In a Dec. 12 research note, H.C. Wainwright & Co. analyst Ram Selvaraju reported that BioXcel Therapeutics Inc. (BTAI:NASDAQ) plans to clinically advance its innate immunity activator, BXCL701, into multiple advanced solid tumors with the launch of a Phase 2 basket trial.
Selvaraju explained the upcoming study, NCT04171219. Open label and to take place at a U.S. cancer center, it will evaluate the combination of BXCL701 and Keytruda (pembrolizumab) in patients with advanced solid cancers. Resulting progression-free survival, overall survival, response duration and safety will be measured.
"We feel that BXCL701 could be positioned across multiple indications as a checkpoint inhibitor enhancer, improving patient responses and survival parameters," Selvaraju commented. "If successful, the planned Phase 2 study of BXCL701 would provide an option for checkpoint inhibitor therapy-relapsed/refractory patients."
Selvaraju pointed out BioXcel is differentiating BXCL701 at least in two ways. One is with the compound's mechanism of action. The innate immunity activator inhibits dipeptidyl peptidase 8/9 and targets the fibroblast activation protein. In so doing it blocks cancer cells from invading the immune system. The method "should enable it to enhance checkpoint inhibitor therapy effectiveness more comprehensively than single pathway approaches," noted the analyst.
Secondly, also to enhance BXCL701's checkpoint inhibitor effectiveness, BioXcel is targeting "hot" versus "cold" tumors, meaning ones that already contain some immune cell infiltration, noted Selvaraju.
Along with the upcoming basket trial, BXCL701 is being evaluated with Keytruda now in an existing trial, a Phase 1b/2 study for treatment-emergent neuroendocrine prostate cancer. Further safety and tolerability results from this are expected shortly, and initial efficacy data are anticipated in 2020.
The analyst highlighted that "there are numerous possible future avenues for BXCL701 development." One is the evaluation of BXCL701 in triple combination therapy, specifically with Bavencio (avelumab) and NKTR-214 (bempegaldesleukin). Such a study in advanced pancreatic cancer could be starting in the coming months.
Additionally, BioXcel is scheduled to start testing BXCL701 in hematological malignancies, now that the compound has orphan drug status for acute myeloid leukemia from the U.S. Food and Drug Administration.
H.C. Wainwright has a Buy rating and a $25 per share, 12-month target price on BioXcel. The biopharma's current share price is about $8.67.[NLINSERT]
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Disclosures from H.C. Wainwright & Co., BioXcel Therapeutics, Inc., Company Update, December 12, 2019
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., 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 BioXcel Therapeutics, Inc. (including, without limitation, any option, right, warrant, future, long or short position).
As of November 30, 2019 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of BioXcel Therapeutics, Inc.
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 received compensation from BioXcel Therapeutics, Inc. for non-investment banking services in the previous 12 months.
The Firm or its affiliates did not receive compensation from BioXcel Therapeutics, Inc. 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.
The Firm does not make a market in BioXcel Therapeutics, Inc. as of the date of this research report.
H.C. Wainwright & Co., LLC and its affiliates, officers, directors, and employees, excluding its analysts, will from time to time have long or short positions in, act as principal in, and buy or sell, the securities or derivatives (including options and warrants) thereof of covered companies referred to in this research report.