VENATORX PHARMACEUTICALS INC — Department of Health and Human Services SBIR Phase II: R
VENATORX PHARMACEUTICALS INC — SBIR Phase II award from Department of Health and Human Services.
Phase II SBIR prototype / development signal
- Phase II is where Department of Health and Human Services funds deeper R&D after feasibility. Incumbents with Phase II history are serious competitors on adjacent topics.
- Use this award as past-performance context and to map customer organizations for STRATFI/TACFI-style transition planning.
- At $3,000,000, this is a large obligation for typical SBIR Phase sizing — worth reviewing for scope breadth and teaming opportunity.
- Topic code R links this award to a solicitation family — search the same topic stem for incumbents and recompete timing.
- Amount
- $3,000,000
- Agency
- Department of Health and Human Services · National Institutes of Health
- Program / Phase
- SBIR · Phase II
- Topic
- R
- Solicitation
- PA20-260
- NAICS
- —
- Place of performance
- PA
- Period
- 2021-05-24 → 2024-04-30
Description
PROJECT SUMMARY Despite the availability of a safe and effective vaccine, there remains over 257 million people chronicallyinfected with hepatitis B virus (HBV) world-wide. Individuals with chronic HBV infections are at risk forcomplications due to liver disease and liver cancer. Chronic HBV is currently managed with nucleos(t)idereverse transcriptase inhibitors (NrtI) which partly suppress HBV DNA replication, normalize alanineaminotransferase levels (ALT) and slow disease progression. Front-line therapies, however, are not curativeand patients with chronic HBV exhibit poor off-treatment responses requiring life-long therapy. New antiviralsand immunomodulatory approaches are, therefore, needed to further suppress viral replication and provide theconditions that are required for immune control known as a “functional cure”. One of the most promisingclasses of compounds under investigation are the core protein allosteric modulators (CpAM) that block HBVreplication at multiple stages of the viral life-cycle. Here, we report on a best-in-class CpAM that exhibits potentpan-genotypic antiviral activity. In this project, we propose to advance our lead CpAM into definitive IND enabling studies to ready the compound for Phase 1 clinical trials in healthy volunteers and chronic HBVpatients. Combination regimens that include a CpAM, antivirals possessing distinct mechanisms of actionand/or novel immunomodulatory agents will be evaluated in a mouse model of HBV infection in preparation forPhase 2 development in chronic HBV patienst.