As our understanding of the human body and the ailments that attack it continues to improve, so to do our medical approaches toward conditions of all levels of severity. While this medical renaissance, so to speak, has led to options that we never thought imaginable, there are still indications that are met with few or no options.
A relatively new approach to addressing some of these conditions is sweeping the medical community as early results show incredible promise. This approach is known as immunotherapy.
In immunotherapy, biotechnology and pharmaceutical companies aren’t working to develop treatment options that attack a specific type of cell. Instead, they are looking to enhance them. The idea is that by enhancing the body’s innate immune system, the patient’s own line of defense will have the ability to break down and destroy cells and pathogens known to cause adverse medical conditions.
Immunotherapies are being developed to target severe, rare, and debilitating diseases with few options available to patients. Targeting these types of indications not only gives patients that suffer from them hope, but presents tremendous market opportunities in spaces with little to no competition.
As a result, when we see catalystic events out of immunotherapy companies, we tend to see incredible movement in the values of their shares. With that said, here are five immunotherapy companies that have multiple catalysts to look forward to…
Eli Lilly (LLY): A Classic Not Afraid To Change With The Times!
Founded in the 1800s, Eli Lilly is no stranger to the development of blockbuster medications. However, the traditional approach taken by the company may lead many of you to wonder why it is on a list of immunotherapy stocks with catalysts to watch for ahead. The answer is simple, the company fits the bill.
Sure, Eli Lilly may be best known for its leading treatments like Trulicity and Basaglar in the diabetes space, but the company is also breaking into immunotherapy, and doing so with a splash. In fact, according to Eli Lilly’s “Lilly Oncology” website, the company currently has 10 active clinical trials in various phases, assessing immunotherapies as potential options for patients facing multiple cancer types.
The most promising clinical candidate in Ely Lilly’s immunotherapy pipeline to date is known as Pegilodecakin. The treatment has already shown incredible promise in the potential treatment of pancreatic cancer. As a result, the company is in the midst of assessing the treatment for the pancreatic cancer indication in a Phase 3 trial.
Should the Phase 3 clinical trial prove to yield positive results, Ely Lilly will likely quickly advance the asset into regulatory submission and could push the treatment to market relatively soon. Pegilodecakin is also in multiple Phase 2 clinical trials for the treatment of non-small cell lung cancer, and in early development for an undisclosed indication.
With several immunotherapy treatment candidates in early stage development, and one option nearing regulatory submission, there are several catalysts ahead. This, combined with the strength that more than a decade in the industry provides, makes Ely Lilly a stock that’s well worth paying attention to.
Gilead Sciences (GILD): A Comeback Waiting To Happen
Over the past year, Gilead Sciences has seen some weakness in the market. As AbbVie competes with the company’s hepatitis C virus franchise, ultimately taking market share, many have been counting on declining sales in some of the company’s key drug products.
Nonetheless, I believe that the declines in sales have been priced in at the moment. Moreover, a bounceback is likely in the making.
Gilead Sciences’ innovation in immunotherapy led to its position as a pioneer in the treatment of HIV. In fact, with six blockbuster HIV drugs on the market, Gilead Sciences is a clear leader in the space.
Importantly, in February of 2018, the company received FDA approval for Biktarby, yet another immunotherapy designed to target HIV. Nonetheless, this treatment is expected to become the best selling HIV drug of all time due to strong efficacy and minimal adverse events. As such, sales reports surrounding Biktarby will likely prove to be catalystic events, causing strong movement in the value of the stock.
It’s also worth mentioning that the Gilead Sciences pipeline is a strong one. In fact, the company currently has 5 treatment candidates under Phase 3 development and more than 15 in Phase 2 clinical studies. Considering the multiple ongoing clinical trials and anticipated sales reports surrounding Biktarby, Gilead Sciences likely has multiple catalysts ahead.
INmune Bio (INMB): An Undervalued Play With Multiple Ongoing Clinical Trials
INmune Bio is a relatively small company by market cap. Nonetheless, the stock comes with explosive potential. That’s because not only does INmune Bio have multiple ongoing clinical development programs, but it is targeting high value indications with little by way of competition.
In my view, the most interesting candidate at INmune Bio is known as XPro1595. The treatment is being studied as a potential option for the treatment of patients with Alzheimer’s disease.
XPro1595 is believed to work by suppressing microglia. Microglia is present in high levels in Alzheimer’s patients. In fact, it’s thought that this is a key factor in the neuroinflammation believed to be a causative factor in Alzheimer’s disease. The idea is that by targeting and reducing Microglia, we will see a reduction in Alzheimer’s disease-related symptoms among the treated patients.
I find this treatment to be compelling because, if it is approved, it will be the only treatment on the market that addresses Alzheimer’s disease in this way. Moreover, it will become one of very few options available, giving INmune Bio a leg up in a market that is expected to grow to be worth more than $12 billion annually by the year 2026.
At the moment, XPro1595 is progressing through Phase 1 clinical studies. Moreover, it’s one of three candidates under development at INmune Bio. In fact, the company is currently developing INKmune and INB103 as potential options in oncology indications, yet another market with incredible potential.
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All in all, with multiple ongoing clinical trials and preclinical development programs, INmune Bio is likely to generate several catalysts ahead. Considering its relatively small market cap, combined with tremendous market potential, this is a stock worth paying close attention to.
Bluebird Bio (BLUE): Breaking Into Commercial Stages With A Potential Blockbuster
Bluebird Bio is a company that is just starting to enter the commercialization phase. In June 2018, the company won European approval for Zynteglo, a gene therapy that’s indicated to treat a rare blood disease. The indication, known as transfusion-dependent beta thalassemia, or TDT, offers up a blockbuster opportunity, but that’s not why the company is on this list.
The truth of the matter is that gene therapy and immunotherapy are two completely different things. Nonetheless, the company is actively involved in the development of immunotherapy options.
In fact, Bluebird is working in collaboration with Celgene (CELG) on very promising CAR-T treatment options. In fact, by the end of the year 2019, the two are expected to release clinical data from a Phase 2 study of ide-cel, also known as bb2121. The treatment is currently being assessed as a potential option for multiple myeloma, yet another high-value indication.
It’s also worth mentioning that bb2121 is not the only CAR-T treatment that the company has under development. It is also working on a similar treatment option known as bb21217 as a potential option for the treatment of multiple myeloma. The company expects to report data from this study by the end of 2019 as well.
All in all, Bluebird is working on four immunotherapy assets, one of which has achieved European regulatory approval, and all of which have the potential to become blockbuster treatment options. Considering the recent approval, sales reports surrounding Zynteglo, and clinical data likely coming from the company’s other assets, we’re likely to see several catalysts ahead.
ZioPharm Oncology (ZIOP): Yet Another Immunotherapy Play With Compelling Potential
Finally, we have ZioPharm Oncology. The company is focused on two primary assets within its pipeline. The first, immunotherapeutic asset, known as Ad-RTS-hIL-12, is believed to change the tumor microenvironment, turning immunologically cold tumors into hot ones.
Cold tumors are cancers that, for multiple reasons, contain few infiltrating T cells. As a result, these cancers are not recognized by the body’s innate immune system, thereby they do not elicit a response from the body’s innate immune system.
Nonetheless, it is believed that Ad-RTS-hIL-12 has the potential to change the tumor microenvironment, turning cold tumors into hot ones that are targeted by the immune system. Should this method of action prove effective, the treatment would not only be a strong monotherapy, but would come with tremendous combination potential, especially in combination with immune blockade inhibitor treatments.
Currently, ZioPharm is in the midst of 3 Phase 1 clinical trials and 1 Phase 2 clinical trial assessing the treatment as a potential option in various oncology indications.
Ziopharm is also working on an asset that it has dubbed “Sleeping Beauty.” The treatment is currently at the center of one Phase 1 clinical trial and multiple preclinical development programs. Moreover, the company has partnered with big names like the MD Anderson Cancer Center and National Cancer Institute for the development of its Sleeping Beauty asset.
All in all, with several clinical development programs under way and promising early results out of Ad-RTS-hIL-12, Ziopharm Oncology likely has multiple positive catalysts ahead. So, keep your eyes peeled for opportunity here.
Immunotherapy is a promising new approach to the treatment of several serious and debilitating conditions. With so much clinical activity in the space, new opportunities are being spotted every day. In my view, the stocks mentioned above represent some of the strongest opportunities in the space.
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