Removab (catumaxomab) / NeoPharm, SOBI, Trion Pharma, LintonPharm - LARVOL DELTA

Catumaxomab: First Approval. (PubMed, Drugs) - "On 11 February 2025, catumaxomab was approved in the EU for the intraperitoneal treatment of malignant ascites in adults with EpCAM+ carcinomas who are not eligible for further systemic anticancer therapy. This article summarizes the milestones in the development of catumaxomab leading to this new approval."

Journal • Review • Bladder Cancer • Gastric Cancer • Oncology • Ovarian Cancer • Solid Tumor

Contemporary Management of Malignant Ascites. (PubMed, J Surg Res) - "While each of the experimental therapies described offers unique benefits and has demonstrated some promise in managing MA, they all have limitations that have thus far prevented any one of them from being routinely used in practice. MA remains a challenging condition to treat, warranting further research into novel therapies."

Journal • Review • Oncology • Palliative care • Peritoneal Cancer

Celonic, LINDIS Biotech Sign Manufacturing Agreement for Catumaxomab (Contract Pharma) - "Celonic Group, a biologics CDMO, has signed a multi-year commercial manufacturing agreement with LINDIS Biotech for the production of catumaxomab for Commercial Supply....Under the terms of the multi-year commercial manufacturing agreement, Celonic Group will leverage its expertise in GMP manufacturing to produce catumaxomab at its manufacturing facility in Heidelberg, Germany."

Commercial • Oncology

LINDIS BIOTECH AND PHARMANOVIA ANNOUNCE EUROPEAN MARKETING AUTHORISATION APPROVAL FOR CATUMAXOMAB, A FIRST-IN-CLASS TREATMENT FOR MALIGNANT ASCITES (Lindis Biotech Press Release) - "LINDIS Biotech GmbH...and Pharmanovia...announced that catumaxomab has received marketing authorisation from the European Commission (EC), making the drug the only approved drug therapy for malignant ascites (MA) for patients living with this debilitating condition across Europe....Under a licensing agreement, LINDIS has granted Pharmanovia the exclusive rights to bring catumaxomab to market and spearhead its launch across Europe"

EMA approval • Oncology

Exploring the role of bispecific and CAR-T cell therapies in gastric cancer: A systematic review and meta-analysis. (ASCO-GI 2025) - "Bispecific antibodies were MCLA-128 (25/138), catumaxomab (15/138), AK104 PD-1/CTLA-4 (16/138), ABL 001 DLL4VEGFA (19/138), and KN026 (25/138) while CART therapy was CT041 (38/138)... This analysis shows promising results in GC patients using bi-specific antibodies and CAR-T cell therapy. However, further clinical trials are needed to fully explore their potential."

CAR T-Cell Therapy • Retrospective data • Review • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CTLA4 • PD-1

REMOVE: Validation Study on the Removal of EpCAM-positive Tumour Cells From Blood Collected During Tumour Surgery Using Catumaxomab/Catuvab Device (clinicaltrials.gov) - P=N/A | N=136 | Completed | Sponsor: Lindis Bloodcare GmbH

New trial • Colon Cancer • Colorectal Cancer • Endometrial Cancer • Gallbladder Cancer • Gastric Cancer • Hepatology • Kidney Cancer • Liver Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Peritoneal Cancer • Prostate Cancer • Renal Cell Carcinoma • Solid Tumor

Catumaxomab: “The CHMP agreed to the request by the applicant for an extension to the clock stop to respond to the list of outstanding issues adopted in April 2024” (European Medicines Agency) - CHMP Final Minutes of the meeting on 27- 30 May 2024

CHMP • Oncology

Trifunctional anti-EpCAM/CD3 bsAb catumaxomab intravesically for high and intermediate risk non muscle invasive bladder cancer (HMR-NMIBC): Interim analysis of a phase I study (ESMO 2024) - P1 | "Intravesical administration of the trifunctional, anti-EpCAM/anti-CD3 bsAb Catumaxomab is well tolerated in pts with HMR-NMIBC. CAT does not enter the systemic circulation and elicits only low and transient immunogenicity. MTD was not reached and the recommended Ph2 dose was determined at 70 μg."

P1 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Orphan Drug Designations and Approvals (FDA) - Generic Name: Catumaxomab, Date Designated: 06/09/2006, Orphan Designation: Treatment of ovarian cancer, Orphan Designation Status: Designated

Orphan drug • Ovarian Cancer

European Commission grants Orphan Drug Designation for the removab® antibody to treat gastric cancer (Fresenius Kabi Press Release) - "Fresenius Biotech today announced that the European Commission has granted Orphan Drug Designation for the removab® (catumaxomab) trifunctional antibody to treat gastric cancer. The Orphan Drug Designation entitles Fresenius to up to 10 years market exclusivity in the EU upon marketing approval."

Orphan drug • Gastric Cancer

Orphan Drug Designations and Approvals (FDA) - Generic Name: catumaxomab, Date Designated: 07/01/2009, Orphan Designation: Treatment of gastric cancer, Orphan Designation Status: Designated

Orphan drug • Gastric Cancer

LINDIS Biotech Announces Online Publication of Abstract on Trifunctional Antibody CATUMAXOMAB for the Treatment of High-Risk Non-Muscle-Invasive Bladder Cancer at the ASCO 2022 Annual Meeting (Yahoo Finance) - P1/2 | N=167 | CATUNIBLA (NCT04819399) | Sponsor: LintonPharm Co.,Ltd. | "The abstract reports clinical data from the first two of three cohorts included in the dose escalation of the ongoing Catunibla trial....The data showed that all patients in the higher dose group (70 μg) achieved a complete remission as best response following first TUR-B and CATUMAXOMAB treatment alone with no recurrence over length of follow-up (1 year). Remarkably, carcinomas in situ observed at first TUR-B were no longer detectable in three of five patients following CATUMAXOMAB treatment. The strong reduction of urinary EpCAM positive cells during and after CATUMAXOMAB treatment, suggests that the trifunctional bispecific EpCAM targeting antibody binds and efficiently kills EpCAM-positive bladder cancer cells in urine milieu."

P1 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

LintonPharm Announces First Patient Dosed in Phase 1 Clinical Trial of Catumaxomab for Non-Muscle-Invasive Bladder Cancer Unresponsive to Bacillus Calmette-Guerin (Businesswire) - "LintonPharm Co., Ltd...announced that the first patient has been dosed in the Company’s Phase 1/2 clinical trial program for catumaxomab....a monoclonal bispecific antibody being studied for the treatment of Non-Muscle-Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG)."

Trial status • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Mitigation of liver toxicity effects of bispecific T cell engagers in immune-competent liver-tumor co-culturing high-throughput platform (AACR 2024) - "Additionally, we established a solid tumor model using human cancer cell lines (HCT116-GFP) and primary cancer-associated fibroblasts, effectively mimicking the complex tumor microenvironment We treated 3D spheroid models with runimotamab (HER2xCD3 BiTE), catumaxomab (EPCAMxCD3), nivatrotamab (GD2xCD3) and control bispecific antibodies in the presence of peripheral blood mononuclear cells (PBMCs)...To mitigate potential liver toxicity, we co-treated spheroid co-cultures with adalimumab (anti-TNF), tocilizumab (anti-IL-6R), raleukin (IL-1R antagonist) (each 100ug/ml), desatanib, dexamethasone or ruxolitinib (each 100nM)...In summary, we have developed a relevant, high-throughput platform for the evaluation of novel immunotherapies closely reflecting clinical scenarios. High throughput of the assay represents a powerful screening tool for clinical candidate development."

Gastrointestinal Cancer • Liver Cancer • Oncology • Solid Tumor

Narrative review of malignant ascites: epidemiology, pathophysiology, assessment, and treatment. (PubMed, Ann Palliat Med) - "Despite these options, no standard treatment for MA has been established yet because few trials have been conducted in this area. There are many issues to be investigated, and future research and treatment development are expected."

Journal • Review • Cardiovascular • Fibrosis • Gastroenterology • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Hypertension • Immunology • Liver Cancer • Liver Cirrhosis • Oncology • Peritoneal Cancer • Portal Hypertension • Solid Tumor

A pivotal decade for bispecific antibodies? (PubMed, MAbs) - "Nevertheless, only three bsAbs (catumaxomab, blinatumomab, emicizumab) were approved through the end of 2020. However, since then, 11 bsAbs received regulatory agency approvals, of which nine (amivantamab, tebentafusp, mosunetuzumab, cadonilimab, teclistamab, glofitamab, epcoritamab, talquetamab, elranatamab) were approved for the treatment of cancer and two (faricimab, ozoralizumab) in non-oncology indications. Notably, of the 13 currently approved bsAbs, two, emicizumab and faricimab, have achieved blockbuster status, showing the promise of this novel class of therapeutics. In the 2020s, the approval of additional bsAbs can be expected in hematological malignancies, solid tumors and non-oncology indications, establishing bsAbs as essential part of the therapeutic armamentarium."

Journal • Hematological Disorders • Hematological Malignancies • Oncology • Solid Tumor

Identification of potential therapeutic drugs targeting core genes for systemic lupus erythematosus (SLE) and coexisting COVID-19: Insights from bioinformatic analyses. (PubMed, Immun Inflamm Dis) - "Four possible drugs that targeted two specific genes, which may be beneficial for COVID-19 patients with SLE."

Journal • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Novel Coronavirus Disease • Respiratory Diseases • Systemic Lupus Erythematosus • CD3E • CD40LG • CD5 • CD7 • GZMK • IL7R • KLRB1

Using biomarkers to allocate patients in a response-adaptive clinical trial. (PubMed, Commun Stat Simul Comput) - "A completed clinical trial for the effect of catumaxomab on the survival of cancer patients is used as an example to demonstrate the use of the method and the differences to a controlled trial with equal allocation. Different regression procedures are investigated and compared to a randomized controlled trial, using efficacy and ethical measures."

Biomarker • Journal • Oncology • Rare Diseases

Immunotherapy for Peritoneal Carcinomatosis: Challenges and Prospective Outcomes. (PubMed, Cancers (Basel)) - "Catumaxomab is a trifunctional antibody intraperitoneal (IP) immunotherapy authorized in Europe that can be used to diminish malignant ascites by targeting EpCAM...This reaction was strengthened by anti-PD-L1 or anti-Gr1. When paired with CD137 co-stimulatory signaling, CAR-T cells for folate receptor cancers made it easier for T-cell tumors to find their way to and stay alive in the body."

Journal • Review • Immune Modulation • Oncology • Peritoneal Cancer • CEACAM5 • TNFRSF9

Global multi-center phase I trial of the intraperitoneal infusion of anti-EpCAM x anti-CD3 bispecific antibody catumaxomab for advanced gastric carcinoma with peritoneal metastasis. (ASCO 2022) - P3 | "This clinical study indicated that multiple cycles of Catumaxomab i.p. were safe and well tolerated in Asian population. PK profile was similar. Early efficacy signals were promising, especially in pts with ascites, which will be further investigated in phase 3 study."

Clinical • P1 data • Cachexia • Gastric Cancer • Gastrointestinal Cancer • Oncology • Pain • Solid Tumor • EPCAM

Catumaxomab in Patients With Non-Muscle-Invasive Bladder Cancer Who Have Failed or Are Intolerant to BCG Vaccine (clinicaltrials.gov) - P1/2 | N=161 | Recruiting | Sponsor: LintonPharm Co.,Ltd. | Not yet recruiting ➔ Recruiting | Trial primary completion date: Nov 2023 ➔ Nov 2024

Enrollment open • Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Results of phase I dose escalation of the trifunctional anti-EpCAM/CD3 bsAb Catumaxomab in intravesical therapy of high risk non muscle invasive bladder cancer (HR-NMIBC): Excellent tolerability and encouraging preliminary efficacy (EMUC 2022) - P1 | "Tx 50 μg 01-04 pTaG3Tis CAT pTis CR CR CR CR CR BCG 01-05 pTaG2Tis CAT CR CR pTaG2 recurrence CR pTaG2 recurrence decl. 01-06 pTaG3Tis CAT pTaG3Tis Tis pTaG3Tis recurrence CR CR BCG 70 μg 01-07 pTaG3 CAT CR CR CR CR BCG 01-08 pTaG3Tis CAT CR CR CR CR BCG 01-09 pT1G3Tis CAT CR CR CR CR 01-10 pT1G3TaG2 CAT CR CR CR 100 μg 01-12 pT1G3 CAT CR CR 01-13 pTaG3 CAT CR CR 02-01 pT1 CAT CR CR CAT, Catumaxomab; CR, complete remission; BCG, Bacille Calmuette Guerin; decl, declined"

Clinical • P1 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • IL6

LINDIS Biotech Presented Encouraging Data from Non-Muscle-Invasive Bladder Cancer Patients Treated with Trifunctional Antibody CATUMAXOMAB at EMUC22 (Yahoo Finance) - P1 | N=30 | NCT04819399 | Sponsor: Lindis Biotech GmbH | "LINDIS Biotech GmbH...announced that encouraging data from all three dose groups of the dose escalation part of its ongoing Catunibla Phase I trial...with the trifunctional anti-EPCAM/CD3 monoclonal antibody CATUMAXOMAB for treatment of non-muscle-invasive bladder cancer (NMIBC) were presented at the 14th European Multidisciplinary Congress on Urological Cancers (EMUC22) November 10-13, 2022 in Budapest, Hungary....Results showed that all patients included in level 2 and 3 dose groups of 70 μg and 100 μg of the dose escalation part achieved a complete remission (7/7 CR) as best response following first transurethral resection of the bladder tumor (TUR-B) and CATUMAXOMAB treatment. The median durable CR up to date is 9.5 months (range 7.3-19.9 months)."

P1 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Intravesical therapy with the trifunctional anti-EpCAM/CD3 bsAb Catumaxomab is well tolerated and shows encouraging preliminary efficacy in patients with high-risk NMIBC (CATUNIBLA phase I trial). (ASCO 2022) - P1 | "Intravesical instillations with the trifunctional, anti-EpCAM/anti-CD3 bsAb Catumaxomab are well tolerated in pts with high risk NMIBC. CAT does not enter systemic circulation and elicits only low and transient immunogenicity. The MTD is not reached and dose escalation is still ongoing with cohort 3 (100 μg)(updated results will be presented at meeting)."

Clinical • P1 data • Nephrology • Oncology • CXCL8 • IL6

Results of a phase II randomized study evaluating the potential benefit of a postoperative intraperitoneal immunotherapy after resection of peritoneal metastases from gastric carcinoma metastases (IIPOP- NCT01784900). (ASCO 2017) - P2; "...The aim of this multicentre, open-label, phase 2 randomized study was to analyze the potential survival benefit of an immediate postoperative intraperitoneal immunotherapy using a bi-specific (anti-EpCAM, anti-CD3), trifonctional agent named catumaxomab... This study has to be stopped prematurely; however, encouraging results regarding overall survival were observed. Intraperitoneal immunotherapy represents an innovative and promising treatment in patients with peritoneal metastases, considering the poor response to systemic chemotherapy and the “immunocompetence” of the peritoneum. The evaluation of a potential benefit of a local immunotherapy has to be pursued."

Clinical • P2 data • Biosimilar • Gastric Cancer