Innate Pharma, a biopharmaceutical company conducting research and development of innovative immunotherapy drug candidates for cancer and inflammatory diseases, has acquired full development and commercialization rights to the anti-NKG2A antibody, a first-in-class immune checkpoint inhibitor ready for phase II development in oncology from Novo Nordisk.

Novo Nordisk conducted a large phase I safety trial with anti-NKG2A in patients with rheumatoid arthritis, demonstrating a good safety profile for both iv and sc routes at single and multiple administrations. Novo Nordisk has decided to advance other compounds for further development in inflammation, including anti-NKG2D , currently in phase II development and generated within the collaboration between Innate Pharma and Novo Nordisk.

Novo Nordisk will receive 2 million euros in cash and 600,000 shares for licensing anti-NKG2A to Innate and be eligible to a total of 20 million euros in potential registration milestones and single-digit tiered royalties on future sales. The acquisition of the Innate shares is subject to approval by Innate's shareholders' at an extraordinary general meeting on March 27, 2014.

Herve Brailly, CEO of Innate Pharma noted: "This is a superb opportunity for Innate Pharma. In addition to lirilumab partnered to Bristol-Myers Squibb and currently in phase II, we now have a proprietary phase II ready, first-in-class, immuno-modulating antibody with favourable phase I safety data and the promise of broad development potential. Our initial clinical development plan is in oncology, and we expect to start the clinical programme before the end of this year. This licence consolidates Innate Pharma's leadership in immuno-modulating antibodies targeting the innate immune system."

Nicolaï Wagtmann, CSO of Innate Pharma, said, "Anti-NKG2A is a very exciting immune checkpoint inhibitor targeting both NK and T cells that was selected in the Novo Nordisk-Innate Pharma research alliance for development in cancer and inflammatory disorders. We are very pleased with the progress in the development of this drug candidate, and we look forward to now taking it forward in cancer indications where there is a great need for better treatments and where drugs of this type have shown tremendous benefit in recent years."

Per Falk, senior vice president Biopharmaceutical Research, Novo Nordisk, added: "The new field of innate immunity pharmacology opened by Innate Pharma has proven highly productive, as exemplified by anti-KIR and anti-NKG2D now in phase II clinical trials. In view of recent successes with this type of drug candidates in cancer patients, we believe that anti-NKG2A has its greatest potential in oncology and that Innate Pharma is in the best position to pursue its development."

IPH2201 (anti-NKG2A) is a first-in-class humanized IgG4 antibody. NKG2A is a checkpoint receptor that inhibits anti-cancer functions of cytotoxic NK and T lymphocytes. NKG2A recognises HLA-E ligands, and by expressing HLA-E cancer cells can protect themselves from killing by CD94/NKG2A-positive NK-, NKT-, and T-cells (?/? and ?/?). HLA-E is frequently up-regulated on cancer cells and this occurs in patients with different types of solid tumours or haematological malignancies. In some types of cancers, high-levels of HLA-E appear to confer poorer prognosis. IPH2201 blocks the inhibitory function of CD94/NKG2A, thereby unleashing NK and T cells to kill cancer cells, despite expression of HLA-E. IPH2201 enhances NK and T cell killing of a variety of cancer cell types. Hence, IPH2201 may potentially re-establish a broad anti-tumour response mediated by NK and T cells. Anti-NKG2A mAb may also enhance the cytotoxic potential of other therapeutic antibodies. In an ongoing single- and multiple-dose Phase I dose-escalation safety trial in patients with rheumatoid arthritis, IPH2201 appears to have a safe and well-tolerated profile at all doses tested.

IPH2201 was the third therapeutic antibody generated in the Novo Nordisk-Innate Pharma partnership to enter clinical trials and the second targeting a checkpoint receptor (after lirilumab). Under this agreement, Novo Nordisk had licensed anti-NKG2A from Innate Pharma in 2006 as part of a multi-year research and collaboration agreement. That initial license included total milestones of 25 million euros and single-digit royalties.

Novo Nordisk is a global healthcare company with 90 years of innovation and leadership in diabetes care. The company also has leading positions within haemophilia care, growth hormone therapy and hormone replacement therapy.

Innate Pharma specializes in the development of first-in-class therapeutic antibodies targeting receptors and pathways controlling the activation of the innate immune system.