As anyone who has followed the local biotech scene would expect, Australian companies are piling-in to the fight against COVID-19. Particularly in areas ranging from drugs, diagnostic tests, devices and preventive measures. Here we focus on some of the most promising companies working on the pandemic in the drug and diagnostics area.
1. Mesoblast (MSB, $3.70)
Share price performance year-to-date: +80.5%
Stem-cell therapy developer Mesoblast has been focused on regenerative treatments for inflammatory ailments, cardiovascular disease and back pain – and has been a long-term disappointment for investors on these fronts – but last month it reported success in trials of its bone marrow product (called remestemcel-L) in treating critically ill Covid-19 patients who were suffering from acute respiratory distress syndrome (ARDS), the most common cause of death from Covid-19 infections. ARDS is caused by what’s become known as a “cytokine storm,” which is an over-reaction of the immune system in which the body ends up damaging the lungs in an attempt to destroy the coronavirus and the lung cells that it has infected. The cytokine storm can cause the deterioration of major organs in a process known as septic shock – which could be the major actual cause of death in Covid-19 patients. Under “emergency compassionate use” protocols, patients at New York’s Mount Sinai hospital with ARDS were given remestemcel-L intravenously, and the results were much better than those in ventilator-dependent Covid-19 patients receiving standard-of-care treatment. Mesoblast has begun enrolling patients in a Phase 2/3 clinical trial in more than 20 medical centres across the US to “rigorously confirm” whether remestemcel-L provides a survival benefit in patients with moderate/severe acute respiratory distress syndrome (ARDS) due to Covid-19.
2. Cynata Therapeutics (CYP, 70 cents)
Share price performance year-to-date: –33.3%
Stem-cell therapy developer Cynata Therapeutics has mesenchymal stem cells (MSCs) from its stem-cell manufacturing platform Cymerus in preparation for three clinical trials, against osteo-arthritis, graft-versus-host disease and critical limb ischaemia, an advanced stage of peripheral artery disease. But in April it announced positive results from an independent study in animals of using MSCs to treat ARDS and the “cytokine storm.” Cynata also has strong pre-clinical study results in sepsis and cytokine release syndrome, which along with ARDS are common hallmarks of severe Covid-19 cases. From these results, Cynata proposed and received approval for a clinical trial in New South Wales to investigate the effectiveness of MSC in treating 24 adults admitted to intensive care with Covid-19 and respiratory distress. CYP says it has decided to re-direct its financial and operational resources to focus on its Covid-19 and ARDS development strategy.
3. PharmAust (PAA, 10 cents)
Share price performance year-to-date: –9.1%
PharmAust’s anti-cancer drug monepantel inhibits the mTOR cellular signalling pathway, a key driver of cancer. The anti-cancer action may also be able to treat viral infections (including Covid-19). At the moment, PharmAust is aiming at veterinary applications: earlier this month, the company released results of a successful clinical trial, which showed that the majority of dog patients responded well to the treatment of Monepantel. The drug already has the green light in some jurisdictions but not specifically for cancer. PharmAust was preparing to launch a phase two clinical trial testing the drug against cancer but is now looking to test it against Covid-19: the first test is being done in vitro at the Walter and Eliza Hall Institute of Medical Research in Melbourne.
4. Noxopharm (NOX, 22 cents)
Share price performance year-to-date: –12.0%
Noxopharm has its Veyonda treatment for end-stage prostate cancer approved by the FDA as an Investigational New Drug (IND): the active ingredient in Veyonda, idronoxil, appears to work as an anti-cancer agent through blocking a tissue signalling pathway known as STING. STING plays a crucial role in detecting the presence of viruses in tissues, triggering the immune system to fight the virus and the body’s inflammatory system to repair any tissue damage. In patients where the viral infection becomes overwhelming, the STING system can become hyper-active, helping to trigger the cytokine storm. Noxopharm says it will test Veyonda in a clinical trial as a potential cytokine storm inhibitor.
5. MGC Pharmaceuticals (MXC, 2.5 cents)
Share price performance year-to-date: –16.7%
Medical and cosmetic cannabis company MGC Pharmaceuticals has begun a Phase 2 clinical trial in Israel on patients diagnosed with Covid-19, evaluating the safety and efficacy of its natural immune-modulating formula its plant-derived cannabinoid ArtemiC in treating the “pathophysiological repercussions” of infection with Covid-19. ArtemiC is designed to target viral infections with inflammatory complications.
6. Biotron (BIT, 9.5 cents)
Share price performance year-to-date: +90.0%
Biotron’s core expertise is the design and development of drugs that target virus-encoded proteins known as viroporins. The company’s scientists were the first to identify and publish data showing that the E-protein of the coronavirus is a viroporin, and a good target for antiviral drugs. Within its proprietary small-molecule compound library, Biotron has compounds with good activity against a range of coronaviruses, ranging from the human coronaviruses that cause mild, cold-like symptoms as well as the SARS coronavirus that was responsible for that outbreak, in 2003. In February, Biotron told the ASX that it was evaluating several promising compounds for activity against coronavirus, including the new Covid-19 strain. No results of this work have been reported, but in March BIT told the sharemarket that Phase 2 trials of its lead drug candidate BIT225 showed that the drug unmasks HIV-infected cells that remain in the body despite treatment with approved anti-HIV-1 drugs: the results could have profound implications for the future treatment and cure of HIV-1 infection.
7. Cyclopharm (CYC, $1.38)
Share price performance year-to-date: +13.1%
Nuclear medicine company Cyclopharm has developed Technegas, a gas made of radioactive carbon that is inhaled through a breathing apparatus, and the carbon is picked up by gamma imaging to identify the life-threatening condition pulmonary embolism (PE), or arterial blockages in the patient’s lungs. Shortness of breath is a major symptom shown in both PE and Covid-19, but the main diagnostic method for determining the presence of the Covid-19 virus is a laboratory test: CYC told shareholder in March that it was receiving reports of an increase in the use of Technegas by doctors to differentiate between Covid-19 and PE in cases where laboratory tests results cannot be attained quickly.
8. Atomo Diagnostics (AT1, 36 cents)
Share price since April IPO issue
At $0.29: +80.0%
The newly listed (April) Atomo Diagnostics has a rapid blood-based diagnostic device for HIV, the only self-administered HIV assay approved by Australia’s version of the FDA, the Therapeutic Goods Administration (TGA). The company was quickly able to tweak its patented blood test devices to pick up antibodies produced in response to Covid-19. Results are obtained from a drop of blood in 15 minutes and indicate whether the person has antibodies in their blood as a result of having been infected with the virus. The test is CE-Marked for professional use for COVID-19 testing in Europe: on current orders, Atomo is supplying French diagnostics company NG Biotech with 1.369 million devices, and says it has also received “urgent inbound inquiries” from other European, US and Chinese diagnostic companies. The Atomo device can be self-administered, reducing the risk to healthcare workers. Atomo says the platform can be used for any number of purposes, including bacterial-versus-viral tests, pregnancy tests, and tests for the presence of malaria, hepatitis C and Ebola.
9. Genetic Signatures (GSS, $1.985)
Share price performance year-to-date: +98.0%
The molecular diagnostics company has a proprietary platform technology, 3BaseT, from which it has developed and is selling tests for a range of respiratory diseases and sexually transmitted diseases (STDs). In March, GSS announced that it had supplemented its existing assays to specifically identify the 2019 novel strain of coronavirus (SARS-CoV-2), the virus that causes Covid-19, in a product called EasyScreen SARS-CoV-2 Detection Kit. In April the test was approved for sale in Europe and Australia.
10. Genetic Technologies (GTG, 0.7 cents)
Share price performance year-to-date: –30.0%
The Melbourne-based company, which is also listed on Nasdaq, uses genetic technology to create personalised tests to predict a person’s risk of developing chronic disease. Its GeneType for Breast Cancer test can determine a woman’s risk of developing non-hereditary breast cancer over a period of time, by combining three major factors that contribute to this risk: genetic markers, breast density and family history. GeneType for Breast Cancer works by combining these risk factors to provide a more accurate assessment of breast cancer risk. Its other product, GeneType for Colo-rectal cancer, combines patient age, family history and genetic markers to provide a more accurate assessment of colorectal cancer risk. Sales of both tests began in the March 2020 quarter. The company is developing similar genetic risk assessment tests for cardiovascular disease, type 2 diabetes, prostate cancer and melanoma. This month, GTG announced that it is fast-tracking development of a genetic test that will determine if people are at a high risk of contracting COVID-19, for global application. The company says it would be able to conduct about 360,000 tests a year, with current capacity.
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