In December, Roche and Chugai Pharmaceutical announced positive new data from the phase 3 COMMODORE 3 study in China, demonstrating that crovalimab, a novel anti-C5 recycling monoclonal antibody is efficacious and well tolerated in people with paroxysmal nocturnal haemoglobinuria (PNH). PNH is an ultra-rare and life-threatening blood condition, in which red blood cells are targeted and destroyed by the complement system.
Chugai Pharmabody Research based in Singapore played a leading role Crovalimab’s development using their antibody engineering technology called recycling antibody technology. Recycling antibodies are designed to allow antibodies to bind with the target antigen multiple times and to act longer in the body. This treatment hopes to address the urgent need for effective care, especially in China where the availability of C5 inhibitors is severely limited.
The results were submitted to the American Society of Haemotology and via China’s Breakthrough Therapy Designation pathway. The submission has been accepted under priority review for approval by China and if the results of this process are positive then crovalimab will potentially become the first global drug originating from Singapore. When speaking to BioSpectrum Asia, Dr Hisafumi Yamada, Executive Vice President (R&D) at Chugai Pharmaceutical, emphasised that this is a good example of the value of Singapore in biomedical research.
1. “Crovalimab could potentially become the first global drug originating from Singapore” (biospectrumasia.com)
2. Roche’s subcutaneous crovalimab given every four weeks achieves disease control in people with PNH, a life-threatening blood condition (yahoo.com)
3. A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibition – Full Text View – ClinicalTrials.gov