On November 15, 2022 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company"), an immune-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus, reported its financial results for the third quarter 2022 and provided a business update (Press release, AIM ImmunoTech, NOV 15, 2022, View Source [SID1234624097]).
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"Over the course of 2022 and throughout this past quarter, we have remained focused on successfully executing on our clinical development programs. I am incredibly pleased with the progress we’ve made and am excited for what remains ahead of us. Not only have we delivered on our commitments by initiating studies, but we have also commenced enrollment and are on track to reach targeted milestones that lay on the horizon. As we enter the final stretch for 2022, I believe we are well-positioned to reach the value-driving catalysts across our pipeline. We have been, and will continue to be, committed to generating near- and long-term value for all stakeholders," commented Thomas K. Equels, Chief Executive Officer of AIM.
Recent Highlights
Presented positive data from research led by Roswell Park Comprehensive Cancer Center medical oncologist, Shipra Gandhi, MD, evaluating Ampligen (rintatolimod) as a component of a CKM regimen for the treatment of early-stage triple negative breast cancer (TNBC) at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting.
Received Orphan Drug Designation for Ampligen (rintatolimod) for the treatment of Ebola Virus Disease.
Announced FDA clearance of IND application to evaluate Ampligen in Phase 2 clinical study for the treatment of post-COVID conditions.
Commenced enrollment with study collaborator, Roswell Park, in an NCI-funded Phase 2 clinical trial evaluating Ampligen in primary PD-1/PD-L1 Resistant Melanoma.
Announced commencement of Phase 2 study of Ampligen for the treatment of Pancreatic Cancer.
Clinical Program Update
Ampligen (rintatolimod): dsRNA being developed for globally important cancers, viral diseases and disorders of the immune system
Ampligen has demonstrated in the clinic the potential for standalone efficacy in a number of solid tumors. Additionally, Ampligen has shown therapeutic synergy with checkpoint inhibitors, including increasing survival rates and efficacy, in the treatment of animal tumors when used in combination with checkpoint blockade therapies. The first detection of Ampligen’s synergistic potential with checkpoint blockade therapeutics was witnessed in pre-clinical mouse models of melanoma and pancreatic cancers. Additionally, the Company now has data from two clinical studies – in advanced recurrent ovarian cancer and triple negative breast cancer – that indicate that the drug may have similar anti-tumor activity in humans.
Ampligen is being evaluated as a combinational therapy for the treatment of a variety of solid tumor types in multiple clinical trials – both underway and planned – at major cancer research centers around the U.S. Ampligen is also being used to treat pancreatic cancer patients in an Early Access Program (EAP) approved by the Inspectorate of Healthcare in the Netherlands at Erasmus Medical Center.
Immuno-Therapy Targeting Multiple Cancers with High Unmet Need
Locally Advanced Pancreatic Cancer ("LAPC") – The Company recently commenced its Phase 2 study of Ampligen as a therapy for LAPC (AMP-270) following receipt of Institutional Review Board ("IRB") approval for the trial protocol. The AMP-270 clinical trial is a randomized, open-label, controlled, parallel-arm study with the primary objective of comparing the efficacy of Ampligen versus a no treatment control group following FOLFIRINOX for subjects with locally advanced pancreatic adenocarcinoma. Secondary objectives include comparing safety and tolerability. AMP-270 is expected to enroll approximately 90 subjects in up to 30 centers across the United States and Europe. The Buffett Cancer Center at the University of Nebraska Medical Center and Erasmus MC in the Netherlands are expected to be the primary study sites. ClinicalTrials.gov: NCT05494697.
Advanced Recurrent Ovarian Cancer – Phase 1/2 study of intraperitoneal chemo-immunotherapy in advanced recurrent ovarian cancer. Phase 1 portion was completed and published in the American Association for Cancer Research (AACR) (Free AACR Whitepaper) publication, Clinical Cancer Research (Clin Cancer Res January 19, 2022 DOI: 10.1158/1078-0432.CCR-21-3659). The Phase 2 portion of the study is planned to be conducted in the future. ClinicalTrials.gov: NCT02432378
Advanced Recurrent Ovarian Cancer – A follow-up Phase 2 study of advanced recurrent ovarian cancer using cisplatin and pembrolizumab, plus Ampligen; up to 45 patients to be enrolled; numerous patients have commenced treatment. We announced interim data from the study demonstrating that evidence of increased biomarkers associated with T cell chemotaxis and cytolytic function was seen when combining Ampligen, pembrolizumab and cisplatin. Increases of these biomarkers in the tumor microenvironment have been correlated with favorable tumor responses. Interim results announced March 2022 detailed an observed clinical response rate of 61% includes two complete and three partial tumor responses, plus three patients with stable disease among the 13 evaluable patients. An important priority will be to confirm these findings through continuing to enroll patients onto this study. ClinicalTrials.gov: NCT03734692
Stage 4 Colorectal Cancer Metastatic to the Liver – Phase 2a study of Ampligen as a component of a chemokine modulatory regimen on colorectal cancer metastatic to liver was completed and met primary endpoint, evidenced by increased CD8a expression post-treatment (p=0.046).; 15 patients were treated and 12 patients were evaluable for the primary endpoint. Data suggest that chemokine modulatory (CKM) regimen with Ampligen may be useful to enhance effectiveness of immunotherapies. The data from the Phase 2a study was presented in April 2022 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022. ClinicalTrials.gov: NCT03403634
Stage 4 Metastatic Triple Negative Breast Cancer – Phase 1 study of metastatic triple-negative breast cancer using CKM therapy, including Ampligen and pembrolizumab, successfully met primary endpoint. Positive data from this proof-of-concept study demonstrate that short-term systemic CKM followed by pembrolizumab is well-tolerated and selectively enhances local cytotoxic T-lymphocyte (CTL) infiltration in the tumor microenvironment (TME). The data from the Phase 1 study was presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022 in April 2022. ClinicalTrials.gov: NCT03599453
Early-Stage Prostate Cancer – Phase 2 study investigating the effectiveness and safety of aspirin and Ampligen with or without interferon-alpha 2b (Intron A) compared to no drug treatments in a randomized three-arm study of patients with prostate cancer before undergoing radical prostatectomy. Patient enrollment has been initiated in this study designed for up to 45 patients. ClinicalTrials.gov: NCT03899987
Early-Stage Triple Negative Breast Cancer – Phase 1 study of chemokine modulation plus neoadjuvant chemotherapy in patients with early-stage triple negative breast cancer has received FDA authorization. The objective of this study is to evaluate the safety and tolerability of a combination of Ampligen and celecoxib with or without Intron A, when given along with chemotherapy. The goal of this approach is to increase survival. Positive data was recently presented at the SITC (Free SITC Whitepaper) 37th Annual Meeting demonstrating the Chemokine-Modulating (CKM) Regimen including Ampligen was well tolerated, with promising clinical activity of pathologic complete response (pCR) + microinvasive residual disease (ypTmic). Planning is underway for a Phase 2 study in early-stage TNBC to determine if CKM including Ampligen may be a safe and effective alternative to pembrolizumab or pembrolizumab/neoadjuvant chemotherapy. ClinicalTrials.gov: NCT04081389
Refractory Melanoma – Phase 2 study that will evaluate polarized dendritic cell vaccine, interferon alpha-2, Ampligen and celecoxib for the treatment of HLA-A2+ refractory melanoma at Roswell Park. Up to 24 patients to be enrolled. ClinicalTrials.gov: NCT04093323
Advanced Ovarian Cancer – AIM plans to develop a Phase 2 Cisplatin Resistant Advanced Recurrent Ovarian Cancer Clinical Study utilizing Ampligen at the University of Pittsburgh.
Broad-Spectrum Immune System Response Against SARS-CoV-2 (COVID-19)
Previous animal studies yielded positive results utilizing Ampligen in Western Equine Encephalitis Virus, Ebola, Vaccinia Virus (which is used in the manufacture of smallpox vaccine) and SARS-CoV-1. The Company has conducted experiments in SARS-CoV-2 showing Ampligen has a powerful impact on viral replication. The prior studies of Ampligen in SARS-CoV-1 animal experimentation may predict similar protective effects against SARS-CoV-2. AIM is currently evaluating the safety and effectiveness of intravenous Ampligen to reduce replication of SARS-CoV-2 virus from upper airway in patients in an ongoing Phase 1/2 study for the treatment of COVID-19 cancer patients. The Company plans to conduct an intranasal study of Ampligen to potentially enhance and expand natural immunity.
The FDA has authorized Ampligen in a clinical trial of patients with COVID-19 who have a pre-existing cancer. That Phase 1/2a study utilizing Ampligen is underway in the investigator-sponsored Phase 2 trial at the Roswell Park Comprehensive Cancer Center. ClinicalTrials.gov: NCT04379518
Immune System Disorders (ISD): Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) / COVID-19 Long Hauler
The Company is currently sponsoring an ongoing, FDA-authorized AMP-511 (See: ClinicalTrials.gov: NCT00215813) expanded access program (EAP) for ME/CFS patients in the United States. AIM has enrolled five post-COVID patients with new onset ME/CFS following acute COVID-19. Preliminary results based on data from the first 4 patients, following at least 12 weeks of Ampligen treatment indicated they had experienced a reduction in fatigue, as measured via Patient-Reported Outcomes questionnaires. A statistical analysis of these data indicated that the decrease in fatigue compared to baseline was statistically significant (p<0.002), despite the small number of patients. Based in part on these early positive data, the FDA recently provided their clearance of the Company’s IND application for a Phase 2 study of Ampligen for the treatment of Post-COVID Conditions.
The planned Phase 2 study ("AMP-518") is a two-arm, randomized, double-blind, placebo-controlled, multicenter study to evaluate efficacy and safety of Ampligen in patients experiencing the post-COVID condition of fatigue. The primary outcome measure of the study is change from baseline to week 13 in PROMIS Fatigue Score. Other study outcomes include: change from baseline to week 6 in PROMIS Fatigue Score; change from baseline to week 6 and 13 in distance traveled during a 6-minute walk test; proportion of subjects with minimal clinically important difference, defined as at least 54 meters, in the Six-Minute Walk Test at the end of 12-week treatment phase; change from baseline to week 6 and 13 in PROMIS Cognitive Function Score; change from baseline to week 6 and 13 in PROMIS Sleep Disturbance Score; and change from baseline to week 6 and 13 in 36-Item Short Form Survey.
Approximately 80 subjects between the ages of 18 to 60 years old are expected to be enrolled across up to 10 centers in the United States. Patients will be randomized 1:1 to receive twice weekly IV infusions of Ampligen or placebo for 12 weeks with a follow up phase of 2 weeks. The Company expects to commence patient enrollment and dosing in the AMP-518 study in Q1 2023.
Recent Ampligen Data Publications
Presented Safety and efficacy of de-escalated neoadjuvant chemoimmunotherapy of triple negative breast cancer (TNBC) using chemokine-modulating regimen (rintatolimod, IFN-α2b, celecoxib)1 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting; and
Presented Rintatolimod (Ampligen): An Investigational Immunomodulatory Agent Targeted at Cancers of High Unmet Need and The Mechanism of PAMP Restricted Rintatolimod in Limiting Systemic Inflammatory Responses at the 2nd Annual Marie Sklodowska-Curie Symposium on Cancer Research and Care.
Summary of Financial Highlights for Third Quarter 2022
As of September 30, 2022, AIM reported cash and cash equivalents of $36.7 million, compared to $48.3 million as of December 31, 2021.
Research and development expenses for the three months ended September 30, 2022 were $1.4 million, compared to $2.0 million for the same period in 2021.
General and administrative expenses were $5.2 million for the three months ended September 30, 2022, compared to $1.8 million for the same period in 2021.
The net loss from operations for the three months September 30, 2022 was $6.4 million, or $0.13 per share, compared to $3.8 million, or $0.08 per share, for the three months ended September 31, 2021.