Loxo Oncology and Bayer have entered into a global partnership to develop and commercialize two targeted cancer therapies.
The partnership is for larotrectinib (LOXO-101, Loxo Oncology) and LOXO-195 (Loxo Oncology), both highly selective tropomyosin receptor kinase (TRK) inhibitors intended for patients with TRK fusion cancers.
TRK gene fusions are found in a variety of tumor types. The abnormality occurs in 0.5% to 1% of common cancers, but in more than 90% of rare cancers, such as salivary gland cancer, infantile fibrosarcoma, and a form of juvenile breast cancer.
Loxo Oncology will lead global development activities and U.S. regulatory activities. Bayer will lead ex-U.S. regulatory activities and worldwide commercial activities. The two companies will share development costs.
“This is a transformational collaboration for the company as we prepare for commercialization,” Jacob Van Naarden, chief business officer of Loxo Oncology, said in a press release. “Bayer has a history of successful co-promotion efforts with emerging biopharmaceutical companies and we are confident that their oncology team has the global reach and expertise, including an existing field force dedicated to cancer, to complement our existing commercial plans. We look forward to working with Bayer and believe that together we can bring our TRK inhibitors to more patients more quickly.”
The agreement calls for Loxo Oncology to receive a $400 million upfront payment. Loxo also will be eligible for $450 million in milestone payments upon regulatory approvals and first commercial sales of larotrectinib in certain major markets, as well as an extra $200 million in milestone payments upon LOXO-195 regulatory approvals and first commercial sales in certain major markets, according to a press release.
Larotrectinib is an oral investigational drug in clinical trials for treatment of cancers that harbor TRK abnormalities. Loxo Oncology expects to submit a new drug application for larotrectinib to the FDA by the end of this year or early next year.
As HemOnc Today reported earlier this year, study results presented at ASCO Annual Meeting showed larotrectinib demonstrated clinical activity in adults and children with various tumors that had neutrophic TRK gene fusions.
LOXO-195 is an oral investigational agent in development for treatment of patients with cancers that have acquired resistance to initial TRK therapy, such as larotrectinib.
“We see great potential in larotrectinib and, moreover, the follow-on compound LOXO-195, which may provide additional benefit for patients who might progress on an initial TRK inhibition therapy,” Robert LaCaze, executive vice president and head of the Oncology Strategic Business Unit at Bayer, said in the release. “These agents have the potential to fulfill the promise of precision medicine, where tumor genetics rather than tumor site of origin define the treatment approach for patients.”