Zymeworks Inc. - ZYME STOCK NEWS

Zymeworks Inc. (NYSE: ZYME) has announced new clinical data on zanidatamab, a HER2-targeted bispecific antibody, showing encouraging results in heavily pretreated HER2-positive breast cancer patients. The drug, administered with chemotherapy, yielded a confirmed objective response rate of 37.5% and a disease control rate of 81.3% in 16 evaluable patients. The updated data will be presented at the SABCS conference from December 7-10, 2021. Zymeworks is progressing zanidatamab through multiple clinical trials and holds Breakthrough Therapy designation from the FDA for specific cancer indications.

Zymeworks Inc. (NYSE: ZYME) announced that Neil Josephson, M.D., will transition from interim Chief Medical Officer to permanent CMO on November 15, 2021. Dr. Josephson has led Zymeworks’ medical organization since May and is tasked with advancing the clinical pipeline, including the pivotal trial enrollment for zanidatamab in treating HER2-positive gastroesophageal adenocarcinomas. Zymeworks focuses on developing multifunctional biotherapeutics, with zanidatamab and ZW49 as its lead candidates, while expanding its preclinical pipeline and strategic partnerships.

Zymeworks (NYSE: ZYME) has initiated the HERIZON-GEA-01 Phase 3 clinical trial to assess zanidatamab combined with chemotherapy for first-line treatment of HER2-positive gastroesophageal adenocarcinoma (GEA). This pivotal study aims to enroll around 700 patients across 300 sites globally, with results expected as early as 2024 for a supplemental Biologics License Application (BLA). Previous Phase 2 data indicated a confirmed objective response rate of 75% for zanidatamab plus chemotherapy, signaling potential for blockbuster therapeutic status.

Zymeworks Inc. (NYSE: ZYME) has announced its participation in three upcoming investor conferences, showcasing its development of multifunctional biotherapeutics.

• At the Stifel 2021 Virtual Healthcare Conference on November 16-17, a fireside chat will occur on November 17 at 1:20 p.m. ET.
• The Jefferies London Healthcare Conference will feature a pre-recorded presentation available on November 18.
• A fireside chat at the Evercore ISI HEALTHCONx Virtual Conference is scheduled for November 30 at 3:05 p.m. ET.

These events will be webcast and available for replay on Zymeworks' website.

Zymeworks reported Q3 2021 financial results, showcasing revenue of $4.4 million, up from $2.6 million in Q3 2020, attributed to milestone payments and R&D support. R&D expenses decreased to $49.9 million from $54.4 million year-over-year, while G&A expenses fell to $15.5 million from $21.9 million. Net loss improved to $60.6 million from $72.6 million in the same period last year. Zymeworks holds $307.8 million in cash resources, expected to fund operations into late 2022. The company advances its clinical programs and prepares for pivotal trials.

Zymeworks Inc. (NYSE:ZYME) has announced a conference call and webcast on November 9 at 4:15 p.m. ET, detailing the launch of its Phase 3 HERIZON-GEA-01 study for zanidatamab in treating HER2-positive gastroesophageal adenocarcinoma (GEA). The study compares zanidatamab plus chemotherapy with the standard trastuzumab plus chemotherapy. Zanidatamab, a bispecific antibody, has received several FDA designations, including Breakthrough Therapy and Fast Track, indicating its potential in the treatment landscape for solid tumors expressing HER2.

Zymeworks Inc. (NYSE: ZYME) and ALX Oncology Holdings Inc. (NASDAQ: ALXO) have initiated a Phase 1b/2 clinical trial, dosing the first patient to assess the safety and efficacy of zanidatamab combined with evorpacept for advanced HER2-positive breast and solid tumors. This combination aims to improve immune clearance of cancer cells. Zanidatamab, a bispecific antibody, is designed to target HER2, while evorpacept blocks the CD47 pathway, potentially enhancing therapeutic effects. This collaboration follows promising results from prior studies involving evorpacept in gastric cancers.

Zymeworks Inc. (NYSE: ZYME) has announced promising clinical results for zanidatamab, a HER2-targeted therapy for first-line HER2-positive gastroesophageal adenocarcinoma (GEA). Data from a Phase 2 study presented at the ESMO Congress showed a confirmed objective response rate (cORR) of 75%, and 93% for the proposed Phase 3 regimen. The median duration of response was 16.4 months. A global Phase 3 trial is planned to start in Q4 2021, which aims to establish zanidatamab as a new standard of care in combination with chemotherapy.

Zymeworks Inc. (NYSE: ZYME) announced new clinical data for zanidatamab, a HER2-targeted bispecific antibody, showing promising results in treating first-line HER2-expressing gastroesophageal adenocarcinoma (GEA). In a trial involving 30 patients, the objective response rate was 68.2%, and the disease control rate reached 90.9%. The updated data will be presented at the ESMO Annual Congress on September 16. Zymeworks is positioning zanidatamab as a foundational HER2-targeted therapy, supported by FDA designations for accelerated approval.