WPD Pharmaceuticals Licensor Announces Confirmatory in Vitro Analysis of WP1122
(firmenpresse) -
Vancouver, British Columbia - June 23, 2020 - WPD Pharmaceuticals Inc. (CSE: WBIO)(FSE: 8SV1) (the Company or WPD), a clinical stage pharmaceutical company, is pleased to announce that Moleculin Biotech Inc. (Moleculin), the company that sublicenses the WP1122 compound to WPD for use in 29 countries mainly in Europe, announced on June 16, 2020 that a repeat of previous in vitro testing has corroborated the antiviral potential of WP1122.
Although developing in vitro data is an initial step and the data may not necessarily reflect the antiviral effects in vivo, the results of this repeated round of in vitro testing received on June 1, 2020, confirm that WP1122 has an antiviral effect on Human Coronavirus 229E ("HCoV-229E"), a surrogate of SARS-CoV-2, the virus responsible for COVID-19.
The guidance provided thus far by Moleculin has been that it expects to file its request for Investigational New Drug (IND) status to test WP1122 for the treatment of COVID-19 patients during the second half of 2020. The opportunity to shorten that time frame may depend on Moleculin's ability to use non-GLP (studies not done in strict adherence to "Good Laboratory Practices") toxicology data for the IND submission and exploring this possibility was a part of Moleculin's request for feedback in its Pre-IND submission to the US Food and Drug Administration, ("FDA"). Based on the FDA's response, Moleculin now plans to present its non-GLP toxicology, when available, to the FDA in a second Pre-IND meeting request. While there can be no assurance that the FDA will allow Moleculin's IND to go into effect on the basis of non-GLP toxicology data, Moleculin believes the possibility is worth pursuing, because it could significantly reduce its timeline to begin clinical trials for WP1122.
On May 27, 2020, Moleculin announced results from the initial preclinical assessment of the potential for WP1122 to address COVID-19. The testing involved a cell viability assay, followed by a virus yield reduction assay. These tests were intended to assess and compare in vitro antiviral properties of WP1122 and its active moiety (subpart) 2-DG. In this regard, an unedited version of an article that has now been accepted for publication in the scientific journal, Nature (Bojkova, D. et al. Proteomics of SARS-CoV-2-infected host cells reveals therapy targets, Nature https://doi.org/10.1038/s41586-020-2332-7 2020), reports that one of the therapeutic targets in SARS-CoV-2 is glycolysis. This work performed by an independent research team at the Göethe-University of Frankfurt further showed that targeting glycolysis with 2-DG stopped replication of SARS CoV-2 in vitro. These results are consistent with previous research reports demonstrating the antiviral activities of 2-DG in other viruses. Notwithstanding the available preclinical data, Moleculin believes that, without the benefit of WP1122's prodrug structure, 2-DG's rapid metabolism and limited drug-like properties prevent it from being sufficiently effective in vivo and that in vivo testing of WP1122 may make its benefits more apparent.
Moleculin's testing was intended to demonstrate the ability of WP1122, a prodrug of 2-DG, to inhibit coronavirus proliferation in a mammalian cell culture. The testing was performed using a surrogate of SARS-CoV-2 called HCoV-229E, which was a validated assay that was immediately available at the time. Moleculin and the independent testing contractor consider HCoV-229E an appropriate surrogate model for SARS-CoV-2 as both 2-DG and WP1122 are thought to act as both inhibitors of glycolysis and also by altering glycoprotein/glycan structures, including the characteristic spikes found on SARS-CoV-2. Glycans have been shown to form on the outside of the virus and can serve to shield it from the host's immune system. Additionally, the glycoprotein/glycan spikes present on HCoV-229E and on SARS-CoV-2 appear to perform similar functions in the viral lifecycle. Moreover, 2-DG and WP1122 are also believed to work by inhibiting glycolysis, which is expected to play a similar role in HCoV-229E as it does in SARS-CoV-2.
The initial tests were intended to provide comparative data, and therefore were done with both WP1122 and 2-DG. The follow-on tests just completed were intended to confirm the antiviral activity of WP1122, and therefore tested only WP1122. Additionally, the results of in vitro testing thus far lead Moleculin to believe that conventional methods of antiviral testing were not designed to test the class of agents represented by 2-DG and WP1122 and testing methods should be optimized to reflect the full antiviral potential of these sugar antimetabolites. The mechanism of action of 2-DG and WP1122 is very different from other drugs being developed for COVID-19. Specifically, because 2-DG has been shown to target glucose metabolism, in vitro testing results are significantly affected by the concentration of natural glucose in the microenvironment present during viral replication and continued infection. For this reason, and consistent with guidance from the FDA, Moleculin will seek to evaluate WP1122 in an animal model for COVID-19 as a part of its IND preparation.
On May 1, 2020, Moleculin submitted a Pre-IND meeting request with the FDA regarding the clinical development of WP1122 for the treatment of COVID-19. On June 2, 2020, Moleculin received the FDA's written response with guidance regarding application of the agency's requirements for clinical development programs in this circumstance.
Moleculin plans to address the FDA's guidance, both in a second Pre-IND meeting and in an IND submission currently anticipated for the end of 2020. Moleculin will seek to conduct a Phase 1a/1b proof-of-concept study, with the Phase 1b being in a relatively small number of early, mild COVID-19 patients.
WPD has not conducted its own independent confirmation of WP1122 and is relying solely on the information contained in Moleculins news release in providing this information to WPDs shareholders.
About WPD Pharmaceuticals
WPD is a biotechnology research and development company with a focus on oncology, namely research and development of medicinal products involving biological compounds and small molecules. WPD has 10 novel drug candidates with 4 that are in clinical development stage. These drug candidates were researched at institutions including the Mayo Clinic and Emory University, and WPD currently has ongoing collaborations with Wake Forest University and leading hospitals and academic centers in Poland.
WPD has entered into license agreements with Wake Forest University Health Sciences and with two U.S. based public companies, respectively, each of which grant WPD an exclusive, royalty-bearing sublicense to certain technologies of the licensor. Such agreements provide WPD with certain research, development, manufacturing and sales rights, among other things. The sublicense territory from CNS Pharmaceuticals and Moleculin Biotech includes 31 countries in Europe and Asia, including Russia.
On Behalf of the Board
Mariusz Olejniczak
Mariusz Olejniczak
CEO, WPD Pharmaceuticals
Contact:
Investor Relations
Email: investors(at)wpdpharmaceuticals.com
Tel: 604-428-7050
Web: www.wpdpharmaceuticals.com
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Investors are cautioned that, except as disclosed in the Companys CSE listing statement, prepared in accordance with the policies of the CSE, any information released or received with respect to the transaction may not be accurate or complete and should not be relied upon. Trading in the securities of the Company should be considered highly speculative.
Neither the Canadian Securities Exchange nor the Investment Industry Regulatory Organization of Canada accepts responsibility for the adequacy or accuracy of this release.
This press release contains forward-looking statements. Forward-looking statements are statements that contemplate activities, events or developments that the Company anticipates will or may occur in the future. Forward-looking statements in this press release include that WPD101s specific targeting of GBM cells should allow for selective elimination of tumor cells by bacteria-toxins-induced cytotoxic effects without affecting normal cells; that the manufacturing for the development of the drug delivery formulation is expected to be completed within approximately one year which will allow us to start human clinical trials; and that WPDs drugs could be developed into novel treatments for cancer. These forward-looking statements reflect the Companys current expectations based on information currently available to management and are subject to a number of risks and uncertainties that may cause outcomes to differ materially from those projected. Factors which may prevent the forward looking statement from being realized is that competitors or others may successfully challenge a granted patent and the patent could be rendered void; that we are unable to raise sufficient funding for our research; that our drugs dont provide positive treatment, or if they do, the side effects are damaging; competitors may develop better or cheaper drugs; and we may be unable to obtain regulatory approval for any drugs we develop. Readers should refer to the risk disclosure included from time-to-time in the documents the Company files on SEDAR, available at www.sedar.com. Although the Company believes that the assumptions inherent in these forward-looking statements are reasonable, they are not guarantees of future performance and, accordingly, they should not be relied upon and there can be no assurance that any of them will prove to be accurate. Finally, these forward-looking statements are made as of the date of this press release and the Company assumes no obligation to update them except as required by applicable law.
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Datum: 22.06.2020 - 13:07 Uhr
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