Collaborations Continue To Be Key For Opdivo’s Development
Executive Summary
Deals with a wide range of companies and academic institutions are exploring nivolumab’s horizons in many solid and hematological malignancies.
While monotherapy with PD-1/L1 inhibitors like Bristol-Myers Squibb Co.’s Opdivo (nivolumab) has been impressive, collaborations could hold even more potential.
Bristol has been focused on pairing up immuno-oncology assets, taking advantage of its in-house CTLA-4 checkpoint inhibitor Yervoy (ipilimumab), but is “keeping an open mind” about combining immunotherapies with non-immunotherapies, said Michael Giordano, Bristol’s head of oncology development, during a recent investor call (see related story, (Also see "Big Market, Broad Plan: Bristol Shares Vision For Opdivo In Lung Cancer " - Pink Sheet, 17 Nov, 2014.)).
“We are expanding and accelerating our business development opportunities through either academic collaborations or collaborations with other companies to really leverage the possibility of having a far broader program than even our internal assets can provide,” the exec said during an Oct. 31 call highlighting results from the CheckMate-063 squamous non-small cell lung cancer study.
The firm has a collaboration with Ono Pharmaceutical Co. Ltd., as well as with Innate Pharma SA[See Deal], Celldex Therapeutics Inc.[See Deal], Five Prime Therapeutics Inc.[See Deal],Celgene Corp., Incyte Corp. and Janssen Biotech Inc./Pharmacyclics Inc. among others (Also see "Bristol Looking For Deals, Immuno-Oncology And Otherwise" - Pink Sheet, 24 Jul, 2014.).
“We’re not shy if the data support combinations with certain high-quality [tyrosine kinase inhibitors] or cytotoxics that have clean profiles,” Giordano added, pointing to agreements with Novartis AG and Celgene (Also see "Combo Craze: For PD-1s, Research Alliances Are The Order Of The Day" - Pink Sheet, 26 Aug, 2014.).
Among other things, work with Celgene explores the effects of Opdivo with Abraxane (nanoparticle paclitaxel formulation) in a variety of tumor types including non-small cell lung cancer and breast cancer.
In October, Bristol unveiled a collaboration with Novartis to test Opdivo with three of the Swiss company’s targeted agents – the ALK inhibitor Zykadia (ceritinib) the MET inhibitor INC280 and EGF816, a third-generation EGFR inhibitor. As part of the deal, Novartis will be running two Phase II studies in NSCLC.
Academic collaborations are also an important part of Bristol’s strategy. In 2012, the company developed a public/private partnership called II-ON (International Immuno-Oncology Network) that covers 11 centers for excellence for translational research and molecular mechanisms in immuno-oncology (Also see "Bristol-Myers Taps Academia To Help Research Immuno-Oncology Pipeline" - Pink Sheet, 29 May, 2012.)
And, during the investor call, Giordano said that Bristol has “added to that an important collaboration with MD Anderson to explore the role of immunotherapy and our assets in hematologic malignancies,” including rare ones.
Sealed in October, the agreement with the University of Texas MD Anderson Cancer Center covers research with “multiple immunotherapies,” including Opdivo, Yervoy and three of Bristol’s early-stage clinical immuno-oncology assets in acute and chronic leukemia and other blood cancers, the company said in a statement announcing the deal.
Blood cancers are a growing focus for Bristol.
Also in mid-October, Bristol announced a deal with Janssen/Pharmacyclics involving testing Opdivo with the recently approved BTK inhibitor Imbruvica (ibrutinib) in non-Hodgkin lymphoma, including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma and chronic lymphocytic leukemia.
Opdivo recently gained breakthrough status for Hodgkin lymphoma after failure of autologous stem cell transplant and brentuximab (Roche’s Adcetris). Bristol is set to release the first data for the drug in Hodgkin lymphoma and non-Hodgkin lymphoma at the American Society of Hematology annual meeting in early December. In terms of other upcoming activity, Giordano reported that GBM studies have enrolled quickly (Also see "Opdivo Survival Data Support PD-1 Upfront In Melanoma" - Pink Sheet, 16 Nov, 2014.).