Zymeworks

Oxford BioTherapeutics announced that Boehringer Ingelheim has selected a third drug candidate targeting OB33 to advance into IND-enabling studies under their ongoing collaboration.

TOLREMO therapeutics has appointed Alessandra Cesano, MD, PhD, to its Board of Directors and named Florian D. Vogl, MD, PhD, as Chief Medical Officer to strengthen leadership capabilities.

China's National Medical Products Administration granted conditional approval to zanidatamab for previously treated, unresectable or metastatic HER2-positive biliary tract cancer, marking the first dual HER2-targeted bispecific antibody approved for this indication in China.

Jazz Pharmaceuticals secures exclusive development and commercialization rights to zanidatamab, a novel HER2-targeted bispecific antibody, in a deal potentially worth $1.76 billion plus royalties.

Zymeworks is set to advance ZW171 and ZW191 in Phase 1 trials for solid tumors, part of their '5 by 5' R&D program.

• The esophageal cancer market is expected to grow significantly, driven by increasing prevalence and the introduction of novel therapies. • In 2023, approximately 77,000 new cases of esophageal cancer were reported across seven major markets, with Japan having the highest number. • Recent FDA approval of TEVIMBRA (tislelizumab) as a monotherapy marks a significant advancement in treating unresectable or metastatic ESCC. • Emerging therapies like zanidatamab and bemarituzumab are expected to revolutionize the esophageal cancer market dynamics during the forecast period.

• Zymeworks received a Buy rating from Bloom Burton following FDA accelerated approval of zanidatamab for HER2-positive biliary tract cancer. • The approval allows Zymeworks to address a niche market with a rare cancer, potentially capitalizing on a first-mover advantage. • A Phase 3 confirmatory trial evaluating zanidatamab in combination with standard-of-care therapy supports potential market expansion. • Analysts anticipate peak global annual sales of zanidatamab to reach $55 million, reinforcing the Buy rating for Zymeworks' stock.

• The FDA has approved zanidatamab (Ziihera), developed by Zymeworks, for treating HER2-positive metastatic biliary tract cancer, a rare and aggressive gastrointestinal cancer. • The approval was based on Phase 2b trial results showing a 52% objective response rate and a median duration of response of 15 months in treated patients. • Biliary tract cancer has a poor prognosis, with a five-year survival rate of under 5% in its metastatic form, highlighting the importance of this new treatment option. • Jazz Pharmaceuticals holds commercialization rights for Ziihera in North America, Europe, and Japan, marking a significant milestone for Zymeworks and offering hope to patients.

• The FDA granted accelerated approval to Ziihera (zanidatamab-hrii) for treating HER2-positive biliary tract cancer (BTC) in previously treated adults. • Ziihera is the first chemotherapy-free, dual HER2-targeted bispecific antibody approved for BTC, offering a new treatment option. • Approval was based on the HERIZON-BTC-01 trial, which demonstrated a 52% objective response rate and a 14.9-month median duration of response. • Jazz Pharmaceuticals will host a webcast on December 11, 2024, to discuss clinical data, patient needs, and commercialization strategy for Ziihera.

• The FDA granted accelerated approval to Ziihera (zanidatamab), a drug developed by Zymeworks, for HER2-positive biliary tract cancer treatment. • Zymeworks is eligible to receive up to $500 million in regulatory milestones and up to $862.5 million in commercial milestones from Jazz Pharmaceuticals. • Clinical trials demonstrated meaningful clinical benefit and a manageable safety profile for zanidatamab in patients with treatment-refractory, HER2-positive biliary tract cancer. • Ziihera's approval validates Zymeworks' Azymetric bispecific platform technology and their capabilities in developing multifunctional medicines.