In a busy week for the antibody-drug conjugate (ADC) field, Merck signed a three-drug deal with Daiichi Sankyo but abandoned two preclinical assets from Kelun-Biotech. Meanwhile, AstraZeneca and Daiichi's TROP2 ADC disappointed in a lung cancer trial. And GSK in-licensed an ADC from China's Hansoh Pharma.
Merck & Co. agreed to pay Daiichi Sankyo $4 billion upfront to co-develop and co-commercialize three antibody-drug conjugates targeting HER3, B7-H3 and CDH6. The value of the deal could eventually swell to $22 billion. The various ADC partnerships allow the company to have a range of target and disease options, Merck’s vice president of early clinical development, Jane Healy, M.D., Ph.D., said in an interview.
Before the Daiichi tie-up, Merck already had certain rights to an antibody-drug conjugate (ADC) portfolio from China’s Kelun-Biotech. But, right after the Daiichi announcement, Kelun said Merck has returned its license to one preclinical ADC and passed on an option to in-license a second preclinical program. The two companies are still collaborating on three clinical-stage ADCs and several other preclinical candidates.
Meanwhile, the second antibody-drug conjugate (ADC) in Daiichi’s partnership with AstraZeneca posted some disappointing data at the European Society for Medical Oncology conference. The two firms’ Dato-Dxd was linked to a higher rate of the side effect interstitial lung disease compared with the chemotherapy docetaxel in patients with previously treated lung cancer. Besides, the TROP2 ADC only improved overall survival by a median of 0.7 months, although the readout was immature. While Daiichi went with Merck on three other ADC projects, AZ is developing its own internal ADC pipeline.
In another antibody-drug conjugate (ADC) deal, GSK ponied up $85 million in cash and committed up to $1.4 billion in biobucks for ex-China rights to Hansoh Pharma’s B7-H4-targeted ADC. Coded HS-20089, the drug is undergoing a phase 1 trial in China. B7-H4 is overexpressed in ovarian and endometrial cancers.
An injected version of Eisai and Biogen’s Leqembi worked as well as the intravenous version at removing the amyloid plaque in Alzheimer’s disease, preliminary data from a clinical trial showed. The subcutaneous formulation also showed a numerically higher rate of the brain side effect amyloid-related imaging abnormalities. But several analysts argued that the safety readout shouldn’t be too much of a concern.
Takeda has incorporated two recent setbacks in its books. The Japanese drugmaker just took about $770 million in impairment losses in the most recent quarter. These include $490 million from stem cell treatment Alofisel’s recent phase 3 flop in Crohn’s disease complex perianal fistulas and $190 million from the ongoing market withdrawal of lung cancer therapy Exkivity.
The FDA has slapped a Form 483 on a Samsung Biologics plant in Incheon, Korea. After a recent inspection of the facility, the FDA found problems related to data integrity and quality control, machine validation and facility maintenance. The agency also issued a two-observation Form 483 to a facility by Nectar Lifesciences in Himachal Pradesh, India.