SPK001, the monoclonal antibody developed by SpikImm, a biotech company founded by the Institut Pasteur and Truffle Capital, has demonstrated a potent and broad neutralization activity across all SARS-CoV-2 variants of concern, including omicron (BA.1 and BA.2). Originally developed in the Humoral Immunology lab headed by Dr Hugo Mouquet at the Institut Pasteur (joint research unit Inserm), SPK001 has also demonstrated in vivo prophylactic and therapeutic efficacies in mouse and hamster models. As most monoclonal antibodies commercially-available and in clinics partially or completely lost their effectiveness against omicron variants BA.1 and BA.2 (dominant worldwide since Dec 2021), SPK001 now appears as one of the most promising mAbs.
Results are available as preprint and have been submitted in an international peer-reviewed journal.
SpikImm expects to initiate clinical trials mi-2022.
SPK001, is developed as a long-acting antibody with a convenient, intramuscular administration for the prevention of COVID-19 (pre-exposure prophylaxis) in immunocompromised patients unable to mount a protective antibody response after vaccination. There is a major unmet medical need for the prevention of COVID-19 in immunocompromised patients such as transplant patients, patients with hematologic cancer or autoimmune diseases (around 300,000 patients in France, 3 M in Europe and 7 M in the US). These patients represent 30 to 40% of all patients hospitalized for COVID-19 with high mortality risk, since a significant portion of them cannot mount sufficient immune responses after vaccination.
SpikImm expects to initiate clinical trials mid-2022 and then, to demonstrate the medical benefit in a phase 2 in immunocompromised patients. Depending on the results, SPK001 may seek Emergency Use Authorization (EUA) as from Q2 2023.
Dr. Hugo Mouquet, head of the laboratory of Humoral Immunology at Institut Pasteur, and Scientific Director of SpikImm, states:
“Antibody responses to the SARS-CoV-2 spike protein strongly contribute to long-term immune protection against severe COVID-19. SPK001 was selected among hundreds of screened anti-SARS-CoV-2 monoclonals, and cross-neutralizes all SARS-CoV-2 variants of concern including Delta, Omicron BA.1 and BA.2. With its breadth and potency, documented by strong structural data, SPK001 appears as a prime candidate for COVID-19 prevention in immunocompromised patients”.