On May 21, 2025 Kaida BioPharma ("Kaida" or the "Company"), an early-stage pharma company dedicated to advancing targeted anti-cancer therapies to address hormone-driven cancers affecting women, reported it has entered into a manufacturing agreement with Northway Biotech, Inc. ("Northway Biotech"), an end-to-end biologics Contract Development and Manufacturing Organization (CDMO), for the manufacturing of lead product candidate, KAD101.
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Under the terms of the agreement, Northway Biotech will leverage its expertise to develop a robust manufacturing process for KAD101. This involves developing and qualifying analytical methods, optimizing the formulation, development and scaling up of the production process, and manufacturing a cGMP drug substance batch for clinical studies.
"We are incredibly pleased to establish this important partnership with Northway Biotech, a pre-eminent CDMO, to manufacture the clinical drug product necessary for our planned Phase 1 clinical study for our lead program, KAD101. We believe that the expertise and skill sets provided to Kaida by entering into this strategic partnership represents a significant step forward for the Company and our clinical development program," commented Craig Pierson, Founder and Chairman of Kaida BioPharma. "We look forward to working closely with the Northway Biotech team to advance our lead product candidate, KAD101, and progress towards providing targeted anti-cancer therapies to address hormone-driven cancers affecting women."
"We are proud to partner with Kaida BioPharma on the development of KAD101," said Prof. Vladas Algirdas Bumelis, CEO and Chairman of Northway Biotech. "Kaida’s scientific leadership and commitment to addressing unmet medical needs make them an ideal partner, and we are committed to supporting the program as it moves toward clinical trials."
Kaida is advancing targeted anti-cancer hormonal therapies to address the root cause of cancers affecting women. The Company’s lead program, KAD101 is a novel biologic that blocks the prolactin receptor to prevent cancer cell growth signals and incite autophagy initially targeting ovarian cancer. The original biologic G129R, demonstrated encouraging results in a human clinical study with all patients showing tumor reduction on the low dose cohort with a clean safety profile as a daily injectable. The Company has transformed G129R into a bi-weekly injectable now known as KAD101 and continues to progress the development towards the launch of a Phase 1 study, expected to commence in Q4 2026/Q1 2027. Additionally, the Company is advancing KAD102, an enhanced pure antagonist of KAD101, for the treatment of uterine cancer.
(Press release, Kaida BioPharma, MAY 21, 2025, View Source [SID1234663812])