- 15 patients treated and CAN04 showed a good safety profile
- A few more patients to be included to establish maximum tolerated or recommended dose
- The phase IIa part of the study to start in Q4 2018
STOCKHOLM, Aug. 13, 2018 /PRNewswire/ -- Cantargia AB today announced the status of the ongoing phase I/IIa clinical trial CANFOUR investigating the lead compound CAN04 (nidanilimab) and further information on the phase IIa part of the trial.
So far, 15 patients have received therapy in the phase I safety part of the study, and generally the immuno-oncology antibody CAN04, targeting IL1RAP, has been well tolerated. Notably, a maximum tolerated dose or recommended phase IIa dose has not yet been established. Therefore a few more patients will be included, with results from the phase I part thereby expected in Q4 2018.
The phase IIa part is also expected to start in Q4 2018, investigating efficacy of CAN04 as both monotherapy as well as combination therapy in patients with non-small cell lung cancer (NSCLC) or pancreatic cancer.
The first patient in the study started therapy in September 2017. The phase I part was originally estimated to include 15-20 patients with NSCLC, pancreatic cancer, colorectal cancer or triple negative breast cancer over a period of 12 months. The primary objective of the trial is to investigate safety and thereby establish a recommended phase II dose. At this stage, a maximum tolerated dose has not been reached, and the recommended phase II dose is not yet established. Therefore, a few more patients will be included, and results are planned to be communicated during Q4 2018. CAN04 has generally been well tolerated, the most common side effect is an infusion related reaction during the first infusion and resolving within a few hours, a side effect often observed with antibody therapy.
The phase IIa part is planned to be initiated in Q4 2018. This part will focus on patients with NSCLC or pancreatic cancer. Besides monotherapy in these indications, combination therapies are planned to be investigated. In NSCLC, a combination will be performed with the standard therapy cisplatin/gemcitabine in patients not previously treated with chemotherapy, and with the standard therapy gemcitabine/nab-paclitaxel in patients with pancreatic cancer. It is estimated that the recruitment in the phase IIa part will take 12 months, with results available early 2020. The phase I part includes five clinical centres in four countries and the phase IIa part is planned to include approximately 20 centres in six to seven countries.
"We are very pleased with the outcome of the CANFOUR trial so far. Patient recruitment has essentially followed communicated timelines, the safety profile of CAN04 is good, and preclinical results support combination therapies. There is a need to study more patients than initially planned, leading to a more extensive phase I part. The data generated will strengthen the phase IIa part", said Göran Forsberg, CEO of Cantargia.
For further information, please contact
Göran Forsberg, CEO
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 8:30 CET on 13 August 2018.
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 tumor cells. Cantargia's second project, currently in the research phase, is aimed at developing an IL1RAP-binding antibody that is optimized for treatment of autoimmune and inflammatory diseases.
Cantargia is listed on Nasdaq Stockholm First North Premier (ticker: CANTA). Sedermera Fondkommission is the company's Certified Adviser. More information about Cantargia is available at http://www.cantargia.com.
The CANFOUR trial includes an initial phase I part to assess safety and tolerability of weekly CAN04 in patients with relapsed or refractory non-small cell lung cancer, pancreatic, breast or colorectal cancer in order to define the Maximum Tolerated Dose/Recommended Phase 2 Dose using a 3+3 dose escalation design. In the second part (phase IIa), CAN04 will be administered to a larger number of patients, with the aim to evaluate clinical activity and to further document safety.
Additional information can be found at: ClinicalTrials.gov (NCT03267316)
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