• Research Category Research & Development Services & Subcontracts
• Solicitation Number S25-102
• NCI OA Contract Number 75N91019D00024 – NCI-FFRDC

Description

Leidos Biomedical Research, Inc. seeks a manufacturer for clinical-grade AAV9-MMAB material that meets all critical quality attributes (CQAs) and complies with the US Food and Drug Administration (FDA) and ICH guidelines for viral vector products. Clinical gene-targeted therapies such as adeno-associated viruses (AAV) aim to deliver a gene product to edit, replace, or turn off mutated genes that cause disease. Methylmalonic acidemia (MMA) refers to a group of inherited disorders in which the body is unable to catabolize certain amino-acids and fats (lipids). Different forms of MMA are known, some forms being rarer than others. The cobalamin B (cblB) type of methylmalonic acidemia is caused by mutations in the MMAB gene. AAV9-MMAB, an Adeno-Associated Virus 9 (AAV9) vector virus expressing a functional self- complementary human codon optimized cDNA encoding the MMAB gene, is being developed as a gene therapy. The proposed clinical use of AAV9-MMAB is for the treatment of patients with cblB-type MMA resulting from deleterious variants in MMAB. The therapeutic goal of AAV9-MMAB gene therapy is to induce expression of the wild-type MMAB gene in cblB-type MMA patients and provide long-term correction of the metabolic defect in the liver and extrahepatic tissues that are transduced by AAV9-MMAB. The aim of this project is to leverage Offeror’s expertise for process transfer, upstream and downstream production, analytical method validation, fill-finish, release testing, stability program establishment, and documentation under current Good Manufacturing Processes (cGMP) suitable for regulatory submission of not less than 1xE16 Genome Copies (GC) clinical material.

Proposal Instructions

Offeror questions are due 1:00 PM (ET) MONDAY, AUGUST 31, 2026. A pre-offer submission teleconference will be held at 10:30 AM (ET) FRIDAY, SEPTEMBER 11, 2026. Offers are due 1:00 PM (ET) WEDNESDAY, SEPTEMBER 23, 2026. For the full solicitation package please contact Ms. Heather Housaman at Heather.Housaman@nih.gov.