Cantargia Advances Nadunolimab In Pancreatic Cancer In PanCAN Precision PromiseSM Phase 2/3 Clinical Trial
STOCKHOLM, January 3, 2022 / PRNewswire / – Cantargia AB today announced that the Pancreatic Cancer Action Network (PanCAN) Precision PromiseSM The Phase 2/3 clinical trial, conducted at leading clinical centers in the United States, plans to include nadunolimab in combination with chemotherapy as an investigational first-line treatment in metastatic pancreatic cancer (PDAC). The trial uses a Bayesian platform designed by PanCAN in collaboration with the United States Food and Drug Administration (FDA) to provide a basis for market approval of therapies in PDAC. The primary endpoint of the trial is overall survival. PanCAN’s plan is to submit a pre-IND application to the FDA in the second quarter of 2022 to include the nadunolimab treatment arm as an experimental arm in Precision Promise.
“With the positive data obtained with nadunolimab in pancreatic cancer, we are proud to have been selected to advance development in collaboration with PanCAN and its strong clinical network. Cantargia’s goal is to provide new treatment options for patients with life-threatening diseases. The study of nadunolimab in Precision Promise fits well with our strategies,“said Göran Forsberg, CEO of Cantargia.
The interleukin-1 receptor accessory protein binding antibody (IL1RAP) nadunolimab is Cantargia’s flagship program and is the subject of five clinical trials evaluating combination regimens in various forms of cancer, with PDAC being the most studied. To date, more than 70 PDAC patients have received treatment with nadunolimab in combination with gemcitabine and nab-paclitaxel in the CANFOUR phase 1 / 2a clinical study. Interim results of 33 PDAC patients, presented at the ESMO congress in September 2021 and updated in december 2021, show that median progression-free survival (iPFS) and overall survival are longer than expected for chemotherapy alone, based on historical control data.
Cantargia has considered several opportunities to advance the clinical development of nadunolimab in PDAC and today announces the decision to participate in PanCAN’s Phase 2/3 adaptive clinical trial, Precision Promise. In addition to advancing the clinical development of PDAC, ongoing activities for nadunolimab in non-small cell lung cancer will continue as planned with the goal of starting a randomized clinical study in late 2022.
PanCAN’s Precision Promise adaptive clinical trials platform is currently being conducted in the United States at 15 leading clinical centers, with additional sites added as the trial progresses. In the trial, patients will be randomized to receive an investigational treatment with nadunolimab plus gemcitabine and nab-paclitaxel, or a standard chemotherapy regimen alone. In addition, consistent with the platform nature of Precision Promise, other experimental arms will be evaluated simultaneously with the nadunolimab arm. The design of the Bayesian trial is to enroll up to 175 patients in each experimental arm while randomizing patients into the standard care control arms. Depending on the results of the arm at that time, the success of a stage 1 of the adaptively randomized trial in 100 patients can be followed seamlessly by a transition to a fixed randomized stage 2 in 75 patients. If a transition to stage 2 of the nadunolimab arm occurs, recruitment will continue without any announcement of the trial results until the final analysis of the comparison of the arm with the control. Trial results for the nadunolimab arm are expected to be available in or before 2027.
Prior to the start of treatment of patients in the nadunolimab arm, additional meetings with regulatory authorities will take place, followed by the regulatory submission of a pre-IND for this investigational arm. The pre-IND is expected to be submitted to the US FDA in the second quarter of 2022. Cantargia will fund the nadunolimab business and be responsible for the supply of the drug.
“The goal of PanCAN’s precision promise is to accelerate drug development and bring new pancreatic cancer therapies to patients faster,“said Anne-Marie Duliege, MD, medical director of PanCAN.”It is important that we continue to partner with innovative pharmaceutical companies to expand the investigational treatments studied in this trial and we look forward to working with Cantargia to incorporate nadunolimab into Precision Promise.“
You can find more information about PanCAN, Precision Promise and participating centers at https://www.pancan.org/research/precision-promise/ and on https://clinicaltrials.gov/ct2/show/NCT04229004.
For more information, please contact
Göran Forsberg, CEO
Telephone: +46 (0) 46-275 62 60
Email: [email protected]
This is information that Cantargia AB is obliged to make public in accordance with the EU Market Abuse Regulation. The information was submitted for publication, through the contact person indicated above, at 8:30 a.m. CET on January 3, 2022.
Cantargia AB (publ), reg. no. 556791-6019, is a biotechnology company that develops antibody-based treatments for life-threatening diseases and has established a platform based on the IL1RAP protein, implicated in a number of forms of cancer and inflammatory diseases. The main project, the nadunolimab antibody (CAN04), is being studied clinically in combination with chemotherapy or immune therapy with a primary focus on non-small cell lung cancer and pancreatic cancer. Intermediate positive data from the combination with chemotherapy indicate greater efficacy than expected from chemotherapy alone. Cantargia’s second project, the CAN10 antibody, focuses on the treatment of severe autoimmune / inflammatory diseases, initially focusing on systemic sclerosis and myocarditis.
Cantargia is listed on Nasdaq Stockholm (ticker: CANTA). More information about Cantargia is available at www.cantargia.com.
About nadunolimab (CAN04)
The CAN04 antibody binds tightly to its IL1RAP target and functions by inducing ADCC and blocking IL-1α and IL-1β signaling. Thus, CAN04 may counteract the contribution of the IL-1 system to the immunosuppressive tumor microenvironment and the development of resistance to chemotherapy. CAN04 is being studied in several ongoing clinical trials. In the CANFOUR phase I / IIa study, first-line combination therapy is being studied with standard chemotherapies in patients with PDAC (gemcitabine / nab-paclitaxel) and patients with NSCLC (cisplatin / gemcitabine) (NCT03267316). Intermediate positive data for combination therapies show durable responses or pseudo-progression in patients with PDAC, resulting in a median iPFS of 7.2 months and a median survival of 12.7 months. Higher efficacy was also seen in patients with NSCLC with a median PFS of 7.2 months. A response rate of 53% was observed in patients with non-squamous NSCLC, with even higher responses in patients previously treated with pembrolizumab. These results show greater efficacy than that expected from chemotherapy alone. CAN04 is being studied with chemotherapy also in the phase I CAPAFOUR study, with the FOLFIRINOX regimen for the first-line treatment of metastatic PDAC (NCT04990037) and in two other clinical studies, CESTAFOUR and TRIFOUR, in other forms of cancer, including cancer of the biliary tract, colorectal cancer and triple negative breast cancer. CAN04 is also being evaluated with the immune checkpoint inhibitor pembrolizumab, with or without chemotherapy, in the phase I study CIRIFOUR (NCT04452214).
About PanCAN and Precision PromiseSM
The Pancreatic Cancer Action Network (PanCAN) is leading the way in accelerating critical progress for pancreatic cancer patients. PanCAN is taking bold action by funding vital research, delivering personalized patient services and creating a community of supporters and volunteers who will stop at nothing to create a world in which all pancreatic cancer patients will thrive . PanCAN’s promise of precisionSM is a Phase 2/3 clinical trial platform and contains an adaptive design for the parallel evaluation of several new treatments for pancreatic cancer. It serves as a catalyst to accelerate the development of pancreatic cancer drugs, reduce the risks of industry participation, increase clinical trial registrations, and transform the way clinical research is done for patients with pancreatic cancer. .
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