In a Nov. 23 research note, H.C. Wainwright & Co. analyst Robert Burns reported that Black Diamond Therapeutics Inc. (BDTX:NASDAQ) is beginning clinical development of its compound BDTX-1535 as a treatment for glioblastoma multiforme (GBM), following encouraging preclinical results.
The biopharma aims to submit a completed investigational new drug application for BDTX-1535 to the U.S. Food and Drug Administration in H1/21.
Burns presented the results of studies done on BDTX-1535 to date. Cell-based assays revealed that the small molecule kinase inhibitor showed "potent and selective inhibition of several oncogenic allosteric epidermal growth factor receptor (EGFR) mutants compared to wild-type EGFR," he wrote.
In subsequent studies in mice that had allosteric EGFR mutants, BDTX-1535 penetrated the brain and inhibited pEGFR completely for 24 hours after one dose. "This led to significant tumor growth inhibition of intracranial patient-derived xenograft GBM tumors," Burns indicated.
He explained that about half of all GBM tumors express oncogenic EGFR variants and noted that the cancer, one of the most aggressive and intractable, represents a serious unmet need.
Burns pointed out that another drug for GBM is in development, Kintara Therapeutics' VAL-083 (dianhydrogalactitol), but "does not seem to be a direct competitor." This is because Kintara is targeting MGMT-unmethylated GBM with it whereas Black Diamond most likely will not limit BDTX-1535 to EGFR+ GBM. In a recent study, Kintara's VAL-083 demonstrated a 10-month median progression-free survival in 27 newly diagnosed study patients already treated with radiation therapy and temozolomide.
H.C. Wainwright has a Buy rating and a $53 per share price target, excluding potential revenues from BDTX-1535, on Black Diamond. The stock is currently trading at about $34.52 per share.[NLINSERT]
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Disclosures from H.C. Wainwright & Co., Black Diamond Therapeutics Inc., Company Update, November 23, 2020
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, Robert Burns and 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 Black Diamond Therapeutics, Inc. (including, without limitation, any option, right, warrant, future, long or short position).
As of October 31, 2020 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Black Diamond 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 did not receive compensation from Black Diamond Therapeutics, Inc. for investment banking services within twelve months before, but 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 Black Diamond 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.