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Our Pipeline
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Antibody Drug Conjugate Induced Toxicity
Antibody-drug conjugates (ADCs) are an important and increasingly promising class of therapeutic agents in oncologic disease management. Conceived as magic bullets, these state-of-the-art molecules contain a small molecue chemotherapeutic agent linked to an antibody designed to bind specifically to cancer cells. The ADC is subsequently internalized, and the antibody is cleaved from the toxic small molecule to which has been bound with a linking structure. Once released into the cell, this small molecule, also called a warhead, kills the cancer cell with the ultimate aim to cure the underlying cancer or to create a remission. Although not all treated patients respond in this manner, excellent clinical outcomes have been described in rigorous clinical trials for the group of ~10 currently FDA-approved ADCs. More are in clinical trials, as well.
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As incredible as ADC’s are, the promise of no to minimal associated side effects or off-target adverse events, unfortunately, has not been realized. Depending on the antibody and warhead, various healthy organ systems can be negatively impacted. One particular frequent, challenging, and important such adverse event is a corneal toxicity associated with approximately half of ADCs on the market. Although the mechanism of uptake into corneal epithelial cells is fairly well understood, there are no effective therapies to mitigate this process, and patients suffer blurred vision and ocular damage and discomfort, sometimes severe. ADC dose holds, dose delays, and even treatment termination can result. These treatment modifications may compromise response rates, add logistical challenges to dosing and oncology management approaches, and require changing therapies , all obviously affecting prescribing patterns and adding to patient anxiety.
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Calm Water Therapeutics has shown that its lead compound (PLL-g-PEG) can physically inhibit ADC uptake into human corneal epithelial cells in vitro, and anticipates similar success clinically. PLL-g-PEG is a safe agent already shown effective in dry eye syndrome. Calm Water Therapeutics anticipates clinical trials for indication to initiate in the near future.
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Dry Eye Disease
Dry Eye Disease (DED), also known as keratoconjunctivitis sicca, is a common ocular disorder characterized by a deficiency in the quantity or quality of tears, leading to inflammation and damage to the surface of the eye. This condition is prevalent globally and affects a significant portion of the population, particularly the elderly and those with specific systemic diseases.
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The primary symptoms of DED include discomfort, visual disturbances, and tear film instability, potentially leading to damage to the ocular surface. These symptoms can significantly impair the quality of life, affecting daily activities like reading, driving, computer use, and watching television. The severity of DED can range from mild irritation to severe inflammation, potentially leading to more serious visual impairments.
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The prevalence of DED increases with age, making it more of a concern in aging populations. Also, occupations involving prolonged screen time, exposure to harsh environmental conditions, intense visual concentration, and irregular working hours can significantly increase the risk of developing
Dry Eye Disease.
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In the United States alone, the market for dry eye syndrome, which encompasses OTC products, was valued at about USD 2.84 billion in 2022 and is projected to increase from USD 3.02 billion in 2023 to USD 4.86 billion by 2030, a CAGR of 7.0%​​. Calm Water Therapeutics has clinically demonstrated that its lead compound (PLL-g-PEG) can significantly prevent and treat DED and is superior to the market leader.