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.
Biotech Stocks To Watch In June: Cara Therapeutics (CARA) & Intellia Therapeutics (NTLA)
Among biotech companies, the competition between Cara Therapeutics Inc (CARA) and Intellia Therapeutics Inc (NTLA) has been an intriguing one. The two companies had been on the same level as far as the market cap goes during most of the year so far.
But Cara has now pulled ahead by as much as $150 million following positive data from its lead product candidate. That being said, it is also important to keep in mind that if an investor is looking at a long term investment, then the disparity in market cap between the two companies is a minor. Here’s a look at the pros and cons of Cara and Intellia.
Cara Therapeutics (CARA)
Cara Therapeutics is currently on the rise. Its lead product candidate Korsuva injection delivered highly encouraging results in its Phase 3 trial. It’s now believed that it would not be long before Cara has its first product on the market.
It is meant for the treatment of moderate-to-severe chronic kidney disease-associated pruritus. According to reports, the results were great. Another late-stage test is going to be conducted soon. The results could be announced by the end of this year. If Korsuve is approved, then it will be marketed by Fresenius Medical Care and Vifor Pharma Group.
Cara has entered joint ventures with those companies to market the product in the United States, Japan, and South Korea. An oral version of Korsuva is also in the pipeline and could prove to be another important development.
Intellia Therapeutics (NTLA)
Intellia Therapeutics (INTA) is involved in creating CRISPR gene editing therapies. It is a segment that has a lot of promise in the future. Even though the company is some years away from having anything on the market, the promise of gene editing therapy is exciting. So much so that Intellia has already found partners in big-ticket firms like Regeneron and Novartis.
Intellia is expected to file for FDA approval for the clinical study into its lead product NLTA-2001 in 2020. It is meant for the treatment of transthyretin amyloidosis, an uncommon genetic disease. Studies into the products have proven to be promising so far. The company is also working on a product to treat myeloid leukemia.
Now when it comes to choosing between Cara and Intellia, experts believe that the former could a better company. It’s already on the verge of having an approved product on the market. Intellia, on the other hand, is likely to be some years away from winning approval.
Is Palatin Technologies (PTN) A Penny Stock To Buy Or Sell?
Will Shares Of Palatin Technologies (PTN) Head Higher As Biotech Stocks Rally This Month?
Biotech stocks are rallying this month. Despite the “pop and drop” this sector saw earlier in the year, June has been a big month for biotechnology companies and people investing in this sector.
In fact, the iShares Trust Biotechnology ETF (IBB) has climbed by more than 8% since the start of June. This sector has been famous for producing volatile returns for investors. Furthermore, biotech penny stocks have increased that potential.
Palatin Technologies (PTN) Is A Biotech Penny Stock To Watch
One of the best performing penny stocks in the biotechnology sector this month has been Palatin Technologies Inc. (PTN). On January 2, this penny stock opened the year at $0.71 and has seen a 2019 high of $1.74. What’s more is that even though PTN stock has consolidated, it has continued to trade above $1.20.
So what’s all the excitement about? Palatin Technologies, Inc. is a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical need and commercial potential.
The company’s main strategy is to develop products and then form marketing collaborations with industry leaders in order to maximize their commercial potential.
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The recent excitement seems to have started in April after the company reported positive top-line results of its oral clinical study of PL-8177. The treatment is designed to address ulcerative colitis and other inflammatory bowel diseases.
“The main objective of the study was to demonstrate release of polymer-bound PL-8177 in the lower gastrointestinal tract after oral administration. Top line data showed favorable pharmacokinetics, and demonstrated PL-8177 was released in the lower gastrointestinal tract, supporting oral administration of PL-8177 using the delayed release polymer formulation.”
New Milestones From Palatine Technologies (PTN) Triggers New Highs
After hitting new highs on May 17th after posting quarterly earnings, shares of PTN stock have consolidated. Regardless, the company continues to progress. Earlier this month the company obtained orphan drug designation for PL-8177. Yes, this is the same one that I talked about above when the company received positive topline results earlier in the year.
Why is orphan drug designation important? This is a good question especially if you’re newer to biotech penny stocks or biopharmaceutical stocks, in general. In the exact words of the FDA:
“The Orphan Drug Act (ODA) provides for granting special status to a drug or biological product to treat a rare disease or condition upon request of a sponsor. This status is referred to as orphan designation (or sometimes “orphanstatus”).”
Essentially it gives companies incentives above and beyond competitors. These incentives include a partial tax credit for clinical trial expenditures, waived user fees, and eligibility for 7 years of marketing exclusivity. The obvious response would be favorable, which has been seen in the market over the past few trading sessions.
Dr. Carl Spana, President and Chief Executive Officer of Palatin Technologies, said in a press release, “Unlike corticosteroids, immunosuppressive agents, and biological therapies targeting specific cytokines or receptors, melanocortin receptor 1 peptides work to resolve chronic inflammations and restore normal immune function. We look forward to initiating clinical trials with PL-8177 for non-infectious uveitis, a high medical need disease with limited treatment options.”
But Here’s Why Palatin Might Be Set For More Excitement
It’s all about sex drive. You read that right. And something that hasn’t really been fully publicized is this “big FDA date.” You see on June 23rd, the application for Vyleesi (bremelanotide), a drug developed by Palatin and licensed to AMAG Pharmaceuticals (AMAG) will be up for review by the FDA as a New Drug.
Vyleesi is a novel melanocortin 4 receptor agonist under evaluation for restoring a natural sexual desire in premenopausal women with HSDD. Think of this like female Viagra. Will this become the sexiest biotech penny stock this month or will stock traders get blue balled?
Like This Article? Check Out: Small Cap Biotech Stocks See Boost From Large Cap M&A
Healthcare Penny Stocks To Watch: Driven Deliveries Inc. (DRVD), Biocept Inc. (BIOC), Cesca Therapeutics Inc. (KOOL), PhaseBio Pharmaceuticals Inc. (PHAS)
Healthcare penny stocks tend to be the largest movers among other penny stocks. This is mainly due to the amount of news they release. For example, any development in treatment becomes a news catalyst, which happens more often than other news.
Driven Deliveries Inc. (DRVD)
Driven Deliveries Inc. (DRVD) is primarily a technology company so why include it with other healthcare penny stocks? It is included because of what Driven’s technology is capable of, delivering medical and recreational marijuana. Medical marijuana legality is sweeping across the US which is only expanding the future demand for the services Driven provides.
More studies are beginning to show the positive effects of marijuana in relation to stress and pain relief. These studies make Driven’s recent announcement way more important. Driven revealed a partnership with Pure Ratios, a company selling 96-hour pain relief CBD and THC patches. This product is the only of its kind as it bypasses the digestive process and is absorbed directly into the bloodstream.
Christian Schenk, CEO of Driven, stated, “We believe that our best-in-class delivery platform coupled with Pure Ratio’s proven popular brands will provide a strong synergistic relationship between the companies. We look forward to expanding our customer base while increasing revenue and enhancing our overall brand recognition. Management has already identified several similar popular brands that it intends to add to our platform in the near future.”
Biocept Inc (BIOC)
Biocept Inc (BIOC) is a healthcare company that uses liquid biopsy technology to assess several forms of cancer for physicians. Biocept has their own liquid biopsy platform known as Target SelectorTM which can analyze tumor markers.
Recently, Biocept announced a new Target SelectorTM platform for breast cancer. It is Biocept’s second tumor-specific panel and will help target the second leading cause of death for women. In addition, Biocept’s platform allows medical personnel to evaluate patients with metastatic breast cancer which is usually very difficult. This news has brought strong volume and a 11% pre-market move.
Cesca Therapeutics Inc. (KOOL)
Cesca Therapeutics Inc. (KOOL) is a medical device healthcare company for cell-based therapeutics. Cesca is an affiliate of the BoyaLife Group which is based out of China. Cesca is using its AutoXpress platform to meet the needs regarding cardio, vascular, and immune diseases.
One of Cesca’s subsidiaries, ThermoGenesis, recently received approval for its Next-Gen AXP II System for cord blood processing. The AXP II System allows for the processing and storage of hematopoietic stem call concentrates. Also, multiple cord blood units can be processed in one centrifuge. Thanks to this approval, Cesca’s stock increased by more than 40%.
PhaseBio Pharmaceuticals Inc. (PHAS)
PhaseBio Pharmaceuticals Inc. (PHAS) is a biopharmaceutical company whose primary goal is creating and selling treatments to orphan diseases. Their primary drug is called PB2452 which reverses antiplatelet activity. PB2452 recently received positive preliminary results from Phase 2a clinical trial. These results pushed the stock from $12.19 to $14.08 on June 18th.
“If approved, PB2452 could help address these critical unmet medical needs by enhancing the safety profile of ticagrelor, which has the potential to become the only antiplatelet therapy on the market with a specific reversal agent. We look forward to reporting full results from the Phase 2a trial at an upcoming medical congress.”John Lee, M.D., Ph.D., Chief Medical Officer of PhaseBio
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