TEZCAT Laboratories LLC — Department of Health and Human Services SBIR Phase II: 102
TEZCAT Laboratories LLC — 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.
- Obligated amount $1,062,082 is consistent with substantial Phase II-scale effort; compare to related awards from the same agency.
- Topic code 102 links this award to a solicitation family — search the same topic stem for incumbents and recompete timing.
- Amount
- $1,062,082
- Agency
- Department of Health and Human Services · National Institutes of Health
- Program / Phase
- SBIR · Phase II
- Topic
- 102
- Solicitation
- PA22-176
- NAICS
- —
- Place of performance
- CT
- Period
- 2023-08-01 → 2025-07-31
Description
Tezcat is an early-stage, biopharmaceutical company developing novel biologics with a unique mechanism of action to treat the most recalcitrant cancers, such as mutant RAS multiple myeloma. Multiple myeloma is an incurable hematologic malignancy with an expected median survival of 7-8 years. Despite an initial response rate approaching 90% to proteasome inhibitor- containing combinations, all patients relapse and eventually become resistant to any treatments. Approximately 70% of these relapse/refractory patients harbor a mutation in RAS. We have observed that mutant RAS multiple myeloma cells display high levels of macropinocytosis, a nutrient scavenging process that facilitates the bulk engulfment of extracellular fluid and its solutes. Our drug candidate, TZT-102, utilizes our proprietary macropinocytosis-selective monobody that carries an FDA-approved cytotoxic payload. Results from our Phase I STTR project demonstrate that TZT-102 has robust anti-tumor activity in mutant RAS MM xenograft models without showing toxicity issues. Based on the success of our Phase I aims, we propose a Phase II SBIR program for investigators at Tezcat to advance TZT-102 through Specific Aims that will pursue bioanalytical assay development (Aim 1) and non-GLP toxicology studies in rats (Aim 2) to prepare for a pre-IND meeting with the FDA (Aim 3). Tezcat has entered into a license agreement with NYU Langone Health for exclusive, worldwide rights to the technology being developed. The commercialization strategy will be based on further development through Phase II SBIR studies and towards IND status and first-in-human clinical trials through a strategic partnership. Thus, we expect this Phase II SBIR to provide additional support for pursuit of GMP protocols and GLP safety and toxicity studies to support IND submission with the FDA.