U19AI189168

Center for Accelerated Development of Drug Candidates Targeting High Threat Bacterial Infections - Summary

The global rise in antimicrobial resistance (AMR) poses a grave public health threat, limiting treatment options and causing substantial morbidity and mortality.

Particularly concerning is the rise of AMR among both Gram-negative (GN) and Gram-positive (GP) bacterial pathogens in hospital and community settings.

Addressing this urgent medical need demands the development of effective new antibiotics targeting high-threat AMR pathogens, yet the current pipeline's capacity to meet this demand is insufficient.

With antibiotic development now predominantly driven by biotech, academia plays an increasingly pivotal role in collaborating with industry to foster the development of clinically viable drug candidates.

Our Center of Excellence in Translational Research (CETR) Drug Accelerator was established to leverage the expertise of five seasoned drug developers from academic (CDI, Rutgers) and pharmaceutical/biopharmaceutical (Merck, Prokaryotics, Bioversys) sectors.

This collaborative effort aims to advance mature antibacterial small molecule inhibitor programs through preclinical development, resulting in multiple IND submissions for clinical assessment.

Our focus is on combating clinically significant, high-threat, drug-resistant bacterial pathogens including GP: nontuberculous mycobacteria (NTM) Mycobacterium abscessus and Mycobacterium avium; methicillin resistant Staphylococcus aureus, and enterococci; fastidious GN: Neisseria gonorrhea, Haemophilus influenzae, Moraxella catarrhalis, Legionella pneumophila, Chlamydia pneumoniae, and Mycoplasma pneumoniae, and non-fastidious GN pathogens: Acinetobacter baumannii and Burkholderia spp by prioritizing development of both narrow- and broad-spectrum small molecule inhibitors targeting key enzymes and prominent pharmacological targets.

All of our projects are advanced with mature compounds representing new chemical classes that can overcome existing mechanisms of resistance and are poised to be developed as preclinical development candidates.

The CETR includes an integrated network of science cores staffed by experienced directors, facilitating efficient compound identification and optimization.

Clear criteria for compound progression with ‘go, no-go’ metrics have been established to ensure streamlined development processes.

The CETR fosters synergy among projects, developing distinct drug candidates targeting overlapping threat agents.

By bringing together highly accomplished project leaders and partners from academia and industry, supported by experienced core leaders, world-class scientific advisory board members, and regulatory specialists, we will effectively navigate preclinical development stages, swiftly advancing optimized leads through rigorous milestones as preclinical development candidates for IND-enabling and de-risking studies.

The goal of our efforts is to develop multiple preclinical development candidates suitable for IND submission.

Strong industry collaboration facilitates downstream clinical development for select projects, while others are poised for licensing or partnership with biopharmaceutical companies.

Through our concerted endeavors, we strive to address the critical need for new antibiotics to combat the growing threat of antimicrobial resistance.

HMH Hospitals Corporation

TO ASSIST PUBLIC AND PRIVATE NONPROFIT INSTITUTIONS AND INDIVIDUALS TO ESTABLISH, EXPAND AND IMPROVE BIOMEDICAL RESEARCH AND RESEARCH TRAINING IN INFECTIOUS DISEASES AND RELATED AREAS, TO CONDUCT DEVELOPMENTAL RESEARCH, TO PRODUCE AND TEST RESEARCH MATERIALS. TO ASSIST PUBLIC, PRIVATE AND COMMERCIAL INSTITUTIONS TO CONDUCT DEVELOPMENTAL RESEARCH, TO PRODUCE AND TEST RESEARCH MATERIALS, TO PROVIDE RESEARCH SERVICES AS REQUIRED BY THE AGENCY FOR PROGRAMS IN INFECTIOUS DISEASES, AND CONTROLLING DISEASE CAUSED BY INFECTIOUS OR PARASITIC AGENTS, ALLERGIC AND IMMUNOLOGIC DISEASES AND RELATED AREAS. PROJECTS RANGE FROM STUDIES OF MICROBIAL PHYSIOLOGY AND ANTIGENIC STRUCTURE TO COLLABORATIVE TRIALS OF EXPERIMENTAL DRUGS AND VACCINES, MECHANISMS OF RESISTANCE TO ANTIBIOTICS AS WELL AS RESEARCH DEALING WITH EPIDEMIOLOGICAL OBSERVATIONS IN HOSPITALIZED PATIENTS OR COMMUNITY POPULATIONS AND PROGRESS IN ALLERGIC AND IMMUNOLOGIC DISEASES. BECAUSE OF THIS DUAL FOCUS, THE PROGRAM ENCOMPASSES BOTH BASIC RESEARCH AND CLINICAL RESEARCH. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM EXPANDS AND IMPROVES PRIVATE SECTOR PARTICIPATION IN BIOMEDICAL RESEARCH. THE SBIR PROGRAM INTENDS TO INCREASE AND FACILITATE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. THE SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM STIMULATES AND FOSTERS SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. RESEARCH CAREER DEVELOPMENT AWARDS SUPPORT THE DEVELOPMENT OF SCIENTISTS DURING THE FORMATIVE STAGES OF THEIR CAREERS. INDIVIDUAL NATIONAL RESEARCH SERVICE AWARDS (NRSAS) ARE MADE DIRECTLY TO APPROVE APPLICANTS FOR RESEARCH TRAINING IN SPECIFIED BIOMEDICAL SHORTAGE AREAS. IN ADDITION, INSTITUTIONAL NATIONAL RESEARCH SERVICE AWARDS ARE MADE TO ENABLE INSTITUTIONS TO SELECT AND MAKE AWARDS TO INDIVIDUALS TO RECEIVE TRAINING UNDER THE AEGIS OF THEIR INSTITUTIONAL PROGRAM.

93.855 - Allergy and Infectious Diseases Research

National Institute of Allergy and Infectious Diseases (NIAID) [HHS - NIH]

New Jersey United States

State-Wide

Centers of Excellence for Translational Research (CETR) (U19 Clinical Trial Not Allowed) (RFA-AI-23-065)