Avaxia is a clinical-stage biotechnology company that is a leader in the growing field of gut-targeted therapeutics — orally administered, minimally absorbed drugs that are designed to act locally in the gastrointestinal (GI) tract including the mouth, throat, and intestines. Avaxia’s proprietary oral antibody platform makes direct delivery of antibodies to the GI tract possible by overcoming some of the traditional limitations of antibody therapeutics. Avaxia’s lead clinical candidate, AVX-470, is an oral anti-TNF antibody for inflammatory bowel disease. This transformative product offers potentially improved safety and efficacy over existing anti-TNF therapies by focusing immune suppression only where needed in the diseased gut. Avaxia is developing gut-targeted therapeutics to address many other serious diseases such as type 2 diabetes, celiac disease, GI acute radiation syndrome, and oral mucositis.
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Avaxia Biologics
1. January 17, 2013
Science Shaping our World
Barbara S. Fox, PhD, CEO
Avaxia Biologics
128 Spring St., Suite 620
Lexington, MA 02421
781-861-0062 x303
bfox@avaxiabiologics.com
2. Avaxia Biologics
Gut-targeted antibody therapeutics
• AVX-470: Oral anti-TNF antibody
– Phase 1b clinical trial in patients with active ulcerative colitis
• AVX oral antibody platform
– Game changing technology expands $50B antibody market
• Full pipeline of products
– Inflammatory bowel disease
– GI acute radiation syndrome
– Diabetes
– Celiac disease
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3. Avaxia Biologics
• Located in Lexington, MA
• 13 FTEs
• Financing history: $16.4M raised to-date
– $5.8M non-dilutive funding
• NIH grants, BARDA contract, Mass Life Science Center
• Additional $1.7M pending from Department of Defense
– $4.1M Series A November 2011
• Cherrystone Angels, Beacon Angels, Boston Harbor Angels,
Launchpad Venture Group, Mass Medical Angels, North
Country Angels and individuals
– $6.5M Series B December 2012
• All Series A angel groups + Golden Seeds, Beta Fund, Granite
State Angels, Maine Angels
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4. Avaxia Team
Management Team Board of Directors
• Barbara Fox, PhD • Barbara Fox, PhD, Avaxia
– CEO & Founder
• Nada Jain, Golden Seeds
• David Dlesk
– COO • Henry Kay, Launchpad, BHA
• Daniel Tracey, PhD • Chris Kiritsy, Arisaph
– VP Research
• Rob Manning, Cherrystone
• Eileen Bostwick, PhD
– VP Development and QC • David Poorvin, PhD, Avaxia
• Michael Rivard Scientific & Clin Advisors
– VP Corporate Development
• Scott Harris, MD • Robert Kamen, PhD
– Chief Medical Officer (consulting) • Stephen Sonis, DMD, DMSc
• Bruce Sands, MD
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5. Inflammatory Bowel Disease
Ulcerative Colitis, Crohn’s Disease
• Serious chronic disease with no cure
– 2.5 million people, 1 million in US
– Abdominal pain, diarrhea, high rate of surgery
• Limited therapeutic options
– Steroids - High efficacy but poor safety
– 5-ASAs – Modest efficacy
– Injected anti-TNF monoclonal antibodies
• High efficacy, but systemic immunosuppression
• Expensive, difficult dosing
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6. AVX-470 for IBD
Anti-TNF antibody from colostrum of immunized cows
• Stable to digestion in GI tract
• Safe for oral delivery (lactose-free)
• Minimal systemic exposure
• High potency
• Low cost of goods
• Strong patent position
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7. AVX-470 for Inflammatory Bowel Disease
Oral anti-TNF antibody as first line therapy
AVX-470 treats IBD in
• TNF is validated target mouse model
• Deliver to the site of 3.0
inflammation
Endoscopy Score
2.5
– Maintain efficacy
– Safer due to limited *
systemic exposure 2.0
• Position as first-line
1.5
therapy Saline
control
Steroid AVX-470 Control
bovine
antibody
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8. 8
AVX-470 for GI Acute Radiation Syndrome
Oral anti-TNF antibody stockpiled for defense
• US government (BARDA/HHS) is developing
countermeasures to protect civilian population in event of
nuclear attack
• Avaxia awarded $3M BARDA contract July 2011 to develop
AVX-470 for GI ARS
100
80
% Survival
60 Mice irradiated with 8Gy total body irradiation
Dosed with saline or AVX-470, oral, once per day
40
Survival at day 10 post-irradiation
20
0
Saline AVX-470m
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9. Avaxia Biologics
Gut-targeted antibody therapeutics
• AVX-470: Oral anti-TNF antibody
– Phase 1b clinical trial in patients with active ulcerative colitis
• AVX oral antibody platform
– Game changing technology expands $50B antibody market
• Full pipeline of products
– Inflammatory bowel disease
– GI acute radiation syndrome
– Diabetes
– Celiac disease
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