Velorum Therapeutics Inc., a Texas-based oncology company, has received a USD 1.26 million National Cancer Institute R44 SBIR award to advance VEL-03, a heme-sequestering protein therapeutic, through investigational new drug (IND)-enabling studies in non-small cell lung cancer (NSCLC) and other solid tumors. The Direct to Phase II award reflects NCI's continued investment in metabolic targeting strategies for cancers that have shown limited responses to existing therapies.
VEL-03 is designed to exploit a metabolic dependency common across tumor types: the reliance on exogenous heme uptake to sustain mitochondrial oxidative phosphorylation and support rapid proliferation. By sequestering heme, the company reported, VEL-03 disrupts tumor energy metabolism while sparing normal cells. Preliminary data cited in the grant indicate the agent inhibits tumor growth across multiple cancer models and reshapes the tumor microenvironment (TME) in ways that may enhance responses to radiation therapy. The grant will fund efficacy studies combining VEL-03 with radiation and cisplatin, manufacturing scale-up, and maximum tolerated dose and dose-finding toxicology studies with pharmacokinetic and pharmacodynamic endpoints.
The heme metabolism angle distinguishes VEL-03 from the dominant approaches in NSCLC, which include EGFR and ALK inhibitors, PD-1/PD-L1 checkpoint inhibitors, and antibody-drug conjugates. Tumors classified as immunologically "cold" — those with limited T-cell infiltration and resistance to checkpoint blockade — remain a persistent clinical challenge, and Velorum asserts that VEL-03's TME-remodeling activity may address that gap. Principal investigator Richard Edward Showalter is leading the program.
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