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Marine Technology Summit November 16, 2010

Marine Technology Summit November 16, 2010. Nereus Pharmaceuticals. Discovering and Developing New Medicines from Marine Microbes. Ken Lloyd, Ph.D. Chief Scientific Officer. 1. Marine Technology Summit November 16, 2010. Marine Microbiology: Paths to Success. Natural Product

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Marine Technology Summit November 16, 2010

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  1. Marine Technology SummitNovember 16, 2010 Nereus Pharmaceuticals Discovering and Developing New Medicines from Marine Microbes Ken Lloyd, Ph.D. Chief Scientific Officer 1

  2. Marine Technology SummitNovember 16, 2010 Marine Microbiology: Paths to Success • Natural Product • Mother Nature best chemist • Derivative of Natural Product • Analogue Chemistry • Precursor Manipulation • Gene Strategies • Marizomib (NPI-0052) • Better characteristics than >60 analogs • Late Phase 1 • Multiple Myeloma • Lymphomas • Plinabulin (NPI-2358) • Better profile than >200 analogs • Late Phase 2 • Non small cell lung cancer • Other solid tumors 2

  3. Marizomib: Second Generation Proteasome Inhibitor with Best-in-Class Properties Marizomib (NPI-0052) Key Points • Unique structure as compared to synthetic competitors • Potent, broad spectrum proteasome inhibitor • Highly selective for proteasome activities as compared to other proteases • Marizomib has commercially relevant benefits secondary to unique structure • Superior safety profile • Superior efficacy (Velcade resistant tumors) • Potential for oral, sc, or sublingual • Significant market opportunity in validated indications with considerable upside in other large market indications H H O H H O N O O H C H 3 • 5 chiral centers • 17-step chemical synthesis • 1-step fermentation C l

  4. Marizomib: Clinical Summation • Excellent clinical safety profile with high levels of proteasome inhibition • Excellent pharmacodynamic results translating from bench to clinic • Proof of mechanism milestone achieved • Anti-tumor activity seen in clinical trials

  5. Cutaneous Marginal Zone Lymphoma Patient Treated with Marizomib Weekly at 0.7 mg/m2 Baseline Cycle 4 Day 22 • Prior Treatments (2006-2009): • Hyper-CVAD • ASCT (Bu-MEL) • XRT (TSEB & IF) • Rituximab • Complete Response – Biopsy Confirmed • Continued Complete Response - • Cycle 4 through Cycle 15

  6. Plinabulin: A Novel, Potent and Highly Selective VDA with First-in-Class Potential Plinabulin; NPI-2358 Themes • On track to be the next major advance in the treatment of multiple cancers after success of angiogenesis inhibitors • Major improvements over: • Anti-angiogenesis agents • Anti-microtubule cytotoxic agents • Unique safety and efficacy profiles, synergy and utility in unmet need populations • Novel plinabulin structure likely responsible for advantages • Significantly improved safety profile • Potent and selective vascular disruption + direct apoptotic effect to improve efficacy • one of >250 analogues of the natural product • Potency >40 fold natural product • Straightforward synthesis

  7. Plinabulin: Clinical Summation • Excellent clinical safety profile vs other VDAs and other approved oncology drugs • CNS/Neurological • Cardiac • Decreases docetaxel induced neutropenia • Major adverse effect of docetaxel, a major chemotherapeutic in the treatment of NSCLC • Exceptional pharmacodynamic results (decrease in tumor blood flow) • Single agent clinical benefit rate of 30% in solid tumors • Durable; up to 2 years • Impressive early signal in 2nd line NSCLC study

  8. Marine Technology SummitNovember 16, 2010 Other low-hanging fruit for drug discovery from marine microbiology • Antiinfectives • Major antibiotic discovery effort ongoing at SIO/UCSD • Antifungals • Antivirals • Metabolic diseases, cardiovascular diseases

  9. Thank you!

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