Exhibit 99.2
FORM 51-102F3
MATERIAL CHANGE REPORT
Item 1: | Name and Address of Company |
Zymeworks Inc. (“Zymeworks” or the “Company”)
1385 West 8th Avenue, Suite 540
Vancouver, BC, Canada
V6H 3V9
Item 2: | Date of Material Change |
December 1, 2020
A news release announcing the material change was disseminated through the facilities of Business Wire on December 1, 2020 and a copy was filed on the Company’s profile at www.sedar.com.
Item 4: | Summary of Material Change |
On December 1, 2020, Zymeworks announced that its partner, BeiGene, Ltd., has dosed the first patient in South Korea in a pivotal, single-arm clinical trial of zanidatamab (formerly ZW25) monotherapy in patients with advanced or metastatic HER2 amplified biliary tract cancer (BTC). Zymeworks will receive a US$10 million payment under its collaboration with BeiGene as a result of the achievement of this development milestone.
Item 5: | Full Description of Material Change |
5.1 Full Description of Material Change
On December 1, 2020, Zymeworks announced that its partner, BeiGene, Ltd., has dosed the first patient in South Korea in a pivotal, single-arm clinical trial of zanidatamab (formerly ZW25) monotherapy in patients with advanced or metastatic HER2 amplified BTC. Zymeworks will receive a US$10 million payment under its collaboration with BeiGene as a result of the achievement of this development milestone.
Zymeworks and BeiGene are progressing the opening of multiple clinical trial sites in support of the global registration-enabling Phase 2b clinical trial of zanidatamab in patients with HER2-amplified BTC. In the Asia region, multiple sites are open for enrollment in South Korea, and in China all sites have been selected with enrollment anticipated to begin in the first quarter of 2021.
This global zanidatamab study may enable the submission of a Biologics License Application by Zymeworks in the United States as early as 2022. Multiple clinical sites are now open to enrollment in the U.S., Europe, and Asia, with additional sites planned, including in Canada and South America.