Innate Pharma has announced that its partner AstraZeneca will advance monalizumab into a Phase III randomised clinical trial.
The Phase III clinical trial will evaluate the safety and efficacy of monalizumab in combination with cetuximab in patients with squamous cell carcinoma of the head and neck (SCCHN).
Monalizumab is a potential checkpoint inhibitor targeting NKG2A receptors expressed on tumour-infiltrating cytotoxic CD8+ T cells and NK cells while cetuximab is an anti-EGFR monoclonal antibody.
The companies will co-fund the trial, which is expected to be initiated in 2020 following regulatory and compliance approvals.
In 2015, Innate Pharma signed a co-development and commercialisation agreement with AstraZeneca to speed up the development of the drug.
Speaking on the current development, Innate Pharma chief executive officer Mondher Mahjoubi said: “This is an important scientific milestone as we continue to invest in innovation and advance our late-stage clinical development pipeline. 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.”
Under the 2015 agreement, Innate will receive potential cash payments of up to $1.275bn from AstraZeneca.
So far, Innate has received $350m, and will receive the next payment of $100m upon dosing of the first patient in a first Phase III trial.
Under the agreement, AstraZeneca will record all sales and will pay low double-digit to mid-teen percentage royalties to Innate on net sales across the world except Europe.
In Europe, Innate Pharma will receive a 50% share of the profits and losses.
Innate will be responsible for co-funding 30% of the costs of the Phase III trial of the drug with a pre-agreed limitation of its financial commitment.
In October 2018, AstraZeneca has received full oncology rights to monalizumab through the 2015 agreement. The ongoing Phase II clinical trial is aimed at evaluating monalizumab in combination therapies.