A clinical combo

SAN FRANCISCO & NEW YORK—In an effort to identify areas of potential efficacy for more a new combination therapy, Bristol-Myers Squibb Co. and Nektar Therapeutics have begun a clinical collaboration to assess the combination of Opdivo (nivolumab) and NKTR-214 in five different tumor types. Opdivo is a PD-1 immune checkpoint inhibitor that can overcome immune suppression by tumors, while NKTR-214 is an investigational immuno-stimulatory therapy meant to boost certain cancer-fighting T and natural killer cells in the tumor micro-environment and increase their expression of PD-1.

NKTR-214 works by targeting CD122-specific receptors found on the surface of CD8+ effector T cells and NK cells. Preclinical work has shown that treatment with the compound leads to a rapid expansion of the targeted immune cells and mobilization into the tumor micro-environment. Nektar is also evaluating NKTR-214 in a Phase 1/2 clinical study as a single agent in cancer patients.

“We’re very pleased to be collaborating with Bristol-Myers Squibb, a global leader in immuno-oncology, in order to advance quickly the development of NKTR-214 with a PD-1 immune checkpoint inhibitor,” Howard W. Robin, president and CEO of Nektar Therapeutics, said in a press release. “NKTR-214 is designed to grow tumor-infiltrating lymphocytes (TILs) in vivo and replenish the immune system, which is critically important as many patients battling cancer lack sufficient TIL populations to benefit from approved checkpoint inhibitor therapies. The combination of checkpoint inhibition with T cell growth could lead to synergistic effects that may provide a new treatment option for patients.”

The combination therapy will be tested in Phase 1/2 clinical trials to determine its potential for improved and sustained efficacy and tolerability compared to the current standard of care in patients with melanoma, kidney, colorectal, bladder and non-small cell lung cancer. In addition, an initial dose-escalation trial is underway for the combination. Though no specific details were released, the companies will share the costs of the trials equally, with Nektar maintaining global commercial rights to its compound.

“We are excited to explore the potential benefits in multiple types of cancer of the combination of Opdivo with Nektar’s innovative cancer immunotherapy,” commented Dr. Fouad Namouni, head of Oncology at Bristol-Myers Squibb. “We believe that a combination regimen which utilizes two different and complementary mechanisms designed to harness the body’s own immune system to fight cancer has the potential to provide new treatment options for patients.”

Nektar shared its financial results for the second quarter of 2016 last month, reporting revenue in the second quarter of $32.8 million, up from $22.7 million in the same quarter last year. Year-to-date revenue for 2016 $91.6 million, compared to $131.5 million in the same period of 2015.

In announcing the results, Robin noted that “NKTR-214 continues to advance in its Phase 1/2 study in cancer patients at MD Anderson and Yale Cancer Centers, with initial top-line data expected before the end of this year. As the first medicine designed to selectively stimulate the in-vivo growth of endogenous tumor-killing T cells and natural killer cells within the tumor micro-environment, we are extremely excited about the potential of NKTR-214 to transform the immuno-oncology landscape."