1. ABOUT GARDP FOUNDATION

GARDP Foundation (The Global Antibiotic Research & Development Partnership) is a not-for-profit global health organization registered in Geneva, Switzerland. GARDP’s mission is to accelerate the development and access of treatments for drug-resistant bacterial infections. It does so by forging public-private partnerships all over the world to develop and expand access to treatments for serious bacterial infections and sepsis in adults, children and newborns, as well as sexually transmitted infections (STIs).

GARDP Foundation responds to the crisis in antimicrobial resistance. In 2015, the World Health Assembly, the decision-making body of the World Health Organization (WHO), adopted the Global Action Plan on Antimicrobial Resistance. The following year, to deliver on this plan, WHO and the Drugs for Neglected Diseases initiative created GARDP. In 2018, the GARDP Foundation was legally established as an independent entity.

Since then, GARDP Foundation has developed a portfolio of antibiotic treatments that targets WHO priority pathogens, priority diseases and key populations/regions that are especially affected by drug resistance. It is also pioneering new access initiatives with innovator, manufacturing and distribution partners.

As of 2024, the GARDP team consists of about 100 people who collectively share extensive cross-sector R&D and access experience. They work with the key public and private sector stakeholders and partners, such as the research and development community, donors, industry and implementing countries.

2. PROJECT BACKGROUND & PURPOSE OF THE RFP

1. Background to project

Apramycin is an aminoglycoside approved only for animal use. As opposed to all other aminoglycosides (AGs) currently used in the clinic which are di-substituted and monocyclic, apramycin is a mono-substituted, bicyclic deoxystreptamine.

In vitro and in vivo data indicate that apramycin has broad-spectrum activity with potential coverage for all GARDP’s critical priority pathogens. Interestingly, apramycin is resilient to almost all AGs resistance mechanisms typically found in multi-drug resistant (MDR) and extensively drug-resistant (XDR) Gram-negative bacteria, including bacteria that become resistant to AGs because of enzymes that methylate the target (16S RNA) and prevent binding of clinically used AGs. Moreover, this mechanism of AG resistance is commonly found in strains that are also resistant to carbapenems including due to the activity of metallo-β-lactamases .

So far, the only clinically relevant apramycin resistance mechanism is via AAC(3)-IV, an enzyme that confers resistance through N-acetylation of the apramycin molecule and that also confers resistance to gentamycin. Nevertheless, genomic analysis of clinical isolates shows very low prevalence despite 40 years of veterinary use.
Interestingly, preclinical in vitro and in vivo data suggest that apramycin has lower nephrotoxicity and ototoxicity than currently used AGs.

The initial development of apramycin for human use was being carried out by Juvabis, a Swiss biotech, that generated the pre-IND data required to carry out a Phase 1 Single Ascending Dose (SAD) PK and safety study as well as an additional Phase 1 study to generate information on apramycin lung penetration (Phase 1 lung PK and safety study), the later carried out by NIAID.

Following Juvabis bankruptcy in 2024, GARDP acquired all Juvabis-generated data in June 2025 in order to pursue the development of this asset for human use. GARDP is planning a Phase 1b multiple ascending dose (MAD) PK and safety study with apramycin to evaluate the safety of multi-day dosing for 5 consecutive days.

The anticipated therapeutic dose (ATD) is 30 mg/kg/day (1). A 30 mg/kg dose is predicted to achieve the AUC/MIC target of 40 in 96.4% of a virtual Phase 2 patient population with an absolute eGFR extrapolated to 80 mL/min when MIC is 8 mg/L (2).

Apramycin has been shown in an animal model to have a higher increase in positive charge at urinary pH when compared to gentamicin or amikacin, which results in sustained drug uptake and bactericidal activity, with a corresponding boost to potency (3).
Simulations using a PK/PD modelling of apramycin in cUTI (4) suggest that an 11 mg/kg daily dose may be sufficient to achieve bacterial stasis in the kidneys and bladder in humans. 7.5 mg/kg/day and 15 mg/kg/day doses will bracket the 11 mg/kg/day dose.

2. Purpose of RFP

The purpose of this RFP is to identify a qualified Service Provider responsible for the development (based on available documentation), validation (including storage long term stability), and execution of bioanalytical assays for the analysis of apramycin in plasma and urine samples collected from patients during clinical studies, in accordance with applicable regulatory requirements and the expectations of relevant regulatory authorities.

3. CRITERIA FOR SELECTING SUPPLIERS

The decision to award any contract as a result of this RFP process will be based on Suppliers’ responses and any subsequent negotiations or discussions. The decision-making process will consider the ability of each supplier to fulfil GARDP Foundation’s requirements as outlined within this RFP and the total cost of the offer.
Proposals will be assessed against, but not limited to, the following criteria:

1. Technical criteria: Technical criteria will weigh a maximum of 70% of the award decision. They include technical expertise, project experience, team structure, project plan proposal, project management capabilities, client recommendations, values and cultural fit.
2. Financial criteria: Financial criteria will weigh a minimum of 30% of the award decision. They include supplier competitiveness and the completeness of the offer, payment schedule based on deliverables, and a special discount for not-for-profit organizations.
3. Proposals evaluation and bid defense meeting: Based on a pre-aligned selection grid, the GARDP Foundation selection committee will evaluate all written proposals to determine which suppliers shall be invited to a virtual meeting with the GARDP Foundation selection committee.
   The duration of each meeting will be around 2 hours, including follow-up questions and answers. Agenda and potential questions will be shared in advance, together with the invitation to participate.
4. Value-add and insight: Please list/describe any additional services that you feel would benefit GARDP Foundation and their associated costs (if any).
5. Data privacy: GARDP Foundation is committed to protecting and respecting your privacy in compliance with the European General Data Protection Regulation (GDPR). Our Privacy Notice sets out the basis on which the personal data collected from you, or that you provide to us, will be processed by us in connection with your relationship with GARDP Foundation, as vendors, suppliers or third parties.

If you are interested to receive the complete documentation, please review, complete and sign that attached confidential framework and send it to: RFP_Procurement@gardp.org.

Due/closing date: June 9th, 2026