Trial in Progress of Antibody Blocking Covid-19 in Immunocompromised

(Gerd Altmann, Pixabay)

20 Oct. 2022. A clinical trial is underway testing a synthetic antibody designed to prevent SARS-CoV-2 viral infections in people with compromised immune systems. The experimental monoclonal antibody is developed by SpikImm SAS, a one year-old enterprise in Paris spun-off from Institut Pasteur, an infectious disease research center, licensing discoveries from one of the institute’s labs.

While the availability of vaccines and boosters has diminished the overall threat of infections from the SARS-CoV-2 coronavirus responsible for Covid-19, people with compromised immune systems remain at increased risk of serious disease, even if fully vaccinated. People with impaired immune systems include those with diseases such as autoimmune disorders, cancer, or HIV, as well as people with organ transplants, inherited immune system deficiencies, or taking drugs to suppress immune responses as part of treatments for other diseases. Treatment guidelines in the U.S. recommend immunocompromised individuals receive extra Covid-19 vaccine doses, take antiviral drugs, or receive monoclonal antibodies such as Evusheld to prevent infection.

SpikImm was founded to advance research from the lab at Institut Pasteur led by immunologist Hugo Mouquet that studies responses to viruses by B-cells in the immune system. Mouquet and colleagues investigate various B-cell responses invoked by monoclonal antibodies that produce specific, highly target antigens. The lab’s research so far identified unique B-cell fingerprints at the molecular and functional levels — e.g., effects on cells and tissue — for HIV, hepatitis, Chikungunya, and SARS-CoV-2 viruses.

Advancing two monoclonal antibody candidates

SpikImm was created last year by technology venture investor Truffle Capital in Paris. The company has an exclusive license for research on SARS-CoV-2 monoclonal antibodies at Institut Pasteur, with Mouquet as its chief scientist. In June 2022, a team led by Mouquet published preclinical findings in the Journal of Experimental Medicine showing an experimental monoclonal antibody elicited immunoglobulin A and G antibody responses in lab animals that neutralize a broad range of SARS-CoV-2 types, including Omicron BA.1 and BA.2 variants responsible for recent Covid-19 infection outbreaks in Europe and North America.

Based on these and other preclinical studies, SpikImm is advancing two antibodies code-named SPK001 and SPK002 as pre-exposure prevention candidates against SARS-CoV-2 viruses. The new early-stage clinical trial, says the company, is testing SPK001 among four different groups of healthy volunteers for safety and potential medical benefits, of which three groups are now underway. However, the study is not yet listed with either ClinicalTrials.gov in the U.S. or the European clinical trial registry.

The company says initial results from trial show the volunteer recipients are tolerating SPK001 doses. Mouquet says in a SpikImm statement released through BusinessWire, “The excellent tolerability demonstrated by the first cohorts of volunteers tested is very encouraging for further clinical trials of SPK001.” He notes that “SpikImm has one of the most promising antibody portfolios competing with very limited prophylactic and therapeutic monoclonal antibody options worldwide since the advent of Omicron.”

SpikImm’s chief medical officer Karine Lacombe — also professor of infectious diseases at the Sorbonne — adds, “We are already well advanced in preparing for the Phase 2 [mid-stage] clinical trial, which could begin in the first quarter of 2023.”

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