Investors have sent shares of three biopharmas zooming since Friday afternoon based on announcements that they are developing treatments for SARS-CoV-2, the virus at the center of the global COVID-19 outbreak—while a U.S./Australian biopharma today disclosed plans to advance a nanobody-based treatment candidate into clinical trials next month.
The largest increase—67% in early market trading as of 9:50 am, to $3.50 from Friday’s close of $2.10 a share—was enjoyed by AIM ImmunoTech after the Ocala, FL, drug developer focused on immune disorders said today that Japan’s National Institute of Infectious Diseases (NIID) will begin testing the company’s marketed drug Ampligen (rintatolimod) as a potential treatment for COVID-19. The experimental program will be conducted at both the NIID and the University of Tokyo.
AIM CEO Thomas K. Equels said in a statement that the company and NIID can draw upon data from prior studies in mice of Ampligen in SARS-CoV-1, which he said may predict similar protective effects against the novel coronavirus. In those studies, according to Equels, Ampligen showed excellent antiviral activity against SARS-CoV-1: 100% of Ampligen-treated mice survived, while none of the untreated mice survived.
“Because SARS-CoV-2 shares many critical similarities with SARS-CoV-1, Ampligen may have an important role to play in developing a protective early-onset therapy for this new highly pathogenic coronavirus in humans, where currently there is no known effective therapy,” Equels said. “We are proud to work with Japan’s universally esteemed NIID in the battle to curb this emerging potential pandemic.”
AIM’s testing and research are being conducted by Hideki Hasegawa, MD, PhD, Director of the NIID’s Influenza Virus Research Center, and Director of the World Health Organization (WHO) Collaborating Centre for Reference and Research on Influenza, Tokyo; and Takeshi Ichinohe, PhD, Department of Pathology at the NIID, Department of Biological Science and Technology, Tokyo University of Science.
Ampligen is one of 35 treatments in development for COVID-19 that were highlighted by GEN in an A-List published last week.
In that list, GEN also mentioned Cocrystal Pharma after it agreed to license proprietary broad-spectrum antiviral compounds for COVID-19 and norovirus from Kansas State University Research Foundation (KSURF). Cocrystal’s technology is designed to generate a 3D structure of inhibitor complexes at near-atomic resolution, enabling the company to identify novel binding sites.
‘Crystal’ clear
Cocrystal shares leaped 34% this morning in early trading, to $1.57 from Friday’s close of $1.14, after the Bothell, WA-based company announced the initiation of a COVID-19 treatment program, saying that it intended to pursue R&D of the antiviral compounds licensed from KSURF, including preclinical and clinical development.
“We are aggressively pursuing the development of novel antiviral compounds for the treatment of Coronavirus infections using our established proprietary drug discovery platform,” Cocrystal Chairman and CEO Gary Wilcox, PhD, stated Friday after the close of financial markets. “Given the global threat of COVID-19, our primary goal is to advance our Coronavirus program into preclinical development.
Cocrystal will seek opportunities for collaborations as it advances its COVID-19 programs, Wilcox added.
A third company, Vienna-based CEL-SCI, said today it will develop an immunotherapy with the potential to treat COVID-19 using its patented Ligand Antigen Epitope Presentation System (LEAPS) peptide platform technology. According to CEL-SCI, LEAPS has shown in several animal models the ability to design antigen-specific immunotherapeutic peptides that preferentially direct the immune response to a cellular, humoral (antibody) or mixed response and are also capable of enhancing important T-regulatory (Treg) responses.
LEAPS and trials
As a result, CEL-SCI reasons, LEAPS offers an opportunity to develop immunotherapeutic products for diseases for which disease associated antigenic peptide(s) sequences have already been identified—not only COVID-19, but several other infectious diseases, some types of cancer, allergic asthma and allergy, select CNS diseases such as Alzheimer’s, and autoimmune diseases such as rheumatoid arthritis. CEL-SCI has been awarded a $1.5 million grant by the NIH’s National Institute of Arthritis and Musculoskeletal and Skin Diseases toward IND-enabling studies of a LEAPS-based treatment in arthritis.
The proposed LEAPS peptides will be directed towards antigens within the NP protein of COVID-19 that elicit cytolytic T cell responses. Such responses attack the virus infected cellular “factories” within the infected host in order to eliminate the source of virus and help subdue the infection. Unlike glycoprotein spike antigens which are important for antibody-based vaccines, the LEAPS peptide antigens are less variable between viral strains and less likely to change in response to antibodies elicited by prior infection or other vaccines, CEL-SCI said.
CEL-SCI said it will use LEAPS since it has shown in animals the ability to elicit both a cell mediated antiviral response and an anti-inflammatory immunomodulating response by activating CD8 T lymphocytes.
In previous studies, the company noted, LEAPS immunogens prevented lethal infection by herpes simplex virus (HSV) and influenza A, and stopped the inflammatory disease progression of rheumatoid arthritis in animal models. LEAPS peptides directed against HSV showed that the T cell response was sufficient to prevent viral disease, with anti-viral antibody generated to further control the spread of the virus if there was residual virus production.
“CEL-SCI is currently in discussion with multiple healthcare partners to expeditiously move this critically important work forward,” CEL-SCI CEO Geert Kersten stated. “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.”
Vienna-based CEL-SCI shares climbed 17% in premarket trading before settling down to $14.00 in early trading, up about 2% from Friday’s close of $13.75.
Also this morning, Beroni Group of New York and Sydney said it is partnering with Tianjin University in China begin cytological experiments this month for a nanobody-based COVID-19 treatment—to be followed by animal experiments, then clinical trials which are expected to occur in April.
Beroni said research teams from the company and the university have obtained information on the coronavirus nanobody sequence and the complex crystal structure of SARS-CoV-2, and have already studied the biochemical characterization of the modified nanobody.
“As the novel coronavirus is now spreading globally, we are leveraging our talents and international government relationships to expedite the clinical study protocol so we can quickly produce a medical solution to help stop the spread of this infectious disease,” Jacky Zhang, chairman and CEO of Beroni Group, said in a statement. “We are confident of finding a long-term solution for the coronavirus using nanobody technology.”
