If you’ve ever invested in the stock market or traded a single share, chances are you’ve familiarized yourself with the “hot markets”. These are the ones that consistently see enormous volatility and gains that most only dream of.
More times than not, biotechnology and healthcare stocks are the “hot markets” and we’ll explain exactly why. We’ll also take a deep dive into a niche that you must be paying attention to in 2019 if you’re looking to take advantage of the next big trend in health science.
Biotech Companies Are Driving Innovation
Why biotech over other sectors? Two words: Life Changing. Sure the latest iPhone or newest gadget may be a “life-changing” product to make your life more exciting but in this hot market, we’re literally talking life-changing and life-saving bi-products.
Think about what would happen to a stock if a company were to find a cure for cancer? Better yet, what would happen if a company found a solution for HIV?
We’ll talk more about these topics but the simple fact of the matter is that companies are dumping billions of dollars into this sector to take advantage of the next trillion-dollar idea. One place, in particular, is in cancer-fighting stocks.
Cancer Fighting Stocks Are Getting Gobbled Up
The global market for cancer drugs is estimated to be about $123 billion and big players are investing heavily to gain an edge in this increasingly competitive market. Pharmaceutical giant Bristol-Myers, a pioneer in immunotherapy, is acquiring rival Celgene for $74 billion.
Merck is acquiring cancer drug developer Peloton Therapeutics for $1.05 billion. The announcement came as Peloton was preparing for its IPO. Earlier this year, Eli Lilly bought Loxo Oncology for $8 billion. And this is just the tip of the iceberg for cancer-fighting stocks!
Where Will The Focus Be Next? Read Between The Lines
According to people like Brad Loncar, CEO of Loncar Investments, companies at the forefront of immunotherapy research is the place to be. He’s focused on the important developments in the space and promising work being done by some smaller, innovative biotech companies.
We may have just uncovered a company set to take the stage in immunotherapy.
One of the top holdings of Loncar’s Cancer Immunotherapy ETF  is Iovance Biotherapeutics (formerly Lion Biotechnologies).
Why’s this important?
The reason isn’t so much about “why” but about “who.” Founder and previous CEO of Iovance Biotherapeutics, Anthony Cataldo was able to grow Iovance early on, and the company currently holds a market cap of over $2 billion with a share price above $17 per share.
This is key because Mr. Cataldo has recently taken the helm of one “small” immuno-oncology company focused on novel therapies, GT Biopharma (GTBP), which may signal the next big opportunity in biotech.
GT Biopharma (GTBP) is under his direct control and the best part is that this isn’t just a story about a biotech industry leader building the next market disruptor. The pipeline that GT Biopharma (GTBP) has amassed could be on the verge of something big.
GT Biopharma (GTBP)’s Next Move
Early, clinical stage companies like GT Biopharma (GTBP) present a number of value propositions for investors. Though many of these companies can hold higher risk due to lack of revenues, incurring high levels of expenses due to research, development, and SG&A, they can also offer higher rewards if early successes are realized.
So far, GT Biopharma has come up favorably with respect to trial results on more than just one of its therapies in the pipeline. Certainly, though the most recent developments with it OXS-1550 could deliver the most near term opportunities.
The company’s previous announcement that it would be working with a “major pharmaceutical company” may suggest that GT Biopharma (GTBP) could be positioning itself for a strategic move at the very least.
Though the “major company” was left nameless, we can infer from comments made by Dr. Daniel Vallera that the “multi-billion dollar oncology drug” is ibrutinib. The statement made in a company press release specifically stated, “We are very excited about our progress with GT’s OXS-1550 (DT2219) combined with ibrutinib, a potent small molecule Bruton Tyrosine Kinase (BTK) inhibitor which is already an established chemotherapeutic agent. We believe combination therapies like these that kill cancer cells based on entirely different mechanisms are the future of cancer treatment.”
Knowing this, we can begin connecting dots to the companies linked to ibrutinib. Its trade name is Imbruvica and is a drug that was developed by Pharmacyclics and Janssen.
Both Pharmacyclics and Janssen are subsidiaries of major pharmaceutical companies; Abbvie and Johnson & Johnson respectively.
Ibrutinib has already shown efficacy with other combination therapies like Venetoclax (marketed by Abbvie & Genentech) as well as Rituxan (rituximab), currently co-marketed by Biogen and Genentech in the U.S., for the treatment of patients with a rare type of non-Hodgkin’s lymphoma called Waldenström’s macroglobulinemia. The U.S. Food and Drug Administration recently approved Imbruvica (ibrutinib) plus Rituxan (rituximab) as a treatment.
That was in August of 2018 and even though this alone might get investors excited about GT Biopharma (GTBP), a lot has happened since then that could really put a spotlight on this company!
GTB-1550 Phase I-II Results Have Opened The Door For Bigger Opportunities
GT Biopharma’s lead treatment, GTB-1550 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. On the surface, the Phase I-II expansion clinical trial demonstrated greater than 50% of Evaluable patients receiving 60 mg/kg dose had a positive clinical response.
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.
“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.”Anthony Cataldo, the Chairman and Chief Executive Officer of GT Biopharma
But this Phase II opportunity is just the “first phase” of GT Biopharma’s potential. In early April of this year, the company received authorization from the University of Minnesota’s Institutional Review Board and Cancer Protocol Review Committee to proceed with a TriKE Phase 1 clinical trial.
Pipeline Therapies Gain Phase I Trial Approval
The study on its GTB-3550 will enroll up to 60 subjects and will be led by Principal Investigator, Erica Warlick, MD. Warlick is Associate Professor of Medicine, Division of Hematology, Oncology, and Transplantation at Masonic Cancer Center, University of Minnesota.
Specifically, the company will be looking for favorable results on the treatment of acute myelogenous leukemia (AML), myelodysplastic syndrome (MDS) and mastocytosis.
And just as with its GTB-1550, GTB-3550 addresses a specific group of patients. AML is the most common form of adult leukemia with 21,000 new cases expected in 2018 alone, according to the American Cancer Society. AML patients typically receive frontline therapy, most commonly chemotherapy, which includes cytarabine and an anthracycline, a therapy that has not changed in over 40 years.
When it comes to other things like MDS, the number of people with MDS diagnosed in the U.S. each year is estimated to be ~10,000 and can progress to AML. Mastocytosis is rarer. An estimate of prevalence from a recent population-based study is approximately 1 case per 10,000 people.
GTB-3550 is being developed to serve as a relatively safe, cost-effective, and easy-to-use therapy for resistant/relapsing AML. It could also be combined with chemotherapy as frontline therapy, thus targeting the broader patient population.
New Findings Suggest GT Biopharma Therapies May Eliminate HIV Infected Cells
It’s a regular occurrence but one that isn’t generally covered with certain biotech companies. But with certain therapies, there can be additional applications. Most of the time they are less impactful than the target endpoints. In the case of GT Biopharma (GTBP) its Tri-Specific Killer Engager may have a massive opportunity after recent findings!
The company’s therapy showed that it could target HIV infected cells in the University of Minnesota’s preclinical testing. Not only that but in specific tests, data showed that HIV-infected targets that express the HIV envelope on their surface could actually be eliminated!
We talked about it at the beginning of this report – Why biotech over other sectors? Two words: Life Changing – and this could be one of those “life changing” moments to pay very close attention to.
GT’s products will need to continue to produce positive results in order for investors to remain interested. And this having been said, indications have already been in motion giving even more legitimacy to GT Biopharma’s platform.
Case and point: would it be out of the question for GT Biopharma to obtain a strategic investment similar to the Affimed/Genentech deal? In our opinion, it wouldn’t be out of the question at all; here’s why:
Standing Toe To Toe With Industry Heavyweights
Both platforms utilize fusion proteins with one end binding to NK cells and the other targeting a tumor antigen however there are still a number of differences in the platforms. Many of these differences are based on exactly how the proteins are created and how they face the NK activation and proliferation issues.
Essentially, without a specific stimulatory agent, the cells become exhausted as their numbers decline. Specifically, GT Biopharma’s NK cell-engager platform incorporates Interleukin (IL)-15. No other, including Affimed’s, NK cell technology has this.
From other research done on NK cells, it has been found that boosting NK cell numbers  by treating them with IL-15 may be a valuable new approach to increasing our immunity to viral infections or cancer. IL-15 is a growth factor for certain kinds of white blood cells, including natural killer cells and T cells.
GT Biopharma’s TriKE (Tri-specific Killer Engager) technology has shown superior NK cell cytotoxicity against hematologic tumors in preclinical work compared to earlier versions of the drug. TriKEs are an off the shelf option that employ a single chain, tri-specific fusion protein that binds to CD16 on NK cells and targets tumor antigens on cancer cells such CD33 in myeloid malignancies.
TriKEs are particularly attractive due to their low cost of manufacture relative to CAR-T therapy and can be used off the shelf without any modifications of autologous cells in the lab. The company is currently in the process of submitting an investigational new drug application to the FDA for the TriKE in order to launch a Phase I/II trial in the second half of this year.
This, in addition to several other key therapies in the company’s pipeline could bode as attractive targets for larger investment from the likes of major pharmaceutical companies.
At The Forefront of the Cancer Wars & Ready To Deliver
Medical science hasn’t yet won the war on cancer, but it is scoring important victories in battles against many forms of the disease. Advances in new treatments have made cancer a hot investing theme over the past 18 months, helping to power fresh interest in biotechnology stocks.
It isn’t just small family offices taking a shot at this arena anymore. Major industry leaders are taking every chance they can at buying up smaller companies before they become the direct competition. The figures are becoming even more staggering as new therapies and phase trials materialize. GT Biopharma (GTBP) can make a convincing argument to become one of the top biotech stocks to watch.
“Big Pharma appreciates innovation and respects how it happens. That’s why the industry is interested in doing great deals with young companies that can move fast to solve big scientific problems.”Abbie Celniker, Ph.D., partner at Third Rock Ventures.
The health sciences market is experiencing unprecedented innovation, and now the race is to get behind the next breakthrough. GT Biopharma’s numerous phase trials, novel treatments, and top tier leadership are just some of the main topics to consider in our opinion.
In the end, this company is in early to mid-phase trials with proven results and has even shown indications for other immune-therapies to the extent that it has eliminated infected targets. With all of the activity going on within the immune-therapy space as it is, can you afford not to be paying attention right now?
Brad Loncar -https:// finance. yahoo. com /news/why-cancer-fighting-stocks-etfs-184606099. html
Loncar ETF Info – https:// etfdb . com /etf/CNCR/
 https:// lymphomanewstoday . com /lymphoma-treatment/
 NK Cell cancer immunity – https:// medicalxpress .com /news/2017-01-natural-killer-cells-cancer-immunity. html
PharmaCyte Biotech to Hold Special Shareholder Meeting
LAGUNA HILLS, Calif.–(BUSINESS WIRE)–
PharmaCyte Biotech, Inc. (PMCB), a clinical-stage biotechnology company focused on developing targeted cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, today announced that it will hold a Special Shareholder Meeting on September 11, 2019. The shareholder meeting, not to be confused with a shareholder conference call, will be held at the Courtyard by Marriott in Irvine, California, and will begin at 11:00 a.m. Pacific Daylight Time.
During the meeting there will be an update on PharmaCyte’s current research-related projects followed by a question and answer session regarding the update. The meeting will then turn to management matters, such as: (i) amending PharmaCyte’s Articles of Incorporation to provide the Board of Directors (“Board”) the power to designate the rights and preferences of PharmaCyte’s preferred stock; (ii) election of six directors as nominated by the Board’s Nominating Committee and approved by the Board, each to serve a one-year term; (iii) ratification of the appointment of Armanino LLP as PharmaCyte’s independent registered public accounting firm for the fiscal year ending April 30, 2020 and (iv) to consider and act upon any other business as may properly come before the Special Shareholder Meeting.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, stated, “This shareholder meeting will be the first during my tenure as CEO. Since the new management team took over in 2014, we have faced untold challenges and hurdles virtually every day. We have persevered. We believe we’re on the brink of a new dawn for the company as we work collaboratively with so many stellar professional colleagues to showcase the unique Cell-in-a-Box® technology in which so many have worked so diligently over the past several years. We feel that it is important to realize our full potential while, at the same time, bringing value to and protecting our shareholders who have stood by us for so long.
“We look forward to meeting many of our long-standing and new shareholders who can attend and in implementing the steps that will enable us to succeed on numerous fronts.”
About PharmaCyte Biotech:
PharmaCyte Biotech is a clinical stage 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.
PharmaCyte’s therapy for cancer involves encapsulating genetically engineered human cells that convert an inactive chemotherapy drug into its active or “cancer-killing” form. For pancreatic cancer, these encapsulated cells are implanted in the blood supply to the patient’s tumor as close as possible to the site of the tumor. Once implanted, a chemotherapy drug that is normally activated in the liver (ifosfamide) is given intravenously at one-third the normal dose. The ifosfamide is carried by the circulatory system to where the encapsulated cells have been implanted. When the ifosfamide flows through pores in the capsules, the live cells inside act as a “bio-artificial liver” and activate the chemotherapy drug at the site of the cancer. This “targeted chemotherapy” has proven effective and safe to use in past clinical trials and results in little to no treatment related side effects.
PharmaCyte’s therapy for Type 1 diabetes and insulin-dependent Type 2 diabetes involves encapsulating a human cell line that has been genetically engineered to produce, store and release insulin in response to the levels of blood sugar in the human body. PharmaCyte is exploring the use of genetically modified liver cells, stem cells and beta islet cells. The encapsulation will be done using the Cell-in-a-Box® technology. Once the encapsulated cells are implanted in a diabetic patient, they will function as a “bio-artificial pancreas” for purposes of insulin production.
This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words “expects,” “anticipates,” “believes,” “intends,” “estimates,” “plans,” “will,” “outlook” and similar expressions. Forward-looking statements are based on management’s current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation to update any forward-looking statement because of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements due to the impact of numerous risk factors, many of which are discussed in more detail in our Annual Report on Form 10-K and our other reports filed with the Securities and Exchange Commission.
More information about PharmaCyte Biotech can be found at www.PharmaCyte.com. Information may also be obtained by contacting PharmaCyte’s Investor Relations Department.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190821005275/en/
Dr. Gerald W. Crabtree
PharmaCyte Biotech, Inc.
Investor Relations Department
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 – 9/12/2019. 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
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
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