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GT BIOPHARMA GTB-1550 Multi-Targeted Bispecific Drug Conjugate Strategically Positioned in New Class of ADC Drugs

A. Lawrence

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Multi-Targeted Bispecific Drug Conjugate

Strategically positioned in new class of ADC Drugs

TAMPA, Florida, June 13, 2019 /PRNewswire/ — GT Biopharma, Inc. (GTBP) (GTBP.PA) an immuno-oncology company developing GTB-1550, a novel multi-target bispecific drug conjugate therapy for the treatment of chemotherapy-refractory B-cell malignancies. 

Today, Bloomberg discussed antibody-drug conjugates (ADC) as effective cancer therapies having the potential to replace traditional chemotherapy. ADCs are essentially a “trojan horse” therapeutics which have several advantages over traditional chemotherapy including less toxicity and higher efficacy due to a more precise targeting of cancer cells compared to non-cancer cells.

[REPORT] Big Investments Are Signaling The Green Light For A ‘Hot Market’ With Cancer-Fighting Stocks

An ADC is composed of an antibody which specifically identifies cancer cells and a cytotoxic agent (the payload) which has been grafted onto the antibody.  When injected into patients, the ADC traffics through the patient’s body to find the targeted cancer cells.  Upon binding to the cancer cell, the ADC is internalized by the cancer cell, and the cytotoxic payload kills the cancer cell.

Anthony Cataldo (CEO GT Biopharma, Inc.) said, “The Bloomberg article points out the excitement that big pharma is now realizing as the potential for ADC’s as a realistic alternative to Chemo Therapies. What differentiates our ADC Bispecific GTB-1550, is the ability for our drug to hit multiple target sites of B-cell malignancies as opposed to the one target ADC’s represented in the Bloomberg article. We are happy to see the attention of the large pharmaceuticals moving in this direction.”

GTB-1550 is a novel, multi-target bispecific cytotoxic therapeutic agent consisting of diphtheria toxin and bispecific single-chain variable fragments (scFV) of antibodies targeting human CD19 and CD22.  By simultaneously targeting cancer cells that express either CD19 or CD22 or both, GTB-1550 is capable of killing a broader variety of hematological malignancies than either a traditional a CD19 antibody drug conjugate or a CD19 CAR-T immunotherapy which are only able to target and attack CD19 expressing hematological malignancies.  Simultaneously targeting multiple cancer targets such as CD19 and CD22 using a single therapeutic agent potentially makes GT Biopharma’s multi-target bispecific drug conjugate therapy the next generation of advanced cancer therapies.

To date, GTB-1550 has completed one dose escalation Phase I-II expansion clinical trial, and one fixed dose Phase I-II expansion clinical trial which collectively enrolled a combined 43 patients. 

Top-line Consolidated Results:

  • Two patients exhibited a Complete Remission (CR) with one patient currently disease-free at 50 months post treatment.
  • Five patients exhibited Stable Disease (SD) with the longest response lasting 12 months post treatment.
  • Two patients with transformed lymphoma showed transient tumor shrinkage, however, therapy was discontinued due to dose-limiting toxicities after the 1st cycle.
  • Greater than 50% of evaluable patients receiving 60 mg/kg dose had positive clinical response defined as stable disease, partial remission, or complete remission.

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 Bispecific Drug Conjugate (MTBDC) 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 Bispecific Drug Conjugate (MTBDC) platform can generate product candidates that are bispecific, 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 a guarantee 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 for GTB-3550 or GTB-1550, 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.

For more information, please visit www. gtbiopharma . com. Pursuant to an agreement between MIDAM VENTURES, LLC and GT Biopharma, Midam was hired for a period from 06/07/2019 – 7/07/2019 to publicly disseminate information about GT Biopharma including on the Website and other media including Facebook and Twitter. We were paid $100,000 (CASH) for & were paid “0” shares of restricted common shares. We may buy or sell additional shares of GT Biopharma 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

4 Biotech Stocks To Watch After Latest M&A Activity

Joe Samuel

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biotech stocks to buy now

This month the American Society of Clinical Oncology held its annual meeting in Chicago, which brought about more attention to the healthcare sector and biotech stocks. The recent deal between Merck and Tilos Therapeutics has sparked increased enthusiasm within the industry.  The takeover will give Merck control of a pipeline of cancer, fibrosis and autoimmune programs targeting the latent TGFβ complex.

Cancer research remains one of the most critical areas of focus for most investors. This is simply due to the fact that if a company can come up with a truly path-breaking product, then the potential for growth could be significant. With this in mind, here are four biotech stocks to watch on Tuesday.

Small Cap Biotech Stocks Take Center Stage

GT Biopharma (GTBP) has followed suit with a clear focus on immune diseases.  The company’s lead treatment, GTB-1550 is a novel multi-target directed therapy for the treatment of chemotherapy-refractory B-cell malignancies, including Non-Hodgkins Lymphoma and Leukemia.  “GTB-1550 has shown positive results in its two Phase I-II clinical trials in advanced cancer patients who have failed all other therapies, and we are now planning to proceed with a Phase II clinical trial,” explained Anthony Cataldo, the Chairman and Chief Executive Officer of GT Biopharma.

Mr. Cataldo took the reigns on GT Biopharma earlier this year.  He is the founder of the company and one of the key leaders within the industry. His past successes include being the founder and previous CEO of Iovance Biotherapeutics. Anthony Cataldo was able to grow Iovance early on, and the company currently holds a market cap of over $2 billion with a share price above $19 per share.

In addition to the above, the company’s therapy has also shown that it could target HIV infected cells in the University of Minnesota’s preclinical testing. Not only that but in specific tests, data showed that HIV-infected targets that express the HIV envelope on their surface could be eliminated. As the company stated, “The HIV TriKE’s possibility to kill the HIV virus would solve a massive economic burden as well as stop infected patients from spreading the disease.”

Adding to this list of novel biotech stocks to watch, Histogenics Corporation (HSGX) is targeting a pipeline of therapies to treat rare eye diseases.  In April, the company announced a deal with Ocugen Inc. to ultimately take over the company. Ocugen was founded by Pfizer’s Shankar Musunuri and University of Colorado professor Uday Kompella. According to reports, once the merger is complete, Ocugen will try to sell Histogenics’ NeoCart, which is its regenerative treatment designed to treat knee cartilages. HSGX shares saw a jump on Tuesday to highs of nearly $0.23 and have been in an uptrend for the last three trading sessions. 

“Since Ocugen’s founding, we have sought to develop innovative therapies to treat rare and underserved eye diseases through a combination of therapeutic approaches that utilize small molecules, biologics, and gene therapies,” said Shankar Musunuri, Ph.D., M.B.A., Chairman, Chief Executive Officer and Co-Founder of Ocugen.

Big Moves On Penny Stock News

Further to the focus on eye care, NovaBay (NBY) stock has taken on a bright light this week. Since making headlines on Monday, shares of the company have jumped from a close of $0.32 last Friday to highs of $4.78 during Tuesday’s premarket session.  This move of nearly 1,400% comes as the company reported that its Avenova eye-care product is now available without a prescription on Amazon.com through its new direct-to-consumer online channel.

“While prescription Avenova continues to be available through retail pharmacies and direct in-office sales by certain eye care specialists, patients and physicians have asked for greater accessibility to the product,” said NovaBay Chief Executive Justin Hall. “In response, we are launching our new U.S. direct-to-consumer channel, which is a significant step in ensuring easy access at an affordable price.”

A Pop & Drop For Others?

Shares of SINTX Technologies, Inc (SINT) have also begun to rally this week.  The move has come after announcing the renewal of its lease with Portfolio Investments at Centrepointe Business Park for a five-year term. Shares are up by more than 50% since Monday afternoon. 

Dr. Sonny Bal, President & CEO, said, “This is a milestone for SINTX. We have right-sized our operations, and the significant cost savings from the building lease will allow SINTX to focus on scaling up our manufacturing, and invest further in R&D activities.”

As the company explains, “The core strength of SINTX Technologies is the research and development of medical-grade silicon nitride ceramics for external partners. The Company presently manufactures silicon nitride spinal implants in its FDA registered and ISO 13485 certified manufacturing facility for CTL-Amedica, the exclusive retail channel for silicon nitride spinal implants.”

Finally, Midatech Pharma Plc (MTP) saw its stock rise on Tuesday morning.  After closing the previous week near June lows of $1.20, MTP shares have jumped as high as $1.73 this week.  The move comes after the company received a patent titled “Nanoparticle Delivery Compositions.” These will specifically be used to target biologically active agents in the central nervous system.

The company itself focuses on patients with rare and serious cancers. Furthermore, the company’s therapies look to improve bio-delivery and bio-distribution of medicines or agents to areas of the body where they are needed and can exert their actions in an effective, safe, and precise manner.

biotech stock to buy 2019
Pursuant to an agreement between MIDAM VENTURES, LLC and GT Biopharma, Midam was hired for a period from 06/07/2019 – 7/07/2019 to publicly disseminate information about GT Biopharma including on the Website and other media including Facebook and Twitter. We were paid $100,000 (CASH) for & were paid “0” shares of restricted common shares. We may buy or sell additional shares of GT Biopharma 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

4 Biotech Stocks Taking Center Stage With Cancer-Fighting Treatments

Joe Samuel

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Investors Turn Their Attention To Stocks Looking To Lead The Way In Immunotherapies

Cancer has been one of the most destructive diseases for more than a century. Even now, a foolproof treatment for the many variants of cancer has not been created. However, that doesn’t mean that a range of companies aren’t spending billions of dollars on cancer research. If a company does come up with a credible cancer drug, it’s likely to be a big focus of the market. Here are several biotech stocks to watch in their quest to become leaders in immunotherapy.

GT Biopharma (GTBP)

Early, clinical stage companies like GT Biopharma (GTBP) present a number of value propositions for investors.  Though many of these companies can hold higher risk due to lack of revenues, incurring high levels of expenses due to research, development, and SG&A, they can also offer higher rewards if early successes are realized.

So far, GT Biopharma has come up favorably with respect to trial results on more than just one of its therapies in the pipeline.  Certainly, though the most recent developments with it OXS-1550 could deliver the most near term opportunities.

The company’s previous announcement that it would be working with a “major pharmaceutical company” may suggest that GT Biopharma (GTBP) could be positioning itself for a strategic move at the very least. 

Though the “major company” was left nameless, we can infer from comments made by Dr. Daniel Vallera that the “multi-billion dollar oncology drug” is ibrutinib. The statement made in a company press release specifically stated, “We are very excited about our progress with GT’s OXS-1550 (DT2219) combined with ibrutinib, a potent small molecule Bruton Tyrosine Kinase (BTK) inhibitor which is already an established chemotherapeutic agent.  We believe combination therapies like these that kill cancer cells based on entirely different mechanisms are the future of cancer treatment.”

Knowing this, we can begin connecting dots to the companies linked to ibrutinib. Its trade name is Imbruvica and is a drug that was developed by Pharmacyclics and Janssen. 

Both Pharmacyclics and Janssen are subsidiaries of major pharmaceutical companies; Abbvie and Johnson & Johnson respectively.

Recent Progress With HIV Treatment Could Become A BIG Competitive Advantage Too. The company’s therapy showed that it could target HIV infected cells in the University of Minnesota’s preclinical testing. Not only that but in specific tests, data showed that HIV-infected targets that express the HIV envelope on their surface could actually be eliminated! Click Here To Read More

Guardant Health (GH)

Guardant Health (GH) is a company that has made a name for itself in two highly important segments within the cancer treatment industry. The company is involved in producing a liquid biopsy. It is also involved in detecting whether cancer is in danger of repapering in a patient or whether an individual is at risk of developing.

The first market is valued at $15 billion, while the market for the second focus is valued at $18 billion. Additionally, its LUNAR DNA Test product detects cancer at an early stage. It has also given the company a huge boost. The stock has soared by as much as 103% in 2019. That is significantly more than the 2.3% in the industry as well.

Illumina (ILMN)

Illumina (ILMN) is another company that holds a lot of promise. It provides researchers with sequencing and that in turn helps in the fight against cancer substantially. The sequencing products made by the company help researchers in understanding the reasons behind the onset of cancer and the company’s products are also used to diagnostic testing purposes.

The demand for its products have been rising steadily and the company has also completed strategic partnerships to further boost its business. Some of Illumina’s partners include Sysmex, Bristol-Myers Squibb and Loxo Oncology.

Exact Sciences Corporation (EXAS)

As if well known by now, colon cancer is one of the dangerous forms of the disease and accounts for many deaths a year. Patients need to go for colonoscopy in order to get the treatment for colon cancer but it is highly expensive.

Exact Sciences Corporation (EXAS) has come up with a product named Cologuard that is an alternative to colonoscopy and the product has proven to be successful ever since its launch back in 2014. In 2018 alone, Cologuard accounted for $454 million in revenues for the company and in 2019, as many as 334000 people have been tested already.

Q1 2019 revenues went up by a whopping 79% year on year. In addition to that, it is the only FDA approved product of its kind and the company has also entered into a partnership with major drug manufacturer Pfizer. The deal will be in place until 2021.

stock_price_health
Pursuant to an agreement between MIDAM VENTURES, LLC and GT Biopharma, Midam was hired for a period from 06/07/2019 – 7/07/2019 to publicly disseminate information about GT Biopharma including on the Website and other media including Facebook and Twitter. We were paid $100,000 (CASH) for & were paid “0” shares of restricted common shares. We may buy or sell additional shares of GT Biopharma 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

Big Investments Are Signaling The Green Light For A ‘Hot Market’ With Cancer-Fighting Stocks

Joe Samuel

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If you’ve ever invested in the stock market or traded a single share, chances are you’ve familiarized yourself with the “hot markets”. These are the ones that consistently see enormous volatility and gains that most only dream of.

More times than not, biotechnology and healthcare stocks are the “hot markets” and we’ll explain exactly why. We’ll also take a deep dive into a niche that you must be paying attention to in 2019 if you’re looking to take advantage of the next big trend in health science.

Biotech Companies Are Driving Innovation

Why biotech over other sectors? Two words: Life Changing.  Sure the latest iPhone or newest gadget may be a “life-changing” product to make your life more exciting but in this hot market, we’re literally talking life-changing and life-saving bi-products. 

Think about what would happen to a stock if a company were to find a cure for cancer? Better yet, what would happen if a company found a solution for HIV?

We’ll talk more about these topics but the simple fact of the matter is that companies are dumping billions of dollars into this sector to take advantage of the next trillion-dollar idea. One place, in particular, is in cancer-fighting stocks.

Cancer Fighting Stocks Are Getting Gobbled Up

The global market for cancer drugs is estimated to be about $123 billion and big players are investing heavily to gain an edge in this increasingly competitive market[1].  Pharmaceutical giant Bristol-Myers, a pioneer in immunotherapy, is acquiring rival Celgene for $74 billion.

Merck is acquiring cancer drug developer Peloton Therapeutics for $1.05 billion. The announcement came as Peloton was preparing for its IPO.  Earlier this year, Eli Lilly bought Loxo Oncology for $8 billion. And this is just the tip of the iceberg for cancer-fighting stocks!

Where Will The Focus Be Next? Read Between The Lines

According to people like Brad Loncar, CEO of Loncar Investments, companies at the forefront of immunotherapy research is the place to be. He’s focused on the important developments in the space and promising work being done by some smaller, innovative biotech companies.

We may have just uncovered a company set to take the stage in immunotherapy.

One of the top holdings of Loncar’s Cancer Immunotherapy ETF [2] is Iovance Biotherapeutics (formerly Lion Biotechnologies).

Why’s this important?

The reason isn’t so much about “why” but about “who.” Founder and previous CEO of Iovance Biotherapeutics, Anthony Cataldo was able to grow Iovance early on, and the company currently holds a market cap of over $2 billion with a share price above $17 per share.

This is key because Mr. Cataldo has recently taken the helm of one “small” immuno-oncology company focused on novel therapies, GT Biopharma (GTBP), which may signal the next big opportunity in biotech.

GT Biopharma (GTBP) is under his direct control and the best part is that this isn’t just a story about a biotech industry leader building the next market disruptor. The pipeline that GT Biopharma (GTBP) has amassed could be on the verge of something big.

GT Biopharma (GTBP)’s Next Move

Early, clinical stage companies like GT Biopharma (GTBP) present a number of value propositions for investors.  Though many of these companies can hold higher risk due to lack of revenues, incurring high levels of expenses due to research, development, and SG&A, they can also offer higher rewards if early successes are realized.

So far, GT Biopharma has come up favorably with respect to trial results on more than just one of its therapies in the pipeline.  Certainly, though the most recent developments with it OXS-1550 could deliver the most near term opportunities.

The company’s previous announcement that it would be working with a “major pharmaceutical company” may suggest that GT Biopharma (GTBP) could be positioning itself for a strategic move at the very least. 

Though the “major company” was left nameless, we can infer from comments made by Dr. Daniel Vallera that the “multi-billion dollar oncology drug” is ibrutinib. The statement made in a company press release specifically stated, “We are very excited about our progress with GT’s OXS-1550 (DT2219) combined with ibrutinib, a potent small molecule Bruton Tyrosine Kinase (BTK) inhibitor which is already an established chemotherapeutic agent.  We believe combination therapies like these that kill cancer cells based on entirely different mechanisms are the future of cancer treatment.”

Knowing this, we can begin connecting dots to the companies linked to ibrutinib. Its trade name is Imbruvica and is a drug that was developed by Pharmacyclics and Janssen. 

Both Pharmacyclics and Janssen are subsidiaries of major pharmaceutical companies; Abbvie and Johnson & Johnson respectively.

Ibrutinib has already shown efficacy with other combination therapies like Venetoclax (marketed by Abbvie & Genentech) as well as Rituxan (rituximab), currently co-marketed by Biogen and Genentech in the U.S., for the treatment[3] of patients with a rare type of non-Hodgkin’s lymphoma called Waldenström’s macroglobulinemia.  The U.S. Food and Drug Administration recently approved Imbruvica (ibrutinib) plus Rituxan (rituximab) as a treatment.

That was in August of 2018 and even though this alone might get investors excited about GT Biopharma (GTBP), a lot has happened since then that could really put a spotlight on this company!

GTB-1550 Phase I-II Results Have Opened The Door For Bigger Opportunities

GT Biopharma’s lead treatment, GTB-1550 is a novel multi-target directed therapy for the treatment of chemotherapy-refractory B-cell malignancies, including Non-Hodgkins Lymphoma and Leukemia.

To date, GT Biopharma has completed one dose escalation Phase I-II expansion clinical trial, and one fixed dose Phase I-II expansion clinical trial which collectively enrolled a combined 43 patients. On the surface, the Phase I-II expansion clinical trial demonstrated greater than 50% of Evaluable patients receiving 60 mg/kg dose had a positive clinical response.

Top-line Consolidated Results:

  • Two patients exhibited a Complete Remission (CR) with one patient currently disease-free at 50 months post-treatment.
  • Five patients exhibited Stable Disease (SD), cancers that are neither increasing or decreasing in severity, with the longest response lasting 12 months post-treatment.
  • Two patients with transformed lymphoma showed transient tumor shrinkage, however, therapy was discontinued due to dose-limiting toxicities after the 1st cycle.
  • Greater than 50% of evaluable patients, (patients where response to treatment can be measured because enough data has been collected), receiving 60 mg/kg dose had positive clinical response defined as stable disease, partial remission, or complete remission.

“GTB-1550 has shown positive results in its two Phase I-II clinical trials in advanced cancer patients who have failed all other therapies, and we are now planning to proceed with a Phase II clinical trial.”

Anthony Cataldo, the Chairman and Chief Executive Officer of GT Biopharma

But this Phase II opportunity is just the “first phase” of GT Biopharma’s potential.  In early April of this year, the company received authorization from the University of Minnesota’s Institutional Review Board and Cancer Protocol Review Committee to proceed with a TriKE Phase 1 clinical trial.

Pipeline Therapies Gain Phase I Trial Approval

The study on its GTB-3550 will enroll up to 60 subjects and will be led by Principal Investigator, Erica Warlick, MD. Warlick is Associate Professor of Medicine, Division of Hematology, Oncology, and Transplantation at Masonic Cancer Center, University of Minnesota.

Specifically, the company will be looking for favorable results on the treatment of acute myelogenous leukemia (AML), myelodysplastic syndrome (MDS) and mastocytosis.

And just as with its GTB-1550, GTB-3550 addresses a specific group of patients.  AML is the most common form of adult leukemia with 21,000 new cases expected in 2018 alone, according to the American Cancer Society. AML patients typically receive frontline therapy, most commonly chemotherapy, which includes cytarabine and an anthracycline, a therapy that has not changed in over 40 years. 

When it comes to other things like MDS, the number of people with MDS diagnosed in the U.S. each year is estimated to be ~10,000 and can progress to AML. Mastocytosis is rarer. An estimate of prevalence from a recent population-based study is approximately 1 case per 10,000 people.

GTB-3550 is being developed to serve as a relatively safe, cost-effective, and easy-to-use therapy for resistant/relapsing AML. It could also be combined with chemotherapy as frontline therapy, thus targeting the broader patient population.

New Findings Suggest GT Biopharma Therapies May Eliminate HIV Infected Cells

It’s a regular occurrence but one that isn’t generally covered with certain biotech companies. But with certain therapies, there can be additional applications.  Most of the time they are less impactful than the target endpoints.  In the case of GT Biopharma (GTBP) its Tri-Specific Killer Engager may have a massive opportunity after recent findings!

The company’s therapy showed that it could target HIV infected cells in the University of Minnesota’s preclinical testing. Not only that but in specific tests, data showed that HIV-infected targets that express the HIV envelope on their surface could actually be eliminated!

We talked about it at the beginning of this report – Why biotech over other sectors? Two words: Life Changing – and this could be one of those “life changing” moments to pay very close attention to.

GT’s products will need to continue to produce positive results in order for investors to remain interested. And this having been said, indications have already been in motion giving even more legitimacy to GT Biopharma’s platform.

Case and point: would it be out of the question for GT Biopharma to obtain a strategic investment similar to the Affimed/Genentech deal? In our opinion, it wouldn’t be out of the question at all; here’s why:

Standing Toe To Toe With Industry Heavyweights

Both platforms utilize fusion proteins with one end binding to NK cells and the other targeting a tumor antigen however there are still a number of differences in the platforms.  Many of these differences are based on exactly how the proteins are created and how they face the NK activation and proliferation issues.

Essentially, without a specific stimulatory agent, the cells become exhausted as their numbers decline. Specifically, GT Biopharma’s NK cell-engager platform incorporates Interleukin (IL)-15. No other, including Affimed’s, NK cell technology has this.

From other research done on NK cells, it has been found that boosting NK cell numbers [4] by treating them with IL-15 may be a valuable new approach to increasing our immunity to viral infections or cancer. IL-15 is a growth factor for certain kinds of white blood cells, including natural killer cells and T cells.

GT Biopharma’s TriKE (Tri-specific Killer Engager) technology has shown superior NK cell cytotoxicity against hematologic tumors in preclinical work compared to earlier versions of the drug. TriKEs are an off the shelf option that employ a single chain, tri-specific fusion protein that binds to CD16 on NK cells and targets tumor antigens on cancer cells such CD33 in myeloid malignancies.

TriKEs are particularly attractive due to their low cost of manufacture relative to CAR-T therapy and can be used off the shelf without any modifications of autologous cells in the lab. The company is currently in the process of submitting an investigational new drug application to the FDA for the TriKE in order to launch a Phase I/II trial in the second half of this year.

This, in addition to several other key therapies in the company’s pipeline could bode as attractive targets for larger investment from the likes of major pharmaceutical companies.

At The Forefront of the Cancer Wars & Ready To Deliver

Medical science hasn’t yet won the war on cancer, but it is scoring important victories in battles against many forms of the disease. Advances in new treatments have made cancer a hot investing theme over the past 18 months, helping to power fresh interest in biotechnology stocks.

It isn’t just small family offices taking a shot at this arena anymore. Major industry leaders are taking every chance they can at buying up smaller companies before they become the direct competition. The figures are becoming even more staggering as new therapies and phase trials materialize. GT Biopharma (GTBP) can make a convincing argument to become one of the top biotech stocks to watch.

“Big Pharma appreciates innovation and respects how it happens. That’s why the industry is interested in doing great deals with young companies that can move fast to solve big scientific problems.”

Abbie Celniker, Ph.D., partner at Third Rock Ventures.

The health sciences market is experiencing unprecedented innovation, and now the race is to get behind the next breakthrough. GT Biopharma’s numerous phase trials, novel treatments, and top tier leadership are just some of the main topics to consider in our opinion.

In the end, this company is in early to mid-phase trials with proven results and has even shown indications for other immune-therapies to the extent that it has eliminated infected targets. With all of the activity going on within the immune-therapy space as it is, can you afford not to be paying attention right now?

biotech stock to buy 2019
Pursuant to an agreement between MIDAM VENTURES, LLC and GT Biopharma, Midam was hired for a period from 06/07/2019 – 7/07/2019 to publicly disseminate information about GT Biopharma including on the Website and other media including Facebook and Twitter. We were paid $100,000 (CASH) for & were paid “0” shares of restricted common shares. We may buy or sell additional shares of GT Biopharma 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.

Endnotes:

[1]Brad Loncar -https:// finance. yahoo. com /news/why-cancer-fighting-stocks-etfs-184606099. html

[2]Loncar ETF Info – https:// etfdb . com /etf/CNCR/

[3] https:// lymphomanewstoday . com /lymphoma-treatment/

[4] NK Cell cancer immunity – https:// medicalxpress .com /news/2017-01-natural-killer-cells-cancer-immunity. html

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