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2.00 PM CEST / 29-Jun-2021 / Cantargia AB (STO:CANTA)
Cantargia broadens the development of nadunolimab in three forms of cancer and submits application for the phase I/II clinical trial CESTAFOUR
Cantargia AB today announced that the development of nadunolimab (CAN04) has been broadened following the submission of an application of a phase I/II clinical trial to evaluate combination with chemotherapy in three different forms of solid tumors. Thus, the development of CAN04 is expanded to biliary tract cancer (BTC) and colorectal cancer (CRC), and extended to new patient populations in non-small cell lung cancer (NSCLC). The study, called CESTAFOUR, will be conducted at approximately 20 clinical centres in Europe. The first patient is estimated to be enrolled in September 2021.
The antibody CAN04, binding to interleukin-1 receptor accessory protein (IL1RAP), is Cantargia's most advanced program and is investigated in multiple clinical trials. CANFOUR, a phase I/IIa trial, investigates CAN04 first line combination with gemcitabine and nab-paclitaxel in patients with advanced pancreatic cancer (PDAC), as well as with gemcitabine and cisplatin in NSCLC (https://clinicaltrials.gov/ct2/show/NCT03267316). In the phase Ib trial CAPAFOUR, CAN04 is also evaluated for treatment of metastatic PDAC in combination with the first line chemotherapy option FOLFIRINOX. Additionally, CAN04 is investigated in a phase Ib trial, CIRIFOUR, in combination with the checkpoint inhibitor pembrolizumab in four different forms of solid tumors (https://clinicaltrials.gov/ct2/show/NCT04452214).
The clinical trial application for a fourth study, called CESTAFOUR, has now been submitted. This is an open label phase I/II clinical trial, which will evaluate CAN04 in combination with chemotherapy frequently used for treatment of three forms of solid tumors. This includes first line treatment of advanced BTC in combination with gemcitabine and cisplatin, CRC in combination with FOLFOX as third line therapy, and NSCLC in combination with docetaxel as second or third line therapy. The format originates from a basket-like design with selected combinations based on previous preclinical and clinical data for CAN04. A cornerstone in the trial is the previously reported synergy between CAN04 and platinum-based chemotherapy. The basket-like design also creates an opportunity for broadening the program into new diseases, such as BTC and CRC, where platinum-based chemotherapy is routinely used. Furthermore, broadening to a later stage patient group in NSCLC is based on previously communicated positive results in this disease. With an expected median survival of less than a year, the medical need in each of the chosen patient segments is very high.
In the initial dose escalation phase, performed in approximately 15 patients for each indication/combination, the primary objective is to assess the safety and tolerability of CAN04, in combination with each of the three chemotherapy regimens. In the phase II part, the primary objective is to assess the antitumor efficacy. The phase II part will include approximately 40 patients for each of the three indications. The phase I part of the study will be performed in France, Spain and the United Kingdom and the first patient is estimated to be enrolled in September 2021. Trial details will be disclosed on clinicaltrials.gov during Q3 2021.
"Based on the intriguing synergies with chemotherapy, the potential for CAN04 could be very high and exploring new opportunities is of great strategic value. We are really pleased to reach this development milestone.", said Göran Forsberg, CEO of Cantargia.
For further information, please contact
Göran Forsberg, CEO
Telephone: +46 (0)46-275 62 60
E-mail: [email protected]
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 14.00 CET on 29 June 2021.
About Cantargia
Cantargia AB (publ), reg. no. 556791-6019, is a biotechnology company that develops antibody-based treatments for life-threatening diseases. The basis for this is the protein IL1RAP that is involved in a number of diseases and where Cantargia has established a platform. The main project, the antibody CAN04, is being studied clinically as combination therapy with chemotherapy or immune therapy with a primary focus on non-small cell lung cancer and pancreatic cancer. Positive interim data from the combination with chemotherapy indicate stronger efficacy than would be expected from chemotherapy alone. Cantargia's second project, the antibody CAN10, 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 CAN04 binds strongly to the target IL1RAP and functions both though ADCC as well as blocking IL-1α and IL-1β signaling. Thereby, CAN04 can counteract the contribution of the IL-1 system to the immune suppressive tumor microenvironment and development of resistance to chemotherapy. CAN04 is investigated in two clinical trials. In the first phase I/IIa-study, CANFOUR, first line combination therapy is investigated using two different standard chemotherapies in patients with NSCLC (gemcitabine/cisplatin) and patients with PDAC (gemcitabine/nab-paclitaxel), as well as monotherapy in late stage patients (https://clinicaltrials.gov/ct2/show/NCT03267316). Phase I monotherapy data from 22 patients were presented at ASCO 2019 and showed good safety with infusion-related reaction being the most common side effect. In addition, the biomarkers IL6 and CRP decreased during treatment. Positive interim data from the combination therapies show durable responses or pseudoprogression in patients with PDAC, resulting in iPFS of 7.8 months, and also a higher response rate of patients with NSCLC, compared to chemotherapy alone. A phase I study, CIRIFOUR, investigating CAN04 in combination with an immune checkpoint inhibitor, started H2 2020 (https://clinicaltrials.gov/ct2/show/NCT04452214). Additional clinical combination studies are planned to start during 2021.
This information was brought to you by Cision http://news.cision.com
https://news.cision.com/cantargia-ab/r/cantargia-broadens-the-development-of-nadunolimab-in-three-forms-of-cancer-and-submits-application-f,c3376316
Cantargia broadens the development of nadunolimab in three forms of cancer and submits application for the phase I/II clinical trial CESTAFOUR
Cantargia AB today announced that the development of nadunolimab (CAN04) has been broadened following the submission of an application of a phase I/II clinical trial to evaluate combination with chemotherapy in three different forms of solid tumors. Thus, the development of CAN04 is expanded to biliary tract cancer (BTC) and colorectal cancer (CRC), and extended to new patient populations in non-small cell lung cancer (NSCLC). The study, called CESTAFOUR, will be conducted at approximately 20 clinical centres in Europe. The first patient is estimated to be enrolled in September 2021.
The antibody CAN04, binding to interleukin-1 receptor accessory protein (IL1RAP), is Cantargia's most advanced program and is investigated in multiple clinical trials. CANFOUR, a phase I/IIa trial, investigates CAN04 first line combination with gemcitabine and nab-paclitaxel in patients with advanced pancreatic cancer (PDAC), as well as with gemcitabine and cisplatin in NSCLC (https://clinicaltrials.gov/ct2/show/NCT03267316). In the phase Ib trial CAPAFOUR, CAN04 is also evaluated for treatment of metastatic PDAC in combination with the first line chemotherapy option FOLFIRINOX. Additionally, CAN04 is investigated in a phase Ib trial, CIRIFOUR, in combination with the checkpoint inhibitor pembrolizumab in four different forms of solid tumors (https://clinicaltrials.gov/ct2/show/NCT04452214).
The clinical trial application for a fourth study, called CESTAFOUR, has now been submitted. This is an open label phase I/II clinical trial, which will evaluate CAN04 in combination with chemotherapy frequently used for treatment of three forms of solid tumors. This includes first line treatment of advanced BTC in combination with gemcitabine and cisplatin, CRC in combination with FOLFOX as third line therapy, and NSCLC in combination with docetaxel as second or third line therapy. The format originates from a basket-like design with selected combinations based on previous preclinical and clinical data for CAN04. A cornerstone in the trial is the previously reported synergy between CAN04 and platinum-based chemotherapy. The basket-like design also creates an opportunity for broadening the program into new diseases, such as BTC and CRC, where platinum-based chemotherapy is routinely used. Furthermore, broadening to a later stage patient group in NSCLC is based on previously communicated positive results in this disease. With an expected median survival of less than a year, the medical need in each of the chosen patient segments is very high.
In the initial dose escalation phase, performed in approximately 15 patients for each indication/combination, the primary objective is to assess the safety and tolerability of CAN04, in combination with each of the three chemotherapy regimens. In the phase II part, the primary objective is to assess the antitumor efficacy. The phase II part will include approximately 40 patients for each of the three indications. The phase I part of the study will be performed in France, Spain and the United Kingdom and the first patient is estimated to be enrolled in September 2021. Trial details will be disclosed on clinicaltrials.gov during Q3 2021.
"Based on the intriguing synergies with chemotherapy, the potential for CAN04 could be very high and exploring new opportunities is of great strategic value. We are really pleased to reach this development milestone.", said Göran Forsberg, CEO of Cantargia.
For further information, please contact
Göran Forsberg, CEO
Telephone: +46 (0)46-275 62 60
E-mail: [email protected]
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 14.00 CET on 29 June 2021.
About Cantargia
Cantargia AB (publ), reg. no. 556791-6019, is a biotechnology company that develops antibody-based treatments for life-threatening diseases. The basis for this is the protein IL1RAP that is involved in a number of diseases and where Cantargia has established a platform. The main project, the antibody CAN04, is being studied clinically as combination therapy with chemotherapy or immune therapy with a primary focus on non-small cell lung cancer and pancreatic cancer. Positive interim data from the combination with chemotherapy indicate stronger efficacy than would be expected from chemotherapy alone. Cantargia's second project, the antibody CAN10, 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 CAN04 binds strongly to the target IL1RAP and functions both though ADCC as well as blocking IL-1α and IL-1β signaling. Thereby, CAN04 can counteract the contribution of the IL-1 system to the immune suppressive tumor microenvironment and development of resistance to chemotherapy. CAN04 is investigated in two clinical trials. In the first phase I/IIa-study, CANFOUR, first line combination therapy is investigated using two different standard chemotherapies in patients with NSCLC (gemcitabine/cisplatin) and patients with PDAC (gemcitabine/nab-paclitaxel), as well as monotherapy in late stage patients (https://clinicaltrials.gov/ct2/show/NCT03267316). Phase I monotherapy data from 22 patients were presented at ASCO 2019 and showed good safety with infusion-related reaction being the most common side effect. In addition, the biomarkers IL6 and CRP decreased during treatment. Positive interim data from the combination therapies show durable responses or pseudoprogression in patients with PDAC, resulting in iPFS of 7.8 months, and also a higher response rate of patients with NSCLC, compared to chemotherapy alone. A phase I study, CIRIFOUR, investigating CAN04 in combination with an immune checkpoint inhibitor, started H2 2020 (https://clinicaltrials.gov/ct2/show/NCT04452214). Additional clinical combination studies are planned to start during 2021.
This information was brought to you by Cision http://news.cision.com
https://news.cision.com/cantargia-ab/r/cantargia-broadens-the-development-of-nadunolimab-in-three-forms-of-cancer-and-submits-application-f,c3376316
29/6 2021 13:43 Helge Larsen/PI-redaktør 094757 OBS: Cantargia har digital IR aftale med ProInvestor.
1/7 2021 08:57 Helge Larsen/PI-redaktør 094839 Cantargia advances development of nadunolimab in triple negative breast cancer through submission of clinical protocol for TRIFOUR study
CEST / 1-Jul-2021 / Cantargia AB (STO:CANTA)
Cantargia AB today announced the submission of the clinical trial application for TRIFOUR, a phase Ib/II trial investigating nadunolimab (CAN04) combined with gemcitabine and carboplatin for treatment of triple negative breast cancer (TNBC). After an initial safety lead in, the study will include a randomized phase II part. This trial will be performed in Spain in collaboration with the Spanish Breast Cancer Group, GEICAM. Up to 120 patients may be included and the first patient is estimated to be enrolled in November 2021.
The antibody CAN04, binding to interleukin-1 receptor accessory protein (IL1RAP), is Cantargia's most advanced program and is investigated in multiple clinical trials. CANFOUR, a phase I/IIa trial, investigates CAN04 first line combination with gemcitabine and nab-paclitaxel in patients with advanced pancreatic cancer (PDAC), as well as with gemcitabine and cisplatin in non-small cell lung cancer (NSCLC), https://clinicaltrials.gov/ct2/show/NCT03267316. In CAPAFOUR, a phase Ib trial, CAN04 in combination with FOLFIRINOX is evaluated for first line treatment of metastatic PDAC. CESTAFOUR, a phase I/ll trial, will also investigate CAN04 with chemotherapy in three forms of solid tumors; biliary tract cancer, colorectal cancer and NSCLC. Additionally, CAN04 is investigated in the phase Ib trial CIRIFOUR, in combination with the checkpoint inhibitor pembrolizumab, in four solid tumor indications, https://clinicaltrials.gov/ct2/show/NCT04452214.
The clinical trial application for a fifth study, called TRIFOUR, has now been submitted to the regulatory authorities in Spain. This study will be conducted in collaboration with GEICAM and the submission follows the previously communicated letter of intent with GEICAM. TRIFOUR is a phase Ib/II trial designed to evaluate CAN04 in combination with gemcitabine and carboplatin as first or second line treatment in patients with advanced TNBC. TNBC is an aggressive and difficult to treat form of breast cancer that expresses IL1RAP at higher levels than other forms of breast cancer.
The primary objective in the initial stage is to evaluate the safety and tolerability of CAN04 in combination with this chemotherapy regimen. Biomarkers and early signs of efficacy will also be evaluated at this stage. If prespecified milestones are reached in the initial open label part, the trial will be expanded into a randomized phase II part, to investigate the efficacy of CAN04 combination with gemcitabine and carboplatin, compared to a control group receiving gemcitabine and carboplatin alone. The trial is estimated to include up to 120 patients at approximately 24 sites in Spain. The first patient is expected to be enrolled in the study in November 2021. Additional trial details will be disclosed on clinicaltrials.gov during Q3 2021.
"The development of nadunolimab is advancing with this study investigating nadunolimab in triple negative breast cancer. It is a disease of high relevance for our therapeutic approach and this study is the first controlled trial we perform to verify the positive effects observed in other inflammatory-driven cancer forms.", said Göran Forsberg, CEO of Cantargia.
For further information, please contact
Göran Forsberg, CEO
Telephone: +46 (0)46-275 62 60
E-mail: [email protected]
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 09.00 CET on 1 July 2021.
About Cantargia
Cantargia AB (publ), reg. no. 556791-6019, is a biotechnology company that develops antibody-based treatments for life-threatening diseases. The basis for this is the protein IL1RAP that is involved in a number of diseases and where Cantargia has established a platform. The main project, the antibody CAN04, is being studied clinically as combination therapy with chemotherapy or immune therapy with a primary focus on non-small cell lung cancer and pancreatic cancer. Positive interim data from the combination with chemotherapy indicate stronger efficacy than would be expected from chemotherapy alone. Cantargia's second project, the antibody CAN10, 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 CAN04 binds strongly to the target IL1RAP and functions both though ADCC as well as blocking IL-1α and IL-1β signaling. Thereby, CAN04 can counteract the contribution of the IL-1 system to the immune suppressive tumor microenvironment and development of resistance to chemotherapy. CAN04 is investigated in three ongoing clinical trials. In the first phase I/IIa-study, CANFOUR, first line combination therapy is investigated using two different standard chemotherapies in patients with NSCLC (gemcitabine/cisplatin) and patients with PDAC (gemcitabine/nab-paclitaxel), as well as monotherapy in late stage patients (https://clinicaltrials.gov/ct2/show/NCT03267316). Phase I monotherapy data from 22 patients were presented at ASCO 2019 and showed good safety with infusion-related reaction being the most common side effect. In addition, the biomarkers IL-6 and CRP decreased during treatment. Positive interim data from the combination therapies show durable responses or pseudoprogression in patients with PDAC, resulting in iPFS of 7.8 months, and also a higher response rate of patients with NSCLC, compared to chemotherapy alone. A phase I study, CAPAFOUR, was initiated in H1 2021 and will investigate CAN04 in combination with the chemotherapy regimen FOLFIRINOX for first line treatment of metastatic PDAC. A phase I study, CIRIFOUR, is also currently investigating CAN04 in combination with an immune checkpoint inhibitor and was started H2 2020 (https://clinicaltrials.gov/ct2/show/NCT04452214). Additional clinical combination studies are planned to start during 2021.
This information was brought to you by Cision http://news.cision.com
https://news.cision.com/cantargia-ab/r/cantargia-advances-development-of-nadunolimab-in-triple-negative-breast-cancer-through-submission-of,c3377699
CEST / 1-Jul-2021 / Cantargia AB (STO:CANTA)
Cantargia AB today announced the submission of the clinical trial application for TRIFOUR, a phase Ib/II trial investigating nadunolimab (CAN04) combined with gemcitabine and carboplatin for treatment of triple negative breast cancer (TNBC). After an initial safety lead in, the study will include a randomized phase II part. This trial will be performed in Spain in collaboration with the Spanish Breast Cancer Group, GEICAM. Up to 120 patients may be included and the first patient is estimated to be enrolled in November 2021.
The antibody CAN04, binding to interleukin-1 receptor accessory protein (IL1RAP), is Cantargia's most advanced program and is investigated in multiple clinical trials. CANFOUR, a phase I/IIa trial, investigates CAN04 first line combination with gemcitabine and nab-paclitaxel in patients with advanced pancreatic cancer (PDAC), as well as with gemcitabine and cisplatin in non-small cell lung cancer (NSCLC), https://clinicaltrials.gov/ct2/show/NCT03267316. In CAPAFOUR, a phase Ib trial, CAN04 in combination with FOLFIRINOX is evaluated for first line treatment of metastatic PDAC. CESTAFOUR, a phase I/ll trial, will also investigate CAN04 with chemotherapy in three forms of solid tumors; biliary tract cancer, colorectal cancer and NSCLC. Additionally, CAN04 is investigated in the phase Ib trial CIRIFOUR, in combination with the checkpoint inhibitor pembrolizumab, in four solid tumor indications, https://clinicaltrials.gov/ct2/show/NCT04452214.
The clinical trial application for a fifth study, called TRIFOUR, has now been submitted to the regulatory authorities in Spain. This study will be conducted in collaboration with GEICAM and the submission follows the previously communicated letter of intent with GEICAM. TRIFOUR is a phase Ib/II trial designed to evaluate CAN04 in combination with gemcitabine and carboplatin as first or second line treatment in patients with advanced TNBC. TNBC is an aggressive and difficult to treat form of breast cancer that expresses IL1RAP at higher levels than other forms of breast cancer.
The primary objective in the initial stage is to evaluate the safety and tolerability of CAN04 in combination with this chemotherapy regimen. Biomarkers and early signs of efficacy will also be evaluated at this stage. If prespecified milestones are reached in the initial open label part, the trial will be expanded into a randomized phase II part, to investigate the efficacy of CAN04 combination with gemcitabine and carboplatin, compared to a control group receiving gemcitabine and carboplatin alone. The trial is estimated to include up to 120 patients at approximately 24 sites in Spain. The first patient is expected to be enrolled in the study in November 2021. Additional trial details will be disclosed on clinicaltrials.gov during Q3 2021.
"The development of nadunolimab is advancing with this study investigating nadunolimab in triple negative breast cancer. It is a disease of high relevance for our therapeutic approach and this study is the first controlled trial we perform to verify the positive effects observed in other inflammatory-driven cancer forms.", said Göran Forsberg, CEO of Cantargia.
For further information, please contact
Göran Forsberg, CEO
Telephone: +46 (0)46-275 62 60
E-mail: [email protected]
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 09.00 CET on 1 July 2021.
About Cantargia
Cantargia AB (publ), reg. no. 556791-6019, is a biotechnology company that develops antibody-based treatments for life-threatening diseases. The basis for this is the protein IL1RAP that is involved in a number of diseases and where Cantargia has established a platform. The main project, the antibody CAN04, is being studied clinically as combination therapy with chemotherapy or immune therapy with a primary focus on non-small cell lung cancer and pancreatic cancer. Positive interim data from the combination with chemotherapy indicate stronger efficacy than would be expected from chemotherapy alone. Cantargia's second project, the antibody CAN10, 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 CAN04 binds strongly to the target IL1RAP and functions both though ADCC as well as blocking IL-1α and IL-1β signaling. Thereby, CAN04 can counteract the contribution of the IL-1 system to the immune suppressive tumor microenvironment and development of resistance to chemotherapy. CAN04 is investigated in three ongoing clinical trials. In the first phase I/IIa-study, CANFOUR, first line combination therapy is investigated using two different standard chemotherapies in patients with NSCLC (gemcitabine/cisplatin) and patients with PDAC (gemcitabine/nab-paclitaxel), as well as monotherapy in late stage patients (https://clinicaltrials.gov/ct2/show/NCT03267316). Phase I monotherapy data from 22 patients were presented at ASCO 2019 and showed good safety with infusion-related reaction being the most common side effect. In addition, the biomarkers IL-6 and CRP decreased during treatment. Positive interim data from the combination therapies show durable responses or pseudoprogression in patients with PDAC, resulting in iPFS of 7.8 months, and also a higher response rate of patients with NSCLC, compared to chemotherapy alone. A phase I study, CAPAFOUR, was initiated in H1 2021 and will investigate CAN04 in combination with the chemotherapy regimen FOLFIRINOX for first line treatment of metastatic PDAC. A phase I study, CIRIFOUR, is also currently investigating CAN04 in combination with an immune checkpoint inhibitor and was started H2 2020 (https://clinicaltrials.gov/ct2/show/NCT04452214). Additional clinical combination studies are planned to start during 2021.
This information was brought to you by Cision http://news.cision.com
https://news.cision.com/cantargia-ab/r/cantargia-advances-development-of-nadunolimab-in-triple-negative-breast-cancer-through-submission-of,c3377699
