Response rate, pharmacodynamics, and safety support continued development


MINNEAPOLIS, MN — A recently published paper in the International Journal of Radiation Oncology – Biology – Physics (Red Journal) details encouraging results from a multicenter clinical study conducted with Humanetics Corporation’s (Humanetics) novel radioprotective drug, BIO 300, in patients with non-small cell lung cancer (NSCLC). Radiation therapy is a vital component of cancer treatment, delivering targeted doses of radiation to tumor sites to eliminate cancer cells. However, the challenge lies in minimizing the damage from radiation to surrounding healthy tissues, which can lead to debilitating side effects and limit treatment options. Humanetics aims to address this critical issue with BIO 300, which can safeguard normal tissues during radiotherapy without protecting the tumor, thereby enhancing patient outcomes and quality of life.

Twenty-one patients were enrolled in the phase 1b/2a study evaluating the safety and clinical utility of BIO 300 as a radioprotector of normal tissues in patients with NSCLC (NCT02567799). The study was a nonrandomized, open-label, single-arm, ascending dose study in NSCLC patients prescribed concurrent radiotherapy and chemotherapy. Patients self-administered BIO 300 orally once daily starting before initiating radiotherapy and continued for the entire 6-7 week course of concurrent chemoradiotherapy. The primary endpoint was acute dose-limiting toxicities attributable to BIO 300. Secondary outcomes included pharmacokinetics, pharmacodynamics, overall toxicity profile, quality of life, local response rate, and survival.

The study found that BIO 300 was safe and well tolerated, and no dose-limiting toxicities were reported. Patient-reported quality of life and body weight were stable throughout the study period. The tumor response rate was 65%, with a complete response rate of 20%. BIO 300 did not alter the pharmacokinetics of standard chemotherapy. Serum TGFβ1, a pro-inflammatory/pro-fibrotic cytokine implicated in pulmonary fibrosis and radiation pneumonitis, was reduced in a dose-dependent manner across cohorts. In addition, patients receiving BIO 300 had a lower rate of hematological, pulmonary, and gastrointestinal toxicities compared to previous clinical studies with the same chemoradiotherapy regimen in the absence of BIO 300.

The pharmacodynamic results, combined with the tumor response and low toxicity rates, support further investigation of BIO 300 as an effective radioprotective drug in patients with NSCLC.

Ronald J. Zenk, CEO at Humanetics, expressed his enthusiasm regarding the clinical trial results, stating, "Showing that BIO 300 is safe and may protect normal lung tissues in NSCLC patients without compromising concurrent chemoradiotherapy has the potential to reform current cancer treatment. By reducing the risk of debilitating side effects, BIO 300 has the potential to improve quality of life for cancer patients undergoing radiation therapy."

BIO 300 is also under advanced development as a radiation medical countermeasure for the military and first responders, and BIO 300 is in a phase 2b trial evaluating the clinical utility of BIO 300 to protect lung tissues against the long-term effects of COVID-19 (NCT04482595).