INDUSTRIAL IMPACT
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.
About Merakris
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.
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Cision PR Newswire | August 31, 2020
Unum Therapeutics Inc. (Nasdaq: UMRX), a biopharmaceutical company focused on developing novel, best-in-class precision kinase inhibitors for a range of patients living with cancer and other unmet medical needs, announced today the sale of its cell-based BOXR programs to SOTIO, a clinical stage immuno-oncology company owned by PPF Group. Under the terms of the agreement, SOTIO will make an upfront payment of $8.1 million for the BOXR technology and will assume development of Unum's lead candidate, BOXR1030, which is on track for near-term entry into the clinic. In addition, Unum will be eligible to receive downstream milestones of up to $3.4 million. The sale to SOTIO will enable it to further advance its goal to develop the next generation of potent immunotherapies for patients with cancer. Unum will retain its antibody coupled T cell receptor (ACTR) technology and continues to explore strategic opportunities for the technology and assets. The sale is final as of August 28, 2020.
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RESEARCH
TurtleTree | August 16, 2021
Solar Biotech, led by industrial biotech expert Alex Berlin, has become a significant piece of the puzzle for sustainable food tech companies taking products to market. TurtleTree knew from the beginning that one of the biggest challenges for food tech companies was developing the technologies required to scale up bio-manufacturing processes.
TurtleTree is a biotech company based in Singapore and the US. The company is focused on providing access to the best nutrients in milk using sustainable technologies. With so many food tech companies coming onto the scene, dedicated talent and resources needed to reach commercial scale are scarce.
Microbes like yeast and fungi are nature's perfect tools for bio-manufacturing. Precision fermentation uses microbial hosts as cell factories to produce specific beneficial ingredients in a controlled environment without having to go through animal agriculture.
What happens in the lab is just half the battle. Efficient precision fermentation and product recovery at an industrial scale demand agility, flexibility, decades of experience, unique multidisciplinary process and equipment engineering, and a well-connected network of bioprocessing and microbial biotech partners, all professionally taken care of by Solar Biotech.
Many startups and VC's believe major breakthroughs in the lab will result in the real-world commercialization of bioproducts. The reality is that many projects run into years of roadblocks and scale-up challenges making commercial viability difficult. There is a major difference between traditional fermentation methods, where the microbial biomass itself is the end product, and precision fermentation, where a highly technical skillset is required to obtain the specific desired bioproduct synthesized by the microbial host.
A key factor in reaching price parity with traditional food production methods is the availability of technologically advanced large-scale food-grade bioprocessing facilities, which combine precision fermentation and downstream processing lines that are customized for each player. Based on a Good Food Institute (GFI) report, available biomanufacturing facilities suitable for food precision fermentation is only 3% of the total manufacturing capacity. With the increasing demand for large-scale precision fermentation, we are already seeing the supply falling short.
Alex Berlin, Solar Biotech Founder, CEO & CTO, having built his extensive experience from his time at Novozymes and other industrial biotech companies, has a track record of developing and scaling up bioproducts that were quite challenging for many others. The TurtleTree team identified this value early on, built a strong collaboration model, and made an investment in Solar Biotech.
"TurtleTree's decision to back Alex Berlin and Solar Biotech's team from the early days has started to pay dividends. Our teams can focus on lab-scale R&D and go-to-market as we look to play a major role in the sustainable food supply chain, while Solar Biotech delivers the bioprocessing technologies required for production at scale," says Max Rye, co-founder and chief strategist of TurtleTree.
"My team and I are passionate about not only producing the food of the future but also about making a difference in the way these bioproducts are made. Industrial Biomanufacturing at scale has not evolved significantly for decades. We are committed to making a difference, in particular, with a focus on the deployment of unique cutting edge and sustainable bioprocessing technologies. We believe solar energy and a circular economy strategy will play a major role in how we produce novel bio-processed ingredients," says Alex Berlin.
About TurtleTree
TurtleTree is unlocking access to the natural ingredients found in milk using a host of cell-based technologies. Together with its valued partners, TurtleTree is able to achieve resource efficiency and provide millions with access to the beneficial nutrients found in milk. We aim to transform performance nutrition, food systems, and cellular agriculture with our cell-based technology platform.
About Solar Biotech
Founded in 2019 by Alex Berlin, Solar Biotech brings bioproducts from benchtop to industrial bioprocessing commercial scale. Its proprietary technology uses a combination of unique technologies, skills, and experience to swiftly adapt to the needs of each bioproduct. Solar Biotech customises modular plant architectures, called BioNodes, for specific bioproducts. Solar Biotech's 100% solar-powered platform and facility help precision fermentation companies scale up their operations sustainably and at a fraction of the cost.
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