SGAustria is the developer of Cell-in-a-Box® and holds world-wide rights for the underlying Cell-in-a-Box® technology including the background IP, trademarks and know how. The Company has enjoyed a close relationship with PharmaCyte Biotech (NASDAQ:PMCB) – formerly Nuvilex, Inc (NVLX.PK) for the last eleven years. The first agreements between the companies were signed in 2011 for the commercial development of SGAustria’s Cell-in-a-Box® technology for specific indications, starting with pancreatic cancer, as well as for diabetes and pain.

SGAustria has an accredited cGMP manufacturing facility that has produced encapsulated cytochrome P450 expressing cells (CypCaps) for technical evaluation and for PharmaCyte’s clinical trials. The data required by the U.S. Food and Drug Administration (FDA) on parameters such as stability and shelf life have also been verified by SGAustria.

Looking back on the close and collaborative relationship between the companies over the years, SGAustria’s Chairman and CTO, Prof. Dr. Walter H. Gunzburg, joins PHarmaCyte in wishing the recently stepped down CEO fo PharmaCyte, Kenneth L. Waggoner, all the best for his future. Dr. Gunzburg added, “We welcome PharmaCyte’s new interim CEO and their new Business Review Committee. We hope these changes will inject positive impetus and activity into PharmaCyte to move its signature Cell-in-a-BoxÒ live-cell encapsulation technology through the remaining FDA approval process, late stage clinical trials and the launch of a commercial product.”

The patent rights specifically for the use of encapsulated cytochrome P450 expressing cells for the treatment of pancreatic carcinoma and other cancers were acquired by PharmaCyte in 2013 for its signature live-cell encapsulation therapy development. Whilst these original patents have now lapsed, PharmaCyte continues to have a patent pending, and new clinical trial data would allow new patents to be filed. SGAustria continues to pledge support to PharmaCyte for filing new patents specifically in cytochrome P450 mediated treatment of tumours, including pancreatic cancer, as well as providing assurances as to PharmaCyte’s ongoing access to SGAustria technology within this context.

Commenting on SGAustria’s commitment to assist PharmaCyte, Dr Gunzburg stated: “The two companies have enjoyed a long and fruitful relationship. Indeed, with no other access to Cell-in-a-Box® technology, which is key to PharmaCyte’s core business, it is obvious that the interests of the two companies remain closely aligned, especially since PharmaCyte is a shareholder in SGAustria.”

The FDA placed a clinical hold on PharmaCyte’s IND application for Pancreatic Cancer using the Cell-in-a-Box® technology in November 2020 until additional data was provided. The clinical hold is to allow PharmaCyte to conduct new FDA-requested preclinical studies and to provide additional information regarding manufacturing information and product release specifications. SGAustria’s Dr. Gunzburg commented: “A whole team of experts and biotech consultants, including SGAustria, have been working with PharmaCyte to provide the FDA with the additional studies and information. It is not unusual for these novel, and highly complex cell and gene therapies to experience such a hold and most holds are eventually lifted by FDA.

Data already has been obtained to address most of the FDA issues that had previously and openly been listed by PharmaCyte, with the exception of a key study in pigs, for which a limited preliminary pilot study was started in July 2022.

Although there have been some delays in moving the signature Cell-in-a-BoxÒ live-cell encapsulation projects forward, with the newly announced change in PharmaCyte’s CEO and the new Board-empowered Business Review Committee, as well as the necessary financing being in place, SGAustria looks forward to PharmaCyte once more becoming a vibrant, productive biotechnology company with a clear strategic direction for the development of its core business and our shared technologies to the benefit of its shareholders as well as to the thousands of cancer patients who can potentially benefit from PharmaCyte’s unique treatments.

Dr. Gunzburg continued, “We believe that the scope of information requested by FDAiv would suggest that the Pancreatic Cancer Cell-in-a-BoxÒ product is close to a late-stage clinical trial with a view to eventual market authorization. We look forward to the resumption of meaningful progress with the newly instated PharmaCyte board and management. Previous clinical studies have shown that this exciting new treatment is effective and has minimal side effects during the treating of this devastatingly serious disease, which is still in dire need of new treatment options.”

About SGAustria

The SGAustria Group, is a group of biotech companies with a global footprint and operations in Singapore and Thailand. SGAustria performs biopharmaceutical and technology development services. The Company develops and manufactures a novel and proprietary technology for the encapsulation of living mammalian (Cell-in-a-Box®) and bacterial (Bac-in-a-Box®) cells. Cell-in-a-Box® protects the encapsulated cells from rejection by the immune system, allows cells to be easily transported, stored and implanted at specific sites in patients.

The technology, which has been proven safe and efficacious in clinical trials carried out in Europe, allows companies to develop any kind of cells as a one-for-all living pharmaceutical. SGAustria’s encapsulated live-cell therapies aid in the treatment of a wide range of diseases including diabetes, genetic diseases, and pancreatic cancer.

Bac-in-a-Box® is a similar protective device adapted for encapsulation of probiotic bacteria where it has human food and animal feed applications as well as rebalancing the microbiome due to its ability to extend storage under lyophilized conditions and to protect encapsulated bacteria against destruction by stomach acid.

The Company also offers GMP4Cells that includes competitively priced Master Cell Bank and Working Cell Bank production as well as “Fill and Finish” services for cell therapy products (such as stem cell therapies, biologics produced from cells e.g. vaccines, antibodies, enzymes, recombinant proteins, exosomes etc).

Forward-Looking Statements

This release includes forward-looking statements regarding SGAustria (the Company) and its respective businesses. Such statements are based on the current expectations of the management of each entity. The forward-looking events and circumstances discussed in this release, may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company, including risks affecting the Company, economic factors and the equity markets generally. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and SGAustria undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise. This is not an offer or solicitation to buy or sell any securities.

SOURCE: SGAustria Pte Ltd

Company and Technology Contact: salmons@SGAustria.com

For more information: http://www.sgaustria.com