Kodiak Sciences : 22nd EURETINA 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

Arshad M. Khanani, M.D., M.A., FASRS

Director of Clinical Research, Sierra Eye Associates, Reno, NV USA

on behalf of the BEACON Study Group

2 September 2022

Disclosures

• Presenter's Financial Disclosures:
• • Consultant: Abbvie, Adverum, AGTC, Aldebaran Therapeutics, Alimera, Apellis, Arrowhead, Asclepix, Aviceda, Bausch and Lomb, Broadwing Bio, Cholgene, 4DMT, Eyepoint, Frontera Therapeutics, Gemini, Genentech, Inc., Graybug, Gyroscope, Iveric Bio, Janssen, Kartos Therapeutics, Kato Pharma, Kodiak, Kriya Therapeutics, Ocular Therapeutix, Oculis, Ocuterra, Opthea, Oxurion, Nanoscope, Novartis, Perfuse, PolyPhotonix, Protagonist, Ray Therapeutics, Recens Medical, Regeneron, Retrotope, Regenxbio, RevOpsis, Roche, Stealth, Thea, Unity Bio, Vanotech, Vial
  • Research Support: Adverum, Alkahest, Annexon, Apellis, Asclepix, 4DMT, Gemini, Genentech, Inc., Graybug Vision, Gyroscope, Iveric Bio, Kodiak, Neurotech, NGM Bio, Ocular Therapeutix, Oculis, Ocuterra, Opthea, Oxurion, Novartis, Recens Medical, Regenxbio, Roche, Unity Bio
  • Speaker: Abbvie, Apellis, Bausch and Lomb, Genentech, Inc., Novartis
  • Equity: Aviceda, Recens Medical, Retrotope, RevOpsis, PolyPhotonix
• 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

Mean VA Change (Letters)

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

# Injections in first 6 months

# Eyes

Mean VA Change (Letters)

2,500

2,000

1,500

1,000

500

0

20

15

10

5

0

CRVO

			2,043
			1,567
			1,311
		440	837
	203	327

1 2 3 4 5 6 7

• Injections in first 6 months
  14.4

5.3

1 2 3 4 5 6 7

# Injections in first 6 months

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

achieves comparable outcomes would be an important advance

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)

[only performed if test #1 successful]

Months 6-12:Masked H2H individualized dosing

Months 12-18:

Open label with individualized dosing

Clinicaltrials.gov, study identifier: NCT04592419	5
RVO: retinal vein occlusion; PE: primary endpoint; H2H: head-to-head; BCVA: best-corrected visual acuity