Latest news with #VladasAlgirdasBumelis
Miami Herald
21-05-2025
- Business
- Miami Herald
Northway Biotech Enters Manufacturing Agreement With Kaida BioPharma for Lead Oncology Program KAD101
Leveraging Northway Biotech's 20+ years of CDMO expertise, Kaida BioPharma is advancing KAD101, a targeted therapy for hormone-driven ovarian cancer WALTHAM, MASSACHUSETTS / ACCESS Newswire / May 21, 2025 / Northway Biotech, Inc. ("Northway Biotech"), an end-to-end biologics Contract Development and Manufacturing Organization (CDMO), and 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 they have entered into a manufacturing agreement for the production of Kaida's 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 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 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 Northway Biotech Contact: Prof. Vladas Algirdas BumelisCEO and Chairman of the BoardNorthway Investor Contact (Kaida BioPharma): Jenene ThomasChief Executive OfficerJTC Team, LLCT: 908.824.0775JTC Team, LLCkaida@ SOURCE: Northway Biotech press release
Miami Herald
05-05-2025
- Business
- Miami Herald
Northway Biotech Launches Full-Service Viral Clearance Studies, Delivering Results Faster Than Industry Standards
With six newly established, identical BSL-2 laboratories now operational, biologics CDMO Northway Biotech can conduct VCS programs for up to six clients simultaneously, significantly alleviating current market bottlenecks VILNIUS, LT / ACCESS Newswire / May 5, 2025 / Northway Biotech, a biopharmaceutical contract development and manufacturing organization (CDMO), today announced the expansion of its protein-based and gene therapy service offerings with the addition of Viral Clearance Studies (VCS) capabilities. This strategic growth follows the opening of Northway Biotech's new Gene Therapy Center with dedicated cGMP facilities for virus-related projects. With six newly established, identical BSL-2 laboratories now operational, Northway Biotech can conduct VCS programs for up to six clients simultaneously, significantly alleviating current market bottlenecks. Additionally, the company has expanded its capabilities to perform GMP-compliant manufacturing and testing under BSL-3 conditions, further strengthening its service offering across gene therapy and broader biologics development. Viral Clearance Studies are now offered both as part of Northway Biotech's integrated CDMO programs and as a standalone service. This flexibility allows external clients to access VCS expertise independently, without requiring a manufacturing agreement. Accelerated Delivery Timelines - Over One Month Faster Than Industry Leveraging expanded infrastructure and integrated analytical capabilities, Northway Biotech is positioned to deliver Viral Clearance Studies substantially faster than the current industry standard. Comprehensive studies, assessing viral removal and inactivation, can now be completed with final regulatory-compliant reporting in under 10 weeks from initiation of project design when two model viruses are employed, and within 12 weeks when four model viruses are used. "Our expansion into Viral Clearance Studies is a natural extension of our CDMO services, enabling us to manage these critical studies in-house and significantly reduce project timelines for our clients," said Prof. Vladas Algirdas Bumelis, CEO of Northway Biotech. "By investing in state-of-the-art BSL-2 and BSL-3 facilities, expanding technical capabilities, and further strengthening our scientific teams, we are uniquely positioned to deliver high-quality VCS data faster - a key advantage for clients advancing through clinical development and regulatory approval." For more information on Northway Biotech's Viral Clearance Study processes, service offerings, and delivery timelines, please complete the contact form to connect with the Northway Biotech team. About Northway Biotech - Northway Biotech is a leading contract development and manufacturing organization (CDMO) supporting customers worldwide. Its highly experienced and professional team executes projects at every stage, from cell line construction and process development to cGMP manufacturing of biopharmaceutical products. The company's extensive expertise and vertically integrated service offering enables rapid execution of multiple projects from its state-of-the-art GMP facilities while ensuring full process and product compliance at all stages of research, development, and commercial manufacturing. Northway Biotech is a privately owned company founded in 2004 and operates locations in Vilnius, Lithuania; London, United Kingdom; and Waltham, MA, USA. Media & Business Contact: bd@ Prof. Vladas Algirdas BumelisCEO and Chairman of the BoardNorthway SOURCE: Northway Biotech press release
Yahoo
04-03-2025
- Business
- Yahoo
Micreos Pharmaceuticals Partners With Biologics CDMO Northway Biotech for Its Engineered Endolysin Therapeutic Manufacturing Program
ZUG, SWITZERLAND AND VILNIUS, LITHUANIA / / March 4, 2025 / Micreos Pharmaceuticals AG ("Micreos"), a preclinical-stage biopharmaceutical company, specializing in developing Engineered Endolysin therapies to target harmful pathogens that cause disease aggravation, has entered into a strategic partnership with Northway Biotech ("NBT"), a Contract Development and Manufacturing Organization (CDMO) to develop scalable cGMP production processes for Micreos' biologic therapeutic MEndoB, which is the first-in-class dual-active domain targeted medicine that will enter the clinic in the coming months as an investigational therapeutic to treat Atopic Dermatitis. Micreos is focused on developing best-in-class targeted therapeutics to precisely target harmful pathogens that cause disease flares to help address significant unmet medical needs in dermatology and oncology. As part of the partnership, Northway Biotech will apply its significant expertise in biologics manufacturing to develop a scalable GMP production process for Micreos' engineered endolysin technology. The collaboration will also include developing and validating robust analytical methods, cell bank manufacturing, technology scale-up for cGMP Drug Substance generation, and IND/IMPD supporting documentation preparation, to ensure that the production of Micreos' engineered endolysins complies with stringent regulatory standards for clinical trials. Matt Regan, CEO of Micreos, stated: "This partnership with Northway Biotech marks a significant milestone for Micreos as we advance our engineered endolysins into scalable therapeutics for clinical trials. By developing targeted medicines that address the underlying pathophysiology associated with disease aggravation in conditions such as atopic dermatitis and cutaneous T-Cell lymphoma, and by leveraging Northway's significant manufacturing expertise, we are poised to make a meaningful impact on patient care in areas of great unmet medical need." Prof. Vladas Algirdas Bumelis, CEO and Chairman of Northway Biotech, highlighted the mutual commitment to high-quality manufacturing: "We are honored to contribute to Micreos' innovative engineered endolysin therapies. With a dedicated and highly experienced team in recombinant protein process development and scale-up, we aim to accelerate Micreos' development by providing cGMP drug substance material available by the end of summer 2024." André Markmann, PhD, VP of Business Development at Northway Biotech, added: "Micreos' engineered endolysins address critical healthcare challenges. We are excited to support Micreos in advancing their breakthrough therapy into clinical trials at a rapid pace while ensuring the highest standards." About MEndoB Micreos' MEndoB is the first-in-class and potentially best-in-class dual-active domain, targeted medicine designed for optimum activity on human skin. It works through targeted enzymatic degradation of the targets cell wall, rapidly killing the harmful pathogen, but without triggering drug resistance or having any off target affects. Micreos' engineering expertise has enhanced drug stability and activity but has also been validated to effectively penetrate biofilms, eliminate dormant & hard to kill pathogenic cells, and potentially deliver synergies with other medications. With demonstrated preclinical efficacy, MEndoB holds significant promise for treating chronic and difficult-to-treat conditions in dermatology and oncology. About Micreos Micreos is a preclinical-stage biopharmaceutical company developing highly innovative, targeted therapies as a new way to treat chronic conditions in dermatology and oncology where there is a high unmet medical need. With its advanced engineering platform, Micreos is developing targeted medicines that selectively eliminate harmful pathogens while preserving the beneficial microbiome, paving the way for future indications in dermatology, oncology, and beyond. For more information, visit About Northway Biotech Northway Biotech is a leading contract development and manufacturing organization (CDMO) supporting customers worldwide. Its highly experienced and professional team executes projects at every stage, from cell line construction and process development to cGMP manufacturing of biopharmaceutical products. The company's extensive expertise and vertically integrated service offering enables rapid execution of multiple projects from its state-of-the-art GMP facilities while ensuring full process and product compliance at all stages of research, development, and commercial manufacturing. Northway Biotech is a privately owned company founded in 2004 and operates locations in Vilnius, Lithuania; London, United Kingdom; and Waltham, MA, USA. For more information, please visit Micreos Contact: Matt ReganCEO and Board member, Micreos Pharmaceutical Northway Biotech Contact: Vladas Algirdas BumelisCEO and Chairman of the Contact Information Vladas Bumelis CEO and Chairman of the SOURCE: Northway Biotech View the original press release on ACCESS Newswire
