Item 7.01. Regulation FD Disclosure.
On
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.
A copy of the abstract titled "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)" is filed as an exhibit to this Current Report on Form 8-K.
The information in this Item 7.01 and in the press release furnished as Exhibit
99.1 to this Current Report on Form 8-K shall not be deemed to be "filed" for
purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or
otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2)
of the Securities Act of 1933, as amended and shall not be incorporated by
reference into any filing with the
The press release furnished as Exhibit 99. to this Current Report on Form 8-K includes "safe harbor" language pursuant to the Private Securities Litigation Reform Act of 1995, as amended, indicating that certain statements contained therein are "forward-looking" rather than historical.
Item 8.01. Other Events.
The Company presented updated results from its ongoing Phase 2 trial of
batiraxcept in clear cell renal cell carcinoma (ccRCC) at the 2023
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.
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Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit Number Exhibit Description 99.1 Press Release ofAravive, Inc. 99.2 Abstract titled "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)" 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
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