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Kodiak (KOD) Advances With Tarcocimab Amid Stiff Competition
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Kodiak Sciences (KOD - 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 (“ABC”) 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.
Currently, Kodiak has no marketed drug in its portfolio and therefore, it is yet to generate any revenues. The company’s lead pipeline candidate, tarcocimab tedromer (formerly KSI-301, also known as tarcocimab), an investigational therapy built on Kodiak's proprietary ABC platform, is being developed for treating various retinal vascular diseases.
Tarcocimab is being evaluated in several late-stage studies for addressing several indications like diabetic retinopathy (DR), including diabetic macular edema (DME), wet age-related macular degeneration (wet AMD), retinal vein occlusion (RVO) and non-proliferative diabetic retinopathy (NPDR) without DME.
In the year so far, shares of Kodiak have decreased 16% compared with the industry’s 9.1% decline.
Image Source: Zacks Investment Research
Currently approved therapies for wet AMD involve frequent injections of proteins every four to eight weeks that block VEGF levels. Tarcocimab is designed to provide sustained inhibition of VEGF for up to six months. The candidate is being developed as a new first-line agent to improve outcomes for patients with retinal vascular diseases. This can be a major catalyst for the drug to gain an upper hand over its peers.
There are four studies ongoing with tarcocimab evaluating the candidate across the previously mentioned indications.
The GLEAM and GLIMMER phase III studies are evaluating tarcocimab for six-month durability in patients with DME. The GLOW phase III study is evaluating tarcocimab in NPDR without DME.
The BEACON phase III study, evaluating tarcocimab’s durability, efficacy and safety in RVO, met its primary endpoint in 2022. Lastly, the DAYLIGHT phase III study is evaluating tarcocimab in wet AMD. The company expects to announce top-line data from all four ongoing studies in the third quarter of 2023. The GLEAM, GLIMMER and DAYLIGHT study results are expected in July and the GLOW study result is expected in September.
Kodiak Sciences plans to file a single Biological License Application (BLA) for tarcocimab to treat wet AMD, DME, DR and RVO. Data from all these studies are expected to be included in the initial BLA for tarcocimab.
Given the lucrative market opportunity, successful development and potential approval for tarcocimab could be a major breakthrough for Kodiak Sciences.
Kodiak Sciences is also using its ABC platform to develop additional product candidates. KSI-501, an anti-IL6 and anti-VEGF bispecific biopolymer conjugate, is in a phase I study for retinal vascular diseases featuring an inflammatory component. Kodiak treated its first patient in the study with KSI-501 in April 2023. The company is also conducting research to develop an ABC platform-based triplet inhibitor for multifactorial retinal diseases.
However, the lack of depth in Kodiak’s pipeline is a matter of serious concern. Any pipeline or regulatory setback in the ongoing studies for tarcocimab will hurt the stock of the company severely.
The targeted market is very competitive with established standard-of-care anti-VEGF therapies. These include therapies marketed by big companies like Regeneron (REGN - Free Report) , Novartis (NVS - Free Report) and Roche (RHHBY - Free Report) , having commercially approved products for the treatment of retinal diseases like wet AMD, DME and RVO.
Regeneron’s Eylea (aflibercept) is a leader in the treatment of wet AMD, DME and macular edema following RVO, which includes macular edema following central RVO and macular edema following branch RVO. The FDA also recently approved Eylea to treat preterm infants with retinopathy of prematurity.
Novartis’ Beovu is approved for the treatment of wet AMD. It is also currently approved in European Union (EU) for the same indication.
Last January, Roche’s Vabysmo was also approved by the FDA for the treatment of wet AMD and DME. Subsequently, Roche received approval for Vabysmo in the EU for the same indication in September 2022.
Image: Bigstock
Kodiak (KOD) Advances With Tarcocimab Amid Stiff Competition
Kodiak Sciences (KOD - 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 (“ABC”) 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.
Currently, Kodiak has no marketed drug in its portfolio and therefore, it is yet to generate any revenues. The company’s lead pipeline candidate, tarcocimab tedromer (formerly KSI-301, also known as tarcocimab), an investigational therapy built on Kodiak's proprietary ABC platform, is being developed for treating various retinal vascular diseases.
Tarcocimab is being evaluated in several late-stage studies for addressing several indications like diabetic retinopathy (DR), including diabetic macular edema (DME), wet age-related macular degeneration (wet AMD), retinal vein occlusion (RVO) and non-proliferative diabetic retinopathy (NPDR) without DME.
In the year so far, shares of Kodiak have decreased 16% compared with the industry’s 9.1% decline.
Image Source: Zacks Investment Research
Currently approved therapies for wet AMD involve frequent injections of proteins every four to eight weeks that block VEGF levels. Tarcocimab is designed to provide sustained inhibition of VEGF for up to six months. The candidate is being developed as a new first-line agent to improve outcomes for patients with retinal vascular diseases. This can be a major catalyst for the drug to gain an upper hand over its peers.
There are four studies ongoing with tarcocimab evaluating the candidate across the previously mentioned indications.
The GLEAM and GLIMMER phase III studies are evaluating tarcocimab for six-month durability in patients with DME. The GLOW phase III study is evaluating tarcocimab in NPDR without DME.
The BEACON phase III study, evaluating tarcocimab’s durability, efficacy and safety in RVO, met its primary endpoint in 2022. Lastly, the DAYLIGHT phase III study is evaluating tarcocimab in wet AMD. The company expects to announce top-line data from all four ongoing studies in the third quarter of 2023. The GLEAM, GLIMMER and DAYLIGHT study results are expected in July and the GLOW study result is expected in September.
Kodiak Sciences plans to file a single Biological License Application (BLA) for tarcocimab to treat wet AMD, DME, DR and RVO. Data from all these studies are expected to be included in the initial BLA for tarcocimab.
Given the lucrative market opportunity, successful development and potential approval for tarcocimab could be a major breakthrough for Kodiak Sciences.
Kodiak Sciences is also using its ABC platform to develop additional product candidates. KSI-501, an anti-IL6 and anti-VEGF bispecific biopolymer conjugate, is in a phase I study for retinal vascular diseases featuring an inflammatory component. Kodiak treated its first patient in the study with KSI-501 in April 2023. The company is also conducting research to develop an ABC platform-based triplet inhibitor for multifactorial retinal diseases.
However, the lack of depth in Kodiak’s pipeline is a matter of serious concern. Any pipeline or regulatory setback in the ongoing studies for tarcocimab will hurt the stock of the company severely.
The targeted market is very competitive with established standard-of-care anti-VEGF therapies. These include therapies marketed by big companies like Regeneron (REGN - Free Report) , Novartis (NVS - Free Report) and Roche (RHHBY - Free Report) , having commercially approved products for the treatment of retinal diseases like wet AMD, DME and RVO.
Regeneron’s Eylea (aflibercept) is a leader in the treatment of wet AMD, DME and macular edema following RVO, which includes macular edema following central RVO and macular edema following branch RVO. The FDA also recently approved Eylea to treat preterm infants with retinopathy of prematurity.
Novartis’ Beovu is approved for the treatment of wet AMD. It is also currently approved in European Union (EU) for the same indication.
Last January, Roche’s Vabysmo was also approved by the FDA for the treatment of wet AMD and DME. Subsequently, Roche received approval for Vabysmo in the EU for the same indication in September 2022.
Kodiak Sciences Inc. Price and Consensus
Kodiak Sciences Inc. price-consensus-chart | Kodiak Sciences Inc. Quote
Zacks Rank
Kodiak currently carries a Zacks Rank #3 (Hold).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.