Camallergy’s UK Based Manufacturing Facility Receives cGMP Licences for Peanut Allergy Treatment
-Only European cGMP-certified manufacturing facility for peanut allergy oral immunotherapy
-Facility to supply drug product for planned Phase 3 clinical trials and early access programme
CAMBRIDGE, England--(BUSINESS WIRE)--Cambridge Allergy Ltd (“Camallergy” or “the Company”), a biopharmaceutical company dedicated to providing innovative, patient-centric treatments for life-threatening food allergies, today announced that its manufacturing facility outside of Portsmouth, United Kingdom was approved by the MHRA, the Medicines and Healthcare products Regulatory Agency, to manufacture its proprietary peanut allergy treatment under current Good Manufacturing Practices (cGMP) standards.
“This clearance is a pivotal regulatory milestone that further supports Camallergy’s leadership and capabilities in the field of peanut allergy immunotherapy with the only cGMP-certified manufacturing facility in Europe producing peanut oral immunotherapy,” said Sherden Timmins, Chief Technology Officer.
The new manufacturing facility will handle cGMP production of CA002, the Company’s proprietary peanut allergy treatment, for planned pivotal clinical trials. Additionally, the facility will supply an ongoing early access programme. Camallergy’s manufacturing facility is the only European GMP production facility for peanut oral immunotherapy and is scalable for commercial production. It also complies with US and EU pharmaceutical regulations.
“The completion of this state-of-the-art-facility manufacturing facility is a significant achievement for Camallergy and a testament to our team’s dedication and expertise. With this significant milestone achieved, we are in position to pursue our IND (Investigational New Drug) and IMPD (Investigational Medicinal Product Dossier) applications in the US, UK, and EU to initiate our pivotal Phase 3 studies planned to commence this year upon the closing of our Series B round,” commented Baxter Phillips, CEO of Camallergy. “Our recent US market research conducted with prominent key opinion leaders throughout the US shows a strong preference for CA002’s safety and tolerability profile compared to other peanut immunotherapy treatments. We are excited to progress this treatment to market so that the millions of children suffering with peanut allergy will have the choice of a safe and tolerable immunotherapy.”
Camallergy (Cambridge Allergy Ltd) is a biopharmaceutical company dedicated to providing innovative, patient centric treatments to address the millions of patients suffering worldwide from food allergies. Camallergy’s lead product, CA002, is a novel oral immunotherapy for the treatment of peanut allergy designed to offer “bite-proof” protection to patients within 14 weeks of therapy. The Company’s unique intellectual property and treatment regimen are based on the clinical work initiated at Cambridge University Hospitals NHS Foundation Trust in Cambridge, UK. For more information, visit www.camallergy.com.
Barry Saint, Chief Financial Officer