Oncology Is Next Destination For Innate’s Checkpoint Inhibitor After Return From Novo

French biotech Innate Pharma is set to take the anti-NKG2A antibody IPH2201 into Phase II after buying out rights from Novo Nordisk for €2 million up front.

French biotech Innate Pharma SA is planning to move its first-in-class anti-NKG2A antibody IPH2201 into Phase II this year, after buying rights from development partner Novo Nordisk AS, which had been testing the candidate in inflammatory disease.

Innate Pharma announced Feb. 5 that it acquired full development and commercialization rights to the checkpoint inhibitor from Novo for €2 million ($2.7 million) upfront, 600,000 shares, up to €20 million ($27 million) in milestone payments and single digit royalties on future sales. Novo Nordisk has a 10% equity stake in the company.

The drug had been in development for inflammatory disease. But during a Feb. 5 investor call, execs said that the drug’s greatest potential lies in oncology and that the company will be looking carefully at potential indications, with a focus on unmet medical need. The drug could have broad applicability in solid and hematological malignancies, according to the company.

In an interview, Innate Pharma CEO Herve Brially explained that based on the biology and potential in cancer, its top priority is immuno-oncology. However, he added: “That being said, we do not exclude further down the road to consider indications in inflammation as well.”

Checkpoint inhibitors work on processes that put the brakes on immune system response to cancer cells. A variety of mechanisms are in development and are in testing as monotherapies and in combinations. In the case of IPH2201, the drug works on HLA-E ligands expressed on cancer cells that help evade the immune system. According to the company, IPH2201 unleashes natural killer cells and T-cells on cancer cells expressing HLA-E. Higher levels of HLA-E are associated with poor prognosis and this could ultimately lead to development of a biomarker.

Checkpoint inhibitors are the center of attention in oncology these days, with the success of Bristol-Myers Squibb Co.’s CTLA-4 inhibitor Yervoy (ipilimumab) and its anti-PD1 drug nivolumab (Also see "Follow The Leader: Bristol Aims To Build On Head Start In Cancer Immunotherapy" - Pink Sheet, 24 Jun, 2013.). Innate Pharma successfully out-licensed rights to its anti-KIR checkpoint inhibitor lirilumab to BMS in July 2011, in a deal that included a $35 million up-front payment (Also see "BMS Adds To String Of Pearls: $470 Mil. Deal With French Biotech Brings Innate Immunity Approach Into Its R&D Pipeline" - Pink Sheet, 7 Jul, 2011.).

Amid hopes for game-changers in cancer treatment, Merck & Co. Inc. has been stepping up checkpoint development activity; the company announced tie-ups with three different pharmas to test combination therapies on Feb. 5 (Also see "Pushing Hard On PD-1, Merck Signs Trio Of Combo Development Deals" - Pink Sheet, 5 Feb, 2014.).

Innate has been working on immunotherapy with Novo since 2003 ([See Deal]). In 2006, the companies expanded their partnership, a move that included development of IPH2201 in inflammatory disease ([See Deal]).

Novo Nordisk had been developing the anti-NKG2A antibody for rheumatoid arthritis and has completed a large Phase I study in this indication. Full results have not been published, but Innate Pharma said that the candidate was safe and well-tolerated at all doses (including subcutaneous and intravenous administration) in the Phase I study, enabling the company to move forward in 2014 to Phase II in oncology. Instead of advancing anti-NKG2A in inflammatory disease, Novo will be moving forward with a Phase II anti-NKG2D candidate developed through the collaboration.

Initially, Innate will develop IPH2201 as a monotherapy, but it foresees a full development program, including combination trials, in the future. Further details on development should be forthcoming in the second quarter. The company acknowledged that it envisions an ambitious program that would require significant resources. At the end of 2013, the company had $41 million in cash.