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

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Presentation on theme: "1 Marine Technology Summit November 16, 2010 1 Discovering and Developing New Medicines from Marine Microbes Nereus Pharmaceuticals Ken Lloyd, Ph.D. Chief."— Presentation transcript:

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

2 2 Marine Microbiology: Paths to Success 2 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 Marine Technology Summit November 16, 2010

3 3 Marizomib: Second Generation Proteasome Inhibitor with Best-in-Class Properties 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 5 chiral centers 17-step chemical synthesis 1-step fermentation H N O O O CH 3 OH Cl H H H Marizomib (NPI-0052)Key Points

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 4

5 Cutaneous Marginal Zone Lymphoma Patient Treated with Marizomib Weekly at 0.7 mg/m 2 5 Cycle 4 Day 22 Baseline  Complete Response – Biopsy Confirmed  Continued Complete Response - Cycle 4 through Cycle 15 Prior Treatments ( ):  Hyper-CVAD  ASCT (Bu-MEL)  XRT (TSEB & IF)  Rituximab

6 6 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 Plinabulin: A Novel, Potent and Highly Selective VDA with First-in-Class Potential one of >250 analogues of the natural product Potency >40 fold natural product Straightforward synthesis Plinabulin; NPI-2358 Themes

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 2 nd line NSCLC study 7

8 Marine Technology Summit November 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 8

9 Thank you! 9


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