STOCKHOLM, Oct. 20, 2018 /PRNewswire/ -- The antibody
CAN04 was well tolerated and 6 mg/kg is a safe dose
- Effects on biomarkers and 5 of 13 evaluable patients achieved
stable disease
- 10 mg/kg currently investigated before start of phase IIa
during Q4 2018
Cantargia AB (publ) today presented interim results from its
clinical Phase I/II trial CANFOUR of lead candidate CAN04
(nidanilimab) in a poster presentation at the ESMO Congress 2018 in
Munich, Germany. Data from 16
patients with advanced cancer treated with weekly infusions between
1 mg/kg and 6 mg/kg were presented.
The poster presentation – with the title A first-in-class,
first-in-human phase I/IIa trial of CAN04, targeting Interleukin-1
Receptor Accessory Protein (IL1RAP), in patients with solid
tumors – was given by the coordinating investigator Professor
Ahmad Awada, Institut Jules Bordet,
Université Libre de Bruxelles,
Brussels, Belgium. The poster is
available on Cantargia's website, www.cantargia.com.
The presentation included data from the cutoff date,
October 5, 2018, on 16 heavily
pretreated patients with advanced colorectal cancer (9), non-small
cell lung cancer (3) or pancreatic cancer (4) treated with weekly
infusions at escalating dose levels from 1 mg/kg to 6 mg/kg. Prior
to CAN04, the patients had received an average of 4 different
cancer therapies.
The most common side effects of CAN04 were infusion related
reactions and related events, such as nausea, fatigue and fever.
These side effects were generally associated with the first dose
and were reversible. It can be concluded that 6 mg/kg is a safe
dose and the maximum tolerated dose of CAN04 is higher. The trial
is now investigating treatment at 10 mg/kg of CAN04 before moving
into phase IIa.
"I am very pleased with the results obtained so far. CAN04 has
generally been well tolerated using repeated dosing. The good
safety profile and initial effects are encouraging and supportive
for the next step in the trial, which is combination with
chemotherapy", said Prof. Ahmad
Awada, the coordinating investigator of the CANFOUR
trial.
The initial biomarker analysis shows that the serum levels of
IL-6 were reduced in 11 out of 14 patients after two weeks and
serum levels of CRP were reduced in 9 out of 11 patients with
available samples. Levels of IL-6 and CRP are often increased in
cancer patients and are associated with disease progression.
Preliminary efficacy results show that five patients achieved
stable disease, eight progressed and three could not be evaluated.
One patient with NSCLC had stable disease for six months.
"Presenting the first clinical dataset from CAN04 treatment of
patients with advanced cancer at a major cancer conference is an
important milestone for Cantargia. The results have strengthened
our view that CAN04 can become an important future cancer therapy.
We look forward to the last step in the Phase I part and the
initiation of Phase IIa in NSCLC and pancreatic cancer using an
expanded number of clinical sites," said Göran Forsberg, CEO of
Cantargia.
The primary objective of the Phase I part of CANFOUR is to
assess safety and tolerability of weekly CAN04 in order to define
the Maximum Tolerated Dose/Recommended Phase II Dose. Patients with
relapsed or refractory non-small cell lung cancer (NSCLC),
pancreatic ductal adenocarcinoma (PDAC), breast or colorectal
cancer are eligible in the initial part of the trial using a 3+3
dose escalation design.
The Phase I part of the trial is currently in the final stage
and is planned to be finalized during Q4 2018 with phase IIa also
starting Q4 2018. Besides monotherapy, combination with
cisplatin/gemcitabine in NSCLC or gemcitabine/nab-paclitaxel in
pancreatic cancer at an earlier stage of the disease will be
studied in phase IIa. More details on the trial design can be found
at www.clinicaltrials.gov .
This constitutes information that Cantargia AB is required to
publish under the EU's Market Abuse Regulation. The information was
submitted for publication through the above contact person on
October 20, 2018, at 12:30.
About Cantargia
Cantargia AB (publ), reg.no. 556791-6019, is a biotech company that
is developing antibody-based treatments for life-threatening
diseases. The original discovery by the research team behind
Cantargia was the overexpression of a specific target molecule,
interleukin 1 receptor accessory protein (IL1RAP) in leukemic stem
cells. Subsequent research has also identified IL1RAP in many other
forms of cancer. The company's main project, the CAN04
(nidanilimab) antibody targeted against IL1RAP, is being studied in
the CANFOUR clinical phase I/IIa study, where the primary focus is
on non-small cell lung cancer and pancreatic cancer. CAN04
(nidanilimab) has two modes of action: it blocks the function of
IL1RAP and stimulates the immune system to destroy tumour cells.
Cantargia's second project, currently in the research phase, is
aimed at developing an IL1RAP-binding antibody that is optimised
for treatment of autoimmune and inflammatory diseases.
Cantargia is listed on Nasdaq Stockholm (ticker: CANTA). More
information about Cantargia is available at
http://www.cantargia.com.
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For further information, please contact
Göran
Forsberg, CEO
Telephone: +46(0)46-275-62-60
E-mail: goran.forsberg@cantargia.com