GT-005

Pictured: Novartis' head office in Canada/iStock, JHVEPhoto Novartis on Monday inked a technology export contract with Korean biotech company Chong Kun Dang Pharmaceutical for an early-stage HDAC6 Inhibitor, according to Korea Biomedical Review. Under the agreement, Novartis will make an upfront payment of $80 million and pledge up to nearly $1.23 billion more in development and regulatory milestones. The Korean biotech will also remain eligible to future sales-based royalties, as well as an ongoing technology fee depending on net sales. In return, Novartis will gain the exclusive global rights—except in Korea—to develop and commercialize the investigational small-molecule HDAC inhibitor CKD-510. The candidate in 2021 cleared a Phase I first-in-human study in 87 healthy volunteers and the Korean company appears to be positioning the drug candidate as a potential treatment for Charcot-Marie-Tooth disease, a rare and heritable disease that afflicts the nerves in the limbs. However, a Chong Kun Dang (CKD) official told Korea Biomedical Review that the indication for CKD-510 “has not been specified yet.” In preclinical studies, the candidate has also shown potential against atrial fibrillation, leading to an increase in acetylated alpha-tubulin and better action potential duration, among other key markers of the disease. “Efficacy for various diseases has been confirmed through many clinical and non-clinical studies, and indications will be confirmed through partners in the development process,” according to the company official. Novartis’ contract with CKD comes as the Swiss pharma sheds assets and franchises in an effort to streamline its business. Most notably, Novartis announced in September 2023 that its shareholders had approved the spin-off of the company’s generics and biosimilars division Sandoz—more than a year after plans of the spinout were finalized. The same month, Novartis turned its back on a 2021 partnership with BeiGene to develop the investigational anti-PD-1 antibody tislelizumab for esophageal squamous cell carcinoma and other oncology indications, including hepatocellular carcinoma and non-small cell lung cancer. Novartis in September also discontinued the development of the mid-stage gene therapy GT005, which was being trialed for geographic atrophy secondary to dry age-related macular degeneration. The candidate originally belonged to Gyroscope Therapeutics, which Novartis acquired in December 2021 for $800 million upfront. A month earlier, Novartis dropped another candidate—the anti-TGFβ antibody NIS793 that it was advancing in partnership with Xoma Corporation. Not all of Novartis’ partnerships end in a discontinued drug, however. Last week, the Swiss pharma reported that the endothelin A receptor antagonist atrasentan met its primary efficacy endpoint in the Phase III ALIGN study in IgA nephropathy. Novartis got access to atrasentan when it bought Chinook Therapeutics for $3.2 billion upfront in June 2023. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.