Researchers from Nuvalent Inc. reported preclinical data of NVL-655, a next-generation anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitors with IC50 of 0.9 and 1.8 nM against ALK wild-type (WT) and ALK G1202R/L1196M, respectively.
The U.S. FDA approved Janssen Biotech Inc.’s Rybrevant (amivantamab-vmjw) plus a new oral tyrosine kinase inhibitor called Lazcluze (lazertinib) as a first-line combination treatment to treat select non-small-cell lung cancers.
South Korea’s HLB Co. Ltd. saw its stock (KOSDAQ:028300) drop nearly 30% on May 17 as CEO Jin Yang-gon announced the U.S. FDA’s complete response letter (CRL) to its NDA seeking approval of its rivoceranib and camrelizumab (Airtuika, Jiangsu Hengrui Pharmaceutical Co. Ltd.) combo for liver cancer.
South Korea’s HLB Co. Ltd. saw its stock (KOSDAQ:028300) drop nearly 30% on May 17 as CEO Jin Yang-gon announced the U.S. FDA’s complete response letter (CRL) to its NDA seeking approval of its rivoceranib and camrelizumab (Airtuika, Jiangsu Hengrui Pharmaceutical Co. Ltd.) combo for liver cancer.
“This is a tough business. It’s never a straight line from start to success.” Those words, from Exelixis Inc. CEO Michael Morrissey, during a presentation at the J.P. Morgan Healthcare Conference (JPM), could easily sum up any aspect of the biopharma industry. But with more biopharma firms than ever having reached commercial status, along with the introduction of new therapeutic modalities into the health care market, many are finding the toughest part comes after regulatory approval, whether it’s navigating a competitive landscape, getting payers and physicians on board, or satisfying regulators’ stringent postmarketing requirements. As industry players and observers head home after a busy week in San Francisco, BioWorld offers a brief glimpse at a few firms taking on those post-approval challenges in 2024.
Keiferx LLC has expanded its exclusive licensing agreement with Georgetown University to advance the development of novel tyrosine kinase inhibitor (TKI) chemical entities for the treatment of multiple disease indications.
Allorion Therapeutics Inc. could receive $40 million in up-front and near-term payments from Astrazeneca plc in the companies’ exclusive option and global license deal. The two plan to develop and commercialize an L858R mutated allosteric inhibitor for treating EGFR inhibitor-mutant non-small-cell lung cancer.
Current standard of care treatment for non-small-cell lung cancer (NSCLC) tumors harboring mutations of the epidermal growth factor receptor (EGFR) gene includes a wide variety of tyrosine kinase inhibitors (TKIs). There are, however, some types of NSCLC tumors, such as the ones with EGFR exon 20 insertion mutations, that have a much-limited margin of therapeutic intervention. Researchers from Suzhou Puhe Pharmaceutical Technology Co. Ltd. have reported the identification and early evaluation of a small-molecule third-generation TKI of EGFR, YK-029A, being developed as an anticancer agent.
Research at Blossomhill Therapeutics Inc. has led to the discovery of new macrocyclic compounds acting as tyrosine kinase inhibitors and reported to be useful for the treatment of autoimmune disease.
