In an Aug. 21, 2018, research note, Ram Selvaraju, an analyst with H.C. Wainwright & Co., reported the FDA gave orphan drug status to ASLAN Pharmaceuticals' (ASLN:NASDAQ) ASLAN003 as a treatment for acute myeloid leukemia (AML). ASLAN003 "has the potential to be first in class in AML," he noted.
As for the status of ASLAN003, the company is currently conducting a Phase 2 trial of the drug in relapsed/refractory AML in Singapore and Australia, for which data could come out in H2/18. In the study, three doses of ASLAN003 as a single therapy are being evaluated in 18 participants for 28 days or until the disease progresses.
Selvaraju pointed out the beneficial aspects of ASLAN003, an orally active inhibitor of human dihydroorotate dehydrogenase (DHODH). First, it is "up to two orders of magnitude more potent at inhibiting DHODH" than first-generation inhibitors leflunomide and teriflunomide.
Second, the drug's 18-hour half-life should afford once-a-day dosing, Selvaraju observed. Further, the rapid clearing from the system once the medication is stopped portends a positive safety profile, a contrast to leflunomide and teriflunomide, which cause significant liver toxicity.
Third, Selvaraju noted, preclinical data showed ASLAN003 can distinguish between AML blast cells in various AML cell lines.
Also in the report, the analyst relayed news involving another of ASLAN's pipeline drugs, varlitinib, which already has orphan drug status in gastric cancer.
Earlier this month, enrollment of 52 patients in Europe and Asia finished for the Phase 2 component of the global Phase 2/3 study of varlitinib in first-line therapy of HER1/HER2 co-expressing advanced or metastatic gastric cancer. The study goal is to determine the efficacy of varlitinib and mFOLFOX6, a chemotherapy regimen, versus mFOLFOX6 alone.
Topline data could be released in Q4/18. If the primary endpoint is achieved in Phase 2, ASLAN could advance to the Phase 3 component, which requires enrollment of 350 additional patients. In that Phase 3, the endpoint would be overall survival.
With respect to vartlitinib as second-line treatment of biliary tract cancer, topline data from the pivotal trial underway China could be reported in Q4/18 also.
Selvaraju reiterated H.C. Wainwright's Buy rating and $12 per share price target on ASLAN. The stock is currently trading at around $7.85 per share.[NLINSERT]
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Disclosures from H.C. Wainwright & Co., ASLAN Pharmaceuticals Ltd., August 21, 2018
Investment Banking Services include, but are not limited to, acting as a manager/co-manager in the underwriting or placement of securities, acting as financial advisor, and/or providing corporate finance or capital markets-related services to a company or one of its affiliates or subsidiaries within the past 12 months.
I, Raghuram Selvaraju, Ph.D. and Yi Chen, Ph.D. CFA , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.
None of the research analysts or the research analyst's household has a financial interest in the securities of ASLAN Pharmaceuticals Limited (including, without limitation, any option, right, warrant, future, long or short position).
As of July 31, 2018 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of ASLAN Pharmaceuticals Limited
Neither the research analyst nor the Firm has any material conflict of interest in of which the research analyst knows or has reason to know at the time of publication of this research report.
The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services.
The Firm or its affiliates did receive compensation from ASLAN Pharmaceuticals Limited for investment banking services within twelve months before, and will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report.
H.C. Wainwright & Co., LLC managed or co-managed a public offering of securities for ASLAN Pharmaceuticals Limited during the past 12 months.
The Firm does not make a market in ASLAN Pharmaceuticals Limited as of the date of this research report.