On October 4, 2021 Ambrx (NYSE: AMAM), a clinical stage biopharmaceutical company using an expanded genetic code technology platform to create Engineered Precision Biologics, reported that NovoCodex Pharmaceuticals Ltd. (NovoCodex), Ambrx’s partner in China, presented positive interim data from the ACE-Gastric-01 Phase 1 clinical study of ARX788 for the treatment of HER2+ metastatic gastric / gastroesophageal junction (GEJ) cancer at The Chinese Society of Clinical Oncology (CSCO) (Press release, Ambrx, OCT 4, 2021, View Source [SID1234590760]). The newly presented data suggests that ARX788 at a 1.7 mg/kg dose has a tolerable safety profile. The data presented here adds to and updates trial data that Ambrx presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2021. Ambrx received Orphan Drug designation from the FDA for the treatment of gastric cancer, including cancer at the GEJ, in early 2021.

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Updated ACE-Gastric-01 Phase 1 Interim Data Highlights

(Data as of June 30, 2021)

7 patients dosed at 1.7 mg/kg every three weeks.
Demonstrated overall response rate (ORR) of 44.4% (12/27) in the response-evaluable patients across all three cohorts (1.3 mg/kg, 1.5 mg/kg, 1.7 mg/kg every three weeks).
Low drug-related severe adverse events (SAE) occurred in 6.7% (2/30) of all treated patients across all three cohorts (1.3 mg/kg, 1.5 mg/kg, 1.7 mg/kg every three weeks). Drug-related grade 3 and above adverse events (AEs) comprised only 10% (3/30).
As expected, the most common AEs observed were ocular-related and dose-dependent.
Median overall survival (mOS) of 10.7 months across all three cohorts (1.3 mg/kg, 1.5 mg/kg, 1.7 mg/kg every three weeks) and mOS for the 1.7 mg/kg cohort has not been reached.
Enrollment in ACE-Gastric-01 is completed with ongoing follow-up.

Source: NovoCodex, CSCO 2021 presentation.

"We are thrilled with the progress from the NovoCodex sponsored study of our lead clinical asset, ARX788, and look forward to continuing our collaboration as we explore the capabilities of our antibody drug conjugate in treating HER2 positive cancers and solid tumors," said Feng Tian, Ph.D., Chairman of the Board, President and CEO of Ambrx. "We are encouraged by the continued positive data from the ACE-Gastric-01 study and we look forward to enrolling more patients in our ongoing global co-sponsored ACE-Gastric-02 Phase 2/3 trial."

ACE-Gastric-01 is a Phase 1 clinical study of ARX788 for the treatment of HER2+ metastatic gastric/GEJ cancer that is being conducted in China by Ambrx’s partner, NovoCodex. The ongoing clinical study recently completed enrollment of 30 patients and is designed to be a dose escalation and expansion study with patients receiving treatment doses of 1.3 mg/kg, 1.5 mg/kg, or 1.7 mg/kg every 3 weeks. Ambrx previously presented data from two Phase 1 studies of ARX788 at ASCO (Free ASCO Whitepaper) where patients received a dose of ARX788 up to 1.5 mg/kg every three weeks or every four weeks.

In August 2021, NovoCodex also announced the dosing of the first patient in the Ambrx and NovoCodex co-sponsored global Phase 2/3 trial of ARX788 in HER2+ gastric cancer. ACE-Gastric-02 is a multicenter, randomized, controlled clinical trial to evaluate the efficacy and safety of ARX788 in patients with HER2+ advanced gastric or gastroesophageal junction adenocarcinoma.