Cantargia AB announced that the Pancreatic Cancer Action Network's (PanCAN) Precision PromiseSM phase 2/3 clinical trial, carried out at leading clinical US centers, plans to include nadunolimab in combination with chemotherapy as first-line experimental therapy in metastatic pancreatic cancer (PDAC). The trial utilizes a Bayesian platform designed by PanCAN in collaboration with the US Food and Drug Administration (FDA) to provide a basis for marketing approval of therapies in PDAC. The primary endpoint for the trial is overall survival.

PanCAN's plan is to submit a Pre-IND application to the FDA in Second Quarter 2022 for including the nadunolimab treatment arm as an experimental arm in Precision Promise. The interleukin-1 receptor accessory protein (IL1RAP)-binding antibody nadunolimab is Cantargia's lead program and is investigated in five clinical trials evaluating combination therapy regimens in various forms of cancer, with PDAC being the most extensively studied. To date, more than 70 PDAC patients have received treatment with nadunolimab in combination with gemcitabine and nab-paclitaxel in the phase 1/2a clinical study CANFOUR.

Interim results from 33 PDAC patients, presented at the ESMO Congress in September 2021 and updated in December 2021, show that both median progression-free survival (iPFS) and overall survival are longer than expected for chemotherapy alone, based on historical control data. Cantargia has reviewed several opportunities to advance the clinical development of nadunolimab in PDAC and are announcing the decision to take part in PanCAN's adaptive clinical phase 2/3 trial, Precision Promise. In addition to advancing the clinical development in PDAC, ongoing activities for nadunolimab in non-small cell lung cancer will continue according to plan with the aim to start a randomized clinical study late 2022.

PanCAN's Precision Promise adaptive clinical trial platform is currently being conducted in the US at 15 leading clinical centers, with additional sites added as the trial progresses. In the trial, patients will be randomized to receive experimental therapy of nadunolimab combined with gemcitabine and nab-paclitaxel, or a standard of care chemotherapy regime alone. Also, consistent with the platform nature of Precision Promise, other experimental arms will be evaluated simultaneously with the nadunolimab arm.

The Bayesian trial design involves enrolling up to 175 patients on each experimental arm while randomizing patients to standard of care control arms. Depending on the arm's results at the time, successful completion of a 100-patient adaptively randomized Stage 1 of the trial may be followed seamlessly by a transition to a 75-patient fixed-randomized Stage 2. Should a transition to Stage 2 of the nadunolimab arm occur, enrollment will continue with no announcements of any of the trial results until the final analysis of the arm's comparison with control. Trial results for the nadunolimab arm are expected to be available in 2027 or earlier.