In an Oct. 30, 2018, research note, analyst Sam Slutsky reported that LifeSci Capital initiated coverage on Anchiano Therapeutics Ltd. (ANCN:TLV), a clinical-stage biotechnology company developing gene therapy-based drugs for the treatment of cancer.
Slutsky outlined the factors that make this company an attractive investment.
One is the advantages of Anchiano's lead candidate, inodiftagene vixteplasmid, or BC-819, he noted. It is a targeted gene therapy with a well-understood mechanism of action. A DNA plasmid vector, it expresses the diphtheria A toxin in malignant cells, thereby potentially protecting disease-free ones.
BC-819 demonstrated activity in a total of six clinical trials in three types of cancer: nonmuscle-invasive bladder cancer (NMIBC), ovarian and pancreatic. In those studies, the therapeutic was well tolerated, both as a monotherapy or in combination with Bacille Calmette-Guérin (BCG) therapy, the standard of care.
Of significance, according to Slutsky, the indication that Anchiano is pursuing NMIBC that has failed or progressed after BCG therapy represents a significant unmet need. NMIBC accounts for 75 85% of all bladder cancer. This year alone, an estimated 81,190 people will receive a bladder cancer diagnosis and for an estimated 17,240 individuals, it will be fatal. No new treatments for the disease have been approved in the past two decades.
In addition, the potential market size for the use of BC-819 as second-line and third-line treatments in NMIBC is significant, at about 97,000 and 11,000 patients, respectively, in the United States, European Union and Japan by 2025, according to LifeSci estimates.
Also noteworthy, Anchiano has outlined a clinical development plan that could result in BC-819 getting approved in two different NMIBC patient populations, Slutsky noted. The company has funds to advance these clinical development programs, having closed a $22.9 million private equity offering in early July.
The first to launch will be the Phase 2 Codex trial, with enrollment slated to start in Q4/18. Codex will evaluate the use of BC-819 in 140 third-line, high-risk NMIBC patients who failed BCG therapy.
Next year, enrollment for the Phase 3 Leo study, in second-line intermediate or high-risk NMIBC patients post BCG failure, should commence. Leo will evaluate BC-819 plus BCG compared to BCG monotherapy in 494 patients.
To see this plan through to approval and product launch is a newly installed, experienced management team. Its members have a track record of conducting clinical trials in oncology and bringing multiple oncology therapeutics to the market. "All of these characteristics bode well for Anchiano as it develops BC-819 in NMIBC," wrote Slutsky.[NLINSERT]
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Disclosures from LifeSci Capital, Anchiano Therapeutics, Initiating Coverage, Oct. 30, 2018
Analyst Certification: The research analyst denoted by an "AC" on the cover of this report certifies (or, where multiple research analysts are primarily responsible for this report, the research analyst denoted by an "AC" on the cover or within the document individually certifies), with respect to each security or subject company that the research analyst covers in this research, that: (1) all of the views expressed in this report accurately reflect his or her personal views about any and all of the subject securities or subject companies, and (2) no part of any of the research analyst's compensation was, is, or will be directly or indirectly related to the specific recommendations or views expressed by the research analyst(s) in this report.
Neither the research analyst(s), a member of the research analyst's household, nor any individual directly involved in the preparation of this report has a financial interest in the securities of the subject company.
LSC (or an affiliate) has received compensation from Anchiano Therapeutics for producing this research report. LSC is paid a monthly payment of $1,000 from the Affiliate for preparing and distributing research pertaining to each subject company under contract with the Affiliate. The subject company of this report is covered by this arrangement between LSC and the Affiliate, and LSC has therefore indirectly received compensation from the subject company for publishing this report. No explicit or implicit promises of favorable research coverage have been made to the subject company by LSC or the Affiliate. Neither LSC nor the Affiliate has promised any specific research content as an inducement for the receipt of business or compensation.
LSC (or an affiliate) has also provided non-investment banking securities-related services, non-securities services, and other products or services other than investment banking services to Anchiano Therapeutics and received compensation for such services within the past 12 months.
Neither LSC nor any of its affiliates beneficially own 1% or more of any class of common equity securities of the subject company.
This research contains the views, opinions and recommendations of LifeSci Capital, LLC ("LSC") research analysts.
Additionally, LSC expects to receive or intends to seek compensation for investment banking services from the subject company/ companies in the next three months.
LSC does not make a market in the securities of the subject company/companies.
Please visit http://www.lifescicapital.com/equity-research/ for disclosures related to each company that is a subject of this report.