- Ambrx Biopharma Inc AMAM announced new preclinical data from studies ARX517 and ARX305 at the 2023 American Association for Cancer Research (AACR) Annual Meeting.
- The stability of ARX517 was demonstrated in a non-human primate (monkey) study.
- Pharmacokinetic measurements confirm the high stability of ARX517 in circulation with a prolonged half-life of 11 or 15 days.
- The major metabolite of the ARX517 cytotoxic linker, pAF-AS269, was barely detectable in serum in a repeat dose study (0.2 ng/mL).
- At the highest non-severely toxic dose (HNSTD), ARX517 serum exposure was greater than ARX517 exposure at a pharmacologically active dose in mice, showing a clear therapeutic index.
- ARX517 demonstrated anti-tumor activity in an enzalutamide-sensitive mouse model of prostate cancer. In addition, the combination of 3 mg/kg ARX517 plus 10 mg/kg enzalutamide resulted in an 86% reduction in tumor size.
- In an enzalutamide-resistant prostate cancer model, three weekly doses of 3 mg/kg ARX517 significantly inhibited tumor growth by 79% in a dose-dependent manner.
- Ambrx is evaluating ARX517 in the Phase 1 APEX-01 study in adult subjects, enrolling patients with advanced prostate cancer whose tumors have progressed after at least two FDA-approved treatments.
- In a xenographic model of renal cell carcinoma (RCC, 786-OS3), ARX305 dose-dependently inhibited tumor growth and outperformed sunitinib.
- In another RCC (Caki-1) xenograph model, weekly administration of ARX305 resulted in significant, dose-dependent antitumor activity.
- Pharmacokinetic studies of ARX305 in mice confirm the high ADC stability in circulation with a long terminal half-life of 16.5 days.
- Price promotion: AMAM shares are down 2.07% to $11.13 on the latest check Wednesday.
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