Pharmanovia, an international pharmaceutical company specializing in novel and revitalized medicines, has augmented its oncology offerings through a licensing agreement for catumaxomab, aimed at treating malignant ascites.
With this arrangement, Pharmanovia gains exclusive rights to introduce catumaxomab, a pioneering bi-specific monoclonal antibody, for intraperitoneal treatment of malignant ascites in adult patients with EpCAM-positive carcinomas who are unsuitable for further systemic anticancer therapy. Malignant ascites involve unusual fluid build-up in the peritoneal cavity, often resulting from advanced cancers.
Dr. Stephen Deacon, the chief scientific officer, highlighted the innovation in catumaxomab, stating, “Its unique targeted technique as a bispecific trifunctional antibody merges traditional monoclonal antibody properties with bispecific features. It directly targets tumor cells expressing EpCAM, enhancing the patient’s immune system to combat these cells.”
This rare condition typically appears in ovarian, pancreatic, and gastric cancers, affecting 20 to 50% of such cases.
According to Pharmanovia CEO, Dr. James Burt, “Our goal is to deliver transformative medicines to those who need them. This collaboration epitomizes our mission. Not only can this first-in-class medicine significantly impact cancer care, but we’re also reviving a crucial treatment that had been previously shelved. Through this partnership with Lindis Biotech, we’re committed to making catumaxomab available again pending regulatory clearance. Our robust expertise in NCEs will help patients access this vital treatment.”
Dr. Horst Lindhofer, CEO of Lindis Biotech, shared, “Partnering with Pharmanovia will facilitate catumaxomab’s commercialization across Europe. We share a vision of maximizing this therapy’s impact for those affected by this challenging condition. Pharmanovia’s expertise in oncology and comprehensive European platform make them the perfect collaborator. We are eager to work together and advance our pipeline for other unmet medical needs, including bladder cancer.”
Prof. Carsten Bokemeyer, from the University of Hamburg, pointed out, “Managing malignant ascites is a persistent medical challenge, lacking standardized treatment protocols. The introduction of catumaxomab brings a tumor-directed therapy that significantly benefits patients, reducing puncture frequency, enhancing quality of life, and potentially increasing survival rates.”
The European Medicines Agency’s CHMP offered a positive outlook on catumaxomab at its October 2024 session, with EU marketing authorization anticipated by year-end. Approval would establish it as the singular cancer-specific treatment for malignant ascites.
Initially marketed under Removab in 2009, catumaxomab was the first trifunctional antibody and T cell engager approved for MA treatment, demonstrating safety and anticancer effectiveness in over 2000 cases. With marketing halted in 2014 and withdrawn in 2017, its commercial viability wavered until Lindis Biotech received CHMP approval under the brand name Korjuny.
Catumaxomab acts by bridging EpCAM and CD3 antigens, drawing T-cells into proximity with cancer cells to facilitate their destruction. Additionally, it engages and activates immune cells such as monocytes, fostering not just a direct attack but also a potential vaccination-like response.