“We are excited to present updated results from our Phase 2 trial in ccRCC, demonstrating the promise of batiraxcept plus cabozantinib combination therapy in this high unmet need population,” said
Poster Presentation Details:
Title: | Phase 2 study of batiraxcept (AVB-S6-500, an AXL inhibitor) as monotherapy, in combination with cabozantinib (cabo), and in combination with cabo and nivolumab (nivo) in patients with advanced clear cell renal cell carcinoma (ccRCC) |
Presenter: | |
Abstract Number: | 4534 |
Format/Session: | Poster; Genitourinary Cancer—Kidney and Bladder |
Session Date/Time: | |
Safety and clinical activity of batiraxcept as monotherapy in heavily pretreated patients with no curative intent, in combination with cabozantinib (cabo) in patients who had failed first line and subsequent therapies, and in combination with cabo and nivolumab (nivo) as first line therapy were evaluated.
The abstract was released by ASCO today and contains data available as of
- Batiraxcept monotherapy and batiraxcept plus cabo or cabo/nivo demonstrated a manageable safety profile, consistent with cabo and nivo prescribing information.
- Batiraxcept plus cabo showed promising results in previously IO and VEGF-TKI-treated ccRCC patients, with an objective response rate (ORR) of 50% in this population (n=12), compared to 38% (n=13) in patients with no prior VEGF-TKI.
- Batiraxcept plus cabo and nivo showed an ORR of 55% (n=11) in first-line treatment, consistent with combination first-line therapies.
- In the batiraxcept monotherapy cohort (n=10), one patient attained stable disease, suggesting that batiraxcept achieves greatest activity in combination therapies, supporting the intended combination approach in the planned registrational Phase 3 trial.
- The combination of batiraxcept and cabo appears to improve median progression-free survival (mPFS) in patients previously treated with IO and VEGF-TKI treatments compared to those without prior VEGF-TKI exposure, consistent with the P1b data and supporting the intended target population of the planned Phase 3 trial.
Batiraxcept was granted Fast Track Designation by the
Publication-only Abstract Details:
Title: | Phase 1b Batiraxcept (AVB-S6-500, BT) plus Gemcitabine (G) and Nab-paclitaxel (NP) as first-line treatment (1L) for pancreatic adenocarcinoma (PDAC) |
Abstract Number: | e16258 |
As of
About
Forward Looking Statements
This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions and includes statements regarding results continuing to support our belief that the highest potential impact of batiraxcept in ccRCC is combined batiraxcept plus cabozantinib treatment in patients treated with prior IO and VEGF-TKI therapies, the therapeutic combination and patient population being the focus of the planned pivotal Phase 3 trial Phase 3 trial initiation of a registrational Phase 3 trial of batiraxcept plus cabozantinib in patients previously treated with IO and VEGF-TKI therapies in 2H 2023following an End-of-Phase 2 meeting with the FDA . Forward-looking statements are based on current beliefs and assumptions, are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results to differ materially from those contained in any forward-looking statement as a result of various factors, including, but not limited to, risks and uncertainties related to the ability to enroll patients as anticipated at the planned sites, the ability to initiate the trial when anticipated and to provide data when anticipated; the Company's dependence upon batiraxcept; batiraxcept's ability to have favorable results in clinical trials; the clinical trials of batiraxcept having results that are as favorable as those of preclinical and clinical trials; the ability to receive regulatory approval, potential delays in the Company's clinical trials due to regulatory requirements or difficulty identifying qualified investigators or enrolling patients especially in light of the COVID-19 pandemic; the risk that batiraxcept may cause serious side effects or have properties that delay or prevent regulatory approval or limit its commercial potential; the risk that the Company may encounter difficulties in manufacturing batiraxcept; if batiraxcept is approved, risks associated with its market acceptance, including pricing and reimbursement; potential difficulties enforcing the Company's intellectual property rights; and the Company's reliance on its licensor of intellectual property and financing needs and the cash runway being sufficient to sustain operations into the fourth quarter of 2023 and beyond the readout on the Company’s Phase 3 Ovarian cancer trial. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company's Annual Report on Form 10-K for the fiscal year ended
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cdavis@lifesciadvisors.com
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i Van Hoff, D.D., et al., 2013, Increased Survival in Pancreatic Cancer with nab-Paclitaxel plus Gemcitabine N Engl J Med 369;18
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