Pfizer, in parallel to its Bavencio collaboration with Merck KGaA, has secured exclusive China rights to CStone Pharmaceuticals' PD-L1 inhibitor sugemalimab. Gilead Sciences' filgotinib has been cleared to treat rheumatoid arthritis in Japan and the EU after an embarrassing FDA snub. Takeda and Ovid Therapeutics posted some mixed data for soticlestat in two rare forms of epilepsy. And more.
Pfizer is investing $200 million for a 9.9% stake in CStone Pharmaceuticals, gaining exclusive China commercial rights to the biotech’s investigational PD-L1 antibody sugemalimab (CS1001). The deal also includes up to $280 million in milestone payments. In August, CStone said adding sugemalimab to chemo cut the risk of disease progression by 50% in newly diagnosed patients with stage 4 non-small cell lung cancer.
Gilead Sciences won approvals for Galapagos-partnered rheumatoid arthritis med Jyseleca (filgotinib) in Japan and the EU. The JAK inhibitor, a key component in Gilead’s plan to branch out beyond antiviral drugs, had been rejected in the U.S. as the FDA raised concerns about sperm toxicity and asked for more data.
Takeda and Ovid Therapeutics have phase 2 data for soticlestat in two rare epilepsies. The results showed a clear benefit for patients with CDKL5 deficiency disorder, with the drug reducing frequency of motor seizures in both the dosing maintenance and extension phases. But for duplication 15q syndrome, patients logged a 12% increase in frequency during the maintenance period, though the four patients who stayed on treatment further saw a major 74% reduction.
The Serum Institute of India (SII) will make an additional 100 million doses of COVID-19 vaccines for low- and middle-income nations in 2021 as part of an expanded distribution effort with Gavi, the Vaccines Alliance, and the Bill & Melinda Gates Foundation. As part of the deal, the Gates Foundation will inject an additional $150 million to boost SII's production capacity.
Artificial intelligence drug designer XtalPi has secured $318.8 million in a series C round co-led by SoftBank, PICC Capital and Morningside Venture Capital. The money will help the Chinese firm expand its AI- and cloud computing-powered platform by simultaneously developing its algorithms, druglike molecule database and computing power.
Junshi Biosciences’ PD-1 inhibitor toripalimab, used alongside chemotherapy duo gemcitabine and cisplatin, beat chemo alone at staving off cancer progression in patients with nasopharyngeal carcinoma in a phase 3 trial. The drug’s already approved in China as a second-line treatment for metastatic melanoma.
Takeda has tapped drug delivery specialist Elektrofi’s microparticle formulation technology for an undisclosed plasma protein. The Elektrofi platform might eventually allow plasma therapies to be injected under the skin rather than infused intravenously.
South Korean biotech Ilias Biologics has completed a $20.6 million series B, bringing the total capital it’s raised to $40.2 million. The company focuses on developing exosome-based therapeutics for inflammatory diseases and cancer. It plans to start a first-in-human clinical trial of its lead candidate, ILB-202, by the second half of 2021.
BioShin, Biohaven Pharmaceutical’s Asia-Pacific subsidiary, has closed a $60 million series A round led by OrbiMed. The funds will be used to build out the company’s China operations and advance its clinical programs in the area. These include running a phase 3 trial for Nurtec ODT for acute treatment of migraine in China and Korea.