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

Slides:



Advertisements
Similar presentations
The Drug Discovery Process
Advertisements

Immune therapy in NSCLC Presentation – 劉惠文 Supervisor – 劉俊煌教授.
Castrate-resistant prostate cancer (CRPC)
Targeted Cancer Therapeutics, LLC Investor Presentation.
Wilson WH et al. Proc ASH 2012;Abstract 686.
Phase 1/2 Study of Weekly MLN9708, an Investigational Oral Proteasome Inhibitor, in Combination with Lenalidomide and Dexamethasone in Patients with Previously.
Carfilzomib: High Single-Agent Response Rate with Minimal Neuropathy Even in High-Risk Patients 1 Baseline Peripheral Neuropathy Does Not Impact the Efficacy.
Confidential Presenting Gonexin December 13, 2001 Providing hope through extension and enhancement of life MBA Consulting Team Larry Morkre Matt Narens.
Lesokhin AM et al. Proc ASH 2014;Abstract 291.
NMF 3/6/03 Susan Galbraith, MB BChir PhD Vice President Clinical Discovery Oncology & Immunology Phase 0 Trials Why aren’t they more widely used by industry?
CR-1 Concluding Remarks and Risk/Benefit Summary Mace L. Rothenberg, MD Professor of Medicine Vanderbilt Ingram Cancer Center.
BY JUSTIN PIHLAJAMAKI ADVANCING TECHNOLOGY IN THE “FIGHT AGAINST CANCER”
Pharmacology embraces knowledge of the sources, chemical properties, biological effects and therapeutic uses of drugs. In general terms, pharmacology.
July 2015 PRABHAVATHI FERNANDES, PhD Founder, President and CEO How the PATH Act Can Rejuvenate Antibiotic R & D.
Dimère alpha-beta tubuline.
New Developments in Cancer Treatment Dulcinea Quintana, MD.
Evaluating Potential Drug Therapies Mike Shuler Biomedical Engineering.
Efficacy and Safety of Single Agent Sunitinib in Treating Advanced Hepatocelluar Carcinoma Patients After Sorafenib Failure: A Prospective, Open-Label,
Antimicrobial Drugs Chemotherapy: Use of chemicals that do not harm the host yet kills others. Chemotherapeutic agent: substance that is used in medicine.
DRUG DEVELOPMENT & REGULATIONS DR ARIF HASHMI. DRUG DEVELOPMENT Discovery and synthesis Preclinical development (chemical testing, biological testing,
Marine Drug Development and Delivery Prof. Dr. Basavaraj K. Nanjwade M. Pharm., Ph. D Department of Pharmaceutics KLE University College of Pharmacy BELGAUM ,
Annual prostate cancer symposium February 23, 2013 The Kimmel Cancer Center, Philadelphia, PA 2nd “ Novel Therapeutic Strategies for Prostate Cancer ”
1 Kepivance™ (Palifermin) Basis for Approval and Pediatric Studies Kepivance™ (Amgen) Approved 12/15/04 Joseph E. Gootenberg, M.D. Office of Oncology Drug.
Mechanisms of Acquired Resistance to Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR-TKI) in Non-Small Cell Lung Cancer (NSCLC) Victor.
Targeted Therapy in Hematology Dieter Hoelzer – Frankfurt am Main Christoph Zielinski – Vienna, Austria Hans-Joachim Schmoll – Halle, Germany Richard Greil.
Weekly MLN9708, an Investigational Oral Proteasome Inhibitor, in Relapsed/Refractory Multiple Myeloma: Results from a Phase I Study After Full Enrollment.
Developing medicines for the future and why it is challenging Angela Milne.
CE-1 IRESSA ® Clinical Efficacy Ronald B. Natale, MD Director Cedars Sinai Comprehensive Cancer Center Ronald B. Natale, MD Director Cedars Sinai Comprehensive.
Heat Shock Protein 90 (HSP90) is over-expressed in p16 negative oropharyngeal squamous cell carcinoma and its inhibition in vitro potentiates the effects.
PUTTING THE PATIENT AT THE CENTER OF HEALTHCARE RESEARCH Towards a more inclusive model.
CI-1 Tarceva ® (erlotinib) Tablets in Combination with Gemcitabine as a 1st-line Treatment of Pancreatic Cancer Presentation to the Oncologic Drugs Advisory.
Ibrutinib, Single Agent or in Combination with Dexamethasone, in Patients with Relapsed or Relapsed/Refractory Multiple Myeloma (MM): Preliminary Phase.
News from the FDA Approvals through June 2003
Project Title Investigators 1 To see TIPS and FAQS for each slide, please look at this template in Notes view.
VR-23, a New Anticancer Drug Developed in Northern Ontario Hai-Yen Vu, PhD and Hoyun Lee, PhD.
Towards an Integrated Research Policy in the Area of Drug Discovery in the Arab Countries Including mechanisms to better utilization of their terrestrial.
12 th Annual CTOS Meeting 2006 AP23573 Induced Long-term Stability in 2 Patients with Desmoplastic Small Round Cell Tumor (#561) Scott Schuetze, Warren.
CON - 1 Conclusions C David R. Parkinson Vice President, Global Head, Clinical Research and Development Novartis Pharmaceuticals Corporation.
Responses to Subsequent Anti-HER2 Therapy After Treatment with Trastuzumab-DM1 in Women with HER2- Positive Metastatic Breast Cancer 1 A Phase Ib/II Trial.
Frontier Pharma Innovative Licensing Opportunities in Non-Hodgkin Lymphoma 2015 Published on : August No. Pages : 115.
Today’s Drug Discovery Process “How Do We Discover Drugs” Dr. Vincent P. Gullo Drew University.
PHASE II RANDOMIZED STUDY OF TRASTUZUMAB EMTANSINE VERSUS TRASTUZUMAB PLUS DOCETAXEL IN PATIENTS WITH HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 – POSITIVE.
RISE Honors Seminar 2014 Ronald Doll RISE Dept. S-332 X 3168 Training – Synthetic Organic Chemist (Ph.D. Duke Univ.) - National Institute.
26th April 2016, BioTrinity - London
Division of Cancer Treatment and Diagnosis Presented By: Michael Difilippantonio, Ph.D. October 1, 2015.
Blood-based biomarkers for cancer immunotherapy: Tumor mutational burden in blood (bTMB) is associated with improved atezolizumab (atezo) efficacy in.
Nymox Pivotal Phase 3 Fexapotide (NX-1207) BPH Extension Trial Successfully Meets Primary Endpoint
Today’s Drug Discovery Process “How Do We Discover Drugs”
Drug Discovery &Development
Pembrolizumab Drugbank ID :DB09037 Half life : 28 days.
G-200 Partnering Opportunity March 2012 Contact: Jonae R. Barnes jonae
Daratumumab Drugbank ID : DB09043.
Industry Perspective: Expanded Access Programs
Nivolumab in Patients (Pts) with Relapsed or Refractory Classical Hodgkin Lymphoma (R/R cHL): Clinical Outcomes from Extended Follow-up of a Phase 1 Study.
Phase I/II Study of Lorlatinib in Advanced ALK+ or ROS1+ NSCLC
Can Drug Discovery Research be Done At An Undergraduate Institution?
Randomized, Open-Label Phase 1/2 Study of Pomalidomide Alone or in Combination with Low-Dose Dexamethasone in Patients with Relapsed and Refractory Multiple.
Intervista a Lucio Crinò
From Bench to Clinical Applications: Money Talks
Innovation & the Pharmaceutical Research & Development Industry
CDK4/6 Inhibitors in Breast Cancer:
Krop I et al. SABCS 2009;Abstract 5090.
More Than Meets the Eye.
CTCL: INNOVATIVE TREATMENTS GEMCITABINE
Treating CD30-Expressing Cutaneous T-Cell Lymphoma
Battling the Flu: Latest Advances in the Influenza Treatment Arsenal
Stat4Onco Annual Symposium Zhenming Shun April 27, 2019
Clinical Pearls in the Management of Patients With Advanced Non-Small Cell Lung Cancer.
Combining Immunotherapy and Chemotherapy in NSCLC
Presentation transcript:

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

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 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

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

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 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

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

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

Thank you! 9