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BACKGROUND & AIMS

AVX-470 is an oral, enteric-coated, bovine-derived, polyclonal

antibody designed to target TNF in the gastrointestinal (GI) tract

without significant systemic exposure. AVX-470 was evaluated in a

double-blind, placebo-controlled, first-in-human trial undertaken to

explore the pharmacodynamics (bio-markers, clinical, endoscopic

response), pharmacokinetics (tissue, stool, systemic bioavailability),

immunogenicity & safety of 4 weeks of AVX-470 administration in

patients with active ulcerative colitis (UC).

• AVX-470 was well-tolerated with no drug-

related SAEs, opportunistic infections or

allergic reactions.

• AVX-470 was stable in passage through the

GI tract and was not associated with

significant systemic exposures. No

immunogenicity was observed.

• Bovine Ig was shown to penetrate the colonic

mucosa, even in areas of normal endoscopic

activity. However, prior dietary exposures

interfered with detection of changes in tissue

levels.

• Efficacy trends were observed across multiple

parameters (clinical, endoscopic, biomarker)

of disease activity, most favoring the 3.5g/d

dose group.

• This is the first study to suggest the benefit of

an orally delivered, locally-active agent in a

moderate-severe UC population. Future

studies will examine the effects of higher

doses and longer dose duration.

1Avaxia Biologics, Lexington, MA, USA. 2Toronto Digestive Disease Associates, Toronto, ON, Canada. 3Nashville Medical Research Institute, Nashville, TN, USA 4University Hospital Gasthuisberg, Leuven, Belgium.

Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Safety of AVX-470, an Oral, Bovine-Derived Anti-TNF Antibody, in Patients with Active Ulcerative Colitis (UC): Initial Human Experience

A concurrent use 36.1%; B concurrent use 30.6%

a uncontrolled UC activity during Week 1 of treatment; b Patient withdrew

before first dosing; c recurrence of nausea and dysphagia for medications,

established pre-study, precluded continued study participation

Parameter

Placebo

(n = 9)

0.2 g/d

(n = 8)

1.6 g/d

(n = 12)

3.5 g/d

(n = 7)

Pooled

Active

(n = 27)

Overall

(n = 36)

All, n (%) A 7 (77.8) 3 (37.5) 6 (50.0) 5 (71.4) 14 (51.9) 26 (72.2)

AEs (Total) B 13 (100.0) 8 (100.0) 13 (100.0) 13 (100.0) 34 (100.0) 47 (100.0)

Mild 9 (69.2) 7 (87.5) 10 (77.0) 9 (69.2) 26 (76.5) 35 (74.5)

Moderate 4 (30.8) 1 (12.5) 2 (15.9) 4 (30.8) 7 (20.6) 12 (23.4)

Severe 0 (0.0) 0 (0.0) 1 (7.7)† 0 (0.0) 1 (2.9) 1 (2.1)

SAEs, n (%) A 0 (0.0) 0 (0.0) 1 (8.3)† 0 (0.0) 1 (3.7) 1 (2.8)

AEs of Special

Interest C 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)

Treatment-Emergent AEs (TEAEs)

A no. of patients experiencing AEs, n (%); B no. of AEs, n (%); C allergic

reaction or opportunistic infection; † worsening UC on Day 3 of study drug

M. Scott Harris, M.D., Chief Medical Officer

Avaxia Biologics Inc.

128 Spring St, Lexington, MA, USA

email: sharris@avaxiabiologics.com

CONTACT

Study Enrollment and Disposition

Demographics

METHODS

BACKGROUND & AIMS

RESULTS

CONCLUSIONS

Screening F/U Double-blind treatment

Colonoscopy-Biopsy

Biomarkers

Colonoscopy-Biopsy

Biomarkers

Week -3 0 4

- 36 patients with active UC - 13 centers in US, Canada, Belgium and Hungary - 4 weeks treatment, 3 ascending-dose cohorts - 0.2 g/d BID, 1.6 g/d BID, and 3.5 g/d TID in divided doses -Within each cohort, patients randomized 3:1 to AVX-470 or placebo

- Colonoscopy with central reading at Baseline and Week 4 - biopsy from cecum/ascending, transverse, descending, sigmoid, & rectum

Barbara S. Fox1, Deborah S. Hartman1, Sharon Spence1, Sally Kennedy1, Theodore Ptak2, Ron Pruitt3, Séverine Vermeire4, M. Scott Harris1

Advantages of Oral Gut-Targeted Anti-TNF Antibodies

Pla

ceb

o

0.2

g/d

ay

1.6

g/d

ay

3.5

g/d

ay

-3 0

-2 0

-1 0

0

1 0

2 0

p = 0.047

† Fold Change

IHC staining index

Changes in TNF Levels in Colon

Tissue Across Treatment Arms

AVX-470 Reduces TNF in Colon:

Direct Effect on Therapeutic Target

TNF immunohistochemistry (IHC) staining in sigmoid colon (A, B) and

rectum (C, D) at baseline (A, C) and Week 4 (B, D) in AVX-470 3.5 g/d

group. Brown staining indicates TNF protein. Magnification 400x.

Lack of Immunogenicity

Competition ELISA

Pharmacokinetics

Bovine immunoglobulin (Ig)

in stool by ELISA analysis

Bovine Ig in colon tissue

by IHC staining

Calculated levels of

TNF binding antibodies

Stool Tissue Serum

0

20

40

60

80

Placebo 0.2 1.6 3.5

AVX-470 (g/d)

% p

ositiv

e s

am

ple

s

0.0

0.5

1.0

1.5

2.0

2.5

3.0

Se

rum

le

ve

ls (

μg

/mL

)

Literature values

SUMMARY: AVX-470 is confined to the GI tract

Parameter

Placebo

(n = 9)

0.2 g/d

(n = 8)

1.6 g/d

(n = 12)

3.5 g/d

(n = 7)

Pooled

Active

(n = 27)

Clinical Response 1/9 (11.1) 3/8 (37.5) 2/12 (16.7) 2/7 (28.6) 7/25 (25.9)

Clinical Remission 0 0 0 1/7 (14.3) 1/27 (3.7)

Endoscopic Response 0 0 1/12 (8.3) 1/7 (14.3) 2/27 (7.4)

Endoscopic Remission 0 0 1/12 (8.3) 1/7 (14.3) 2/27 (7.4)

† expressed as n/N (%)

Clinical & Endoscopic Remission†

Clinical Response Reduction of ≥ 3 points on the total Mayo score and an overall decrease of at least 30%, plus a decrease in the rectal bleeding subscore of at least 1-point or an absolute rectal bleeding score of 1 or less

Clinical Remission: Total Mayo score of 2 or lower and no subscores higher than 1

Endoscopic Response: 1-point decrease in Mayo endoscopic subscore

Endoscopic Remission: Mayo endoscopic subscore of 0-1

5

†3.5 g/day vs placebo;

two-tailed, unpaired t-

test of geometric means

of changes across five

colon segments No change from Baseline in serum levels of HABA (human anti-bovine

antibody) in AVX-470 or placebo treatment arms.

The authors would like to acknowledge Daniel E. Tracey, Brenda Lemos, Emma Erlich, Dave Keane & Rutvij Patel (current and former employees of Avaxia Biologics) for their contributions to the biomarker analysis.

ACKNOWLEDGEMENTS

p = 0.015

Ch

ange

in S

eru

m I

L-6

pg/

ml

Pla

ceb

o

0.2

g/d

ay

1.6

g/d

ay

3.5

g/d

ay

-1 5

-1 0

-5

0

5

1 0

1 5

* *Change in IL-6

compared by ANCOVA

as a function of

treatment adjusting for

baseline: AVX-470 3.5 g

vs. placebo (p = 0.015).

Changes in Serum IL-6 Levels

Across Treatment Arms

Changes in Serum CRP Levels

Across Treatment Arms & Duration

Ch

ange

in S

eru

m C

RP

ug/

ml

Week 1

Week 2

Week 3

Week 4

-3 0

-2 0

-1 0

0

1 0

2 0

p = 0.052

†

p = 0.058

††

† 3.5 g/day vs placebo – two-sided, two-sample paired t-tests †† Week 4 vs baseline CRP, paired analysis

Change over 4 weeks Time course of change (3.5 g/d)

Change over 4 weeks

Change over 4 weeks

Stool, tissue, and serum samples collected at Week 4