Cel-Sci: LEAPS And COVID-19

Summary

• CEL-SCI announced that it is developing an immunotherapy for COVID-19 based on its LEAPS peptide technology.
• CEO  says the company is currently in talks with multiple healthcare partners to expeditiously develop the therapy.
• •LEAPS/COVID-19 technology has unique characteristics that give it favorable advantages in the COVID-19 management space.

About CEL-SCI

CEL-SCI is a small-cap market (~$500 million) clinical-stage cancer bio-pharmaceutical company. It has two products in the pipeline: Multikine and LEAPS.

Multikine, a cocktail combination of cytokines and chemokines, is a prospective neoadjuvant treatment and an investigational drug candidate in Phase III Event-Driven clinical development for newly diagnosed advanced primary head and neck cancer.

The goal of Multikine is to boost the body's immune system prior to Standard of Care (“SOC”). The Event-Driven Phase III study is fully enrolled with 928 patients, and the last patient was treated in September 2016.

To prove an overall survival benefit, the study requires CEL-SCI to wait until 298 events (deaths) have occurred among the two main comparator groups. We believe that this 9-year Phase III trial has just ended or will end very soon. Thus, top line results are imminent.

But Multikine was really the only game in town, until today!

LEAPS

LEAPS has been on the back-burner for years so that the company could focus on Multikine.

The Ligand Antigen Epitope Presentation System ("LEAPS") platform technology has demonstrated in several animal models the ability to design antigen-specific immunotherapeutic peptides that preferentially direct the immune response to a cellular (e.g., T-cell), humoral (antibody) or mixed response and are also capable of enhancing important T-regulatory (Treg) responses. Therefore, the LEAPS technology provides the opportunity to develop immunotherapeutic products for diseases for which disease associated antigenic peptide((s)) sequences have already been identified, such as: a number of infectious diseases, some cancers, autoimmune diseases (e.g., RA), allergic asthma and allergy, select CNS diseases (e.g., Alzheimer's) and the COVID-19 virus.

The Company's LEAPS technology is also being developed as a therapeutic vaccine for rheumatoid arthritis and is supported by $1.5 million grant for IND enabling studies from the National Institute of Arthritis and Musculoskeletal and Skin Diseases.

Zacks recently did a nice write-up of it as well.

The Press Release

CEL-SCI announced on March 9th 2020 that it is in

discussion with multiple health care partners to expeditiously develop an immunotherapy with the potential to treat COVID-19 using its patented LEAPS technology."

Partners bring in cash and awareness. Expect more Press Releases in the coming weeks for further developments on partners.

LEAPS/COVID-19 may act as both a treatment and as a vaccination

This is important as it puts LEAPS/COVID-19 in an exclusive space in the management of the COVID-19 outbreak.

The LEAPS peptides will utilize conserved regions of coronavirus proteins to stimulate protective cell-mediated T-cell responses and reduce viral load. The LEAPS technology can be used to construct immunotherapeutic peptides that exhibit both antiviral and anti-inflammatory properties. Consequently, these products not only can be used to treat an active viral infection, but can also elicit the appropriate protective response against COVID-19.

Human trials to ascertain treatment efficacy will likely take less time than trials for vaccination efficacy; resulting in a near first-to-market treatment.

Due to ethical constraints, human subjects treated with prospective vaccines would not be introduced to the COVID-19 virus. The result is that determination of vaccine efficacy will take longer, as patients are vaccinated and observed against a control group.

LEAPS/COVID-19 could be used as a treatment to those who have been exposed to COVID-19. The treatment effect would be evaluable within days; resulting in a faster path to market.

CEL-SCI CEO Geert Kersten said, “CEL-SCI is currently in discussion with multiple health care partners to expeditiously move this critically important work forward. We look forward to combining the LEAPS technology, experience and expertise of CEL-SCI with the expertise of various partners to promote the rapid development of a LEAPS/COVID-19 product to help particularly those patients who are at very high risk from COVID-19 infection.”

LEAPS has evidence of treatment efficacy by activating T-cell response rather than inflammatory response. It is thought that the morbidity and mortality in the at-risk population is due to lung damage resulting from inflammatory immune responses to the virus.

Leveraging LEAPS technology against COVID-19 coronavirus are based on previous studies conducted in collaboration with the National Institutes for Allergies and Infectious Diseases (NIAID) with a different respiratory virus, pandemic influenza (H1N1). In those studies, LEAPS peptides elicited protection of mice from morbidity and mortality after the introduction of infection by activating appropriate T-cell responses rather than an inflammatory response.

COVID-19 is particularly problematic in the elderly and individuals with compromised lung function or immunosuppression. It is believed that, in most cases, onset of symptoms takes between 2 and 14 days post infection, a period of time that may allow intervention for those at highest risk and with a known exposure.

Daniel Zimmerman, Ph.D. Senior VP of Research, Cellular Immunology at CEL-SCI Corporation, said, ”We believe that a LEAPS COVID 19 coronavirus peptide will reduce or arrest the progression of the virus infection and prevent tissue damage from inflammation resulting from lung infection by the virus. In short, we believe that we can stimulate the correct immune responses to the virus without producing unwanted inflammatory responses associated with lung tissue damage. That should be particularly important in the older population who is at highest risk of dying from this virus.”

The initial limited supply can be prioritized to patient treatment, mitigating the inherent controversy of who will receive a limited supply of vaccinations.

LEAPS Mechanism of Action

LEAPS Mechanism of Action is more likely to treat the inevitable variants of COVID-19 than a traditional antibody mediated vaccine.

LEAPS targets antigens within the NP protein of COVID-19 that produce cytolytic T-cell responses. Unlike the mechanism behind antibody based vaccines, these antigens are less variable between viral strains and less likely to change in response to antibodies elicited by prior infection or other vaccines.

COVID-19 may become the 5^th endemic coronavirus, requiring vaccination and treatment past 2020, and perhaps the need for recurring vaccinations.

Several experts believe that COVID-19 will become endemic. Dr. Amesh Adalja, an infectious disease specialist at the Johns Hopkins Center for Health Security said, “We know that respiratory viruses are especially difficult to control, so I think it’s very possible that the current outbreak ends with the virus becoming endemic.”

Stephen Morse of Columbia University’s Mailman School of Public Health, an epidemiologist and expert on emerging infectious diseases, said, “I can imagine a scenario where this becomes a fifth endemic human coronavirus.”

Richard Webby, an expert at St. Jude Children’s Research Hospital said, “The toll of a seasonal-flu-like coronavirus also depends on immunity — which is also scientifically uncertain. Exposure to the four endemic coronaviruses produces immunity that lasts longer than that to influenza, but not permanent immunity. Like respiratory syncytial virus, which can re-infect adults who had it in childhood, coronavirus immunity wanes.”

Conclusion

Biotechnology is risky, and so is investing in it. A majority of all biotech trials fail.

We believe that CEL-SCI is deeply undervalued and adding LEAPS into the mix creates an amazing opportunity for investors

Analyst’s Disclosure: I am/we are long CVM. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.