Dear All,
Supplementing and augmenting their review of the clinical and preclinical pipeline through 31 Dec 2023 (see the 15 June 2024 newsletter for details), WHO have now released:
- A call for data on preclinical antibacterial projects
- Scope: Traditional and non-traditional antibacterial candidates covering the WHO bacterial priority pathogens as well as other resistant pathogens of public health importance such as Clostridioides difficile and Helicobacter pylori. Diagnostics, vaccines, antivirals, antiparasitics, and antifungals are out scope (but covered through other WHO programs).
- Deadline: The call is open through 27 Oct 2024.
- This is the type of data that influences policy and is thus a VERY important project. If you are doing preclinical antibacterial work, please share data on your project!
- A policy brief on AMR entitled: Antibacterial pipeline trends and recommendations to enhance research and development. The policy brief is well-timed for the HLM at UNGA 2024. The document makes 7 key points that can be summarized as:
- We need a robust pipeline!
- The SMEs (small-medium enterprises) that drive the pipeline are struggling!
- We do not have the agents we need, especially for critical priority Gram-negative pathogens!
- We need more oral drugs!
- Children have a high burden but pediatric development lags!
- Drug development occurs mostly in High-Income Countries (HICs) despite the disproportionately higher burden of AMR in LMICs (low-middle-income countries)!
- More support is needed for non-traditional agents!
- And finally, a dashboard for preclinical projects that complements the previously released dashboard for clinical projects.
Indeed all very timely during the run-up to the HLM (High-Level Meeting) on AMR at UNGA 2024:
- The Policy Brief is indeed brief and to the point. I agree wholeheartedly with its messages and I am especially glad to see the specific shout-outs for oral drugs and pediatric development.
- Please do be sure to respond to the preclinical data call if you are doing antibacterial R&D … clear messages on the state of the global R&D effort are very influential!
With thanks to our colleagues at WHO and with 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.
- ENABLE-2 has continuously open calls for both its Hit-to-Lead program as well as its Hit Identification/Validation incubator. Applicants must be academics and non-profits in Europe due to restrictions from the funders. Applications are evaluated in cycles … see the website for details on current timing for reviews.
- CARB-X has open calls at intervals that span four areas: (i) Therapeutics for Gram-Negatives, (ii) Prevention for Invasive Disease, (iii) Diagnostics for Neonatal Sepsis, and (iv) Proof-Of-Concept for Diagnosing Lower-Respiratory-Tract Infections. See this 6 Mar 2024 newsletter for a discussion of the call and go here for the CARB-X webpage on the call. There are multiple opportunities to submit — see the CARB-X webpage for details.
- 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. A closing date is not posted insofar as I can see — applications are accepted on a rolling basis; go here for more details.
- The AMR Action Fund is open on an ongoing basis 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-X, C-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).
John’s Top Recurring Meetings
Virtual meetings are easy to attend, but regular attendance at annual in-person events is the key to building your network and gaining deeper insight. My personal favorites for such in-person meetings are below. Of particular value for developers are the AMR Conference and the ASM-ESCMID conference. Hope to see you there!
- 17-20 Sep 2024 (Porto, Portugal): ASM/ESCMID Joint Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance. Go here to register!
- 16-20 Oct 2024 (Los Angeles, USA): IDWeek 2024, the annual meeting of the Infectious Diseases Society of America. Go here for details.
- 25-26 February 2025 (Basel, Switzerland): The 9th AMR Conference 2025. Go here to register!
- 11-15 April 2025 (Vienna, Austria): ESCMID Global 2025, the annual meeting of the European Society for Clinical Microbiology and Infectious Diseases. Go here for details.
Upcoming meetings of interest to the AMR community:
- [HAS HAPPENED; NOTEWORTHY VIDEO]: 22-23 May 2024 meeting of PACCARB. If you were intrigued by the 23 July 2024 newsletter entitled “Conflict-Borne XDR Superbugs”, you should note that PACCARB devoted its 23 May 2024 morning session to the topic of combat-related drug resistance. See page 3 of the agenda and then follow along in the video on YouTube.
- 22 Aug 2024 (virtual, 11a-12.30p EDT, 5p-630p CEST): GARDP REVIVE Webinar entitled “Exploring non-traditional antimicrobials: Insights from three cases.” Go here for details and to register. If non-traditional approaches interest you, please do be sure to review the challenges that are raised in the papers discussed in the 6 Aug 2019 newsletter entitled “Non-Traditional Antibiotics: A Pipeline Review And An Analysis Of Key Development Challenges.” Developing non-traditional products is MUCH harder than you might expect … it is important to know the issues!
- [NEW – DON’T MISS IT] 28 Aug to 28 Sep (Off-Broadway, New York City, the Alice Griffin Jewel Box Theatre): Lifeline, the musical story of Sir Alexander Fleming’s discovery of penicillin. Previously entitled The Mould that Changed the World, the musical is a two-time Edinburgh Festival Fringe sell-out (2018 and 2022) and has toured to London, Glasgow, Atlanta and Washington DC (2022). This 5-week run in NYC is timed to be in support of the High-Level Meeting on AMR (HLM AMR) during UNGA 2024. Go here for a blurb and here to book your tickets!
- [NEW – DON’T MISS IT] 9 Sep 2024 (9a-4p ET, in-person or virtual): FDA have announced an AMDAC (Antimicrobial Drugs Advisory Committee) meeting that will discuss “new drug application 213972, for oral sulopenem etzadroxil/probenecid tablets consisting of 500 milligrams (mg) sulopenem etzadroxil and 500 mg probenecid, submitted by Iterum Therapeutics US Ltd., for the proposed indication of treatment of uncomplicated urinary tract infections caused by designated susceptible bacteria in adult women 18 years of age and older.” Try to make time to listen to this … every FDA Advisory Committee is a master class in regulatory thinking! Go here for the Federal Register notice and here for the meeting’s webpage: materials are typically posted 2 days before the meeting.
- 17-20 Sep 2024 (Porto, Portugal): ASM/ESCMID Joint Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance. See Recurring Meetings list, above.
- [NEW] 19 Sep 2024 (virtual, 10-11.30a CEST / 18.00–19.30 AEST): GARDP-sponsored webinar entitled “An introduction to antibiotic research and development (R&D).” Go here to register.
- 24 Sep 2024 (in person, 7.45-10a ET, New York City): Breakfast meeting entitled “Advancing Together: Securing the Global AMR Agenda by Harnessing the Collective Strength of Multi-Sector Partnerships”, sponsored by bioMèrieux, The Wellcome Trust, The American Society of Microbiology, and the Republic of Malawi. This occurs two days before the 26 Sep 2024 UNGA HLM on AMR. Go here to register.
- 16-20 Oct 2024 (Los Angeles, USA): IDWeek 2024, the annual meeting of the Infectious Diseases Society of America. See Recurring Meetings list, above.
- 16 Oct 2024 (virtual and in-person, 10a-1p ET): FDA’s Rare Disease Innovation Hub, in collaboration with the Reagan-Udall Foundation will discuss how the recently announced Rare Disease Innovation Hub can engage and prioritize its work. This may seem somewhat remote, but could this have implications for rare infections? Hmm! Attend if you can! Go here for the meeting’s webpage.
- 19-27 Oct 2024 (Annecy, France, residential in-person program): ICARe (Interdisciplinary Course on Antibiotics and Resistance). Now in its 8th year, Patrice Courvalin directs the program with the support of an all-star scientific committee and faculty. The resulting soup-to-nuts training covers all aspects of antimicrobials, is very intense, and routinely gets rave reviews! Seating is limited, so mark your calendars now if you are interested. Applications open in March 2024 — go here for more details.
- 4-5 Dec 2024 (in person, Washington, DC): “Fungal Dx 2024: Fungal Diagnostics in Clinical Practice” is a 2-day in-person workshop organized by ISHAM‘s Fungal Diagnostics Working Group. The program and registration links are available at https://fungaldx.com/; the agenda is comprehensive and features an all-star global list of speakers.
- 11-15 April 2025 (Vienna, Austria): ESCMID Global 2025, the annual meeting of the European Society for Clinical Microbiology and Infectious Diseases. See Recurring Meetings list, above.