Having failed in their efforts to get the U.S. NIH to march in on Xtandi’s patents under the Bayh-Dole Act because of price, Knowledge Ecology International and two other advocacy groups are now asking the Centers for Medicare & Medicaid Services (CMS) to do what the NIH refused to do. But rather than pressing for a march-in, which can be a lengthy process, the groups are pushing for CMS to use other statutory tools to clear the way for Xtandi (enzalutamide) generics to launch in the U.S. before Astellas Pharma Inc.’s three remaining patents for the prostate cancer drug expire in 2026 and 2027.

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.

Exact Sciences Corp., Seekin Inc. and Serum Detect Inc. presented encouraging results for the field of multicancer early detection at the American Association for Cancer Research annual meeting in San Diego April 6-10, but delays in coverage may slow further progress.

Researchers from Beigene (Beijing) Co. Ltd. have disclosed preclinical data for BGB-B167, a first-in-class immunoglobulin G (IgG)-based bispecific antibody (bsAb) targeting 4-1BB and CEA, being developed for the treatment of advanced or metastatic solid tumors.

Insilico Medicine Inc. recently discussed the generative artificial intelligence (AI)-powered design of ISM-6331, a novel, potent, selective and non-covalent pan-TEAD inhibitor that blocks TEAD palmitoylation to suppress YAP/TAZ-TEAD transcriptional activity and shows strong antitumor activity in a preclinical model of Hippo pathway-dysregulated cancers and other solid cancers were discussed.

The U.S. FDA has cleared Biocity Biopharma Co. Ltd.’s IND application for a phase I study of BC-2027. This is the company’s second first-in-class antibody-drug conjugate (ADC) to be approved for clinical trials, following BC-3195, which is directed against placental-cadherin (CDH3).

The discovery of a potent, selective and orally bioavailable serine/threonine-protein kinase PLK4 (STK18) inhibitor with synthetic lethality in TRIM7-amplified cancers was reported by Oric Pharmaceuticals Inc. at the ongoing AACR meeting in San Diego.