Kodiak Sciences (KOD Quick QuoteKOD - Free Report) is a clinical-stage biopharmaceutical company engaged in developing novel therapeutics to treat chronic and high-prevalence retinal diseases, which are the major causes of blindness. The company’s proprietary antibody biopolymer conjugate platform is designed to maintain potent and effective drug levels in ocular tissues for longer periods than the currently marketed biologic medicines for treating retinal diseases.

The company currently has no marketed drug in its portfolio.

Kodiak is developing its lead investigational candidate, tarcocimab, a novel anti-VEGF antibody biopolymer conjugate, for the treatment of retinal vascular diseases. Such diseases include diabetic eye disease and wet age-related macular degeneration (wet AMD).

KOD’s Lead Program Exhibits Significant Potential

In late 2023, Kodiak decided to reboot the development program of tarcocimab following positive phase III results from the GLOW study, which evaluated the treatment in patients with moderately severe to severe non-proliferative diabetic retinopathy (NPDR).

The company had previously reported the success of its phase III DAYLIGHT and BEACON studies evaluating tarcocimab in patients with wet AMD and retinal vein occlusion (RVO), respectively. The positive data readouts from DAYLIGHT, BEACON and GLOW studies give the company three successful phase III pivotal studies with the candidate across three different retinal vascular and exudative diseases, such as wet AMD, RVO and NPDR.

Based on feedback from the FDA, Kodiak believes that it requires one additional pivotal study to support a regulatory filing of tarcocimab for all three indications.

Leveraging the GLOW1 study's success, Kodiak initiated the GLOW2 study in late 2023 to further investigate tarcocimab for diabetic retinopathy and began dosing patients in May 2024, with enrollment expected to complete by the year’s end. The success of the GLOW2 study is expected to serve as the basis for a single biologics license application submission for tarcocimab, seeking its approval.

The revival of tarcocimab in Kodiak's pipeline, after a major setback earlier in 2023, has restored stakeholder confidence in the drug’s potential for treating retinal diseases.

KOD’s Other Pipeline Programs Progressing Well

Kodiak is also developing KSI-501, a dual inhibitor bioconjugate molecule, to address inflammation and abnormal blood vessel growth in retinal vascular diseases.

Following the successful phase I study, Kodiak is preparing to advance KSI-501 into phase III through the DAYBREAK study, which will assess its efficacy, durability and safety for wet AMD. The company also plans to study tarcocimab as a second investigational arm in the DAYBREAK study for wet AMD, with KSI-501 being the first investigational arm. The study is designed to be a non-inferiority study, evaluating KSI-501 dosed every four to 24 weeks, compared with Regeneron’s (REGN Quick QuoteREGN - Free Report) Eylea dosed per label. The phase III DAYBREAK study on tarcocimab and KSI-501 is currently enrolling patients.

By initiating a second phase III study, Kodiak is positioning itself with two late-stage candidates, providing a potential fallback if one program encounters challenges.

Additionally, Kodiak plans to develop the unconjugated protein component of KSI-501, known as KSI-101 (formerly known as KSI-501P), for patients with diabetic macular edema (DME) and macular edema secondary to inflammation. It is a novel, potent and high-strength bispecific protein targeting IL-6 and VEGF.  At present, there are no available intravitreal biologic therapies addressing the spectrum of inflammatory conditions of the retina, which represents a huge new market opportunity separate from the established anti-VEGF market. 

Kodiak has aligned with the FDA regarding the pivotal study program for KSI-101, comprising two pivotal studies, a phase Ib APEX dose-finding study and dual phase IIb/III (PEAK and PINNACLE) studies. Enrollment in the APEX study is ongoing.

Potential Limiting Factors

Despite the encouraging developmental updates of pipeline candidates, clinical studies carry significant risks and can encounter setbacks. Investors should remember that in 2023, Kodiak faced a major developmental setback that led to the abandonment of the development program of tarcocimab for retinal vascular diseases. This decision followed the failure of the late-stage GLEAM and GLIMMER studies, which did not meet the primary efficacy endpoints of showing non-inferior visual acuity gains for tarcocimab compared with Regeneron’s Eylea (aflibercept) in the treatment of DME. Moreover, an unexpected rise in cataracts was observed in the tarcocimab treatment groups in both studies.

Although Kodiak has since resumed the tarcocimab program, the development timeline has been considerably delayed. The company’s other pipeline candidates, KSI-501 and KSI-101, are still far from reaching commercialization. Any further setbacks could negatively impact the stock. Additionally, Kodiak currently lacks partnership agreements for the development or commercialization of its products, which is a concern.

Regeneron’s Eylea is one of its key growth drivers, which is being already approved for wet AMD, DME, RVO and diabetic retinopathy in the United States.The FDA has also approved Eylea to treat preterm infants with retinopathy of prematurity as well.

Please note that Bayer’s (BAYRY Quick QuoteBAYRY - Free Report) HealthCare unit co-develops Eylea with Regeneron. REGN records net product sales of Eylea in the United States. Bayer records net product sales of Eylea outside the United States. Regeneron records its share of profits/losses in connection with sales of Eylea outside the United States.