Leading cancer center to evaluate the safety and efficacy of BIO 300 Oral Suspension

Humanetics Corporation (Humanetics) announced today the launch of a new investigator-initiated clinical trial (IIT) of BIO 300 Oral Suspension (BIO 300), led by Dr. Narek Shaverdian, Director of Thoracic Radiation Oncology at Memorial Sloan Kettering Cancer Center (MSK). This study is designed to evaluate the efficacy of BIO 300 in reducing the toxicity of thoracic radiation therapy in patients with non-small cell lung cancer (NSCLC) and concomitant interstitial lung disease (ILD), compared to historical results. The trial will enroll approximately 24 participants at MSK in New York.

BIO 300 is a promising candidate in the development pipeline for Humanetics, aimed at improving quality-of-life outcomes for patients receiving radiation therapy for NSCLC, head and neck cancer, and prostate cancer. The product has shown strong potential across complementary therapeutic areas, including inflammatory lung diseases.

Initial clinical research of BIO 300 in NSCLC found lower rates of hematological, pulmonary, and gastrointestinal toxicities compared to historical controls. In multiple clinical studies, the product has been found to be safe and well-tolerated, with no dose-limiting toxicities reported to date.

“Patients with NSCLC and interstitial lung disease represent a historically high-risk population for standard therapies,” said Dr. Shaverdian. “This trial aims to develop a new strategy that would allow us to deliver thoracic radiation more safely and effectively through the use of BIO 300, potentially expanding treatment options and improving outcomes for these patients.”

This study is a single-arm, prospective, phase II trial that will evaluate the time to Grade ≥ 3 pneumonitis, defined as the time from completion of radiation therapy to the occurrence of Grade ≥ 3 pneumonitis as the primary endpoint. Secondary endpoints include safety assessments, pulmonary function testing, and patient-reported quality of life. The first participant was enrolled in January 2026.

“As BIO 300 has been shown to be safe, while demonstrating efficacy in patients with NSCLC, we believe the same effect can be shown in patients with NSCLC in the setting of ILD,” said Dr. Michael D. Kaytor, Chief Scientific Officer at Humanetics. “We are extremely enthusiastic about this clinical study, and the commitment of Dr. Shaverdian and the team at MSK.”

About Humanetics Corporation

Humanetics is an advanced clinical-stage pharmaceutical company engaged in the accelerated discovery, development, and commercialization of proprietary drugs in markets with urgent and unmet needs, with a focus on medical countermeasures, radiation modulators for oncology and inflammatory lung diseases. For more information, visit www.humaneticscorp.com.

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