Researchers detailed positive phase 1 data for CanSino Biologics' COVID-19 vaccine in The Lancet but cautioned against readthrough to protection. Takeda's Alunbrig entered first-line ALK-positive non-small cell lung cancer to rival Roche's Alecensa and Novartis' Zykadia. GlaxoSmithKline tapped Samsung Biologics in a $231 million deal to expand manufacturing. And more.
Detailed phase 1 data from CanSino Biologics’ adenovirus-based recombinant COVID-19 vaccine showed the vaccine was generally well-tolerated in 108 healthy adults. All participants developed binding antibodies against the coronavirus’s spike protein, as well as neutralizing antibodies and T-cell responses. But, as the researchers cautioned in the Lancet paper, the roles of antibodies or T cells in building effective protection against the virus are yet unknown.
Takeda’s Alunbrig has won its FDA nod for previously untreated, ALK-positive non-small cell lung cancer based on phase 3 data showing it could cut the risk of disease progression or death by 51% compared with Pfizer’s Xalkori at 25 months. But Alunbrig’s true rivals are Roche’s market-leading Alecensa and Novartis’ Zykadia.
GlaxoSmithKline has signed Samsung Biologics in a deal worth more than $231 million to help it make biologic products over the next eight years. The deal will initially cover lupus drug Benlysta and could expand to other products. Possible candidates could come from GSK’s cancer pipeline, including the anti-BCMA antibody-drug conjugate belantamab mafodotin that’s under FDA priority review.
Mumbai-based BDR Pharmaceuticals has reportedly sought approval from the Drug Controller General of India to make and sell a generic version of Gilead Sciences’ remdesivir without a licensing agreement. Gilead has contacted the government and questioned the application, The Economic Times reported, citing people familiar with the matter.
I-Mab said a phase 1 study of its anti-GM-CSF antibody TJM2 in patients with cytokine release syndrome associated with COVID-19 has moved into the second segment of the trial. The advance came at the recommendation of a data monitoring committee after the med was found to be safe. Now, all patients will receive the higher dose at 6mg/kg or placebo.
Genome editing specialist EdiGene formed an R&D collaboration with Immunochina to develop CAR-T therapies for cancer. EdiGene has gene-editing platforms for hematopoietic stem cells and T cells as well as screening technology to discover novel drugs. Immunochina currently lists three CAR-T drugs in its pipeline, targeting CD19, BCMA and CD123, respectively.