SAN FRANCISCO, CA--(Marketwired - August 18, 2014) - US Equity Holdings' newly established entity, Mount Tam Biotechnologies, has completed an exclusive worldwide licensing and collaboration agreement with the Buck Institute for Research on Aging. The agreement includes the Institute's most advanced R&D assets in the area of autoimmune disorders. The license contains TAM-01, a pre-IND stage compound, which represents a promising therapeutic for the treatment of systemic lupus erythematosus (SLE) -- the most common form of lupus. The agreement also includes other, earlier stage compounds and an extensive library of assets positioned in the autoimmune disease space. The licensed assets are supported by an extensive portfolio of intellectual property consisting of over 45 worldwide issued patents and patent applications, including composition of matter, manufacturing and therapeutic area applications.
"We are very excited to complete this licensing agreement with the Buck Institute and US Equity Holdings. The high value, development-ready therapeutic candidates, as well as the broad technology basis and supporting intellectual property give Mount Tam Biotech a strong, differentiated position in the field of autoimmune disorders. We are looking forward to working with Chester Aldridge and the US Equity Holdings team, as well as our world class medical advisory board to bring these assets to the clinic very shortly," said Stelios Tzannis MS/PhD, Co-Founder and CEO of Mount Tam Biotechnologies.
The licensed assets come with an extensive history of research and development. Originally discovered at the University of Cambridge, the technology was expanded by Biotica Ltd to enable the production of novel, highly target-specific, polyketides -- a class of compounds with a highly successful track record with the U.S. Food & Drug Administration (FDA) drug process. After nearly 15 years of technology development through multiple Biotica collaborations with world-renowned research institutes, the Buck Institute gained ownership of Biotica's technology and its optimized rapamycin-like compounds.
The Buck Institute is the nation's first and foremost independent non-profit research organization focused exclusively on the research of aging and its connection to chronic disease. Its mission is to increase the healthy years of life. Led by Professor Brian Kennedy, PhD, the Institute's President & CEO, and a renowned aging specialist with expertise in mTOR (mammalian target of Rapamycin), the Buck identified the value of Biotica's assets and proceeded in their acquisition. "At the Buck, we are working to understand how normal aging contributes to the development of conditions specifically associated with getting older. mTOR is a keystone in this scientific journey as we work on understanding how chronic diseases, like the autoimmune diseases Mount Tam is working on, make it harder to live healthier as we age," said Kennedy. "TAM-01 represents one of our most valuable assets that is ready to enter the FDA process. There has been extensive interest in this library of compounds and we have gone through a diligent process to select our partner. It is time for TAM-01 to come to fruition."
The Lupus Foundation of America estimates that more than 1.5 million Americans suffer from Lupus, although estimates vary due to the difficulty of diagnosing lupus. Despite recent advances in the field, SLE remains an underserved market: no cure exists while available treatments, such as steroids, anti-malarials and immunosuppressant, address only symptoms of the disease with a significant side effect burden. Newer, targeted therapies (such as antibodies) have proven beneficial to only a limited numbers of patients, mostly with advanced disease. Rapamycin, an mTOR inhibitor, has shown significant promise in the treatment of SLE in proof-of-concept clinical research studies. However, its chronic use is severely limited by its poor side effect profile, including glucose intolerance, insulin resistance, anemia and lipid dysregulation, and others.
TAM-01, a novel, balanced mTOR inhibitor, has been optimized for the treatment of SLE. It maintains the efficacy of rapamycin (demonstrated in multiple validated preclinical models of the disease) while significantly reducing or abolishing its side effects. It is the most advanced compound in Mount Tam's pipeline. It has completed full discovery, lead optimization and pre-development activities, including preliminary scale up. TAM-01 is ready to enter IND-enabling studies -- the first step in the FDA drug approval process. "There are millions of people affected by lupus who have not been given the attention they deserve. As our basic and clinical research has shown, mTOR is a validated pathway for the treatment of the disease," said Dr. Andras Perl, MD/PhD, Professor and Chief, Division of Rheumatology, SUNY Upstate Medical University and a world renown expert and innovator in the field of lupus research and practice. "TAM-01 represents an exciting compound towards a therapeutic breakthrough."
"The value and depth of scientific data supporting these assets is what sets them apart and what drove this license. TAM-01's clear and differentiated value, I believe, will accelerate its development towards commercialization," said Chairman and CEO of US Equity Holdings, Chester Aldridge, who is also the Chairman of Mount Tam Biotechnologies. "In the hands of our team of seasoned executives and medical experts, I am convinced that TAM-01 will be successfully brought to fruition. The presence of Stelios Tzannis, a senior executive with immense knowledge across the industry -- from research and development to commercialization -- brings tremendous value in this direction," said Mr. Aldridge.
"We are looking forward to fully leveraging the great value that this licensing agreement brings to Mount Tam Biotech, including TAM-01's swift development towards the clinic and the enhancement of our pipeline with some of our newer assets focused on other autoimmune disorders, such as multiple sclerosis," said Dr. Tzannis.
About Mount Tam Biotechnologies
Formed on World Lupus Day 2014, Mount Tam Biotechnologies was established to develop, optimize and bring to market leading medical compounds to better the health and well being of millions of people who have been affected by autoimmune diseases. The organization's most advanced product focuses on the treatment of Systemic Lupus Erythematosus (SLE).
For more information visit www.MountTamBiotech.com
About US Equity Holdings
US Equity Holdings establishes organizations by creating or licensing valuable intellectual property, forming strong management teams and financing its initiatives to successful exits. The company provides a number of advisory services for individuals and companies ranging from start-ups to large publicly traded corporations. US Equity Holdings areas of expertise include licensing, strategic planning and analysis, business development, merchant banking, venture capital and investment banking. The company has led ventures in multiple industries -- from entertainment and technology, to renewable energy and biotechnology. Headquartered in the San Francisco Bay Area with offices in Boston, Canada and the United Kingdom, US Equity Holdings is held and led by serial entrepreneur Chester Aldridge. For more information visit www.usequityholdings.com
About the Buck Institute for Research on Aging
The Buck Institute is the U.S.'s first and foremost independent non-profit research organization devoted to Geroscience -- focused on the connection between normal aging and chronic disease. The Buck is dedicated to extending "Healthspan," the healthy years of human life, and does so utilizing a unique interdisciplinary approach involving laboratories studying the mechanisms of aging. Buck scientists strive to discover new ways of detecting, preventing and treating age-related diseases such as Alzheimer's and Parkinson's, cancer, cardiovascular disease, osteoporosis, autoimmune diseases, macular degeneration, diabetes and stroke. In their collaborative research, they are supported by the most recent developments in genomics, stem cell technologies, proteomics and bioinformatics. For more information visit www.thebuck.org.
About systemic lupus erythematosus (SLE)
Lupus is a chronic autoimmune disease involving many systems in the human body, including joints, kidneys, central nervous system, heart, hematological system and others. The biologic basis of the disease is a defect in the immune (defense) system, leading to production of self- (auto)-antibodies, attacking the normal organs and causing irreversible damage. This results in symptoms such as inflammation, swelling, and damage to joints and almost every major organ in the body, including the heart, kidneys, skin, lungs, and brain. According to the Lupus Foundation of America, 1.5 million Americans have the disease with more than 16,000 new cases diagnosed each year. The majority of patients are women of childbearing years.