Invenshure | June 03, 2022
Venture studio Invenshure announces the launch of MEKanistic Therapeutics, a biotechnology company redefining precision oncology. Co-inventors and pioneers in the MEK inhibitor field, Judith Sebolt-Leopold, PhD, and Christopher Whitehead, PhD, MBA, have rationally designed a drug that blocks two, key pathways (EGFR and PI3K) used to signal cancer cell growth, with a single molecule. In preclinical studies, this first-in-class dual inhibitor shows unparalleled tumor shrinkage without the toxicity generally associated with current kinase inhibitors.
MEKanistic is using cutting edge computational tools to not only understand how these pathways work, but also design medications that perfectly fit within those sites to inhibit the spread of cancer. We have two unique advantages. First, our lead drug's expanded therapeutic window means dramatically reduced side effects for cancer patients. Second, when it's paired with existing cancer therapies, our drug makes them much more effective, We are excited to partner with Pfizer Global R&D veterans, Drs. Leopold and Whitehead, to propel this important technology forward into clinical trials."
Danny Cunagin, CEO of MEKanistic.
MEKanistic will be launching a round of funding in the coming weeks to support the translation of our lead candidate (MTX-531) towards IND approval later this year with the anticipation of initiation of Phase 1 clinical trials in early 2023.
MTX-531's initial application targets head and neck cancers with 900,000 cases worldwide per year. Ultimately, this drug has possible future applications for colon/rectal, esophageal, pancreatic, and some breast cancers. Our work could potentially impact millions of people each year."
Chief Scientific Officer, Dr. Sebolt-Leopold.
Invenshure is a venture studio that scours university research labs for novel and disruptive technologies ready for commercialization. Invenshure partners with top scientists, physicians, and researchers from the most trusted institutions in healthcare and technology. The company focuses on high-growth sectors including biotech, genomics, healthcare IT, diagnostics, cloud computing technologies, and wireless technologies.
Gilead Sciences, Inc. | August 05, 2022
Gilead Sciences, Inc. and MiroBio, a privately-held U.K.-based biotechnology company focused on restoring immune balance with agonists targeting immune inhibitory receptors, today announced that the companies have entered into a definitive agreement pursuant to which Gilead will acquire MiroBio for approximately $405 million in cash, subject to customary adjustments.
The acquisition will provide Gilead with MiroBio’s proprietary discovery platform and entire portfolio of immune inhibitory receptor agonists. MiroBio’s lead investigational antibody, MB272, is a selective agonist of immune inhibitory receptor B- and T-Lymphocyte Attenuator and has entered Phase 1 clinical trials, with the first patient dosed earlier this week. MB272 targets T, B and dendritic cells to inhibit or blunt activation and suppress an inflammatory immune response.
MiroBio’s I-ReSToRE platform (REceptor Selection and Targeting to Reinstate immune Equilibrium) has the potential to be used to develop best-in-class agonist antibodies targeting immune inhibitory receptors, a novel approach to the treatment of inflammatory diseases. The I-ReSToRE platform supports identification and development of therapeutics that utilize inhibitory signaling networks with the goal of restoring immune homeostasis for patients. Gilead anticipates advancing additional agonists derived from MiroBio’s I-ReSToRE platform, including a PD-1 agonist, MB151, and other undisclosed early-stage programs, over the next several years.
“The team at MiroBio has spearheaded foundational research for agonist antibodies following a rigorous scientific approach,” said Flavius Martin, Executive Vice President, Research, Gilead Sciences. “We believe that MiroBio’s unique platform technology has the potential to produce best-in-class agonist antibodies targeting immune inhibitory receptors.”
“We are excited to be joining Gilead. MiroBio has a deep understanding of checkpoint receptor signaling and a proprietary approach to select and generate superior agonist antibodies. Combining this with Gilead’s drug development and therapeutic area expertise will allow us to fully explore the potential of checkpoint agonist antibodies for patients with autoimmune disease.”
Eliot Charles, Chairman of MiroBio
Under the terms of the agreement, Gilead will acquire all of the outstanding share capital of MiroBio for a total of $405 million in cash consideration, subject to customary adjustments, which is payable at closing. Beginning in the first quarter of 2022, consistent with recent industry communications from the U.S. Securities and Exchange Commission (SEC), Gilead no longer excludes acquired IPR&D expenses from its non-GAAP financial measures. We expect the transaction with MiroBio to reduce Gilead’s GAAP and non-GAAP 2022 EPS by approximately $0.30-$0.35. Closing of the transaction is subject to expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions.
MiroBio is a clinical-stage private biotechnology company whose mission is to develop a new class of therapeutic agents, checkpoint agonist antibodies, to restore immune balance in autoimmune patients. MiroBio has developed I-ReSToRE, a proprietary discovery platform, combining its Checkpoint Atlas™, a cutting-edge receptor mapping database and visualization tool, with proprietary antibody engineering. It was spun out of Oxford University in 2019 and is based on more than 15 years of foundational research from the labs of Professor Simon Davis and Professor Richard Cornall with the potential to create safer and more efficacious medicines for patients with autoimmune disease. MiroBio is backed by a strong group of international investors including Oxford Science Enterprises, Samsara BioCapital, SR One, Medicxi, Advent Life Sciences, OrbiMed and Monograph.
About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California
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.