Merakris Therapeutics | February 09, 2022
Merakris Therapeutics announced that it has entered into a Cooperative Research and Development Agreement (CRADA) with the United States Department of Veterans Affairs (VA) to test its investigational drug product, Dermacyte® Amniotic Wound Care Liquid.
The VA plans to enroll patients, ages 18-75, in a two-part Phase II clinical study to evaluate Merakris’ first in class subcutaneous – or below the skin – injectable wound healing therapy. The study is designed to address the frequency of administration, safety and efficacy of Dermacyte Liquid in treating non-healing venous stasis ulcers. These types of ulcers are caused by problems with blood flow in the veins of the legs.
The therapy consists of an acellular, sterile-filtered human amniotic fluid allograft. It works by stimulating skin cell migration and activating gene expression pathways that promote wound healing.
“Wound care can be a huge issue for some of our veterans,” the VA said in a statement. “We are pleased to participate in studies like this one that are designed to contribute to the quality of life of veterans everywhere.”
If approved, Dermacyte Liquid will be the first subcutaneous biologic indicated for VSUs, which account for between 60 and 80 percent of all leg ulcers. An estimated 500,000-600,000 people suffer from this condition in the United States each year. Fortune Business Insights forecasts that the global market for treatments will reach close to $5 billion annually by 2026.
Merakris said prescreening will begin soon for patients with non-infected VSUs who haven’t improved after at least four weeks of conventional wound therapy. The clinical trial should be underway within the next several weeks. Participants will be randomized 1:1 to receive Dermacyte Liquid either weekly or biweekly in Part 1 of the study. That data will be used to determine dosing frequency for the double-blinded and placebo controlled second part of the study.
The second stage will last 12 weeks. Reductions in participants’ VSU wound surface area will be measured against baseline in weeks 4, 8 and 12. Total wound closure also will be evaluated at the end of week 12.
“This clinical trial marks a significant milestone for our biotechnology company. Dermacyte Liquid contains the natural biomolecules present in amniotic tissues and fluids, and our data suggest that these components may allow us to usher in a new era of precision wound healing.”
Merakris CEO Chris Broderick
Broderick said the company has filed patents covering Dermacyte Liquid and its unique mode of action and plans to conduct more clinical studies in the future.
Merakris Therapeutics – founded in 2016 and headquartered in Research Triangle Park, North Carolina – pioneers the use of commercially scalable stem cell-derived biotherapeutic technologies to promote the healing of damaged tissue. Its mission is to improve global patient care and outcomes through regenerative biotechnologies.
CELL AND GENE THERAPY
Biogen, Ginkgo Bioworks | May 22, 2021
Biogen and Ginkgo Bioworks announced a partnership in gene therapy today. The companies aim to redefine the industry standard for manufacturing recombinant adeno-associated virus (AAV)-based vectors by working together.
Recombinant AAV-based vectors are extensively used in the development of novel gene therapies with the ability to cure neurological and neuromuscular diseases, as well as other conditions in a variety of therapeutic areas. Manufacturing is now time-consuming and expensive, making it difficult to develop therapies for diseases with high dosage requirements and large patient populations.
Ginkgo intends to address these issues by using its mammalian cell programming platform to increase the performance of AAV-producing plasmid vectors and cell lines, potentially accelerating Biogen's development of novel gene therapies.
“We believe that Ginkgo's unique combination of cell programming expertise, proprietary tools, and biological system awareness makes them a perfect collaborative partner to explore a broad range of design ideas to optimize constructs,” said Alphonse Galdes, Ph.D., Biogen's Head of Pharmaceutical Operations and Technology.“They share our goal of ensuring that approved therapies are not delayed due to manufacturing constraints and are available to patients all over the world.”
“We are delighted to partner with Biogen as they seek to develop treatments that can potentially delay, stop, or cure neurological and neurodegenerative diseases, as well as to improve the industry standard for AAV manufacturing,” said Jason Kelly, CEO of Ginkgo Bioworks. “Synthetic biology is utilizing the power of living cells to develop the next generation of therapeutics, including CAR-T, CRISPR, and gene therapies, which we hope would have a significant effect on the lives of many people.”
Biogen will have access to Ginkgo's proprietary cell programming platform and capabilities under the terms of the agreement. Ginkgo will use its bioengineering facilities and resources to improve Biogen's gene therapy manufacturing processes' AAV output titers. Ginkgo will receive a $5 million initial payment and will be eligible for milestone payments of up to $115 million if the partnership programs achieve certain research, development, and commercial milestones.
Our mission at Biogen is clear: we are neuroscience pioneers. Biogen discovers, develops, and delivers innovative therapies for people suffering from severe neurological and neurodegenerative diseases, as well as related therapeutic adjacencies, around the world. Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray, and Nobel prize winners Walter Gilbert and Phillip Sharp as one of the world's first major biotechnology firms. Biogen currently has the leading portfolio of medicines for the treatment of multiple sclerosis, is the first approved treatment for spinal muscular atrophy, commercializes biosimilars of advanced biologics, and is focused on advancing research programs in multiple sclerosis and neuroimmunology, Alzheimer's disease, and dementia, neuromuscular disorders, movement disorders, ophthalmology, and neuropsychiatry.
About Ginkgo Bioworks
Ginkgo is building a platform for program cells in the same way as we program machines. The platform is enabling the growth of biotechnology across a wide range of markets, from food and agriculture to industrial chemicals and pharmaceuticals. Ginkgo is also closely involved in a variety of COVID-19 response efforts, such as community testing, epidemiological tracing, vaccine development, and therapeutics discovery.
CELL AND GENE THERAPY
Curi Bio Inc. | December 30, 2021
Curi Bio Inc., a leading developer of human stem cell-based platforms for drug discovery, announced the second closing of a $10 million oversubscribed Series A financing. New investors include UTC Investment and DS Asset Management, joining current Curi Bio investor and Series A lead Dynamk Capital. The investment will be used to scale Curi’s existing business and accelerate the development of its innovative engineered tissue analysis platforms, including its Mantarray™ platform.
“Curi Bio is thrilled to partner with the distinguished teams at UTC Investment, DS Asset Management, and Dynamk Capital to fuel our next stage of growth. To discover new therapies requires human-relevant disease models. Curi is working to close the gap between preclinical results and clinical outcomes, not only in small molecule discovery, but also in frontier areas like next-generation genetic medicines and cell therapies.”
Michael Cho, JD, CEO of Curi Bio
With costs to develop a single new medicine now exceeding $2Bn, the need for more human-relevant disease models to improve translational efficiency in the drug development process has never been greater. Curi’s core platform – the Curi Engine™ – integrates human stem cells, tissue specific biosystems, and A.I./M.L.-enabled data analysis to accelerate the discovery and development of new therapeutics. With this three-pronged strategy — human cells, systems and data — Curi is rapidly becoming a market leader in creating high-fidelity models of human diseases for drug discovery, especially for striated muscle, including cardiac and skeletal muscle, and neuromuscular models.
“Curi Bio’s technology platforms create significant value for pharma and biotech companies by accelerating discovery timelines and increasing the chances of success for new therapies in development,” said Dr. Gustavo Mahler, Managing Partner, Dynamk Capital. “We look forward to strong growth in Curi Bio’s customer portfolio.”
Curi Bio’s core technologies and products include NanoSurface™ Plates for structural maturation, Cytostretcher™ cell-stretching instruments, and the Mantarray platform for contractility analysis. The Mantarray platform enables researchers to generate and analyze 3D engineered human muscle tissues, providing clinically relevant functional readouts, and reducing reliance on poorly predictive animal models. Curi also offers a suite of customized research services utilizing the Curi Engine, including new assay and model development and phenotypic screening. Curi Bio counts all of the top-ten global pharmaceutical companies among its clients, customers, and partners.
About Curi Bio
Curi Bio’s preclinical discovery platform combines human stem cells, systems, and data to accelerate the discovery of new medicines. The Curi Engine is a seamless, bioengineered platform that integrates human iPSC-derived cell models, tissue-specific biosystems, and A.I./M.L.-enabled phenotypic screening data. Curi’s suite of human stem cell-based products and services enable scientists to build more mature and predictive human iPSC-derived tissues—with a focus on cardiac, musculoskeletal, and neuromuscular models—for the discovery, safety testing, and efficacy testing of new drugs in development. The company’s proprietary technologies are supported by over 100 publications and 19 patents. By offering drug developers an integrated preclinical platform comprising highly predictive human stem cell models to generate clinically-relevant data, Curi is closing the gap between preclinical data and human results, accelerating the discovery and development of safer, more effective medicines.