Epeius Biotechnologies Corporation, an emerging leader in the field of targeted genetic medicine, received a notice of allowance from the USPTO for another crucial patent covering its leading tumor-targeted gene delivery platform. The issuance of this high-value patent protection for targeting metastatic disease follows on the heels of two major patent issuances covering tumor-targeted gene delivery and precision-targeted cancer immunotherapy, respectively. Like the exceedingly tiny, precision targeted, stealthy tumor-seeking nanomedicine itself, this small California biotechnology company has advanced to the forefront of the biopharmaceutical "War on Cancer" with formal demonstrations of safety and efficacy in the clinic and best-of-breed solutions for the pharmaceutical industry.
As the development of its lead oncology product advances in the clinic towards regulatory approval, the critical proofs-of-principle, i.e., definitive demonstrations of overall safety and single-agent efficacy in clinical trials, serve as the scientific and innovative basis for attaining additional patent protections in the emerging field of tumor-targeted biologics. Indeed, Epeius Biotechnologies has accumulated more than 150 issued/allowed/granted patents in the area of genetic medicine, including more than 40 pending applications. Furthermore, the U.S. FDA has recently granted Orphan Drug status to Rexin-G, the company's lead product, for three separate clinical indications based on formal evaluations of clinical safety and potential efficacy, which provides additional market protections and economic incentives pertaining to such a significant and yet unmet medical need as the treatment of chemotherapy-resistant cancers.
Exhibiting broad-spectrum anti-cancer activity against many otherwise intractable cancers, Rexin-G has demonstrated a number of first-in-class, best-in-class characteristics: (1) The tumor-targeting properties of the gene delivery platform are profound, capable of seeking-out, accumulating-in, and halting-the-progression-of widespread cancers by means of simple intravenous infusions. (2) The broad-spectrum anti-cancer activity is achieved "by design", as the genetic payload is focused on a critical locus of cellular growth control and tumor suppression. (3) Years of progressive clinical trials have advanced the field by establishing cumulative safety (with no dose-limiting toxicities), practical pharmacological thresholds, quantitative dose-response relationships, and clinical infusion protocols which optimize patient benefits, including significant survival benefits. (4) Equally important are the advancements in biopharmaceutical science that provide for greater purities, potencies, GMP productivity, and economies-of-scale, and which translate into more-affordable treatments for cancer patients. All in all, it seems that Small, Smart, and Stealth may turn out to be a very cool hand to grasp, and to hold on to.
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