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1. BIO 300 use led to reduced levels of a proinflammatory/profibrotic cytokine associated with lung injury from radiation therapy.

2. BIO 300 did not interfere with the pharmacokinetics of chemotherapy, did not result in dose limiting toxicities, and led to only mild-moderate adverse events.

The Latest

A recent multicenter phase 1b/2a clinical trial funded by the National Institute of Health and the Humanetics Corporation investigated the utility of BIO 300, an oral synthetic genistein nanosuspension, as a radioprotectant for patients undergoing chemoradiotherapy for non-small cell lung cancer (NSCLC). Researchers found BIO 300 led to a reduction in Transformation Growth Factor β1 (TGF-β1), a proinflammatory/profibrotic cytokine implicated in lung injury.  BIO 300 did not change the pharmacokinetics of the cancer therapy, and a 65% tumor response rate was achieved. BIO300 also did not lead to any appreciable toxicities requiring dose limitations, and a maximum tolerated dose was never met. Patients also reported improved quality of life.

Physicians Perspective

Lung cancer is known to affect 230,000 Americans per year, resulting in 135,000 deaths per year. NSCLC is a term used to describe various cancers which affect the lungs. These include adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. The pathophysiology of NSCLC depends on the type of cancer in question. For example, lung adenocarcinoma develops through the formation of glandular tumor cells. Presently, depending on the stage, NSCLC is treated by chemotherapy, radiation therapy, and surgery. Amifostine is currently the only radioprotectant used in clinical practice, however it is currently only used in the treatment of head and neck cancer. BIO 300 is an exciting new therapy that shows promise as an adjunct in the treatment of lung cancer which may reduce the damaging effects of radiation, and ultimately improve patient quality of life.

Molecular Targets

BIO 300 is an oral synthetic genistein nanosuspension which is being used as a radioprotectant in NSCLC patients being treated with chemoradiotherapy. Patients undergoing radiation therapy can suffer from radiation induced pneumonitis, and pulmonary fibrosis. Genistein acts on estrogen receptor β leading to a reduction of various inflammatory cytokines implicated in lung injury which includes TGF-β1.

Company History

BIO 300 was developed by Humanetics Corporation. BIO 300 is also being investigated as a potential radioprotectant in the treatment of prostate, and head and neck cancer. BIO 300 is also being trialed in the general management of inflammatory lung diseases, in particular lung injury from COVID-19 pneumonia. Humanetics Corporation also envisions BIO 300 applications for war fighters and first responders that may face threats of radiation exposure.

Further reading: https://www.sciencedirect.com/science/article/pii/S0360301623078458

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