Active Biotech’s cancer immunotherapy candidate Anyara (naptumomab estafenatox) has been licensed to NeoTX Therapeutics, which has agreed to develop and commercialize the compound in a collaboration that could generate up to $71 million for Active Bio.

NeoTX said the deal marked a key milestone in its strategy of bringing to market new therapies that target tumor recognition. The company has agreed to oversee worldwide clinical development and commercialization of Anyara.

Anyara is a tumor-targeting superantigen (TTS) compound designed to enhance the immune system’s ability to recognize tumors. Development of the compound has focused on cancer indications deemed to have high unmet need.

In 2013, Active Bio acknowledged that Anyara missed the primary endpoint in a Phase II/III trial designed to evaluate the effect of the compound in combination with interferon-alpha in patients with advanced renal cell cancer, compared with interferon-alpha alone. The study failed to show a prolonged overall survival in the “intention to treat” (ITT) population, the company said, adding that a majority of patients in the 513-patient study had high levels of preformed antibodies against the superantigen component of Anyara.

Active Bio also said that Anyara showed a trend for survival benefit in a subgroup of patients that excluded those with high levels of preformed antibodies. The Phase II/III trial also showed that baseline levels of the biomarker interleukin-6 (IL-6) were an important predictive marker for a positive treatment effect of Anyara.

However, Anyara generated positive data in Phase I trials in lung cancer, renal cell cancer, and pancreatic cancer, both as a single agent (monotherapy) and in combination with docetaxel (Taxotere®) in patients with advanced cancer. And Anyara has shown synergistic activity in combination with checkpoint inhibitors in animal models.

“As such, Anyara would be attractive in combination with checkpoint inhibitors whose efficacy can be limited by poor tumor recognition,” NeoTX CMO Marcel Rozencweig, M.D., said in a statement.

NeoTX has agreed to pay Active Bio $250,000 upfront and up to $71 million in payments tied to achieving clinical, regulatory, and commercial milestones. NeoTX has also agreed to pay Active Bio progressive, double-digit royalties on net sales.








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