Replies to post #188358 on Biotech Values

[bladerunner1717]

re: ARQL

Yes, it is the follow-on Akt inhibitor, if my memory serves me correctly.


Bladerunner

[biocqr]

ARQL > Ohad Hammer...

ArQule – Finally out of the penalty box

http://www.orf-blog.com/arqule-finally-out-of-the-penalty-box/

ArQule (ARQL) has doubled in less than two months, following two years of weakness. While tivantinib’s phase III liver cancer is the company’s most visible asset, investors are starting to notice ArQule’s early stage pipeline and its potential to generate meaningful data in the coming year. Both ARQ 092 (Akt inhibitor) and ARQ 087 (FGFR inhibitor) are being tested in biomarker-enriched trials with the potential to have clear efficacy signals during 2015.

ARQ 092 – Fast follower in oncology but leading in rare diseases

ARQ 092 is in phase Ib in patients whose tumors harbor relevant mutations (Akt, PI3K). ARQ 092 appears to be a high quality, potentially differentiated Akt inhibitor but primary risk associated with program is related to Akt as a target for cancer.

To date, Akt inhibitors generated preliminary efficacy signs in biomarker-defined patients but were not effective enough to justify single agent development. As a result, development of Akt programs shifted to combination studies in an attempt to identify the right combination regimens and patient populations. Roche’s GDC-0068 (licensed from Array Biopharma [ARRY]) is being evaluated in three large trials in breast, gastric and prostate cancer. AstraZeneca’s (AZN) AZD5363 is in several randomized trials that are funded predominantly by research institutes.

Since ArQule is evaluating ARQ 092 as monotherapy, expectations from the current trial should be modest. When I spoke with the company’s management earlier this week, they acknowledged the limited activity observed to date with other Akt inhibitors but still felt the drug deserves a chance to demonstrate an effect in relevant patient population. In that sense, being a fast follower plays to ArQule’s favor as it can use information generated by competitors to optimally design the expansion cohorts. ARQ 092 may also have advantages over other Akt inhibitors such as prolonged target coverage due to long half-life, better safety profile and different isoform selectivity.