Clinical Araviv-ederci's goals are derailed by a phase 3 cancer...

Araviv-ederci’s goals are derailed by a phase 3 cancer failure

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Aravive has encountered a significant setback as its phase 3 clinical trial for ovarian cancer yielded disappointing results, causing a considerable decline in its stock price. The company’s financial situation is also precarious, with only $18 million in cash reserves remaining by the conclusion of the second quarter. This leaves Aravive with a limited timeframe, spanning just a few months, to navigate its current challenges.

The phase 3 trial involved 366 patients grappling with ovarian cancer that had become resistant to platinum-based treatments. Among the participants, half had previously received Roche’s Avastin prior to joining the trial. The treatment options included chemotherapy using paclitaxel or Aravive’s experimental decoy protein, batiraxcept, in combination with paclitaxel. The assessment of progression-free survival (PFS) was initially focused on patients who had not been exposed to Avastin, before expanding the analysis to encompass the entire trial population.

Both analyses yielded unfavorable results for batiraxcept. In the subgroup of patients who had not received bevacizumab (Avastin) before, the PFS duration was identical at 5.4 months for both the batiraxcept and paclitaxel treatment arms. When evaluating the entire study population, batiraxcept fared even worse, demonstrating a median PFS of 5.1 months, compared to the control group’s 5.5 months when treated with paclitaxel. Notably, no new safety concerns came to light during the study.

Aravive is currently in the process of analysing the phase 3 trial data, which will ultimately shape the company’s subsequent actions. These actions were initially intended to encompass the commencement of a phase 3 trial targeting clear cell renal cancer in the latter half of 2023. However, the failure of the primary ovarian cancer trial has cast doubt over these plans.

Aravive’s CEO, Gail McIntyre, Ph.D., highlighted the ongoing scrutiny of the AXLerate-OC phase 3 trial data, expressing the company’s commitment to comprehensively evaluating the outcomes and determining the optimal path forward. Additionally, the company is eagerly awaiting the release of phase 1b/2 data related to batiraxcept’s performance in pancreatic adenocarcinoma.

With time running thin, Aravive’s financial situation is growing increasingly dire. The company concluded the second quarter with a mere $18 million in cash reserves, which it anticipates will suffice to support its operations until early in the fourth quarter. Remarkably, batiraxcept remains the sole drug candidate within Aravive’s development pipeline.

This unfavorable turn of events is especially disheartening as Aravive had staked its future prospects on the success of batiraxcept. The company believed that the decoy protein held the potential to generate substantial revenue, estimating a staggering $3 billion opportunity. This optimism was rooted in evidence suggesting that batiraxcept could enhance treatment outcomes across three distinct indications by emulating the AXL receptor and inhibiting the AXL/GAS6 pathway.

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