When it rains, it pours … and sometimes in a good way! Today saw the release of requests for proposals by NIAID and BARDA for therapeutics (antibacterial, antifungal, antiviral), vaccines (again, all 3 areas), and diagnostics. It’s an impressive list of opportunities that covers both biothreat pathogens as well as NIAID’s list of Emerging Diseases/Pathogens. Here’s a brief summary to get you started:
- BARDA: An RFP seeking to use Project Bioshield funds to support the late-stage development, regulatory approval, and potential procurement of an antibiotic for the treatment of infections due to biothreat pathogens.
- This call for proposals is seeking antibiotics for the treatment and, if feasible, post-exposure prophylaxis of one or more of the following pathogen(s): Yersinia pestis, Francisella tularensis, Burkholderia pseudomallei.
- Antibiotics for Bacillus anthracis will not be sought under this effort.
- Go here for the details. Proposals are due by 21 April 2022.
- NIAID: A four-pronged BAA (Broad Agency Announcement (HHS-NIH-NIAID-BAA2022-1) with a due date of 18 Mar 2022:
- Research Area 001: “Development of Vaccine Candidates for
Biodefense, Antimicrobial Resistant (AMR) Infections, and Emerging
- Vaccines for the list of NIAID Emerging Infectious Diseases / Pathogens. This includes RNA viruses with pandemic potential (e.g., Coronaviridae) as well as Burkholderia spp, Group A & B Streptococci, Hepatitis C, Mycobacterium tuberculosis, New or improved vaccines against Streptococcus pneumoniae, Bordetella pertussis, and Tick-borne viruses
- Vaccines for Antimicrobial Resistant (AMR) Organisms:
- Vaccines focused on antimicrobial resistant Gram-negative bacteria, such as but not limited to, Pseudomonas aeruginosa, Escherichia coli, Salmonella, and Shigella spp.
- Vaccines focused on multi drug resistant Gram-positive bacteria, such as but not limited to, Staphylococcus aureus and Mycobacterium tuberculosis
- Vaccines focused on fungal pathogens, such as but not limited to, Candida auris, other AMR Candida species, Aspergillus fumigatus, Mucorales and Coccidioides.
- Research Area 002: “Development of Therapeutic Candidates
for Biodefense, Antimicrobial Resistant (AMR) Infections, and Emerging
- Therapeutics to address infections and diseases caused by the NIAID Emerging Infectious Diseases / Pathogens and selected bacterial and fungal pathogens identified in the 2019 CDC Antibiotic Resistance Threats Report.
- Support is available from Lead Optimization through Phase 2
- Research Area 003: “The Antiviral Program for Pandemics
(APP): Development of Antivirals for Specific RNA Viral Families of Pandemic Potential“. This one seeks new antivirals that meet these criteria:
- Directly block viral targets and function
- Are active against RNA viruses of pandemic potential (Coronaviridae, Bunyavirales, Filoviridae, Flaviviridae, Paramyxoviridae, Picornaviridae, and Togaviridae)
- Are new chemical entities which include small molecules and small biotherapeutics that are directly acting against viral targets and functions (not through the modulation of the host responses)
- Have suitable routes of administration (e.g. oral or intranasal) and safety profiles for broad use in the outpatient setting to treat early stages of infection by reducing viral burden
- Research Area 004: “Development of In Vitro Diagnostics for
Biodefense, Antimicrobial Resistant Infections (AMR), and Emerging
Infectious Diseases” supports development of promising diagnostics technologies in three areas for detection of signatures from a range of pathogens. A key focus that (to my eye) runs through the RFP is on ease of use — one of the requirements is that manual processing must take less than 5 minutes! Technologies sought are:
- Next-Generation Nucleic Acid Sequencing on Portable Systems
- Rapid Protein Detection
- Bacterial Identification and Phenotypic Antimicrobial Resistance Characterization
- Research Area 001: “Development of Vaccine Candidates for
Well done, Team NIAID and Team BARDA … the vision here is impressive! Could one of these be for you? I hope so! Get going!
All best wishes, –jr
John H. Rex, MD | Chief Medical Officer, F2G Ltd. | Operating Partner, Advent Life Sciences. Follow me on Twitter: @JohnRex_NewAbx. See past newsletters and subscribe for the future: https://amr.solutions/blog/. All opinions are my own.
Current funding opportunities (most current list is here):
- JPIAMR’s 14th call is now open. Entitled “Disrupting drug resistance using innovative design”, the call seeks consortia that would seek to “improve the treatment of bacterial and fungal infections (including co-infection) and/or the prevention of the emergence/spread of resistance in humans, animals or plants through the improvement of the efficacy, specificity, delivery, combinations and/or repurposing of drugs and plant protection agents.” Bacteria, fungi, human health, animal health, and plant health are all in scope! Pre-proposals are due 8 Mar 2022; full proposals would be due 5 July 2022. Go here for details.
- The AMR Action Fund is now open to proposals for funding of Phase 2 / Phase 3 antibacterial therapeutics. Per its charter, the fund prioritizes investment in treatments that address a pathogen prioritized by the WHO, the CDC and/or other public health entities that: (i) are novel (e.g., absence of known cross-resistance, novel targets, new chemical classes, or new mechanisms of action); and/or (ii) have significant differentiated clinical utility (e.g., differentiated innovation that provides clinical value versus standard of care to prescribers and patients, such as safety/tolerability, oral formulation, different spectrum of activity); and (iii) reduce patient mortality. It is also expected that such agents would have the potential to strongly address the likely requirements for delinked Pull incentives such as the UK (NHS England) subscription pilot and the PASTEUR Act in the US. Submit queries to email@example.com.
- INCATE (Incubator for Antibacterial Therapies in Europe) is a newly launched early-stage funding vehicle. Details are still coming into focus, but per comments on 25 Aug 2021 at the BIOCOM conference, their goal is to support ~4 companies per year with about $250k/company. Contact details are on their website (https://www.incate.net/).
- CARB-X recently announced that their existing resources will be reserved to fund their existing portfolio (more than 80 total awards, and counting, as they include contracting from prior rounds). New rounds from CARB-X will occur only after new funding is obtained in 2021.
- It’s not a funder, but AiCuris’ AiCubator offers incubator support to very early stage projects. Read more about it here.
- The Global AMR R&D Hub’s dynamic dashboard (link) summarizes the global clinical development pipeline, incentives for AMR R&D, and investors/investments in AMR R&D.
- In addition to the lists provided by the Global AMR R&D Hub, you might also be interested in my most current lists of R&D incentives (link) and priority pathogens (link).
Upcoming meetings of interest to the AMR community (most current list is here):
- [If you missed it, you can now watch the video] 8 Dec: “The New Winds Pushing and Pulling Antibacterial Development.” This was a GREAT program that featured talks from the UK team behind the NHS “Netflix” pilot, Kevin Outterson’s recently released report documenting the need for global Pull incentives to have a value of $2.2 – 4.8b, and speakers covering PASTEUR and work in the EU on pull incentives. The video is here — please make time to listen to this program!
- 26 Jan 2022 (virtual, 2-3.30p CET): REVIVE (GARDP) Webinar: New technologies and strategies to overcome the challenges of sexually transmitted infections. Moderated by Amir Schroufi and Remco Peters, the program will covers strategies for managing STDs with a particular focus on the developing world. Go here to register.
- 2-3 Feb 2022 (virtual): 10th Advances Against Aspergillosis and Mucormycosis. Registration closes on 30 Jan 2022. Go here for details.
- 2-3 Feb 2022 (virtual): Antimicrobial Chemotherapy Virtual Conference jointly organised by GARDP with the British Society for Antimicrobial Chemotherapy (BSAC), Center for Disease Dynamics, Economics & Policy (CDDEP) and the Indian Council of Medical Research (ICMR). Click here for details.
- 7 Feb 2022 (virtual, 10a-11.30a and 3:30p-5p CET): 2-part webinar entitled Antimicrobial Consumption & Use – Data for Action as part of the WHO Global Webinar Series. Be sure to register for both session 1 and session 2!
- 3-6 Mar 2022 (Albuquerque, New Mexico): Biannual meeting of the MSGERC (Mycoses Study Group Education and Research Consortium). Details are here.
- 6-11 Mar 2022 (Il Ciocco, Tuscany): Gordon Research Conference entitled “New Antibacterial Discovery and Development”. Go here for details, go here for the linked 5-6 Mar Gordon Research Seminar that precedes it.
- 9 Mar 2022 (virtual, and in-person): BioInfect Conference, Alderley Park, UK (near Manchester). This long-running Bionow-sponsored annual conference draws a very strong audience. Go here for details.
- 7-8 Apr 2022 (Basel and in person, we hope): The 6th edition of the annual AMR conference sponsored by the BEAM Alliance, CARB-X, the Novo REPAIR Impact Fund, the IMI Accelerator, and the European Biotechnology Network. Go here for the hold-the-date page and a way to be kept informed about the meeting.
- 9-13 May 2022 (Athens and online): 40th Annual Meeting of the European Society for Paediatric Infectious Diseases, Go here for details.
- 20-24 Sep 2022 (New Delhi): 21st Congress of the International Society for Human and Animal Mycology (ISHAM). Go here for details.
- 25-28 Oct 2022 (Stellenbosch, South Africa): The University of Cape Town’s H3D Research Centre will celebrate its 10th anniversary with a symposium covering the Centre’s research on Malaria, TB, Neglected Tropical Diseases, and AMR. Go here to register.