TAMPA, Florida, May 29, 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, announced today that the results of its second Phase I-II trial (NCT02370160) for GTB-1550 (DT2219), an MTBDC targeting CD22 and CD19 for treatment of refractory B-cell malignancies, will be published (J Clin Oncology 37, 2019 suppl; abstract e19066) on-line in conjunction with the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago from May 31 – June 4.
Top Line Results Summary:
- Treatment was well tolerated at 60 mcg/kg x 8 doses and 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.
Mr. Anthony Cataldo, the Chairman and Chief Executive Officer of GT Biopharma commented, “We are pleased with the results GTB-1550 has shown in the current Phase I-II clinical trial and in our earlier Phase I-II clinical trial. This now positions us to move forward with the FDA phase II clinical trial.”
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 excited about the progress GTB-1550 is making in the clinic, and look forward to the possibility of exploring additional monotherapy and synergistic combination studies against various B-cell malignancies.” Both clinical studies were conducted at the University of Minnesota’s Masonic Cancer Center in Minneapolis.
About GTB-1550 Multi-Target Directed Bispecific Therapy
GTB-1550 targets cancer cells expressing the CD19 receptor or CD22 receptor or both receptors thereby maximizing cancer cell recognition by binding to CD19+, CD22+ and CD19+/CD22+ cancer cells. When GTB-1550 binds to cancer cells, the cancer cells internalize GTB-1550, and are killed due to the action of drug’s cytotoxic diphtheria toxin payload. GTB-1550 has previously demonstrated success in a Phase I-II human clinical trial in patients with relapsed/refractory B-cell lymphoma or leukemia. At the time of the interim review, 13 patients met the evaluation criteria, including nine NHL and four ALL patients. More than 50% of patients (seven of 13) exhibited a clinical benefit, defined as stable disease, partial remission or complete remission at Day 29. Of the seven patients, one demonstrated a complete remission (CR), one demonstrated a partial remission (PR) and five demonstrated stable disease (SD).
About the TriKE Platform
The Company’s TriKE product candidates are single-chain, tri-specific scFv recombinant fusion proteins composed of the variable regions of the heavy and light chains (or heavy chain only) of anti-CD16 antibodies, wild-type or a modified form of IL-15 and the variable regions of the heavy and light chains of an antibody designed to precisely target a specific tumor antigen. GT Biopharma utilizes the NK stimulating cytokine human IL-15 as a cross linker between the two scFvs which is designed to provide a self-sustaining signal leading to the proliferation and activation of NK cells thus enhancing their ability to kill cancer cells mediated by antibody-dependent cell-mediated cytotoxicity (ADCC). 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.
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). 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.
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.
Acadia (ACAD) Stock Price is up 60% This Month; Bullish Signal For Biotechs?
One sector that has always been a favorite of investors of all varieties is the pharmaceutical sector and all investors like a turnaround story. Over the years, ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) had been one of the better-known strugglers in the industry. That was reflected in the stock price as well. But recent developments have breathed new life in the stock, which could be an indicator for the biotech industry at large.
Biotech Stocks To Watch: PharmaCyte Biotech (PMCB)
There has been no lack of attention on biotech penny stocks this year. At the beginning of August, one small biotech stock broke to highs of over $10 from a starting price below $2 a share after releasing news. PharmaCyte Biotech (PMCB) focuses on ways to effectively deliver treatments to patients with diseases ranging from cancer to diabetes.
The company’s proprietary cellulose-based live-cell encapsulation technology known as “Cell-in-a-Box®is the platform that the company uses to develop its therapy delivery methods. For most of the quarter, shares of PMCB stock have traded between $0.033 and $0.04 with volume recently surging.
On September 12, PharmaCyte saw more than 4 million shares trade; well above its daily average. Most of the attention surrounding the company has been on two things. First, its progress with Cell-In-A-Box and the application for Pancreatic cancer has continued to progress. The company brought on Dr. Manuel Hidalgo, has confirmed that he will be Principal Investigator (PI) for PharmaCyte’s planned clinical trial in locally advanced, inoperable pancreatic cancer (LAPC) now that he is at Weill Cornell Medical Center.
Second, the company has been ramping up for a much-anticipated shareholder update call on September 20. The call will cover PharmaCyte’s preparations for submission of its Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA) to treat locally advanced, inoperable pancreatic cancer and developments related to PharmaCyte’s product pipeline on which PharmaCyte has been working and that have not yet been reported in a press release.
Acadia (ACAD) Stock Price: Important Developments
People who had held on to the stock through the barren years got a nice boost recently. This came after Acadia’s well-known medicine Nuplazid recorded better than expected sales. In addition to that, there were encouraging results from a dementia-driven psychosis study. Hence, it is important to figure out whether it is perhaps time to buy the stock.
While the signs are no doubt encouraging, it is important to note that data reveals that around 60,000 people in the United States are diagnosed with Parkinson’s every year. Out of those, a large proportion (50% to 80%) suffers from dementia. Hence it can be argued that the market is simply not too big for Acadia’s Nuplazid.
Moreover, different types of dementia are brought on by Alzheimer’s disease, which is why all of it might not actually fall into Acadia’s lap. That being said, it is also well known that antipsychotic drugs have only been approved for the treatment of Parkinson’s and hence the Alzheimer’s market is already out of the question.
Projections suggest that the sale of Nuplazid could grow to more than $1 billion in 2023 from $224 million in 2018. While that is encouraging, it is also important to note that the growth has been priced into the Acadia stock price.
However, if Acadia’s plans for growth somehow run into any trouble, then there is every chance of the stock price plummeting once again. The company is recovering and there is some time before the patient population for Nuplazid can be expanded sufficiently. In the meantime, investors need to be a bit more patient.
Shares of ACAD are up over 60% over the past week and made a new multi-year high of $43.98.
Top Biotech Stocks To Watch This Week
Biotech stocks rarely perform well during the summer months, and 2019 has proven to be no exception in regards to this historical pattern. The iShares Nasdaq Biotechnology ETF, for example, has fallen by nearly 2% since the official start of summer.
The values of biotech equities, however, do generally start to pick up as the year winds down. The underlying reason is that the latter part of the year is chock-full of key data readouts, regulatory decisions, and thousands of scientific conferences across the globe.
Biotech Stocks To Watch
GT Biopharma (GTBP)
Earlier this quarter GT Biopharma, Inc. (GTBP) an immuno-oncology company focused on innovative treatments based on the Company’s proprietary NK cell engager announced that Jeffrey Miller, M.D. has been hired by the Company as its Consulting Chief Medical Officer.
Further to this, the company confirmed that it had notified FDA that it was commencing enrollment in its first-in-human GTB-3550 Phase I/II clinical trial. 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.
GTB-3550 (OXS-3550) is the Company’s first Tri-specific NK cell Engager (TriKE™) product candidate being initially developed for the treatment AML. GTB-3550 is a single-chain, tri-specific scFv 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.
Since making the announcement, shares of GTBP are up by 13.2%.
NewLink Genetics Corp (NASDAQ:NLNK)
NewLink Genetics Corp (NASDAQ:NLNK) said the FDA has accepted partner Merck & Co., Inc. (NYSE:MRK)’s BLA for its investigational Ebola vaccine, according to the application priority review status. The PDUFA goal date has been set for March 14, 2020.
Potential approval of the vaccine will trigger issuance of a priority review voucher, owned by Merck and in which NewLink has a substantial economic interest. NewLink can then monetize its share of interest in the voucher. The vaccine candidate, originally developed by the Public Health Agency of Canada, was licensed to NewLink.
vTv Therapeutics Inc (NASDAQ:VTVT)
vTv Therapeutics Inc (NASDAQ:VTVT) is scheduled to present at the European Association for the Study of Diabetes 55th annual meeting being held in Barcelona, Spain with a new Phase 1/2 Simplici-T1 study of liver-selective glucokinase activator TTP399 as an adjunctive treatment for Type 1 diabetes.
Biotech IPO To Watch
IGM Biosciences priced its IPO of 10.938 million shares at $16, the midpoint of the estimated price range of $15-$17 per share. The shared of the preclinical and clinical-stage immuno-oncology biotech will be listed on the Nasdaq under the ticker symbol “IGMS.”
3 Biotech Stocks Jumped Big Last Month
The biotech sector has thrown up a high number of gems over the years and helped generate hefty returns for investors. Due to the advancements made in biotechnology over the years and those which are still being made, it is a sector that will continue to be a favorite of many investors.
Plenty of companies are doing revolutionary work in this space and have the potential of turning into excellent investments eventually. Here is a look at 3 biotech stocks that jumped significantly over the past few weeks and deserve to be on the watch lists of investors.
Tiziana Life Sciences (TLSA)
This biotech stock has been riding under the radar for the better part of the last 6 months. But in September, shares of Tiziana Life Sciences (TLSA) have enjoyed a much more active market. This has been due, in part to recent Phase Trial news related to the company’s pipeline therapies:
[9/10/19] Tiziana Reports Phase 1 Clinical Data Demonstrating Nasal Treatment with Foralumab was Well-tolerated and Produced Positive Trend in Biomarkers of Immunomodulation and Anti-inflammation in Healthy Volunteers
[9/4/19] Tiziana Life Sciences (TLSA) Reports Positive Phase 2a Clinical Data Exhibiting Positive Clinical Activity with Milciclib Monotherapy in Advanced Sorafenib-refractory or -intolerant Patients with Unresectable or Metastatic Hepatocellular Carcinoma
Tiziana Life Sciences (TLSA) is focusing on to develop novel treatment for liver diseases such as NASH and hepatocellular carcinoma (HCC). Tiziana (TLSA) holds extensive IP and a strong pipeline of in-licensed clinical assets. Tiziana has clinical development programs for Foralumab and Milciclib. Strong IP for oral and nasal administration is for the platform technology, which is applicable to all antibodies drugs for treatment of human diseases. Click To Read More About Tiziana Life Sciences (TLSA)
The next company to watch: Mesoblast Limited (MESO Stock Report). Its shares skyrocketed last week after it emerged that it had entered into a lucrative partnership with Grunethal. Grunethal is a privately held German company. According to the terms of the deal, the companies are focusing on the development as well as sales of the product MPC-06-ID.
According to the terms of the deal, Grunethal is going to pay $15 million to Memoblast straightaway for the right to sell the medicine in South America and Europe. However, the company stands to earn as much as $135 million more if certain targets are met. The Phase 3 trials for patients in the United States are already happening and the data could be available by mid-2020.
Kodiak Science (KOD)
The other stock which made a major move last week was Kodiak Science (KOD Stock Report). The company is involved in AMD or age-related macular degeneration and similar other conditions that hamper the vision in people of advanced age.
Vision loss is one of the most important categories of treatments in the sector and there is a lot of conflict in the sector with regards to the effectiveness of anti-VEGF medicines. Kodiak is developing its own antibody known as KSI-301and recently human proof of concept data points with regards to the anti-VEGF medicine showed that the company might have actually found something that could work. That resulted in the remarkable rise in the stock price last week.
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