IND for HuMax®-TF-ADC submitted to FDA
Genmab’s first IND submission for antibody-drug conjugate (ADC) product
Patient enrolment in clinical trial expected to start in 2013
COPENHAGEN, Denmark I July 18, 2013 I Genmab A/S (OMX: GEN) announced today the filing of an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) to start a Phase I dose escalation trial of HuMax-TF-ADC to treat multiple solid tumors. A maximum of 78 patients with cancer of the ovary, cervix, endometrium, bladder, prostate, head & neck, esophagus or lung that have failed or are not eligible for standard treatments will be enrolled in the study. The safety and tolerability of HuMax-TF-ADC will be established during a dose escalation part of the study. This will be followed by a cohort expansion part that will investigate longer-term safety and potential signs of anti-tumor activity.
“HuMax-TF-ADC has shown an impressive ability to induce tumor regression in multiple pre-clinical cancer models. We aim to start the clinical evaluation of HuMax-TF-ADC in the coming months, adding another antibody, with the potential to help cancer patients, to Genmab’s clinical pipeline,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
About HuMax-TF-ADC
HuMax-TF-ADC is an antibody-drug conjugate (ADC) composed of a human antibody against tissue factor (TF) conjugated to the cytotoxic drug monomethyl auristatin E (MMAE). HuMax-TF-ADC is being developed for the treatment of solid cancers. TF is an attractive tumor target because of its high expression in a broad range of solid cancers. After binding to TF, HuMax-TF-ADC enters the tumor cells where the cytotoxic agent is specifically released, leading to cell death. HuMax-TF-ADC was demonstrated to have potent anti-tumor activity in in vivo studies in mouse models in which a diverse panel of patient-derived tumors was assessed. HuMax‑TF‑ADC was shown to have an acceptable safety profile in non-clinical safety studies.
Genmab is developing HuMax-TF-ADC using Seattle Genetics’ ADC technology under an agreement between the companies. Seattle Genetics may elect to co-develop HuMax-TF-ADC with Genmab at the end of Phase I clinical development.
About Genmab A/S
Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated human antibody therapeutics for the treatment of cancer. Founded in 1999, the company’s first marketed antibody, ofatumumab (Arzerra®), was approved to treat chronic lymphocytic leukemia in patients who are refractory to fludarabine and alemtuzumab after less than eight years in development. Genmab’s validated and next generation antibody technologies are expected to provide a steady stream of future product candidates. Partnering of innovative product candidates and technologies is a key focus of Genmab’s strategy and the company has alliances with top tier pharmaceutical and biotechnology companies. For more information visit www.genmab.com.
SOURCE: Genmab
Post Views: 153
IND for HuMax®-TF-ADC submitted to FDA
Genmab’s first IND submission for antibody-drug conjugate (ADC) product
Patient enrolment in clinical trial expected to start in 2013
COPENHAGEN, Denmark I July 18, 2013 I Genmab A/S (OMX: GEN) announced today the filing of an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) to start a Phase I dose escalation trial of HuMax-TF-ADC to treat multiple solid tumors. A maximum of 78 patients with cancer of the ovary, cervix, endometrium, bladder, prostate, head & neck, esophagus or lung that have failed or are not eligible for standard treatments will be enrolled in the study. The safety and tolerability of HuMax-TF-ADC will be established during a dose escalation part of the study. This will be followed by a cohort expansion part that will investigate longer-term safety and potential signs of anti-tumor activity.
“HuMax-TF-ADC has shown an impressive ability to induce tumor regression in multiple pre-clinical cancer models. We aim to start the clinical evaluation of HuMax-TF-ADC in the coming months, adding another antibody, with the potential to help cancer patients, to Genmab’s clinical pipeline,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
About HuMax-TF-ADC
HuMax-TF-ADC is an antibody-drug conjugate (ADC) composed of a human antibody against tissue factor (TF) conjugated to the cytotoxic drug monomethyl auristatin E (MMAE). HuMax-TF-ADC is being developed for the treatment of solid cancers. TF is an attractive tumor target because of its high expression in a broad range of solid cancers. After binding to TF, HuMax-TF-ADC enters the tumor cells where the cytotoxic agent is specifically released, leading to cell death. HuMax-TF-ADC was demonstrated to have potent anti-tumor activity in in vivo studies in mouse models in which a diverse panel of patient-derived tumors was assessed. HuMax‑TF‑ADC was shown to have an acceptable safety profile in non-clinical safety studies.
Genmab is developing HuMax-TF-ADC using Seattle Genetics’ ADC technology under an agreement between the companies. Seattle Genetics may elect to co-develop HuMax-TF-ADC with Genmab at the end of Phase I clinical development.
About Genmab A/S
Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated human antibody therapeutics for the treatment of cancer. Founded in 1999, the company’s first marketed antibody, ofatumumab (Arzerra®), was approved to treat chronic lymphocytic leukemia in patients who are refractory to fludarabine and alemtuzumab after less than eight years in development. Genmab’s validated and next generation antibody technologies are expected to provide a steady stream of future product candidates. Partnering of innovative product candidates and technologies is a key focus of Genmab’s strategy and the company has alliances with top tier pharmaceutical and biotechnology companies. For more information visit www.genmab.com.
SOURCE: Genmab
Post Views: 153
