CetuGEX (tomuzotuximab) / Glycotope - LARVOL DELTA

Efficacy and safety of CetuGEX in recurrent/metastatic squamous cell carcinoma of the head and neck (RM-HNSCC): Results from the randomized phase II RESGEX study. (ASCO-SITC 2018) - P2; "Standard treatment for RM-HNSCC is a combination of cisplatin (P), 5-FU (F), and the epidermal growth factor receptor (EGFR) blocking monoclonal antibody cetuximab. The RESGEX study is the first head-to-head comparison of an ADCC-optimized to a conventional EGFR-directed antibody. The study failed to show superior efficacy of CetuGEX over cetuximab. Both compounds appear to have the same efficacy and a similar safety profile."

Clinical • P2 data • Head and Neck Cancer

CetuGEX and cetuximab in recurrent/metastatic squamous cell carcinoma of the head and neck (RM-HNSCC): PK/PD results from the phase II RESGEX study. (ASCO-SITC 2018) - P2; "Standard treatment for RM-HNSCC is a combination of cisplatin (P), 5-FU (F), and the EGFR blocking monoclonal antibody (mAb) cetuximab (C). The RESGEX study is the first head-to-head comparison of an ADCC-optimized to a conventional anti-EGFR mAb. The biomarker assessment may help to understand differences between the two mAbs."

P2 data • Head and Neck Cancer

[VIRTUAL] Results from the primary analysis of a 30 patient extension of the GATTO study, a phase Ib study combining the anti-MUC1 Gatipotuzumab (GAT) with the anti-EGFR Tomuzotuximab (TO) or Panitumumab in patients with refractory solid tumors (AACR-NCI-EORTC 2020) - "Results from this study extension confirm the good safety profile of combining TA-MUC1 and EGFR inhibition. Preliminary activity was observed in CRC and NSCLC patients. Levels of serum TA-MUC1 may have predictive value and potentially be used as companion biomarker for further development of the combination."

Clinical • Late-breaking abstract • P1 data • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MUC1

Safety and preliminary activity results of the GATTO study, a phase Ib study combining the anti-TA-MUC1 antibody gatipotuzumab with the anti-EGFR tomuzotuximab in patients with refractory solid tumors. (PubMed, ESMO Open) - P1 | "Combination of a TA-MUC1-targeting antibody and an EGFR-targeting antibody is safe and feasible. Interesting antitumor activity was observed in heavily pretreated patients. Future studies should test this combination together with chemotherapy and explore the potential of sTA-MUC1 as a companion biomarker for further development of the combination."

Journal • P1 data • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MUC1

Preliminary results in colorectal cancer (CRC) patients enrolled in the GATTO study, a phase I study of Tomuzotuximab in combination with Gatipotuzumab in patients with EGFR positive solid tumors (ESMO-GI 2019) - "PK and PD results will also be reported.   Preliminary results of this study warrant further investigation of the combination of TO and GAT in refractory pat with K-RAS WT CRC."

Clinical • Combination therapy • P1 data

[VIRTUAL] Results from the primary analysis of a 30 patient extension of the GATTO study, a phase Ib study combining the anti-MUC1 Gatipotuzumab (GAT) with the anti-EGFR Tomuzotuximab (TO) or Panitumumab in patients with refractory solid tumors (AACR-NCI-EORTC 2020) - "Results from this study extension confirm the good safety profile of combining TA-MUC1 and EGFR inhibition. Preliminary activity was observed in CRC and NSCLC patients. Levels of serum TA-MUC1 may have predictive value and potentially be used as companion biomarker for further development of the combination."

Clinical • Late-breaking abstract • P1 data • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MUC1

The GATTO study: A phase I of the anti-MUC1 Gatipotuzumab (GAT) in combination with the anti-EGFR Tomuzotuximab (TO) in patients with EGFR positive solid tumors. (ASCO 2018) - P1; "Extensive pharmacokinetics (PK) and pharmacodynamics (PD) (cellular immune status, serum and tissue biomarkers) will be also analyzed. As of January 2018, the study is ongoing and 2 patients have been treated."

Clinical • Combination therapy • P1 data • Solid Tumor

[VIRTUAL] Activity results of the GATTO study, a phase Ib study combining the anti-TA-MUC1 antibody gatipotuzumab with the anti-EGFR tomuzotuximab or panitumumab in patients with refractory solid tumors. (ASCO 2021) - P1 | "Combination of TA-MUC1 and EGFR targeting antibody is safe and feasible . Interesting anti-tumor activity was observed in heavily pretreated CRC and NSCLC patients . Levels of soluble TA-MUC1 may have predictive value and potentially be a companion biomarker for further development of the combination"

Clinical • P1 data • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MUC1

[VIRTUAL] Safety and tolerability results of the GATTO study, a phase Ib study combining the anti-TA-MUC1 antibody gatipotuzumab with the anti-EGFR tomuzotuximab or panitumumab in patients with refractory solid tumors. (ASCO 2021) - P1 | "Combination of TA-MUC1 and EGFR targeting antibody is safe and feasible . Future studies should test this combination together with chemotherapy"

Clinical • P1 data • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MUC1

The GATTO study: A phase I of the anti-EGFR Tomuzotuximab (TO) in combination with the anti-MUC1 Gatipotuzumab (GAT) in patients with EGFR positive solid tumors. (ESMO 2018) - P1; "Extensive pharmacokinetics (PK) and pharmacodynamics (PD) (cellular immune status, serum and tissue biomarkers) will be also analyzed. As of the beginning of May 2018 the study is ongoing and 6 patients are being treated."

Clinical • Combination therapy • P1 data • Solid Tumor

A randomized phase II study comparing the efficacy and safety of the glyco-optimized anti-EGFR antibody tomuzotuximab against cetuximab in patients with recurrent and/or metastatic squamous cell cancer of the head and neck - the RESGEX study. (PubMed, ESMO Open) - "The glyco-engineered antibody tomuzotuximab failed to demonstrate improved efficacy with a chemotherapeutic backbone in the first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma. It remains a so far unanswered question whether such antibody would partner better with different drugs such as checkpoint inhibitors."

Clinical • Journal • P2 data • Head and Neck Cancer • Oncology • Palliative care • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Glycotope Poster Presentation at the 2021 American Society of Clinical Oncology (ASCO) Virtual Annual Meeting (GlobeNewswire) - “Glycotope..announced it is presenting two posters at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting…Safety and tolerability results of the GATTO study, a phase Ib study combining the anti-TA-MUC1 antibody Gatipotuzumab with the anti-EGFR Tomuzotuximab or Panitumumab in patients with refractory solid tumors…Activity results of the GATTO study, a phase Ib study combining the anti-TA-MUC1 antibody Gatipotuzumab with the anti-EGFR Tomuzotuximab or Panitumumab in patients with refractory solid tumors.”

P1 data • Oncology • Solid Tumor

Glycotope Announces Poster Presentations at the 2021 American Society of Clinical Oncology (ASCO) Virtual Annual Meeting (GlobeNewswire) - "Glycotope GmbH...today announced it will present two posters at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, which is being held virtually this year due to COVID-19."

P1 data • Oncology • Solid Tumor

GATTO: Combination of Gatipotuzumab and Tomuzotuximab in Patients With Solid Tumors (clinicaltrials.gov) - P1; N=50; Completed; Sponsor: Glycotope GmbH; Recruiting ➔ Completed; N=20 ➔ 50; Trial completion date: Oct 2019 ➔ Sep 2020; Trial primary completion date: Oct 2019 ➔ May 2020

Clinical • Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • HER2 Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2

RESGEX: CetuGEX™ in Comparison to Cetuximab for the Treatment of Patients With Head and Neck Cancer (clinicaltrials.gov) - P2; N=240; Completed; Sponsor: Glycotope GmbH; Active, not recruiting ➔ Completed

Clinical • Trial completion • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

CetuGEX™: dose escalation study (clinicaltrials.gov) - P1, N=41; Sponsor: Glycotope GmbH; Active, not recruiting -> Completed. 

Trial completion • Biosimilar • Oncology

CetuGEX: dose escalation study (clinicaltrials.gov) - P1, N=85; Recruiting; Completion date: Mar 2012 -> Jun 2012

Completion date • Oncology

Glycotope: Pipeline update (Glycotope) - Anticipated first BLA filing for head and neck cancers in 2016/2019

Anticipated regulatory • Biosimilar • Oncology

Phase I clinical and pharmacological study of CetuGEX, a novel anti-egfr monoclonal antibody with an optimized antibody dependent cellular cytotoxicity (TAT 2013) - Abstract # L03.03; P1, N=41; Sponsor: Glycotope GmbH; NCT01222637; “Treatment was well tolerated and a RP2D has been determined. Confirmed objective responses were reported. Detailed safety, pharmacokinetic and pharmacodynamic results and preliminary data of antitumor activity will be presented.”

P1 data • Oncology

Preliminary results in colorectal cancer (CRC) patients enrolled in the GATTO study, a phase I study of Tomuzotuximab in combination with Gatipotuzumab in patients with EGFR positive solid tumors. (PubMed, Ann Oncol) - No abstract available

Clinical • Combination therapy • Journal • P1 data • EGFR