Laying the groundwork
A previous $200,000 grant from WRF allowed the research teams to evaluate the potential of a dozen plus technologies, two of which they selected as research priorities: an engineered tumor cell receptor, or TCR, T-cell therapy for high-risk acute myeloid leukemia, or AML, in adult patients and a CAR T-cell therapy for AML in children.
The research teams are also evaluating how to create time- and resource-efficient ways to translate protein therapeutic research into first-in-human trials.
The three-year grant is part of WRF’s BioInnovation Grants program, created to increase support for big, emergent opportunities to advance Washington state’s life sciences ecosystem and improve lives.
Grant funding will used for two main purposes, according to Otegbeye, who holds the Fred Hutch Fleischauer Family Endowed Chair in Cell and Gene Therapy Translation.
“Four million dollars will be used as direct support for four clinical trials (two each at Fred Hutch and Seattle Children’s Research Institute), with matching commitments by each institution for Phase 1 trials,” she said.
The remaining $1.2 million will go towards strategic planning and infrastructure development to enable these clinical trials to take off, she said, adding that this money will also help “create a sustainable framework for translating other innovative therapies from both institutions.”
Fred Hutch and Seattle Children’s routinely conduct clinical trials, but the “one-off” nature of clinical trial funding makes it difficult for institutions to strategically monitor their pipelines and conduct advance planning for bringing promising products to patients. First-in-human studies at research institutions are often the only way for patients to access leading-edge therapies and provide crucial evidence of a drug’s safety and efficacy that could result in development at scale.