Participants Dosed on Adessia® in Germany in a Phase 1 Trial, a First for an Adalimumab Biosimilar Candidate Developed in Africa
- Category: Antibodies
- Published on Monday, 06 March 2023 15:00
- Hits: 2514
BERLIN, Germany I March 06, 2023 I MiGenTra, a Berlin-based healthcare transforming company, reported today that the first participants in a Phase 1 clinical trial for Minapharm Pharmaceuticals adalimumab biosimilar candidate (brand name: Adessia®) were dosed on February 24, 2023 in Germany.
This follows a prior announcement made by Minapharm Pharmaceuticals on February 13, 2023 reporting that said Phase 1 trial received unconditional approval from the Paul-Ehrlich Institut (PEI).
"Our ambition for Africa and the transformation of healthcare is clear: healthcare is a human right and testing the first ever in Africa (Egypt) developed monoclonal antibody biosimilar candidate in Healthy Volunteers in an EMA-regulated country speaks to the quality of analytical data obtained so far and accepted by PEI. Our approach remains holistic and patient centric and directed towards addressing unmet medical needs in Egypt, the Middle East and all of Africa", said Dr. Lutz Hilbrich, Chief Executive Officer at ProBioGen and MiGenTra and Chief Medical Officer at MiGenTra.
"This milestone is pivotal in the short history of MiGenTra. It validates our scientific approach of leveraging the best of two worlds available at ProBioGen and Minapharm Pharmaceuticals, our founding companies, towards the efficient development of high-quality biosimilar products", said Dr. Thomas Dümmler, Director Clinical Operations Strategy at MiGenTra.
MiGenTra and Minapharm Pharmaceuticals will be sharing responsibilities to file, launch and commercialize Adessia in Africa and the Middle East.
About Adessia Phase 1 Trial
The Phase 1 clinical trial of Minapharm Pharmaceutical's adalimumab biosimilar candidate is a multi-center, randomized, double-blind, 2-arm, parallel group trial in 154 healthy male and female participants, comparing the pharmacokinetics, safety, immunogenicity and tolerability of the Adalimumab biosimilar, Adessia, and its reference product Humira®.
Results from the study are expected by the end of 2023.
MiGenTra was founded in 2021. MiGenTra combines the scientific and manufacturing expertise from both contributing companies, ProBioGen and Minapharm Pharmaceuticals. It is established for product development and commercialization in the field of Biosimilars, Cell- and Gene Therapies (CGT) and Vaccines, capitalizing on the strong development and manufacturing capabilities of ProBioGen and Minapharm as well as on the excellent market position of Minapharm in the region.
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ProBioGen is a Berlin-based specialist for developing and manufacturing complex therapeutic glycoproteins. Combining both state-of-the-art development services, based on ProBioGen's CHO.RiGHT® expression and manufacturing platform, together with intelligent product-specific technologies yields biologics with optimized properties.
Rapid and integrated cell line and process development, comprehensive analytical development and following reliable GMP manufacturing is performed by a highly skilled and experienced team. All services and technologies are embedded in a total quality management system to assure compliance with international ISO and GMP standards (EMA/FDA). ProBioGen has been operational for more than 25 years. At three locations in Berlin, nearly 300 employees contribute to the creation of new therapies in medicine and groundbreaking innovations worldwide through their creative and meticulous work. Diversification is a complement driver, while the focus is strict on enabling the development of biopharmaceuticals for tomorrow.
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About Minapharm Pharmaceuticals
Minapharm Pharmaceuticals is a leading pharmaceutical company in Egypt and the Middle East and the premier biopharmaceutical company in Africa with over 20 years of experience in cellular and bioprocess engineering. Headquartered in Cairo, Minapharm Pharmaceuticals commercializes over 100 life-saving and life-enhancing products ranging from small molecules to complex genetically-engineered proteins, with an impressive immunotherapy pipeline. Together with its wholly owned Berlin-based subsidiary, ProBioGen, Minapharm Pharmaceuticals has established an integrated business model making it to-date the only gene-to-market biopharmaceutical company in the region. Minapharm Pharmaceuticals employs a collective workforce of over 1400 and is listed on the Cairo and Alexandria stock exchange (Symbol: MIPH).