Patented Universal Tumor-Targeting Drug Delivery Platform Co.
This pharmaceutical company has developed and patented a universal tumor-targeting drug-delivery platform that can improve the safety and efficacy of many existing chemo treatments, with the ability to target numerous different types of cancer. The technology encapsulates existing FDA-approved drugs inside lipid nanoparticles (liposomes or emulsions) coated with patented human-sourced antinuclear antibodies (ANA). The lipid nanoparticle provides long-term storage stability of the drug and controlled release of the drug over time at body-temperature, and is expected to improve the safety and efficacy profile of the drug, including passive accumulation at the tumor while not harming normal tissues. The Company’s ANA, sourced from lupus patients, binds to nuclear material present in abundance in areas of necrosis (dead / ruptured cells) present in and around all solid tumors, thus anchoring the drug-filled nanoparticles at the tumor where the nanoparticle is designed to slowly release the drug directly on the tumor for more effect. As the Company’s ANA is not tumor-marker specific, but rather targets necrosis present in solid tumors, the technology is designed to "universally" target many different types of cancer including breast cancer, lung, ovarian, colon, prostate, etc., as well as rare childhood cancers.
The Company completed a successful proof-of-concept study at Children's Hospital using Ewing's Sarcoma transplanted in immunodeficient mice. Treatment with the Company's forumlation significantly inhibited tumor growth and extended survival times compared to control mice receiving no treatment or treatment with plain liposomal doxorubicin.
The Company has been granted Orphan Drug Designation by the FDA on 2 of the lead drug formulations, providing FDA fee waivers, priority review, and 7-years exclusivity upon market approval. The orphan pathway also enables the potential for New Drug Approval after successful completion of Phase 2 studies, with Phase III data collected while in the market, thus significantly lowering the time and cost to market approval. This same drug inside the Company's tumor targeting delivery system will likely have potential to treat other pediatric cancers, and/or cancers in larger adult populations.
As the Company’s platform and ANA has the potential to improve the safety and efficacy of many existing FDA approved drugs or even compounds in development, the Company anticipates the potential for multiple licensing agreements with multiple pharmaceutical companies seeking to improve their existing portfolio and extend patient life as they advance into clinical stage. And as it may be possible to file for New Drug Approval following successful Phase II studies, the Company anticipates licensing potential at early clinical stage. Multiple exit opportunities exist with high impact & high ROI.
The Company is seeking a supportive capital partner to maintain momentum up to $20M. Funding will be used to advance the lead drug through formal Investigational New Drug enabling studies towards New Drug Approval; estimating $3-5 Million now to advance into clinical studies. Preclinical / animal studies estimate ($3 - 5 Million and 12-18 months); follwed by potential combined Phase I-II clinical study in a rare cancer (approximately 2-3 years and $10M) to potential New Drug Approval, plus additional capital to advance additional drugs in the pipeline simultaneously, thus adding tremendous value to the Company’s valuation. Valuations of pharma companies often exceed $100 Million valuation at Phase I (approx. 18 months), and New Drug Approval can exceed valuations above $1 Billion. The Company has numerous, improved high-impact cancer drugs advancing with proper support.
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