Novartis pitches two new CAR-T applications to EMA; J&J reports positive data for lupus program
→ Basel-based Novartis $NVS has pushed along a double-barreled application for its leading CAR-T drug Kymriah (CTL019). The pharma giant has applied to the EMA for approvals in B-cell acute lymphoblastic leukemia as well as diffuse large B-cell lymphoma, which will likely put it head-to-head with rival Gilead’s Yescarta. “Since the historic FDA approval of Kymriah, formerly CTL019, we have launched, manufactured and supplied this highly individualized immunocelluar therapy in a commercial setting and the submission to the EMA is a major step toward our goal of delivering it to more critically ill cancer patients around the world,” said Vas Narasimhan, who’s in the process of stepping up to the CEO post.
→ Brisbane, CA-based Aimmune $AIMT CEO Stephen Dilly says he plans to step down by the end of the year so he can spend more time with his family. The biotech plans to mount a search for a new CEO. Dilly noted: “My decision to retire is based solely on my personal desire to have more time for my family, especially my eldest son, who has special needs. We are announcing this now in order to facilitate an orderly executive search and transition period, and I remain completely committed to continuing to lead Aimmune through the exciting events ahead. We are looking forward to the completion of our pivotal Phase 3 PALISADE trial around year-end and sharing top-line data in the first quarter of 2018.”
→ Translate Bio CEO Ron Renaud has recruited Agios vet Ann Barbier for the CMO position. Barbier had been vice president of clinical development, rare genetic diseases at Agios, a trendsetter in the Cambridge, MA biotech hub. Earlier, she had worked at Shire for 7 years. “With near-term clinical programs in cystic fibrosis and OTC deficiency, Translate Bio is approaching a critical and exciting time,” said Barbier.
→ J&J $JNJ has had some setbacks on the R&D front recently, but over the weekend it produced some impressive results for their blockbuster Stelara — already approved for psoriasis and Crohn’s — in lupus. The drug helped 60% of the group on the drug arm in a recent study, compared to only 31% for the placebo-plus standard of care. Reuters notes that the only drug approved for lupus in the last 50 years has been GSK’s Benlysta.