Technology Transforming Life

Transcription

1 Technology Transforming Life

2 Technology Transforming Life

3 Licensing Executive Society USA Canada Emerging Enterprise Committee Commercialization: Building the Custom Fit for Success : Gary N. Keller, CLP CEO - Xomix Ltd. LESI Life Science Committee Chair - Emerging Enterprise Chairman Emeritus

4 Commercialization into Startups Each company is a unique evolution of a technology based opportunity This is the art of science

5 What is the Optimal Pathway for Commercializtaion? Determine if the IP based invention is: A Project A Product A Company Develop a path for commercialization that optimizes the value creation and impact. Optimize through License or Incorporate or both?

6 Assessing the Technology Identify the market niches for the technology Determine the competition and competitive landscape Evaluate the competitive IP landscape for insight into other key inventors, companies, and research institutions Evaluate key ongoing research that can lead to competitive products and processes Speak with end-users to determine if there is an unmet need and market demand

7 Assessing the Technology Determine market size and market dynamics, including drivers and barriers Characterizes the technology s likely commercial potential and estimates market size and share Speak with industry experts and companies in the technology are to determine opportunities for collaboration, licensing, and milestones for investment or acquisition.

8 Assessing the Technology Determine the alternatives Identify the current products and methods on the market, new versions of existing products and new products in development. Identify companies with capacity to accelerate development into the area through modification of existing products.

9 Building the Commercialization Strategy Develop a market entry strategy for the entry niche for commercialization or licensing. Company vs. Product Strategy Actual vs. Virtual Collaboration Strategies and Agreements

10 Building the Commercialization Team Identify the Dream Team Internal vs. External Outsourced vs. Incubated Structure the roles including responsibilities and benefits Most biotech companies will change technologies. It is often easier to change the technology than the team.

11 Phase I - ZelleRx

12 NK-92 Technology Granulocytes- White cells containing granules Neutrophils Eosinophils Basophils Lymphoid Cells- White cells containing no granules Monocytes/Macrophages Lymphocytes T-cells B-cells Natural Killer Cells* *AKA- Large Granular Lymphocytes (have granules)

13 NK-92 A Proprietary Natural Killer Cell Line

14 Grants Awarded to NK-92 Programs Federal Ministry of Education & Research, DE $2,109,210 Production Assistance for Cellular Therapies: $553,000 UPCI Allocated NCI Core Grant: $175,000 Jose Carreras Foundation: $650,000 Ontario Institute For Cancer Research: $475,000 RUSH University: $180,000 Sramek Center for Cell Therapy: $200,000 Coleman & Last Chance Foundations: $180,000 Grant Total: $4,519,210 (All non-dilutive except for RUSH)

15 US Phase I trial with NK-92 Diagnosis Cell dose/m 2 Side Effects Outcome 1 RCC 1 x 10E8 0 SD* 2 RCC 1 x 10E8 0 PD 3 RCC 1 x 10E8 0 PD* 4 RCC 3 x 10E8 0 PD 5 RCC 3 x 10E8 0 PD 6 RCC 3 x 10E8 0 MR 7 RCC 1 x 10E9 0 PD* 8 RCC 1 x 10E9 0 SD 9 RCC 1 x 10E9 I - fever SD 10 Melanoma 3 x 10E9 III - fever CIR 11 RCC 3 x 10E9 IV - hypoglycemia SD 12 RCC 3 x 10E9 I - fever SD All patients enrolled had advanced metastatic disease, with progressive cancer growth through last regimen despite multiple treatment modalities including surgery, high-dose IL-2, interferon, radiation, chemotherapy, and stem cell transplantation. Clinical responses to a single course of NK-92 monotherapy observed in the higher dose groups. RCC = Renal Cell Carcinoma PD = Progressive Disease SD = Stable Disease * followed by allo SCT MR = Mixed Response CIR = Clinical Response marked reduction in one tumor site Arai, et. al., Cytotherapy 10-6:

16 ZelleRx Leverage of Development Opportunities - Cato Ventures CRO Investment - up to $1M - University of Pittsburgh Clinical Development - up to $1M (not pursued)

17 Phase II - ConKwest

18 Out-Licensing Program NK-92 cell lines serve as a QC and for testing. High degree of accuracy and reproducibility, Ease of maintenance and an inexhaustible supply, More accurate and reliable data at a fraction of the cost and effort, Competitive advantage in the race among companies to commercialize the next blockbuster antibody therapeutics. Use the NK-92 family of cell-lines for non-therapeutic applications including quality testing for antibody production, antibody research and development, discovery research, patient testing.

19 Phase III - NantKwest NantKwest is an innovative clinical-stage immunotherapy company focused on harnessing the power of the innate immune system by using the natural killer cell to treat cancer, infectious diseases and inflammatory diseases.

20 Phase III - NantKwest July 27, NantKwest ($NK) priced its IPO at $25 a share, far above the range, raising $207 million on the sale of 8.3 million shares. Its shares opened at $37 and a that established a market cap baseline at $2.6 billion.

21 Thank You! Gary N. Keller, CLP CEO, Xomix Ltd. Chairman, LESI Life Science Committee (773)

22 Technology Transforming Life