AIM ImmunoTech Inc (NYSEAMERICAN:AIM) revealed growing cash on hand and updated investors on the advancement of its drug Ampligen as a treatment for the coronavirus (COVID-19) in a business and clinical update released Monday.
The company had cash, cash equivalents and marketable securities of $40.3 million as of June 30, nearly 5 times more than the $8.8 million it had at the end of 2019.
On the coronavirus front, Ampligen’s Phase 1/2a trial of ampligen with Roswell Park Comprehensive Cancer Center is on track to commence patient enrollment soon, the company said. The trial will examine Ampligen in combination with interferon alfa-2b in cancer patients with COVID-19.
Additionally, AIM recently signed a trilateral material transfer and research agreement with Japan's National Institute of Infectious Diseases and Shionogi & Co Ltd, a pharmaceutical company headquartered in Japan, to test Ampligen as a potential vaccine adjuvant for COVID-19. Ampligen has been shipped to Japan, to be followed up with an additional shipment.
"AIM is engaged in extremely important and potentially groundbreaking pre-clinical and clinical research in critical unmet medical needs such as COVID-19 and cancer-providing us ‘multiple shots on goal' within large addressable markets,” CEO Thomas Equels said in a statement.
READ: AIM ImmunoTech inks pact with Roswell Park to test Ampligen as part of an antiviral treatment combo for COVID-19 among cancer patients
"Given these multiple indications, AIM's strategy to support these trials has been to maximize third-party, non-dilutive funding directly awarded to the clinical sites, which we have accomplished in many of our trials,” Equels said. “We believe we are extremely well positioned to execute on our strategy going forward, which, in turn, we expect will drive significant value for stockholders."
Ampligen has also proven to be a powerful drug conferring protective survival in SARS animal experiments. The drug has shown heightened levels of activity in Phase 2 and 3 trials of patients with chronic fatigue syndrome (CFS). Ampligen is approved in Argentina for CFS, and the company is preparing to test the drug as a therapy for the fatigue-like illness induced by the coronavirus.
"There is a significant risk that SARS-CoV-2, the virus that causes COVID-19, will trigger a large number of chronic fatigue-like cases, similar to what occurred in the prior SARS-CoV-1 epidemic," Equels said.
Ampligen received clearance from Argentinian regulators to import the first shipment of commercial-grade vials of the drug. After a final inspection and release tests, the company hopes to receive approval for commercial sales.
"Ampligen's strong history of preclinical outcomes with the SARS-CoV-1 virus gives AIM hope for the drug's potential as a prophylaxis, as a vaccine adjuvant and as an early-onset treatment for the SARS-CoV-2 virus and for COVID-19-induced chronic fatigue-like illness,” Equels added. “This potential therapy may be especially important for cancer patients, who face significantly increased risk of severe symptoms or death from COVID-19."
On the cancer front, the National Cancer Institute recently issued an award of $14.5 million to Roswell Park to fund five clinical trials in melanoma, colorectal and ovarian cancers. These trials will test chemokine modulation incorporating Ampligen as an immuno-modulator, as part of a strategy to turn "cold" less responsive tumors into "hot" tumors.
"Given the advances in our third-party funded, investigator-sponsored cancer clinical trials, we believe there is real potential for AIM to become a powerhouse in oncology, as clinical data is reported in these trials,” Equels said. “The fact that tens of millions of dollars in grants have been provided to world-class investigator/oncologists at top national cancer centers, from such esteemed organizations as Merck, the US Department of Defense and the National Cancer Institute, clearly supports my faith in Ampligen."
Roswell Park and Moffitt Cancer Center have both received Breakthrough Awards from the DoD. Together, these clinical trials are receiving approximately $15 million in federal funding in part with a significant focus upon Ampligen as a potential synergistic agent in combination with several other immunotherapies, including pembrolizumab (Keytruda) and Intron A.
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