Mount Tam Biotechnologies: An Emerging Leader in the Treatment of Systematic Lupus Erythematosus

NEW YORK, NY / ACCESSWIRE / June 21, 2016 / Compass Equity Research, LLC announced today the release of its Initial Equity Report on Mount Tam Biotechnologies (OTCBB: MNTM), Mount Tam Biotechnologies is an emerging specialty biopharmaceutical company developing a portfolio of pharmaceutical products targeting the treatment of autoimmune diseases. Their most advanced product candidate is TAM-01, is a pre-clinical stage compound, which represents what is believed to be a promising therapeutic candidate for the treatment of systemic lupus erythematosus (“SLE“), the most common forms of lupus. On August 17, 2014, Mount Tam partnered with the world-renowned Buck Institute for Research on Aging through a worldwide exclusive licensing and collaboration agreement. The assets, which are focused on autoimmune diseases, are highly target-specific polyketides–a class of compounds with an extremely successful track record with the FDA drug approval process. Mount Tam intends to apply its first and most advanced asset, TAM-01, to the Investigational New Drug (IND) application phase of the FDA. It has already completed non-GLP pre-clinical development. The primary focus is to develop TAM-01 for the treatment of systemic lupus erythematosus (SLE) in an expanding orphan drug market. The Company will use the research and development conducted on TAM-01 as the core science for additional assets, including its second product known as TAM-02, which is currently focused on multiple sclerosis (MS). On June 14th, 2016, the company received financial commitments from private investors in the amount of $5 million, which they believe to be adequate to fund clinical development through the filing of their IND.

About Systematic Lupus Erythematosus

According to the Lupus Foundation of America, 1.5 million Americans have some form of lupus and more than 16,000 new cases are reported annually in the United States alone. Despite the significantly larger patient population over the defined orphan disease limit, the FDA continues to classify lupus as an orphan disease. The exact etiology of lupus is unknown. As an autoimmune disease, lupus makes the immune system unable to differentiate between healthy tissues and foreign invaders, leading the immune system to attack healthy tissues. This may cause inflammation of the joints, heart, lungs, kidneys, brain and blood vessels. Lupus is a disease that goes through stages of remission and flares.

SLE is one of the most common forms of lupus. It is a chronic, inflammatory disorder that can damage any part of the body, including the skin, joints and internal organs. Lupus nephritis (“LN“) is a common complication for people with SLE, affecting up to 60% of SLE patients. LN is a kidney inflammation that may lead to significant illness and even death. There is currently no known cure for SLE and no treatment that fully stabilizes the disease. Patients diagnosed with lupus are treated with different types of supportive therapy, primarily consisting of antimalarials, corticosteroids, immunosuppressants, and newer biologic agents that primarily address the symptoms of the disease at the expense of significant adverse events of varying severity. Such adverse events include but are not limited to inflammation, joint pain, blood clotting, mouth ulcers, skin rash, skin color changes, damage to the retina of the eye, morbidity, immune suppression, suppressed growth in children, diabetes, osteoporosis and high blood pressure.

TAM-01

TAM-01, is a rapamycin analog which exerts its action through direct binding and inhibition of the mammalian Target of Rapamycin (“mTOR“). mTOR is a key regulatory pathway which is altered in individuals suffering from autoimmune disorders, including lupus. Based on extensive research conducted by various institutes, mTOR inhibitors may reduce disease activity and normalize T cell activation-induced calcium fluxing in SLE patients. The only effective mTOR targeting drugs currently approved by the FDA, are rapamycin (Sirolimus) and its first generation analogs (Temsirolimus, Everolimus). Unfortunately their utility as therapeutic agents for the treatment of chronic diseases such as SLE is severely limited due to their significant side effects, including impaired glucose tolerance, insulin resistance, and lipid dysregulation. Mount Tam’s product candidate, TAM-01, is a small-molecule inhibitor of mTOR, which has shown in their pharmacology studies to maintain high therapeutic efficacy of rapamycin while significantly reducing or abolishing some of its side effects.

Market Potential

Decision Resources Group forecasts that sales of SLE therapies will increase approximately 2.5-fold by 2024, with peak sales of SLE treatments expected to be in excess $4 billion. Historically, developers of systemic lupus erythematosus (SLE) drugs faced formidable challenges: drug development for a complex, multifaceted, poorly understood disease; regulatory hurdles; a small but heterogeneous population; and a multiplicity of manifestations. Recent positive clinical trial results and the regulatory approval of belimumab (GlaxoSmithKline’s Benlysta) have lowered some development hurdles, and a growing list of emerging agents have ushered in a new era of SLE drug development. However, physician’s perceptions of Benlysta have been mixed due to modest efficacy, slow onset to action, and its restrictive label, which does not include patients with severe, active renal and central nervous system (CNS) disease. Given these shortcomings, there exists the opportunity for emerging agents with better efficacy profiles and acceptable safety to gain market share.

Investment Summary

Mount Tam Biotechnologies is an emerging growth, life science company developing novel agents for the treatment of systematic lupus erythematosus and multiple sclerosis. Their lead clinical candidate TAM-01 has shown to be effective in pre-clinical trials and the company anticipates beginning early stage clinical trials in 2017. The company is also advancing their second pre-clinical candidate, TAM-02 for the treatment of multiple sclerosis. To assist in their clinical development activities, Mount Tam has assembled an experienced management team, multiple advisory boards and is working extensively with the world-renowned Buck Institute for Research on Aging. It has an exclusive worldwide licensing and collaboration agreement with the Buck Institute, which includes some of the Institute’s first R&D assets in the area of autoimmune disorders. The licensed assets are supported by an extensive portfolio of intellectual property consisting of over 45 worldwide issued patents and patent applications. The company recently received commitments in the sum of $5 million from private investors, providing them with adequate financial resources to advance their lead products to early stage clinical trials. With adequate financing and promising pre-clinical candidates addressing multi-billion dollar markets, Mount Tam has created a solid foundation for future growth.

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SOURCE: Compass Equity Research

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