Daiichi Sankyo informed Nektar that it was terminating a collaboration and licensing deal, effective Feb. 4, 2018.
Daiichi Sankyo Europe GmbH informed Nektar Therapeutics that it was terminating a collaboration and licensing deal, which will become effective Feb. 4, 2018. As part of that termination, Nektar will pay Daiichi a $12.5 million termination fee. All rights and licenses that Daiichi acquired in the deal will revert to Nektar.
The two companies inked the deal in 2016. Daiichi Sankyo paid $20 million up front for marketing rights to Onzeald in Europe, Switzerland and Turkey. Brittany Meiling, writing for Endpoints News, says, “The duo was gambling on an early approval for Onzeald after the researchers extracted data from their BEACON study on 67 advanced breast cancer patients with a history of brain metastases. The Committee for Medicinal Products for Human Use was not impressed.”
The European Medicines Agency (EMA)’s rejection noted, “The claim of effectiveness relied on data from a subgroup of patients from a main study which, overall, failed to convincingly show the effectiveness of Onzeald.”
Nektar indicates that the payment won’t change its 2017 financial guidance.
Although this was undoubtedly bad news, it’s not all bad news for the company. On Nov. 11, Nektar and Bristol-Myers Squibb presented data from the PIVOT-02 Phase I/II clinical trial that evaluated Bristol-Myers’ Opdivo (nivolumab) with Nektar’s NKTR-214 in several different types of cancers. Opdivo is an immune checkpoint inhibitor. NKTR-214 is an immuno-stimulatory therapy that activates specific cancer-fighting T cells and natural killer (NK) cells.
“In the dose-escalation stage of the PIVOT trial, we’ve observed important response rates across all three tumor types—melanoma, renal cell carcinoma and non-small lung cancer—in both PD-L1 positive and PD-L1 negative patients,” said Mary Tagliaferri, Nektar’s senior vice president of Clinical Development, in a statement. “All patients with responses in the trial continue on treatment. Of note, we observed responses in three of four Stage IV non-small cell lung cancer patients whose tumors did not express PD-L1 and who had progressed on prior chemotherapy, including one patient who experienced a complete response. In the combination treatment, there were no Grade 3 or higher immune-mediated adverse events at the recommended Phase II dose or below. Nektar and Bristol are now actively enrolling patients in the Phase II expansion part of the PIVOT study in five different tumor types.”
And on Nov. 7, Nektar presented preclinical data on NKTR-358 at the 2017 American College of Rheumatology (ACR/ARHP) Annual Meeting. The compound is an immunological therapy that targets the interleukin (IL-2) receptor complex to stimulate the proliferation of regulatory T cells. This appears to bring the immune system back into balance. It is being developed in a strategic collaboration with Eli Lilly and Company for multiple autoimmune conditions.
“Data from these studies show that NKTR-358 drives the proliferation and sustained preferential activation of regulatory T cells, both of which are critically important to restore balance to the immune system,” Jonathan Zalevsky, Nektar’s senior vice president of Biology and Preclinical Development, said in a statement. “NKTR-358 also produces antigen-specific Treg memory to suppress inflammatory responses in experimental mouse models of hypersensitivity, and showed strong efficacy in a mouse model of systemic lupus erythematosus. We are very excited about the potential for NKTR-358 to restore the body’s natural self-tolerance mechanisms and resolve the immune system dysfunction associated with autoimmune disorders.”
