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PharmaCyte Biotech (PMCB) Q&A Discussion with Cellular Biologist David A. Judd

Joe Samuel

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LAGUNA HILLS, Calif.–(BUSINESS WIRE)–PharmaCyte Biotech, Inc. (PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, announced today the latest in its series of Q&A articles that are conducted with some of the key team members of PharmaCyte’s research and development program related to its upcoming clinical trial in locally advanced, inoperable pancreatic cancer (LAPC).

This interview-style Q&A article is with David A. Judd, a cellular biologist and a member of PharmaCyte’s Medical and Scientific Advisory Board. Mr. Judd has over 30 years of experience in the research and development of cell culture materials and methods for the culturing of various types of human cells. His work includes research, process development and cGMP production of biotechnology and cell therapy processes. Most importantly, Mr. Judd has worked for many years with the cells that PharmaCyte uses in its treatment of cancer and has a wealth of knowledge regarding their growth properties.

What attracted you to PharmaCyte and its cellular therapy for pancreatic cancer?

David Judd: “PharmaCyte’s approach is exceedingly unique in how it treats pancreatic cancer. This unique approach potentially spares a patient a lot of side effects that would be associated with typical chemotherapy. Far fewer patient cells should be affected peripherally with PharmaCyte’s cellular therapy, and with this treatment lower amounts of the chemotherapy drug ifosfamide can be used.

“In the big picture, this is the type of cellular therapy that I feel there could be a number of possibilities with cells and different agent combinations to make improvements and apply to cell-based chemotherapy.”

With your years of experience in cellular biology, what are your impressions of the Cell-in-a-Box® technology and how the therapy works for pancreatic cancer?

David Judd: “Cell-in-a-Box® is another encapsulation technology that is being evaluated in the market, but unique in its use of cellulose. Cellulose makes for a more rigid structure that is more robust and is also biocompatible – a remarkable combination.”

When you were in Thailand at Austrianova’s GMP facility, what impressions did you have about the manufacturing process and the dynamic of the PharmaCyte/Austrianova team?

David Judd: “The process is also unique. There is significant customization to this process. It is certainly not a process that can be suddenly transferred to a Contract Manufacturing Organization without some planning and investment made. There will be technology transfer and adaptation required.

“The PharmaCyte/Austrianova team is dedicated to a goal of improving lives and providing hope to patients and their families. The team is working together to solve issues and find the path forward with the best chance of success in the least amount of time.”

Are the changes that are being made to the manufacturing process common to the R&D process involving a cellular product?

David Judd: “Changes to a manufacturing process early on is standard; the process at Austrianova is no exception. Companies spend a lot of money and time on process development to get to goals as fast as possible with large, dedicated inhouse teams or contractors.

“This process should be compared to a cell therapy process rather than a biological drug. The product development is far more complicated. In this case, the process has unique hardware and software that have their own processes, which adds time to set up a single run. At this stage there is not enough hardware to make parallel run test iterations, and again that adds time to our clinical development timeline.”

Given your years of experience with the exact cell line PharmaCyte is using for its treatment of pancreatic cancer treatment, is there anything you can tell us about this cell line with regard to growth, sensitivity, ability to adapt, etc. to give us a better idea why the R&D process with this cell line isn’t as simple as encapsulate and grow to completion?

David Judd: “These cells are great tools for protein production, especially for human use. They are not as robust as CHO cells (the standard biological drug production cell line), so it does not take much to affect their growth behavior. These cells require more nurturing than the standard biologic or cell therapy. However, not being limited to autologous cells makes large scale manufacturing and distribution possible.

“Having human cells as the substrate I would think is preferable, but I am not an expert here; I’d think there is less chance of an adverse reaction occurring in patients, which might happen with an animal cell line should there be leakage.”

Can you talk about some of the changes that have been made to improve the manufacturing process and why they were made?

David Judd: “Austrianova changed to 3 passages of the Master Cell Bank (MCB) cells before encapsulation to increase the speed of cell doubling. A ‘passage’ is when the cells that are being grown are harvested and reseeded into another cell culture flask. It’s the way one expands the number of cells being grown and to put them in new cell culture medium.

“Austrianova changed from cultivating the cells in Hyperflasks to cultivating the cells in T75 flasks prior to encapsulation. The T75 flask is smaller than the Hyperflask. Austrianova found that the gas exchange is different in the different flasks. Hyperflasks are designed to be used to grow up large quantities of cells. T75 flasks are used to grow up a smaller number of cells like the number Austrianova is growing for PharmaCyte. Hyperflasks are good for very robust cells and very slow growing cells. The PharmaCyte cells are neither. There is the possibility to use other larger cell culture technologies, but this is not the time to be evaluating these.

“Austrianova changed from using 50L bags of cell culture medium to 1000 mL bottles of cell culture medium. A comparison of the growth properties of PharmaCyte’s Research Cell Bank (RCB) cells post-encapsulation using cell culture medium from 1000mL bottles, compared to a batch made for use in a bioreactor using 50L bags, demonstrated poor growth and uneven growth properties using the 50L bags. Austrianova reduced the pack size to reduce risk.

“Austrianova changed the number of cells it uses for the encapsulation process. Encapsulation is now being done using 2 times the number of cells than originally planned. There was a certain risk associated with increasing the number of cells for each manufacturing run as this can lead to nozzle blockage in the manufacturing process. However, Austrianova’s data suggested that doubling the number of cells used should not result in this effect. Austrianova was correct. It did not. It improved the growth properties of the cells.

“Shaking of the encapsulated cells changed. Initially, the encapsulated cells were grown without shaking immediately after encapsulation. That’s because the MCB cells grow worse after encapsulation with shaking than without. This is in contrast with what Austrianova observed in Singapore using the cells from PharmaCyte’s RCB. Based upon the experiments in Singapore, about one week after the cells were encapsulated in Thailand the encapsulated cells were moved from no shaking to shaking to encourage better oxygenation and cell growth at higher cell densities.

“Exposure of the cells from the MCB to phosphate-buffered saline (PBS) changed. The times of exposure to PBS and the volumes used were reduced. This was done because the MCB cells were found to be more sensitive to PBS than the RCB cells were. PBS is used to wash the cells after they have been grown in cell culture medium containing fetal calf serum during the initial cell culturing phase of the manufacturing process.

“Finally, the cell culture media change schedule was altered based upon test results in Singapore.”

Beyond pancreatic cancer, what are your thoughts on PharmaCyte’s treatment for other forms of solid cancerous tumors?

David Judd: “I think as long as cells can be placed near a tumor in an organ for local administration, this technology can provide hope for a more effective and less harmful treatment of solid cancerous tumors using chemotherapy as the treatment modality.

What are your early impressions of PharmaCyte’s diabetes therapy?

David Judd: “I think diabetes is where this type of technology really lends itself to the application. The key is to develop the right type of cell line to treat Type 1 and insulin-dependent Type 2 diabetes. There are several cell lines being explored by PharmaCyte simultaneously to do this. Selecting the right cell line to become our leading product candidate to treat diabetic patients in need of insulin is key to the success of PharmaCyte’s Diabetes Program.”

To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced inoperable pancreatic cancer, we encourage you to watch the company’s documentary video complete with medical animations at: https://www. PharmaCyte. com/Cancer

About PharmaCyte Biotech

PharmaCyte Biotech, Inc. (PharmaCyte) is a biotechnology company developing cellular therapies for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as “Cell-in-a-Box®.” This technology will be used as a platform upon which therapies for several types of cancer and diabetes are being developed.

PharmaCyte’s therapy for cancer involves encapsulating genetically engineered human cells that convert an inactive chemotherapy drug into its active or “cancer-killing” form. For pancreatic cancer, these encapsulated cells are implanted in the blood supply to the patient’s tumor as close as possible to the site of the tumor. Once implanted, a chemotherapy drug that is normally activated in the liver (ifosfamide) is given intravenously at one-third the normal dose. The ifosfamide is carried by the circulatory system to where the encapsulated cells have been implanted. When the ifosfamide flows through pores in the capsules, the live cells inside act as a “bio-artificial liver” and activate the chemotherapy drug at the site of the cancer. This “targeted chemotherapy” has proven effective and safe to use in past clinical trials and results in little to no treatment related side effects.

PharmaCyte’s therapy for Type 1 diabetes and insulin-dependent Type 2 diabetes involves encapsulating a human cell line that has been genetically engineered to produce and release insulin in response to the levels of blood sugar in the human body. PharmaCyte is developing the use of genetically modified liver cells and stem cells, as well as beta islet cells, to treat diabetes. The encapsulation will be done using the Cell-in-a-Box® technology. Once the encapsulated cells are implanted in a diabetic patient, they will function as a “bio-artificial pancreas” for purposes of insulin production.

Safe Harbor

This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that express the current beliefs and expectations of the management of PharmaCyte, including statements regarding the timing and commencement of our first Phase 2b clinical trial. Any statements contained herein that do not describe historical facts are forward-looking statements that are subject to risks and uncertainties that could cause actual results, performance and achievements to differ materially from those discussed in such forward-looking statements. Factors that could affect our actual results are included in the periodic reports on Form 10-K and Form 10-Q that we file with the U.S. Securities and Exchange Commission. These forward-looking statements are made only as of the date hereof, and we undertake no obligation to update or revise the forward-looking statements, except as otherwise required by law, whether as a result of new information, future events or otherwise

More information about PharmaCyte can be found at www. PharmaCyte. com. Information may also be obtained by contacting PharmaCyte’s Investor Relations Department.

Disclaimer: Pursuant to an agreement between MIDAM VENTURES, LLC and Complete Investment And Management LLC, a Non-affiliate Third Party, Midam was hired for a period from 07/09/2019 – 8/09/2019 to publicly disseminate information about PharmaCyte Biotech including on the Website and other media including Facebook and Twitter. We were paid $150,000 (CASH) for & were paid “0” shares of restricted common shares. We were paid an additional $150,000 (CASH) BY Complete Investment And Management LLC, a Non-affiliate Third Party, AND HAVE EXTENDED coverage for a period from 8/12/2019 – 9/12/2019. We may buy or sell additional shares of PharmaCyte Biotech in the open market at any time, including before, during or after the Website and Information, provide public dissemination of favorable Information. Click Here For Full Disclaimer

View source version on businesswire.com: https://www.businesswire.com/news/home/20191001005404/en/

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Biotechnology

3 Biotech Stocks To Watch As The Sector Heats Up

A. Lawrence

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top biotech stocks to watch list

When it comes to building a portfolio, money managers almost always ask their clients to diversify their portfolio. That’s in order to hedge against market risks. Hence, an investor needs to explore a wide range of sectors and choose stocks from those. One of the hottest sectors lately is the biotech sector.

It has managed to generate impressive growth over the past decade and remains a potentially high growth space for investors. On that note, here is a quick look at two biotech stocks that should be tracked by investors.

Biotech Stocks To Watch #1: GT Biopharma (GTBP)

GT Biopharma (GTBP) is a clinical-stage, immuno-oncology biotech company focused on innovative treatments based on its patent-pending TriKE™ technology. GT Biopharma (GTBP) is in good company within this space. Obviously you have the biotech giants:Gilead Sciences, Inc. (NASDAQ:GILD), Incyte Corporation (NASDAQ:INCY), &Merck & Co. (NYSE:MRK). But according to a recent article that was published on The Motley Fool it may be time for investors to give their attention to the “little guys” aka the Small Cap Stocks.

Within this article, The Motley Fool talks about 3 “Out of favor” “Cancer Treatment Stocks.” One of the companies is a small-cap stock that, according to the article, “sports marquee oncology partnerships with Gilead Sciences, Incyte, as well as Merck.” 

top biotechnology stocks to watch today

Similarly, when investors look at GT Biopharma (GTBP) they will notice that the company is indeed a small-cap stock and like the company The Motley Fool mentioned, has ties to a large entity to help further its own corporate missions. GT Biopharma (GTBP) has deep ties to the University of Minnesota & its prestigious Masonic Cancer Center, a comprehensive cancer center designated by the National Cancer Institute. Thanks to this relationship, GT Biopharma has been able to capitalize on several key developments:

GT Biopharma (GTBP) announces that Tim Schacker, M.D., Jeffrey S. Miller, M.D., and their colleagues at the University of Minnesota presented data showing its HIV-TriKE™ was able to kill HIV infected cells in the reservoir

GT Biopharma (GTBP) Announces Solid Tumor Targeting TriKe™ Kills Non-small Cell Lung Cancer (NSCLC) Tumor Cells

Read more on GT Biopharma Here.

Biotech Stocks To Watch #2: Jaguar Health (JAGX)

The first biotech stock to consider is that of Jaguar Health Inc (NASDAQ:JAGX), which made a major announcement at the end of October. That has resulted in the major rally in the stock through November and so far, the stock has gained as much as 45%. The company had announced that its fully owned subsidiary Napo Pharmaceutical has agreed on a distribution agreement with TannerGAP.

TannerGAP is part of the larger Tanner Pharma Group and will distribute the product Mytesi in places at which it is not yet registered. At this point in time, Mytesi is registered in Israel, the United States and Canada. Recently Jaguar also appointed Ian Wendt as its Vice President of Commercial Strategy.

On November 14 the company announced that Georgetown University ‘s Data Safety Monitoring Committee (“DSMC”) has reviewed the interim analysis for futility for the third-party, investigator-initiated Phase 2 HALT-D study evaluating the effectiveness of Mytesi® (crofelemer) for symptomatic relief in HER2 positive breast cancer patients receiving chemotherapy with trastuzumab, pertuzumab, and docetaxel or paclitaxel or trastuzumab, pertuzumab, carboplatin, and docetaxel (the “Study”). The DSMC has notified the Principal Investigator that the Study is allowed to enroll to completion. Enrollment in the Study now exceeds 85%, and the treatment period for each patient is 3 months.

SPECIAL REPORT | What Curing Cancer & HIV Could Mean for This Company, Its Investors & The World!

Biotech Stocks To Watch #3: Therapix Biosciences (TRPX)

The other biotech stock that warrants attention is that of Therapix Biosciences Ltd (NASDAQ:TRPX). The company is involved in developing treatments that are CBD based and today it announced top line results from the Phase 2A clinical study of its product THX-110. The study revealed that the product did, in fact, have a positive effect on patients who are afflicted with obstructive sleep apnea (OSA).

The study was conducted at the Assuta Hashalom Medical Center located in Israel and it represents a major positive for Therapix. After the news broke, the rocketed by as much as 19.45% and has emerged as one of the biotech stocks to watch for the rest of the week.

SPECIAL REPORT | What Curing Cancer & HIV Could Mean for This Company, Its Investors & The World!

best penny stocks Clovis Oncology (CLVS)

Pursuant to an agreement between Midam Ventures LLC and GT Biopharma (GTBP), Midam has been paid $100,000 for a period from October 1, 2019 to November 15, 2019. We may buy or sell additional shares of GT Biopharma (GTBP) in the open market at any time, including before, during or after the Website and Information, to provide public dissemination of favorable Information about GT Biopharma (GTBP). Click Here For Full Disclaimer.

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Biotechnology

3 Biotech Stocks to Watch After Key, 4th Quarter Developments

Joe Samuel

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top biotech stocks to buy

Biotech stocks have been one of the best performing sectors for a few weeks now. It’s hardly surprising that many analysts believe that investors should have one or more of those stocks on their watch lists. However, when it comes to choosing a stock, an investor needs to be very diligent with research.

They also need to watch the market very closely for the latest movements. Making a list of the stocks to watch is the best way to go about it. On that note, here is a look at three biotech stocks solidifying big developments this quarter.

PharmaCyte Biotech (PMCB)

top biotech stocks to buy now

PharmaCyte Biotech (PMCB) is in the prep phase of clinical trials and readying to complete its Investigational New Drug Application for the FDA.  Whether you’re new to biotech stocks or a seasoned vet, you should understand how important milestones like this are for a company.

David A. Judd, a cellular biologist and a member of PharmaCyte’s Medical and Scientific Advisory Board, was recently interviewed. Right now, PharmaCyte Biotech (PMCB) is putting together the necessary material for its planned clinical trial for inoperable pancreatic cancer, one of the most deadly forms of cancer today.

“We are in the late stages of preparing an Investigational New Drug application (IND) to conduct a clinical trial involving patients with LAPC whose tumors no longer respond to either of these two first-line therapies,” stated Pharmacyte in a recent article*.  “We hope to be in a position to file our IND in 2019.  [Pharmacyte is] in the process of developing the final data we need to finish preparation of the IND by completing the second of two staggered and back-to-back manufacturing runs of our clinical trial product.”

As one report puts it, “Clinical trials are essential for the development of new treatments, and PharmaCyte will enter this upcoming trial with two essential goals in mind—the future of its pancreatic cancer treatment and the future of its technology.”

Dare Bioscience (DARE)

best penny stocks Clovis Oncology (CLVS)

The first biotech stock that should be put on the watch list is that of Dare Bioscience Inc (NASDAQ:DARE). The Dare stock has soared in yesterday’s session the back of a significant announcement from the company. Dare is involved in the development of innovative health solutions for women and today entered into an agreement to acquire the pioneering drug delivery technology developed by Microchips Biotech Inc.

The technology in question can help in storing and delivering hundreds of doses over a period of as much as a year. It is a significant development for Dare and the stock has jumped by as much as 8% after the news. This is definitely a stock that should be tracked closely.

Agenus (AGEN)

The other biotech stock that has made a strong start this week is that of Agenus Inc (NASDAQ:AGEN), an immuno-oncology company. on Monday, the company announced that it has reached a licensing agreement with UroGen Pharma Ltd for its product zalifrelimab. More importantly, Agenus has received $10 million upfront from UroGen and that sent the stock price higher by 9.24% on Monday.

November has been a good month for the stock and so far it has gained as much as 45%. It released its quarterly results on November 4 and it proved a pleasant surprise for investors. The loss per share came in at $0.33, which beat analysts’ estimates of $0.38. On the other hand, the revenues of $19.94 also managed to surpass analysts’ estimates by 27.82%.

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Disclaimer: Pursuant to an agreement between MIDAM VENTURES, LLC and Complete Investment And Management LLC, a Non-affiliate Third Party, Midam was hired for a period from 07/09/2019 – 8/09/2019 to publicly disseminate information about PharmaCyte Biotech including on the Website and other media including Facebook and Twitter. We were paid $150,000 (CASH) for & were paid “0” shares of restricted common shares. We were paid an additional $150,000 (CASH) BY Complete Investment And Management LLC, a Non-affiliate Third Party, AND HAVE EXTENDED coverage for a period from 8/12/2019 – 10/15/2019. We were paid an additional $150,000 (CASH) BY Complete Investment And Management LLC, a Non-affiliate Third Party, AND HAVE EXTENDED coverage for a period from 10/16/2019 – 11/15/2019.We may buy or sell additional shares of PharmaCyte Biotech in the open market at any time, including before, during or after the Website and Information, provide public dissemination of favorable Information. Click Here For Full Disclaimer.

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Biotechnology

Biotech Stocks To Watch This Week

A. Lawrence

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make money with penny stocks biotech

With Biotech Continuing Higher, Are These Buys Or Sells This Week?

Biotech penny stocks have proven to be one of the best sectors for investments. That’s as far as the stock market is concerned. If experts are to be believed then it may continue to be among the best options in the years to come. That being said, it does not mean that investing in biotech stocks is an easy ride.

An investor needs to conduct a lot of research and also watch the market closely. Similar to other high-risk industries, volatility is a big factor. At any given point in time, a bad report could send stocks plummeting. Similarly, one good DA report can trigger a monster move. Here is a quick look at a few biotech penny stocks which made moves recently. Will they be better stocks to buy or avoid this month?

GT Biopharma Inc. (GTBP)

This company’s stock made new 3 month highs on October 22. GT Biopharma (GTBP) announced that its solid tumor targeting TriKE killed a non-small cell lung cancer tumor cell. This is a major development news for the company’s TriKE platform because the market potential for non-small lung cancer is big.

biotech stock to watch 2019

Non-small lung cancer accounts for 84% of all lung cancer diagnoses. Shareholders clearly felt this way, which may have been why GT Biopharma’s stock shot up by more than 25%.

There could be another potential reason why stockholders are reacting this way to the recent news. Earlier in October, the company announced that the design of HIV-TriKE was able to successfully target the HIV-Env protein.

This would allow the company’s TriKE technology to eliminate replicating HIV infected cells. Because of the success of TriKE with lung cancer cells, investors might feel that the company will be able to successfully destroy HIV cells. For more on GT Biopharma’s novel treatment pipeline and progress, click here.

WHAT CURING CANCER & HIV COULD MEAN FOR THIS COMPANY, ITS INVESTORS & THE WORLD!

Pieris Pharmaceuticals (PIRS)

The first stock to consider in the biotech sector with regards to the latest movements is that of Pieris Pharmaceuticals Inc (NASDAQ:PIRS). Back on November 5, the company announced that dose escalation monotherapy data with regards to one of its products is going to be presented at the Immunotherapy of Cancer (SITC) Annual Meeting that is going to be held at National Harbor, Maryland.

stock_price_mental

The medicine in question is PRS-343, which is meant for treating HER2-positive solid tumors. It goes without saying that it is a positive development and the Pieris stock has reacted positively to the news as well. Since the news broke, the stock has gained as much as 10%.

WHAT CURING CANCER & HIV COULD MEAN FOR THIS COMPANY, ITS INVESTORS & THE WORLD!

Foamix Pharmaceuticals (FOMX)

The other biotech stock that has been on a tear for much of the week is the Foamix Pharmaceuticals Ltd (NASDAQ:FOMX) stock. Back on October 18, the company announced that one of its products known as AMZEEQ has been approved by the United States Food and Drug Administration. The medicine in question is a topical foam and is meant for treating inflammatory lesions in both adults as well as pediatric patients, who are older than 9. That was the initial trigger for the rise in the stock price.

Last week, the company also published a peer review of the long term open-label safety of AMZEEQ and that proved to be the trigger for the rally. During the course of the week so far, the Foamix stock has soared by as much as 60%. This is a stock that should definitely be tracked by investors.

WHAT CURING CANCER & HIV COULD MEAN FOR THIS COMPANY, ITS INVESTORS & THE WORLD!

biotechnology stocks to buy

Pursuant to an agreement between Midam Ventures LLC and GT Biopharma (GTBP), Midam has been paid $100,000 for a period from October 1, 2019 to November 15, 2019. We may buy or sell additional shares of GT Biopharma (GTBP) in the open market at any time, including before, during or after the Website and Information, to provide public dissemination of favorable Information about GT Biopharma (GTBP). Click Here For Full Disclaimer.

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