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.
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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.
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.
Stock Price Morning Update For Thursday, August 15, 2019
3 Biotech Stocks In Focus As Cancer Treatment Heats Up
Over the years, biotech stocks have been able to create a lot of wealth for investors and hence, it is no surprise that there are investors who are actively in search of the next big thing in cancer-related stocks. Here is a look at two such stocks which should be on investors’ watch lists.
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3 Biotech Stocks In Focus As Cancer Treatment Heats Up
For as long as anyone can remember, biotech stocks and pharmaceutical companies get lots of attention. Many are involved in cancer research have always generated a lot of interest for investors. The reason is that any kind of breakthrough in cancer treatments can lead to enormous profits for the company. That is what investors look for.
Over the years, such stocks have been able to create a lot of wealth for investors and hence, it is no surprise that there are investors who are actively in search of the next big thing in cancer-related stocks. Here is a look at two such stocks which should be on investors’ watch lists.
Biotech Stock To Watch#1: PharmaCyte Biotech (PMCB)
If you’re looking at PharmaCyte Biotech (PMCB Stock Report) 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 pharmaceutical stocks or a seasoned vet, you should understand how important milestones like this are for a company.
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. Just to give you an idea, pancreatic cancer, in general, has the highest death rate of all major cancers. Only 9% of people with this cancer will survive more than five years .
This isn’t “just another cancer company.” PharmaCyte (PMCB) has developed a technology that could completely change the way cell therapies are conducted! Right now, the company isn’t just focused on cancer, they’ve also begun to apply Cell In A Box ® to other diseases like Diabetes.
Read The Latest On This Development: PharmaCyte Biotech (PMCB) and UTS Creating Advanced Version of Melligen Cells to Treat Diabetes
PharmaCyte (PMCB) has entered into a new research agreement with the University of Technology Sydney (UTS) in Australia to create a new version of Melligen cells for the treatment of diabetes with the potential to express higher levels of insulin. PharmaCyte has obtained the exclusive worldwide license rights from UTS to use these cells to develop a therapy for Type 1 and insulin-dependent Type 2 diabetes.
Deciphera Pharmaceuticals (DCPH) Has Biotech Stock Investors Watching Closely
The next on this list of biotech stocks to watch: Deciphera Pharmaceuticals Inc (DCPH Stock Report). This stock has been in the middle of a hugely impressive rally this week. The biotech company has been working on a stomach cancer medicine of its own. In a new development, it emerged that the medicine in question proved to be beneficial to patients.
It was further pointed out that the patients in question had been treated with all other medicines. But none of those proved to be effective enough. This announcement was made on Tuesday and soon enough DCPH stock started to climb. The stock rose by as much as 80% and remains one of the hottest cancer-related stocks in the market at the moment.
High Priced Biotech Stock To Watch: Amgen (AMGN)
The other cancer-related stock that has been in the news this month is Amgen, Inc. (AMGN Stock Report). The company announced a major breakthrough. Amgen managed to produce a medicine named AMG 510. It helps target KRAS mutated cancer. It goes without saying that it is a breakthrough that took decades to delivery. But it is believed that it is a product that could eventually change the face of the company as a whole.
The company also won its case against Novartis, this month. Amgen’s opponent, Sandoz (a unit of Novartis) didn’t meet its burden to claim several patent infringements were invalid.
“We are pleased with today’s decision recognizing the validity of these patents. Protecting intellectual property is critical to incentivize innovation and the large investments in research and development that are required to bring new medicines to patients and fully develop their therapeutic potential for patients.”Robert A. Bradway, chairman and chief executive officer at Amgen
3 Cancer Related Stocks to Watch Right Now
The pharmaceutical and biotech sectors have been some of the most exciting sectors for quite some time and it continues to be so to this day. From among those, there has always been a high degree of interest in the stocks of companies which are involved in cancer treatment and currently, there are two stocks which are in focus due to a range of important developments. Here are 3 biotech stocks to watch right now
When you typically think about cancer, you would assume myriad treatments. But one thing that was overlooked until recently has been the way drugs are delivered to the body.
Over the last 10 years, biotech has been one of the best performing sectors in the entire market. It’s been for good reason too. A number of biotech stocks have produced life-changing returns because of their treatments and opportunities have only gotten bigger as time goes on.
Since the most frequently used treatment for cancer right now is chemotherapy, patients may not be getting a treatment that is truly effective. In fact, many patients are told that chemo has a 50/50 shot of success. This leaves the door open for companies to jump on the potential of targeted treatments and novel delivery methods.
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.
Furthermore, as the markets shake off short term turmoil, the biotech sector could quickly come in favor. As far as PharmaCyte is concerned, current levels show to be similar to those of this past January. Looking at the stock chart, PMCB stock price traded at this level before a move to its 2019 high of $0.0678
Exelixis Inc. (EXEL Stock Report) has been one of the leading companies in the area of cancer treatments and the most important factor in favor of the company is its cancer medicine Cabometyx. According to analysts, Cabometyx could prove to be one of the company’s most important products in years.
The clinical study data points support that assertion. Additionally, it could also leverage its partnerships to further grow sales of Cabometyx. Currently, the company is collaborating with Bristol Myers-Squibb to figure out if Exelixis’ flagship medicine could be used in combination with Opdivo. All of this has lead to a topsy-turvy year. However, recent trends could indicate potential from historical, technical events seen in January and June.
However, one of the most important factors in favor of Exelixis is new opportunities. The company is not planning to merely live off Cabometyx. Exelixis is actively looking to develop new products internally. The fact that the company is sitting on a cash mountain of $800 million is positive. That’s since it can then finance long term product development with far more ease.
On the other hand, Bristol-Myers Squibb Co (BMY Stock Report) is one of the traditionally powerful companies in the cancer treatment industry. Currently, the biotech stock is waiting to close its acquisition of Celgene (CELG Stock Price). Celgene works in cancer treatments as well as in cancer research. BMY hopes that the $74 billion acquisition will help it in cutting costs significantly.
Bristol-Myers currently has a research and development budget of $5 billion a year. After the merger, it may increase further. Thereby, the company could become a far more attractive proposition.
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