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GT Biopharma (GTBP) Announces HIV TriKE™ Data Demonstrating NK Cell Killing of Patient HIV Infected Cells

Joe Samuel

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TAMPA, Florida , Oct. 3, 2019 /CNW/ — GT Biopharma, Inc. (GTBP) (GTBP.PA), an immuno-oncology company focused on innovative treatments based on the Company’s patent-pending TriKE™ technology, announced today that Tim Schacker , M.D., Jeffrey S. Miller , M.D., and their colleagues at the University of Minnesota presented data during a poster session held at the 18th meeting of the Society for Natural Immunity in Luxembourg discussing their design of an HIV-TriKE™ containing an antigen-binding fragment (Fab) from a broadly-neutralizing antibody targeting the HIV-Env protein. The HIV-TriKE™ is designed to target HIV while redirecting NK cell killing specifically to actively replicating HIV infected cells.

Special Report | 1 Biotech Stock Presenting First-Look Opportunity For Investors

While the use of anti-retroviral drugs have substantially improved the health and increased the longevity of individuals infected with the human immunodeficiency virus (HIV), these drugs are designed to suppress virus replication to help modulate progression to AIDS and to limit further transmission of the virus. Despite the use of anti-retroviral drugs, infected individuals retain reservoirs of latent HIV-infected cells that, upon cessation of anti-retroviral drug therapy, can reactivate and re-establish an active HIV infection. For a curative therapy, destruction of these latent HIV infected cells must take place.

Research findings from Dr. Schacker’s and Dr. Miller’s laboratories show enhanced NK cell cytokine production and killing of infected targets expressing HIV-Env when incubated with the HIV-TriKE™. Peripheral blood mononuclear cells (T-cells, B-cells, NK cells and monocytes) from healthy donors incubated with the HIV-TriKE™ showed marked increases in immune cell activation in NK cell, CD4 T-cell and CD8 T-cell population subsets. The HIV-TriKE™ also induced NK cell proliferation, and demonstrated the ability in vitro to reactivate and kill HIV-infected T-cells. 

These findings indicate a potential role for the HIV-TriKE™ in the reactivation and elimination of the latently infected HIV reservoir cells by harnessing the NK cell’s ability to mediate the antibody-directed cellular cytotoxicity (ADCC).

Mr. Anthony Cataldo , the Chairman and Chief Executive Officer of GT Biopharma, commented, “We are pleased to see how the TriKE™ technology is able to be extended to the treatment of infectious disease, and is able to kill HIV in the reservoir.”  Mr. Cataldo further stated, “We believe the HIV-TriKE™ will become part of a scalable and curative therapeutic strategy.”

About HIV

HIV (human immunodeficiency virus) harms the immune system by destroying white blood cells which fight infection. Infected individual are at risk for serious infections and certain cancers. The virus can be transmitted through contact with infected blood, semen, or vaginal fluids. The disease is usually asymptomatic until it progresses to AIDS (acquired immunodeficiency syndrome). No cure exists, but strict adherence to expensive antiretroviral therapy can dramatically slow the disease’s progress and prolong life. According to the World Health Organization, there are over 36 million people currently infected with HIV. Current drugs only treat the symptoms of HIV at a significant economic cost. HIV infected individuals remain infected for the rest of their lives. The challenge in the HIV field is to kill virus infecting a patient’s T-cells, and destroy virus hiding in sanctuary reservoir sites within the body.

About GTB-3550 TriKE™ and GTB-3550 TriKE™ Phase I/II Clinical Trial

GTB-3550 is the Company’s first TriKE™ product candidate which is a single-chain, tri-specific recombinant fusion protein construct composed of the variable regions of the heavy and light chains of anti-CD16 and anti-CD33 antibodies and a modified form of IL-15. The GTB-3550 Phase I/II clinical trial for treatment of patients with CD33-expressing, high risk myelodysplastic syndromes, refractory/relapsed acute myeloid leukemia or advanced systemic mastocytosis opened for patient enrollment September 2019 . The clinical trial is being conducted at the University of Minnesota’s Masonic Cancer Center in Minneapolis, Minnesota under the direction of Dr. Erica Warlick .

About GT Biopharma, Inc.

GT Biopharma, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of immuno-oncology products based off our proprietary Tri-specific Killer Engager (TriKE™) and Multi-Target Directed Bispecific Drug Conjugate technology platforms. Our TriKE platform is designed to harness and enhance the cancer killing abilities of a patient’s immune system natural killer cells (NK cells). GT Biopharma has an exclusive worldwide license agreement with the University of Minnesota to further develop and commercialize cancer therapies using proprietary TriKE technology developed by researchers at the university to target NK cells to cancer. Our Multi-Target Directed Bispecific Drug Conjugate platform can generate product candidates that are bi-specific, ligand-directed single-chain fusion proteins that, we believe, represent the next generation of targeted therapy.

Forward-Looking Statements

This press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict, including statements regarding the potential acquisition, the likelihood of closing the potential transaction, our clinical focus, and our current and proposed trials.  Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as “believes”, “hopes”, “intends”, “estimates”, “expects”, “projects”, “plans”, “anticipates” and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking.  Our forward-looking statements are not guarantees of performance and actual results could differ materially from those contained in or expressed by such statements. In evaluating all such statements, we urge you to specifically consider the various risk factors identified in our Form 10-K for the fiscal year ended December 31, 2018 in the section titled “Risk Factors” in Part I, Item 1A and in our subsequent filings with the Securities and Exchange Commission, any of which could cause actual results to differ materially from those indicated by our forward-looking statements.

Our forward-looking statements reflect our current views with respect to future events and are based on currently available financial, economic, scientific, and competitive data and information on current business plans.  You should not place undue reliance on our forward-looking statements, which are subject to risks and uncertainties relating to, among other things:  (i) the sufficiency of our cash position and our ongoing ability to raise additional capital to fund our operations, (ii) our ability to complete our contemplated clinical trials, or to meet the FDA’s requirements with respect to safety and efficacy, (iii) our ability to identify patients to enroll in our clinical trials in a timely fashion, (iv) our ability to achieve approval of a marketable product, (v) design, implementation and conduct of clinical trials, (vii) the results of our clinical trials, including the possibility of unfavorable clinical trial results, (vii) the market for, and marketability of, any product that is approved, (viii) the existence or development of treatments that are viewed by medical professionals or patients as superior to our products, (ix) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, and social conditions, and (x) various other matters, many of which are beyond our control.  Should one or more of these risks or uncertainties develop, or should underlying assumptions prove to be incorrect, actual results may vary materially and adversely from those anticipated, believed, estimated, or otherwise indicated by our forward-looking statements.

We intend that all forward-looking statements made in this press release will be subject to the safe harbor protection of the federal securities laws pursuant to Section 27A of the Securities Act, to the extent applicable. Except as required by law, we do not undertake any responsibility to update these forward-looking statements to take into account events or circumstances that occur after the date of this press release. Additionally, we do not undertake any responsibility to update you on the occurrence of any unanticipated events which may cause actual results to differ from those expressed or implied by these forward-looking statements.

Disclosures 

TriKE™ is a trademark of GT Biopharma, Inc.

Dr. Miller also serves as Consulting Chief Medical Officer of GT Biopharma, Inc.

For more information, please visit www.gtbiopharma.com
800-304-9888

Disclaimer: 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.

View original content:http://www.prnewswire.com/news-releases/gt-biopharma-announces-hiv-trike-data-demonstrating-nk-cell-killing-of-patient-hiv-infected-cells-300930348.html

SOURCE GT Biopharma, Inc.

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Biotechnology

3 Penny Stocks Looking To Change The Biotech Industry

Jon Phillip

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The world of biotech investing can be tricky. That’s particularly true when it comes to small-cap stocks in the industry. These companies often have terrific science, but no profits and little revenue; if any at all. But biotech stocks can offer true potential for investors who know what to look for.

Perhaps the best strategy for gaining exposure to this space is to look at early-stage, small-cap biotechs. By doing so, you put yourself at the front-line for cutting edge, experimental companies that could one day hit it big. Given this, here are 3 small-cap biotechs working to evolve in the biotech industry.

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

GT Biopharma Inc. (GTBP)

One company making groundbreaking developments in the biotechnology field is GT Biopharma Inc. (GTBP). GT Biopharma Inc. is an immune-oncology biotech company determined to create new treatments for cancer. In order to do this, the company leverages its proprietary TriKE technology to develop its pipeline. As of now, GT Biopharma has 6 treatment plans undergoing the clinical trial process.

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So, what exactly is this TriKE technology platform? TriKE is actually an acronym for tri-specific killer engagers that are made to target NK’s or natural killer and tumor cells. Once they target NK cells, it binds to the CD16 receptor which makes a longer and stronger response compared to current treatment methods.

TriKE Therapy

One use of TriKE has been to develop a way to target the HIV-Env protein. The design to do this is known as HIV-TriKE. As a matter of fact, the company recently announced data that showed the effectiveness of HIV-TriKE. It was shown that it enhanced NK cell cytokine production and effectively killed infected targets with HIV-Env.

“We are pleased to see how the TriKE™ technology is able to be extended to the treatment of infectious disease and is able to kill HIV in the reservoir.”  Mr. Cataldo further stated, “We believe the HIV-TriKE™ will become part of a scalable and curative therapeutic strategy,” expressed Anthony Cataldo, CEO and Chairman of GE Biopharma.

Conatus Pharmaceuticals Inc. (CNAT)

This next biotechnology company is known as Conatus Pharmaceuticals Inc. (CNAT). This company’s focus is different compared to GT Biopharma. It aims to treat chronic diseases that have a large unmet need. Its lead product candidate CTS-2090, inhibits IL-1β which treats inflammatory diseases.

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In terms of news releases, the company has been slightly lackluster over the last two months. However, in early August Conatus released its Q2 financials which showed some profitability promise in its income statement.

Revenues increased and expenses decreased in Q2 2019 compared to Q2 2018 which significantly reduced the company’s net loss by $3.8 million. One potential hindrance factor in the financials could be Conatus’ consistently declining free cash flow.

Nuvectra Corporation (NVTR)

To top things off, we have a neurostimulation company known as Nuvectra Corporation (NVTR). The company has a commercial product called Algovita Spinal Cord Stimulation which treats chronic pain of the trunk and limbs. In addition to this, Nuvectra is awaiting FDA pre-market approval for its Virtis Sacral Neuromodulation which treats chronic urinary retention and overstive bladders.

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Compared to Conatus, Nuvectra has produced recent news that investors can sink their teeth into. First off, the company appointed Jennifer Kosharek as CFO around a month ago. This is a strong appointment thanks to her 15+ years of accounting experience and other leadership positions with Nuvectra.

Furthermore, the company recently submitted its supplementary chemical composition and biocompatibility data to the FDA to support Virtis’ pre-market approval.

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

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Pursuant to an agreement between Midam Ventures LLC and GT Biopharma Inc. (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 Inc. (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 Inc. (GTBP). Full Disclaimer Click Here

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Biotechnology

Are These Biotech Names On Your October Watch List?

Joe Samuel

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Over the past two decades, the biotech sector has been one of the best sectors to watch. If experts are to be believed, then it is likely to continue to be a hot sector for the foreseeable future. However, biotech stocks require research and that can help when it comes to making a list of biotech stocks.

Once that is done, the investor needs to track the companies closely. Then it’s easier to decide upon the best course of action. Here is a look at three biotechnology penny stocks this month.

Biotech Stocks To Watch: PharmaCyte Biotech (PMCB)

If you’re looking at PharmaCyte Biotech (PMCB) at this exact moment, you’re seeing it before the company begins clinical trials and just as it’s preparing 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.

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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. Though there has been a targeted focus on Pancreatic cancer with PharmaCyte, its diabetes application may also have promise according to 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.”

Over the last week, shares of PMCB stock have jumped from $0.0319 to highs of $0.0367 on Friday.

Biotech Stocks To Watch: Hepion Pharmaceuticals (HEPA)                                           

The next biotech stock to watch is Hepion Pharmaceuticals Inc (NASDAQ:HEPA). The company is involved in manufacturing medicines meant for liver conditions emanating from non-alcoholic reasons. The company announced that its research article has been published by the highly influential peer-reviewed journal, the Journal of Pharmacology and Experimental Therapeutics.

The paper in question is titled “A Pan-Cyclophilin Inhibitor, CRV431, Decreases Fibrosis and Tumor Development in Chronic Liver Disease Models.” The study shows that Hepion’s product CRV431 could well be a solution for treating chronic diseases of the liver. The paper also stated that the medicine is suited to address a range of therapeutic needs.

Once the news broke, the company’s stock started soaring and soared over 43% at $3.58, well off the session high of $5.59.

Biotech Stocks To Watch: Protalix Biotherapeutics (PLX)

The other biotech stock that broke out more this week is Protalix Biotherapeutics Inc (NYSE:PLX). The company released data from the BRIDGE Phase 3 clinical study of its product PRX-102 and the revelations have proven to be highly encouraging. Out of a total of 22 patients who had been enrolled for the study, the data was gleaned from 16 of them.

The patients in question had been treated with PRX-102 for 12 months. The medicine is meant for treating Fabry disease and it has been revealed that there was an improvement in the function of kidneys in the patients. The stock soared by as much as 75% on Thursday and should definitely be on the watch lists of most investors.

list of healthcare stocks to watch

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. Full Disclaimer Here.

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Biotech ETF’s Just Hit New Highs: 3 Stocks To Watch

Joe Samuel

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Biotech & Healthcare ETF’s Made New October Highs; Watching Sector Stocks?

There are certain sectors in the stock market that regularly excite investors. Much of that has to do with the core strength of the sector in question. While tech has been such a sector for more than three decades now, the biotech sector has also been a sector that has helped investors make excellent returns for many years now.

Over the last few trading sessions, both the IBB and XLV ETF’s have taken off to make new October highs. So why wouldn’t healthcare and biotechnology catch someone’s eye?

The biotech sector has a plethora of stocks though. Therefore, an investor needs to put in the necessary research. On that note, here is a look at three biotech stocks to watch as sector stocks enjoy a bull run in October.

GT Biopharma (GTBP) Pops After HIV Data Presentation

GT Biopharma, Inc. (GTBP) is an immuno-oncology company focused on innovative treatments based on the Company’s patent-pending TriKE™ technology. It’s also a biotech stock that has been on the move this month. Earlier in October the company announced key presentation data on its HIV TriKE™ platform.

GT Biopharma (GTBP) Announces HIV TriKE™ Data Demonstrating NK Cell Killing of Patient HIV Infected Cells

Tim Schacker , M.D., Jeffrey S. Miller , M.D., and their colleagues at the University of Minnesota presented data during a poster session held at the 18th meeting of the Society for Natural Immunity in Luxembourg.

biotechnology stocks to watch

Research findings from Dr. Schacker’s and Dr. Miller’s laboratories show enhanced NK cell cytokine production and killing of infected targets expressing HIV-Env when incubated with the HIV-TriKE™. This could be a big step for the company and one that has caught some attention this month.

In comparison, the use of anti-retroviral drugs have substantially improved the health and increased the longevity of individuals infected with the human immunodeficiency virus (HIV). But these drugs are designed to suppress virus replication to help modulate progression to AIDS and to limit further transmission of the virus. In this case, GTBP’s HIV-TriKE™ was actually able to kill HIV in the reservoir.

Achillion Pharmaceuticals (ACHN) Jumps On Buyout

One of the biotech stocks that made a remarkable move this week was Achillion Pharmaceuticals, Inc. (NASDAQ:ACHN) after it was announced that the company was going to be acquired by Alexion Pharmaceuticals. According to the announcement, Achillion is going to be acquired in a deal worth $930 million.

 It is a deal that is going to be completed entirely in cash. Alexion is paying a premium of 73% above the closing price of the Achillion stock on Tuesday. That works out to a price of $6.30 a share and on Tuesday, the stock had closed at $3.65 a share.

The announcement lit a fire on the Achillion stock and it zoomed by as much as 75% on Wednesday. Considering the sort of premium that is being paid, it is not really a surprise for most market watchers to take notice.

Atossa Genetics (ATOS) Gains On Phase 2 clinical study

The other biotech stock that is in the news today is that of Atossa Genetics Inc (NASDAQ:ATOS). The clinical-stage biopharmaceutical company that is engaged in developing treatments for breast cancer, made a major announcement.

[REPORT] BIOTECH INVESTORS TURN ATTENTION TO TARGETED TREATMENT; ONE COMPANY STANDS OUT

It has been announced that its microcatheter technology has been approved for a Phase 2 clinical study by the Institutional Review Board (IRB).

The technology helps in administering fulvestrant in breast cancer patients and could have major implications for the company’s long term growth. The market believed so as well and the Atossa stock climbed as much as 4.50% after the news broke on Wednesday.

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Disclaimer: 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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