Bristol-Myers Squibb pays $1 billion upfront under deal for Nektar's immuno-oncology programme NKTR-214

Bristol-Myers Squibb entered a deal with Nektar Therapeutics potentially worth over $3.6 billion, including an upfront payment of $1 billion, to develop the latter's immuno-oncology programme NKTR-214, the companies announced Wednesday. NKTR-214, a CD122-biased agonist, is designed to selectively expand T cells and natural killer cells directly in the tumour micro-environment and increase PD-1 expression on those immune cells.

Under the agreement, which will also see Bristol-Myers Squibb make an equity investment of $850 million in Nektar, the companies will jointly develop and commercialise NKTR-214 in combination with the former's Opdivo (nivolumab) and Yervoy (ipilimumab) in more than 20 indications across nine tumour types. The drugmakers noted that pivotal studies in renal cell carcinoma and melanoma are expected to be initiated in mid-2018.

In November last year, Bristol-Myers Squibb and Nektar announced the first data evaluating the combination of Opdivo and NKTR-214, with results coming from the PIVOT-02 Phase I/II study in patients with melanoma, renal cell carcinoma and non-small-cell lung cancer (NSCLC). Data presented at the Society for Immunotherapy of Cancer (SITC) annual meeting showed response rates of 63 percent in patients with melanoma, 46 percent in those with renal cell carcinoma and 75 percent for subjects with NSCLC.

"Bristol-Myers Squibb has established Opdivo plus Yervoy as the only approved immunotherapy combination for cancer patients," remarked Bristol-Myers Squibb CEO Giovanni Caforio, adding that with NKTR-214, "we now have a third validated I-O mechanism that has demonstrated a clinical benefit in patients, and holds significant potential to expand the benefits that these immuno-oncology agents can bring to patients with cancer."

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In 2016, Bristol-Myers Squibb and Nektar entered a collaboration to evaluate the combination of Opdivo and NKTR-214 for the treatment of five tumour types and seven potential indications. As part of the agreement, Bristol-Myers Squibb gained the first right over the following two years to negotiate a licence for the therapy over a three-month period, as well as an option to match any other company's offer for the drug within 90 days until the end of September, 2018.

Under the terms of the latest agreement, Nektar is eligible to receive an additional $1.78 billion in milestones, of which $1.43 billion are development and regulatory milestones, with the remainder linked to sales. The companies noted that if approved, Nektar will book revenue for worldwide sales of NKTR-214 and receive 65 percent of the profits, with Bristol-Myers Squibb receiving the remaining 35 percent.

The drugmakers added that for a specified period of time, neither will commence development with overlapping mechanisms of action in the same indications as those included in the joint clinical development plan.

For related analysis, see ViewPoints: Is Bristol-Myers Squibb’s mega-deal for NKTR-214 a steal? See also, ViewPoints: Like moths to a flame – Nektar's I/O success attracts inevitable murmurings.

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