Tyme flops on cancer drug data; Lilly IND filing triggers $8M payment to partner Zymeworks
→ Tyme Technologies on Friday touted “substantially improved survival benefit” from its experimental drug SM-88 in a single arm study in advanced pancreatic cancer patients with progression despite treatment with at least two prior therapies, but investors did not buy into the company’s enthusiasm, causing the stock $TYME to crater about 36%. The trial was designed to enroll 115 patients, including 36 patients in the initial stage of the trial, according to clinicaltrials.gov, and the primary endpoint of the study is response rate — suggesting Tyme was being misleading about the “survival benefit” it was brandishing. The company elected to highlight that 68% of patients treated with SM-88, (19 of 28) remained alive after a median of 4.3 months of follow-up. But, only 17 patients had undergone tumor scans, and the response rate, that would come from tumor scans, was revealed much lower down in the release — 12% of patients (2 out of 17) saw tumor reductions of more than 30%. As pointed out by STAT’s Matthew Herper, the study raised important red flags, most importantly that it was impossible to conclude survival benefit based on the available data.
→ Zymeworks has collected $8 million in milestone payments as Eli Lilly submits an IND for an immuno-oncology bispecific antibody developed on its platform — the second within a six-month period, the company highlights. The partners’ licensing and collaboration agreement date back to 2014.
→ Pulling off the biggest biotech IPO ($604 million) of 2018 was enough for Moderna $MRNA president John Mendlein, who is transitioning to the role of executive partner at Flagship Pioneering.