STRADEFY STRATEGIC DERMATOLOGIC ENGINEERING FROM YALE

Transcription

1 STRADEFY STRATEGIC DERMATOLOGIC ENGINEERING FROM YALE

2 UNMET NEED: THE BURDEN OF SKIN CANCER Skin cancer is highly prevalent with 5.4 million cases diagnosed each year. UV exposure causes nearly 90% of all skin cancers. Skin cancers costs $8.1B annually in the U.S. and result in ~15,000 deaths. Surgical complications include wound infections, scarring, undesirable cosmesis.

3 TECHNOLOGY: BIOADHESIVE NANOPARTICLES (BNP) Dermal Drug Delivery Platform Drug encapsulation and controlled release Biodegradable polymer core Bioadhesive hydrophilic surface

4 BNP-SUNSCREEN FOR SKIN CANCER PREVENTION BNPs prevent chemical penetration BNPs offer ALL-DAY protection BNPs provide at least SPF 15 BNP SAFE LONG-LASTING EFFECTIVE Deng Y, Ediriwickrema A, Yang F, Lewis J, Girardi M, Saltzman WM. A sunblock based on bioadhesive nanoparticles, Nature Materials 14: (2015).

5 ANTI-TUMOR BNPs SHOW PROMISE FOR THE TREATMENT OF SQUAMOUS CELL CARCINOMA BNP-EB (epothilone B) improves survival outcomes for ovarian and uterine serous carcinoma BNP-CPT (camptothecin) intratumoral injection resolves mouse PDV squamous cell carcinoma. Deng Y, Yang F, Cocco E, Song E, Zhang J, Cui J, Mohideen M, Bellone S, Santin AD, and Saltzman WM. Improved intraperitoneal drug delivery with bioadhesive nanoparticles, Proceedings of the National Academy of Sciences 113: (2016).

6 MARKET OPPORTUNITY FOR STRADEFY Sunscreen & Anti-Aging (SPF) Market US Market Size: Suncare $2 B, Skincare with SPF $16 B Industry Leaders (suncare): Edgewell 35%, Bayer 15%, J&J 13% Industry Leaders (skincare): L Oréal 28%, Estée Lauder 12% Key Differentiators: safe, long-lasting, more effective License to industry (along with other consumer indications) Skin Cancer Therapeutic Market US Market Size: $8.3 B Industry Leaders: Bayer, J&J, Pierre Fabre, Elanco/Eli Lilly Key Differentiators: local non-surgical therapy, minimal side effects Develop Rx with strategic partners

7 DEVELOPMENTAL MILESTONES ADDRESS INDUSTRY FEEDBACK Aim 1: ESTABLISH MANUFACTURING SCALABILITY (CRO: Particle Sciences) BNP-AVO/OCTR to potential sunscreen licensees ( + First steps towards GMP BNP-CPT/PXL/EB) Aim 2: IN VITRO ANTI-TUMOR ASSESSMENT (Yale) BNP-CPT/PXL/EB to pre-clinical CRO Aim 3: PRE-CLINICAL SKIN CANCER ANIMAL STUDIES (CRO: Biomodels) DE-RISKED ANTI-TUMOR (BNP-Rx) DEVELOPMENT to start-up for potential VC funding Manufacturing + Scalability + Pre-clinical Safety/Efficacy

8 FUTURE OUTLOOK OF STRADEFY S PLATFORM Redefine skin cancer prevention and treatment using breakthrough nanotechnology For more info, contact: mark.saltzman@yale.edu michael.girardi@yale.edu linda.fong@yale.edu Develop and license OTC indications (i.e. sunscreen) Build a multi-asset pipeline with the potential to improve skin cancer patient outcomes Establish commercial leadership in medical dermatology

9 THANK YOU

10 BNP COMPETITIVE ADVANTAGES 1. Innovative Sunscreen A. SAFER: prevents sunscreen chemicals from penetrating into skin. B. LONGER-LASTING: adherence to stratum corneum extends re-application time. C. MORE EFFECTIVE: eliminates direct and indirect DNA damage. 2. Novel Therapeutic A. LOCALIZED TREATMENT: nonsurgical alternative without systemic toxicity concerns. B. CONTROLLED DRUG RELEASE: tunable pharmacokinetics improves efficacy vs drug alone. C. RETENTION IN TUMOR MATRIX: with increased uptake by tumor cells, and decrease clearance rate.

11 ENHANCED PROTECTION: BNP-SUNSCREEN STAYS AT THE SKIN S SURFACE STRADEFY BNP UV filters BNP-Sunscreen UV filters BNP-Sunscreen UV filters BNP-Sunscreen

12 SYNTHESIS OF BIOADHESIVE BNP-SUNSCREEN HPG terminal aldehydes NaIO 4 polylactic acidhyperbranched polyglycerol (PLA-HPG) PLA-HPG-Aldehyde (~17)

13 REGULATORY PATHWAY: Sunscreen: Our product adheres to the FDA Monograph. SPF testing in 10 individuals is required to market an OTC sunscreen. Therapeutic: IND NDA Pathway

14 BNP-SUNSCREEN (CONSUMER): SKIN CANCER PREVENTION BNPs bind the stratum corneum to prevent penetration BNPs persist all-day and are water-resistant BNP Deng Y, Ediriwickrema A, Yang F, Lewis J, Girardi M, Saltzman WM. A sunblock based on bioadhesive nanoparticles, Nature Materials 14: (2015).

15 BNP-SUNSCREEN (CONSUMER): SKIN CANCER PREVENTION BNPs protect against DNA damaged caused by sunscreen chemicals. Pilot study in human volunteers demonstrates SPF protection. Deng Y, Ediriwickrema A, Yang F, Lewis J, Girardi M, Saltzman WM. A sunblock based on bioadhesive nanoparticles, Nature Materials 14: (2015).

16 PRELIMINARY STUDIES SHOW PROMISE FOR LOCAL RX OF SQUAMOUS CELL CARCINOMA Dye-loaded BNPs show increased uptake and cellular association by PDV SCC cells, relative to NNPs in a dose-dependent manner BNP-CPT (camptothecin) intratumoral injection resolves mouse PDV SCC.

17 ANTI-TUMOR BNPS FOR LOCAL THERAPEUTIC TREATMENT BNP-EB (epothilone B) improves survival outcomes for ovarian and uterine serous carcinoma Deng Y, Yang F, Cocco E, Song E, Zhang J, Cui J, Mohideen M, Bellone S, Santin AD, and Saltzman WM. Improved intraperitoneal drug delivery with bioadhesive nanoparticles, Proceedings of the National Academy of Sciences 113: (2016).

18 BNP THERAPEUTIC FOR SKIN CANCER TREATMENT Superficial BCC/SCC/ Melanoma: First-line, minimally invasive alternative to destruction/surgery. Locally-invasive BCC/SCC (nodular, limited to dermis): First-line, minimally invasive option for nonsurgical candidates. Invasive/Advanced SCC/ Melanoma: Adjunct to standard surgical therapy to reduce recurrence.

19 STRADEFY S BNP PLATFORM: BUSINESS STRATEGY STRADEFY, LLC {Consumer} SUNSCREEN {Rx Dermatology} SKIN CANCER Rx BNP-Sunscreen Licensing Continued OTC Platform Development & Licensing Skin Cancer Rx Partner Continued Rx Platform Development & Licensing

20 PLATFORM OPPORTUNITIES BNPs can address a variety of OTC and Rx areas