PARIS– The monoclonal antibody SPK001, SpikImm’s lead candidate originally developed in the Humoral Immunology lab headed by Dr Hugo Mouquet at the Institut Pasteur (joint research unit Inserm), has demonstrated a potent and broad neutralization activity in vitro against SARS-CoV-2 and all variants of concern (including Delta and Omicron), as well as 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.
SPK001, is developed as a long-acting antibody with a convenient, intramuscular administration for the prevention of COVID19 (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 COVID19 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 COVID19 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.
“Antibody responses to the SARS-CoV-2 spike protein strongly contribute to long-term immune protection against severe COVID19. 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 COVID19 prevention in immunocompromised patients”. Said Dr. Hugo Mouquet, head of the laboratory of Humoral Immunology at Institut Pasteur
“We are thrilled with the promising results of SPK001 and would like to thank the Institut Pasteur and SpikImm teams for the hard work accomplished. SpikImm will continue, along with its partners to focus on its accelerated development plan, initiating clinical trials and making SPK001 available as soon as possible to patients.” Said Antoine Pau, acting CEO of SpikImm
“Monoclonal antibody therapy is one of the most efficient and safe approach to prevent COVID19 in immunocompromised patients unable to respond to vaccination. With these important results, SpikImm is now very well positioned to become a major player in COVID19 prevention for immunocompromised patients and will also explore potential strategic partnerships that could accelerate its development and support broad commercialization.” Said Philippe Pouletty, MD Chairman of SpikImm and CEO & co-founder of Truffle Capital
