An oral Bruton’s tyrosine kinase (BTK) inhibitor that Sanofi SA acquired in 2020 through its $3.68 billion buyout of Principia Biopharma Inc. is headed toward regulatory filings in the U.S and EU by the end of the year, following phase III data in immune thrombocytopenia.
There was a time not that long ago when Merck & Co. Inc.’s Keytruda (pembrolizumab), with its multiple cancer indications, was seen as the heir apparent to Humira’s title of the biggest blockbuster drug. Not anymore. That title now belongs to Novo Nordisk A/S’ semaglutide, approved as Ozempic in 2017 to treat diabetes and as Wegovy in 2021 to help with weight loss.
Samsung Bioepis Co. Ltd. and Celltrion Inc. are making headway in Europe and U.S. with respective follow-on biologic products, with Samsung Bioepis the latest to gain EMA approval for Pyzchiva, a Stelara (ustekinumab, Janssen Pharmaceuticals Inc.) biosimilar, on April 23.
Having addressed the manufacturing issues that resulted in a few complete response letters, Alvotech Holdings SA and Teva Pharmaceutical Industries Ltd.’s biosimilars partnership is now on a roll, with the U.S. FDA approving the team’s second biosimilar, Selarsdi, less than two months after approving the first one, Simlandi, as an adalimumab interchangeable.
With an IND filing in systemic lupus erythematosus expected during the third quarter of 2024, Cullinan Therapeutics Inc. changed its name from Cullinan Oncology Inc. and detailed its plans to target autoimmune diseases with CLN-978, a CD19xCD3 T-cell engager.
“Hot and cold tumors may need different types of immunotherapy,” Jay Berzofsky told the audience as the American Association for Cancer Research’s (AACR) 2024 annual meeting kicked off this weekend. In an educational session on cancer vaccines, Berzofsky, who is head of the National Cancer Institute’s Molecular Immunogenetics and Vaccine Research section, explained that when immunotherapy fails in hot tumors, it fails despite the existence of an immune response, due to an immunosuppressive microenvironment.
SARS-CoV-2 could proliferate in the lungs causing severe COVID-19 through a special type of immune cell. A group of scientists from Stanford University observed how this coronavirus infected interstitial macrophages through a CD209 receptor, triggering the inflammatory response observed in hospitalized patients.
Following decisions in 2023 to back away from its lead neurological therapies and conserve cash, Eliem Therapeutics Inc. found a vote of investor confidence and a new direction through its acquisition of privately held Tenet Medicines Inc. and its anti-CD19 antibody for autoimmune disease.
The timing is ripe for a robust biosimilar market in China, given the rapid increase of novel biologics approved to treat cancer and inflammatory diseases in the country over the past decade and the looming patent cliffs for several established biologics. As of December, the NMPA had approved more than 20 biosimilars that were developed in China. Most of those referenced just two biologics – Roche AG’s cancer drug Avastin (bevacizumab) and Abbvie Inc.’s immunology drug Humira (adalimumab). In 2022, the oncology and immunology biosimilar market in China garnered sales of about $2 billion, according to Clarivate estimates. To reach their full potential in China though, biosimilars must win over prescribers and patients.
After reviewing data from its phase II trial of farnesoid X receptor agonist ASC-42 in primary biliary cholangitis, Ascletis Pharma Inc. said it was quitting development of the molecule in all indications.