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SkyranBiologics

Treating diabetic retinopathy without intraocular injections

 

Presenter: Matt Handel, President

 

Monday, April 16, 2018

Embassy Suites, Chesterbrook, Pennsylvania (directions)

 

About

 

Diabetic retinopathy (DR) is a leading cause of blindness and impacts 35% of diabetics. Current therapies require direct injections into the eye, yet are not used to treat early-stage pathologies, fail to elicit a response in ~30% of patients, and induce retinal thinning with long-term therapy. In 2015, 30.3 million adults in the United States (9.4%) suffered from diabetes. In 2014, the global diabetic retinopathy market was valued at $5.9 billion.

 

Therapeutic Approach

We identified a 44-mer PEDF fragment (P78) that showed therapeutic potential in DR via an eye drop and further isolated a 17-mer minimum active region of this fragment. Using a series of conservative peptide modification strategies, we generated several novel, more active PEDF mimetics. Spx81-5, our lead candidate, shows increased biological activity over the native fragment with no evidence of toxicity in preliminary studies and adopts a well-defined alpha helical structure, making it a pharmaceutically attractive molecule. Spx81-5 is formulated for use as an eye drop that shows bioavailability in the Ins2Akita genetic mouse model of DR and in the non-human primate eye.

 

Robust In Vitro and In Vivo Data

Spx81-5 is stable in the vitreous; amounts after topical delivery in mouse eyes were ~2x greater than native P78 and achieved therapeutic levels in the vitreous in African Green Monkeys. Spx81-5 shows potent anti-angiogenic, anti-inflammatory, and neuroprotective effects in human RPE cells. There was no evidence of illness, weight loss, corneal damage or cloudiness in the lens in a six-week mouse study.

 

Strong IP

U.S. patent 9,611,314, which protects the composition of matter of Spx81-5 and several other sequences, was filed September 12, 2014 and issued April 4, 2017. A divisional has been filed to protect composition of matter on additional sequences.

 

Competitive Advantages

Invasive surgical treatments include laser (to seal leaking blood vessels), and vitrectomy (to excise vitreous gel containing blood and/or neovascular tissue). Anti-VEGF therapies, including Avastin®, Lucentis®, and Eyelea®, are the most prevalent medical treatments for DR. Despite over $5 billion in annual sales there remain many unmet medical needs:

  • Anti-VEGF therapies require regular ocular injections (every 4-6 weeks) in a doctor’s office. Our data-to-date show the utility of Spx81-5 in a drop formulation.
  • Current treatments fail to address early-stage retinal damage. Skyran will test Spx81-5 in early disease.

2018-19: 18-Month Research Plan to be Funded by Seed Round ($3 million)

  • Additional animal efficacy data, including visual acuity
  • Validation of eye drop PK in second animal model
  • IND-enabling studies, including GLP/GMP process and toxicology
  • Build team: pre-clinical lead, PK/toxicology, CMC, regulatory
  • File IND

2020-2022: Future Work to be Funded by Series A (estimated $10-15 million)

  • Phase I/Ila clinical studies
  • Expand team: head of R&D, clinical operations lead
  • Build support functions as needed

 

3 Major Issues

 

  1. What is your response to our preclinical plan, particularly the timing and overall cost? Are there any key activities that are missing?
  2. What are your thoughts on how we plan to structure the team?
  3.  What are your recommendations for financing? Who should Skyran target? How should we structure the round?

 

 

Program:

 

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

8:00 - Matt Handel, President of Skyran will deliver "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

 

 

 

Available Media

Please note: All information obtained here is the property of those presenting and should not be copied or duplicated without written consent.

 

Slides

None available at this time

Audio

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Video

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Webcast

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Contact Info:

 

 

Our Sponsors

EisnerAmperGlaxoSmithKlineKEH Insurance Agency
New Jersey Institute of Technology
Science CenterWhite and Williams

 

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Questions or Coments?

Contact: Peter van der Kam,

peter@rxpcci.com | (610) 296-8086

 

 

 

Good Company! Good Drink! Good Food! Good Program! Good Fun!

 

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