With a deal worth up to $1.3 billion, Takeda could get its hands on a “potentially best-in-class” third-generation BCR-ABL tyrosine kinase inhibitor (TKI) that could rival Novartis' Scemblix.
Thanks to an agreement with Ascentage Pharma, Takeda may later choose to in-license the Chinese biotech's olverembatinib, which is being developed for chronic myeloid leukemia (CML) along with “other hematological cancers,” Takeda said in a press release. If the option is exercised, Takeda can license global development and commercialization rights in all territories outside of Greater China and Russia.
Ascentage, for its part, will get a signing payment of $100 million and is in line for milestones up to approximately $1.2 billion plus “double-digit royalties” on annual sales, the Chinese pharma said in an announcement. Besides, Takeda will also make a minority equity investment worth $75 million in Ascentage, a Takeda media aide told Fierce Pharma over email.
While the Japanese pharma now has the option on the table, it’s not a done deal. Takeda will decide if it will exercise the licensing option based on “prespecified undisclosed development milestones,” the media aide said. The exact timing is subject to the clinical development timeline, which Ascentage is still solely responsible for now.
Olverembatinib is already approved in China, where it’s the first marketed third-generation BCR-ABL1 inhibitor and the only drug cleared to treat CML patients with T315I mutations. More specifically, it’s approved for patients with TKI-resistant chronic-phase CML or accelerated-phase CML who have the T315I mutation.
Outside of China, the med holds an FDA fast-track designation and an orphan drug designation from the European Medicines Agency.
TKIs have already greatly impacted CML treatment ever since Novartis’ Gleevac, the first approved TKI, turned a “once fatal diagnosis into a manageable condition,” according to the Leukemia and Lymphoma society. Still, there remains an unmet need for patients whose disease is resistant or refractory to those therapies or who develop difficult-to-treat mutations stemming from the treatments, Takeda said.
“Takeda has a long history of driving important treatment advances for patients, particularly those with hematological cancers facing treatment gaps,” president of Takeda’s global oncology business unit, Teresa Bitetti, noted in the release. Takeda is “highly encouraged” by the “promising results” olverembatinib has shown to date and is excited for the opportunity to potentially further develop and market the med, she added.
Ascentage, meanwhile, looks to “leverage the global commercial expertise” of its partner, CEO Dajun Yang, M.D., said in the release.
Olverembatinib is entering a global registrational phase 3 study coded POLARIS-2 in previously treated adult patients with chronic-phase CML with or without the T315I mutation. The trial was cleared for take-off by the FDA in February and is set to commence over the first half of this year.
Novartis, too, is looking to tackle the unmet need traditional TKIs leave. The Swiss pharma's newer Scemblix has conditional FDA approval in third-line CML treatment. Now, it's looking to move into first-line treatment after beating its predecessor Gleevac with quicker and deeper molecular response rates in a head-to-head phase 3 study.