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FDA Grants Fast Track Designation for ARX517 in Metastatic Castration-Resistant Prostate...

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ARX517, a proprietary anti-PSMA antibody-drug conjugate (ADC) investigational being therapy developed by Ambrx for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) upon progression on an androgen receptor pathway inhibitor.
Signing Ceremony between Ambrx an NovoCodex. Courtesy 2019 NovoCodex.

Ambrx and Novocodex to Jointly Develop and Commercialize 2nd Antibody-drug Conjugate

Novocodex Biopharmaceuticals, a subsidiary of Zhejiang Medicine, and  Ambrx, a privately-held clinical stage biopharmaceutical company, have confirmed that the companies will jointly develop and...
On October 16, 2019 Novocodex Biopharmaceuticals, a subsidiary of Zhejiang Medicine, and WuXi Biologics signed a strategic partnership for Phase III clinical trial production of ARX788 as well ongoing large-scale commercial production of the innovative antibody-drug conjugate.

WuXi Biologics Opens New Facility to Supports Novocodex ADC Manufacturing

Earlier this month China-based Contract Research Organization (CRO) WuXi Biologics started commercial production at the company's new Current Good Manufacturing Practice (cGMP)-approved DP3 bulk...

Ambrx and MabSpace Biosciences Jointly Develop New Antibody Drug Conjugates

San Diego based biotech company Ambrx and MabSpace Biosciences, a biotechnology company focusing on discovery and development antibody therapeutics using its immune tolerance breaking...

ARX788 First-In-Human Phase I Clinical trial in HER2 cancer patients

A First-In-Human phase I clinical trial with ARX788, an site-specific antibody-drug conjugate being developed by Ambrx® and Zhejiang Medicine has been initiated as a multicenter...

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