The biotech company is working to make tumors less resistant to radiation therapy, ideally improving the treatment’s efficacy.

Biotech is a high-risk, high-reward endeavor. Research, lab work, and clinical trials conducted in a complex regulatory environment make medical advancements costly, if not highly rewarding, for the companies that bring drugs to market and the investors who help make it so. But it’s a high-stakes lottery; approval processes often span more than a decade, and for the few therapies that earn FDA approval, commercial success still depends on navigating a landscape of market access, adoption, competition, and patient engagement.

And that’s one of the reasons why radiotherapy is starting to get a second look for cancer treatment.

Treating cancer with radiation is an approach that’s been around for nearly a century. But despite its low cost and proven efficacy, it’s not an option for more than half of cancer patients. The reason comes down to oxygen, or rather, lack thereof.

A potential approach to tumor hypoxia

Oncology biotech company Kortuc is exploring how it can resolve tumor hypoxia, a condition where a low-oxygen environment makes tumors resistant to radiotherapy. It’s often considered one of the most pressing barriers to cancer treatment. And the solution for it, KORTUC hopes, may be KRC-01, a novel but highly cost-effective radiosensitizer designed to improve the effectiveness of radiation therapy in solid tumors by increasing oxygen levels in the tumor microenvironment and reducing the tumor’s natural resistance mechanisms.

This process is not intended to replace radiotherapy but to unlock its full potential. Ongoing clinical studies are designed to further validate the performance of KRC-01 in standard clinical settings. “We are not competing with immunotherapy or precision medicine,” said Kazu Matsuda, CEO of KORTUC. “We are enabling radiation therapy to deliver on the curative promise it already holds in the standard of care for the patients it is already treating today.”

The current state of KRC-01

KORTUC is currently conducting a clinical trial led by UC San Diego to bring KRC-01 treatment to the US. The trial consists of administering the treatment as an injection that goes into the tumor of interest prior to radiation treatment. This relatively straightforward approach is designed to integrate into existing radiation therapy workflows without requiring new equipment or major changes to clinical infrastructure.

And without the billion-dollar, high-stakes gamble that goes along with so many other pharma developments in the space.

The active ingredient in KRC-01 is 3% hydrogen peroxide, which helps generate oxygen inside the tumor microenvironment and inactivates protective antioxidative enzymes. The second ingredient, 1% sodium hyaluronate, acts as a viscous carrier that helps sustain elevated oxygen levels in the tumor for at least 24 hours. Combined, these ingredients may contribute to the oxygen-rich environment that radiotherapy needs to function to its fullest capacity.

To date, the company states that the underlying radiosensitizer approach, KRC-01, has been used in more than 1,000 patients in Japan across multiple solid tumor types, with no major safety concerns reported.

KORTUC’s emphasis on oxygenating tumor microenvironments to improve radiation therapy efficacy matters because approximately 60% of cancer patients globally receive radiation therapy at some point in their treatment, making the potential impact broad.

KORTUC’s work outside of KRC-01

Although most of KORTUC’s resources are currently dedicated to advancing KRC-01’s use in international markets, the company is also advancing global clinical development across multiple indications.

For example, the company’s larger platform thesis is that tumor hypoxia is common across many solid tumors, meaning the approach could eventually apply to multiple cancer types. As such, KORTUC’s current programs include locally advanced and recurrent breast cancer, locally advanced cervical cancer, and rectal cancer.

The company is also exploring whether reoxygenating tumors could improve the tumor microenvironment and support future radiation/immunotherapy combination strategies. This could potentially establish a roadmap for KORTUC’s future endeavors as it continues to improve KRC-01 and other clinical-stage oncology treatments.

A novel approach to advancing clinical-stage oncology

Many biotech companies forgo advancing existing treatments in clinical-stage oncology to develop new ones instead. While there is merit in this approach, KORTUC’s method of enabling existing treatments to work as intended could prove to be an equally valuable development in the field, if not more so.

“Some of the most consequential opportunities in medicine are not about discovering something entirely new,” Matsuda said. “They are about finally fixing something that has been broken for a long time.”

Whether KORTUC’s novel methodology will be as effective as the company intends it to be will be determined by the success of its upcoming clinical trial led by UC San Diego.

This article is for informational purposes only and does not substitute for professional medical advice. If you are seeking medical advice, diagnosis or treatment, please consult a medical professional or healthcare provider.

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