Cantargia advances development of CAN04 through successful production scale up
Cantargia AB (publ) today announced it has reached an important milestone in the development of its antibody project CAN04, currently in clinical phase IIa studies for cancer treatment, with the first GMP batch of CAN04 in the 2,000-litre scale. The upscaling means that Cantargia secures production methodology for later stage clinical trials with CAN04 and towards commercial manufacturing.
The development of the CAN04 antibody is advancing and recently communicated data suggest a synergistic effect with chemotherapy. These interim data were part of an ongoing phase IIa clinical trial. Part of the long-term strategy for CAN04 involved the transfer of GMP production to Patheon Biologics B.V. With the first batch of CAN04 successfully produced in 2,000-litre scale, the foundation for late stage clinical development has been laid.
“This is a major step in the development of CAN04, and the scale we have reached is suitable for late-stage clinical development and commercial phase. It is an important milestone in the preparations for upcoming pivotal studies,” said Göran Forsberg, CEO of Cantargia.
“Technology transfers of biological processes are delicate, and we have worked intensively with Patheon’s engineering and production teams over the last months to implement the process in detail at the new facility. The upscaling is proof of the successful transfer to Patheon,” said Liselotte Larsson, VP Operations at Cantargia.
CAN04 is currently in phase IIa clinical development for non-small cell lung cancer and pancreatic cancer. With the successful upscaling, Cantargia has manufactured sufficient amount of product to perform the planned clinical studies. The information obtained will also form an important part of the documentation of the production process for registration purposes.
The supply agreement with Patheon complements the current agreement with Celonic AG (formerly Glycotope Biotechnology GmbH). Patheon has manufacturing facilities in both Europe and the US and has extensive experience with clinical and commercial manufacturing.
For further information, please contact
Göran Forsberg, CEO
Telephone: +46 (0)46-275 62 60
This is information that Cantargia AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 12.30 CET on 14 February 2020.
Cantargia AB (publ), reg. no. 556791-6019, is a biotechnology company that develops antibody-based treatments for life-threatening diseases. The basis for this is the protein IL1RAP that is involved in a number of diseases and where Cantargia has established a platform. The main project, the antibody CAN04, is being studied in the clinical phase I/IIa CANFOUR study with a primary focus on non-small cell lung cancer and pancreatic cancer. The study is focused on combination therapies, but also includes a monotherapy arm. Positive interim data from the combination therapies were presented in December 2019. Cantargia’s second project, the antibody CAN10, addresses treatment of serious autoimmune/inflammatory diseases, with initial focus on systemic sclerosis and myocarditis.
Cantargia is listed on Nasdaq Stockholm (ticker: CANTA). More information about Cantargia is available at http://www.cantargia.com.
The antibody CAN04 binds IL1RAP with high affinity and functions through both ADCC and blockade of IL-1α and IL-1β signaling. CAN04 is investigated in an open label phase I/IIa clinical trial, CANFOUR, examining first line chemotherapy combination with two different standard regimes in 31 patients with NSCLC (gemcitabine/cisplatin) and 31 patients with PDAC (gemcitabine/nab-paclitaxel) as well as monotherapy in late stage patients (www.clinicaltrials.gov). The phase I monotherapy data from 22 patients were presented at ASCO 2019 and showed a good safety with infusion related reaction being the most common side effect. In addition, the biomarkers IL6 and CRP were decreased with treatment and 9/21 patients had stable disease. Positive interim data from the combination therapies were presented in December 2019. A phase I trial investigating CAN04 in combination with an immune checkpoint inhibitor is planned to start H1 2020.