SpikImm's monoclonal antibody has demonstrated a potent and broad neutralization activity across all SARS-CoV-2 variants of concern
"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.”
Philippe Pouletty, MD Chairman of SpikImm and CEO & co-founder of Truffle Capital
SPIKIMM, A BIOTECH COMPANY FOUNDED BY TRUFFLE CAPITAL AND INSTITUT PASTEUR, ANNOUNCES THAT SPK001, ITS MONOCLONAL ANTIBODY HAS DEMONSTRATED A POTENT AND BROAD NEUTRALIZATION ACTIVITY ACROSS ALL SARS-COV-2 VARIANTS OF CONCERN, INCLUDING OMICRON (BA.1 AND BA.2)
▪ RESULTS ARE AVAILABLE AS PREPRINT AND HAVE BEEN SUBMITTED IN ANINTERNATIONAL PEER-REVIEWED JOURNAL.
▪ SPIKIMM EXPECTS TO INITIATE CLINICAL TRIALS MID-2022
Paris, April 12th, 2022
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.