EQS-News: LINDIS Biotech receives positive CHMP recommendation for KORJUNY® (catumaxomab) in the European Union (German)
LINDIS Biotech receives positive CHMP recommendation for KORJUNY® (catumaxomab) in the European Union
EQS-News: Lindis Biotech GmbH / Key word(s): Marketing authorization application LINDIS Biotech receives positive CHMP recommendation for KORJUNY® (catumaxomab) in the European Union 10/21/2024 / 09:00 CET/CEST For the content of the announcement the issuer/publisher is responsible. ————————————————– ———————— LINDIS Biotech receives positive CHMP recommendation for KORJUNY® (catumaxomab) in the European Union * After approval by According to the European Commission, KORJUNY® would be the only approved and available drug for the intraperitoneal treatment of malignant ascites in adults with epithelial cell adhesion molecule (EpCAM)-positive carcinomas * Data show that the effectiveness of treatment with the combination of paracentesis and catumaxomab is statistically significantly superior to paracentesis alone, both in terms of puncture-free survival time and the time to the first therapeutic ascites puncture * EU approval is expected by the end of 2024 Munich, Germany, October 21, 2024 – LINDIS Biotech GmbH, a biopharmaceutical Company with a proprietary multi-specific antibody platform and an advanced development pipeline in immuno-oncology, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has made a positive recommendation for the marketing authorization of KORJUNY® ( catumaxomab), a trifunctional anti-CD3 x anti-EpCAM antibody (trAb), for the intraperitoneal treatment of malignant ascites (MA) in patients with EpCAM-positive carcinomas for whom no other systemic anticancer therapy is available. The positive opinion from the CHMP will now be examined by the European Commission (EC) and a final decision on approval will then be made. The EC’s decision applies to all member states of the European Union as well as to Iceland, Liechtenstein and Norway. If approved, KORJUNY® would be the only approved drug for the specific and targeted cancer therapy of malignant ascites, an abnormal accumulation of fluid in the abdominal cavity that often occurs as a result of advanced cancer, particularly cancer of the ovaries ¶cke, the stomach, intestines, pancreas, prostate, lungs and endometrium. “Our experience shows what a profound impact catumaxomab can have for patients with this critical disease. We are therefore very pleased that the CHMP has recommended the approval of catumaxomab for the indication of malignant ascites and about the possibility of using this innovative therapy again to bring it to market,” commented Dr. Horst Lindhofer, Managing Director of Lindis Biotech. “We look forward to the formal approval of this treatment and to further developing the potential of this unique immunotherapy in other indications with high unmet medical needs, such as bladder cancer.” The CHMP recommendation for KORJUNY® dated October 18, 2024 is based on data from a large, randomized, international, multicenter Phase II/III clinical trial (IP-REM-AC-01), which demonstrated a statistically significant improvement in the primary endpoint, puncture-free survival. The study demonstrated that patients treated with KORJUNY® achieved puncture-free survival four times longer than patients who received puncture alone. Paracentesis remains the most common procedure and standard therapy for chemotherapy-refractory patients with malignant ascites [Heiss et al., 2010]. Prof. Carsten Bokemeyer, Director of the Clinic and Polyclinic for Medical Oncology and Hematology at the University of Hamburg, UKE, explained: “Ascites is a common problem in patients with intensively pretreated and advanced gastrointestinal malignancies, especially gastric cancer frequently occurring complication. The clinical treatment of malignant ascites remains a major challenge in medicine. Unfortunately, to date there are no generally accepted, evidence-based guidelines or specific recommendations for the treatment of MA and little progress has been made in reducing the burden Therefore, the availability of catumaxomab, a specific tumor-targeted therapy, would be a clear advantage for patients in this difficult situation. Catumaxomab reduces the need for punctures, improves the quality of life and appears to be in In some cases even extending survival.” “I was instrumental in the development of catumaxomab as an intraperitoneal treatment for ovarian cancer. The withdrawal of the drug from the market for commercial reasons alone was a regrettable decision, particularly given its potential benefit to patients. Based on my extensive experience with the drug “In both clinical work and research, I am convinced that this therapy can be a key element in controlling the very serious symptoms of this disease while providing the best possible supportive treatment,” added Prof. Dr. Jalid Sehouli, director of the clinic for gynecology with center for oncological surgery at the Virchow campus and Benjamin Franklin campus of the Charité – Universitätsmedizin Berlin, added. “The safety profile observed is very favorable, particularly when compared to currently available treatments. Catumaxomab has the potential to become an important therapeutic agent in the treatment protocols for patients with malignant ascites, and I look forward to integrating the treatment into my clinical routine.” In addition to the treatment of malignant ascites, the use of catumaxomab in other indications and via additional routes of administration is currently being investigated in order to further develop its therapeutic potential in EpCAM-positive carcinomas. Recruitment for a Phase I dose escalation and expansion study (CATUNIBLA) in the indication of high- and intermediate-risk non-muscle invasive bladder cancer (HR-NMIBC) has already been completed. Encouraging interim results from the study on the safety and effectiveness of the therapy were recently presented at the ESMO 2024 conference in Barcelona (Link). Based on forecasts, the market potential for catumaxomab in this indication is estimated at EUR 1.35 billion by 2030 [DelveInsight, Non-Muscle Invasive Bladder
Cancer (NMIBC) – Market Insight, Epidemiology and Market Forecast – 2030]. KORJUNY® – the re-approval of the first bispecific trifunctional antibody approved for the treatment of cancer In 2009, catumaxomab was approved in Europe for the indication of malignant ascites (the accumulation of fluid in the free abdominal cavity around the organs that contains cancer cells ) approved. An innovative new treatment, catumaxomab was the first approved trifunctional T-cell engager antibody worldwide for the treatment of malignant ascites. Since then, the antibody has demonstrated its safety and anti-tumor effectiveness in over 2,000 patients. Although catumaxomab was voluntarily withdrawn from the European market in 2017 for purely commercial reasons, its initial approval sparked growing international interest in the development of bispecific T cell engagers for cancer treatment. Further information: About CATUMAXOMAB CATUMAXOMAB is a bispecific trifunctional antibody that binds directly to the tumor cell with one of its binding arms and activates two essential components of the immune system with the other binding sites: T cells and Fc-gamma receptor positive cells (phagocytic cells etc. ). The antibody recognizes and binds all EpCAM-positive tumor cells, including critical cancer stem cells and all CD3-positive T cells. The EpCAM marker is present on most carcinomas and is therefore suitable for targeted cancer treatment. The EpCAM marker is a tumor-specific antigen that is highly expressed on almost all carcinomas (including gastric, intestinal, ovarian, prostate, pancreatic, bladder, lung and endometrial cancer) and also as a marker on tumor-initiating cancer stem cells is known – a main driver of metastasis. About LINDIS Biotech GmbH LINDIS Biotech GmbH, a biopharmaceutical company with a proprietary multispecific antibody platform and advanced development pipeline, was founded in 2010 by Dr. Horst Lindhofer, a pioneer in the field of immuno-oncology and inventor of the Triomab® platform. The Company’s Triomab® platform stands out in the multi-specific antibody market with its unique ability to activate not just two, but three different cell types. This makes LINDIS Biotech the only company that has a technology that combines extremely effective tumor cell destruction with a potentially possible patient-specific vaccination. As the owner of the IP rights to the Triomab® trifunctional antibody platform, LINDIS Biotech decided to redevelop catumaxomab after acquiring all necessary rights. For further information please contact: LINDIS Biotech GmbH Dr. Horst Lindhofer CEO Zeppelinstr. 4 82178 Puchheim / Germany Email: info@lindisbiotech.de Website: www.lindisbiotech.com Media inquiries MC Services AG Anne Hennecke Tel.: +49 (0) 211-529-252-22 Email: lindis-biotech@ mc-services.eu ——————————————- ——————————– October 21, 2024 CET/CEST Publication of a corporate news/financial news, transmitted by EQS News – a service from EQS Group AG. The issuer/publisher is responsible for the content of the message. EQS distribution services include statutory reporting requirements, corporate news/financial news and press releases. Media archive at ———————————————— ————————- Language: German Company: Lindis Biotech GmbH Am Klopferspitz 19 82152 Martinsried Germany Telephone: +4989200066440 E-Mail: info @lindisbiotech.de Internet: EQS News ID: 2011893 End of message EQS News Service ——————————– ——————————————- 2011893 10/21/2024 CET/CEST
