GENERATION 2.0
Inspired to build the world’s leading high-science retina pipeline
OUR PIPELINE
We are investing in a pipeline of product candidates that brings new capabilities towards the prevention and treatment of high-prevalence ophthalmology diseases
TARCOCIMAB TEDROMER (KSI-301) PRODUCT VISION
Tarcocimab tedromer is an investigational anti-VEGF therapy designed to maintain potent and effective drug levels in ocular tissues for longer than existing available agents. Our objective is to develop a new agent that extends dosing and improves outcomes for patients with retinal vascular diseases.
- According to clinical practice for aflibercept, ranibizumab, and bevacizumab.
- Across six tarcocimab tedromer pivotal studies for wet age-related macular degeneration, diabetic macular edema, retinal vein occlusion, and diabetic retinopathy.
TARCOCIMAB TEDROMER (KSI-301) TRIAL OVERVIEW
We are developing tarcocimab tedromer to be the only Generation 2.0 anti-VEGF biologic agent, with the objective to deliver a new first line agent for RVO, DME, wet AMD and DR. The clinical program includes a wide range of dosing intervals to maximize flexibility and reimbursement confidence for physicians and patients
Diabetic Macular Edema
GLEAM and GLIMMER Studies
Tarcocimab tedromer:
Once every 2 to 6 months
After 3 monthly loading doses
COMPARED TO
EYLEA:
Once every 2 months
After 5 monthly loading doses
4 minimum doses in Year 1
2 minimum doses in Year 2
Non-Proliferative Diabetic Retinopathy
GLOW Study
Tarcocimab tedromer:
Once every 6 months
After 3 initiating doses
COMPARED TO
SHAM
4 doses in Year 1
2 doses in Year 2
Retinal Vein Occlusion
BEACON Study
Tarcocimab tedromer:
Once every 2 months or longer
After 2 monthly loading doses
COMPARED TO
EYLEA:
Once every month
4 minimum doses in Year 1
Wet AMD
DAYLIGHT Study
Tarcocimab tedromer:
Once every month
COMPARED TO
EYLEA:
Once every 2 months
After 3 monthly loading doses
Monthly dosing
CURRENT MEDICINES MUST BE DOSED ON AN INTENSIVE REGIMEN TO MAINTAIN VISION
Current standard therapies for VEGF-mediated retinal vascular diseases require frequent and burdensome intravitreal injection of anti-VEGF proteins every 4 to 8 weeks1.
1. Per current anti-VEGF treatment labels
2. Rosenfeld PJ et al; MARINA study group. N Engl J Med. 2006;355:1419-14313
PATIENTS ARE UNDERTREATED AND LOSING VISION TODAY1
Adherence to an intensive treatment regimen is difficult for patients and caregivers. Without frequent treatment, vision loss due to under-dosing can begin quickly and within 3 months.
1. Retrospective studies demonstrate that most patients receive ~5 injections a year.
2. The AURA Study, adapted from Holz FG et al. BR J Ophthalmol 2015; 99 (2): 220-226.
3. Adapted from Sierra AMD, Khanani A, et al. Ophthal. Retina 2020 Feb; 4(2):122-123. EMR= Electronic Medical Records
TARCOCIMAB TEDROMER (KSI-301) AIMS TO MAINTAIN THERAPEUTIC ACTIVITY FOR LONGER
Tarcocimab tedromer is a novel anti-VEGF biologic designed to rapidly inhibit VEGF and provide extended durability of action to reduce the burden of frequent anti-VEGF injections. Delivering potent and sustained VEGF inhibition enables patient compliance, results in long-term efficacy and improves visual acuity outcomes.
DATA FROM PHASE 1B AND PHASE 2B/3 DEMONSTRATE STRONG DURABILITY WITH TARCOCIMAB TEDROMER (KSI-301)
Results from these trials show consistency in the unprecedented durability of tarcocimab tedromer and by extension our ABC Platform
Results from Phase 2b/3 study of tarcocimab tedromer in treatment-naïve patients with wet AMD (n=238)1
- While the study did not meet its primary endpoint of showing non-inferiority in visual acuity gains compared to aflibercept Q8W, nearly 60% of tarcocimab tedromer patients achieved every 5-month dosing at Year 1 with visual acuity gains and anatomic improvements comparable to the overall aflibercept group.
- The study did not allow for more frequent treatment than Q12W, which resulted in a minority of patients being undertreated.
Primary results available here
1. Phase 2b/3 is a randomized, double-masked non-inferiority study of tarcocimab tedromer Q12W to Q20W vs aflibercept Q8W in treatment-naïve wet AMD patients.
Results from Phase 1b study of tarcocimab tedromer in treatment-naïve patients with wet AMD (n=50)2
- In wet AMD, 66% of patients were on a 6-month or longer treament-free interval at Year 1 after 3 loading doses.
- Beyond wet AMD, 69% of patients with DME and 66% of patients with RVO were on a 6-month or longer treament-free interval at Year 1.
One-year results available here
2. Phase 1b is a randomized, open label study to evaluate mulitdose safety, efficacy and durability in wet AMD, DME and RVO. Year 1 data, 2.5 & 5 mg doses pooled. Includes only patients that received all (3) loading doses and either a) received a dose before Week 52 or b) did not receive a dose and were followed for at least six months after the last loading dose (Week 52 visit). Interval at Year 1 reflects the treatment interval ongoing at the Week 52 visit (where available) or the last interval before Week 52.