Press Release

LINDIS Biotech Signs Licensing Agreement with Pharmanovia for the Commercialization of Catumaxomab

• Catumaxomab received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) at its October 2024 meeting and if approved catumaxomab will be the only approved drug for the treatment of malignant ascites
• Pharmanovia will lead all activities to launch catumaxomab
• Partnership underscores potential of this unique immunotherapy; development in further indications with high unmet medical need, such as bladder cancer, is ongoing

Munich, Germany, November 19, 2024 - LINDIS Biotech GmbH, a clinical stage biopharmaceutical company with a proprietary multi-specific antibody platform and an advanced development pipeline in immuno-oncology, today announced a licensing agreement with global pharmaceutical company Pharmanovia 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 (MA) in adults with epithelial cellular adhesion molecule (EpCAM)-positive carcinomas, who are not eligible for further systemic anticancer therapy¹. Malignant ascites is an abnormal accumulation of fluid in the peritoneal cavity that commonly arises from advanced-stage cancers.

“We are excited to partner with Pharmanovia to support the commercialization 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.”

Pharmanovia CEO, Dr. James Burt added: “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.”

Malignant ascites is most common in ovarian, pancreatic and gastric cancers with an incidence of 20 to 50 % of all cases. Malignant ascites develops late in the course of the cancer disease and has a strong impact on the patient’s quality of life². Treatments such as paracentesis offer temporary relief but pose challenges, leading to ongoing efforts to find more lasting, effective solutions.

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 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.”

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, catumaxomab would become the only drug approved for the specific and cancer-directed treatment of malignant ascites.

Alira Health acted as the exclusive transaction advisor to LINDIS Biotech, providing strategic guidance throughout the execution process and final negotiation.

More Information:

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 authorization under the brand name Removab® in the EU on 20^th 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^nd 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^{3, 4}.

The EpCAM marker is a tumor associated antigen highly expressed on almost all carcinomas (as e.g. gastric-, colorectal-, ovarian-, prostate-, pancreas-, bladder-, lung- and endometrial cancer) and is also known as a marker on tumor initiating cancer stem cells – a main driver of metastasis. Therefore, it is a promising approach for targeted treatment of various carcinomas.

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.

For more information please contact:

LINDIS Biotech GmbH
Dr. Horst Lindhofer
CEO
Zeppelinstr. 4
82178 Puchheim / Germany
E-Mail: info@lindisbiotech.de
Website: www.lindisbiotech.com

Media inquiries
MC Services AG
Anne Hennecke
Tel.: +49 (0) 211-529-252-22
E-Mail: lindis-biotech@mc-services.eu

References
¹https://www.ema.europa.eu/en/medicines/human/EPAR/korjuny
² Ref: BMJ, https://spcare.bmj.com/content/13/e3/e1292
³https://www.ema.europa.eu/en/documents/overview/removab-epar-summary-public_en.pdf
⁴ Atanackovic et al., Human Vaccines & Immunotherapeutics 9:12, 1–10; 2013; https://pubmed.ncbi.nlm.nih.gov/23955093/