AIM ImmunoTech developing immuno-therapeutics to treat cancer and fight coronavirus

Lead drug Ampligen in clinical trials to address both chronic fatigue syndrome and to treat multiple cancers Clinical trial also widened to include cancer patients suffering from long-term effects of coronavirus Positive results from a pancreatic cancer Early Access Program (EAP) evaluating Ampligen in the Netherlands. What AIM ImmunoTech does: AIM ImmunoTech Inc. (NYSEAMERICAN:AIM) is an immuno-pharma company headquartered in Ocala, Florida which is focused on the research and development of therapeutics to treat multiple types of cancers, as well as immune-deficiency disorders. It has established a strong foundation of laboratory, pre-clinical and clinical data with respect to the development of nucleic acids and natural interferon to enhance the natural antiviral defense system of the human body and to aid the development of therapeutic products for the treatment of certain cancers and chronic diseases. The group’s lead drug Ampligen (rintatolimod) is an experimental ribonucleic acid (RNA) that is in clinical trials to address both chronic fatigue syndrome and to treat multiple cancers. However, a study has also shown that Ampligen can decrease the infectious viral yield of coronavirus (COVID-19) trigger SARS-CoV-2 by 90% (in an vitro model). In conjunction with the Institute for Antiviral Research at Utah State University, the company tested intranasal Ampligen and found that dramatic reduction in viral yield could be achieved at clinically achievable dosage levels. How is it doing: AIM ImmunoTech entered 2021 with cash, cash equivalents, and marketable securities of $54.4 million --  a telling increase compared to the $8.8 million on-hand at the start of 2020. The runway is plenty sufficient to support the company's advancement of Ampligen.  Meanwhile, given the deadly pandemic sweeping the world, it is no surprise that the focus for AIM ImmunoTech recently has been on using Ampligen in the fight against coronavirus (COVID-19). On February 16, the company said it has received approval from the required Ethics Committee in the Netherlands to commence its Phase 1 clinical study on the safety of Ampligen as an intranasal therapy. The company said this is a critical step in its ongoing efforts to develop Ampligen as a potential prophylaxis or treatment for coronavirus (COVID-19) and other respiratory viral diseases. Earlier this year, the company announced that it had entered into a sponsorship agreement with the Centre for Human Drug Research (CHDR) for the proposed AMP-COV-100 (CHDR2049) trial. CHDR, an independent institute located in Leiden in The Netherlands, will conduct and manage the proposed clinical study titled “A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Activity of Repeated Intranasal Administration of Ampligen (Poly I:Poly C12U) in Healthy Subjects.”  The current study has enrolled eight healthy subjects in each of four Ampligen treatment groups and eight placebo subjects, for a total of 40 healthy subjects. This will assess the safety, tolerability and biological activity of repeated administration of Ampligen intranasally. The subjects will receive intranasal dosing every other day for 13 days, for a total of seven doses each, and the first patient has been dosed. And in January, AIM ImmunoTech said its active AMP-511 Expanded Access Program (EAP) had dosed its first coronavirus 'Long Hauler' patient with Ampligen. The company said the initial dosing marked a significant milestone in its efforts to develop an effective therapeutic for people suffering from post-COVID-19 infection chronic fatigue-like symptoms. Additional patients are in the process of being enrolled.  The Ampligen EAP protocol is authorized at any one time to enroll up to 100 active Chronic Fatigue Syndrome trial participants, 20 of whom may be Long Haulers. All study subjects will receive the same Ampligen treatments.  Cancer fight going on too Away from coronavirus, on the cancer front, on February 24,  AIM ImmunoTech announced that its subsidiary NV Hemispherx Biopharma Europe had received formal notification from the European Commission approving the company’s Orphan Medicinal Product Application for Ampligen as a treatment for pancreatic cancer. The company noted that medications designated as Orphan products by the European Medicines Agency (EMA), once commercially approved in the European Union (EU), receive benefits including up to 10 years of protection from market competition from similar medicines with similar active components and indication-for-use that are not shown to be clinically superior. Orphan medicinal product designations promote the clinical development of drugs that target rare life-threatening conditions, and which are expected to provide significant therapeutic advantage over existing treatments. The EMA designation follows a similar approval from the US Food and Drug Administration (FDA) in December last year, which also awarded AIM ImmunoTech with orphan drug designation status for Ampligen as a treatment for pancreatic cancer. The FDA orphan designation followed the company’s September 2020 announcement of statistically significant positive pancreatic cancer survival benefit in the Ampligen arm as compared to a historical control cohort seen in a multi-year Early Access Program conducted at Erasmus University Medical Center.  The use of Ampligen following the current standard of care for pancreatic cancer (FOLFIRINOX) yielded an overall survival of 19 months, 7.9 months greater than FOLFIRINOX treatment alone, AIM ImmunoTech said. On February 10, the company said the Dutch Health and Youth Care Inspectorate (IGJ) had approved use of its treatment for six pancreatic cancer patients as part of a new, follow-up Early Access Program at Erasmus Medical Center in the Netherlands. Subject to further authorization, AIM ImmunoTech said it plans to treat up to 16 pancreatic cancer patients with Ampligen under the program, which follows the success of a previous multi-year Ampligen Early Access Program for pancreatic cancer patients at Erasmus.  The new approval was designed to include several patients treated under the previous program, who are still alive despite their diagnoses several years ago of locally advanced or metastatic pancreatic cancer, the company noted. AIM ImmunoTech announced on September 22, 2020, that the initial Early Access Program had demonstrated statistically significant positive pancreatic cancer survival benefits in its Ampligen arm, as compared to a historical control cohort. The use of Ampligen, following the current standard of care for pancreatic cancer (FOLFIRINOX), yielded an overall survival of 19 months, or 7.9 months greater than FOLFIRINOX treatment alone. This new group will help focus on immunological markers which will aid in identifying high-level Ampligen responders. Inflection points: News on Phase 1 clinical study on the safety of Ampligen as an intranasal therapy Progress in AMP-511 Expanded Access Program for coronavirus “Long Hauler” patients Advance of plans to treat up to 16 pancreatic cancer patients with Ampligen under the Dutch Early Access Program What the boss says: “We are proud to have achieved a number of important milestones throughout 2020 and believe we have a number of key upcoming catalysts," said CEO Thomas Equels after the company released 2020 earnings recently.  "We are conducting important and potentially groundbreaking pre-clinical and clinical research in critical unmet medical needs within large addressable markets. We are in a solid financial position that enables us to continue to execute on our corporate strategy without relying on third-party grants or assistance. Our strong balance sheet also allows us to accelerate our clinical trials without the need to wait for grants. We look forward to updating stockholders and the market as developments unfold.” Contact the author: patrick@proactiveinvestors.com Follow him on Twitter @PatrickMGraham