Could The Watershed Moment For Merck Mean Even Bigger Things For Cancer Stocks?

Merck’s (NYSE:MRK) big news on July 27th marked a watershed moment for the company’s cancer treatment, Keytruda. The Food & Drug Administration approved Keytruda for treating patients with high-risk early-stage triple-negative breast cancer (TNBC), in combination with chemotherapy. Following surgery, Keytruda could then continue as a single agent adjuvant. This approval was based on Merck’s Phase 3 KEYNOTE-522 trial.

“Even when TNBC is diagnosed early, 30-40% of patients will suffer cancer recurrence after standard neoadjuvant chemotherapy and surgery.”

Dr. Joyce O’Shaughnessy, chair of Breast Cancer Research, Baylor University Medical Center, Texas Oncology, U.S. Oncology, Dallas, Texas.

Dr. O’Shaughnessy went on to say, “There is a high unmet need for new treatment options. Today’s approval is very welcome news has the potential to change the treatment paradigm by now including an immunotherapy as part of the regimen for patients with high-risk early-stage TNBC.”

This latest win brings Keytruda’s approved indications to 30 in the U.S. But what it also does is emphasize the true potential of immunotherapy.

What Is Immunotherapy & Why Should You Be Paying Attention?

In short, immunotherapy is a type of cancer treatment using the body’s own immune system to fight or manage cancer. In fact, according to the Cancer Research Institute1, immunotherapy can actually “train” the immune system to “remember” cancer cells. This can ultimately result in longer-lasting and even permanent protection against cancer recurrence.

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Right now, the standard of care is usually something like chemotherapy. But the major difference between immunotherapy and chemo is that chemo is a form of attack on cancer cells, which can also affect normal cells. This type of treatment tends to last as long as treatment continues. Immunotherapy, on the other hand, engages a patient’s immune system to build a stronger immune response. This is the way that the immune system essentially “learns” how to recognize and ultimately eradicate cancer cells. While the downside of immunotherapy is taking longer to have an impact, the lasting effects can remain long after treatment has concluded.

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But immunotherapy can be expensive. For example, Keytruda’s recommended dosing2 is either every 3 weeks at $10,067.36 per dose or every 6 weeks at $20,134.723. While insurance can play its part, the 12-24 month regimen can get pricey very quickly. While Keytruda (Pembrolizumab) may be one of the headliners, companies are working quickly to develop the next generation of immunotherapy that is more scalable and more affordable. This is where Natural Killer or NK cell treatment has started to make some noise in the oncology treatment community & where some investors are beginning to focus right now.

NK Cell Immunotherapies: A New Generation For Targeted Treatment

As I said above, chemotherapy is more of a “blanket treatment” that can affect cancer cells and normal cells to try and “fix” the problem. With immunotherapy, the treatment “targets” cancer cells, specifically to bring about a better immune response in patients. The advent of this new, targeted treatment for cancer has already begun evolving. NK cell treatment could be the next iteration of effective targeted cancer treatment.

One of the companies developing a new platform to benefit from this new generation is GT Biopharma Inc. (NASDAQ:GTBP). The company’s tri-specific natural killer engager treatment platform or TriKE has become the backbone of a robust pipeline of treatment candidates. This therapy combines proteins that bridge an immune cell and a tumor cell then drive tumor cell killing power to exponential levels. It has led to new first-in-human phase studies to treat leukemia and is being studied in other cancers including breast, lung, gastric, colorectal, and ovarian indications.

GTB-3550, the company’s first TriKE™ candidate, is under development for treating acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and other types of CD33+ hematopoietic malignancies. This treatment is currently in Phase I/II clinical trials and has already shown meaningful results in the first few handfuls of patients undergoing treatment.

Favorable Results Could Be Just The Start

According to the company, initial study results have shown that 57% of patients experiencing “significant reduction in AML/MDS cancer cell burden” when treated with GTB-3550. There was also up to a 63.7% reduction in bone marrow blast levels in some patients. At all dose levels, the treatment was well-tolerated without any adverse events, which is something the market is keeping in mind as well.

This is important because other comparable types of “targeted” treatment tend to cause cytokine release syndrome (CRS). This is a systemic response to the activation and proliferation of CAR-T cells, which can provoke high fever and severe flu-like symptoms. Since even the higher dose levels didn’t produce such a response, the company has been especially optimistic about the treatment’s potential.

“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.”

GT Biopharma CEO Anthony Cataldo to

For those looking at GT Biopharma right now, there are several, very near-term things to look for. The Phase 1 safety portion is expected to finish up in late August with a data publication scheduled for the end of September.

What’s more, Wall Street analysts also have high hopes for GT’s pipeline, GTB-3550 in particular. In fact, analysts from B. Riley have explicitly stated, “Based on the press release and our subsequent conversation with management, we are encouraged by the mounting evidence of clinical activity and the emerging safety profile of lead asset GTB-3550…With the dose-escalation portion of the trial expected to complete towards the end of August 2021, we are raising our probability of success for GTB-3550 in CD33+ acute myeloid leukemia (AML) and higher-risk myelodysplastic syndrome (HR MDS) from 25% to 30%, with a commensurate increase in our 12-month price target.” Read Full Analyst Report Here.

Other firms, including H.C. Wainwright & Roth Capital, have also expressed bullish stances on the company. Both currently have $25 price targets on the stock right now.

A Bright Future For “Off The Shelf Treatments”

Cell therapies have revolutionized cancer research. These targeted treatments are designed to specifically target individual cells or cell types. In this case, things like chimeric antigen receptor (CAR) T-cell therapy (CAR-T) have built a new pathway for how healthcare professionals manage patient outcomes. Novartis (NASDAQ: NVS), for instance, brought its Kymriah 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.”

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But it didn’t come without risks. In fact, treated patients can actually face serious and potentially life-threatening side effects. Among them is CRS or the “cytokine storm” discussed earlier. CAR-T treatment is also very expensive. Kymriah has a price tag of $475,000 for just a one-time treatment. This is due partly to the fact that CAR-T therapies generally need a match from a specific donor to a specific patient. So, this makes it difficult to scale since everyone is different.

NK therapies, on the other hand, have found a place within cancer research and investors are beginning to pay close attention to companies developing therapies. NK treatments are being labeled a type of “off-the-shelf” treatment option. The term itself references therapeutics that don’t need to be manufactured specifically for each patient individually.

Rather, NK treatments are genetically engineered from 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 the success rates of other monotherapies.

Where Immunotherapies Started, Advanced Treatments Are Taking Over

There’s no denying what drugs like Merk’s Keytruda, Novartis’ Kymriah, and Bristol-Myers Squibb’s (NYSE:BMY) Opdivo have done to build the foundation for mass adoption of immunotherapy. But the fact is, the next generation could bring in the golden age of cancer treatment. This not only includes monotherapies but combination treatments as well.

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Other TriKE candidates from GT Biopharma have demonstrated efficacy in combination with other treatments. For instance, GT Biopharma’s B7H3 TriKE was combined with Fate Therapeutic’s (NASDAQ:FATE) FT538 iNK cells targeting tumor cells in prostate cancer. While FT538 alone showed a slight impact to cells in the model, the combination with GT’s TriKE demonstrated a complete eradication of cancer cells:

GTBP TriKE treatment gtb5550

GT Biopharma’s CEO, Anthony Cataldo told, “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, but the potential also 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.”

Industry Veterans Linking Up With GT Biopharma

One of the leading voices of NK cell treatment, Dr. Jeffrey S. Miller, M.D., Deputy Director of the University of Minnesota’s Masonic Cancer Center has been credited with pioneering NK cell therapies. He initially found that these cells can induce remission in patients with refractory leukemia.

Dr. Miller, who is also the Consulting Chief Scientific Officer of GT Biopharma, recently signed a sponsored research agreement (SRA) with the company. This SRA focuses on the further clinical development of GT’s TriKE product candidates. Based on his previous endeavors with NK cell candidates, this news has been circulating among those searching for new cancer stocks to watch. Dr. Miller has supervised over 400 NK cell products and sponsored more than 10 investigational new drug applications.

Promising Breakthroughs In Cancer Treatment Make It One Of The Hottest Niches In Biotech

A report from Business Research Company, “Oncology Drugs Market – Opportunities And Strategies – Global Forecast To 2030,” states that the global market value of cancer therapeutics is expected to reach $201 billion by the end of this year4. That number is expected to jump to $284.5 billion by 2023. New therapies and collaborative initiatives are two of the factors to act as a boon to 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.”

Data Shows Growing Market Share

In Deloitte’s 2021 Global Life Sciences Outlook5, data shows major favor supporting oncology companies: “Beyond vaccines, oncology is expected to continue to be a major driver of the sector’s topline growth in 2021. Oncology accounts for six out of the 10 biggest new sales generators and four of the top 10 bestselling products.”

cancer stocks biggest new sales

Deloitte’s data also shows the sheer size and scope of cancer treatments as far as expected sales in 2021 are concerned:

  • Keytruda is expected to be a $16.8 Billion drug in 2021 as far as annual sales are concerned.
  • Bristol Myers Squibb’s Revlimid and Opdivo are expected to do a combined $21.5 Billion this year.
  • EvaluatePharma expects Johnson & Johnson (NYSE: JNJ)/Abbvie’s (NYSE: ABBV) Imbruvica 2021 sales to come in at $7.6 Billion.
cancer stocks biggest selling drugs

The list goes on. However, new research into immunotherapy drug development has given the market a push toward further expansion. Thanks to milestones from companies like Merck and its Keytruda platform, there’s been a huge initiative to find companies working on the next generation of targeted cell therapies. The market is wide open for disruption and clearly, investors have shown an interest.

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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.

End Notes:

  1. org/en-us/immunotherapy/what-is-immunotherapy
  2. https://www.keytrudahcp .com/dosing/options/
  3. https://www.keytruda. com/financial-support/
  4. 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
  5. Deloitte Life Sciences Outlook: com/global/en/pages/life-sciences-and-healthcare/articles/global-life-sciences-sector-outlook.html

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