Innate Pharma’s lead candidate monalizumab – which is licensed by AstraZeneca – is heading for a pivotal phase 3 clinical trial.
The biotech – based in Marseille, France – will proceed into a phase 3 trial evaluating monalizumab in combination with Eli Lilly’s Erbitux (cetuximab) in patients suffering from recurrent or metastatic squamous cell carcinoma of the head and neck.
The anti-NKG2A antibody, which targets a pathway thought to inhibit the activity of natural killer (NK) and cytotoxic T-cells in cancer, was licensed by AZ last year in a deal that included £100m in near-term payments and a further $825m in development and sales milestones.
AZ has vested interested in Innate’s candidate because of data which shows that it can improve the effectiveness of PD-1/PD-L1 inhibitors like AZ’s own Imfinzi (durvalumab).
AZ has been seeking Imfinzi combinations which could help it gain on earlier-to-market rivals in the checkpoint inhibitor category, including Merck & Co’s Keytruda and Bristol-Myers Squibb’s Opdivo.
“This is an important scientific milestone as we continue to invest in innovation and advance our late-stage clinical development pipeline,” said Mondher Mahjoubi (pictured below), chief executive officer of Innate Pharma.
Mondher Mahjoubi
“Together with AstraZeneca, we are working diligently to progress this potential novel treatment for head and neck cancer patients, a population with a high unmet medical need,” he added.
The two companies are set to co-fund the trial, with Innate meeting 30% of the costs. The trial is set to begin in 2020, depending on regulatory and compliance approvals.
Also as part of the initial deal, AZ agreed to pay $50m for an option on anti-CD39 candidate IPH5201, which is in preclinical development and – like monalizumab – is thought to inhibit an immunosuppressive pathway in the tumour microenvironment.
For another $20m, AZ also gets an option on four other immuno-oncology molecules from Innate’s pipeline that have yet to be agreed.
AZ has suffered from numerous setbacks with Imfinzi – although it did score an encouraging approval in early-stage lung cancer last year which has helped to build momentum.
However, the drug also failed to hit the first of two primary endpoints in the MYSTIC trial of Imfinzi plus AZ’s experimental CTLA4 inhibitor tremelimumab in first-line lung cancer treatment.