In its first significant partnering deal since being founded in 2020, Medilink Therapeutics Co. Ltd. licensed exclusive global rights to an antibody-drug conjugate (ADC) targeting HER3 to Biontech SE in exchange for an up-front payment of $70 million, with the possibility for additional payments tied to development, regulatory and commercial milestones exceeding $1 billion. Medilink retains rights in mainland China, Hong Kong Special Administrative Region and Macau Special Administrative Region.
A recent Jiangsu Hansoh Pharmaceutical Group Co. Ltd. and Shanghai Hansoh Biomedical Co. Ltd. patent describes nitrogen-containing heterocyclic derivatives acting as EGFR (del19 mutant) inhibitors and reported to be useful for the treatment of non-small-cell lung cancer.
Just as Wall Street had begun mulling the possible fallout of the regulatory vote against full U.S. FDA clearance for Amgen Inc.’s KRAS G12C therapy for non-small-cell lung cancer, a new – albeit not entirely unexpected – development cropped up in the space. Mirati Therapeutics Inc. disclosed Oct. 9 that Bristol Myers Squibb Co. (BMS) is offering to take over the firm in a deal that could be worth as much as $5.8 billion, historically one of the larger takeovers for 2023.
Radiopharm Theranostics Ltd. has been granted human research ethics committee (HREC) approval to commence a first-in-human phase I study in Australia for RAD-204, the company’s radiotherapeutic for patients with PD-L1-positive non-small-cell lung cancer (NSCLC).
The dark cloud of what the U.S. FDA called potential “systemic bias” rained on Amgen Inc.’s bid for full approval of Lumakras (sotorasib), a KRAS-G12C inhibitor that was granted accelerated approval in May 2021 for locally advanced or metastatic non-small-cell lung cancer after at least one systemic therapy.
Bad news for Amgen Inc. could mean upside for Mirati Therapeutics Inc., though the meeting of the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) has yet to tell the tale regarding Lumakras (sotorasib), the former’s KRAS-G12C inhibitor.
Providing the right therapy at the right time has proven more difficult in the world of cancer than in other disease areas thanks to the variability in treatment response, but a new study hints that this problem may be at least partly solved for non-small cell lung cancer (NSCLC). A study presented at this year’s meeting of the American Society for Radiation Oncology (ASTRO) in San Diego shows that circulating tumor DNA (ctDNA) can provide therapeutic guidelines for oligometastatic forms of the disease, including when high-dose radiation therapy may or may not be indicated.
Ocean Biomedical Inc. has demonstrated the effectiveness of its anti-chitinase 3-like-1 (CHI3L1) antibody in suppressing and reversing tumor growth in studies of epidermal growth factor receptor (EGFR)-mutant non-small-cell lung cancer (NSCLC) cells.
Takeda Pharmaceutical Co. Ltd. said it will work with U.S. regulators on the market withdrawal of Exkivity (mobocertinib), only two years after the oral tyrosine kinase inhibitor gained the FDA’s accelerated approval for use in locally advanced or metastatic non-small-cell lung cancer patients with EGFR exon 20 insertion mutations whose disease has progressed after chemotherapy.
Upbeat phase III findings outweighed less encouraging late-stage trial news, as big pharma provided a mixed bag of cancer findings – with one data batch to form the basis of global approval bids, as Astrazeneca plc with Daiichi Sankyo Co. Ltd. unveiled interim results from a study called Tropion-Breast01. Targeting trophoblast cell surface antigen 2, datopotamab deruxtecan (dato) hit the mark in progression-free survival for patients with hormone receptor-positive, HER2-low or negative breast cancer in the study called Tropion-Breast01.