Tarsier Pharma | August 28, 2021
Tarsier Pharma, a late clinical stage pharmaceutical company focused on the development and commercialization of novel therapeutics to treat patients with blinding ocular diseases, today announced it raised capital to execute a phase-3 clinical trial of its TRS01 program in the US and Europe. Strategic and new investors alongside existing investors participated in this transaction.
Following a successful End of Phase II meeting with the FDA, the Company obtained all necessary regulatory approvals to execute phase 3 and has recruited leading uveitis experts as principal investigators. Tarsier plans to enroll the first patient in Q4 of 2021.
Tarsier's technology, TRS, is a novel immunomodulator molecule that showed, in a dose-ranging, randomized, double-masked phase I\II trial in the target indication, a prompt and statistically significant improvement in signs and symptoms of uveitis.
"We are excited to have the support of our existing and new investors, as we continue our clinical development of TRS01 in advanced stages," said Dr. Haim Langford, CEO of Tarsier. "Looking ahead, we are eager to bring our lead product to market and simultaneously progress our development of important pipeline projects for other back-of -the-eye blinding diseases, and plan to raise additional capital to realize these as well."
About Tarsier Pharma
Tarsier Pharma is a late clinical stage pharmaceutical company, phase-3 ready, focused on the discovery, development, and commercialization of first-in-class pharmaceutical therapies to treat ocular blinding diseases. TRS is a breakthrough proprietary technology platform, based on a new bio-inspired chemical entity, with novel mechanism of action and demonstrated safety and efficacy in a rare debilitating and blinding indication.
Lead product candidate for uveitic glaucoma
Non-infectious uveitis is an autoimmune blinding ocular inflammation, considered the third leading cause of blindness in the developed world. Tarsier's TRS01 is a potent fast-acting immunomodulator, delivered as eye drops, for the treatment of non-infectious anterior uveitis in patients with uveitic glaucoma – considered an end-stage condition of uveitis. Once a uveitis patient has also developed glaucoma (uveitic glaucoma), the only available treatments for active inflammation, which are steroids, should be avoided, due to their negative side effects in expediting glaucoma and vision loss. Thus, TRS01 has the potential to become the standard of care for uveitic glaucoma.
Quantum Leap, SignalPath | February 24, 2021
Quantum Leap Healthcare Cooperative (Quantum Leap) and SignalPath reported a partnership today that will further enable the I-SPY platform trials with vigorous, streamlined technology infrastructure to drive the straightforwardness and efficiency of trial execution. SignalPath will integrate existing work process instruments being utilized to control the I-SPY trials into SignalPath's research operations and financial platform. In view of the public health emergency surrounding the COVID-19 pandemic, this advanced technology infrastructure will initially be conveyed for I-SPY COVID-19 with subsequent expansion to I-SPY2.
“As we continue to grow our platform trials with a focus on I-SPY COVID-19, and the growing complexity of processing drug candidates through our platform trials, we need sophisticated infrastructure to ensure we can maintain our efficiency and agility. SignalPath provides the missing link for a comprehensive, tech-enabled trial technology platform to unlock the full potential of adaptive trial designs. This further empowers us to address urgent health needs that can only be solved through exceptional, technology-enabled clinical research,” observed James Palazzolo, CEO of Quantum Health.
The I-SPY platform has had incredible accomplishment in working with leading academic medical centers around the United States. SignalPath is helping to extend that footprint across the a-list community health systems on the SignalPath platform. The objective is to continue to draw in community health systems with hearty research programs in cutting edge research to help their patients.
“We founded SignalPath to re-imagine clinical trial execution through technology,” stated Brad Hirsch, MD, CEO and Co-Founder, SignalPath. “The Quantum Leap team has already accomplished an amazing amount in the fight against breast cancer and is now applying their full force to drive insights into COVID-19. It is an incredible opportunity for us to collaboratively support trial execution through our powerful technology infrastructure to meaningfully reduce the complexity for both the Quantum Leap team and the sites involved in the I-SPY trials. Everyone’s goal is the same - to bring life-saving medicines to patients that need them most.”
SignalPath is the premier clinical trial technology partner for research sites and sponsors, focused on improving the ease and efficiency of trial execution and management. Supporting over 5,000 trials across more than 300 sites and thousands of active users, SignalPath is the industry standard that addresses key pain points in the conduct of trials.
About Quantum Leap Healthcare Collaborative
Quantum Leap Healthcare Collaborative is a 501c(3) charitable organization established in 2005 as a collaboration between medical researchers at University of California, San Francisco and Silicon Valley entrepreneurs. Our mission is to integrate care and research, and to foster high-impact trials with embedded clinical processes and systems technology and improved data management, greater access to clinical trial matching, and greater benefit to patients, providers, and researchers. Our goal is to improve and save lives. Quantum Leap provides operational, financial, and regulatory oversight to I-SPY.
About the I-SPY TRIALs
The I-SPY TRIAL (Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular analysis) was designed to rapidly screen promising experimental treatments and identify those most effective in specific patient subgroups based on molecular characteristics (biomarker signatures). The trial is a unique collaborative effort by a consortium that includes the Food and Drug Administration (FDA), industry, patient advocates, philanthropic sponsors, and clinicians from 16 major U.S. cancer research centers. Under the terms of the collaboration agreement, Quantum Leap Healthcare Collaborative is the trial sponsor and manages all study operations.
Regeneron | November 24, 2020
Covid-19 Regeneron antibody cocktail, one of the drugs of President Donald Trump was given after he was infected with the SARS-COV-02 virus, had been cleaned for emergency use by the FDA. And, despite the towering vaccine slide, one analyst still sees therapy as a $ 1 billion-plus business.
Authorization of Emergency Use (EUA) for Regn-COV2, a combination of monoclonal antibodies Kasarivimab and IMdevimab, marked the second for antibody therapy. The first to go to Bamlanivimab Eli Lilly, who was given EUA a few days ago.
In addition to the difference between Regn-COV2 is a concoction of several drugs, while Lilly's maintenance contains only one drug, both EUU is almost identical; The two of them for Covid-19 patients were light to medium for a minimum of 12 years old who were not hospitalized but at high risk to advance to Covid-19.
“The emergency authorization of these monoclonal antibodies administered together offers health care providers another tool in combating the pandemic,” Patrizia Cavazzoni, M.D., acting director of the FDA’s Center for Drug Evaluation and Research, said in a statement.
FDA fact sheet detail the criteria for determining "high-risk" patients. These include obese people with more than 35 body mass index, older patients in or more than 65 years, or people with fundamental conditions such as chronic kidney disease, diabetes, cardiovascular disease or breathing conditions, among others.
Data from a phase 1/2 study in 799 patients showed the cocktail could reduce viral load significantly better than placebo did. More importantly, there were lower rates of hospital visits among REGN-COV2-treated patients within 28 days. “This benefit was greatest in patients most at risk for poor outcomes due to high viral load, ineffective immune response at baseline or pre-existing risk factors,” George Yancopoulos, M.D., Ph.D., Regeneron’s chief scientific officer, said in a statement Saturday.
Through a $450 million agreement signed in July with the Trump administration’s Operation Warp Speed, Regeneron could provide up to 300,000 treatment doses of REGN-COV2 to the federal government for distribution.
The company plans to have the single-dose therapy available to about 80,000 patients by this month and hit the 300,000 mark by the end of January. The U.S. government has a separate $375 million pact with Lilly for 300,000 doses of bamlanivimab.
Antibody drugs are hard to produce, and 300,000 doses are dwarfed in comparison by the 2 million treatment courses Gilead Sciences has pledged to produce of its small-molecule therapy Veklury (remdesivir) by the end of this year. With that limited initial supply, Regeneron CEO Len Schleifer, M.D., Ph.D. warned that demand of REGN-COV2 may exceed supply during the early days.