Kodiak Sciences : 2022 American Academy of Ophthalmology Presentation

KSI-301Anti-VEGF Antibody Biopolymer Conjugate for Retinal Vein Occlusion:

Primary 24-Week Efficacy and Safety Outcomes

of the BEACON Phase 3 Pivotal Study

Michael Singer, M.D.

Clinical Professor of Ophthalmology, University of Texas Health Science Center

Director of Clinical Research, Medical Center Ophthalmology Associates

San Antonio, TX

on behalf of the BEACON Study Group

30 September 2022

Disclosures

• Presenter's Financial Disclosures:
• • Consultant: Aerie, Allegro, Alimera, Allergan, Eyepoint, Genentech, Kodiak Sciences, Novartis, Regeneron, Santen
  • Contracted Research: Aerie, Alimera, Allegro, Allergan, DRCR.net, Genentech, Icon, Ionis, Kalvista, Kodiak Sciences, Novartis, Opthea, Optos, Regeneron, Santen, Senju, Sydnexis
  • Equity: Aviceda, Inflammasome, Nanoscope
  • Speakers Bureau: Allergan, Genentech, Mallinckrodt, Novartis, Regenerson, Spark
• This presentation will discuss IRB/IEC approved research of an investigational medicine.

2

RVO real-worldanti-VEGF treatment outcomes fall short of clinical trial outcomes - more durable treatments are needed

# Eyes

Change (Letters)

					BRVO
3,000					2,637
2,500							2,049
2,000
				1,699
1,500				1,082
1,000
	354	635			413
500
0
	1	2	3	4	5	6	7
		# Injections in first 6 months
20
15							13.1
10					8.0

# Eyes

Change (Letters)

CRVO

2,500

2,043

2,000

1,567

1,500				1,311
1,000			440	837
500							327
203
0
1	2	3	4	5	6	7

# Injections in first 6 months

20

14.4

15

10

Monthly dosing is difficult to achieve in clinical practice, where 72% of patients

received less than monthly dosing.

With currently available anti-VEGFs, treatment less often than monthly compromises vision outcomes in RVO

A less frequent therapy that

Mean VA

5

0

Mean VA

5

0

5.3

achieves comparable outcomes would be an important advance

1

2

3

4

5

6

7

# Injections in first 6 months

1 2 3 4 5 6 7

# Injections in first 6 months

Adapted from Ciulla T, et al. Br J Ophthalmol 2021;105:1696-1704.doi:10.1136/bjophthalmol-2020-317337. Represents 8,876 BRVO eyes, 6,737 CRVO eyes from Vestrum database. Mean 4.5 and 4.6 anti-VEGF injections over first 6	3
months (aflibercept, ranibizumab, or bevacizumab) in BRVO and CRVO, respectively. VA, Visual acuity. RVO, retinal vein occlusion. BRVO, branch retinal vein occlusion. CRVO, central retinal vein occlusion.

KSI-301 (tarcocimab tedromer): Antibody Biopolymer Conjugates (ABCs)

A novel class of biologics engineered for increased durability and efficacy

+=

ANTIBODY	BIOPOLYMER	CONJUGATE
lgG1 Anti-VEGF Antibody	Branched, Optically Clear,
Immunologically inert	High Molecular Weight
	Phosphorylcholine Polymer

KSI-301 (tarcocimab tedromer) is an anti-VEGF ABC that blocks all VEGF-A isoforms

4

BEACON: Phase 3 non-inferiority study of tarcocimab tedromer every 2 months after only two loading doses vs aflibercept every 1 month in treatment-naïve RVO patients

Matched

Maintenance phase

PE

phase

Week

0

4

8

12

16

20

24

Tarcocimab tedromer 5 mg Q8W

(N~275)

Aflibercept 2 mg Q4W

(N~275)

Tarcocimab injection

Primary Endpoint:

Aflibercept injection

Sham injection

Mean change in BCVA at Week 24

Hierarchical testing for control of type 1 error: 1. Test non-inferiority in BRVO patients

2. Test non-inferiority in all RVO patients (BRVO+CRVO)

Months 6-12:Individualized dosing in both arms

Months 12-18:

Open-label tarcocimab Individualized dosing

Clinicaltrials.gov, study identifier: NCT04592419	5
RVO: retinal vein occlusion; PE: primary endpoint; BCVA: best-corrected visual acuity