Kaida BioPharma, an early-stage pharmaceutical company focused on targeted anti-cancer therapies for hormone-driven cancers affecting women, has announced a strategic manufacturing partnership with Northway Biotech, Inc. for the production of its lead product candidate KAD101. The agreement represents a significant milestone in advancing this novel biologic prolactin receptor antagonist toward clinical trials for platinum-resistant ovarian cancer (PROC).
Manufacturing Partnership Details
Under the terms of the agreement, Northway Biotech will leverage its expertise as an end-to-end biologics Contract Development and Manufacturing Organization (CDMO) to develop a robust manufacturing process for KAD101. The collaboration encompasses developing and qualifying analytical methods, optimizing formulation, scaling up production processes, 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," commented Craig Pierson, Founder and Chairman of Kaida BioPharma. "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."
Prof. Vladas Algirdas Bumelis, CEO and Chairman of Northway Biotech, expressed enthusiasm for the collaboration: "We are proud to partner with Kaida BioPharma on the development of KAD101. 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."
KAD101 Development 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 drug candidate evolved from the original biologic G129R, which demonstrated encouraging results in a human clinical study where all patients showed tumor reduction in the low dose cohort with a clean safety profile as a daily injectable. Kaida has transformed G129R into a bi-weekly injectable formulation now designated as KAD101.
The company continues to progress development toward launching a Phase 1 study, expected to commence in Q4 2026 or Q1 2027. Beyond ovarian cancer, KAD101 presents expansion opportunities into endometrial, uterine and breast cancers, broadening its potential therapeutic impact.
Scientific Foundation and Pipeline
Kaida BioPharma was founded on research principles and clinical evidence supporting the therapeutic benefit of blocking prolactin (PRL) binding to its receptor (PRLR), given their roles as growth factors in tumor growth and proliferation. KAD101 is designed as a growth hormone antagonist to selectively and effectively block the tumoral PRL/PRLR axis, which has been shown to induce programmed cell death (autophagy) in gynecologic tumors.
The company collaborates closely with leading researchers including Dr. John Langenheim, professor at Thomas Jefferson University, and Dr. Anil Sood, professor and vice chair for translational research in the departments of gynecologic oncology and cancer biology at MD Anderson Cancer Center. Both have published extensive research on prolactin's role as a growth factor in tumor growth and progression and the potential therapeutic benefit of drG129R.
Additionally, Kaida is advancing KAD102, an enhanced pure antagonist of KAD101, for the treatment of uterine cancer, further expanding its pipeline of hormone-targeted therapies.
Strategic Significance
This manufacturing partnership positions Kaida to advance its clinical development program for addressing treatment-resistant gynecological cancers. The collaboration with Northway Biotech, a CDMO with state-of-the-art GMP facilities and expertise spanning from cell line construction to commercial manufacturing, provides the infrastructure necessary to support KAD101's progression through clinical trials.
The partnership underscores the growing focus on hormone-driven cancer therapies and represents a significant step forward in developing innovative treatments for patients with limited therapeutic options in platinum-resistant ovarian cancer and other gynecologic malignancies.
