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Cantargia - Nyt studie med CAN04 i brystcancer


93363 Helge Larsen/PI-redaktør 6/5 2021 19:15
Oversigt

Cantargia advance development of antibody CAN04 by a new clinical trial in triple negative breast cancer

Cantargia AB today announced signing a Letter of Intent with the Spanish Breast Cancer Group (GEICAM) to perform a new clinical trial investigating the antibody nadunolimab (CAN04) in combination with carboplatin/gemcitabine for the treatment of patients with advanced triple negative breast cancer (TNBC). The trial will investigate the safety and efficacy of the combination in this difficult to treat breast cancer. The total number of patients is estimated to be up to 120 and includes a randomized part after initial safety lead in. The protocol is planned to be submitted during Q2 2021.

Cantargia develops antibody-based pharmaceuticals against interleukin-1 receptor accessory protein (IL1RAP). The antibody CAN04 binds IL1RAP with high affinity and functions through both blockade of IL-1 signaling and Antibody-Dependent Cellular Cytotoxicity (ADCC). Preclinical data show that CAN04 can increase the efficacy of chemotherapy. CAN04 is investigated in an open label phase I/IIa clinical trial, CANFOUR, examining combination with two different frequently used chemotherapy regimes in patients with advanced non-small cell lung cancer (NSCLC) or pancreatic cancer (PDAC) (https://clinicaltrials.gov/ct2/show/NCT03267316) in the first line chemotherapy setting. A second trial, CIRIFOUR, investigates CAN04 in combination with pembrolizumab in four different solid tumor indications (https://clinicaltrials.gov/ct2/show/NCT04452214) and a third trial will investigate CAN04 in combination with FOLFIRINOX for first line treatment of PDAC.

TNBC is an aggressive and difficult to treat form of breast cancer. It affects approximately 200.000 persons each year globally corresponding to 10-15% of all breast cancer cases. It is more common in people aged below 50. If metastasized, it is treated with platinum-based chemotherapy combinations with taxanes or gemcitabine with a 5 year survival rate of 12%. TNBC is a disease overexpressing IL1RAP at levels higher than other forms of breast cancer.

Cantargia and GEICAM will join forces in this new trial in TNBC with the aims of testing the safety of the CAN04 combination and its efficacy as first or second line treatment. The initial stage will investigate safety, biomarkers and early efficacy in an open label design. If reaching prespecified milestones, the trial will be expanded into a randomized phase II part investigating CAN04 plus carboplatin/gemcitabine vs. carboplatin/gemcitabine. In total up to approximately 120 patients are planned for the study. The clinical trial protocol is planned to be submitted during Q2 2021 with first patient in during Q4. The trial will be carried out at approximately 40 clinical centers in Spain.

This trial has been expanded and broken out from a parallel trial investigating CAN04 in combination with chemotherapy in different cancer forms. That trial is planned to be performed in patients with colorectal cancer, biliary tract cancer or NSCLC. Submission is planned for Q2 2021.

"The IL-1 pathway is a very attractive target for the TNBC subgroup. The clinical and preclinical results available with CAN04 are very promising and indicate that our patients may benefit from the combination of CAN04 with platinums. This collaboration also reinforces the commitment of GEICAM in the development of novel drugs" says Prof. Miguel Martín, President of GEICAM.

"We are very happy to start this study with GEICAM, a leading group in breast cancer research. With this advancement of our clinical activities, we now have parallel development of CAN04 in three indications", says Göran Forsberg, CEO of Cantargia.

For further information, please contact
Göran Forsberg, CEO
Telephone: +46 (0)46-275 62 60
E-mail: goran.forsberg@cantargia.com



9/5 2021 11:10 EIMiller 393400



Cantargia er som andre nye biotek firmaer vildt risikabel.

Hvis CAN04 viser gode resultater er der flere 100% op. Fejler den må vi forvente at kursen falder til under 10 igen - hvor den var for et par år siden.

Jeg har selv Cantargia og venter indtil resultaterne fra fase 2 kommer senere på året.

Men markedets vurdering af risikoen skiftede i sidste kvartal, da en konkurrent fejlede med deres produkt. Kursen er derfor halveret siden nytår.



10/5 2021 15:20 Helge Larsen/PI-redaktør 193416



10-May-2021 / Cantargia AB (STO:CANTA)
Cantargia presents new preclinical data showing unique improvement of heart function in myocarditis using antibody CAN10

Cantargia AB today presented new results on the antibody CAN10 at the annual meeting of the American Association of Immunologists (AAI), Virtual IMMUNOLOGY 2021. These data demonstrate that the interleukin-1 receptor accessory protein (IL1RAP)-binding antibody CAN10 reduces inflammation and/or fibrosis in several disease models including myocarditis. CAN10, which blocks signaling of IL-1, IL-33 and IL-36, counteracted deterioration of the cardiac function more potently than blockade of IL-1 signaling only.

Cantargia develops antibody-based immunotherapies targeting IL1RAP. Cantargia's most advanced program, CAN04 (nadunolimab), is currently in phase IIa clinical development for treatment of cancer, while CAN10 is in preclinical development for treatment of myocarditis and systemic sclerosis. Clinical studies with CAN10 are planned to be initiated early 2022. CAN10 binds to IL1RAP and has a unique capability to simultaneously inhibit signaling via the IL-1, IL-33 and IL-36 receptors, involved in promoting inflammatory responses.

The poster presented is titled "Blocking IL1, IL33 and IL36 signaling by an anti-IL1RAP antibody is an efficient anti-inflammatory treatment that improves heart function in a model of autoimmune myocarditis". Favorable therapeutic effects were presented using a murine surrogate CAN10 antibody in multiple preclinical models of inflammatory or autoimmune diseases, including myocarditis. In myocarditis, disease development is driven by inflammation and subsequent fibrosis of the myocardium, resulting in deterioration of the cardiac function. CAN10 significantly reduced the development of inflammation and fibrosis in a preclinical model when treatment was given during five weeks after induction of disease. Treatment with CAN10 also significantly counteracted the deterioration of the cardiac function, in contrast to other anti-inflammatory therapies such as an anti-IL-1β antibody, the IL-1 receptor antagonist anakinra, or prednisone. More specifically, electrocardiography shows that CAN10 preserved up to 95% of the cardiac function observed before onset of the disease

CAN10 was also evaluated in other inflammatory disease models, such as peritonitis, psoriasis, and psoriatic arthritis. CAN10 reduced the recruitment of disease-promoting monocytes and neutrophils, and proinflammatory molecules such as IL-6, in the peritonitis model. CAN10 also reduced disease progression of psoriasis and psoriatic arthritis, accompanied by reduced IL-17 levels. Finally, CAN10 showed a more potent activity than IL-1 blockade by an anti-IL-1β antibody or anakinra in these models as well.

Collectively, these results suggest that a potent clinical effect can be achieved in inflammatory disease by simultaneous blockade of IL-1, IL-33 and IL-36 with CAN10. The poster is available on Cantargia's webpage: www.cantargia.com.

"These novel results are strongly supportive of the CAN10 development strategies in myocarditis and we look forward to advance remaining development activities in order to allow patient studies", said Göran Forsberg, CEO of Cantargia.

For further information, please contact
Göran Forsberg, CEO
Telephone: +46 (0)46-275 62 60
E-mail: goran.forsberg@cantargia.com

(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-presents-new-preclinical-data-showing-unique-improvement-of-heart-function-in-myocarditis-,c3343997



10/5 2021 15:34 EIMiller 193417



Markedet er ikke særlig imponeret. Aktien falder i dag.



10/5 2021 16:02 Helge Larsen/PI-redaktør 293418



Det er præklinik - og biotek er i generel modvind for tiden.



14/5 2021 09:55 Helge Larsen/PI-redaktør 193526



Cantargia: Intervju med vd Göran Forsberg (video)

Redeye har talat med Göran Forsberg, Vd på Cantargia, om nya indikationer för CAN04 på cancerområdet och om de lovande prekliniska resultaten för CAN10.

https://www.redeye.se/research/811901/cantargia-intervju-med-vd-goran-forsberg-video-6



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