Embattled Cel-Sci to tackle COVID-19 with immunotherapy platform tech LEAPS

In 2018, Cel-Sci CEO Geert Kersten wrote a letter to skeptical shareholders asking that they keep the faith the company would be able to transform its three pipeline assets into successes. Now, it’s turning one of those projects—an immunotherapy technology called Ligand Epitope Antigen Presentation System (LEAPS)—against COVID-19.

Cel-Sci announced Monday it has formed a research partnership with the University of Georgia’s Center for Vaccines and Immunology to develop a drug candidate for patients at high risk of dying from COVID-19. The drug candidate will work by stimulating an immune response to COVID-19 without producing dangerous lung inflammation, the company said.

LEAPS is used to design peptide-based treatments that generate immune responses from specific cells or antibodies or both. In using the technology to tackle COVID-19, Cel-Sci and its academic collaborators plan to build upon preclinical data generated in the development of LEAPS therapies for H1N1, the highly lethal influenza A virus, and for herpes simplex virus. In the case of herpes, LEAPS peptides were able to produce a strong enough T-cell response to prevent the disease, or they could generate antibodies against the disease to prevent its spread if it had already started replicating in the body.

Cel-Sci has also generated LEAPS peptides to treat rheumatoid arthritis and shown in preclinical models that they relieve inflammation by activating CD8 T lymphocytes.

Cel-Sci plans to aim LEAPS peptides against antigens in the COVID-19 nucleoprotein, or NP, which is critical to the virus’ ability to replicate. Targeting the NP protein could prompt T cells to attack the virus “factories” inside infected cells, thus eliminating the source of COVID-19 and tamping down the infection.

It’s a different approach from that being pursued by other companies and academic research teams, many of which are focusing on the spike proteins that all coronaviruses have on their cell surfaces. Regeneron, for example, said last week it is designing antibodies that target the spike protein on COVID-19 in the hopes of preventing the virus from interacting with the host.

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Cel-Sci’s researchers believe targeting NP antigens may offer an advantage in that they are less likely than spike proteins to vary significantly from one viral strain to another, the company said.

The news comes at a critical time for Cel-Sci, which narrowly escaped a delisting from the New York Stock Exchange early last year. In his earlier letter to shareholders, Kersten promised an “inflection point” for the company’s immunotherapy drug to treat head and neck cancers, Multikine. But nine years after the start of the phase 3 trial, the company still hasn’t produced data from the study.

In another letter to shareholders, sent Feb. 26 of this year, Kersten said Cel-Sci is waiting for key events that need to happen before it can determine survival statistics from the treatment. “We believe that we are nearing the end of this long Phase 3 study, and we hope the results will prove that stimulating the immune systems of cancer patients with Multikine to fight cancer BEFORE they are ravaged by the effects of surgery, radiation, and chemotherapy will help these patients to survive longer,” he wrote.

The company’s LEAPS work had taken a back seat to Multikine until the University of Georgia collaboration came about. Cel-Sci will be working with Ted Ross, Ph.D., professor of infectious diseases at the university. “LEAPS has the potential to be a powerful tool against SARS-CoV-2, the causative agent of COVID-19, based on its dual anti-viral and anti-inflammatory properties,” Ross said in the statement.