This pharmaceutical company has developed and patented a universal tumor-targeting drug-delivery platform that improves the safety and efficacy of existing chemo treatments, with the ability to target many 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 improves the safety and efficacy profile of the drug with 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 for more effect. As the Company’s ANA is not tumor-marker specific, but rather targets necrosis present in solid tumors, the technology can "universally" target many different types of cancer including 100% of breast cancer, lung, head & neck, prostate, etc., as well as rare childhood cancers.
They completed a successful proof-of-concept study at Children's Hospital using Ewing's Sarcoma transplanted in immunodeficient mice. The study showed significant inhibition of tumor growth and extended survival times (60% reduction in mortality) 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 on approximately 50 patients, thus significantly lowering the time and cost to market. This same drug inside the Company's tumor targeting delivery system will also work on other larger cancer indications, enabling the potential for off-label usage, or expansion of clinical studies into larger cancers.
As the Company’s platform and ANA has the ability to improve the safety and efficacy of many existing FDA approved drugs or even compounds in development, they anticipate 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 following the Orphan Drug pathway enables expedited approval after successful Phase II studies, we anticipate 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. This will add to the additional existing funding already in place to secure the lead drug to New Drug Approval; or $3-5 Million now to advance into clinical studies. They anticipate the preclinical / animal studies ($3 - 5 Million and 12-18 months); then a combined Phase I-II clinical study in a rare cancer (approximately 2-3 years and $10M) to New Drug Approval, plus additional capital to advance additional drugs in the pipeline simultaneously, thus adding tremendous value to the Company’s valuation. They anticipate the Company to advance above a $100 Million valuation at Phase I (approx. 18 months) and each drug holding a potential $1 Billion value upon approval. The Company has numerous improved cancer drugs advancing with proper support.
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About the Business
Contact the Seller
Trying to improve existing therapies and develop novel approaches to hard to treat cancers.
Growth & Expansion:
Huge market potential.
About the Sale
- Reason For Selling:
Seeking supportive capital partners to take to the next level(s).
Transition team included.
- Seller Financing:
If the price and deal structure is right.
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