Kaida BioPharma Announces New Partnership with Northway Biotech for the Manufacturing of KAD101

Represents significant milestone in the development of KAD101, a novel biologic prolactin receptor antagonist, being initially developed for the treatment of platinum resistant ovarian cancer (PROC) with expansion opportunities into endometrial, uterine and breast cancers

Supports advancement of KAD101 towards Phase 1 study targeted to initiate in Q4 2026/Q1 2027

/EIN News/ -- FORT LAUDERDALE, FL, May 21, 2025 (GLOBE NEWSWIRE) -- 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, today announced 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.

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.

About Northway Biotech

Northway Biotech is a leading contract development and manufacturing organization (CDMO) supporting customers worldwide. Its highly experienced, professional team executes projects at any stage, from cell line construction and process development to cGMP manufacturing of biopharmaceutical products. The company's wide-ranging expertise and vertically integrated service offering translate to the ability to rapidly execute multiple projects from its state-of-the-art GMP facilities while ensuring complete process and product compliance at all stages of research, development and commercial manufacturing. Northway Biotech is a privately owned company founded in 2004 and located in Vilnius, Lithuania, London, United Kingdom, and Waltham, MA, US. Further information can be found on Northway's website at www.northwaybiotech.com.

About Kaida BioPharma

Kaida BioPharma was founded on the research principles and clinical evidence of the therapeutic benefit of blocking the binding of prolactin (PRL), a multifunctional hormone, to its receptor (PRLR), given their roles as growth factors in tumor growth and proliferation. The Company’s lead product candidate KAD101 is a growth hormone antagonist designed to selective and effectively block the tumoral PRL/PRLR axis which has been shown to induce programmed cell death (autophagy) in gynecologic tumors. The Company is collaborating closely with 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, who have both published extensive research on prolactin and it role as a growth factor in tumor growth and progression and the potential therapeutic benefit of drG129R. Kaida is dedicated to providing a new hope for patients with treatment-resistant gynecological cancers. The Company’s mission is to develop innovative therapies that target the specific needs of those patients, offering a medical treatment that can make a significant difference. For more information, please visit kaida-biopharma.com.

Investor Contact

Jenene Thomas
Chief Executive Officer
JTC Team, LLC
T: 908.824.0775
E: kaida@jtcir.com