As our understanding of how cancer works evolves, so too are the methods that we are taking to treat the condition. In my opinion, one of the most important breakthroughs in the field of oncology today is immunotherapy.
With the first form of immunotherapy approved for an oncology indication in 1997, this approach to the treatment of cancer is relatively young. However, it is also incredibly promising.
Instead of focusing on harmful treatment options that not only attack cancer, but also attack healthy tissue, leading to severe adverse events, immunotherapies enable the body’s own immune system to fight back.
As a relatively new therapeutic option, many companies are racing to develop the next big immunotherapy in the field of oncology, and several are on the verge of accomplishing this goal. Of course, with the global oncology market expected to grow to be worth $200 million by 2022, the immunotherapies under development offer an interesting, and potentially highly lucrative, investment opportunity. Here are some stocks in the field that may be worth your attention:
Incyte Corp. (INCY, Financial): Jakafi is a blockbuster drug
Incyte is a perfect example of what a strong early move in the immunotherapy space can do. About 10 years ago, the stock was trading with a market cap of around $800 million. Today, the stock is trading at more than 22 multiples higher with a market cap of more than $18 billion.
While the stock has seen tremendous growth over the past decade, continued innovation likely means more opportunity ahead. The company’s lead product, Jakafi, is approved in the U.S. for patients with intermediate or high-risk myelofibrosis and for patients with polycythemia vera who have an inadequate response or are intolerant to hydroxyurea.
As a result of its multiple approvals, Jakafi is already yielding significant revenue. However, with the potential for multiple coming label expansions, the sky's the limit. At the moment, Jakafi is being assessed across 12 clinical development programs.
It’s also worth mentioning Jakafi isn’t the only immunotherapy that is being developed at Incyte. The company’s pipeline is an incredibly robust one, including 19 clinical candidates that are being developed to address 17 molecular targets.
As an up-and-coming commercial-stage immunotherapy company, I believe Incyte represents a strong opportunity. Not only can investors look forward to increasing sales of the company’s flagship product, but several ongoing clinical studies have the potential to yield catalysts as well. All in all, this is a stock that is well worth watching.
Bluebird Bio (BLUE, Financial): A $1.8 million drug could just be the beginning
Bluebird Bio recently had its first big break in immunotherapy. In early June, the European Medicines Agency approved Zynteglo as a treatment option for patients aged 12 and over with transfusion-dependent thalassaemia, also known as TDT. These are the most severely affected patients.
While the company has caught a bit of bad press from its decision to put a $1.8 million price tag on the drug, the strategy is an interesting one that could pay off. First and foremost, the treatment is being developed for the patients that are most severely affected in a relatively rare disease indication. So the pool of potential patients isn’t massive, warranting what many would consider to be a very high price point.
Moreover, the company decided to take an interesting strategy. Payers will be given a monthly payment option under which they will be able to pay for the treatment over the course of five years. Should the treatment prove to be ineffective at any point over this period, they can stop making payments without penalty. This strategy could make it easier for insurance companies to decide to cover the treatment.
Nonetheless, Zynteglo isn’t the only asset that comes with incredible potential. Not only is the company addressing autoimmune disorders, it also has 11 ongoing disclosed clinical development programs using immunotherapy as an option in oncology. According to the pipeline page on its investor relations website, it also has multiple undisclosed programs addressing cancer by enabling the body’s immune system to fight the condition.
One key asset in the pipeline is bb2121. At the moment, the company is working toward a New Drug Application for the treatment as a potential late-line option in multiple myeloma. This is a key treatment as commercialization was licensed to Celgene (CELG) and, as part of the acquisition agreement with Bristol-Myers Squibb (BMY), there are contingent-value rights based on Food and Drug Administration approval by March 31, 2021, making submitting the application a top priority.
With a pending commercial launch and several clinical development programs underway at Bluebird Bio, this stock has the potential to yield several catalysts and incredible growth ahead.
Hemispherx Biopharma (HEB, Financial): Innovative technology with incredible promise
What I find to be most interesting about Hemispherx Biopharma is what the company has going on in the clinic.
The flagship treatment is known as Ampligen. In Argentina, the treatment is currently approved as an option for patients with myalgic encephalomyelitis/chronic fatigue syndrome, commonly referred to as ME/CFS. This is impressive in and of itself, as this is the first and only drug that has been approved in this particular indication.
However, as mentioned above, the company’s work in the clinic is what really puts the shine on this stock. Evidence from a variety of animal models of cancer as well as human experimental data indicates Ampligen may be capable of modulating the tumor microenvironment, providing broad spectrum enhancement of the immune system to eliminate cancers.
Interestingly, the treatment has not only shown potential efficacy as a mono-therapy in immuno-oncology, it may also prove to be an effective combination therapy. In previous studies, data indicated synergies between Ampligen and immune blockade inhibitor drugs (checkpoint inhibitors) by modulation of the tumor’s microenvironment. By providing synergistic support for the method of action taken by the checkpoint inhibitors, Ampligen is expected to improve their efficacy.
As a result of its potential in oncology indications, Ampligen is a key factor in the robust pipeline of research at Hemispherx Biopharma. At present, the treatment is in active clinical trials in ovarian, colorectal and breast cancers. It is also expected to move into further studies soon with the design of a study in renal cell carcinoma and melanoma taking place as we speak.
All in all, Hemispherx offers up a compelling growth opportunity. With several clinical trials underway, investors can look forward to a slew of catalysts that are likely to drive value through the foreseeable future.
Genprex (GNPX, Financial): Oncoprex could become a leading option
Genprex is an immunotherapy company with more than a focus on the oncology space, it’s a vendetta. The company is led by Rodney Varner, a CEO that has not only proven his worth in various management positions, but who has also won a battle of his own against cancer. Today, he leads the charge as Genprex looks to generate similar outcomes for other patients fighting this devastating ailment.
The lead candidate at Genprex is a product known as Oncoprex. Currently in Phase 2 clinical trials, Oncoprex has shown incredible potential as an option for patients with non-small cell lung cancer, the most commonly diagnosed form of lung cancer.
So far, the data surrounding Oncoprex has been very positive. In fact, both preclinical and clinical data suggest the treatment may be an effective option as a monotherapy or as a combination therapy with targeted small molecule drugs in the war against lung cancer.
Additionally, the data suggests Oncoprex may facilitate the action of checkpoint inhibitors like erlotinib and gefitinib. If this is the case, Oncoprex may lead to heightened levels of efficacy when used in combination with these drugs.
The treatment works by encapsulating cancer fighting genes in nanoscale hollow spheres that Genprex calls nanovesicles. Essentially, active genes are wrapped in cholesterol, which is then taken up by tumor cells. From there, these genes express proteins that are missing or present in low quantities, changing the environment within the tumor and potentially allowing the body’s immune system, as well as checkpoint inhibitors, to target and kill the cancerous cells that make up the tumor.
Ultimately, Genprex and its Oncoprex candidate have shown incredible promise. Should the data continue to be so positive, we could expect to see a pivotal trial and a potential market entrance in the relatively near future, making this stock one to watch closely.
Atara Biotherapeutics (ATRA, Financial): A robust pipeline and an impressive flagship candidate
Atara Biotherapeutics may be last, but the company is by no means least. Like the others on this list, the company is focused on the development of immunotherapies that assist the body’s immune system in fighting severe medical conditions.
The company’s flagship candidate is known as Tab-cel and is being assessed across multiple clinical development programs. In fact, the company is in late-stage development of Tab-cel as a potential option for patients with Epstein-Barr virus associated post-transplant lymphoproliferative disorder, or EBV+PTLD.
Atara is also working on multiple early and mid-stage clinical development programs to assess the treatment as a potential option in other EBV-associated hematologic and solid tumors, including nasopharyngeal carcinoma.
Nonetheless, Atara is no one-trick pony. The company’s pipeline is actually quite robust, with 17 ongoing clinical programs assessing a robust line of diverse immunotherapies. With multiple late-stage trials, a potential New Drug Application filing could be just around the corner. Moreover, with several ongoing early to mid-stage clinical trials, investors have plenty to look forward to. So keep a close eye on this stock.
Final thoughts
As medical innovation continues to lead to better outcomes, including stronger survival rates and an improved quality of life, patients and their physicians are not the only parties benefiting. With oncology being such a large market, there’s also plenty of opportunity for investors. The oncology-focused immunotherapy companies above have a strong chance of launching blockbuster treatments down the line, making their stock well worth watching.
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