Scientific Publications

Lindis Biotech

Company News

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

February 13, 2025

LINDIS Biotech and Pharmanovia announce european marketing authorisation approval for Catumaxomab, a first-in-class treatment for malignant ascites.

  • Catumaxomab becomes the only approved drug therapy for malignant ascites, a rare and debilitating complication of advanced-stage cancer
  • Under licensing agreement, LINDIS has granted Pharmnovia the exclusive rights to bring Catumaxomab to market and lead all activities to launch Catumaxomab across Europe
  • This marks another milestone for Pharmanovia, as it deepens its footprint within specialty pharmaceuticals

Full press release Download:

Download the full press release (EN) here: PDF, 0.9MB
Download the full press release (DE) here: PDF, 0.7MB

November 19, 2024

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

Read the full press release (German / English) at eqs-news.de

Read the full press release (English) here:

Press Release, November 19, 2024

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 20th 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 2nd June 2017 the product was withdrawn from the EU due to commercial reasons.

On 17th 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 effect3, 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:
Website: www.lindisbiotech.com

Media inquiries
MC Services AG
Anne Hennecke
Tel.: +49 (0) 211-529-252-22
E-Mail:

References

1 https://www.ema.europa.eu/en/medicines/human/EPAR/korjuny
2 Ref: BMJ, https://spcare.bmj.com/content/13/e3/e1292
3 https://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/

Read the full press release (German) here:

Press Release, November 19, 2024

LINDIS Biotech und Pharmanovia schließen Lizenzvereinbarung für die Vermarktung von catumaxomab

  • Catumaxomab erhielt im Oktober 2024 vom Ausschuss für Humanarzneimittel (CHMP) der EMA eine positive Empfehlung;
  • Nach Zulassung wäre catumaxomab das einzige zugelassene Medikament zur Behandlung des malignen Aszites
  • Pharmanovia wird alle Aktivitäten zur Markteinführung von catumaxomab leiten
  • Partnerschaft unterstreicht das Potenzial dieser einzigartigen Immuntherapie; Entwicklung in weiteren Indikationen mit hohem ungedecktem medizinischem Bedarf, wie z. B. Blasenkrebs, ist im Gange

München, Deutschland, 19. November 2024 – LINDIS Biotech GmbH, ein biopharmazeutisches Unternehmen im klinischen Stadium mit einer proprietären multispezifischen Antikörperplattform und einer fortgeschrittenen Entwicklungspipeline in der Immunonkologie, gab heute den Abschluss einer Lizenzvereinbarung mit dem globalen Pharmaunternehmen Pharmanovia für catumaxomab zur Behandlung des malignen Aszites bekannt.

Im Rahmen der Vereinbarung erhält Pharmanovia die exklusiven Rechte zur Markteinführung von catumaxomab, einem neuartigen trifunktionalen bispezifischen monoklonalen Antikörper, der für die intraperitoneale Behandlung des malignen Aszites bei Erwachsenen mit epithelial Zelladhäsionsmolekül (EpCAM)-positiven Karzinomen indiziert ist, für die keine weitere systemische Antikrebstherapie zur Verfügung steht1. Maligner Aszites ist eine abnormale Ansammlung von Flüssigkeit in der Bauchhöhle, die häufig als Folge einer fortgeschrittenen Krebserkrankungen auftritt.

„Wir freuen uns sehr über die Partnerschaft mit Pharmanovia, um die Vermarktung von catumaxomab in Europa voranzutreiben. Gemeinsam sind wir von der Bedeutung, die catumaxomab für Patienten mit dieser verheerenden Erkrankung haben kann, überzeugt, und sind fest entschlossen, catumaxomab so vielen Menschen wie möglich zugänglich zu machen“, sagte Dr. Horst Lindhofer, Geschäftsführer von LINDIS Biotech. „Pharmanovias Fokus auf supportive Therapien, die breite europäische Plattform des Unternehmens sowie die starke Expertise im Bereich der Onkologie machen Pharmanovia zu einem idealen Partner für LINDIS. Wir freuen uns auf die Zusammenarbeit und werden gleichzeitig unsere Pipeline in anderen Indikationen mit hohem ungedecktem medizinischem Bedarf, wie z. B. Blasenkrebs, weiterentwickeln.“

Dr. James Burt, CEO von Pharmanovia, ergänzte: „Unsere Mission ist es, innovative und verbesserte Medikamente Patientinnen und Patienten, die diese Arzneimittel benötigen, zur Verfügung zu stellen, und diese Kooperation verkörpert genau das. Catumaxomab ist ein erstklassiges Medikament, das eine entscheidende Rolle in der supportiven Therapie bei Krebserkrankungen spielen kann, bereits zugelassen war, jedoch nicht länger verfügbar ist. Durch diese Partnerschaft mit LINDIS Biotech möchten wir diesen Umstand ändern und catumaxomab, vorbehaltlich der behördlichen Genehmigung, wieder auf den Markt bringen. Wir freuen uns, unsere ausgeprägten Fähigkeiten in der Einführung neuartiger Wirkstoffe (NCEs) einzusetzen, um dieses wichtige Medikament den Patienten zur Verfügung zu stellen.“

Der maligne Aszites tritt vorwiegend in Zusammenhang mit Eierstock-, Bauchspeicheldrüsen- und Magenkrebs auf und betrifft etwa 20 bis 50 % aller Fälle. Diese Komplikation entwickelt sich spät im Verlauf der Krebserkrankung und beeinträchtigt die Lebensqualität der Patienten erheblich2. Therapien wie die Parazentese können zwar vorübergehende Linderung verschaffen, sind jedoch mit Herausforderungen verbunden, weshalb fortlaufend nach dauerhafteren und wirksameren Lösungen gesucht wird.

Prof. Carsten Bokemeyer, Direktor der Klinik und Poliklinik für Medizinische Onkologie und Hämatologie an der Universität Hamburg, UKE, erklärte: „Die klinische Behandlung des malignen Aszites stellt nach wie vor eine große Herausforderung in der Medizin dar. Leider existieren bis heute keine allgemein anerkannten, evidenzbasierten Richtlinien oder spezifischen Empfehlungen zur Behandlung dieser Erkrankung und es wurden kaum Fortschritte erzielt, um die Belastung der Betroffenen zu verringern und ihre Lebensqualität zu verbessern. Daher wäre die Verfügbarkeit von catumaxomab, einer spezifischen tumorgerichteten Therapie, ein klarer Vorteil für Patienten in dieser schwierigen Situation. Catumaxomab reduziert die Notwendigkeit von Punktionen, verbessert die Lebensqualität und scheint in einigen Fällen sogar das Überleben zu verlängern.“

Der Ausschuss für Humanarzneimittel (CHMP) der Europäischen Arzneimittel-Agentur (EMA) sprach im Rahmen seiner Sitzung vom 24. Oktober eine positive Empfehlung für catumaxomab aus. Die EU-Zulassung wird bis Ende 2024 erwartet. Im Falle einer Zulassung wäre catumaxomab das einzige zugelassene Arzneimittel für die spezifische und zielgerichtete Krebstherapie des malignen Aszites.

Alira Health fungierte in der gesamten Transaktion sowie in den abschließenden Verhandlungen als exklusiver strategischer Berater für LINDIS Biotech.

Weitere Informationen:

Über LINDIS Biotech

LINDIS Biotech ist ein biopharmazeutisches Unternehmen im klinischen Stadium, das sich der Entwicklung von Triomab®-Antikörpern widmet – einer neuen Klasse von T-Zellen aktivierenden, bispezifischen, trifunktionalen Antikörpern, die das Immunsystem dabei unterstützen, bösartige Krebserkrankungen in beherrschbare und potenziell heilbare Krankheiten zu verwandeln.

Über CATUMAXOMAB

Catumaxomab wurde ursprünglich am 20. April 2009 in der EU unter dem Markennamen Removab® zur Behandlung des malignen Aszites bei Erwachsenen mit EpCAM-positiven Karzinomen zugelassen, für die keine Standardtherapie zur Verfügung steht oder bei denen diese nicht mehr anwendbar ist. Catumaxomab war der erste trifunktionale T-Zell-Engager-Antikörper und die erste zugelassene Therapie weltweit für die Behandlung des malignen Aszites. Seitdem hat der Antikörper seine Sicherheit und anti-tumorale Wirksamkeit bei über 2000 Patienten unter Beweis gestellt. Das Produkt wurde seit 2014 nicht mehr vermarktet und wurde schließlich am 2. Juni 2017 aus kommerziellen Gründen vom europäischen Markt genommen.

Am 17. Oktober erhielt die LINDIS Biotech GmbH eine positive Empfehlung des Ausschusses für Humanarzneimittel (CHMP) unter dem Markennamen KORJUNY®.

Catumaxomab zerstört effektiv Krebszellen, indem der Antikörper an zwei Antigene bindet: EpCAM und CD3, und so eine Brücke zwischen den Krebszellen und den T-Zellen bildet. Dies bringt die Zellen in unmittelbare Nähe, sodass die T-Zellen die Krebszellen abtöten können. Catumaxomab bindet darüber hinaus auch an Fc-gamma-Rezeptor positive Immunzellen, wie z.B. Monozyten und Makrophagen, und aktiviert diese. So trägt der Antikörper dazu bei, dass das Immunsystem des Körpers nicht nur Krebszellen angreift und zerstört, sondern möglicherweise auch eine Vakzinierung induziert3, 4.

Der EpCAM-Marker ist ein tumorspezifisches Antigen, das auf fast allen Karzinomen (u.a. bei Magen-, Darm-, Eierstock-, Prostata-, Pankreas-, Blasen-, Lungen- und Endometriumkrebs) stark exprimiert wird und auch als Marker auf tumorinitiierenden Krebsstammzellen bekannt ist – einem Haupttreiber der Metastasierung. Daher ist er ein vielversprechender Ansatz für eine gezielte Krebsbehandlung.

Über Pharmanovia

Pharmanovia ist ein globales Unternehmen für Lifecycle-Management im Gesundheitswesen. Unser Ziel ist es, Medikamente für die Zukunft neu zu positionieren, um das Leben von Patienten weltweit zu verbessern.

Wir tun dies, indem wir etablierte Medikamente wiederentdecken, neue Anwendungen finden oder umgestalten oder indem wir neuartige Medikamente auf den Markt bringen, um so bessere Ergebnisse und Erfahrungen für Patienten zu erzielen.

Dank unseres vielfältigen und wachsenden Teams in über 160 Ländern weltweit, liefern wir qualitativ hochwertige, rezeptpflichtige und nachhaltige Lösungen in unseren vier therapeutischen Kernbereichen – Endokrinologie, Neurologie, Herz-Kreislauf und Onkologie – sowohl im Bereich der seltenen als auch verbreiteten Beschwerden und Erkrankungen.

Für weitere Informationen kontaktieren Sie bitte:

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

Medienanfragen
MC Services AG
Anne Hennecke
Tel.: +49 (0) 211-529-252-22
E-Mail:

Referenzen

1 https://www.ema.europa.eu/en/medicines/human/EPAR/korjuny
2 Ref: BMJ, https://spcare.bmj.com/content/13/e3/e1292
3 https://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

October 21, 2024

LINDIS Biotech receives Positive CHMP Opinion for KORJUNY® (catumaxomab) in the European Union

  • Upon authorization by the European Commission, KORJUNY® will be the only drug approved and available for the intraperitoneal treatment of malignant ascites in adults with epithelial cell adhesion molecule (EpCAM)-positive carcinomas
  • Data demonstrate that the efficacy of the treatment with paracentesis and catumaxomab was statistically significantly superior to that of paracentesis alone in terms of puncture-free survival and time to first need for therapeutic ascites puncture
  • EU marketing authorization expected end of 2024

Here you can download the complete press release: Lindis Biotech receives Positive CHMP Opinion for Korjuny® (cartumaxomab) in the European Union

Read the full press release (German / English) at eqs-news.de

Read the full press release (English) here:

Press Release, October 21, 2024

LINDIS Biotech receives Positive CHMP Opinion for KORJUNY® (catumaxomab) in the European Union

  • Upon authorization by the European Commission, KORJUNY® will be the only drug approved and available for the intraperitoneal treatment of malignant ascites in adults with epithelial cell adhesion molecule (EpCAM)-positive carcinomas
  • Data demonstrate that the efficacy of the treatment with paracentesis and catumaxomab was statistically significantly superior to that of paracentesis alone in terms of puncture-free survival and time to first need for therapeutic ascites puncture
  • EU marketing authorization expected end of 2024

Munich, Germany, October 21, 2024 – LINDIS Biotech GmbH, a biopharmaceutical company with a proprietary multi-specific antibody platform and an advanced development pipeline in immuno-oncology, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of trifunctional anti-CD3 x anti-EpCAM antibody (trAb) KORJUNY® (catumaxomab) for the intraperitoneal treatment of malignant ascites (MA) in adults with EpCAM-positive carcinomas who are not eligible for further systemic anticancer therapy.

The positive opinion from the CHMP will now be reviewed by the European Commission (EC) which renders the final decision on approval. The EC’s decision will be applicable to all member states of the European Union, plus Iceland, Liechtenstein, and Norway. If approved, KORJUNY® would become the only drug approved for the
specific and cancer-directed treatment of malignant ascites, an abnormal accumulation of fluid in the peritoneal cavity that commonly arises from advanced-stage cancers, particularly those of ovarian, gastric, colorectal, pancreatic, prostate, lung and endometrial origin.

“Our experience demonstrates the profound impact catumaxomab can have on patients facing this critical condition. We are therefore thrilled that the CHMP has recommended approval of catumaxomab for the indication of malignant ascites and about the opportunity to bring this pioneering therapy back onto the market,” commented Dr. Horst Lindhofer, Chief Executive Officer of Lindis Biotech. “We very much look forward to the formal approval of this treatment and to further develop the potential of this unique immunotherapy in other indications with high unmet medical need, such as bladder cancer.”

The CHMP recommendation for KORJUNY®, dated October 18, 2024, is supported by data from a Phase II/III study (IP-REM-AC-01), a large randomized, international, multi-center clinical study which demonstrated a statistically significant improvement of the primary endpoint puncture-free survival. Patients receiving KORJUNY® had a 2 four-fold increase in puncture-free survival over therapy with puncture alone, still the most common intervention and standard therapy in chemotherapy-refractory MA patients [Heiss et al., 2010].

Prof. Carsten Bokemeyer, Director of the Department of Medical Oncology and
Hematology at the University of Hamburg, UKE stated: “Ascites is a typical complication in patients with intensively pre-treated and advanced gastrointestinal malignancies – particularly gastric cancer. 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.”

“I have been significantly involved in the development of catumaxomab as an intraperitoneal treatment for ovarian cancer and its withdrawal from the market, driven solely by commercial factors, was a regrettable decision, especially considering the potential benefits for patients. Based on my extensive experience with the drug, both in clinical work and research, I am convinced that this treatment is a key element in controlling the very dramatic symptoms of this disease while providing the best supportive care possible”, added Prof. Jalid Sehouli, MD, director of the Clinic Campus Virchow and Campus Benjamin Franklin Charité Center Gynecology,
Charité – Universitätsmedizin Berlin. “The observed safety profile is very favorable, especially compared to currently available treatments. Catumaxomab has the potential to become the backbone of therapeutic protocols for patients with malignant ascites and I look forward to integrating the treatment in my clinical routine.”

In addition to MA, the use of catumaxomab in other indications and additional routes of administration are currently being investigated to further exploit its therapeutic potential in EpCAM-positive carcinomas. A Phase I dose escalation and expansion study (CATUNIBLA) has already completed recruitment in high and intermediate-risk non-muscle invasive bladder cancer (HR-NMIBC), representing a market opportunity for catumaxomab of 1.35bn € in 2030 [DelveInsight, Non-Muscle Invasive Bladder Cancer (NMIBC) – Market Insight, Epidemiology and Market Forecast – 2030]. Encouraging interim data from the trial regarding safety and efficacy were recently
presented at the ESMO 2024 conference in Barcelona (Link).

KORJUNY® – the re-approval of the first bispecific trifunctional antibody approved for cancer

In 2009, catumaxomab was approved in Europe for the indication of malignant ascites (the buildup of fluid containing cancer cells in the space around the organs in the abdomen). A pioneering treatment, catumaxomab was the first T cell engager trifunctional antibody and the first drug in the world approved specifically for the 3 treatment of MA and has since proven its safety and anti-tumor efficacy in more than 2000 patients.

While catumaxomab was voluntarily withdrawn from the EU markets in 2017 due to commercial reasons, its first approval sparked a worldwide growing interest in the development of bispecific T-cell engagers for cancer treatment.

More Information:

About CATUMAXOMAB

Catumaxomab is a bispecific trifunctional antibody that binds directly to the tumor cell with one of its binding sites and activates two essential components of the immune system with the other binding sites: T-cells and Fc-gamma receptor positive cells (macrophages etc.). The antibody recognizes and binds to all EpCAM-positive tumor cells, including critical cancer stem cells and all CD3-positive T-cells. 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.

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: https://meetings.asco.org/abstracts-presentations/209733/video

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

2010P 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.  A.A. Antoniewicz, F. Albert, F. Wessels, M. Lenhart, M. Neuberger, P. Ruf, H. Lindhofer, R. Oberneder, M. Kriegmair  ESMO Annals of Oncology Urothelial cancer Volume 35, Supplement 2 S1160 September 2024.  | SEE ABSTRACT

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 (springer.com)

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

Combination of GD2-directed bispecific trifunctional antibody therapy with Pd-1 immune checkpoint blockade induces anti-neuroblastoma immunity in a syngeneic mouse model.

Ivasko SM, Anders K, Grunewald L, Launspach M, Klaus A, Schwiebert S, Ruf P, Lindhofer H, Lode HN, Andersch L, Schulte JH, Eggert A, Hundsdoerfer P, Künkele A, Zirngibl F.Front Immunol. 2023 Jan 9;13:1023206. doi: 10.3389/fimmu.2022.1023206. eCollection 2022.PMID: 36700232 | SEE ABSTRACT

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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Location

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.

Address

TRION Research GmbH
Am Klopferspitz 19
82152 Martinsried