BioAffinity Technologies Inc. (NASDAQ:BIAF) announced that the U.S. Patent and Trademark Office has issued a new patent covering a novel composition and method for selectively eliminating cancer cells by targeting CD320 and LRP2 receptors on the cell membrane. The patent, titled "Compositions and Methods for Treating Cancer" (Patent No. 12,305,171), represents a significant advancement in the company's therapeutic pipeline and expands their intellectual property portfolio to 19 awarded U.S. and foreign patents.
Broad-Spectrum Cancer Application
The therapeutic approach outlined in the patent applies to a wide spectrum of cancers, including those of the lung, breast, prostate, brain, and skin. BioAffinity Technologies has already initiated research toward developing a topical treatment for cutaneous malignancies and neoplasms of the skin, marking their first target application for this novel therapy.
"This patent marks a significant advancement in our therapeutic pipeline as well as our intellectual property portfolio," said Maria Zannes, President and CEO of bioAffinity Technologies. "This discovery is a continuation of the scientific curiosity that led to our CyPath® Lung diagnostic for early-stage lung cancer and opens a potential new path to precision treatment across multiple cancer types."
Dual-Target siRNA Mechanism
The invention utilizes small interfering RNAs (siRNAs) to suppress the expression of CD320 and LRP2 proteins simultaneously. In vitro studies demonstrated that the double knockdown of both proteins using siRNAs is selectively cytotoxic to human cancer cells while sparing normal cells under the same treatment conditions.
The research revealed a critical finding regarding the necessity of targeting both receptors simultaneously. When only one of the receptors was down-regulated, there was an increase in protein expression in the other receptor. This compensatory mechanism meant that targeting a single receptor was insufficient to kill cancer cells or significantly inhibit their proliferation, making the dual knockdown approach essential for therapeutic efficacy.
Fundamental Cancer Vulnerability Discovery
"The cancer cells killed by this discovery were not selected on the basis of any characteristic or biomarker, and the effect appears to be quite general," said William Bauta, PhD, Chief Science Officer at bioAffinity Technologies. "We believe our research has discovered a fundamental vulnerability of cancer that could be leveraged for new, highly selective therapies."
This broad applicability suggests that the CD320 and LRP2 dual-targeting approach may represent a universal mechanism for cancer cell elimination, independent of specific cancer subtypes or biomarker profiles.
Expanding Intellectual Property Portfolio
The therapeutic patent strengthens bioAffinity Technologies' intellectual property position, which now includes 19 awarded U.S. and foreign patents and 36 pending patent applications related to both their diagnostic platform and cancer treatment therapeutics. This expansion reflects the company's dual focus on developing both diagnostic tools and therapeutic interventions for cancer treatment.
The company's existing CyPath® Lung diagnostic platform uses proprietary advanced flow cytometry and artificial intelligence to identify cell populations in patient sputum that indicate malignancy. Clinical study results demonstrated that CyPath® Lung achieved 92% sensitivity, 87% specificity, and 88% accuracy in detecting lung cancer in high-risk patients with small lung nodules less than 20 millimeters.
