cidara Therapeutics Inc. for the prevention and treatment of seasonal and pandemic influenza.
A new FDA approval for United Therapeutics Corp.'s prostacyclin analogue, Tyvaso (treprostinil), has expanded its label to include the treatment of pulmonary hypertension associated with interstitial lung disease to improve exercise ability. The regulatory win could double the number of patients taking the medicine by the end of 2022, barring any COVID-19-related delay, said company President and CEO Michael Benkowitz.
Marking its second acquisition this year after snapping up cancer-focused Five Prime Therapeutics Inc., Amgen Inc. is adding to its inflammatory disease portfolio through the purchase of Seattle-based Rodeo Therapeutics Corp. The deal includes $55 million up front for the private company's shareholders, plus contingent milestone payments worth up to an additional $666 million. Rodeo's lead preclinical program targets 15-prostaglandin dehydrogenase to increase tissue levels of prostaglandin PGE2.
Pyxis Oncology Inc., a company building a portfolio of antibody-drug conjugates (ADCs) and immunotherapies for cancer, has closed a $152 million series B financing co-led by Arix Bioscience and RTW Investments LP. The fresh funds will help the company advance multiple ADC candidates in-licensed from Pfizer Inc. and Legochem Biosciences Inc. as well as its discovery-stage pipeline, CEO Lara Sullivan told BioWorld. The ADCs are expected to move to the clinic in 2022.
Bridgene Biosciences Inc., a company using an in-house chemoproteomic platform to find and develop small molecules for hard-to-drug targets, has signed its first major pharma partnership with Takeda Pharmaceutical Co. Ltd. for an undisclosed up-front payment.
Shares of Humanigen Inc. (NASDAQ:HGEN) leapt 54.5% to $21.61 March 29 on news that its monoclonal antibody, lenzilumab, improved the relative likelihood of survival without mechanical ventilation in hospitalized patients with COVID-19, setting the company up to submit an application for emergency use authorization (EUA) in the U.S. "as soon as possible," it said. Separately, a combination of two monoclonal antibodies, the Eli Lilly and Co.-Abcellera Biologics Inc.-developed therapy bamlanivimab and the Vir Biotechnology Inc.-Glaxosmithkline plc candidate VIR-7831, demonstrated a 70% relative reduction in persistently high SARS-CoV-2 viral load at day seven compared to placebo for low-risk adult patients with mild to moderate COVID-19, the companies reported.
