St. Louis-based cancer drug company launches clinical trial with European partner

St. Louis biotech company Immunophotonics is testing its drug to enhance a cancer treatment in collaboration with the Cardiovascular and Interventional Radiological Society of Europe (CIRSE).

Between 300 and 500 patients will be enrolled in a study to test the effectiveness of Immunophotonics' clinical asset IP-001, which is designed to reduce cancer recurrence after a standard non-surgical tumor treatment.

"This is an absolutely tremendous milestone for the company," Immunophotonics CEO Lu Alleruzzo said in an interview. "It's been an incredible journey for us, taking this asset that was discovered in the United States in the clinical trials, and now we're moving into the later-stage clinical trials."

The clinical-stage startup's drug is intended to enhance a non-surgical procedure called tumor ablation, which destroys tumors through targeted heat or cold. But there's a higher recurrence rate, Alleruzzo said, up to 50% within 12 months for some types of cancer.

"What Immunophotonics did is invent a drug that you inject directly into the ablated tumor that utilizes the immune system to amplify the effect of the ablation and reduce recurrence rates," Alleruzzo said. "It's a first-of-its-kind technology, never been done before. And we call the combination of our drug with tumor ablation a new field called 'interventional immuno-oncology.'"

He said, "Tumor cells are sneaky. They leave behind residual disease. They leave behind cells that are waiting to grow. Essentially, that's what Immunophotonics is focused on: eliminating those hidden tumor cells to prevent recurrences for patients and for those who we care about who have been affected by this disease. 

"The bottom line is, we believe that immunotherapy or utilizing the immune system to combat cancer should be integrated seamlessly into routine treatments that are already happening every single day. There's the potential to transform those routine procedures today into some much more powerful implications," he said.

CIRSE is a medical society of around 10,000 interventional radiologists in 92 countries, split between focuses in cardiology and oncology. Alleruzzo said the group wants to provide oversight and guidance on the study for its members who perform tumor ablation. Vienna, Austria-based Next Research is the contract research organization for the study, designing and implementing the research trials and submitting drug applications to U.S. and European regulatory bodies. 

"We expect to enter this Phase 2/3 clinical trial in 2025," Alleruzzo said. "Our hope is that within two years we have early readouts to identify and assess IP-001's effect on transforming ablation into something much more powerful, and within four years — hopefully, if we're successful — be able to submit a new drug application to take this drug to market. It's the last trial in a decade's worth of research to be able to take this drug to market and to patients who need it."

Alleruzzo and CIRSE President-designate Dr. Philippe Pereira both said tumor ablation experts are eager to investigate a new tool to combat cancer

“The collaboration between Immunophotonics, CIRSE, and Next Research highlights the importance of multidisciplinary partnerships in advancing major medical breakthroughs for patients in need," Pereira said in a statement. "Tumor recurrence following radical tumor ablation is a major unmet medical need, and Immunophotonics’s novel approach is not only practical for clinicians and patients, but early data indicates it has tremendous promise.”

Earlier this month, Immunophotonics won the St. Louis regional finals of the Startup World Cup (organized by Silicon Valley venture capital firm Pegasus Tech Ventures), besting 100 local startups that competed in pitch events over the summer. It will compete at the final competition in San Francisco next month for a $1 million investment prize.

Immunophotonics formed a research collaboration in January with Johnson & Johnson Enterprise Innovation Inc.

Venture financing backed Immunophotonics raised $21.4 million in 2022 in Series B funding to advance clinical trials and research efforts. Its Series B round was led by Zubizoom Investments LLC, ROVAQ Ventures LLC, Immune LLC and St. Louis-based iSelectFund. Entrepreneur and St. Louis native Jim McKelvey, co-founder of payments company Block (NY:SQ), is affiliated with Immune LLC, and Zubizoom Investments is the investment fund of Miguel Zubizarreta, former chief technology officer of Westlake, Ohio-based Hyland Software.

Immunophotonics' local operations are based in the BioGenerator Labs in the BioSTL Building at 4340 Duncan Ave. in the Cortex innovation district, and it has a European office in Bern, Switzerland. The company said in January that it has less than 20 full-time employees and partners with other organizations for its clinical research operations.