Lindis Biotech gets positive CHMP Opinion for Korjuny in the EU
October 21, 2024The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of Lindis Biotech’s trifunctional Korjuny (catumaxomab), anti-CD3 x anti-EpCAM antibody (trAb) for the intraperitoneal treatment of malignant ascites (MA) in adults with EpCAM-positive carcinomas who are not eligible for further systemic anticancer therapy.
Lindis Biotech GmbH, a biopharmaceutical company with a proprietary multi-specific antibody platform and an advanced development pipeline in immuno-oncology, said the positive opinion from the CHMP will now be reviewed by the European Commission (EC) which renders the final decision on approval. The EC’s decision will be applicable to all member states of the European Union, plus Iceland, Liechtenstein, and Norway, the company said.
Furthermore, if approved, Korjuny would become the only drug approved for the specific and cancer-directed treatment of malignant ascites, an abnormal accumulation of fluid in the peritoneal cavity that commonly arises from advanced-stage cancers, particularly those of ovarian, gastric, colorectal, pancreatic, prostate, lung and endometrial origin.
“Our experience demonstrates the profound impact catumaxomab can have on patients facing this critical condition. We are therefore thrilled that the CHMP has recommended approval of catumaxomab for the indication of malignant ascites and about the opportunity to bring this pioneering therapy back onto the market,” commented Dr. Horst Lindhofer, Chief Executive Officer of Lindis Biotech. “We very much look forward to the formal approval of this treatment and to further develop the potential of this unique immunotherapy in other indications with high unmet medical need, such as bladder cancer.”
The CHMP recommendation for Korjuny from October 18, 2024, is supported by data from a Phase II/III study (IP-REM-AC-01), a large randomized, international, multi-center clinical study which demonstrated a statistically significant improvement of the primary endpoint puncture-free survival, the company noted. Patients receiving Korjuny had a four-fold increase in puncture-free survival over therapy with puncture alone, still the most common intervention and standard therapy in chemotherapy-refractory MA patients, the company said. [Heiss et al., 2010].
Prof. Carsten Bokemeyer, Director of the Department of Medical Oncology and Hematology at the University of Hamburg, UKE stated: “Ascites is a typical complication in patients with intensively pre-treated and advanced gastrointestinal malignancies – particularly gastric cancer. The clinical management of malignant ascites remains a distressing problem in the medical field. Unfortunately, to this day, no generally accepted, evidence-based treatment guidelines or specific management recommendations for MA exist and there has been little progress to ease the burden for patients and improve their quality of life. Thus, the availability of catumaxomab as a specific tumor-directed therapy is a clear benefit for patients in this difficult situation. Catumaxomab reduces the need for punctures, improves quality of life, and even seems to improve life expectancy in a number of cases.”
Prof. Jalid Sehouli, MD, director of the Clinic Campus Virchow and Campus Benjamin Franklin Charité Center Gynecology, Charité – Universitätsmedizin Berlin, said: “I have been significantly involved in the development of catumaxomab as an intraperitoneal treatment for ovarian cancer and its withdrawal from the market, driven solely by commercial factors, was a regrettable decision, especially considering the potential benefits for patients. Based on my extensive experience with the drug, both in clinical work and research, I am convinced that this treatment is a key element in controlling the very dramatic symptoms of this disease while providing the best supportive care possible. The observed safety profile is very favorable, especially compared to currently available treatments. Catumaxomab has the potential to become the backbone of therapeutic protocols for patients with malignant ascites and I look forward to integrating the treatment in my clinical routine.”