- Zymeworks Inc and Daiichi Sankyo
DSNKY
terminated a license agreement dated September 26, 2016, as amended on September 25, 2018, July 2, 2021, and June 6, 2022. - Under the 2016 agreement, Zymeworks licensed its Azymetric and EFECT platforms to Daiichi Sankyo to develop one bispecific antibody therapy for an upfront technology access fee payment of $2.0 million and research and commercial option-related payments totaling $4.5 million.
- Zymeworks was also eligible to receive additional development milestone payments of up to $63.4 million and commercial milestone payments of up to $80.0 million.
- Zymeworks also gained non-exclusive rights to develop and commercialize up to three products (revised to up to six under the June 2022 amendment) using Daiichi Sankyo's proprietary immune-oncology antibodies.
- Under the non-exclusive immune-oncology antibody license, Zymeworks was solely responsible for the resulting products' research, development, and commercialization.
- Zymeworks reported $492.2 million in cash resources as of December 31, 2022, with an expected cash runway through 2026.
- FDA's Peripheral and Central Nervous System Drugs Advisory Committee will virtually meet on Wednesday, March 22, to discuss Biogen Inc's ALS drug tofersen.
- FDA staff, citing a briefing document, said Biogen's investigational ALS drug might have a "clinical benefit" on a rare and aggressive form of the disease, despite failing a broader late-stage clinical trial last year.
- "Despite the notable limitations of a failed study and the many post hoc exploratory analyses conducted after [the Phase III trial], the Division considers that the data may suggest a treatment effect of tofersen in SOD1-ALS," the FDA wrote. "This is a very rare and devastating disease; therefore, it is of utmost importance that we give full consideration to all available data."
- Tofersen did not achieve the primary goal of its Phase 3 VALOR trial, failing to prove it could slow SOD1-ALS patients' functional decline better than a placebo. Biogen said the p-value for the primary endpoint was p=0.97.
- "This is a situation where there is a negative clinical study that failed to show a statistically significant treatment effect in the prespecified primary analysis population," the report says.
- It notes, however, that the study was limited in its ability to determine whether the drug affected the overall population because of how it was designed.
- At the same time, the data indicate that targeted drug use was shown to reduce "a biomarker that is correlated with disease progression and prognosis in patients with ALS."
- The FDA accepted Biogen's application for full approval of tofersen in July. Last October, the agency extended its application review by three months, with a PDUFA date of April 25.
