IL1RAP

August 27, 2024 I Cantargia (Cantargia AB; Nasdaq Stockholm: CANTA) today reported currently expected timelines for nadunolimab clinical trials. The US FDA has granted MD Andersson Cancer Center the IND for nadunolimab related to the upcoming phase 1b/2a clinical trial of patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) with an estimate for trial initiation during Q4 2024. The first results on safety and short-term efficacy in the ongoing phase 2 clinical trial in triple negative breast cancer (TNBC), in collaboration with GEICAM, is expected during H1 2025. “The granted IND is an important milestone for the development of nadunolimab in leukemia. The remaining steps, including IRB review, are currently in process before the trial can be initiated” said Göran Forsberg, CEO of Cantargia. “ We are also looking forward to completing the Phase 2 study with nadunolimab in triple negative breast cancer and obtaining the results during H1 2025.” The new phase 1b/2a clinical trial is designed to investigate nadunolimab in up to 20 patients with AML and 20 with MDS. The trial is sponsored by a grant from the US Department of Defense, DOD, to The University of Texas MD Anderson Cancer Center which will be responsible for conducting the trial. More details on the trial, including estimated timelines will be disclosed once the trial has received full IRB approval, which is expected during Q3 2024, followed by initiation during Q4 2024. Based on the positive phase 1 clinical data previously presented for nadunolimab combination therapy in TNBC, the randomized, controlled phase 2 clinical trial in approximately 100 patients with TNBC is advancing even though recruitment temporarily slowed down during summer. The first results of the trial, including safety and short-term efficacy, are therefore expected during H1 2025. Cantargia will present new clinical results using nadunolimab at the upcoming ESMO conference in Barcelona Sep 13-17, 2024. Details on the presentation will be disclosed when abstracts become public Sep 9, 2024. About Cantargia 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 protein IL1RAP, involved in a number of cancer forms and inflammatory diseases. Cantargia’s oncology program, the antibody nadunolimab (CAN04), is being studied clinically primarily in combination with chemotherapy with a focus on pancreatic cancer, non-small cell lung cancer and triple-negative breast cancer. Positive interim data for the combinations indicate stronger efficacy than would be expected from chemotherapy alone. Cantargia’s second development program, the antibody CAN10, blocks signaling via IL1RAP in a different manner than nadunolimab and 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 www.cantargia.com . About nadunolimab (CAN04) The antibody nadunolimab binds strongly to its target IL1RAP and functions by inducing ADCC and blocking IL-1alpha and IL-1beta signaling. Nadunolimab can thereby counteract the IL-1 system which contributes to the immune suppressive tumor microenvironment and development of resistance to chemotherapy. Nadunolimab is investigated in multiple clinical trials; the phase I/IIa trial CANFOUR, NCT03267316 , evaluates nadunolimab in combination with standard chemotherapies in patients with PDAC (gemcitabine/nab-paclitaxel) or NSCLC (platinum-based chemotherapies). Positive interim data show durable responses for the combination therapy in 73 PDAC patients, resulting in median iPFS of 7.2 months and median OS of 13.2 months. An even higher median OS of 14.2 months was observed in a subgroup of patients with high tumor levels of IL1RAP. Strong efficacy was also observed in 30 NSCLC patients with median PFS of 7.0 months and a response rate of 53%; even higher responses were observed in non-squamous NSCLC patients. Early efficacy data from the phase Ib/II trial TRIFOUR, NCT05181462 , also shows signs of promising efficacy in TNBC with a 60% response rate for nadunolimab combined with carboplatin/gemcitabine. Nadunolimab is also investigated with chemotherapy in the clinical trials CAPAFOUR, NCT04990037 , and CESTAFOUR, NCT05116891 , and with the checkpoint inhibitor pembrolizumab in the CIRIFOUR trial, NCT04452214 . SOURCE: Cantargia

LUND, SE / ACCESSWIRE / June 14, 2024 / Cantargia (STO:CANTA) Cantargia (Cantargia AB; NasdaqStockholm:CANTA) today reported progress in the ongoing phase 1 clinical trial of the CAN10 antibody. Seven dose groups have now been concluded without any safety concerns. Furthermore, additional receptor occupancy studies confirm that CAN10 saturates its target molecule, IL1RAP, on immune cells from the study participants. The study follows timelines with the next dose group starting immediately, followed by the first group investigating multiple dosing, planned to start during Q3. "The CAN10 program has passed another important milestone, and the new data strengthen our confidence in the program. With its unique mechanism of action addressing the disease promoting activity of the IL-1 family, CAN10 has huge potential to treat a large number of autoimmune/inflammatory diseases. We look forward to the continued evaluation including upcoming studies in patients," said Göran Forsberg, CEO of Cantargia. CAN10 is one of two clinical projects in the Cantargia pipeline. The CAN10 antibody has been designed for treatment of autoimmune/inflammatory diseases and has "pipeline in a pill" potential with several possible target indications. The phase 1 clinical trial investigates increasing levels of CAN10 as single dose administration in healthy subjects followed by studies of multiple dosing in participants with mild to moderate psoriasis. The primary endpoint relates to safety. Details on the trial can be found at . The first seven dose groups in healthy volunteers have now concluded the treatment period. No safety concerns have been observed and the eighth dose group is about to start in accordance with the protocol. In addition, the important receptor occupancy study continues to follow predictions from preclinical studies and complete target saturation has now been documented on both monocytes and neutrophils. Biomarker samples taken during the study are being analyzed to document a dose dependent inhibition of IL-1 and IL-36 stimulated release of biomarkers from immune cells. Additional biomarker results based on the first seven dose groups are expected mid-2024. Dosing in participants with psoriasis are expected to start Q3 2024 ahead of phase 2 in 2025. This information is information that Cantargia is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2024-06-14 11:05 CEST. About Cantargia 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 protein IL1RAP, involved in a number of cancer forms and inflammatory diseases. Cantargia's oncology program, the antibody nadunolimab (CAN04), is being studied clinically primarily in combination with chemotherapy with a focus on pancreatic cancer, non-small cell lung cancer and triple-negative breast cancer. Positive interim data for the combinations indicate stronger efficacy than would be expected from chemotherapy alone. Cantargia's second development program, the antibody CAN10, blocks signaling via IL1RAP in a different manner than nadunolimab and 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 . About CAN10 The CAN10 antibody binds strongly to its target IL1RAP and has a unique capability to simultaneously inhibit signaling via IL-1, IL-33 and IL-36. Inhibition of these signals can be of significant value in the treatment of several inflammatory or autoimmune diseases. The initial focus of CAN10 will be on two severe diseases: myocarditis and systemic sclerosis. In preclinical in vivo models of myocarditis, a CAN10 surrogate antibody significantly reduced the development of inflammation and fibrosis, and significantly counteracted the deterioration of the cardiac function. The CAN10 surrogate also inhibited disease development in models of systemic sclerosis, psoriasis, psoriatic arthritis, atherosclerosis and peritonitis. A clinical phase I study, investigating CAN10 in healthy volunteers and psoriasis patients, is ongoing. Up to 80 subjects may be included in the trial, the first clinical data set shows good safety. Additional data from the trial are expected continuously during 2024. Attachments Cantargia reports further progress in ongoing phase 1 clinical trial with CAN10 SOURCE: Cantargia View the original press release on accesswire.com

LUND, SWEDEN / ACCESSWIRE / June 1, 2024 / Cantargia (STO:CANTA) Cantargia (Cantargia AB; Nasdaq Stockholm: CANTA) today gave a presentation at the ASCO conference showing clinical data on nadunolimab counteracting the serious problem of chemotherapy induced neuropathy, an additional positive finding beyond its promising antitumor effects. The data focus on 73 pancreatic cancer patients receiving nadunolimab and chemotherapy. A key finding is higher dose levels of nadunolimab correlated to lower incidence of neuropathy. This protective effect is further supported by strong preclinical findings on neuropathy induced by two different types of chemotherapy. The new results can be accessed at Cantargia's webpage . "The ASCO presentation, highlighting these unique new data on nadunolimab, is an important opportunity for Cantargia to meet with the key stake holders in oncology and take the next step in the development of nadunolimab," said Göran Forsberg, CEO of Cantargia. The key data were published in a press release May 23. Major findings are: The incidence of neuropathy was notably lower than expected from chemotherapy treatment in the 73 first line pancreatic cancer patients treated with nadunolimab and gemcitabine/nab-paclitaxel. Only one grade 3 event was observed and a statistically significant (p=0.042) relationship between dose level and any grade neuropathy was observed. At 1 mg/kg nadunolimab, 60% of patients had any grade neuropathy with a median time to onset of 112 days. At 2.5 mg/kg or higher, only 36% had any grade neuropathy and median time to onset was not reached. The efficacy also shows signals of activity with median survival of 13.2 months and iPFS of 7.2 months, both longer than expected from historical control data for the chemotherapy alone(1). Studies in mouse models show that several aspects of chemotherapy induced neuropathy, such as sensitivity to mechanical pressure, temperature and decreased grip strength, all were prevented by concomitant treatment with the nadunolimab surrogate antibody. Combination studies were performed with either paclitaxel or vincristine and all results were statistically significant. Neuropathy is a serious medical condition and a side effect of several classes of chemotherapies. The main symptoms are weakness, pain and numbness in hands and feet. Neuropathy often leads to discontinuation of therapy in patients despite effective antitumor activity. The mechanisms behind chemotherapy induced neuropathy relate to damaged nerve cells and neuroinflammation, where the IL-1 pathway has been indicated as a key driver. The preclinical data were generated in collaboration with Hana Starobova and colleagues at University of Queensland, Australia. The results were presented by Prof. Eric van Cutsem, UZ Leuven Gashuisberg, Belgium at the ASCO Annual Meeting May 31st - June 4th, 2024, in Chicago, USA and the poster has been published on Cantargia's website . Reference 1) OS 8.5 mo, PFS 5.3 mo, (Von Hoff et al, N Engl J Med 2013); OS 9.2 mo, PFS 5.6 mo, (Wainberg et al, Lancet 2023) About Cantargia 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 protein IL1RAP, involved in a number of cancer forms and inflammatory diseases. The main program, the antibody nadunolimab (CAN04), is being studied clinically primarily in combination with chemotherapy with a focus on pancreatic cancer, non-small cell lung cancer and triple-negative breast cancer. Positive interim data for the combinations indicate stronger efficacy than would be expected from chemotherapy alone. Cantargia's second development program, the antibody CAN10, blocks signaling via IL1RAP in a different manner than nadunolimab and 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 . About nadunolimab (CAN04) The antibody nadunolimab binds strongly to its target IL1RAP and functions by inducing ADCC and blocking IL-1alpha and IL-1beta signaling. Nadunolimab can thereby counteract the IL-1 system which contributes to the immune suppressive tumor microenvironment and development of resistance to chemotherapy. Nadunolimab is investigated in multiple clinical trials; the phase I/IIa trial CANFOUR, NCT03267316 , evaluates nadunolimab in combination with standard chemotherapies in patients with PDAC (gemcitabine/nab-paclitaxel) or NSCLC (platinum-based chemotherapies). Positive interim data show durable responses for the combination therapy in 73 PDAC patients, resulting in median iPFS of 7.2 months and median OS of 13.2 months. An even higher median OS of 14.2 months was observed in a subgroup of patients with high tumor levels of IL1RAP. Strong efficacy was also observed in 30 NSCLC patients with median PFS of 7.0 months and a response rate of 53%; even higher responses were observed in non-squamous NSCLC patients. Early efficacy data from the phase Ib/II trial TRIFOUR, NCT05181462 , also shows signs of promising efficacy in TNBC with a 60% response rate for nadunolimab combined with carboplatin/gemcitabine. Nadunolimab is also investigated with chemotherapy in the clinical trials CAPAFOUR, NCT04990037 , and CESTAFOUR, NCT05116891 , and with the checkpoint inhibitor pembrolizumab in the CIRIFOUR trial, NCT04452214. Attachments Cantargia ASCO presentation highlights positive clinical data on nadunolimab counteracting neuropathy CANFOUR PDAC Poster ASCO 2024 SOURCE: Cantargia View the original press release on accesswire.com