On November 9, 2021 Aravive, Inc. (Nasdaq: ARAV), a clinical-stage oncology company developing transformative, targeted therapeutics to treat life-threatening cancers, reported that positive new data from the Phase 1b portion of its open-label Phase 1b/2 trial evaluating batiraxcept (AVB-500) in combination with cabozantinib in patients with clear cell renal cell carcinoma (ccRCC) will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting on November 13, 2021 (Press release, Aravive, NOV 9, 2021, View Source [SID1234594804]). The presentation will highlight interim safety, pharmacokinetic (PK), pharmacodynamic (PD), and clinical activity data.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"We are encouraged by the preliminary performance of batiraxcept in combination with cabozantinib in patients with clear cell renal cell carcinoma," said Gail McIntyre, Ph.D., DABT, Chief Executive Officer of Aravive. "These results highlight the potential of batiraxcept to improve outcomes for patients with advanced kidney cancer. We look forward to sharing these new clinical data with the research and medical community at this year’s SITC (Free SITC Whitepaper) Annual Meeting."
As of July 21, 2021, seven patients received at least one dose of batiraxcept 15 mg/kg in combination with cabozantinib, six patients were ongoing treatment, and five patients were evaluable for efficacy. No dose-limiting toxicities were observed. Trough levels at cycle 1 day 15 were above the minimal efficacious concentration identified from the Company’s model informed drug development approach, and serum GAS6 levels were suppressed prior to cycle 2 day 1. A best overall response of partial response was observed in 3 of 5 patients (60%, unconfirmed as of July 21, 2021), based on investigator assessment, RECIST v 1.1 criteria. In addition, all patients demonstrated tumor decrease from baseline.
Aravive’s presentation at the SITC (Free SITC Whitepaper) Annual Meeting will include updated safety, PK, PD, and clinical activity data from a larger set of patients treated with batiraxcept 15 mg/kg in combination with cabozantinib as of October 16, 2021.
Poster Presentation Details
Title: A Phase 1b/2 randomized study of AVB-S6-500 in combination with cabozantinib versus cabozantinib alone in patients with advanced clear cell renal cell carcinoma who have received front-line treatment
Presenter: Reshma Rangwala, M.D., Ph.D., Chief Medical Officer of Aravive
Date: November 13, 2021
Time: 7:00 AM – 8:30 PM ET
Location: Hall E
For additional information, please visit the SITC (Free SITC Whitepaper) 36th Annual Meeting website: View Source
Conference Call Information
Aravive will host a conference call and webcast on November 12, 2021 at 8:30 a.m. ET to discuss these clinical data. The conference call may be accessed by dialing (877) 423-9813 (domestic) and (201) 689-8573 (international) and referring to conference ID 13724115. A webcast of the conference call will be available in the Investors section of the Aravive website at View Source The archived webcast will be available on Aravive’s website after the conference call.
About the Batiraxcept (AVB-500) Phase 1b/2 ccRCC Trial
Aravive initiated the Phase 1b portion of the Phase 1b/2 trial of batiraxcept in ccRCC in March 2021. The Phase 1b portion of the clinical trial, a dose escalation study, is expected to enroll approximately 18 patients in three dosing arms (15 mg/kg, 20 mg/kg and 25 mg/kg) to evaluate tolerability, pharmacokinetics, pharmacodynamics, and clinical activity of batiraxcept in combination with cabozantinib. The controlled, randomized, open-label Phase 2 portion of the clinical trial is expected to enroll approximately 45 patients and investigate the recommended batiraxcept dose identified during the Phase 1b portion of the clinical trial in combination with cabozantinib versus cabozantinib alone. The primary endpoint is progression-free survival. The trial is enrolling patients with advanced ccRCC who have progressed on front-line treatment. The Phase 1b/2 trial is listed on clinicaltrials.gov NCT04300140.
About Batiraxcept (AVB-500)
Batiraxcept is a therapeutic recombinant fusion protein that has been shown to neutralize GAS6 activity by binding to GAS6 with very high affinity in preclinical models. In doing so, batiraxcept selectively inhibits the GAS6-AXL signaling pathway, which is upregulated in multiple cancer types including ovarian, renal and pancreatic cancer. In preclinical studies, GAS6-AXL inhibition has shown anti-tumor activity in combination with a variety of anticancer therapies, including radiation therapy, immuno-oncology agents, and chemotherapeutic drugs that affect DNA replication and repair. Increased expression of AXL and GAS6 in tumors has been correlated with poor prognosis and decreased survival and has been implicated in therapeutic resistance to conventional chemotherapeutics and targeted therapies. Batiraxcept is currently being evaluated in multiple clinical trials and has been granted Fast Track designation by the U.S. Food and Drug Administration and orphan drug designation by the European Commission in platinum resistant recurrent ovarian cancer.