The opportunity for companies within this sector is massive. We are now talking about a global industry that is currently worth over $ 141 billion with the potential in the next 7 years to be worth over $ 394 billion.
Cancer has a major impact on society in the United States and across the world. And the opportunities being created from novel treatments and breakthrough therapies has reached a feverish pitch in 2020
Cancer.org estimates that in 2018 1.8 million new cases of cancer will be diagnosed & 606,520 people will die from the disease in the United States alone!
Investors Are Quickly Learning That Biotech Stocks Are The Thing To Watch Right Now & GT Biopharma (GTBP) Could Be On The Verge Of A Major Breakthrough
Keep Reading Below for More Info…
There’s no doubt that the COVID-19 pandemic has caused entire economies to shutdown. However, what has come from that is twofold. First, quite literally millions of new investors are now actively participating in markets. Hand-in-hand with this, their initial focus was capitalizing on the massive surge in coronavirus vaccine stocks. What that also did was push biotech to the forefront and, moreover, immunotherapy companies.
While vaccine stocks are still part of the conversation, the bigger focus is now back on traditional things like oncology. Cancer stocks have been red hot during the second half of 2020 and the mergers & acquisitions climate is just as hot. Larger companies aren’t looking to acquire COVID companies, they’re looking at the long-term; they’re acquiring companies with novel immune-oncology pipelines.
In fact, Gilead just spent $21 billion just to gain access to a breast cancer treatment platform held by Immunomedics in September. What’s more, is that Gilead paid a premium of nearly 100% on this deal without batting an eye.
You’ve also got major advances from Bristol Myers Squibb and bluebird bio recently gaining FDA priority review for a CAR T cell therapy. The fact of the matter is that this is such a new and emerging type of therapy, we’re certainly just scratching the surface. Furthermore, the Gilead’s and Birstol Myers of the world are much further out of reach by average investors. They’ve already had their growth phase, paying early investors handsomely. Now the market is looking for the next breakthrough candidate.
This is a Massive Opportunity for Companies In This Space
GT Biopharma (GTBP) is a clinical-stage, immuno-oncology biotech company focused on innovative treatments based on its novel 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 as I said above, these companies are more focused on pushing around their billions to build a value investment for long-term investors. Their “explosive growth” phases happened years, even decades ago. There is little room left for that explosive growth, early investors search for. With everything that’s going on with the COVID-19 pandemic, many healthcare companies have grabbed plenty of attention during these tough times. However, at the same times, there’ve been a few that slipped through the cracks as COVID headlines took more fanfare.
Small-cap biotech stocks that aren’t actively involved in developing tests, vaccines or treatments for COVID-19 have waited in the wings for the market to rotate. And rotate it has. Now we’re seeing major headlines more focused on targeted treatments and immunotherapies outside of “just COVID.” That has translated into big wins for investors not only in the form of big buy outs but huge breakouts following key milestones
The Next Wave Of Cancer Fighting Treatments Has A Name
When investors look at GT Biopharma (GTBP) they will notice that the company is indeed a small-cap stock and as discussed above, it has a breakthrough pipeline that has begun to prove its effectiveness in preclinical studies. The company has also built deep-rooted relationships with some of the most experienced names and organizations in this arena.
GT Biopharma (GTBP) has ties to the University of Minnesota & its prestigious Masonic Cancer Center, a comprehensive cancer center designated by the National Cancer Institute.
The University of Minnesota is the site for the current in-human TriKE™ phase 1 clinical trial.
In addition to being the host site for GT Biopharma (GTBP) ’s in-human clinical trial Deputy Director of the University of Minnesota’s Masonic Comprehensive Cancer Center. Dr. Jeffery Miller was hired to be GT Biopharma (GTBP) ’s Consulting Chief Medical Officer.
The Secret Weapon In The Fight Against Cancer
Whether you call it a silver bullet or a secret weapon, GT Biopharma (GTBP) and Dr. Miller have been heavily focused on advancing somewhat of a “Designer Cancer Treatment”. With the University of Minnesota, the company is working on first-in-human clinical trials for acute myeloid leukemia. But based on early findings, the company’s treatment may have myriad other applications in immune-therapies for a true, off-the-shelf option for eager patients with unmet medical needs right now.
The Science
The company is harnessing the power of what are known as “Natural Killer Cells” to win the fight against cancer. It enhances the tumor cell killing by increasing the amount of specific NK cells within the tumor’s own microenvironment.
But here’s where GT Biopharma’s secret weapon comes into play, and that is the discovery of tri-specific natural killer engagers (TriKE™). It’s a combination protein that bridges an immune cell and a tumor cell to drive tumor cell killing power exponentially. It has led to new first-in-human phase studies to treat leukemia.
What’s more is that TriKE™ has been evaluated in ovarian, breast, prostate, pancreatic ductal adenocarcinoma and lung cancer models. According to GT Biopharma (GTBP), it demonstrated a significant reduction in tumor burden in animal models. It also boosted overall survival in animal models of solid tumor cancers.
What Is GTB-3550 & Why Should You Be Familiar With It?
Specifically, GTB-3550 is the company’s first TriKE™ product candidate being initially developed for the treatment of acute myeloid leukemia (AML).
GTB-3550 is a “tri-specific recombinant fusion protein conjugate”. 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 NK cell stimulating cytokine human IL-15 portion of the molecule provides a self-sustaining signal that activates NK cells and enhances their ability to kill.
The reason why investors should be familiar with it is because GTB-3550 is currently in a Phase I/II clinical trial (ClinicalTrials.gov NCT03214666) for the treatment of CD33 positive leukemias such as AML, myelodysplastic syndrome and other CD33+ hematopoietic malignancies.
Furthermore, GT Biopharma has just completed treatment of the first patient enrolled at Dose Level 3 in its GTB-3550 TriKE™ Phase I/II clinical trial. In short, the findings have already shown promise:
- GTB-3550 at a 25mcg/kg/day dose showed a decrease in AML blast levels from 18% to 12% in the bone marrow.
- GT Biopharma observed an increase in the patient’s NK cell activity and numbers attributable to the IL-15 component of the TriKE™ molecule.
- There were no appreciable increase of a hyper-active T-cell population which could have resulted in cytokine release syndrome (CRS) or other T-cell associated toxicities.
- Improvement in marrow cellularity
- A decrease in AML blast levels
- Improving platelet and red blood cells numbers.
All of these findings support the clear potential that GTB-3550 could hold and that’s just for one indication right now.
Current Trial Specifics:
The open-label, dose-escalation Phase I portion of the trial will evaluate GTB-3550 in patients with CD33-expressing, high risk myelodysplastic syndromes, refractory/relapsed AML or advanced systemic mastocytosis, and will determine safety and tolerability as well as the pharmacologically active dose and maximum tolerated dose of GTB-3550.
GT Biopharma (GTBP) Is Developing Treatments That Stand Head-To-Head With Some Of The Industry’s Top Companies
A unique opportunity could be presenting itself for GT Biopharma (GTBP) to far surpass some of the industry’s biggest companies.
The key to this opportunity is within the use of NK cells versus the standard “T-Cell” treatment methods. CAR-T has become the early form of changing the way cancer treatments are administered. But it is still very costly and cannot be easily changed and applied to multiple indications. Even with much to be desired, it is the newest method for targeted treatment – for now.
But that doesn’t mean companies aren’t spending billions trying to find the next treatment platform to revolutionize immune-therapy.
Are Cancer Stocks Worth It? Let’s Explain Further With A Few “Small” Examples…
Amgen (AMGN) – $175 Million Revenue Potential
Amgen’s T-cell cell engager was approved for marketing in December 2014. Under the branded treatment, Blincyto, Amgen’s treatment targets patients with specific types of leukemia. Where this treatment is based on T-cell therapy, it needs to activate the body’s immune system first, which could present its own list of risks. In comparison, GT BIopharma’s TriKEs/TetraKEs engage NK cells which may have potential advantages as there’s no need to “prime” the immune system. The bottom line is that even in this case, the more archaic T-cell treatment helped generate $175 million in sales in 2017 for Amgen’s Blincyto.
Gilead (GILD) And Its Acquisition of Kite Pharma – Buyout Valued At $11.9 Billion
In October 2017, Kite Pharma’s (previously publicly traded as “KITE”) therapy, Yescarta became the first CAR-T therapy approved by the FDA for the treatment of adult patients with certain types of lymphoma after two or more lines of systemic therapy. Based on this development, one of the mega-industry leaders, Gilead (GILD) bought out the company for a cool $11.9 Billion. As with the Amgen case, GT Biopharma (GTBP) NK cell platform poses even more opportunity beyond the simple T-Cell or “CAR-T” cell treatment as targeted therapies begin to take a more prominent place in cancer and immuno-oncology treatment.
Affimed (AFMD) & Roche (RHHBY) Collaboration Through Genentech – $5.9 Billion Deal
Clinical stage biopharmaceutical company Affimed (AFMD) inked a deal with a potential value of nearly $6 billion with Roche (RHHBY) company, Genentech. This is one of the clearest examples of the potential of NK cell platforms. Because these “engager-based” immunotherapeutics can treat multiple cancers, the therapies can be tailor-made for patients without having to “pre-stimulate” the body’s immune system. Not only did Affimed get an upfront payment of $96 million but with milestones, it can receive up to another $5 billion.
Gilead (GILD) And Its Acquisition of Immunomedics (IMMU) For Novel Cancer Platform – $21 Billion Deal
Gilead Sciences acquired biopharmaceutical company Immunomedics for $21 billion. The acquisition expands Gilead’s portfolio of treatments for various types of cancer. The deal specifically provides Gilead with Trodelvy, an antibody drug for advanced triple-negative breast cancer. The drug was given accelerated FDA approval in April, 2020. Immunomedics was acquired at $88 per share in cash — more than double the $42.25 at which shares traded prior to the acquisition.
Long story short, the much larger focus for investors and industry bellwethers is on immunotherapy platforms that can deliver.
Corporate Leadership
No biotechnology company is worth anything with a single treatment alone. The science behind it and oversight of phase trials are crucial factors that only sound leadership can take to the finish line. GT Biopharma has started stacking its deck with top brass:
Anthony J. Cataldo
Chairman, Chief Executive Officer & President
Mr. Cataldo founded GT Biopharma Inc. From February 2011 to June 2013 Mr. Cataldo served as Founder and Chairman & CEO of Iovance Biotherapeutics, Inc., (IOVA). Mr. Cataldo has served as Chairman/CEO of several biotech companies including: Calypte Biomedical Corporation and Senetek, PLC.
Jeffrey S. Miller, M.D.
Consulting Chief Medical Officer
Dr. Miller is the inventor of GT Biopharma’s TriKE™ technology. Dr. Miller is currently a Professor of Medicine at the University of Minnesota, and is the Deputy Director of the University of Minnesota Masonic Comprehensive Cancer Center. Dr. Miller has more than 20 years of experience studying the biology of NK cells and other immune effector cells and their use in clinical immunotherapy with over 170 peer-reviewed publications. Dr. Miller received his M.D. degree from Northwestern University School of Medicine, and completed his internship and residency in Internal Medicine at the University of Iowa in Iowa City. After completing a post-doctoral fellowship in Hematology, Oncology and Transplantation at the University of Minnesota, he joined the faculty in 1991.
Martin Schroeder, M.S.c
Consulting Chief Technology Officer
Mr. Schroeder has been Executive Vice President and Managing Director of the Emmes Group, Inc. Mr. Schroeder has also held a number of industry management and executive positions, including Chairman, President and Chief Executive Officer of AMS, Inc., a venture capital-backed molecular genomics company. Mr. Schroeder also played key roles in the founding of Intercept Pharmaceuticals, a public biotech company focused on the treatment of patients with progressive non-viral liver diseases, and the founding of Iovance Biotherapeutics, a public company developing cell therapies. Mr. Schroeder was also a Visiting Scientist at the U.S. Department of Agriculture following completion of his graduate studies in biochemistry. Mr. Schroeder holds a Bachelor of Science degree in Biochemistry from UCLA, and a Master of Science degree in Biochemistry from CSULB.
Download GT Biopharma Corporate Presentation
How Does GT Biopharma (GTBP) Measure Up Against the Competition?
- GT Biopharma (GTBP) is operating within a space that is currently valued at $141 billion. It is estimated to be valued at US$ 394 billion by 2027. This is a massive growth opportunity.
- GT Biopharma (GTBP) has a novel immunotherapy platform that has just begun enrolling patients into Phase trials.
- GT Biopharma’s (GTBP) deep ties with the University of Minnesota & its Masonic Cancer Center, its Deputy Director & now GT Biopharma’s (GTBP) Consulting Chief Medical Officer Dr. Jeffery Miller give the company a huge advantage.
- Earlier findings in its GTB-3550 TriKE™ Phase I/II clinical trial have already shown favorable results with desirable outcomes in one of its patients.
- GT Biopharma (GTBP) has a management team comprised of some of the biggest, brightest and most successful professionals within the biotech sector.
Sources
https://www.fortunebusinessinsights.com/oncology-drugs-market-103431
https://clinicaltrials.gov/ct2/show/record/NCT03214666
Pursuant to an agreement between Midam Ventures LLC and GT Biopharma (GTBP), GT Biopharma is required to pay $200,000 per month for 4 months of services, $400,000 of which has already been paid for 2 months of services (first and last month) for a period from September 22, 2020 to January 22, 2021. 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).
