CytoAgents, a clinical-stage biotechnology company developing an oral small-molecule immune modulator to prevent cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), has been awarded a $2.25m Small Business Innovation Research (SBIR) grant from the National Cancer Institute of the National Institutes of Health. The award is the fourth NIH grant to CytoAgents in five years and brings total NIH support to $7.85m, funding the continued development of lead candidate CTO1681 and expansion into the multiple myeloma patient population receiving CAR T-cell therapy.

The latest R44 award (R44CA295189) will support work to evaluate CTO1681 as a preventative strategy for CRS and ICANS — severe toxicities frequently observed in patients treated with CAR T-cell and other T-cell engager immunotherapies. The company says the grant will enable research into CTO1681’s use in multiple myeloma patients, a population with growing CAR T activity and a recognised need for safer outpatient-care models.

“We are appreciative of the ongoing support from the National Cancer Institute of the NIH; this funding will help to expand into the multiple myeloma patient population receiving CAR T-Cell therapy at risk for CRS and ICANS,” said Teresa Whalen, chief executive officer of CytoAgents. She added that better management of treatment-related toxicities could enable movement of care from inpatient academic centres into outpatient and community settings, supporting broader adoption of CAR T and T-cell engager therapies.

Clinical development to date includes a Phase 1b/2a multi-site trial in lymphoma patients receiving CAR T-cell therapy where CTO1681 is being evaluated for safety, tolerability and preliminary efficacy across multiple dose levels. The company intends to leverage the new NIH funding to open additional arms or sites focused on multiple myeloma, accelerating the path toward a universal preventative approach for CRS and ICANS across immunotherapy indications.

“We are deeply honored to receive a fourth NIH grant, which further validates the importance and potential of our research at CytoAgents,” said Arthur P. Bertolino, chief medical officer at CytoAgents. The company frames CTO1681 as an oral option designed to prevent excessive cytokine production — the biological driver of CRS — thereby reducing the need for hospital-level interventions and supporting more scalable delivery of curative immunotherapies.

CytoAgents highlights the high incidence of CRS and associated neurotoxicity with current advanced immunotherapies as a barrier to broader patient access. The company says that effective CRS management could be an enabling strategy to extend CAR T-cell benefits beyond specialised centres and to diversify the range of treatable patients.

“CAR T has transformed the treatment paradigm for the multiple myeloma patient population; it is imperative to find a solution to prevent CRS and ICANS which will allow us to treat and cure more patients with CAR T-cell therapy,” said Stanley M. Marks, medical oncologist and chairman of CytoAgents.

The SBIR grant is non-dilutive and the company notes the content of its grant materials is the responsibility of the authors and does not necessarily reflect the official views of the NIH.