Scientific Publications

Lindis Biotech

Company News

Below you will find current information, press releases and updates from our company.

November 14, 2022

LINDIS Biotech Presented Encouraging Data from High Risk-Non-Muscle-Invasive Bladder Cancer Patients Treated with Trifunctional Antibody CATUMAXOMAB at EMUC22

  • Results from Phase I dose escalation trial of anti-EPCAM/CD3 presented at the EMUC 2022 congress demonstrated encouraging preliminary efficacy and excellent safety and tolerability profile, treatments at the recommended dose of 70 μg have been initiated
  • Data showed that 100% of patients that completed treatment in the 70 μg and 100 μg dose groups achieved a complete remission as best response with no recurrence throughout the period of follow-up
  • High risk and very high risk NMIBC is a type of bladder cancer, that is particularly challenging to tackle as patients experience a high risk of recurrence and progression; current standard of care BCG comes with significant side effects, high dropout rates, while rates of recurrence and progression remain substantial

Here you can download the complete press release: LINDIS Biotech Presented Encouraging Data from High Risk-Non-Muscle-Invasive Bladder Cancer Patients

June 01, 2022

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

LINDIS Biotech GmbH, a biopharmaceutical company with a proprietary multi-specific antibody platform and an advanced development pipeline with three clinical product candidates in immuno-oncology, announces the online publication of an abstract presenting interim data from the Company’s Catunibla Phase I dose escalation trial with CATUMAXOMAB at the American Society of Clinical Oncology (ASCO) Annual Meeting.

The abstract is available at:

Here you can download the complete press release: Lindis Biotech Announces Online Publication of Abstract on Trifunctional Antibody CATUMAXOMAB

December 21, 2021

LINDIS Biotech Announces Formation of Advisory Board to Support Next Phase of Growth

LINDIS Biotech GmbH, a biopharmaceutical company with a proprietary multi-specific antibody platform and an advanced development pipeline with three clinical product candidates in immuno-oncology, today announced the formation of its Advisory Board comprising three industry experts in the fields of business development, clinical development, and regulatory affairs. The new committee will be a valuable resource to shape and guide the strategy of LINDIS Biotech as the company continues to advance its pre-clinical and clinical candidates.

Here you can download the complete press release: LINDIS Biotech Announces Formation of Advisory Board to Support Next Phase of Growth

June 01, 2021

LINDIS Biotech Announces Publication of Patient Data Highlighting the Potential of Trifunctional Antibody CATUMAXOMAB for Treatment of Non-Muscle-Invasive Bladder Cancer in Peer-Reviewed Journal

  • Follow up data from two patients published in Cancer Immunology, Immunotherapy (CII)
  • Following exclusive treatment with CATUMAXOMAB (no TUR-B), tumors were undetectable and no tumor cells were observed in the patient’s urine samples
  • Phase 1 study to evaluate safety and initial signals of efficacy in up to 30 patients initiated
  • CATUMAXOMAB would be the first specific immunotherapy for non-muscle-invasive bladder cancer, an indication with an extremely high unmet medical need due to high recurrence rates and considerable side effects and costs of standard therapy

Here you can download the complete press release: Lindis Biotech, Potential of Trifunctional Antibody CATUMAXOMAB (PDF, 0,2MB)

April 13, 2021

LINDIS Biotech Reports Successful Initiation of Clinical Phase I Dose Escalation Study with the Trifunctional Antibody CATUMAXOMAB for Treatment of Non-Muscle-Invasive Bladder Cancer

  • First dose cohort successfully treated
  • Study to evaluate safety and initial signals of efficacy in up to 30 patients; results of an interim analysis anticipated in fall 2021
  • CATUMAXOMAB would be the first specific immunotherapy for non-muscle-invasive bladder cancer, an indication with an extremely high unmet medical need

Here you can download the complete press release: Lindis Biotech, Catubibla Study (PDF, 0,18MB)

Scientific Publications & News

In the context of our collaborations, we have significantly contributed to numerous articles published in peer-reviewed journals. Please find below a list of selected publications:

Catumaxomab / EpCAM

Removal of EpCAM-positive tumor cells from blood collected during major oncological surgery using the Catuvab device- a pilot study. Andreas Winter , Kai Zacharowski , Patrick Meybohm , Andreas Schnitzbauer , Peter Ruf 5, Claudia Kellermann , Horst Lindhofer BMC Anesthesiol. 2021 Oct 29;21(1):261. doi: 10.1186/s12871-021-01479-3. | SEE ABSTRACT

First time intravesically administered trifunctional antibody catumaxomab in patients with recurrent non-muscle invasive bladder cancer indicates high tolerability and local immunological activity. Ruf P, Bauer HW, Schoberth A, Kellermann C, Lindhofer H. Cancer Immunol Immunother 2021 April 10. doi: 10.1007/s00262-021-02930-7. Online ahead of print. Online Link (

Randomised phase II trial to investigate catumaxomab (anti-EpCAM × anti-CD3) for treatment of peritoneal carcinomatosis in patients with gastric cancer. Knödler M, Körfer J, Kunzmann V, Trojan J, Daum S, Schenk M, Kullmann F, Schroll S, Behringer D, Stahl M, Al-Batran SE, Hacker U, Ibach S, Lindhofer H, Lordick F. Br J Cancer. 2018 Aug;119(3):296-302. doi: 10.1038/s41416-018-0150-6. Epub 2018 Jul 10 | SEE ABSTRACT

The role of relative lymphocyte count as a biomarker for the effect of catumaxomab on survival in malignant ascites patients: results from a phase II/III study. Heiss MM, Ströhlein MA, Bokemeyer C, Arnold D, Parsons SL, Seimetz D, Lindhofer H, Schulze E, Hennig M. Clin. Cancer Res. 2014 June | SEE ABSTRACT

First patient treated with a re-challenge of catumaxomab in recurrent malignant ascites: a case report. Klaus Pietzner, Michael Jäger, Alexandra Schoberth, Gülten Oskay-Özcelik, Marc Kuhberg, Horst Lindhofer, Jalid Sehouli. Med. Oncol. 2012 June | SEE ABSTRACT

Humoral response to catumaxomab correlates with clinical outcome: Results of the pivotal phase II/III study in patients with malignant ascites. Marion G Ott, Frederik Marmé, Gerhard Moldenhauer, Horst Lindhofer, Michael Hennig, Rolf Spannagl, Mirko M Essing, Rolf Linke, and Diane Seimetz. Int. J. Cancer. 2012 May | SEE ABSTRACT

Immunomonitoring Results of a Phase II/III Study in malignant ascites patients with the Trifunctional Antibody Catumaxomab (anti-EpCAM x anti-CD3). JägerM, SchoberthA, RufP, HessJ, HennigM, SchmalfeldtB, WimbergP, StröhleinMA, TheissenB, HeissMM, LindhoferH, Cancer Res. 2011 Nov. 1 | SEE ABSTRACT

Pharmacokinetics, immunogenicity and bioactivity of the therapeutic antibody catumaxomab intraperitoneally administered to cancer patients. Ruf P, Kluge M, Jäger M, Burges A, Volovat C, Heiss MM, Hess J, Wimberger P, Brandt B, Lindhofer H.
Br J Clin Pharmacol. 2010 Jun | SEE ABSTRACT

Efficacy of catumaxomab in tumor spheroid killing is mediated by its trifunctional mode of action. Hirschhaeuser F, Walenta S, Mueller-Klieser W. Cancer Immunol Immunother. 2010 Jul 21. | SEE ABSTRACT

Palliative treatment of malignant ascites: profile of catumaxomab. Ammouri L, Prommer EE. 2010 May 25;4:103-10. | SEE ABSTRACT

The trifunctional antibody catumaxomab for the treatment of malignant ascites due to epithelial cancer: Results of a prospective randomized phase II/III trial. Heiss MM, Murawa P, Koralewski P, Kutarska E, Kolesnik OO, Ivanchenko VV, Dudnichenko AS, Aleknaviciene B, Razbadauskas A, Gore M, Ganea-Motan E, Ciuleanu T, Wimberger P, Schmittel A, Schmalfeldt B, Burges A, Bokemeyer C, Lindhofer H, Lahr A, Parsons SL. Int J Cancer. 2010 Apr 27. | SEE ABSTRACT

Structural and functional characterization of the trifunctional antibody catumaxomab. Chelius D, Ruf P, Gruber P, Plöscher M, Liedtke R, Gansberger E, Hess J, Wasiliu M, Lindhofer H. MAbs. 2010 May 16;2(3). | SEE ABSTRACT

Development and approval of the trifunctional antibody catumaxomab (anti-EpCAMxanti-CD3) as a targeted cancer immunotherapy. Seimetz D, Lindhofer H, Bokemeyer C. Cancer Treat Rev. 2010 Mar 26. | SEE ABSTRACT

Catumaxomab: Clinical development and future directions. Linke R, Klein A, Seimetz D. MAbs. 2010 Mar 16;2(2). | SEE ABSTRACT

Test system for trifunctional antibodies in 3D MCTS culture. Hirschhaeuser F, Leidig T, Rodday B, Lindemann C, Mueller-Klieser W. J Biomol Screen. 2009 Sep;14(8):980-90. Epub 2009 Aug 12. | SEE ABSTRACT

Current and future options in the treatment of malignant ascites in ovarian cancer.
Woopen H, Sehouli J. Anticancer Res. 2009 Aug;29(8):3353-9. | SEE ABSTRACT

Intraperitoneal immunotherapy to prevent peritoneal carcinomatosis in patients with advanced gastrointestinal malignancies. Ströhlein MA, Heiss MM. J Surg Oncol. 2009 Sep 15;100(4):329-30. | SEE ABSTRACT

Catumaxomab: A bispecific trifunctional antibody. Sebastian M, Kuemmel A, Schmidt M, Schmittel A. Drugs Today (Barc). 2009 Aug;45(8):589-97. | SEE ABSTRACT

Bispecific antibodies for cancer therapy. Chames P, Baty D. Curr Opin Drug Discov Devel. 2009 Mar;12(2):276-83. | SEE ABSTRACT

Treatment of malignant pleural effusion with the trifunctional antibody catumaxomab (Removab) (anti-EpCAM x Anti-CD3): results of a phase 1/2 study. Sebastian M et al. J Immunother. 2009 Feb-Mar;32(2):195-202. | SEE ABSTRACT

Induction of anti-tumor immunity by trifunctional antibodies in patients with peritoneal carcinomatosis. Ströhlein MA, Siegel R, Jäger M, Lindhofer H, Jauch KW, Heiss MM. J Exp Clin Cancer Res. 2009 Feb 14;28:18. | SEE ABSTRACT

The evolving role of catumaxomab in gastric cancer. Lordick F. et al., Expert Opin Biol Ther. 2008 Sep;8(9):1407-15. | SEE ABSTRACT

Induction of long-lasting antitumor immunity by concomitant cell therapy with allogeneic lymphocytes and trifunctional bispecific antibody. Morecki S, Lindhofer H, Yacovlev E, Gelfand Y, Ruf P, Slavin S. Exp Hematol. 2008 Aug;36(8):997-1003. | SEE ABSTRACT

Treatment of non-small cell lung cancer patients with the trifunctional monoclonal antibody catumaxomab (anti-EpCAM x anti-CD3): a phase I study. Sebastian M, Passlick B, Friccius-Quecke H, Jäger M, Lindhofer H, Kanniess F, Wiewrodt R, Thiel E, Buhl R, Schmittel A. Cancer Immunol Immunother. 2007 Oct;56(10):1637-44. Epub 2007 Apr 5. | SEE ABSTRACT

EpCAM an immunotherapeutic target for gastrointestinal malignancy: current experience and future challenges. Chaudry MA, Sales K, Ruf P, Lindhofer H, Winslet MC.Br J Cancer. 2007 Apr 10;96(7):1013-9. | SEE ABSTRACT

Characterisation of the new EpCAM-specific antibody HO-3: implications for trifunctional antibody immunotherapy of cancer. Ruf P. et al., Br J Cancer. 2007 Aug 6;97(3):315-21. | SEE ABSTRACT

Effective relief of malignant ascites in patients with advanced ovarian cancer by a trifunctional anti-EpCAM x anti-CD3 antibody: a phase I/II study. Burges A. et al., Clin Cancer Res. 2007 July 1;13, 3899-3905 | SEE ABSTRACT

Prednisolone reduces TNF-alpha release by PBMCs activated with a trifunctional bispecific antibody but not their anti-tumor activity. Walz A. et al., Anticancer Res. 2005 Nov-Dec;25(6B):4239-43. | SEE ABSTRACT

Immunotherapy of malignant ascites with trifunctional antibodies. Heiss, M. M. et al., Int J Cancer. 2005 Nov 10;117(3):435-43. | SEE ABSTRACT

Induction of a long-lasting antitumor immunity by a trifunctional bispecific antibody. Ruf P, Lindhofer H. Blood. 2001 Oct 15;98(8):2526-34 | SEE ABSTRACT

Preferential species-restricted heavy/light chain pairing in rat/mouse quadromas. Implications for a single-step purification of bispecific antibodies. Lindhofer H, Mocikat R, Steipe B, Thierfelder S. J Immunol. 1995 Jul 1;155(1):219-25 | SEE ABSTRACT

Ertumaxomab / HER 2

A phase I trial of the trifunctional anti Her2 × anti CD3 antibody ertumaxomab in patients with advanced solid tumors. Haense N, Atmaca A, Pauligk C, Steinmetz K, Marmé F, Haag GM, Rieger M, Ottmann OG, Ruf P, Lindhofer H, Al-Batran SE.BMC Cancer. 2016 July | SEE ABSTRACT

The trifunctional antibody ertumaxomab destroys tumor cells that express low levels of human epidermal growth factor receptor 2. Jäger M, Schoberth A, Ruf P, Hess J, Lindhofer H. Cancer Res. 2009 May 15;69(10):4270-6. | SEE ABSTRACT

Ertumaxomab: a trifunctional antibody for breast cancer treatment. Philipp Kiewe & Eckhard Thiel, Expert Opin Investig Drugs. 2008 Oct;17(10):1553-8. | SEE ABSTRACT

Phase I trial of the trifunctional anti-HER2 x anti-CD3 antibody ertumaxomab in metastatic breast cancer. Kiewe P. et al., Clin Cancer Res. 2006 May 15;12(10):3085-91 | SEE ABSTRACT

Lasting remission following multimodal treatment in a patient with metastatic breast cancer. Stemmler H. J. et al., Anticancer Drugs. 2005 Nov;16(10):1135-1137. | SEE ABSTRACT

Bi20 (FBTA05) / CD20 / Lymphomun

Immunotherapy with the trifunctional anti-CD20 × anti-CD3 antibody FBTA05 in a patient with relapsed t(8;14)-positive post-transplant lymphoproliferative disease. Kieslich A, Ruf P, Lindhofer H, Buhmann R, Eggert A, Hundsdoerfer P. Leuk Lymphoma. 2017 Aug;58(8):1989-1992. doi: 10.1080/10428194.2016.1272687. Epub 2017 Jan 16 | SEE ABSTRACT

Bispecific and Multivalent Antibodies – New Swords to Combat Hematological Malignancies Pp. 81-131 (51) Michael Stanglmaier and Juergen Hess. Published in Frontiers in Clinical Drug Research: Hematology Volume: 2 eISBN: 978-1-68108-181-6. 2016

Immunotherapy with the trifunctional anti-CD20 x anti-CD3 antibody FBTA05 (Lymphomun) in paediatric high-risk patients with recurrent CD20-positive B cell malignancies. Schuster FR, Stanglmaier M, Woessmann W, Winkler B, Siepermann M, Meisel R, Schlegel PG, Hess J, Lindhofer H, Borkhardt A, Buhmann R. Br. J. Haematol. 2015 April | SEE ABSTRACT

Immunotherapy with FBTA05 (Bi20), a trifunctional bispecific anti-CD3 x anti-CD20 antibody and donor lymphocyte infusion (DLI) in relapsed or refractory B-cell lymphoma after allogeneic stem cell transplantation: study protocol of an investigator-driven, open-label, non-randomized, uncontrolled, dose-escalating Phase I/II-trial. Buhmann R, Stanglmaier M , Hess J, Lindhofer H, Peschel C, Kolb HJ.J Transl. Med. 2013 July.

Immunotherapy of recurrent B-cell malignancies after allo-SCT with Bi20 (FBTA05), a trifunctional anti-CD3 x anti-CD20 antibody and donor lymphocyte infusion. Buhmann et al., Bone Marrow Transplant. 2008 Oct 13. | SEE ABSTRACT

Bi20 (FBTA05), a novel trifunctional bispecific antibody (anti-CD20 x anti-CD3), mediates efficient killing of B-cell lymphoma cells even with very low CD20 expression levels. Stanglmaier et al., Int J Cancer. 2008 Sep 1;123(5):1181-9. | SEE ABSTRACT

Use of trifunctional bispecific antibodies to prevent graft-versus-host disease induced by allogeneic lymphocytes. Morecki S. et al., Blood. 2006 Feb 15;107(4):1564-9 | SEE ABSTRACT

Ektomun / GD2

GD2-directed bispecific trifunctional antibody outperforms dinutuximab beta in a murine model for aggressive metastasized neuroblastoma. Felix Zirngibl , Sara M Ivasko , Laura Grunewald  Anika Klaus , Silke Schwiebert , Peter Ruf  , Horst Lindhofer , Kathy Astrahantseff , Lena Andersch , Johannes H Schulte , Holger N Lode , Angelika Eggert , Kathleen Anders , Patrick Hundsdoerfer , Annette Künkele  J Immunother Cancer. 2021 Jul;9(7): e002923. doi: 10.1136/jitc-2021-002923 | SEE ABSTRACT

Two new trifunctional antibodies for the therapy of human malignant melanoma. Ruf P. et al., Int J Cancer. 2004 Feb 20;108(5):725-32. | SEE ABSTRACT

Increased chondroitin sulphate proteoglycan expression (B5 immunoreactivity) in metastases of uveal melanoma. Kiewe P, Bechrakis NE, Schmittel A, Ruf P, Lindhofer H, Thiel E, Nagorsen D. Ann Oncol. 2006 Dec;17(12):1830-4. | SEE ABSTRACT

Ganglioside GD2-specific trifunctional surrogate antibody Surek demonstrates therapeutic activity in a mouse melanoma model. Peter Ruf, Beatrix Schäfer, Nina Eissler, Ralph Mocikat, Juergen Hess, Matthias Plöscher, Susanne Wosch, Ivonne Suckstorff, Christine Zehetmeier and Horst Lindhofer. J Transl. Med. 2012 November | SEE ABSTRACT

Trifunctional bispecific antibodies induce tumor-specific T cells and elicit a vaccination effect. Eissler N, Ruf P, Mysliwietz J, Lindhofer H, Mocikat R. Cancer Res. 2012 August | SEE ABSTRACT

Potential of the trifunctional bispecific antibody surek depends on dendritic cells: rationale for a new approach of tumor immunotherapy. Eissler N, Mysliwietz J, Deppisch N, Ruf P, Lindhofer H, Mocikat R. Mol. Med. 2013 April | SEE ABSTRACT

Efficacy and Tolerability of a GD2-Directed Trifunctional Bispecific Antibody in a Preclinical Model: Subcutaneous Administration Is Superior to Intravenous Delivery. Deppisch N, Ruf P, Eissler N, Neff F, Buhmann R, Lindhofer H, Mocikat R. Mol. Cancer Ther. 2015 August | SEE ABSTRACT

Potent CD4+ T cell-associated antitumor memory responses induced by trifunctional bispecific antibodies in combination with immune checkpoint inhibition. Deppisch N, Ruf P, Eißler N, Lindhofer H, Mocikat R. Oncotarget. 2017 Jan 17;8(3):4520-4529. doi: 10.18632/oncotarget.13888 | SEE ABSTRACT

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TRION Research is located in the Innovation and Start-up Center for Biotechnology (IZB) in Martinsried, Munich – one of the most vibrant biotech hot spots in Europe.