Biotech Companies Like GT Biopharma & Fate Therapeutics Are In The Spotlight Thanks To Novel & Breakthrough Treatment Platforms
In this article, we’re going to dive into the multi-billion-dollar cancer treatment industry. We’ll also look at very recent developments that have shown why small-cap biotech stocks could be important to watch in 2021.
Things like targeted cell treatments and “off-the-shelf” candidates are now coming to the forefront. I’ll explain more on what these are next. However, the point is that chemotherapy and radiation are now ancient in comparison to new cancer treatments & small-cap companies could benefit the most.
What Are Targeted & “Off-The-Shelf” Treatments?
Cell therapies have revolutionized the way cancer treatments are being developed. This is where targeted treatment comes into play. Drug candidates are designed to specifically target individual cells or cell types. In this case, the discoveries that produced chimeric antigen receptor (CAR) T-cell therapy (CAR-T) helped bring new treatments to market, which have dramatically changed how healthcare professionals manage patient outcomes. Novartis (NASDAQ: NVS) brought its Kymriah breakthrough treatment to market in 2017. The FDA called it “a historic action… ushering in a new approach to the treatment of cancer and other serious and life-threatening diseases.”
While this unprecedented event has brought a new treatment type to the forefront, it doesn’t come without downsides. For instance, there is a risk that treated patients face serious and potentially life-threatening side effects. Among them is what’s known as cytokine release syndrome (CRS) or the “cytokine storm.” This stems from a response to the activation and increase in number of CAR-T cells, which can lead to high fever and severe flu-like symptoms. CAR-T treatment is also very expensive. For instance, Kymriah boasts a price tag of $475,000 for just a one-time treatment.
While CAR-T showed promise, the next evolution of targeted treatment could be even more groundbreaking. CAR-T therapies need a match from a specific donor to a specific patient. So, this makes it hard to mass-produce since everyone is different. It can’t be made like an “off-the-shelf” drug.
NK or “natural killer” cell therapies, on the other hand, have now found a place within cancer treatment and investors are beginning to pay close attention to companies developing therapies. These are being called a new type of “off-the-shelf” treatment options. Now, we aren’t talking about something you go into a pharmacy and buy right next to the Tylenol. The term references therapeutics that don’t need to be manufactured specifically for each patient individually.
These are genetically engineered healthy cells manufactured from normal, healthy donors. Since this treatment entails allogeneic cell lines, NK cells can be created to trigger certain immune responses in a variety of patients. These cells “identify” cancer cells on their own as well as in combined with CARs. They allow each dose to have a more durable response and the ability to give multiple doses (versus just a single dose). NK cell treatment has even shown the ability to boost success rates of other monotherapies.
Small-Cap Biotech Stocks Capitalizing On NK Cell Treatment
Now that you’ve got a general understanding and brief history lesson on recent cancer treatment evolution, let’s look at companies taking an active position. Believe it or not, many are small-cap companies in comparison to the likes of Pfizer (NYSE: PFE), Merk, (NYSE: MRK), and Novartis. Take Fate Pharmaceuticals (NASDAQ: FATE) & GT Biopharma Inc. (NASDAQ: GTBP) for instance.
Last year, Fate was valued at just 17% of its current market value as shares were trading around $17. Once the company announced a key FDA clearance event for its FT538 treatment in May, the market began waking up. The FDA cleared the company’s Investigational New Drug (IND) application for this cancer immunotherapy. Dubbed as an “off-the-shelf” NK cell therapy, FT538 was initially set to target indications for acute myeloid leukemia. So far, 1 of 3 patients in the first dose-escalation portion of Fate’s FT538 study showed an objective response and complete Leukemic blast clearance in bone marrow.
While a 30% success rate would appear “significant,” this study also had 1 patient that completely discontinued the study before completing it because of a failure to respond to the therapy. Even though this is the case, it clearly hasn’t stopped FATE stock from mounting a move of more than 400% since last March and making the move from small-cap to mid-cap stock.
New Platform For NK Cell Treatment: GT Biopharma’s TriKE
Fate’s response from a single member of the patient population of a 3 patient trial showed the promise of its NK candidate in AML. However, other companies are taking this type of treatment a step further with novel technology platforms already showing early success in clinical trials. GT Biopharma Inc. has developed a treatment technology called TriKE. This is a “tri-specific” recombinant protein biologic. TriKE is made up of 3 things: an NK cell engaging domain targeting CD16 on the NK cell, an NK cell activating domain consisting of Interleukin IL-15, and a cancer cell targeting domain.
According to the company, the “NK cell-stimulating cytokine human IL-15 portion of the molecule offers a ‘self-sustaining’ signal. This activates a patient’s own, exhausted/inhibited NK cells and enhances their ability to kill and proliferate without a need for additional engineered NK cells.”
GT’s lead treatment candidate, GTB-3550, like Fate’s FT538 is targeting acute myeloid leukemia. However, unlike Fate, its current Phase 1/2 study has enrolled more than 3 times the number of patients. Interim data from the Phase 1 portion of the trial has already shown that GTB-3550 was well tolerated by all patients without any cytokine storm observed. There was also up to a 63.7% reduction in bone marrow blast levels in some patients.
“We have now completed treatment of eleven patients. In addition to strong safety results, we have seen significant reductions in CD33+ cancer cells in four of the last seven patients (57%) treated with doses of GTB-3550 ranging from 25mcg/kg/day to 150mcg/kg/day. This early sign of CD33+ target-specific cancer cell killing is very encouraging as we begin to focus on transitioning to the expanded efficacy part of the current GTB-3550 clinical trial.”Anthony Cataldo, GT Biopharma’s Chairman and Chief Executive Officer
More Evidence Supports Targeted Combination Treatment With TriKEs
There’s a reason that both GT Biopharma & Fate were mentioned together. Aside from both companies working on separate NK treatments for acute myeloid leukemia, another one of GT Biopharma’s TriKEs, B7H3 TriKE, was recently combined with Fate’s FT538 iNK cells targeting tumor cells in prostate cancer. While FT538 alone showed a little impact to cells in the model, its combination with GT’s TriKE demonstrated a complete eradication of cancer cells:
In data published last November at the Society for Immunotherapy of Cancer, researchers stated that “the combination of B7H3 TriKE with an off-the-shelf NK cell therapy presents an appealing therapeutic strategy for the treatment of solid tumors with decreased risk of toxicity in allogeneic settings compared to T-cell derived products.”
What’s more, GT Biopharma’s CEO, Anthony Cataldo told PennyStocks.com that:
“GT Biopharma’s TriKE™ technology is a clear breakthrough in cancer treatment. Not only has it shown early success in hematologic diseases like acute myeloid leukemia, the potential demonstrated in combination with Fate’s FT538 iPSC NK cells opens up endless possibilities for the application of TriKE combination treatment in other potential drug therapy platforms targeting things like IL-15.”
Cataldo went on to state, “I’m impressed by the progress being made in the Phase 1/2 GTB-3550 clinical trials. To date, we still have yet to see one patient experience an adverse event like cytokine release syndrome even at the highest dose levels in this cohort.”
Though GTBP is still considered a “small-cap stock” with a market cap of less than $500 million right now, its TriKEs have already shown meaningful progress not only as monotherapies but also in combination with treatments from leading companies like Fate Therapeutics.
Promising Breakthroughs In Cancer Treatment
The Business Research Company’s report*: “Oncology Drugs Market – Opportunities And Strategies – Global Forecast To 2030,” the global market value of cancer therapeutics is expected to reach $201 billion by the end of this year. That number is expected to jump to $284.5 billion by 2023. The report credits new therapies and collaborative initiatives as factors igniting this growth.
“Over the last few years, there has been a significant rise in accelerated approval of cell and gene therapies for cancer treatment by regulatory bodies across the globe.”
Thanks to new oncology research, there’s been a huge push for developing targeted cell therapies. With NK treatments like FT538 and cutting-edge technologies like GT Biopharma’s TriKE, the future of cancer medicine is bright. As investors begin discovering names like these, it’s clear that the appetite is strong for companies focusing in this area of biotechnology. The question now is “Which company will be the one to make the FDA respond the same way it did when Novartis’ Kymriah first came to market?”
Pursuant to an agreement between Midam Ventures LLC and GT Biopharma (GTBP) Midam has been paid $150,000 for a period from March 1, 2021, to April 1, 2021. This compensation is payment 1 of 12 as part of a 12-month agreement between Midam Ventures LLC & GT Biopharma (GTBP), for a period from March 1, 2021, to February 28, 2022. Midam Ventures LLC expects to be paid $150,000 per month for a total of 12 months by GT Biopharma (GTBP). Midam has been paid an additional $150,000 for a period from April 2, 2021, to May 1, 2021. This compensation is payment 2 of 12 as part of the Agreement. Midam has been paid an additional $150,000 for a period from May 2, 2021, to June 1, 2021. This compensation is payment 3 of 12 as part of the Agreement. Midam has been paid an additional $150,000 for a period from June 2, 2021, to July 1, 2021. This compensation is payment 4 of 12 as part of the Agreement. Midam has been paid an additional $200,000 for a period from July 2, 2021, to July 29, 2021. This compensation is payment 5 of 12 as part of the Agreement. Midam has been paid an additional $200,000 for a period from July 29, 2021, to September 2, 2021. This compensation is payment 6 of 12 as part of the Agreement. We may buy or sell additional shares of GT Biopharma (GTBP) in the open market at any time, including before, during, or after the Website and Information, to provide public dissemination of favorable Information about GT Biopharma (GTBP). Click here for full disclaimer.
* https://www.globenewswire. com/fr/news-release/2020/10/06/2104100/0/en/Oncology-Market-Size-2020-Particularly-Prone-To-Disruption-During-Pandemic-In-The-Global-Oncology-Market.html