LOS ALTOS, CA, USA I August 15, 2016 I AbGenomics International Inc., a privately-held biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug Application (IND) for its AbGn-107 antibody drug conjugate (ADC) candidate for treating pancreatic, gastric, and colorectal cancers. The company will be initiating a Phase I proof of concept clinical trial for the treatment of patients with advanced gastrointestinal cancers.
“The commencement of this clinical trial will mark a significant milestone for AbGenomics,” said Ron Lin, Ph.D., President and Chief Executive Officer of AbGenomics, “We are pleased to have received FDA acceptance for our clinical trial protocol and look forward to evaluating the use of our own ADC product candidate for the treatment of solid tumors.”
The Phase I dose escalation with cohort expansion clinical study will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of AbGn-107 therapy in patients with chemo-refractory, locally advanced, recurrent, or metastatic gastric, colorectal, or pancreatic cancer. AbGenomics expects to enroll approximately 54 patients in the study at multiple clinical sites across the country.
About AbGenomics (www.abgenomics.com)
AbGenomics International Inc. (AbG), incorporated in Delaware in 2006 with its principal office in the San Francisco Bay Area, California, is a clinical stage biopharmaceutical company aiming to develop targeted antibody therapeutics for the treatment of cancers and immune-mediated inflammatory diseases with significant unmet medical needs. AbGenomics owns a strong patent portfolio for the protection of our best-in-class therapeutic product candidates. Our lead candidate AbGn-168H/Neihulizumab has demonstrated the proof of clinical efficacy in Phase II clinical trials for T-cell mediated diseases such as psoriasis and psoriatic arthritis. This innovative drug candidate has the potential to bring game-changing benefits to the patients with many other T-cell mediated diseases. Another important asset of the company is our proprietary ADC technology and products. We demonstrate the superior benefits and the competitive strength of our biosuperior ADCs over existing ADCs both in the market and under development.
SOURCE: AbGenomics
Post Views: 280
LOS ALTOS, CA, USA I August 15, 2016 I AbGenomics International Inc., a privately-held biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug Application (IND) for its AbGn-107 antibody drug conjugate (ADC) candidate for treating pancreatic, gastric, and colorectal cancers. The company will be initiating a Phase I proof of concept clinical trial for the treatment of patients with advanced gastrointestinal cancers.
“The commencement of this clinical trial will mark a significant milestone for AbGenomics,” said Ron Lin, Ph.D., President and Chief Executive Officer of AbGenomics, “We are pleased to have received FDA acceptance for our clinical trial protocol and look forward to evaluating the use of our own ADC product candidate for the treatment of solid tumors.”
The Phase I dose escalation with cohort expansion clinical study will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of AbGn-107 therapy in patients with chemo-refractory, locally advanced, recurrent, or metastatic gastric, colorectal, or pancreatic cancer. AbGenomics expects to enroll approximately 54 patients in the study at multiple clinical sites across the country.
About AbGenomics (www.abgenomics.com)
AbGenomics International Inc. (AbG), incorporated in Delaware in 2006 with its principal office in the San Francisco Bay Area, California, is a clinical stage biopharmaceutical company aiming to develop targeted antibody therapeutics for the treatment of cancers and immune-mediated inflammatory diseases with significant unmet medical needs. AbGenomics owns a strong patent portfolio for the protection of our best-in-class therapeutic product candidates. Our lead candidate AbGn-168H/Neihulizumab has demonstrated the proof of clinical efficacy in Phase II clinical trials for T-cell mediated diseases such as psoriasis and psoriatic arthritis. This innovative drug candidate has the potential to bring game-changing benefits to the patients with many other T-cell mediated diseases. Another important asset of the company is our proprietary ADC technology and products. We demonstrate the superior benefits and the competitive strength of our biosuperior ADCs over existing ADCs both in the market and under development.
SOURCE: AbGenomics
Post Views: 280
