In a May 27 research note, H.C. Wainwright & Co. analyst Yi Chen reported recent news concerning two of Anixa Biosciences Inc.'s (ANIX:NASDAQ) development programs.
One, the National Cancer Institute (NCI) awarded resources to Anixa to advance the preclinical studies of its ovarian cancer vaccine candidate targeting AMHR2-ED, Chen noted.
"In our view, the award provides peer validation of the company's ovarian cancer vaccine program and non-dilutive resources to advance preclinical studies," he stated.
Through its PREVENT program, the NCI will provide scientific and financial resources to the Cleveland Clinic, working with Anixa, through four milestones. The purpose of PREVENT is to support the preclinical development of innovative cancer interventions and biomarkers, moving them toward clinical trials.
Chen relayed that the first milestone is vaccine immunogenicity and efficacy testing in a mouse model. Anixa will begin this work after contracts are executed and experiments are designed.
The subsequent milestones are development of the expression vector for optimal vaccine production, then vaccine manufacturing following good manufacturing practices and a meeting with the U.S. Food and Drug Administration before an investigational new drug (IND) application filing, followed by good laboratory practice studies and an IND application submission.
Clinical trials of Anixa's vaccine could commence in 2022, according to H.C. Wainwright estimates.
In other news, Chen indicated, the FDA, in reviewing the IND application for Anixa's chimeric antigen receptor T-cell (CAR-T) therapy developed with Moffitt Cancer Center, asked for information about the chemistry, manufacturing and controls of the product. Anixa and Moffitt intend to provide the bulk of information within 30 days. As for any assays that may take longer than that to validate, the two firms will submit those when available.
"The agency has recently started to press cell and gene therapy developers to more consistently measure the characteristics of their therapies," Chen commented. "Therefore, we believe a more rigorous standard would be applied to all players in the space of cell and gene therapies going forward."
H.C. Wainwright forecasts that a Phase 1 trial of Anixa's CAR-T could start by the end of this year, 2021.
The investment bank has a Buy rating and an $11 per share price target on Anixa whereas its current share price is $3.93.[NLINSERT]
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Disclosures from H.C. Wainwright & Co., Anixa Biosciences Inc., Company Update, May 27, 2021
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, Yi Chen, Ph.D. CFA 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 off Anixa Biosciences, Inc. (including, without limitation, any option, right, warrant, future, long or short position).
As of April 30, 2021 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Anixa Biosciences, 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 Anixa Biosciences, Inc. for non-investment banking services in the previous 12 months.
The Firm or its affiliates did receive compensation from Anixa Biosciences, 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.
H.C. Wainwright & Co., LLC managed or co-managed a public offering of securities for Anixa Biosciences, Inc. during the past 12 months.
The Firm does not make a market in Anixa Biosciences, Inc. as of the date of this research report.