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Anthrax Plague Tularemia

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Anthrax Plague Tularemia July 29, 2019 Paula Bryant Acting Director, OBRRTR OBRRTR in DMID Office of the Director Clinical Research Coordination Office of Office of Office of Office of Office of Office of Biodefense, Scientific Clinical Clinical Genomics Regulatory Research Resources, Coordination Research Research and Advanced Affairs and Translational and Program Affairs Resources Technologies Research (OBRRTR) Operations Parasitology and Enterics & Sexually Bacteriology and Respiratory International Transmitted Virology Branch Mycology Branch Diseases Branch Programs Infections Branch Branch HHS Priority Biological Threats* NIAID Cat A NIAID Cat B NIAID Cat C Bacillus anthracis (anthrax) Burkholderia mallei (glanders) Antimicrobial resistance MDR anthrax Burkholderia pseudomallei Pandemic influenza Smallpox (melioidosis) Ebola virus Rickettsia prowazekii (typhus) Marburg virus Yersinia pestis (plague) Francisella tularensis (tularemia) Clostridium botulinum toxin (BoNT) Emerging infectious diseases (EID) – ‘Disease X’ Other VHFs (Junin, Machupo, Alphaviruses (WEE,EEE,VEE) Lassa, RVF) Ricin, Brucellosis, SEB, Q-fever Yellow Fever Additional DoD and/or lower priority *PHEMCE SIP 2017-18 From OBRA to OBRRTR Broad spectrum MCMs & Narrow-spectrum MCMs Enabling Platform for CatA-BioD Technologies for CatA-C BioD & EID preparedness OBRRTR’s Role 1. ‘PHEMCE’: Address USG’s identified biodefense and public health needs • Execute and represent NIH’s BioD and public health emergency R&D to the PHEMCE 2. Product Development: advance candidate MCMs and Platform Technologies late preclinical, IND/IDE- Phase I clinical testing, enabling testing & mfg with Phase II capabilities • Biothreats = PHEMCE requirements based on DHS assessments • EID’s and other public health threats • Regulatory path - accelerated approval, Animal rule, or EUA • Transition to BARDA, DoD or industry 3. Translational Research: facilitate and manage….. • Pre-Clinical Services • Concept Acceleration Program (CAP) • Partnerships Program and CETRs • Containment Facilities/Infrastructure Preclinical Services: Provides critical data to evaluate candidate MCMs Therapeutics Vaccines Interventional In Vitro Biopharmaceutical Testing External Requests: full Assessment Agent Products of Antimicrobial suite of capabilities to Activity address key gaps Outbreak Response: Rapid access to evaluate interventions Leveraged by CAP to Chemistry, Manufacturing Manufacturing, and advance promising ideas Controls (CMC) into development Documentation for IND Research Resources OBRRTR’s Approach Adv. promising candidates & tech Gap filling studies for PD efforts Integrated • Move MCMs along Product Dev Preclinical Services critical path Contracts Modular Gap- • Go-no-go decisions Filling Studies MCM Candidates & • De-risk platforms & Technologies to Ph I/II technologies • Outbreak response Promising Candidates ext. requestors Evolution of the BioD Centers of Excellence Regional Centers of Excellence for BioD & EID Centers of Excellence for Translational Research RCE 1 (FY2003-08) RCE 2 (FY2009-13) CETR 1 (FY2014-18) CETR 2 (FY2019-23) 10 Centers 11 Centers 14 Centers 11 Centers Basic/Applied Research Basic/Applied Research Translational Translational Research Category A Category A-C Research AR Bacteria Emerging Pathogens AR Bacteria Emerging Viruses Emerging Viruses Erica Saphire Scripps Research Institute Consortium for Immunotherapeutics Against VHFs • Platform to ID efficacious mAb’s against select emerging viruses OBRRTR Vaccines . Goal: develop vaccines and biologics through Phase 1, facilitate handoff to government or industry partners . Product Product Development: ~14 active contracts: ~13 Development diseases; multiple platform technologies, adjuvants Contracts and delivery technologies BAAs . PCS: ~54 Vx Testing and Manufacturing TOs . Collaborative efforts: FANG, Zika, CEPI, Collaborative CarbX, CIVICs, IPTs, etc. PCS Efforts . Successes: 1 PEP indication, 3 product handoffs Task Orders to BARDA, 1 to Industry, 1 to DoD, Significant assay and animal model development contributions that benefit entire community 9 Evolution of BioD Vaccines in OBRRTR Hanta Univ. (DNA) MTB Flu (adj) Plague (adj + Lyo) H7N9 rPA RiVax Tuli Filo rPA rPA (adj) MVA (lyo) HPAI E. Histolytica MVA Filo rPA rPA (Ad6) Dengue Filo + rPA Tuli (adj) AV7909 AV7909 Lassa Zika-YF BoNT AV7909 Filo Filo + (lyo) (RNA) Lassa Platform Vx for Technologies for Vx for BioD Priority BioD/NIAID priority and EID BioD pathogens = Classical BioD = EID Highlight: Anthrax Vaccine Program Goal: Improved Ax Vaccine [PD contracts from 2012/2014 BAAs & Preclinical services (PCS)]* AVA PEP indication Liquid AV7909 Thermostable AV7909 Enhanced, ≤ 2 Dose (Biothrax) (Nuthrax) . used rPA GUP NHP data . CpG 7909 adjuvant . *Lyophilized, 2 doses . rPA (E. Coli) + W805EC; to support PEP . 2 doses . equivalency to liquid in GP IN - Pfeiffer Bidose (PBL) . accepted by 2010 . transitioned to BARDA . cGMP mfg ongoing cGMP mfg complete VRBPAC . 2015 . Phase I trial in 2020 Phase I trial 2019 . PEP approved 2015 1st Gen ‘part B’ 2nd Gen 3rd Gen 4th Gen Criteria: *Discontinued: *First dual adj combo to . rAd4-PA oral (PaxVax/Emergent) be co-lyo with Ag dose sparing - single dose preferred . rPA (plant) + QS21 (Fraunhofer) . rPA (P. fluorescens) ± adj.; ID - glide SDI (Pfenex) dry formulation/enhanced stability . Lyo. rPA; IM - dual chambered syringe (Pharmathene) ease of delivery . MVA-PA and MVA-PA+LF+EF with DepoVax; IM (BN, Immunovaccine) FOUO Highlight: Filovirus Vaccine Program NHP efficacy data to support Ad26/MVA hetero prime boost BN PD contract: MVA-multi-filo Efficacy testing of Crucell PD contract: Filo Vx’s in NHPs Ad26/Ad35 multi-filo + modified Dev. of STD Crucell PD contract: Immune Assays Ad26/MVA Ebola Preclinical and Reagents Integrated Product Dev mono- & multi-valent Services Contracts GUP Immuno & challenge studies to identify CoP Ebola Monovalent: Completed Ph I on monovalent Ferret Trans. to BARDA 2015 Challenge Control Animal EMEA sub. Nov 2019 Model (NHP) Meta- BLA sub. Mar 2021 Analysis Multivalent Filo: Completed Ph1 - Red indicates outbreak response MARV vialed DP to DoD 12 Additional Vx PD Accomplishments . 2nd Gen Smallpox vaccine . Quadrivalent Filovirus/Lassa vaccines • Preclinical through Phase I & II • rVSV platform demonstrated 100% protection in NHP • BN MVA-Imvamune transitioned to BARDA 2010 model • In the SNS; approved for use in Europe and Canada • Rabies platform demonstrated immunogenicity in NHP model . Inviragen/Takeda Dengue vaccine . • provided cGMP and non-clinical support for vaccine Hantavirus DNA vaccine • IND preparation completed; Phase 1 in progress • Transitioned to PD for advanced development . • Phase 3 completed Thermostable Tuberculosis vaccine • First oil based adjuvant to be co-lyophilized with . DoD IND Tularemia vaccine antigen • cGMP and clinical support • Phase I clinical trial in progress • Transferred back to DoD for SIP . Entamoeba histolytica vaccine . Thermostable Ricin vaccine • rLecA, GLA, 3M-052, and phospholipid • cGMP manufacture/release in Oct 2019 • optimizing formulation • initiate Phase 1 in Dec 2019 . Pandemic Influenza Vaccine • CpG & Advax (delta inulin) Masterfile and IND submissions • H7N9 + Advax + CpG - screening formulations Judy Hewitt Deputy Director, OBRRTR 14 The Regulatory Leap of Faith, aka Animal Rule Animal PK or Animal Safety Animal Efficacy Immunogenicity ?? Human PK or Human Safety Human Efficacy Immunogenicity ?? 15 14 Animal Rule Approvals to Date Date Drug Indication 2003 Pyridostigmine Bromide For military personnel exposed to Soman nerve gas 2006 Cyanokit (hydroxycobalamin) * For cyanide poisoning 2012 Levaquin * For treatment of pneumonic plague Raxibacumab For treatment of inhalational anthrax, along with antibiotics 2013 Botulism Antitoxin Heptavalent (Equine) For treatment of botulism 2015 Ciprofloxacin * For treatment of pneumonic plague Anthrasil (anthrax immune globulin) For treatment of inhalational anthrax, along with antibiotics Neupogen (filgrastim) * For treatment of Hematopoietic Syndrome of Acute Radiation Syndrome Moxifloxacin * For treatment of pneumonic plague Neulasta (pegfilgrastim) * For treatment of Hematopoietic Syndrome of Acute Radiation Syndrome BioThrax (vaccine) For post-exposure prophylaxis of anthrax, with antibiotics 2016 Obiltoxaximab (Anthim) For treatment of inhalational anthrax, along with antibiotics 2018 Leukine (sargramostim)* For treatment of Hematopoietic Syndrome of Acute Radiation Syndrome TPOXX (Tecovirimat, ST-246) For treatment of smallpox * Drugs approved with a single animal model (7) italics = new drug (5) NIAID Animal Model Used (7) NIAID Directly Involved (4) 16 Animal Rule Approval Requires: 17 What does it take to turn a research model into a pivotal model? 18 NIH-FDA Working Groups Selected Antibiotics Criteria: Anthrax Plague Tularemia . Effective against similar disease manifestations (e.g., pneumonia) Levofloxacin Gentamicin Ciprofloxacin Amoxicillin Ciprofloxacin Levofloxacin . Different classes, to combat Augmentin Levofloxacin Doxycycline potential for resistance Azithromycin Doxycycline Tigecycline . Appropriate formulations available Clarithromycin Ceftriaxone Gentamicin . Safety database Rifampin . Special populations 19 Animal Disease is Very Similar to Human Disease 150 Bacteremia ̶ ̶ + + + + 100 Respiratory Rate 50 0 40 190 39 160 38 Heart Rate Temperature 130 37 100 36 70 6/28 6/29 6/30 7/1 7/2 20 Efficacy of 2 Fluoroquinolones 21 sNDA Submission: 400 MB, >250 files 4 NHP natural history
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