Deargen Inc. | December 23, 2021
Deargen, a company specializing in the development of novel NCE drugs using artificial intelligence, announced on the 22rd that it had discovered and synthesized a new anticancer target compound using its own AI platform and had already applied for a patent for it.
Deargen has the technology to predict candidates for a novel drug without the 3D structure data of proteins. Deargen's technology, which uses amino acid sequence data rather than the structure information of proteins, possesses global-level differentiated artificial intelligence technology that enables the rapid development of novel drugs even for proteins whose 3D structure has not yet been identified.
"The new compound for which we have applied for a patent this time is a first-in-class candidate, and we plan to develop a therapeutic agent targeting triple-negative breast cancer. TNBC is an area where there are few novel drugs available and it is difficult to find innovative targets, so it is a disease with a high demand for new therapeutics…Deargen confirmed the efficacy of the new compound discovered through in-vitro experiments."
An official from Deargen
Also, the substance that Deargen discovered through this study is an NCE. An NCE refers to a new chemically synthesized drug, which requires a great deal of time and money because it is difficult to develop such a drug that has not been previously approved by the FDA. However, it is within an area with high needs by many global pharmaceutical companies as it has the advantage of being able to receive market monopoly rights for 5 years in the U.S. and 10 years in Europe after product approval.
In particular, Deargen's achievements are significant in that it discovered the new compound in a shorter time than the existing novel drug discovery process through its collaboration of advanced AI and in-house experts for novel drug development. The target discovery and substance design process, which usually takes about 3 to 4 years in the existing traditional drug development process, was carried out in just 10 weeks, and it took merely 2 weeks for target discovery and 8 weeks for substance design and synthesis.
Currently, Deargen is establishing a large-scale R&D center. With this R&D center, the plan is to further shorten the period of the discovery of candidates by efficiently managing the time required for designing and synthesizing substances. The R&D center will be in charge of fast verification of substances by conducting the design and synthesis verification of substances under joint research with Deargen's internal pipeline, along with the production of high-quality data.
Daniel Bae, Chief Business Officer of Deargen said : "We plan to continuously derive new substances with patentability through our synthesis research center, which will be established in the first half of next year. We plan to not only build our own pipeline centered on anticancer drugs, but also to introduce various business models with our partners that go beyond the existing joint research contracts." He also said, "Deargen plans to establish its position among global AI drug developers as a company specializing in NCE drug development, from target discovery to compound design and synthesis."
About Deargen Inc.
Established in December 2016, Deargen is an AI-based drug discovery and development company. In February 2020, the company released study results on predicting the development of COVID-19 treatments. Candidate compounds for treating COVID-19 predicted by Deargen include remdesivir, which was first approved as an emergency therapy. The company conducts research on and owns core AI technologies in-silico, such as 'prediction of bio-markers', 'selection of disease targets', and 'extraction of candidate substances for new drugs', utilizing techniques of meta analysis of genome big data and its unique AI technologies. Building on these outcomes, the company is developing new drugs in collaboration with multiple pharmaceutical companies and research institutions, demonstrating its outstanding technology capabilities as being named as top awardees at the ILSVRC, a world-prominent deep-learning competition, and Dream Challenge, an international AI-based new drug development competition.
ILC Dover | March 11, 2022
ILC Dover LP specializing in innovative single-use and chemical workflow solutions for biotherapeutics and pharmaceutical processing, announced plans to significantly expand production capabilities in its Juarez, Mexico facility. This expansion is in response to the Company’s unprecedented growth in its life sciences business and entry into sterile liquid handling and chemicals content market. This investment will generate additional production capacity for its single-use powder storage, single-use fluid storage, and fluid transfer solutions and is scheduled to come online later this year. It also dovetails with recent acquisitions of critical sterile liquid production to provide broader workflow solutions for the Company’s growing customer base.
The expansion in Juarez will complement the current global manufacturing footprint in Frederica DE, Durham NC, Stockport UK, Rossens Switzerland, and Blarney Ireland for its pharma and biotherapeutics customers.
“Expansion in Juarez is an investment in our customers’ success and the next step in ILC Dover’s global growth journey. It strengthens our partnership with key pharmaceutical and biotherapeutics customers around the world — solidifying our ability to expand our presence in critical products for life-saving therapies, improve lead times, and securing our customers’ supply chain in North America. Most importantly, this expansion strengthens our position as a valuable and vertically integrated partner for our life science customers — supporting customers to continue to improve and optimize their workflows.”
Corey Walker, CEO of ILC Dover
Operational in Mexico since 2013, the addition of 20,000 sq ft of new Class 6 and 7 clean room space will support multi-site production of solutions for the biotherapeutic, cell & gene therapy, and pharmaceutical markets. ILC Dover’s Juarez site will use the same processes, raw materials, and equipment as other sites in the global network to provide redundant supply and reduced lead times for customers — consistent with the Company’s global quality system.
This most recent expansion showcases ILC Dover’s commitment to growing its life science solutions for its global customer base. The Company acquired two strategic businesses this past year to accelerate its trajectory in critical life science applications: sterile solutions manufacturer KSE Scientific and medical contract design and manufacturing company Flexan. The proven capabilities and synergies offered with the addition of both companies enable ILC Dover to link single-use solutions and chemical solutions across its customers’ workflows.
About ILC Dover
ILC Dover is a world-leader in the innovative design and production of solutions for biopharmaceutical, pharmaceutical, medical device markets as well as a leading supplier for the (aero)space industries. Our customers will attest to our relentless dedication to high value products, advanced technology, and responsive service, as our visionary solutions have improved efficiency while safeguarding people, product, and infrastructure in hazardous conditions through flexible protective solutions since 1947.
About New Mountain Capital
New Mountain Capital is a New York-based investment firm that emphasizes business building and growth, rather than debt, as it pursues long-term capital appreciation. The firm currently manages private equity, public equity, and credit funds with over $35 billion in assets under management. New Mountain seeks out what it believes to be the highest quality growth leaders in carefully selected industry sectors and then works intensively with management to build the value of these companies.
Direct Biologics | April 13, 2022
Direct Biologics, an innovative biotechnology company with a groundbreaking extracellular vesicle platform drug technology, announced that the U.S. Food and Drug Administration has awarded their EV drug product ExoFlo with a Regenerative Medicine Advanced Therapy (RMAT) designation for the treatment of Acute Respiratory Distress Syndrome associated with COVID-19. The RMAT program is designed to expedite the approval of promising regenerative medical products in the US that demonstrate clinical evidence indicating the ability to address an unmet medical need for a serious life-threatening disease or condition. Under the RMAT designation, the FDA provides intensive guidance on drug development and post-market requirements through early and frequent interactions. Additionally, an RMAT confers eligibility for accelerated approval and priority review of biologics licensing applications.
"After intensively reviewing our preclinical data, manufacturing processes, and clinical data from our Phase II multicenter, double blinded, placebo controlled randomized clinical trial, the FDA has recognized ExoFlo as a lifesaving treatment for patients suffering from Acute Respiratory Distress Syndrome (ARDS) due to severe or critical COVID-19. The additional attention, resources, and regulatory benefits provided by an RMAT designation demonstrate that the FDA views ExoFlo as a product that can significantly enhance the standard of care for the thousands still dying from ARDS every week in the US," he said.
Mark Adams, Chief Executive Officer
"We are very pleased that the FDA has recognized the lifesaving potential of our platform drug technology ExoFlo. The RMAT has provided a pathway to expedite our drug development to achieve a BLA in the shortest possible time," said Joe Schmidt, President. "I am very proud of our team. Everyone has been working around the clock for years in our mission to save human lives taken by a disease that lacks treatment options, both in the US and abroad. We are grateful for the opportunity to accelerate development of ExoFlo under the RMAT designation as it leads us closer to our goal of bringing our life saving drug to patients who desperately need it."
ExoFlo is an acellular human bone marrow mesenchymal stem cell derived extracellular vesicle product. These nanosized EVs deliver thousands of signals in the form of regulatory proteins, microRNA, and messenger RNA to cells in the body, harnessing the anti-inflammatory and regenerative properties of bone marrow MSCs without the cost, complexity and limitations of scalability associated with MSC transplantation. ExoFlo is produced using a proprietary EV platform technology by Direct Biologics, LLC.
Physicians can learn more and may request information on becoming a study site at clinicaltrials.gov. For more information on Direct Biologics and regenerative medicine, visit: https://directbiologics.com.
About Direct Biologics
Direct Biologics, LLC, is headquartered in Austin, Texas, with an R&D facility located at the University of California, and an Operations and Order Fulfillment Center located in San Antonio, Texas. Direct Biologics is a market-leading innovator and cGMP manufacturer of regenerative medical products, including a robust EV platform technology. Direct Biologics' management team holds extensive collective experience in biologics research, development, and commercialization, making the Company a leader in the evolving segment of next generation regenerative biotherapeutics. Direct Biologics has obtained and is pursuing multiple additional clinical indications for ExoFlo through the FDA's investigational new drug (IND) process.
MedX Health Corp | January 28, 2022
Teledermatology company MedX Health Corp. is pleased to announce the launch of MedX Screening Services to be offered at two locations in Ottawa, Canada – ProMed Pharmacy, an independent, pharmacist owned pharmacy enterprise, and Dura Wellness Clinic a retail, clinical focused esthetic services group. Both locations will now offer MedX scanning services and accept walk-in patients.
"This represents the next step in our business plan for North America. ProMed Pharmacy, under the Leadership of Lubna Fawaz, is a perfect model of modern health care delivery as it integrates many services and, most importantly, telehealth services on demand for their patients. Patients can now enter the pharmacy and have a telemedicine consult with a General Practitioner and receive an immediate referral to the Dermsecure Screening Service on site. Incorporating a telemedicine consult with a General Practitioner is a vital step to make DermSecure screening services easily accessible to the public by facilitating both the referral and the screening at the same location."
MedX VP of North American Sales, Paul Ziemer
The addition of ProMed Pharmacy to MedX's Pharmacy network will allow for the "Walk-in-Patient" to get service for their Dermatology concerns if they do not have a Family Doctor or do not have time to get a direct referral.
"MedX remains focused on expanding its footprint into existing and new target markets, and our team is continuing to establish and accelerate many new commercial relationships and partnerships," stated Mike Druhan, MedX President, Dermatology Services. "I remain confident in our team’s ability to expand MedX's teledermatology platform to new markets and greatly improve outcomes for those dermatology patients seeking high-quality, virtual services."
Teledermatology is a subspecialty of dermatology that offers safe and effective virtual care – patient screening and assessment – eliminating the need for in-person appointments with a dermatologist. MedX is a global leader in teledermatology through its high-definition image capture technology, SIAscopy®, and its secure, cloud-based patient management system, DermSecure®, which transmits and stores patient data throughout the assessment process. MedX's SIAscopy® is the only technology globally that captures five high-resolution images of suspicious moles, lesions and skin conditions, including four spectrophotometric images 2mm below the skin's surface. This technology provides detailed patient scans for virtual dermatological assessment by a certified dermatologist within 72 hours.
About MedX Health Corp
MedX, headquartered in Ontario, Canada, is a leading medical device and software company focused on skin health with its SIAscopy® on DermSecure® telemedicine platform, utilizing its SIAscopy® technology. SIAscopy® is also imbedded in its products SIAMETRICS®, SIMSYS®, and MoleMate®, which MedX manufactures in its ISO 13485 certified facility. SIAMETRICS®, SIMSYS®, and MoleMate® include hand-held devices that use patented technology utilizing light and its remittance to view up to 2 mm beneath suspicious moles and lesions in a pain free, non-invasive manner, with its software then creating real-time images for physicians and dermatologists to evaluate all types of moles or lesions within seconds. These products are cleared by Health Canada, the U.S. Food and Drug Administration, the Therapeutic Goods Administration and Conformité Européenne for use in Canada, the US, Australia, New Zealand, the European Union, Brazil and Turkey.