ArQule ARQL Stock News

ArQule, Inc. (NASDAQ: ARQL) is running for the top this morning with gains of around 40% pushing the stock near a 12 year high. The move comes after the company announced positive preliminary data from an early stage clinical study of a cancer treatment candidate.

The data suggests that not only is the candidate generating a strong anti-tumor response, it is also showing a favorable safety profile. Here’s the scoop:

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ARQL Stock Rises On ARQ 531 Preliminary Data

In a press release that hit the wire in the wee hours of the morning, ArQule offered a clinical update with regard to its work with ARQ 531. ARQ 531 is a reversible dual inhibitor of both wild type and C4815-mutant Bruton’s tyrosine kinase (BTK). The treatment is being assessed in early-stage clinical studies as a potential option for patients with relapsed or refractory hematologic malignancies.

The data offered up in the release was announced originally by ARQL at the 2019 European Hematology Association Annual Meeting in Amsterdam. Moreover, the data proved to be incredibly positive.

What We Saw From The Data Release

The data that was released this morning comes from a Phase 1, open label, single arm dose escalation study of ARQ 531. During the study, the company is assessing multiple dose levels, ranging from 5 mg to 75 mg across more than 30 patients

The patients included in the study are suffering from relapsed or refractory chronic lymphocytic leukemia, small lymphocytic leukemia, Richters Transformation, Waldenstrom macroglobulinemia and other B-cell Non-Hodgkin lymphomas. At the moment, the highest dose cohort, the 75 mg cohort, is still enrolling with all other cohorts completely enrolled.

The data suggests that ARQ 531 is well-tolerated from the 5 mg dose through the 65 mg dose. As the 75 mg dose cohort is still enrolling, that data is unavailable at the moment, but is expected to be positive as well.

Both pharmacokinetic and pharmacodynamic data proved to be positive, especially in higher dose cohorts. In fact, at doses 20-30  mg, the data suggests complete pBTK inhibition and substantial CCL3 suppression.

Moreover, robust dose-dependent anti-tumor activity was reported with 4 of 6 evaluable heavily pretreated patients achieving an overall response rate. The company also said that a partial response was seen in the first patient with Richter’s Transformation. Unfortunately, this patient saw progression on ibrutinib and R-CHOP, suggesting that ARQ 531 can be used to address the most difficult to treat patients.

ARQL also said that a Follicular Lymphoma patient reached a partial response. This patient has been on therapy for about two years, giving great data when it comes to long-term safety and durability of response.

ArQule Management Commentary

In a statement, Dr. Brian Schwartz, CMO at ARQL, had the following to offer:

The profile of ARQ 531 continues to strengthen, and we are delighted to be able to demonstrate such compelling clinical activity at a well-tolerated dose in patients who have already exhausted available therapies.

We are now focused on finalizing the recommended phase 2 dose and planning for the expansion of our clinical efforts with ARQ 531 into later stage trials across multiple indications as a single agent and as a combination therapy.

Final Thoughts

With ARQ 531 showing such strong results in early phase clinical trials, the company may be sitting on a figurative gold mine. After all, lymphoma drugs generate billions of dollars per year for the companies that offer them. Not to mention, the market is growing at a rapid rate.

While the market is growing and plenty of money is being spent, lyphomas and other B-cell malignancies are incredibly difficult to treat, leaving patients and their caregivers with few effective treatment options. Should the data surrounding ARQ 531 continue to be positive, pushing the product to approval, it could become a blockbuster treatment option, offering up incredible value to investors!

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What Do You Think?

Where do you think ARQL stock is headed moving forward? Join the discussion in the comments below!

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