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A pre-clinical stage biotechnology start-up

Presenter: Debra Travers, President and CEO


Monday, October 10, 2016

Embassy Suites, Chesterbrook, Pennsylvania (directions)




PolyAurum is a pre-clinical stage biotechnology start-up founded to develop and commercialize biodegradable gold nanoparticles (BGNP) for diagnostic and therapeutic indications. Gold nanoparticles enter tumors selectively through a radiation enhanced penetration and accumulation effect, providing excellent contrast for CT and X-Ray imaging and intensifying the effect of radiotherapy without increasing harm to healthy tissues adjacent to the tumor, i.e. increasing the therapeutic window.



Of the 1.7 million cancer patients diagnosed each year in the United States, roughly half of them receive radiotherapy, resulting in $5.8 billion spent on such treatments per year. Although radiotherapy has improved over the decades, there is still a pressing need for better outcomes for patients with locally-advanced tumors. Nanotechnology can provide these needed improvements.



There is a high rate of local recurrence in many tumors post-radiotherapy for a variety of reasons. Radiotherapy is very effective at eradicating tumors and can result in cure if the dose needed can be tolerated by the patient. Even with today's advances in focusing and shaping radiation beams, it remains difficult to increase the therapeutic window for radiotherapy patients. Often, healthy adjacent tissues are damaged, with significant life-threatening or life-altering side effects. The doses that patients can tolerate can be insufficient to kill all cancer cells within the tumor. This leads to local recurrence and reduced survival for those patients whose tumors progress. For example, 2 year survival for the 10K+ patients diagnosed annually with glioblastoma is only 30%. Locally advanced tumors of the esophagus (9K+ per year) and lung (53K+ per year) have average survival of 18% and 31% respectively.



Gold is known to be an excellent radiosensitizer. Past formulations of gold nanoparticles were developed that specifically targeted tumors, intensified radiation absorption and resulted in an excellent therapeutic effect. However, these gold nanoparticles were large and could not be excreted well, leading to accumulation of gold in sensitive organs such as the kidneys and liver with potential long-term toxicity. Small gold nanoparticles that are easily excreted do not accumulate in the tumor long enough for a good therapeutic effect. PolyAurum combines the best of both large and small nanoparticles by encapsulating small gold nanoparticles in a larger biodegradable polymer nanoparticle, allowing enough gold to accumulate in the tumor for a therapeutic effect, but also facilitating easy excretion in the urine and feces as the polymer degrades. In a mouse glioblastoma model, PolyAurum's BGNP studies doubled survival over radiotherapy alone.



3 Major Issues


  1. Based on input from the FDA we have assumed that PolyAurum's therapeutic will be viewed as a drug and not a device. Development as a device however has important cost and timeline implications. Both are less. We are submitting a request for designation to the FDA but this will take some time. Should we go for a device or a drug? Why?
  2. We must talk to medical institutions and third party payers about technology adoption, budget processes, and payment for the technology. Who should we engage in the reimbursement landscape as we move forward?
  3. We are contemplating an all-comers PhaseI/II where we would recruit patients with all five tumor types to satisfy FDA'ssafety requirements and get a hint on efficacy. This will help us pick the best tumor for achieving a positive result. What are the advantages/disadvantages of such an approach? How easy is it to recruit? Conduct? Analyze for useful information? Draw conclusions for lead indications or PhaseIII design?




6:30 - Cocktails & Dinner (Cash bar and special 2-entree buffet menu)

8:00 - Debra Travers, President and CEO PolyAurum, will deliver the Company's "Elevator" Pitch to the Group

8:20 - A Panel will address three major issues crucial to helping the Company reach the next level.

9:00 - Open discussion: members and guests



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Contact: Peter van der Kam, | (610) 296-8086




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