SOTERA HEALTH COMPANY
Mr. KURT ROTH
SVP, CORPORATE DEVELOPMENT AND STRATEGYSPARTA BIOMEDICAL INC
Approximately 900,000 people annually in the United States suffer from damage to the articular cartilage and subchondral bone, with the knee being the most commonly affected. Articular cartilage lesions have a limited intrinsic ability to heal and often result in osteoarthritis (OA). Progression to OA poses significant economic burden for the United States, totaling over $300 billion annually, and negatively impacting 54.4 million adults (23% of the population). Current strategies for cartilage restoration include bone marrow stimulation (microfracture) and autologous chondrocyte implantation (ACI). These methods have high failure rates (25-50% at 10 years), prolonged rehabilitation times (> 12 months), and show decreasing efficacy in patients older than 40-50 years of age.
Sparta Biomedical is developing the first-of-its kind osteochondral repair technology (SBM-01) for support the restoration of the cartilage-bone unit. This purpose-built technology is comprised of a novel biomimetic material possesses cartilage-like properties-- tension, compression, tribology, and fatigue. The patent-pending surface is combined with a uniquely designed base to promote efficient osseous attachment and stable fixation over the long-term. Sparta’s technology will be a significant advancement in the current surgical standard of care. It will result in substantial pain reduction, immediate weight bearing post-operatively, and full range ambulation.
Sparta has assembled a nationally recognized team of scientists, clinicians, orthopedic regulatory experts to develop SBM-01 rapidly and cost effectively. SBM-01's risk profile enables an efficient regulatory path. Furthermore, it is well positioned to obtain Breakthrough Device Designation from the US FDA.
Mr. DUSHYANTH SURAKANTI
Founder & CEOStingray Therapeutics, Inc.
Summary / Data Stingray Therapeutics: Novel Innate Immunity Target - Ectonucleotide Pyrophosphatase / Phosphodiesterase 1 (ENPP1). Stingray Therapeutics, a biotechnology company located in the Texas Medical Center (TMC), is developing next-generation innate immune modulators targeting the STING (Stimulator of Interferon Genes) pathway. Clinical Candidate (SR-8541A) - Potent and Selective Inhibitor of ENPP1 SR-8541A Binds the Catalytic Pocket of ENPP1ENPP1 Inhibitors Activate the STING pathway and Promote Lympocyte Infiltration of Breast Cancer Single-Agent Activity (CT26 - Colon), 57.8% Decrease in Tumor Volume SR-8541A Treatment and Radiation Theapy Demonstrate Synergy and Abscopal Anti-Tumor Response in MC38 Mode Description - STING / ENPP1 The STING pathway is the body’s first level of defense against foreign pathogens (bacteria / viruses) and critical for enabling the adaptive immune system (e.g. T-Cells) to recognize cancer cells and attack. SR-8541A blocks ENPP1’s activity which cancer upregulates to suppress the STING ST imulator of IN terferon G pathway both in cancer cells and in the surrounding tumor microenvironment (TME). By downregulating ENPP1, SR-8541A enhances the innate immune response where adaptive immunity (e.g. checkpoint inhibitors) cannot defeat the cancer alone.SR-8541A used in combination with checkpoint inhibitors enables both arms of the immune system (innate / adaptive) to fight cancer providing a dramatic leap forward in immune-oncology treatment in tumors unresponsive to checkpoint inhibition (prostate , colorectal) and aiding response in tumors where checkpoint inhibitors are currently used melanoma, head and neck, triple-negative breast). Other advantages of ENPP1 inhibition include blocking adenosine production, an important immune suppressor, and helping to block cancer’s ability to repair DNA following targeted and / or chemotherapy. While Stingray's primary focus is oncology, it is also known that activation of the STING pathway via ENPP1 inhibition could have a major impact in infectious diseases, including Mycobacterium Tuberculosis and Hepatitis B, through the stimulation of host defense immunity. Timeline: Pre-IND Enabling Studies: 3Q2020 - 1Q2020 GLP Toxicology Single-Agent Pre-Clinical Studies (interferon responsive tumors - CTCL, Myelofibrosis and immune responsive tumors) Combination Studies - checkpoint inhibitors, anti-CD38 in multiple myeloma, PRRT (liquid radiation), PARP inhibitors, chemotherapy, CAR-T / CAR-NK cells File IND - 1Q2020 Financing: Stingray is raising $1.5M of bridge financing (convertible note funding pre-IND studies) leading to a $15M Series A advancing the company’s lead small molecule compound, SR-8541A, through Phase 1 clinical studies. Use of Proceeds $1M: Pre-Clinical (Chemistry, Biology, CMC, Toxicology) $1M: IP, Legal $11M: Two (2) Phase 1 Clinical Studies $2M: Administration