Amid a big cancer push, Daiichi Sankyo lured Kite Pharma exec Ken Takeshita to lead its R&D work. China’s Clover Biopharmaceuticals secured $230 million in an oversubscribed series C to help advance its COVID-19 vaccine program and expand manufacturing capabilities. In several firsts for artificial-intelligence-based drug discovery, Insilico Medicine discovered a novel target for idiopathic pulmonary fibrosis, designed a new molecule and validated it in preclinical models in 18 months. And more.
1. Daiichi Sankyo poaches Kite’s research lead Takeshita from parent Gilead
Daiichi Sankyo, on its way to becoming a major cancer player, has poached Ken Takeshita, M.D., from Gilead Sciences’ cell therapy unit Kite Pharma to be its new global head of development and interim head of research, effective April 1. He takes over from Junichi Koga, Ph.D., who will retire after 12 years. The Japanese pharma has said it intends to develop seven new molecular entities from 2018 to 2025, with antibody-drug conjugates such as Enhertu the most prominent.
2. Clover raises $230M as COVID-19 vaccine nears phase 3, multivariant prospect gets going
Clover Biopharmaceuticals has raised $230 million in series C, led by GL Ventures and Temasek. The Chinese company will use the money to help fund development of its S-Trimer protein-based COVID-19 vaccine, SCB-2019, which is going to be paired with a Dynavax adjuvant in a global phase 2/3 in the first half of the year. It also plans to start work on a multivalent COVID-19 shot as well as to expand its R&D team and manufacturing capabilities.
Insilico Medicine’s artificial intelligence has uncovered a novel biological target to address idiopathic pulmonary fibrosis and then designed a novel molecule from scratch to treat the disease. The Hong Kong-headquartered company said it marks the first time the effectiveness of an AI-designed novel drug target and molecule has been validated by multiple human cell and animal model tests. It went through all those processes in less than 18 months at a total cost of about $2 million.
SK Bioscience plans to raise $900 million in its IPO on the Korea Exchange next month, CEO Ahn Jae-yong said during a press conference. The company plans to invest $360 million in domestic facilities and $90 million abroad. Another $180 million is earmarked for developing a pneumococcal COVID-19 vaccine with Sanofi. It’s also helping AstraZeneca make the British pharma’s COVID-19 shot for Korea.
5. AstraZeneca’s Indian COVID-19 vaccine partner told to prioritize local supplies: CEO
Speaking of the AstraZeneca vaccine, the Serum Institute of India has been tapped to make the shot available to low- and middle-income countries, and AZ is said to be looking to divert its supply for EU amid a manufacturing delay. But the Serum Institute has been told to prioritize supplies for its home country as India aims to vaccinate 300 million people by August.
6. Dr. Reddy’s gets FDA nod for orally disintegrating lansoprazole
Dr. Reddy’s Laboratories has won U.S. approval for an orally disintegrating formulation of lansoprazole, a therapeutic equivalent of Takeda’s acid reflux med Prevacid SoluTab. Besides the originator, three other companies have received FDA nods for their versions. Quoting IQVIA data, Dr. Reddy’s has put U.S. sales of branded and generic Prevacid at about $87 million in 2020.
7. Otsuka and Click Therapeutics tap Verily’s platform for digital depression treatment study
Otsuka and Click Therapeutics have launched a fully remote clinical trial to test digital interventions for adults with major depressive disorder. The trial aims to enroll 540 participants through Verily’s Project Baseline platform and evaluate their depression status over 10 weeks as they engage with digital cognitive exercises through an app coded CT-152.
8. FDA slaps import alert on India’s Shilpa after sterile injectables issues multiply
After a warning letter, the FDA has slapped an import alert on Shilpa Medicare’s formulation plant in Telangana, India. Three drugs were spared from the ban: myelodysplastic syndrome therapy azacitidine, chemotherapy cyclophosphamide and a generic of Roche’s lung cancer med Tarceva.
9. Astellas’ nonhormonal drug hits phase 3 goals for menopausal symptoms (release)
Astellas’ fezolinetant has hit its goals in two phase 3 trials testing the nonhormonal drug for the treatment of moderate to severe hot flash symptoms associated with menopause. The NK3R antagonist showed that both the 30-mg and 45-mg once-daily doses significantly reduced the frequency and severity of vasomotor symptoms compared with placebo.
