Enzolytics Inc (ENZC)

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What did ENZC envision in April 2022?

Enzolytics' primary U.S. lab is focused on the production of fully human monoclonal antibodies targeting multiple infectious disease?s?, including SARS-CoV-2 and HIV-1. The lab uses the Company's proprietary methodology for producing fully human monoclonal antibodies which target conserved, immutable sites on the viruses, thereby avoiding ineffectiveness due to virus mutation.

Enzolytics's Dallas laboratory is managed by Harry Zhabilov, the Company's CSO. From the Dallas laboratory, Mr. Zhabilov coordinates the development and the production of two of the Company's primary therapeutics, ITV-1 and IPF Immune. Both therapeutics are produced under patents invented by Mr. Zhabilov, U.S. Patent Nos. 8,066,982, 7,479,538, and 8,309,072.

Upon completion of scheduled toxicology studies, the ITV-1 therapeutic will be made available in the countries in Africa, including Rwanda, the Democratic Republic of Congo, Angola, Kenya and South Africa. Dr. Chandra is coordinating the introduction of ITV-1 for individuals in Africa. This is significant, recognizing that out of the 34 million HIV-positive people worldwide, 69% live in sub-Saharan Africa. There are roughly 23.8 million infected persons in all of Africa. In addition, 91% of the world's HIV-positive children live in Africa.

Prior successful Clinical Trials were completed earlier under the Bulgarian Drug Agency requirements. The Company plans to complete further clinical trials to fulfill EMA requirements to launch the therapy in the EU followed by seeking FDA approval for use in North America.


The Company has engaged Scendea (https://www.biospace.com/article/enzolytics-reports-its-engagement-of-scendea-usa-inc-a-leading-international-product-development-and-regulatory-consulting-group-to-guide-the-progress-toward-clinical-trials-and-market-approval-for-its-itv-1-anti-hiv-therapeutic/) to assist in introducing ITV-1 to EU countries through the EMA and to North America through FDA.Scendea (https://www.scendea.com) is a leading product development and regulatory consulting group serving the pharmaceutical and biotechnology industry. Scendea's service will focus on reducing time-to-market and minimizing development costs. Scendea's team offers strategic and operational support in quality/CMC, non-clinical/toxicology, clinical/medical, and regulatory, guiding the Company's ITV-1 therapy efficiently to market approval.

In the approval process, Scendea's critical role is finalizing a comprehensive clinical development plan based on the prior clinical trials completed earlier, preparing a CMC non-clinical Gap analysis, and a necessary EU Regulatory Strategy.

Thereafter, CMC and GMP Requirements for FDA and EMA will be completed under the direction of Eurofin, followed by production of ITV-1 as per EMA and FDA requirements and Fast-Tracked Clinical Trial to fulfill EMA and FDA requirements

https://www.centralcharts.com/en/1224249-enzolytics-inc/news/3675740-correction-enzolytics-inc-reports-progress-and-future-plans

IPF Immune is in the marketplace

ITV-1 therapeutic is next to hit the marketplace

What will follow next?

Charles and company may have miss projected deadlines however they have delivered the goods and will continue to do so.

Certainly there are many unknowns at the present time and much will be revealed at some point.

This little bitty biotech company is heading towards some humongous accomplishments that should allow to dance with Big Pharma.

It is March Madness

Go Huskies

Go ENZC