Pharma Focus Asia

Ambrx Biopharma Inc. Announces Submission of IND Application for ARX305 with the U.S. FDA

Wednesday, February 16, 2022

Ambrx Biopharma Inc., or Ambrx, a clinical stage biopharmaceutical company using an expanded genetic code technology platform to create Engineered Precision Biologics, today announced it received a “Study May Proceed” letter from the U.S. Food and Drug Administration (FDA) related to an Investigational New Drug (IND) application for ARX305, an antibody drug conjugate (ADC) designed to target CD70 to treat a broad range of solid and hematologic tumors such as renal cell carcinoma. ARX305 is the third ADC developed by Ambrx on its proprietary Engineered Precision Biologics platform that has received IND clearance.

The clinical study cleared by the FDA, ARX305-01, is a first in human, Phase 1, multicenter, open-label, dose-escalation, and dose-expansion study to evaluate the safety, pharmacokinetics and preliminary anti-tumor activity of ARX305 in adults with clear cell renal cell carcinoma who are resistant or refractory to prior standard therapies.

ARX305 is an anti-CD70 ADC designed to target cancer cells displaying CD70, a protein expressed on a broad range of tumors including renal cell carcinoma, nasopharyngeal cancers, multiple myeloma, non-Hodgkin’s lymphoma and acute myeloid leukemia. Ambrx previously licensed the rights to develop and commercialize ARX305 in China to NovoCodex Pharmaceuticals Ltd. (NovoCodex).

“I am pleased with the milestones that we have reached on the development of antibody drug conjugates, marked by the filing and clearance of the IND application for ARX305, our third ADC program to reach this stage of development,” said Feng Tian, Ph.D., Chairman of the Board, President, and CEO of Ambrx. “As we continue to explore potential indications for Ambrx’s proprietary ADC technology, the progression of ARX305 towards clinical trials targeting patients with various CD70 expressing tumors reinforces our confidence in the broad application of our platform.”

magazine-slider-imageMFA + MMA 2024CPHI Chine || PMEC China 2024Asia Healthcare Week 2024Advance DoE WorkshopNitrosamine Advance Workshop 2024CPHI Korea 2024CHEMICAL INDONESIA 2024INALAB 2024 Thermo Scientific - DynaDrive and DynaSpinDigital Health Asia 2024Rehab Expo 2024ISPE Singapore Affiliate Conference & Exhibition 20242024 PDA Pharmaceutical Manufacturing & Quality Conference2024 PDA Cell and Gene Pharmaceutical Products Conference 2024 PDA Aseptic Manufacturing Excellence Conference2024 PDA Aseptic Processing of Biopharmaceuticals ConferencePharma Quality Excellence Awards 20244th Annual Pharma GMP Quality Management 20243rd World ADC Asia 2024LogiPharma Asia 2024