US-based immuno-oncology firm Agenus and China-based Betta Pharmaceuticals have signed an exclusive collaboration and license agreement for balstilimab and zalifrelimab.

The licensing agreement allows Betta to develop and commercialise the drugs in Greater China, including Mainland China, Hong Kong, Macau and Taiwan.

Under the terms of the license agreement, Agenus will receive $35m, of which $15m as upfront cash and $20m as equity investment, in addition to the $100m in potential milestones and royalties on net sales of the products.

Also, Betta will receive exclusive rights for the development and commercialisation of balstilimab and zalifrelimab, either as monotherapies or combination therapies, except as intravesical delivery in greater China.

Betta Pharmaceuticals chairman and chief executive officer Lieming Ding said: “We are delighted to enter this collaboration with Agenus, a leader in the immuno-oncology field, as the first step in a long-term strategic partnership.

“Based on the compelling clinical data reported to date, we believe Agenus’ balstilimab and zalifrelimab hold great promise for Chinese patients with cervical cancer, with the potential to further expand in additional tumour types through synergistic combinations with Betta’s existing pipeline programs.”

The US FDA has granted Fast Track designation for balstilimab and its combination with zalifrelimab

Agenus said that its balstilimab, which is being evaluated under trials, is planned for BLA filing as a monotherapy and in combination with zalifrelimab for the treatment of refractory or metastatic cervical cancer.

The company has recently unveiled positive results, demonstrating durable responses of balstilimab and zalifrelimab in patients with relapsed or refractory metastatic cervical cancer.

Furthermore, the US FDA has recently granted Fast Track designation for balstilimab alone and in combination with zalifrelimab the same indication.

Agenus chairman and chief executive officer Garo Armen said: “Betta has a strong track record of advancing innovative products in China and a growing portfolio of complementary oncology therapies.

“Betta is an ideal partner to enable us to address significant patient needs in China while also advancing global development of balstilimab and zalifrelimab.”