Catalyst accelerates TrNK’s breakthrough

Learn how Stanford Medicine Catalyst is helping TrNK launch a clinic-ready therapy for solid tumors, whose stubborn defenses often thwart effective treatment. If you have an innovation that could be a good fit for Catalyst, consider applying by March 16.

At Stanford Medicine, Catalyst accelerates innovations with funding, incubation support, network connections and more to drive real-world, global impact. TrNK joined Catalyst in May 2024 as one such venture.

When the laboratory of principal investigator John Sunwoo, MD uncovered a unique subset of natural killer cells they named cytotoxic tissue-resident NK (trNK) cells, they saw a path to overcoming long-standing obstacles in solid tumors such as head and neck squamous cell carcinoma, cutaneous squamous cell carcinoma, melanoma and lung cancer. Solid tumors have stubborn defenses: limited penetration by therapeutic cells and a hypoxic tumor microenvironment that can blunt effectiveness. 

Sunwoo’s group demonstrated that this cytotoxic subset of trNK cells could infiltrate tumors more effectively and attack cancer cells without requiring genetic engineering, offering the promise of an off-the-shelf, outpatient therapy. Yet turning that laboratory insight into a treatment for patients requires more than science alone. It demands funding, manufacturing at scale, regulatory strategy and industry connections.

That’s where Catalyst stepped in. With support from Catalyst and in collaboration with the Stanford Laboratory for Cell and Gene Medicine led by Steve Feldman, PhD, the TrNK team – composed of Sunwoo, Feldman, and two oncologists, Allison Betof-Warner, MD, PhD and A. Dimitrios Colevas, MD – established a scalable and cost-efficient manufacturing process for therapeutic trNK. They generated data to better define which patients are most likely to benefit from the therapy. Additionally, the team further improved the manufacturing method that involved new intellectual property (IP) resulting from concurrent work in Sunwoo’s lab. These advances contributed to an infusion of donor funding — more than $2 million — to push the therapy toward clinical testing.

The project has been accepted into the Stanford Center for Cancer Cell Therapy program, a signal that the work was ready to advance toward an Investigational New Drug Application – enabling development and eventual FDA submission. The team began parallel efforts to design a first-in-human trial at Stanford Health Care, collaborating with key surgical and cell therapy experts Vasu Divi, MD and Hany Elmariah, MD to map out trial structure, patient eligibility and safety considerations.

Catalyst connected the TrNK team with industry experts and potential investors, provided strategic guidance on which conditions TrNK should target and clinical positioning, and helped shape an IP strategy that protected and clarified the therapy’s value as it moved toward these regulatory milestones. 

 “It is uncommon for foundational laboratory discoveries to advance to clinical therapies, given the high costs of development and translation and the scarcity of adequate funding,” Sunwoo said. “Achieving a clear path toward a clinical trial has only been possible because of Stanford Catalyst’s support, which is distinguished by both the scale of its funding and the strength of its strategic guidance.”

Today, the TrNK team stands on a solid, well-supported path toward a first-in-human trial, with the goal of bringing an off-the-shelf cell therapy closer to patients who need new options for solid tumors. Catalyst’s role — from strategic positioning and IP planning to manufacturing scale-up and investor connections — helped turn a laboratory insight into a tangible, market-ready clinical program poised to change how solid tumors are treated.

Is your project the next Catalyst innovation? 

Catalyst is now seeking health care innovations from all members of the Stanford community (faculty, university and health care staff and students) that can significantly impact global health care. Catalyst will award select projects with validated science that hold the promise of becoming transformative solutions and are ready to be implemented through piloting, advanced prototype development or early-stage utilization.

Take the next steps by:

• Reviewing the Catalyst site for additional details and FAQs.

• Evaluating whether your project might be a good fit.

• Interested teams can apply through March 16 on the Catalyst website. 

Read the Original Article in Stanford Medicine Pulse: https://pulse.stanfordmedicine.org/contents/41861209