BigThink Therapeutics Signs Domestic Licensing Agreement with US BlueNote for 'Digital Therapeutics for Mental Disorders in Cancer Patients'

[Asia Economy Reporter Lee Gwanju] KPS's bio-subsidiary BigThink Therapeutics announced on the 10th that it has signed a domestic licensing agreement with the U.S. company Blue Note Therapeutics for digital therapeutics (DTx) for mental disorders in cancer patients, 'attune' and 'DreAMLand.'

Under this agreement, BigThink Therapeutics will hold exclusive rights for localization, clinical development, product approval, and commercialization of attune and DreAMLand in South Korea.

Attune is a digitalized therapy specializing in face-to-face behavioral therapy for cancer patients. In 2020, it was designated by the U.S. Food and Drug Administration (FDA) as a Breakthrough Devices Program (BDD) for treating anxiety and depression in adult cancer patients. The BDD is a system designed to expedite the development and review of medical devices. Blue Note plans to apply for FDA approval of attune based on ongoing confirmatory clinical trials.

Additionally, DreAMLand is the first prescription-only digital therapeutic for patients with acute myeloid leukemia, aiming to treat anxiety and depressive symptoms in hospitalized patients undergoing intensive remission induction therapy. It was designated as a BDD by the FDA in January based on usability assessments and exploratory clinical data.

Han Migyeong, CEO of BigThink, said, “We are encouraged to be able to introduce digital therapeutics that can professionally treat anxiety and depression in cancer patients domestically through this contract with Blue Note. We plan to prepare treatment apps optimized for domestic patients and clinical environments in collaboration with academia and the medical community.” She added, “We will continuously expand our partnership with Blue Note to maximize synergy with BigThink’s anticancer drug business group.”

BigThink plans to complete the localization of attune in the second half of this year and submit the clinical trial protocol to the Ministry of Food and Drug Safety, starting full-scale clinical trials from next year.