A few months ago, we briefly discussed new developments in the use of programmed cell death (or cell apoptosis) to combat cancer. Today we are going to take an in-depth look at one of the biotech companies involved in this fascinating realm, examine some of its prospects and probabilities for success, and offer a better understanding of just what it entails to convince a cancerous cell to shut itself down.
The company is Soligenix (SNGX), and its pipeline specializes in cures for what are known as “rare and orphan” diseases, that, is diseases, including forms of cancer, that do not afflict large groups of people (relatively speaking) and thus are often difficult to find funding to cure. While this would limit Soligenix’s market if it were only focusing on a handful of specific orphan diseases, the fact that the company has a novel treatment idea for battling cancer—the focus of this week’s biotech digest—makes Soligenix an interesting case study.
The market—T-cell lymphoma
Cutaneous T-cell lymphoma (CTCL) is a type of cancer of the white blood cells of the body; malignant versions of these white blood cells, rather than helping the body’s immune system, gravitate towards the skin and result in the appearance of lesions. There is currently no cure for the disease, and life expectancy can vary from 2.5 to 12 years depending on when one is diagnosed with it. Current treatments involve either skin therapies or the use of UVA rays, which can sometimes cause mutation or secondary skin cancers. The goal, therefore, is to find a potential cure without the side effect of harming other cells.
Enter cell apoptosis
The word apoptosis is specific, and it refers to self-induced cell destruction. It occurs when a cell purposefully fragments its DNA (which is the genetic makeup of every cell) and then devolves, and is also known as programmed cell death because cells in the human body engage in apoptosis frequently when they become damaged or unneeded.
Cancer cells, however, are notorious not only for their overgrowth but for the fact that they do not undergo apoptosis. They don’t die. Soligenix’s proposed solution, which is now through Phase 2 testing, is to induce cell apoptosis in the malignant T-cells involved in CTCL.
How do you convince a cell to self-destruct? Photodynamic therapy
Soligenix’s SGX301 drug candidate proposes using photodynamic therapy to induce programmed cell death. The process starts by created synthetic hypericin (hypericin is a component of the flower genus hypericum, which is a photosensitizer (meaning it reacts to the influence of light). The hypericin is topically applied to specific areas of CTCL and activated with visible fluorescent light.
That last part is key. Unlike methods that require chemotherapeutic drugs or UVA light for activation (both of which can have carcinogenic side effects), ordinary visible light is a perfectly safe means of activating the hypericin. When activated, the hypericin generates what is known as singlet oxygen, and this singlet oxygen is able to induce the programmed cell death in the cancerous T-cells. The overgrowing cells are thus convinced to self-destruct, all without the need to use activation technologies that might cause melanoma or other secondary skin cancers.
So, is there a market? What’s the probability of success here?
Given that Phase 2 testing is complete and there are strong signs that the drug is ready for Phase 3 clinical testing, the probability of success is much higher than it would be if the drug were still in preclinical or early clinical testing. The big question is: what are the prospects for such a drug? Is the potential market large enough that Soligenix can survive until the end of testing? One fact that assists in this area is that CTCL, which is a rare form of non-Hodgkin’s lymphoma, may not be the only area in which this type of phototherapy is useful. In fact, psoriasis and other skin conditions may also benefit from similar phototherapy treatment.
The potential in this area is fascinating. The use of visible light to active necessary active ingredients, avoiding the use of more dangerous UVA rays or other types of chemotherapy, can be a powerful tool, and while the current market for Soligenix is small, there are other possibly markets which it might explore with this method. Furthermore, the cause of pursuing an orphan or rare disease has permitted Soligenix to go through the “fast-track” method of FDA approval, which also increases the company’s probability of success.
It will be interesting to see where Soligenix and its discoveries go in Phase 3 testing.
That’s it for this week’s biotech digest analysis. Remember that, apart from probability of success and marketplace analysis, a key component of any biotech study is an examination of the chance that a company such as Soligenix (SNGX) has enough funds to survive through FDA testing without having to significantly dilute its stock (meaning create more stock to raise money, which makes current stock less valuable). For examples of this type of additional analysis, which we at BTA do for our Monthly Biotech Focus subscription newsletter, you can visit our sample page by visiting http://belltowerassoc.com/biotech-monthly/.
Disclaimer: The information contained in this publication is obtained from sources believed to be reliable, but its accuracy cannot be guaranteed. The information contained herein is not intended to constitute individual investment advice and is not designed to meet your personal financial situation. The opinions expressed in this publication are those of the publisher and are subject to change without notice. The information in this publication may become outdated and there is no obligation to update any such information.
Bell Tower Associates, LLC. and other entities in which it has an interest, employees, officers, family, and associates may from time to time have positions in the securities or commodities covered in this publication or web site. Corporate policies are in effect that attempt to avoid potential conflicts of interest and resolve conflicts of interest that do arise in a timely fashion.