September 27, 2016
By Alex Keown, BioSpace.com Breaking News Staff
SAN FRANCISCO – Drug giant Bristol-Myers Squibb forged a research pact with Nektar Therapeutics to explore immunotherapy treatments for five different tumor types by combining its blockbuster immuno-therapy Opdivo with Nektar’s investigational medicine, NKTR-214.
NKTR-214, a CD122-biased immune-stimulatory cytokine, is an investigational immuno-stimulatory therapy designed to expand specific cancer-fighting T cells and natural killer (NK) cells directly in the tumor micro-environment and increase expression of PD-1 on these immune cells. Opdivo is a PD-1 immune checkpoint inhibitor designed to overcome immune suppression. A combination of the two drugs could result in greater treatment results for cancer patients, particularly in areas where PD-1 inhibitors have already shown promise.
In December 2014, Opdivo was approved by the U.S. Food and Drug Administration for patients with advanced melanoma who no longer respond to other drugs, or cannot be treated via surgery. In March 2015, it was approved for treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Opdivo is an immuno-therapy drug delivered via injection that harnesses the patient’s own immune system to fight cancerous cells. It was the first PD-1 inhibitor to receive regulatory approval.
The companies will initiate Phase I/II clinical trials to evaluate the potential for the combination of the drugs. The drugs will aim at the treatment of melanoma, kidney, colorectal, bladder and non-small cell lung cancer patients. An initial dose-escalation trial has already commenced, the companies said in a joint statement.
Fouad Namouni, BMS’ head of oncology research, said combining Opdivo with Nektar’s experimental drug has potential to provide new treatments due to the use of different, but complementary mechanisms of action.
While PD-1 inhibitors have been effective, they are not always so. Sometimes cancer tumors do not have the sufficient number of T cells to turn them into killer cells. That’s why BMS is looking to pair the drug with NKTR-214, which could stimulate those T-Cells and make Opdivo more effective. Preclinical studies show that NKTR-214 demonstrated a “rapid expansion” of the T Cells, the company said.
“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 Robin, president and chief executive officer of Nektar said in a statement. “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.”
Under terms of the deal, BMS and Nektar will equally share costs of the combined therapy trials. Nektar will maintain its global commercial rights to NKTR-214.
Opdivo, which is being heavily advertised in the media, had sales near $1 billion in 2015, but analysts predict it could go much, much higher, hitting nearly $13 billion annually within a few years.
