Arctic Vision | July 05, 2022
Arctic Vision, a China-based biotech company focused on innovative ophthalmic therapies, announced that the first patient has been enrolled in a Phase III clinical study evaluating ARVN003, a proprietary pilocarpine formulation leveraging its micro dosing platform Optejet®, as a treatment to temporarily improve vision in adults with presbyopia in China.
The Phase III study is double-masked, placebo-controlled, randomized, and multicenter trial evaluating the efficacy and safety of ARVN003 in achieving temporary improvement of vision in adults with presbyopia. It is the first clinical trial approved in China for presbyopia drugs and Arctic Vision's study marks the first patient enrollment in a Phase III clinical trial for presbyopia drugs in China.
Presbyopia is a physiological condition that makes it difficult to read and work in near distance. It is caused by the hardening of the lens and weakening of the ciliary muscle and often occurs with aging. Pre-presbyopia typically affects people between the ages of 35 and 45; early presbyopia affects people between the ages of 45 and 52; and late presbyopia, also known as absolute presbyopia, affects people over the age of 52. Today, nearly a quarter of the world's population is affected by presbyopia. With China's rapidly ageing population, the nation is seeing a year-on-year increase in the number of people suffering from presbyopia. Latest data revealed more than 390 million people in China are diagnosed with presbyopia in 2021.
Current treatment options for presbyopia include presbyopic reading glasses, contact lenses and surgery. However, due to limited treatment options and inadequate scientific understanding of the disease, many presbyopia patients in China do not receive intervention or vision correction in time. Untreated and escalated, presbyopia adversely impacts vision, quality of work and life, and the psychological well-being of middle-aged and elderly people. It might also increase financial burden on families and society.
Professor Jia Qu, the Principal Investigator and renowned leader in China's ophthalmology sector – President of Eye Hospital of Wenzhou Medical University said, "With China's rapidly aging population and a growing number of younger presbyopia patients, there is exponential demand for effective, safe, and convenient presbyopia treatments. We are excited to lead China's first clinical study of presbyopia medication and look forward to the approval of ARVN003 in the near future."
"ARVN003's significant clinical progress is encouraging. This clinical achievement follows the successful dosing of the first DME patient in Asia with is testimony of the strength of Arctic Vision's proprietary microdose array print technology in the public eye health sector. We strive to make ARVN003 the first approved presbyopia drug in China, and benefit more presbyopia patients with innovative and diverse treatment options that will help them see and live better."
Dr. Qing Liu, Co-Founder and Chief Medical Officer at Arctic Vision
Arctic Vision obtained an exclusive license in August 2020 for the development and commercialization of ARVN003 in Greater China and South Korea from Eyenovia, a U.S.-based clinical-stage biopharma company. In May 2021, Eyenovia announced positive results from the first Phase 3 MicroLine study, VISION-1, in the U.S. In that trial, the primary endpoint was achieved with MicroLine 2% statistically superior to placebo, determined by improvement in high contrast binocular distance corrected near visual acuity measured in low light conditions two hours after treatment.
ARVN003 is a proprietary pilocarpine formulation leveraging microdosing platform Optejet® for the pharmacologic treatment for presbyopia. Pilocarpine ophthalmic solution is known to constrict the pupil and improve near-distance vision by creating an extended depth of focus through its small aperture effect. The administration of pilocarpine uses high-precision microdosing platform Optejet® to provide improvement in near vision while enhancing tolerability and usability.
Optejet uses high-precision piezo-print technology to deliver approximately 8μL of drug, consistent with the capacity of the tear film of the eye. The volume of ophthalmic solution administered with the Optejet is 80% less than that delivered using conventional eye drops, thus reducing overdosing and exposure to drug and preservatives. Eyenovia's patented microfluidic ejection technology, MAP™ is designed for fast ocular surface delivery, where medication is dispensed as an array of microdroplets to the ocular surface in approximately 80 milliseconds, faster than the ocular blink reflex. Ease of use and successful delivery of medication by Optejet has been demonstrated in more than 85% of the attempts after basic training in a variety of clinical settings compared to 40 – 50% with conventional eyedroppers[i]. Additionally, its smart electronics and mobile e-health technology are designed to track and enhance patient compliance.
About Arctic Vision
Arctic Vision is a China-based ophthalmic biotech focusing on breakthrough therapies, with a leading portfolio covering pre-clinical stage to commercial stage products. Our vision is to provide innovative therapies in China, Asia and globally to address unmet clinical needs and benefit ophthalmic patients at large. Arctic Vision is supported by top-tier life sciences investors and led by an elite team of ophthalmic industry veterans with substantial regional and global experiences in R&D and commercialization of ophthalmic products.
AbCellera and Atlas Venture | August 04, 2022
AbCellera and Atlas Venture announced a multi-target partnership to discover therapeutic antibodies for up to three drug targets that can be developed and commercialized by a stealth-stage Atlas-backed company. The collaboration leverages Atlas’ proven track record in forming innovative biotechnology companies and AbCellera’s unique ability to quickly deliver lead drug candidates to bring transformational new medicines to patients faster.
"AbCellera’s clinically validated platform lets us start discovery in a virtualized model that aligns well with our capital efficient investment strategy. This partnership supports our approach to value creation by allowing us to focus on building companies that aim to deliver impactful medicines to patients.”
Steven Robinette, Ph.D., Venture Partner at Atlas Venture
“Atlas has proven expertise in finding and transforming innovative scientific research into exciting new biotechs,” said Carl Hansen, Ph.D., CEO and President of AbCellera. “By eliminating their need to build internal antibody discovery capabilities at inception, we provide newly launched biotech ventures with a competitive advantage that empowers them to move faster and increase their probability of success. We look forward to working alongside Atlas’ entrepreneurs to unlock their breakthrough science and create new therapies for patients in need.”
Under the terms of the agreement, Atlas’ portfolio company will have the right to develop and commercialize therapeutic antibodies resulting from the collaboration. AbCellera will receive research payments and will be eligible to receive clinical and commercial milestone payments and royalties on net sales of products.
About Atlas Venture
Atlas Venture is a leading biotech venture capital firm. With the goal of doing well by doing good, we have been building breakthrough biotech startups for over 25 years. We work side by side with exceptional scientists and entrepreneurs to translate high impact science into medicines for patients. Our seed-led venture creation strategy rigorously selects and focuses investment on the most compelling opportunities to build scalable businesses and realize value.
About AbCellera Biologics Inc.
AbCellera is a technology company that searches, decodes, and analyzes natural immune systems to find antibodies that its partners can develop into drugs to prevent and treat disease. AbCellera partners with drug developers of all sizes, from large pharmaceutical to small biotechnology companies, empowering them to move quickly, reduce cost, and tackle the toughest problems in drug development.
Anthos Therapeutics | July 11, 2022
Anthos Therapeutics, a clinical-stage biotechnology company developing innovative therapies for cardiovascular and metabolic diseases, announced that the U.S. Food and Drug Administration has granted Fast Track Designation to its investigational Factor XI inhibitor, abelacimab, for the treatment of thrombosis associated with cancer. The company will also be announcing this important milestone today at a session of the ongoing 2022 Congress of the International Society on Thrombosis and Haemostasis Congress in London, UK.
The Fast Track Designation process is designed to facilitate the development and expedite the review of treatments for serious medical conditions, thereby, addressing unmet medical needs. Drugs that are included in this program may be eligible for more frequent interactions with the FDA to discuss the development path, and if the program criteria are met, eligibility for a potential Rolling Review, Accelerated Approval, and Priority Review.
Venous Thromboembolism including both deep vein thrombosis and pulmonary embolism, is the second most prevalent cause of death in patients with cancer, second only to the disease itself.1 However, treatment of Cancer Associated Thrombosis (CAT) can be challenging because the currently available anticoagulants used to treat VTE can have an increased risk of bleeding.2,3
"We believe that abelacimab has the potential to provide patients with cancer associated thrombosis an enhanced safety profile and overall low risk of bleeding, without sacrificing any efficacy of currently available agents. This unmet need is particularly true in patients with gastrointestinal / genitourinary (GI/GU) cancers who are at an even higher risk of bleeding and can be further burdened by the inconvenience of daily injections. Fast track designation by the FDA is a significant milestone for abelacimab and Anthos Therapeutics, but more importantly represents another hopeful step forward for patients. We look forward to working closely with the FDA on our clinical trial program to bring once-monthly abelacimab to patients in need."
Dan Bloomfield, Chief Medical Officer at Anthos Therapeutics
"Caring for cancer patients is a delicate and complex process, requiring a fine balance between the risks and benefits of their anticoagulant treatments. Managing thrombosis episodes is of the utmost importance for physicians, patients, and their caregivers, as untreated blood clots or bleeding episodes associated with currently available anticoagulants, can have dire consequences," said Jean Marie Connors, M.D., Associate Professor of Hematology at Harvard Medical School. "The hemostasis sparing potential of FXI inhibitors, such as abelacimab, may represent an important treatment advance in how we manage patients moving forward."
About the Abelacimab Phase 3 Program in Cancer Associated Thrombosis (CAT)
The abelacimab phase 3 CAT program comprises two complementary studies targeting to enroll approximately 2700 patients across 220 sites in more than 20 countries -- the largest program of any anticoagulant performed in Cancer-Associated Thrombosis.
ASTER is an international multicenter, randomized, open-label, blinded endpoint evaluation, phase 3 study comparing the effect of abelacimab relative to apixaban on venous thromboembolism recurrence and bleeding in patients with cancer associated VTE in whom DOAC treatment is recommended. Abelacimab 150 mg will be administered intravenously (IV) on Day 1 and subcutaneously (SC) monthly thereafter for up to 6 months; Apixaban 10 mg will be administered orally, twice daily (bid) for the first 7 days, followed by 5 mg bid up to 6 months. Enrollment in this trial began in May 2022.
MAGNOLIA is an international multicenter, randomized, open-label, blinded endpoint evaluation, phase 3 study in patients with gastrointestinal (GI) / genitourinary (GU) cancer in whom DOAC treatment is not recommended. The study will compare the effect of abelacimab relative to dalteparin on VTE recurrence and bleeding in patients with cancer associated VTE who are at a high bleeding risk with non-resectable, locally or regionally invasive GI / GU tumors. Abelacimab 150 mg will be administered intravenously (IV) on Day 1 and subcutaneously (SC) monthly thereafter for up to 6 months; dalteparin administered subcutaneously will be given daily, 200 IU/kg/day for the first month, and then 150 IU/kg/day up to 6 months.
About the AZALEA-TIMI 71 Phase 2 Trial
The AZALEA-TIMI 71 trial is an event-driven, randomized, active-controlled, blinded endpoint, parallel-group study to evaluate the effect of two blinded doses of abelacimab relative to open label rivaroxaban on the rate of major or clinically relevant non-major (CRNM) bleeding events in patients with atrial fibrillation (AF) who are at moderate-to-high risk of stroke. The trial completed enrollment in December 2021, with 1287 patients across 95 global study sites including the U.S., Canada, as well as from parts of Europe, and Asia.
Abelacimab is a novel, highly selective, fully human monoclonal antibody designed to induce effective hemostasis-sparing anticoagulation through Factor XI inhibition. Abelacimab targets the active domain of Factor XI, demonstrating dual inhibitory activity against both Factor XI and its activated form, Factor XIa. Abelacimab can be administered intravenously (IV) to achieve rapid inhibition of Factor XI activity and then used subcutaneously (SC) monthly to maintain nearly complete inhibition in a chronic setting. In a PK/PD study, abelacimab administered IV provided profound suppression of Factor XI within one hour after the start of therapy and maintained near maximal inhibition for up to 30 days. 4,5 In a Phase 2 study whose results were published in the New England Journal of Medicine in 2021, a single intravenous dose of abelacimab after knee surgery reduced the rate of venous thromboembolism by 80%, measured 10 days after surgery, compared to enoxaparin.4 Factor XI inhibition offers the promise of hemostasis-sparing anticoagulation for the prevention and treatment of arterial and venous thromboembolic events.6 Abelacimab is an investigational agent and has not been approved for any indication.
About Anthos Therapeutics
Anthos Therapeutics is a clinical-stage biopharmaceutical company focused on the development and commercialization of genetically and pharmacologically validated innovative therapies to advance care for people living with cardiovascular and metabolic diseases. Anthos Therapeutics aims to combine the agility of a biotech with the rigor of a large pharmaceutical company.