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GT Biopharma (GTBP) GTB-1550 Clinical Development Update

Joe Samuel

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Durable Complete Remission in Patient Currently Disease-free at 50 Months Post Treatment

Greater than 50% of Evaluable Patients Receiving 60 mg/kg Dose had Positive Clinical Response

TAMPA, Florida, May 30, 2019 /PRNewswire/ — GT Biopharma, Inc. (GTBP) (GTBP.PA) an immuno-oncology company focused on innovative treatments based on the Company’s proprietary NK cell engager (TriKE) platform and Multi-Target Directed Bispecific Drug Conjugate (MTBDC) platform, today provided an update with respect to the further clinical development of GTB-1550.

GTB-1550 (DT2219) 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. 

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.

Dr. Veronika Bachanova, Associate Professor of Medicine, Division of Hematology, Oncology and Transplantation at the University of Minnesota and the Principal Investigator for both clinical trials commented: “We are pleased the patient who experienced a complete remission following treatment with GTB-1550 is doing well, and we are excited about moving forward with a GTB-1550 Phase II clinical trial for the treatment of chemotherapy-refractive B-cell malignancies.”

Mr. Anthony Cataldo, the Chairman and Chief Executive Officer of GT Biopharma commented: “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.”

The initial Phase I-II expansion clinical trial (clinicaltrials.gov NCT 00889408Clin Cancer Res 21(6) pgs 1267–72) demonstrated decreased tumor mass in one patient, and a complete response in a second patient that remains on-going at 50 months post treatment.  After a single course of GTB-1550 (DT2219) at dose level 40 mg/kg/day x 4, a 77-year-old patient with chemotherapy-refractory CD19+/CD22 chronic lymphocytic leukemia (CLL) experienced a 40% reduction in cervical and axillary adenopathy with decrease of an abdominal tumor mass at day 28 after treatment, which was sustained for 2 months.  The second clinical response occurred in a 53-year-old patient with relapsed CD19+/CD22+ diffuse large B cell lymphoma (dose level 60 mg/kg) who experienced a 75% reduction in size of lymphoma lesion after a single course complicated by a grade 3 capillary leak syndrome.  Eight weeks later after FDA approval, this patient received a second DT2219 course at a reduced dose of 40 mg/kg/dose for 4 days, which resulted in a complete resolution of a subcutaneous mass and pelvic lymphadenopathy.  The patient is alive and in complete remission with no neutralizing antibodies, currently at 50 months after therapy.

The results of the second GTB-1550 Phase I-II expansion trial (clinicaltrials.gov NCT02370160J Clin Oncology 37, 2019 suppl; abstract e19066) targeting CD22 and CD19 for treatment of refractory B-cell malignancies showed treatment was well tolerated at 60 mg/kg x 8 doses.  The most common adverse events included capillary leak syndrome, elevated AST/ALT, low albumin, weight gain and leukopenia.  All were Grade 1-2 and resolved after 3-5 days allowing day 15 GTB-1550 administration.  There were no neutropenic fever or immune mediated adverse events.  Four patients experienced dose limiting toxicity (DLT) at dose 80 μg/kg/day: Grade 4 capillary leak syndrome (n=1), Grade 3 liver function test (LFT) abnormalities (n=2) and Grade 4 thrombocytopenia >7 days duration (n=1).  Thirteen patients were evaluable for response, and 3 experienced objective clinical benefit.  One patient with primary refractory pre-B acute lymphoblastic leukemia achieved complete remission after 1st cycle.  Two patients with transformed lymphoma demonstrated transient tumor shrinkage, however, GTB-1550 therapy was discontinued due to DLT and increased neutralizing antibody titer after 1st cycle (pre C1 28%, pre C2 108%).  Correlative studies showed a low incidence of neutralizing antibody in Non-Hodgkin Lymphoma (NHL) patients recently exposed to Rituximab.

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 (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 Directed Bispecific Drug Conjugate (MTBDC) 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 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.

Contact: +1-800-304-9888

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Biotechnology

Biotech Names To Know In November 2019

A. Lawrence

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Biotech Stocks Have rallied since The End Of September; What’s Next?

Over the years, the biotech sector has become one of the fastest-growing sectors in the stock market and naturally, investors are keen to get hold of stocks that could follow a similar growth trajectory. However, just because a sector is growing does not mean that an investor can bet on any stock and hope to make decent returns.

In order to choose the right stock, he needs to do a lot of personal research and watch the market closely. Here is a look at three biotech stocks that investors should track closely owing to recent developments.

Sernova Corp’s (TSX:SVA) (OTC:SEOVF)

Sernova’s therapeutic approach to regenerative medicine focuses on providing direct cell therapies where the cells, transplanted within an organ-like vascularized implantable device, generates proteins, hormones or factors released into the bloodstream for treatment of diseases requiring replacement of these molecules in the body.

The company’s Cell Pouch is a novel, proprietary, scalable, implantable macro-encapsulation device designed for the long- term survival and function of therapeutic cells. At the end of October Sernova Corp. (SVA) (SEOVF) detected enduring levels of C-peptide in the bloodstream of a fasting patient in its continuing phase I/II Cell Pouch United States clinical study of type-1 diabetes. This C-peptide is a biomarker of transplanted beta-cell insulin production,

Why is this important? According to Dr. Piotr Witkowski, Director of Pancreatic, and Islet Transplant Program at the University of Chicago, “Along with the preliminary safety and early indicators of efficacy, I am excited that we are observing C-peptide levels in the patient’s bloodstream after recent transplant, not only following stimulation with a meal but also when the patient is fasting. These findings represent progress in clinical outcomes and evidence of enduring islet survival and function within Sernova’s Cell Pouch.”

Read This Full Press Release Here

Genprex (GNPX)

The first one to put in the watch list is that of Genprex Inc (NASDAQ:GNPX). On Tuesday, the company revealed preclinical data from its study of its product TUSC2 immunogene therapy. The product in question is meant for raising the effectiveness of chemotherapy and anti-PD1 in people suffering from metastatic lung cancers.

The data proved to be positive and that has naturally resulted in a rally in the stock. It is a significant development for Genprex and could potentially help the company in cornering an important portion of the gene therapy market. Hence, it is hardly a surprise that the stock has rallied by as much as 60% after hitting a session’s high of $1.09.

 Can Fite Biopharma (CANF)

The other biotech stock that has made a strong move is the Can Fite Biopharma (NYSE:CANF) stock. The biotech company announced this morning that one of its products, which is meant for the treatment of liver diseases and cancer, has been granted a patent as a sexual dysfunction medicine.

The patents have been granted by the relevant authorities in Canada, Israel, and South Korea. In addition to that, the company has also been awarded patents in Japan, China, United States, Australia, and Hong Kong. It is a highly important development for Can-Fite and it was no surprise when the stock rallied this morning. It has rallied by 3% on Tuesday on the back of the news.

top biotech stocks to watch list

Disclaimer: Pursuant to an agreement between Midam Ventures LLC and Sernova (TSX:SVA) (OTC:SEOVF), Midam has been paid $350,000 for a period from September 23, 2019 to September 22, 2020. We may buy or sell additional shares of Sernova (TSX:SVA) (OTC:SEOVF) in the open market at any time, including before, during or after the Website and Information, to provide public dissemination of favorable Information about Sernova (TSX:SVA) (OTC:SEOVF). Click Here For Full Disclaimer.

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The Biotech Index Just Hit New Highs; Stocks To Watch

Joe Samuel

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The Biotech ETF – IBB – Just Made New November Highs, What’s Next?

Investment experts and professional money managers almost always tell people to invest across a range of experts. This is usually in order to generate bigger returns in the long term. One of the sectors that is almost always favored by professionals is the biotech sector and the simple reason behind that is the fact that the sector has managed to grow at an impressive pace.

However, in order to pick stocks, an individual would need to conduct his own research with regard to different companies. Here is a look at three biotech stocks that should be tracked closely due to recent events.

PharmaCyte Biotech (PMCB)

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.

What Happened This Week?

top biotech stocks to buy

This week was important for the company as it hit a milestone never met. The company announced that its partner, Austrianova Singapore, has successfully completed the second and final GMP manufacturing run to produce PharmaCyte’s clinical trial product. The product is now ready for “release testing.”

The data from the “release testing” of both manufacturing runs will be included in an Investigational New Drug application (IND) and submitted to the U.S. Food and Drug Administration to support PharmaCyte’s planned clinical trial in patients with locally advanced, inoperable pancreatic cancer.

“We have cleared what was a major hurdle for us and have completed our most impactful milestone to date. Successfully completing two manufacturing runs is a milestone that has now been met as we progress toward our submission of an IND to the FDA so we can begin our clinical trial in LAPC.”

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner

NovaBay Pharmaceuticals (NBY)

The first biotech stock to consider is that of NovaBay Pharmaceuticals, Inc. (NYSE:NBY). The NovaBay stock has been on a tear this morning owing to an important product announcement from the company. The company issued a press release this morning in which it revealed that its product NovaSight has been launched on Amazon.

The product in question is a mineral supplement and a daily vitamin that is meant for the eyes. After the announcement was made, the stock rose by as much as 26.50% in Monday’s trade and it remains one of the stocks to watch on the market today. The announcement is a significant one and could have far-reaching implications for NovaBay.

REPORT: 1 Biotech Stock is Positioning Itself for Success

BioCryst Pharmaceuticals (BCRX)

Another biotech stock that has been in the middle of a highly impressive rally in recent sessions is that of BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX). The stock has gained over the course of the past three trading sessions and has generated gains of as much as 28% so far.

In a new development, the company completed a capital raise by offering its equity and managed to raise as much as $55 million. This prompted Bank of America analysts Tazeen Ahmad to upgrade the stock from neutral to buy. The capital raise and the upgrade possibly resulted in the remarkable rally in the BioCryst stock in recent days.

REPORT: 1 Biotech Stock is Positioning Itself for Success

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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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3 Biotech Stocks To Watch As Markets Gain Momentum

Joe Samuel

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biotech stocks to buy

The biotech sector has generated impressive growth over the past decade or so and consequently, many of the biotech stocks in the market have also proven to turn heads. Hence, it is not a surprise that most who look for cutting edge companies focus on the biotech sector.

In order to find the right stocks, an investor needs to do a lot of research and needs to keep a close eye on the latest developments. Here is a quick look at 3 biotech stocks that investors are watching closely this quarter.

PharmaCyte Biotech (PMCB)

PharmaCyte Biotech (PMCB) has developed a drug delivery platform that could be on the verge of a major FDA event. In fact, the news shared on November 18 by the company could be a clear indicator of such an event.

The company announced today that its partner, Austrianova Singapore (Austrianova), has successfully completed the second and final GMP manufacturing run. This was to produce PharmaCyte’s clinical trial product. The product is now ready for “release testing.”

Why Is Release Testing Important For PharmaCyte?

The data from the “release testing” of both manufacturing runs will be included in an Investigational New Drug application (IND) and submitted to the U.S. Food and Drug Administration (FDA). It essentially supports PharmaCyte’s planned clinical trial in patients with locally advanced, inoperable pancreatic cancer.

top biotech stocks to buy

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, commented, “Today is a great day at PharmaCyte. We have cleared what was a major hurdle for us and have completed our most impactful milestone to date. Successfully completing two manufacturing runs is a milestone that has now been met as we progress toward our submission of an IND to the FDA so we can begin our clinical trial in LAPC.

Learn more about PharmaCyte Biotech Here

Titan Medical (TMDI)

The first biotech stock that should go into the watch list is that of Titan Medical Inc. (NASDAQ: TMDI). The stock has been on an impressive over the past week or so after the company made a significant announcement.

Titan announced on November 15 that its robotic surgery system has been suspended due to the cash crunch at the company. It stated that it is now looking for options with regards to funding and until then the project will remain suspended.

[Report] 1 Biotech Stock is Positioning Itself for Success.

Investors probably believe that is a positive development since Titan would not be bleeding cash in the middle of a cash crunch and the stock has gone up by as much as 55% after the announcement was made.

Catalyst Pharmaceuticals (CPRX)

The other biotech stock that should be tracked at this point is that of Catalyst Pharmaceuticals Inc (NASDAQ: CPRX). The company announced its financial results for the third quarter on November 14 and there are two important things to keep in mind with regards to the company’s business currently.

biotech stocks to watch now Catalyst Pharmaceuticals (CPRX)

Catalyst announced that its product Firdapse is going to generate $100 million worth of sales for the full year 2019. However, that is well short of analysts’ expectations of $111 million. Additionally, the company’s upper limit for its revenues guidance for 2020 is also short of analysts’ expectations. The higher limit is projected at $155 million but that is $11 million short of analysts’ estimates.

best biotech stocks to watch this month

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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