Applied DNA Sciences | October 11, 2022
Applied DNA Sciences, Inc. a leader in PCR-based DNA technologies, announced that it received its largest single purchase order for LinearDNA™ valued above the mid-six-figures. The order was placed under a long-standing supply agreement for the bulk manufacture of LinearDNA for a global manufacturer of in vitro diagnostics. Under the terms of the repeat order, the Company will deliver quantities of LinearDNA to the customer in the current quarter, with the full order expected to be fulfilled over the subsequent three quarters.
LinearDNA is produced using an enzymatic manufacturing platform that eliminates the use of fermenters and bacteria required by plasmid DNA, the industry’s current manufacturing standard for DNA. LinearDNA eliminates many of the challenges associated with current plasmid-based DNA manufacturing and produces a DNA product without the risks of bacterial contamination and non-target DNA sequences. The enzymatic process provides the means to optimize a customer-specific chemistry and sequence of LinearDNA. This capability has been leveraged for diagnostic applications, including today's announced repeat order, and is commonly used when customers order LinearDNA for use as IVT templates for RNA production.
“The application of DNA-based probes in molecular diagnostics is rapidly expanding to give the industry powerful new tools to enhance the diagnosis of infectious diseases, genetic disorders, and malignancies. Our proprietary enzymatic approach to manufacturing DNA via PCR underpins our ability to produce DNA more efficiently and rapidly relative to other DNA production methods and at scale. Applying this capacity also to the manufacture of therapeutic DNA for the next generation of genetic medicines, we believe LinearDNA sits at the intersection of two growing life sciences segments that hold the potential to transform human health.”
Dr. James A. Hayward, president and CEO of Applied DNA
About Applied DNA Sciences
Applied DNA Sciences is a biotechnology company developing technologies to produce and detect deoxyribonucleic acid . Using PCR to enable both the production and detection of DNA, we operate in three primary business markets: (i) the manufacture of DNA for use in nucleic acid-based therapeutics; (ii) the detection of DNA in molecular diagnostics testing services; and (iii) the manufacture and detection of DNA for industrial supply chain security services.
The Company’s common stock is listed on NASDAQ under the ticker symbol ‘APDN,’ and its publicly traded warrants are listed on OTC under the ticker symbol ‘APPDW.’
CELL AND GENE THERAPY
Tiziana Life Sciences Ltd. | September 16, 2022
Tiziana Life Sciences Ltd. a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announces that a Lawrence & Isabel Barnett Drug Development Program Grant will be awarded to the Ann Romney Center for Neurologic Diseases at the Brigham and Women’s Hospital by the ALS Association for the study of an intranasal anti-CD3 monoclonal antibody in an animal model of Amyotrophic Lateral Sclerosis (ALS).
Howard L. Weiner, M.D., Co-Director of the Ann Romney Center for Neurologic Diseases at BWH and Chairman of Tiziana's Scientific Advisory Board, stated, “This prestigious research grant will be used to further study the role of intranasal anti-CD3 mAb in dampening the microglial activation which amplifies ALS disease progression. This research follows our recently presented positive findings on intranasal anti-CD3 mAb in Alzheimer’s Disease preclinical models of neuroinflammation. Additionally, we are currently studying foralumab, the first entirely human anti-CD3 mAb, in patients with secondary progressive multiple sclerosis.”
Gabriele Cerrone, Executive Chairman and interim Chief Executive Officer of Tiziana, remarked, “Intranasal foralumab has demonstrated potential across multiple Central Nervous System (CNS) indications. We are encouraged by the preclinical research using an intranasal anti-CD3 mAb in the neuroinflammatory related diseases of ALS and Alzheimer’s, as well as the impressive clinical benefits we have already shown for foralumab in patients with multiple sclerosis. While our initial focus is on our ongoing MS program which will continue to generate clinical read-outs, we are excited by foralumab’s potential to help highly debilitated ALS patients with limited therapeutic options and high unmet need.”
“We have now seen the potential of intranasal foralumab to dampen microglial activation in three major neuroinflammatory-related diseases, which creates significant optionality for exploring its benefits in some of the most important and burdensome medical conditions of our time.”
Matthew W. Davis, M.D., RPh, Chief Medical Officer of Tiziana
About the Barnett Drug Development Grant
The ALS Association’s Barnett Drug Development grant program supports preclinical drug discovery and development of new or repurposed treatments for ALS. There is an urgent need for new and improved therapies for ALS, as there is still no cure. The Lawrence and Isabel Barnett Drug Development Program is open to industry and academic investigators proposing to develop novel or repositioning approaches for ALS. The Association seeks applications for the preclinical assessment of therapeutics for ALS that have a high probability of reaching the clinic within three years.
Foralumab the only entirely human anti-CD3 mAb, has shown reduced release of cytokines after IV administration in healthy volunteers and in patients with Crohn's disease. In a humanized mouse model it was shown that while targeting the T-cell receptor, orally administered foralumab modulates immune responses of the T-cells and enhances regulatory T-cells thereby providing therapeutic benefit in treating inflammatory and autoimmune diseases without the occurrence of potential adverse events usually associated with parenteral mAb therapy. Once a day treatment for 10 consecutive days with intranasal foralumab was both well tolerated and produced clinical responses in COVID-19 patients. Based on these studies, the intranasal and oral administration of Foralumab offers the potential to become a well-tolerated immunotherapy for autoimmune and inflammatory diseases by the induction of Tregs.
About Tiziana Life Sciences
Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana’s innovative nasal, oral and inhalation approaches in development have the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana’s two lead candidates, intranasal foralumab, the only fully human anti-CD3 mAb, and milciclib, a pan-CDK inhibitor, have both demonstrated a favorable safety profile and clinical response in patients in studies to date. Tiziana’s technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications.
LightDeck Diagnostics and Heska | September 13, 2022
Heska Corporation a leading global provider of advanced veterinary diagnostic and specialty solutions, announced today that the Company has entered a definitive agreement to acquire 100% of the share capital of MBio Diagnostics, Inc. d/b/a LightDeck Diagnostics a pioneer in innovative planar waveguide fluorescence immunoassay diagnostics with strong manufacturing and specialized production capabilities.
Founded in 2009 and headquartered in Boulder, Colorado, LightDeck has developed a scalable and innovative platform for rapid and accurate point of care diagnostics. LightDeck's 80-member team includes industry veterans, engineers, and scientists, with deep technical expertise in assay development, manufacturing, and software development, who have collaborated with commercial, academic, and government partners worldwide to build an extensive intellectual property portfolio of 16 US patents and 15 international patents with broad applications, including in veterinary diagnostics, water testing, and human in-vitro diagnostics use. LightDeck's planar waveguide technology optimizes laser activated fluorescence and microfluidics to provide point of care cartridge-based testing without compromise, enabling reference lab-quality results in minutes with inexpensive, quantitative, and easy-to-use functionality. LightDeck's current Boulder location includes fully equipped laboratories for assay development and controlled manufacturing capabilities that support its new, state-of-the-art, highly automated facility in Longmont, Colorado, anticipated to go online in 2023 to dramatically scale-up capacity, production, and research and development.
"We are thrilled to welcome the entire LightDeck team to Heska. We have known and closely followed their success for years and we are happy to fully join with them today as one team focused on supercharging their great work. LightDeck brings to Heska best-in-breed, highly scalable manufacturing and world-class assay development to help drive our strategies for winning at innovation and winning at scale," commented Kevin Wilson, Heska's Chief Executive Officer and President. "LightDeck was central in developing Heska's leading immunodiagnostic platform, Element i+®, including its current menu of Total T4, cTSH, Cortisol, and Progesterone. Having proven our capability, we now take this next important step as we aim to drive production of Element i+® analyzers and cartridges at scale and to accelerate key test menu expansion, such as our recently announced Nu.Q® Vet Cancer Screen, cCRP, SDMA, infectious diseases, and more, in single and multi-plex formats that are substantially better than the competition. We expect to drive gross margin improvement with new manufacturing capabilities and scaling across the business. The addition of LightDeck is a great strategic, financial, and cultural fit with Heska as we continue our march to the top of the innovation and manufacturing competition for the most valuable diagnostics," concluded Mr. Wilson.
"This is a terrific outcome for LightDeck and Heska and their shareholders, employees and commercial partners. We have known and worked with Heska for years and we greatly admire the Heska organization. Since its founding in 2009, LightDeck has been dedicated to revolutionizing testing at the point of care- for faster, more accurate, less expensive, multi-plex testing of the most important diagnostic tests. We have developed one of the most innovative and technologically-advanced assay platforms in the world, which has led to our recent addition to Fast Company's Annual List of the World's 50 Most Innovative Companies for 2022. I am very proud of the work our team has accomplished over the last 13 years." LightDeck's Co-Founder and Chief Technology Officer, Mike Lochhead, went on to say, "We are excited to now enter this next phase with Heska to dramatically expand our reach and scale. What we do at LightDeck matters a great deal. With Heska, we go confidently into our next commercial, manufacturing, and development chapters, strongly engaged, highly supported, and clearly set-up for long-term success and growth."
Nick Traggis, LightDeck's Chief Executive Officer
Heska Corporation manufactures, develops and sells advanced veterinary diagnostics, informatics, and specialty healthcare solutions through its two business segments: North America and International. Both segments include Point of Care Lab testing instruments and consumables, digital imaging products, software and services, data services, allergy testing and immunotherapy, and single-use offerings such as in-clinic diagnostic tests and heartworm preventive products. The North America segment also includes private label vaccine and pharmaceutical production for third-parties, primarily for herd animal health.
About LightDeck Diagnostics
LightDeck Diagnostics believes in a new approach to healthcare, where quick and accurate diagnostic tests will be run wherever and whenever they are needed. The company's proprietary LightDeck® platform combines an advanced laser waveguide with novel materials and patented manufacturing techniques to deliver lab-quality results anywhere, in minutes. The LightDeck platform is achieving success in veterinary diagnostics and for environmental testing. LightDeck is also developing a portfolio of in vitro diagnostic panels. The company is based in Boulder, Colorado, and is recognized as Colorado BioScience Association's Company of the Year, 2021.