Exelixis Inc. (NASDAQ:EXEL) Receives Approval For Commercialization Of CABOMETYX® In Japan, Plans To File IND For XB002

Exelixis Inc. (NASDAQ:EXEL) has announced that its Japanese partner, Takeda Pharmaceutical Company Ltd responsible for CABOMETYX® commercialization has received approval to manufacture and market CABOMETYX® in Japan. Takeda will market the CABOMETYX for unresectable hepatocellular carcinoma (HCC) treatment in patients who have progressed following previous systemic therapy.

Takeda to sell CABOMETYX in Japan

Takeda applied for approval based on data from two clinical studies in advanced HCC patients that had previously received systemic therapy. The CELESTIAL Phase 3 clinical and Cabozantini-2003 phase 2 clinical studies were conducted in Japan. CABOMETYX received EU and US approvals for HCC treatment in patients previously treated with sorafenib based on the CELESTIAL study.

Michael Morrisey, Exelixis CEO and President said that Hepatocellular carcinoma results in around 30,000 deaths in Japan annually and it is the leading cancer-related death cause globally. CABOMETYX’s approval in Japan is a massive step for the company towards delivering liver cancer treatment for patients having limited treatment alternatives after previous systemic therapy.

According to terms of the Takeda and Exelixis collaboration and license agreement, Takeda will pay Exelixis a $15 million milestone payment after the first CABOMETYX commercial sale for unresectable HCC. At the beginning of this year, Takeda received Approval for the manufacture and sale of CABOMETYX as an unresectable HCC treatment triggering a $10 million milestone payment to Exelixis.

Exelixis to file IND for tissue factor ADC, XB002 in 2021

Recently Exelixis exercised its exclusive option for Iconic Therapeutics Inc.’s lead oncology antibody-drug conjugate (ADC) program under the May 2019 agreement. This implies that Exelixis will be responsible for future clinical development, manufacturing, and commercialization of Tissue Factor-T targeting ADC called XB002. XB002 is a next-generation ADC comprising a Tissue Factor-targeting antibody with Zymerworks Inc.’s (NYSE:ZYME) novel ZymeLink™ linker payload. It creates the potential for an enhanced therapeutic index and favorable safety profile relative to previous generations.

Exelixis will submit an Investigational New Drug Application with the FDA for XB002 soon and pending approval the company plans to start Phase 1 XB002 clinical study next year.