EPA (part 2, streptomycin!) / $104m ARPA-H BAA and AMR project

This is the second of a 4-part newsletter series. There is an initial 27 Sep 2023 newsletter introducing the EPA concept note, a third (12 Jan 2024) newsletter about ending the use of streptomycin spray on citrus crops, and finally a 4th newsletter (27 Jan 2024) containing some additional resources.

Dear All (OK, so now it’s 5 newsletters in as many days … exciting times … can’t keep up!),

Two follow-up items today. First, yesterday’s newsletter about EPA’s concept note regarding AMR risks of pesticides prompted one of your fellow readers to remind me about this lawsuit filed with the U.S. Court of Appeals, Ninth Circuit:

  • Case number 21-70719, filed 25 Mar 2021
  • Name: Migrant Clinicians Network, et al v. USEPA, et al
  • A copy of the petition for review is here and it begins as follows (lightly edited by me for ease of reading):
    • Pursuant to Rule 15(a) of the Federal Rules of Appellate Procedure and section 16(b) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. § 136n(b),
      • “Petitioners Migrant Clinicians Network, Beyond Pesticides, Center for Biological Diversity, Environmental Confederation of Southwest Florida, Farmworker Association of Florida, Farmworker Justice, Natural Resources Defense Council, and United States Public Interest Research Group
      • petition this Court to review and set aside the final order of the U.S. Environmental Protection Agency (EPA) granting
      • unconditional registration of the new use of the active ingredient streptomycin sulfate on citrus crop group 10‐10 for a period of seven years.”
    • Petitioners respectfully petition this Court to find that EPA’s approval of streptomycin as a pesticide on citrus violated FIFRA because the Agency failed to ensure that the use of streptomycin would not cause unreasonable harm to human health or the environment. 7 U.S.C. §§ 136a(c)(5)(C), (D), 136(bb). 
  • Digging a bit further, you can learn that legal arguments were set to begin on 23 Jan 2023 according to this blog post by NRDC (a US-based international environmental advocacy group):
    • “SAN FRANCISCO – On January 23, the Ninth Circuit Court of Appeals will hear oral argument challenging the U.S. Environmental Protection Agency’s approval of the medically-important antibiotic streptomycin as a pesticide on citrus crops.
    • The lawsuit, brought by farmworker and public-interest groups, argues the use of streptomycin on citrus crops is unlawful under the Federal Insecticide, Fungicide, and Rodenticide Act and the Endangered Species Act.
    • Streptomycin is used to treat serious illnesses ranging from tuberculosis to urinary tract infections.
    • The misuse of medically important antibiotics has contributed to increased antibiotic resistance in bacteria–a pressing public health crisis causing over 35,000 deaths each year in the United States.
    • “The widespread uses of streptomycin can also cause harmful, long-term effects on endangered species like Florida panthers and San Joaquin kit foxes, who use habitat in and around treated fields, as well as bee and butterfly pollinators who are already suffering serious declines.”
  • In case it’s not instantly obvious, the key point is that streptomycin is part of the aminoglycoside family of antibiotics that we use to important infections … and resistance to one aminoglycoside may mean resistance to most (or all) other aminoglycosides.
  • I don’t see action on the case since January other than an indication that the 23 Jan 2023 oral argument occurred (audio and video recordings are at http://www.ca9.uscourts.gov/media/) and some subsequent notices about changes in legal representation.

I recall seeing this news item in 2021 but did not put two and two together … but now we have the fascinating EPA Concept Note discussed yesterday! Amazing!


Second, yesterday I also mentioned news about an announcement by President Biden regarding a $100 million research drive from/within the Advanced Research Projects Agency for Health (ARPA-H). A few more details are now available:

  • The press release from ARPA-H: “ARPA-H is funding through its Open Broad Agency Announcement (Open BAA) the Defeating Antibiotic Resistance through Transformative Solutions (DARTS) project.”
  • The award is for up to $104m to Harvard Medical School for this project (shortened summary by me):
    • “Current methods of bacterial identification and antibiotic susceptibility … can take hours, if not days…
    • DARTS aims to address these challenges by advancing an ultra-high throughput imaging and culturing platform
    • “If successful, the system will serve as a rapid platform for the discovery and development of new antibiotics (and) … as a microbial diagnostic …”
  • !! Well, I was entirely unaware of ARPA-H’s Open BAA … it is open until 14 Mar 2024 and is quite wide-ranging in its scope. Please take a look … as these text excerpts from the BAA make clear, it is obvious that AMR-related projects are in scope:
    • ARPA-H will foster innovations that are entirely novel proofs of concept or contribute directly to advance the goals of government-wide initiatives such as … the National Action Plan for Combatting Anti-Microbial Resistance …”
    • And under an area of interest called Proactive Health: “Interest areas include, but are not limited to … Novel techniques to reduce the spread of disease or eliminate risk factors, including new vaccine or therapeutic modalities that block pathogen transmission, induce mucosal immunity, or boost or sustain native immunity without triggering auto-immune dysfunction.”

All best wishes (and really hoping this is the last newsletter this week to add to your overflowing inboxes … when it rains, it pours!), –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)

  • BARDA’s long-running BAA (Broad Agency Announcement) for medical countermeasures (MCMs) for chemical, biological, radiological, and nuclear (CBRN) threats, pandemic influenza, and emerging infectious diseases is now BAA-23-100-SOL-00004 and offers support for both antibacterial and antifungal agents (as well as antivirals, antitoxins, diagnostics, and more). Note especially these Areas of Interest: Area 3.1 (MDR Bacteria and Biothreat Pathogens), Area 3.2 (MDR Fungal Infections), and Area 7.2 (Antibiotic Resistance Diagnostics for Priority Bacterial Pathogens). Although prior BAAs used a rolling cycle of 4 deadlines/year, the updated BAA released 26 Sep 2023 has a 5-year application period that ends 25 Sep 2028 and is open to applicants regardless of location: BARDA seeks the best science from anywhere in the world! See also this newsletter for further comments on the BAA and its areas of interest.
  • HERA Invest was launched August 2023 with €100 million to support innovative EU-based SMEs in the early and late phases of clinical trials. Part of the InvestEU program supporting sustainable investment, innovation, and job creation in Europe, HERA Invest is open for application to companies developing medical countermeasures that address one of the following cross-border health threats: (i) Pathogens with pandemic or epidemic potential, (ii) Chemical, biological, radiological and nuclear (CBRN) threats originating from accidental or deliberate release, and (iii) Antimicrobial resistance (AMR). Non-dilutive venture loans covering up to 50% of investment costs are available. Applications are accepted on a rolling basis; go here for all the details.
  • The ENABLE-2 consortium has announced a call to support hit-to-lead compound development by researchers at publicly-funded European universities. The call is focused on molecules with the potential to be direct-acting therapies for one or more of the following priority pathogens: ESBL-producing/carbapenem-resistant Enterobacteriaceae (E. coli, K. pneumoniae), P. aeruginosa, A. baumannii, methicillin-resistant S. aureus, or vancomycin-resistant E. faecium. The Call is open continuously, applications are reviewed at intervals, and funding is non-dilutive. Expressions of interest received before 30 Sep 2023 would be considered in November 2023. Applications received after this date will be evaluated in the spring of 2024 (date to be decided). Go to https://www.ilk.uu.se/enable2/apply/ for further 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 contact@amractionfund.com.
  • INCATE (Incubator for Antibacterial Therapies in Europe) is an early-stage funding vehicle supporting innovation vs. drug-resistant bacterial infections. The fund provides advice, community, and non-dilutive funding (€10k in Stage I and up to €250k in Stage II) to support early-stage ventures in creating the evidence and building the team needed to get next-level funding. Details and contacts on their website (https://www.incate.net/).
  • These things aren’t sources of funds but would help you develop funding applications
    • 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.
    • Diagnostic developers would find valuable guidance in this 6-part series on in vitro diagnostic (IVD) development. Sponsored by CARB-XC-CAMP, and FIND, it pulls together real-life insights into a succinct set of tutorials.
  • 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):

  • General note: Virtual meetings are easy to attend, but regular attendance at in-person events is the key to networking and deeper insight. My personal favorites for such in-person meetings are marked below as HIGHLY RECOMMENDED and are the BEAM Alliance’s AMR Conference (March, Europe), ECCMID (April, Europe), the ASM-ESCMID Developer’s meeting (September, alternates sides of the Atlantic), and ID Week (October, USA). Of particular value for developers are the AMR Conference and the ASM-ESCMID conference. Hope to see you there!
  • 4 Oct 2023 (Museum of Science, Boston, MA; in person, 11.30a-2.30p ET): Co-sponsored by the Boston’s Museum of Science and the Rijksmuseum Boerhaave (Netherlands), you can attend a luncheon and panel discussion entitled “Celebrating 300 Years of Innovation and Beyond: How van Leeuwenhoek’s Discovery of the Microworld Sparked a Medical Revolution, with a Focus on Antimicrobial Resistance.” Go here for details and to register. I knew about Boston’s MOS but did not know about the exceptional collection of the Rijksmuseum Boerhaave which seeks to “… show what science is all about: curiosity, guts, creativity and perseverance.” Fascinating!
  • 7-15 Oct 2023 (residential, Annecy, France): ICARe, the Interdisciplinary Course on Antibiotics and Resistance. Now in its 7th year, this course is a deep-dive into the world of antibiotic development. Intense, rigorous, and HIGHLY recommended. Seats are always limited … apply sooner rather than later! Go here for details.
  • 11-15 Oct 2023 (Boston, USA): IDWeek 2023, the annual meeting of the Infectious Diseases Society of America. Go here for details and to register. HIGHLY RECOMMENDED.
  • 12 Oct 2023 (virtual, 2-3p CET) GARDP-sponsored webinar entitled “Market interventions to improve access to antibiotics for resistant infections.” Go here to register.
  • 20-23 Oct 2023 (Athens, Greece): 11th TIMM (Trends in Medical Mycology). Go here for details.
  • 6-7 Feb 2024 (online): Antimicrobial Chemotherapy Conference. This is an annual, free of charge conference that is co-organized by GARDP and the British Society for Antimicrobial Chemotherapy (BSAC). Details to follow — for now, just mark your calendar.
  • 6-7 Mar 2024 (Basel,[NEW]  6-7 Mar 2024): Sponsored by the BEAM Alliance, the AMR Conference is now in its 8th year and is consistently an excellent meeting for developers. You can’t register yet but you can mark your calendar and signup for notifications about the meeting. HIGHLY RECOMMENDED.
  • 17-22 Mar 2024 (Ventura Beach, CA, in person): Gordon Research Conference (GRC) entitled “New Antibacterial Discovery and Development” with a 16-17 Mar 2024 pre-conference Gordon Research Seminar (GRS) for young doctoral and post-doctoral researchers. An intensive residential meeting, GRCs are highly recommended for networking and deep research insights. Apply here for the GRC and here for the GRS.
  • 27-30 April 2024 (Barcelona, Spain): 34th ECCMID, the annual meeting of the European Society for Clinical Microbiology and Infectious Diseases. Go here for details. HIGHLY RECOMMENDED.
  • 26-31 May 2024 (Montreal, Canada): EDAR7, the McGill AMR Centre’s 7th edition of their Environmental Dimension of Antimicrobial Resistance conference. Go here for details; final abstract deadline is 21 Dec 2023.
  • 13-17 June 2024 (Atlanta, Georgia): ASM Microbe, the annual meeting of the American Society for Microbiology. You can’t register yet, but you can go here for general details.
  • 17-20 Sep 2024 (Porto, Portugal): ASM/ESCMID Joint Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance. Go here for the meeting’s general website. You can’t register (yet) for the 2024 event, but you can mark your calendar. HIGHLY RECOMMENDED.

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