As we all navigate the COVID-19 pandemic we want to focus on everything we can do for our patients, our employees and their families, and the communities where we live and work to help limit the spread of the virus.
Below are the current activities the Company is taking to address the COVID-19 pandemic. We want to be timely and transparent in providing updates to our external stakeholders. We are closely monitoring the rapidly evolving environment, and will continue to provide relevant information on this Web site page as the situation evolves.*
Innate Pharma takes the health and safety of its employees and their families very seriously. In alignment with recommendations from French and US government agencies, all employees who can work from home will do so until further notice and will use digital and virtual tools to ensure business continuity.
Our Marseille offices and laboratories are now open in a limited capacity, in line with recommendations from French government agencies. To respect safety measures, work in our labs have been re-organized, and we have limited the number of people on-site to respect social distancing efforts. We have also implemented strict health safety measures for all on-site employees.
We will continue to evolve our plans in line with the government measures taken in France and the US.
Our clinical development activities are critical to deliver innovative medicines to patients. Currently, there is varying impact to our clinical trials in relation to COVID-19. We anticipate the impact on trial enrollment and protocol adherence will most likely vary from site to site and country by country. However, we are working to minimize disruption as much as possible. We are in regular contact with our study investigators, contract research organizations (CROs) and partners, and are closely monitoring the situation as it evolves.
The Phase I clinical trial evaluating IPH5201 (an anti-CD39 blocking monoclonal antibody) in adult patients with advanced solid tumors has reactivated, following a temporary pause due to the COVID-19 pandemic.
Given our scientific expertise in innate immunity, we have been conducting an exploratory translational study, called EXPLORE COVID-19, in collaboration with La Timone, North and Laveran hospitals and the Marseille Immunopôle/AP-HM immunoprofiling laboratory at La Timone hospital, Marseille, to analyze immune cells in COVID-19 patients at different stages of the disease.
Through this analysis, scientists' goals is to better understand the impact of the immune response on the evolution of COVID-19 and pathways able to modulate this response. This has included a focus on Innate Pharma targets that may have a role in controlling viral infection or SARS-Cov2-induced inflammation.
Please click here to read the press release that was issued on April 3, 2020.
EXPLORE Study Results
On May 7th, results from the EXPLORE translational study were published via the Research Square open access platform. This research revealed several key findings.
Researchers reported an increase in soluble C5a, a highly inflammatory peptide of the complement cascade, which was elevated based on the severity of the disease in patients with pneumonia and acute respiratory distress syndrome (ARDS). This is in line with the key role of the C5a/C5aR pathway in the initiation and maintenance of inflammatory responses, by recruiting neutrophils and monocytes in the lungs. Avdoralimab, a clinical-stage anti-C5aR1 therapeutic monoclonal antibody, prevents C5a-induced myeloid cell recruitment and activation. Based on these findings, we announced the start of a Phase II clinical trial with avdoralimab to test its potential to reduce the inflammatory response in the lungs (further detail below – FORCE Study).
In addition, lymphocyte characterization showed an increase in expression of the CD39, NKG2A and PD-1 inhibitory receptors on natural killer (NK) cells, suggesting that blocking therapeutic antibodies targeting these molecules already used for cancer immunotherapy could be developed in COVID-19. These results support exploring blocking therapeutic antibodies targeting these molecules in COVID-19 (see below – IMMUNONCOVID-20 Study).
Please click here to read the press release issued on May 8, 2020.
On April 28, 2020, we announced that the first patient was dosed in a randomized, double-blind Phase II clinical trial, evaluating the safety and efficacy of our anti-C5aR antibody, avdoralimab, in COVID-19 patients with severe pneumonia.
The primary objective of this investigator-sponsored trial, named FORCE (FOR COVID-19 Elimination), is to improve the proportion of COVID-19 patients with severe pneumonia who no longer need to be hospitalized, and to reduce the need for and duration of mechanical ventilation in patients with COVID-19 pneumonia complicated by ARDS.
Please click here to read the press release.
A controlled, randomized, study will explore monalizumab and avdoralimab, amongst other treatment arms, to investigate the potential efficacy against COVID-19 in cancer patients with mild symptoms and pneumonia respectively.
The main objective of this study, sponsored by Centre Léon Bérard, Lyon, named IMMUNONCOVID-20, is to compare versus standard of care short-term mortality rates in advanced or metastatic cancer patients who are positive for COVID-19 treated with a chloroquine analog (GNS561), an anti-PD1 (nivolumab), an anti-NKG2A (monalizumab), an anti-IL-6R antibody (tocilizumab) or an anti-C5aR (avdoralimab).
At this time, there is no impact on the integrity of our supply chain due to COVID-19. We will continue to closely monitor supply chain operations.
Innate has recently donated approximately 3,000 masks to the ICU department at the Timone Hospital in Marseille, France. The masks will provide support to local healthcare workers and other first-line responders battling the COVID-19 pandemic.
* If any event arises to a higher level of materiality, we will issue a press release in compliance with our regulatory obligations.