SpikImm, a biotech company founded in 2021 by Truffle Capital in collaboration with the Institut Pasteur, has been awarded a €15 million non-dilutive financing from the French governmentFrance 2030 program for its "PROPHYMAB" project, which is supported as part of the "Emerging Infectious Diseases and CBRN Threats" Acceleration Strategy.
SPK001, the first treatment candidate (monoclonal antibody) against SARS-CoV-2, originally discovered by the Institut Pasteur's Humoral Immunology Laboratory, led by Dr Hugo Mouquet, has been tested in all four cohorts of healthy volunteers, and has demonstrated excellent safety and pharmacokinetics profile, in the Phase 1 clinical trial, which was recently labeled as a "national priority" by CAPNET (National Steering Committee for Therapeutic Trials and other Research on COVID-19). The second monoclonal antibody, SPK002, is currently in advanced regulatory preclinical development and is expected to enter the clinic in the second quarter of 2023.
SPK001 and SPK002 are intended for the prevention of COVID-19 "pre-exposure prophylaxis" in immunocompromised patients such as organ transplant patients, patients with hematologic malignancies, autoimmune diseases, or certain HIV patients, who are often poor or non-responders after a complete vaccination schedule (approximately 300,000 patients in France, 10 million in Europe and the United States). These patients represent 30 to 40% of all patients hospitalized for COVID-19 with a much higher level of severe forms and mortality than in the general population (risk multiplied by 2 to 4).
These antibodies have demonstrated potent in vitro neutralizing activity against SARS-CoV-2 and several variants of concern, as well as excellent in vivo therapeutic efficacy in reference animal models. The Phase 1 clinical study has already been successfully completed for SPK001. SpikImm plans to launch a Phase 2 trial in the second quarter of 2023 to demonstrate the medical benefit of SPK001 and/or SPK002 in immunocompromised patients. Depending on the results, SpikImm could seek Emergency Use Authorization in 2023.