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.
ImaginAb | November 23, 2022
ImaginAb Inc., a global biotechnology company developing 89Zr crefmirlimab berdoxam imaging agent and radiopharmaceutical therapy products, is pleased to announce the signing of a new non-exclusive License and Supply Agreement with TriSalus Life Sciences, Inc. an oncology therapeutics company integrating immunotherapy with disruptive delivery technology to transform the treatment paradigm for patients with liver and pancreatic tumors.
Under the terms of the agreement, ImaginAb will license and supply clinical doses of ImaginAb's investigational CD8 ImmunoPET to TriSalus for use in its clinical trials using its proprietary Pressure-Enabled Drug Delivery™ method for intravascular delivery of its investigational SD-101 compound.
"We are delighted that TriSalus will use our investigational CD8 ImmunoPET technology in an imaging sub-study within its PERIO-01 clinical trial which leverages its PEDD™ methodology and SD-101, a novel therapeutic candidate designed to re-activate the immune system within the liver and pancreas. Our agreement with TriSalus highlights our expanding partnership network and showcases the increasing adoption of our CD8 ImmunoPET technology."
Ian Wilson, Chief Executive Officer of ImaginAb
ImaginAb is a clinical stage, revenue-generating global biotechnology company developing the next generation of imaging agents and radiopharmaceutical therapy products through its proprietary minibody and cys-diabody platforms. The lead candidate 89Zr crefmirlimab berdoxam imaging agent is currently in Phase II clinical trials and has been licensed by numerous pharmaceutical and biotech companies for imaging in their immunotherapy clinical trials, primarily in oncology.
About 89Zr crefmirlimab berdoxam
CD8 ImmunoPET is an 89Zr-labelled minibody that has been designed to bind to the CD8 receptor on human T cells for quantitative, non-invasive PET imaging of CD8+ T cells. CD8+ T cells are the main effector cells involved in the immune response against tumour cells induced by immunotherapies and they also play a key role in multiple autoimmune diseases. As such, quantitative imaging of CD8+ T cells is currently being researched to determine whether it may be used to diagnose the immune status of a patient, to measure the efficacy of immunotherapies and predict patient outcomes.
About TriSalus Life Sciences
TriSalus Life Sciences® is an oncology therapeutics company integrating immunotherapy with disruptive delivery technology to transform the treatment paradigm for patients with liver and pancreatic tumors. The company works to enable more patients to benefit from established and emerging cancer treatments by overcoming intratumoral pressure and immunosuppression, significant barriers that can limit delivery and efficacy. The proprietary TriSalus delivery method—Pressure-Enabled Drug Delivery™—modulates pressure and flow within blood vessels to improve therapy uptake and tumor response in ways traditional approaches cannot. Two FDA-cleared devices utilize TriSalus' proprietary approach to delivery of therapeutics: the TriNav® Infusion System and the Pancreatic Retrograde Venous Infusion™ System.
Currently, in clinical trials across multiple indications, the TriSalus™ Platform uses PEDD™ to administer the company's investigational immunotherapy, SD-101, through a regional intravascular approach with the goal of strengthening immunotherapy responses for liver and pancreatic cancer patients. In partnership with leading cancer centers across the country, and by leveraging deep immuno-oncology expertise and inventive technology development, TriSalus is committed to advancing innovation that improves outcomes for patients.
The Pressure-Enabled Regional Immuno-Oncology™ PERIO™-01 clinical trial is studying a new investigational drug, SD-101, delivered intravascularly by the TriNav® Infusion System using the Pressure-Enabled Drug Delivery™ method of administration. The study will evaluate if this platform approach can improve the performance of systemic checkpoint inhibitors in treating uveal melanoma with liver metastases.
Ginkgo Bioworks | October 20, 2022
Today, Ginkgo Bioworks the leading horizontal platform for cell programming, and Zymergen announced that Ginkgo has completed its previously announced acquisition of Zymergen. The acquisition is expected to significantly enhance Ginkgo's platform by integrating strong automation and software capabilities as well as a wealth of experience across diverse biological engineering approaches.
"Today marks an important step in our long-term growth as we complete the Zymergen acquisition and welcome their world-class team to Ginkgo. We are excited to integrate Zymergen's capabilities into our platform and explore new and expanded partnerships and opportunities for their diverse array of product concepts currently under development."
Jason Kelly, CEO and co-founder of Ginkgo Bioworks
Under the terms of the merger agreement entered into on July 24, 2022, Zymergen stockholders received, for each share of Zymergen common stock, 0.9179 shares of Ginkgo Class A common stock. Zymergen shares will no longer be traded on Nasdaq. Ginkgo Class A common stock will continue to trade on NYSE under the ticker symbol DNA.
About Ginkgo Bioworks
Ginkgo is building a platform to enable customers to program cells as easily as we can program computers. The company's platform is enabling biotechnology applications across diverse markets, from food and agriculture to industrial chemicals to pharmaceuticals. Ginkgo has also actively supported a number of COVID-19 response efforts, including K-12 pooled testing, vaccine manufacturing optimization and therapeutics discovery.
Zymergen is a biotech company that designs and produces molecules, microbes and materials for diverse end markets. Zymergen partners with nature to make better products, a better way, for a better world.