Gracell Biotechnologies stole the show at the American Society of Hematology 2022 annual meeting, showcasing a 100% tumor response rate for its BCMA-targeted CAR-T therapy. Takeda is betting big on Nimbus Therapeutics’ TYK2 inhibitor. Merck & Co. and Indonesia’s Bio Farma struck a production deal.
Gracell Biotechologies' BCMA/CD19 dual-targeting CAR-T therapy, GC012F, wowed at the American Society of Hematology 2022 annual meeting by posting a 100% tumor response rate in a phase 1 trial in China. The company is looking for a partner to move development along as it might go up against several BMCA CAR-T candidates from big drugmakers, Wendy Li, M.D., Gracell’s chief medical officer, told Fierce Biotech.
2. Takeda bets $4B upfront on Nimbus' phase 3-ready prospect to challenge Bristol Myers in psoriasis
After Nimbus last month presented top-line data from a phase 2b clinical trial of NDI-034858, its TYK2 inhibitor, Takeda put down $4 billion upfront to buy Nimbus’ subsidiary, Nimbus Lakshmi, to secure the candidate. Upon the deal's closing, Takeda will try to position the drug to rival Bristol Myers Squibb’s Sotyktu.
3. Merck & Co. inks pact with Indonesia's Bio Farma to make HPV vaccine
Merck & Co. and Indonesia’s Bio Farma inked a licensing agreement allowing the manufacturer to produce Merck's four-valent human papillomavirus (HPV) vaccine locally. The deal strengthens Indonesia’s efforts to launch a national HPV immunization program in 2023.
4. Chasing Gilead, AstraZeneca-Daiichi lay down phase 1 breast cancer data for antibody-drug conjugate
AstraZeneca and Daiichi Sankyo’s TROP2 antibody-drug conjugate datopotamab deruxtecan (Dato-DXd) delivered response and survival results that show the drug has a shot at shaking up the market. In 41 patients with HR-positive, HER2-low or negative metastatic breast cancer who had previously received a median of five lines of treatment for metastatic disease, the medicine compared favorably to a phase 3 trial testing Gilead Sciences' Trodelvy in a similar patient population. Still, there are major caveats in comparing results from a small, uncontrolled trial to those from the pivotal trial that tested Trodelvy.
5. Boston Scientific angles for majority stake with $523M for Chinese devicemaker Acotec
Boston Scientific will fork over about $523 million in cash to secure a majority stake of Beijing-based medtech Acotec Scientific, which focuses on cardiovascular treatment devices. Acotech’s portfolio includes drug-coated balloons and percutaneous transluminal angioplasty hardware plus radiofrequency ablation catheters, all of which are manufactured and approved in China.
Six pharma companies were slapped with drug marketing breeches by the U.K.’s drug marketing regulatory. Daiichi Sankyo breached four clauses of the local pharma code, regulators said, including by not flagging risks of using some medicines in conjunction with others.
Other News of Note
7. Takeda's Poseida partnership starts to pay off with promising hemophilia A gene therapy data
8. BeiGene wants greater blending of mental health into cancer care as new survey reveals worrying gaps
9. Antibiotics pro Centrient runs afoul of FDA at Indian manufacturing plant