Catumaxomab

BASILDON, UK I November 19, 2024 I Pharmanovia, a global pharmaceutical company that commercialises novel medicines and revitalises, extends and expands the lifecycle of established medicines, has today announced the expansion of its oncology portfolio with a new licensing agreement for catumaxomab, for the treatment of malignant ascites. The agreement gives Pharmanovia the exclusive rights to bring to market, catumaxomab, a first-in-class, trifunctional bi-specific monoclonal antibody, indicated for the intraperitoneal treatment of malignant ascites in adults with epithelial cellular adhesion molecule (EpCAM)-positive carcinomas, who are not eligible for further systemic anticancer therapy 1 . Malignant ascites is an abnormal accumulation of fluid in the peritoneal cavity that commonly arises from advanced-stage cancers. Dr Stephen Deacon, Chief Scientific Officer explains: “What is exciting about catumaxomab is that it has a novel targeted approach. This bispecific (anti-EpCAM x anti-CD3) trifunctional antibody combines the characteristics of classical monoclonal antibodies and bispecific molecules 2 . It binds directly to the tumour cells expressing EpCAM and then enhances the activation of the patient’s own immune system resulting in the killing of tumour cells.” Malignant ascites is a rare condition, most common in ovarian, pancreatic and gastric cancers, with an incidence of 20 to 50% of all cases. 3 Pharmanovia CEO, Dr. James Burt commented; “Our mission is to bring innovative and improved medicines to patients who need them, and this deal is the epitome of this. We have a first-in-class medicine, that can play a critical role in cancer supportive care that has previously been approved but is no longer available. We’re looking to change that through this partnership with Lindis Biotech, reintroducing catumaxomab to the market, subject to full regulatory approval. We’re excited to put our strong capabilities in New Chemical Entities (NCEs) to bring this important medicine to patients.” “We are excited to partner with Pharmanovia to support the commercialisation of catumaxomab in Europe. Both companies share a firm belief in the profound impact this therapy can have on the lives of patients facing this devastating condition and uphold a steadfast commitment to making catumaxomab available to as many people as possible,” said Dr. Horst Lindhofer, Chief Executive Officer of Lindis Biotech . “Pharmanovia’s supportive care focus, broad European platform and strong expertise in the oncology space make them the ideal partner for us. We look forward to working together while continuing to further expand our pipeline in other indications with high unmet medical need, such as bladder cancer.” Prof. Carsten Bokemeyer, Director of the Department of Medical Oncology and Hematology at the University of Hamburg, UKE stated: “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 tumour-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.” Catumaxomab received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) at its October 2024 meeting with EU marketing authorization expected end of 2024. If approved, it would become the only drug approved for the specific and cancer-directed treatment of malignant ascites. About Pharmanovia Pharmanovia is a global lifecycle management healthcare company. Our purpose is to make medicines fit for tomorrow, to improve the lives of patients globally. We do this by rediscovering, repurposing or re-engineering established medicines or by bringing to market novel medicines to improve patient outcomes and experiences. With a diverse and growing team in over 160 countries across the globe, we deliver high-quality solutions, ethically and sustainably, across our four core therapeutic areas – Endocrinology, Neurology, Cardiovascular and Oncology both in rare and established diseases or conditions. About Lindis Biotech Lindis Biotech is a clinical stage bio-pharmaceutical company that is committed to the development of Triomab® antibodies – a new class of T-cell engaging bispecific trifunctional antibodies, empowering the immune system to turn malignant cancers into manageable and possibly curable diseases. About CATUMAXOMAB Catumaxomab was originally granted marketing authorisation under the brand name Removab in the EU on 20 April 2009 for treatment of malignant ascites in adults with EpCAM-positive carcinomas where standard therapy is not available or no longer feasible. catumaxomab was the first T cell engager trifunctional antibody and the first drug in the world approved specifically for the treatment of MA and has since proven its safety and anti-tumor efficacy in more than 2000 patients. The product has not been marketed since 2014 and on 2 June 2017 the product was withdrawn from the EU due to commercial reasons. On 17 th October Lindis Biotech GmbH received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) with the brand name KORJUNY®. Catumaxomab effectively destroys cancer cells by attaching to two antigens: EpCAM and CD3 to form a bridge between the cancer cells and the T-cells. This brings the cells close together so that the T-cells can kill the cancer cells. Catumaxomab also attaches to and activates Fc-gamma receptor positive immune cells like e.g. monocytes and macrophages, which also helps the body’s immune system to not only attack and destroy cancer cells, but also potentially induce a vaccination effect 4,5 . References 1 https://www.ema.europa.eu/en/medicines/human/EPAR/korjuny 2 https://pmc.ncbi.nlm.nih.gov/articles/PMC2840231/ 3 Ref: BMJ, https://spcare.bmj.com/content/13/e3/e1292 4 https://www.ema.europa.eu/en/documents/overview/removab-epar-summary-public_en.pdf 5 Atanackovic et al., Human Vaccines & Immunotherapeutics 9:12, 1–10; 2013; https://pubmed.ncbi.nlm.nih.gov/23955093/ SOURCE: Lindis Biotech

The European Medicines Agency’s human medicines committee again decided not to recommend the renewal of the conditional marketing authorization for PTC Therapeutics’ Duchenne muscular dystrophy drug Translarna. The treatment has gone through multiple reviews by the committee. Friday’s decision is the fourth time the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended against the drug. The CHMP first decided against Translarna in September 2023, then confirmed that decision in January 2024, following a re-examination requested by PTC Therapeutics. In June, the committee reviewed the drug after the European Commission asked the committee to consider additional data — but the committee’s decision remained the same. PTC Therapeutics asked the committee again to reconsider in July, which led to this fourth decision. Since its initial authorization in 2014, PTC Therapeutics has carried out two more studies in an attempt to show the drug’s effectiveness. The first study failed to confirm the efficacy of the treatment, though the data suggested that a subgroup of patients — those with a progressive decline in their ability to walk — might see more efficacy. A second study did not reach statistical significance in that subgroup of patients. The drug will remain available while the EMA reviews CHMP’s recommendation. “CHMP again based its decision on the results of the primary analysis subpopulation of Study 041 instead of the totality of evidence for Translarna,” PTC Therapeutics CEO Matthew Klein said in a statement . Leerink Partners wrote Friday that they expect this to be “the final negative opinion,” adding that although PTC Therapeutics resubmitted an NDA to the FDA in late July, there have been no more updates in the US, and they “remain skeptical on the likelihood of US approval.” In addition to the Translarna decision, here’s a look at the medicines that CHMP recommended ahead of a potential thumbs-up from the European Commission: