STOCKHOLM, Feb. 14, 2020 /PRNewswire/ -- 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
"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
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.
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
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
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.
For further information, please contact
Göran Forsberg, CEO
Telephone: +46 (0)46-275-62-60
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