KEX: Next Generation Biologics

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KEX: Next Generation Biologics

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kex-pitch

kex pitch

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KEX: Next Generation Biologics

Team

CEO: Isaac Yonemoto, PhD President, indysci.org, nonprofit 501(c)(3) developing anticancer small molecules COO: Sarah Hanson, PhD Project Manager, BP Biofuels, Yeast expression systems. Domain Expertise (PhD) in eukaryotic glycosylation CSO: Amber Murray, PhD Staff Scientist, Eli Lilly, inc., R&D of insulin manufacturing process. Domain Expertise (PhD) in eukaryotic glycosylation.

Mission

KEX's mission is to decrease the cost of anticancer drugs.
  • Currently top-of-the-line 'biologics', which offer effective treatments* with minimal side effects, cost $20-40K per patient.
*In some cases, these drugs only buy the patient a few months.

What is the Problem?

Although there are many platforms for manufacturing 'biologics', therapeutic anticancer antibodies are special.
  • 'ADCC' antibodies require a glycosylation only mammallian cells produce
  • CHO cells are an expensive manufacturing platform
    • Expensive media
    • High batch-to-batch variability
    • Difficult to cleanly purify product

The Patent Cliff: An Opportunity

Drug Market Patent Expiry (US) Rituxan $7B 2015 Avastin $6B 2019 Herceptin $6B 2015 Velcade $2B 2017 Erbitux $2B 2016

A New Business Model

Short Term

  • Begin manufacture of Rituxan and Herceptin.
  • Develop "process" strains for manufacture of these drugs.
  • Scale to the 100, 1000L fermenter scale.
  • Develop cGMP quality control using modular, cGMP-ready manufacturing units.
  • Partner with a generics manufacturer/distributor to obtain approval of at least one candidate biosimilar
  • Achieve cashflow positive status ASAP

A New Business Model

Long Term

  • Fork a "release" strain and create a GPL-like licence for this strain.
  • Strategically select 'best candidates' from researchers using the strain.
  • Offer at-cost cGMP validated scaleup services for preclinical and clinical experimentation on the drug.
  • Obtain 'early mover' advantage in the process R&D and capture the market for clinical manufacture.

Market Analysis

  • Rituxan: $7B
  • Herceptin: $6B
  • Correcting for a 20-fold decrease in asking price: ~$300M per drug per year.
  • With a 10% market penetration, yields ~$5M/yr in profit per drug

Challenges

  • Major competition: Merck/Glycofi
  • Patent Landscape and legal risk
    • Addressable through UC Hastings 'IP boot camp'

First Steps

  • Your opportunty: Invest $1M for 10% equity
  • 5-6 employees, 1 year
  • 6 month Deliverable: Rapidly iteratable proof of concept strain that glycosylates
  • One year deliverable a): "Release" strains that produces Herceptin at the 10L scale
  • One year deliverable b): An initial low-cost purification strategy for Herceptin
  • Conclusion: Seek series A fundraising at a valuation of > $50M

Next Steps

  • Partnership with modular cGMP specialists
  • Partnership with an established manufacturer/distributor to relabel candidate
  • Aggressively work towards cashflow positive status

The Big Picture Goal

  • Within 25 years...
  • 80% cure rate for Cancer...
  • At a cost of < $4k (equivalent) per person...
  • With minimal side effects.
  • The Big Pharma model doesn't work with the low margins in this market.
  • This market is wide open. How much can we capture?

Thanks