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Biotech to Launch Preclinical Studies of Antibody in Eight Cancer Types

Streetwise Reports
0 Comments|March 1, 2019

This company's new trials, preferred dosing and upcoming biologics license application submission are discussed in an H.C. Wainwright & Co. report.

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In a Feb. 20 research note, H.C. Wainwright & Co. analyst Ram Selvaraju reported that CytoDyn Inc. (CYDY:OTCQB) plans to launch preclinical studies of its leronlimab (PRO 140) monoclonal antibody in eight cancer indications at a total cost of $1.5 million. Leronlimab blocks CCR5, which plays a role in advancing cancer metastasis and HIV.

These studies, one each being conducted in melanoma, pancreatic cancer, breast cancer, prostate cancer, colon cancer, lung cancer, liver cancer and stomach cancer, could generate data to support Phase 2 investigational new drug applications. Should they prove positive, CytoDyn intends to "evaluate several opportunities with multiple Phase 2 trials in cancer," wrote Selvaraju.

Regarding dosage of leronlimab, the FDA has instructed CytoDyn to use 700 milligrams (700 mg) and is allowing the company to switch all patients on the lower 350 mg dose in current studies to 700 mg, Selvaraju relayed. The 700 mg in the monotherapy trial yielded a higher response rate than the 350 mg in the combination study.

Additionally, the FDA indicated it will accept safety data concerning the 100 patients on 700 mg in the monotherapy trial. CytoDyn will be able to use 700 mg in its biologics license application (BLA) for leronlimab as a combination therapy for HIV. Additionally, Selvaraju commented, "given the 92% response rate at 700 mg, we believe the company should have a more persuasive data package of leronlimab for its upcoming BLA submission," expected in Q2/19.

H.C. Wainwright has a Buy rating and $1.50 per share price target on CytoDyn, whose stock is currently trading at around $0.51 per share. Because the financial institution's estimated value of leronlimab does not include its potential cancer applications, positive results in this regard "could drive additional upside to our price target," noted Selvaraju.

 

Disclosure:
1) Doresa Banning compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.

Disclosures from H.C. Wainwright & Co., CytoDyn Inc., Company Update, February 20, 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. 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 CytoDyn, Inc (including, without limitation, any option, right, warrant, future, long or short position).

As of January 31, 2019 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of CytoDyn, 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 CytoDyn, 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 CytoDyn, Inc. as of the date of this research report.

 


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