PankoMab-GEX (gatipotuzumab) / Glycotope, Daiichi Sankyo - LARVOL DELTA

Daiichi Sankyo Acquires Intellectual Property Rights for Anti-TA-MUC1 Antibody in DS-3939 from Glycotope GmbH (Businesswire) - "Daiichi Sankyo Company, Ltd...announced today that it will pay Glycotope $132.5 million to acquire intellectual property rights of the anti-tumor-associated mucin-1 (TA-MUC1) antibody, gatipotuzumab. Such payment by Daiichi Sankyo satisfies all potential clinical, regulatory and sales milestone payments, as well as royalties of products that include gatipotuzumab as part of a 2018 licensing agreement between the parties."

Commercial • Solid Tumor

[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

A Double-blind, placebo-controlled, randomized, phase 2 study to evaluate the efficacy and safety of switch maintenance therapy with the anti-TA-MUC1 antibody PankoMab-GEX after chemotherapy in patients with recurrent epithelial ovarian carcinoma (ESMO 2017) - P2; "This study shows that PMG switch maintenance does not improve outcome in ovarian cancer TA-MUC1 positive patients."

Clinical • Late-breaking abstract • P2 data • Ovarian Cancer

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

Maintenance therapy of patients with recurrent epithelial ovarian carcinoma with the anti-tumor-associated-mucin-1 antibody gatipotuzumab: results from a double-blind, placebo-controlled, randomized, phase II study. (PubMed, ESMO Open) - P2 | "Gatipotuzumab switch maintenance therapy does not improve outcome in TA-MUC1-positive ovarian cancer patients."

Clinical • Journal • P2 data • Oncology • Ovarian Cancer • Palliative care • Peritoneal Cancer • Solid Tumor • MUC1 • MUC16

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

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

PankoMab-GEX™ Versus Placebo as Maintenance Therapy in Advanced Ovarian Cancer (clinicaltrials.gov) - P2; N=216; Completed; Sponsor: Glycotope GmbH; Active, not recruiting ➔ Completed

Clinical • Trial completion • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • MUC16

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

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

EP3 receptor is a prognostic factor in TA-MUC1-negative ovarian cancer. (PubMed, J Cancer Res Clin Oncol) - "The potential prognostic relevance of EP3 expression for OS in TA-MUC1 negative patients might reflect an interplay between the COX and the MUC1 pathway, as it has been shown that MUC1 could induce COX2 expression. Our findings support the importance of the prostanoid signaling in TA-MUC1 negative ovarian cancer; however, future studies are necessary to characterize specific pathways and possible interactions."

Biomarker • Journal

Therapeutic influence of the Wnt signaling pathway to overcome platinum resistance in ovarian carcinoma (OEGGG-BGGF 2019) - "The results showed that gatipotuzumab at a concentration of 50 μg / ml causes upregulation of the TA-MUC1 epitope in the A2780cis line and has the opposite effect in the A2780 line. The opposite results were observed in the OV90 cell line."

Potential Interplay of the Gatipotuzumab Epitope TA-MUC1 and Estrogen Receptors in Ovarian Cancer. (PubMed, Int J Mol Sci) - "The data suggest an interplay of TA-MUC1 and ERs in OC. Whether the combination of Gatipotuzumab and TTamoxifen may enhance efficacy of either of the two drugs in vivo, or may even translate into a clinically relevant benefit over the respective monotherapies, remains to be investigated."

Journal