Many immunocompromised patients (organ transplant patients, patients suffering from hematologic malignancies, auto-immune diseases or certain HIV patients) respond only poorly or partially to Covid-19 vaccines. They represent, however, 300,000 individuals in France, 10 million throughout Europe and the USA and 30 to 40% of all patients hospitalized for Covid-19.
This is why Phase 1 of the clinical trial on monoclonal antibody SPK001 has been labeled a “national priority” by the CAPNET (National Steering Committee for Therapeutic Trials and other Research into Covid-19). Discovered by the Humoral Immunology Laboratory of the Institut Pasteur, headed by Dr. Hugo Mouquet (Inserm Joint Research Unit), SPK001 has demonstrated activity, excellent safety and a very favorable pharmacokinetics profile. SPK002 is currently in advanced regulatory preclinical development and is expected to enter the clinic in the second quarter of 2023. SpikImm has obtained an exclusive worldwide license for a series of broad spectrum antibodies with high potential, developed by Hugo Mouquet’s teams.
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 on reference animal models.
“Organ transplant patients, who suffer from cancer and are immunocompromised in general, and who are at high risk of developing a serious form of Covid-19, are entitled to be as well protected as healthy vaccinated subjects. Currently, with the new variants, these patients have few alternatives. Our broad spectrum antibodies are considered to be one of the safest methods, with regard to tolerance and long-term protection,” Dr. Philippe Pouletty, Chairman of SpikImm, CEO and Co-founder of Truffle Capital.
The two monoclonal antibodies developed by SpikImm are administered as a prophylactic. SPK001 and SPK002 could, according to SpikImm, become “the new standard in the prophylaxis of Covid-19”, in particular because they are claimed to be effective over the long term (6 month) and against currently known variants. “The project, although very promising, is not without its risks. It requires additional clinical stages before it can be confirmed,” said Dr. Pouletty. The collaboration with Hugo Mouquet’s laboratory and the Institut Pasteur is therefore continuing, not only for Covid-19 but also for the possible future development of antibodies in other respiratory diseases.
Phases 2 of SPK001 and SPK002 will start over the second quarter of 2023, as a multicentric trial. If these phases prove conclusive, the antibodies may benefit from early access authorization and be marketed as early as the end of 2023, thus making up for the lack of an effective medical response to protect immunocompromised patients. “Due to a lack of activity on the new variants, there are currently no authorized therapeutic or prophylactic antibodies,” Antoine Pau, CEO of SpikImm and Senior partner at Truffle Capital pointed out.
In early December, SpikImm announced that its PROPHYMAB project would be supported by the France 2030 relaunch program in connection with the “Emerging Infectious Diseases and CBRN (chemical, biological, radiological and nuclear) Threats Acceleration Strategy”. €15 million are available to accelerate the clinical development and industrialization of antibodies, with the partner LFB. Other investors, both institutional and private, will supplement the financing requirements by means of a fundraising round.
The SpikImm teams have welcomed this State aid enthusiastically. “We are very happy to receive the support of France 2030 and Bpifrance. Their experts analyzed the project quickly and effectively and ANSM (Agence nationale de sécurité du médicament et des produits de santé) was very responsive to our needs,” said Philippe Pouletty.
SpikImm was created by Truffle Capital in April 2021, an investment fund that bets on companies that it founds or co-founds that “have a strong interest in human health or the health of the planet, and that focus on very high-level science that meets essential needs,” said Dr. Philippe Pouletty. These companies include Carmat (artificial heart), Carbios (enzymatic processes for biodegradation and biorecycling of plastics), Abivax (new treatments for inflammatory diseases, viral diseases and cancer) or Diaccurate (new drugs to treat breast cancer and certain leukemias).