On November 14, 2024 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and LaNova Medicines Ltd. (LaNova), a privately held clinical-stage biotechnology company, reported that Merck has entered into an exclusive global license to develop, manufacture and commercialize LM-299, a novel investigational PD-1/VEGF bispecific antibody from LaNova (Press release, Merck & Co, NOV 14, 2024, View Source [SID1234648405]).
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"At Merck, we continue to assemble a strong and diversified oncology pipeline spanning differentiated mechanisms and multiple modalities," said Dr. Dean Y. Li, president, Merck Research Laboratories. "This agreement adds to Merck’s growing oncology pipeline and we look forward to advancing LM-299 with speed and rigor for patients in need."
Under the agreement, LaNova has granted Merck an exclusive global license to develop, manufacture and commercialize LM-299. LaNova will receive an upfront payment of $588 million. LaNova is also eligible to receive up to $2.7 billion in milestone payments associated with the technology transfer, development, regulatory approval and commercialization of LM-299 across multiple indications.
"This agreement with Merck is a strong testament to the hard work of LaNova’s talented team of scientists who created LM-299," said Dr. Crystal Qin, founder, chairwoman and chief executive officer, LaNova. "Through internal R&D innovation and strategic external partnerships, LaNova is committed to advancing its pipeline to benefit patients worldwide."
Closing of the proposed transaction is subject to approval under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions. The transaction is expected to close in the fourth quarter of 2024. Merck expects to record a pre-tax charge relating to the $588 million payment due upon closing to be included in GAAP and non-GAAP results in the quarter that the transaction closes, and the EPS impact of such charge will be disclosed at that time.
About LM-299
LM-299 is an investigational bispecific antibody targeting both programmed cell death protein-1 (PD-1) and vascular endothelial growth factor (VEGF). This innovative therapeutic approach is designed to inhibit both PD-1/PD-L1 and VEGF/VEGFR receptor signaling pathways releasing a key immune checkpoint while also inhibiting the production of new blood vessels (angiogenesis). LM-299 has a differentiated molecular design, comprising an anti-VEGF antibody linked to two C-terminal single domain anti-PD-1 antibodies. A Phase 1 clinical trial for LM-299 is currently enrolling patients in China.