As the coronavirus (COVID-19) pandemic persists and could possibly strengthen again this fall, dozens of biopharmaceutical companies worldwide are racing to develop life-saving therapies and vaccines.
Five of those companies will participate in the virtual One2One Investor Forum entitled “New Approaches to COVID-19: Hidden Breakthroughs” to be held on September 10 at 1pm ET.
The virtual panel discussion will include Tom Equels, CEO of AIM ImmunoTech Inc (NYSEAMERICAN:AIM); Jeff Wolf, CEO of Heat Biologics Inc (NASDAQ:HTBX); Dr David Jin, CEO of Avalon GloboCare Corp (NASDAQ:AVCO); Vered Caplan, CEO of Oregenisis Inc (NASDAQ:ORGS); and Dr Jennifer Bath, CEO of ImmunoPrecise Antibodies Ltd (CVE:IPA) (OTCQB:IPATF).
The virtual One2One Investor Forum will be moderated by broadcast journalist Christine Corrado of Proactive Investors. The event, co-sponsored by investor relations firm Crescendo Communications, is an online variant of the popular conference format Proactive has run for more than a decade and enables communication between investors and management from some of the world's most cutting-edge businesses.
Joining the race for a vaccine
Heat Biologics is a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, including multiple oncology product candidates and a novel COVID-19 vaccine.
The North Carolina-based company heads into the forum just after releasing some promising preclinical results from a study of a potential vaccine based on its already-developed gp96 platform – which is designed to activate immune responses against cancer or pathogenic antigens. The company also just won a second US patent protection for the platform.
Heat said the study found the vaccine significantly increases the frequency of systemic and tissue-specific CD8+ T-cells by conferring cellular immunity that‘s essential against any viral infection, including SARS-CoV-2, the virus that causes the COVID disease.
Also, the company said the vaccine elicits a robust immune response directed against the Spike protein of SARS-CoV-2, generating both helper CD4+ T-cells that aid in antibody production as well as virus killing cytotoxic CD8+ T cells.
The company said the generation of a durable cellular immune response driven by memory CD8+ T cells also may protect against re-infection. Heat's vaccine is designed to prophylactically "train" the immune system to induce this response in patients, especially in individuals most prone to severe infection such as the elderly, those with comorbidities, or others who are immuno-suppressed.
"We believe that these results are a powerful reinforcement that this platform represents a unique and relevant paradigm for novel vaccine development, capable of inducing cellular immune responses in epithelial tissues such as the lungs,” said CEO Wolf in a recent statement
“This publication demonstrates the potential utility and versatility of our vaccine platform to address SARS-CoV-2, relevant mutations and other pathogens of interest."
Attacking SARS-CoV-2 through the nose
Florida-based AIM ImmunoTech focuses on the research and development of therapeutics to treat immune disorders, viral diseases, and multiple types of cancers.
But it also has developed the drug Ampligen, which the company said decreased the infectious viral yield of SARS-CoV-2 by 90% in a recent in vitro model.
"We are pleased with these results, as they establish Ampligen's bio-activity against SARS-CoV-2 as well as support our decision to test Ampligen in humans as an intranasal prophylaxis and early-onset therapy against COVID-19," said CEO Equels in a recent statement.
In conjunction with the Institute for Antiviral Research at Utah State University, the company tested Ampligen and found that a dramatic reduction in viral yield could be achieved at clinically achievable dosage levels. These results support Ampligen’s goal of developing an intranasal prophylactic approach using Ampligen to prevent the coronavirus. Ampligen has already been tested on the SARS-CoV-1 (SARS) virus, showing antiviral promise.
Also, the company recently signed a trilateral material transfer and research agreement with Japan's National Institute of Infectious Diseases and a Japanese pharmaceutical company 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.
Furthermore, the company has plans for a Phase 1/2a trial of Ampligen with Roswell Park Comprehensive Cancer Center to commence patient enrollment soon. The trial will examine Ampligen in combination with interferon alfa-2b in cancer patients with COVID-19.
AIM also has the financial runway to advance the development of Ampligen, which is also being studied as an immuno-modulator to treat melanoma, colorectal and ovarian cancers. It amassed $40.3 million as of June 30, nearly 5 times more than the $8.8 million it had at the end of 2019.
Battling COVID on three fronts
Avalon GloboCare, which specializes in developing cell-based technologies to combat cancer, has been marshaling its resources to help fight the pandemic on three fronts: marketing a test kit for a partner company, developing therapeutics to fight cytokine storms (body’s immune attacks its own cells), and creating a vaccine.
The company also has established the Avalon Combat Covid-19 Taskforce to accelerate scientific/clinical development to help combat the Covid-19 pandemic through a strategic combination of therapeutic and vaccine approaches.
Last month, the New Jersey-based company won distribution rights to market Cellex Inc’s coronavirus antibody-based rapid test. Cellex recently earned Emergency Use Authorization from the US Food and Drug Administration to build and sell the kits. Both are working as well to source manufacturing facilities and to develop next-generation COVID-19 detection kits.
For COVID therapeutics, Avalon is working with the Massachusetts Institute of Technology to co-develop a therapeutic platform against the cytokine storm, which causes lung damage. Cytokines are small protein molecules in the body required to regulate and maintain proper physiological functions, but when released in excess, the cytokine storm damages vital tissues and organs.
Avalon’s AVA-Trap therapeutic program is currently entering animal model testing followed by expedited clinical studies with the goal of providing an effective therapeutic option to combat COVID-19 and other life-threatening conditions involving cytokine storms.
In early September, the company launched its new allogeneic mesenchymal stromal cell (MSC) therapeutic platform as a potential therapy for COVID-19 and bone marrow transplant-related complications of acute graft versus host disease (aGVHD).
Avalon also recently formed a partnership with the University of Natural Resources and Life Sciences (BOKU) in Vienna to co-develop a surface-layer vaccine for SARS-CoV-2.
The vaccine is expected to both decrease the severity of a SARS-CoV-2 infection – preventing the more severe respiratory inflammation and organ damage – and building immunity against the virus. Avalon plans to complete the proof-of-concept pre-clinical studies in 2020, followed by a first-in-human clinical study of this candidate vaccine during 2021.
Killing the virus with anti-viral agents
Orgenesis Inc (NASDAQ:ORGS), which develops cell and gene therapy platforms, is collaborating with Leidos Holdings Inc (NYSE:LDOS) to develop and potentially obtain FDA marketing approval of Orgenesis’ Ranpirnase to treat patients suffering from severe acute respiratory syndrome.
Maryland-based Orgenesis recently acquired the assets of Tamir Biotechnology Inc, including Ranpirnase, a broad spectrum anti-viral agent. Ranpirnase catalyzes the degradation of RNA, and mediates several essential biological activities, including the regulation of cell proliferation, maturation, differentiation, and cell death.
Over 1,000 patients have been dosed with Ranpirnase in previous cancer/mesothelioma clinical trials. Ranpirnase has already demonstrated a strong safety and tolerability profile. Ranpirnase also has shown preclinical antiviral activity in serious viral diseases, such as cytomegalovirus (CMV), influenza, HIV, Ebola, and SARS.
Leidos has conducted in vitro studies of Ranpirnase at the University of Tennessee Health Sciences Center Regional Biocontainment Laboratory and George Mason University National Center for Biodefense and Infectious Diseases against the SARS CoV-2 virus. The in vitro studies demonstrated that Ranpirnase was significantly effective in killing the virus – with an eight-fold average decrease in the number of plaque-forming units when cultures with Ranpirnase were compared to the controls treated with a placebo.
Based on these initial pre-clinical results, a pre-IND meeting request to fast track Ranpirnase for the treatment of SARS-COV-2 has been submitted by Leidos to the FDA.
"We believe this platform could address a significant need in the market and we look forward to leveraging Leidos’ expertise in the development and clinical trial oversight, as well as relationships with government agencies, to possibly accelerate the development of Ranpirnase and its use as a potential treatment of patients with SARS-COV-2,” said CEO Caplan recently.
Seeing promise in neutralizing antibodies
In July, the Vancouver company announced that its DeepDisplay phage technology confirmed that a subset of six of these antibodies that were analyzed in combination resulted in near-complete neutralization of SARS-CoV-2 pseudovirus infection.
“As we characterize IPA’s approximately seventy-five functional lead candidates it is clear that our extensive program has generated therapeutics with broadly diverse profiles, providing substantial opportunities for multi-epitope targeted strategies,” said CEO Bath in a recent statement.
“After selecting approximately sixteen hundred antibodies with the most desirable binding profiles to various spike protein formats, we down-selected our leads based on very specific criteria, all of which are key in our ongoing determination of ideal candidates.”
The company continues to further analyze multiple subsets of antibodies, including neutralizing antibodies demonstrated to bind to the S1 and S2 domains of the SARS-CoV-2 spike protein. Furthermore, the company has begun steps for the expression of the lead antibodies for pre-clinical and clinical manufacturing.
For ImmunoPrecise, PolyTope is the name of its scientifically rigorous and comprehensive approach employed in its anti-COVID-19 programs, as company scientists lead extensive efforts toward the development of effective coronavirus preventions and therapies.
The company noted that its lead antibodies against COVID-19 (or SARS-CoV-2) have not yet been studied in human clinical trials and, as a result, ImmunoPrecise is not making any express or implied claims that its products have been proven to have the ability to eliminate, cure or contain both the virus and disease at this time.
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