Dear All, Two quick items today.
First, FDA have announced an Antimicrobial Drugs Advisory Committee on 17 April 2023 (9a-4.30p ET).
- The committee will “discuss new drug application (NDA) 216974, for sulbactam-durlobactam for injection, submitted by Entasis Therapeutics, Inc. The Applicant’s proposed indication is for the treatment of infections due to Acinetobacter baumannii-calcoaceticus complex including multidrug-resistant and carbapenem-resistant strains.”
- As usual, meeting materials will be available 2 days prior and the meeting will be webcast.
- I strongly urge everyone to listen in … advisory committee meetings are free masterclasses in drug development. There will be a recording made available at some point, but I think it is compelling to listen in real-time.
- Yes, it overlaps with ECCMID but do try to fit it in!
Second, CARB-X have announced an open-round for funding applications with a deadline of 1 May 2023. Applications are sought for any of 3 themes (oral products, vaccines for neonatal sepsis, gonorrhea products) as described in this newsletter!
And, now it’s back to the always excellent BEAM-sponsored AMR Conference in Basel!
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)
- NIAID BAA with a biodefense focus: Vaccines, Therapeutics, and Diagnostics are all in scope. See this newsletter for details; various due dates through 11 April 2023.
- [UPDATED – New application round] CARB-X again have an open-round for funding applications with a deadline of 1 May 2023. Applications are sought for any of 3 themes (oral products, vaccines for neonatal sepsis, gonorrhea products) as described in this newsletter!
- 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.
- BARDA’s long-running BAA-18-100-SOL-00003 offers support for both antibacterial and antifungal agents. This BAA has offered 4 deadlines/year since 2018 … check the most current amendment for details.
- 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/).
- 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):
- 23-24 March 2023 (virtual, 10a-4p ET): 23rd Meeting of the Presidential Advisory Council on Combating Antibiotic Resistance (PACCARB). The PACCARB will vote on the report from the Pandemic Preparedness Working Group (PPWG) on how to strengthen defenses against AMR pathogens in the face of a potential future, large-scale disease event. Go here for details and to register.
- 14 Apr 2023 (Copenhagen, Denmark; 3-6.30p CEST): ECCMID and the Global Leaders Group on AMR will jointly sponsor a symposium entitled “Forging partnerships between science and policy in Antimicrobial Resistance (AMR).” Go here to register.
- 15-18 Apr 2023 (Copenhagen, Denmark): 33rd ECCMID. Go here for details and to register.
- 26 Apr 2023 (virtual, noon-1.30p CET): Webinar entitled “WHO Human health AMR research agenda” from WHO’s series entitled “WHO Global Webinar Series to Support Implementation of National Action Plans on Antimicrobial Resistance (AMR).” Go here to register.
- 8-12 May 2023 (Lisbon, Portugal): 41st Annual Meeting of the European Society for Paediatric Infectious Diseases. Go here for details.
- 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.
- 20-23 Oct 2023 (Athens, Greece): 11th TIMM (Trends in Medical Mycology). Go here for details.