Breast cancer is one of those indications that markets see as a holy grail space. More than 12% of all women will be diagnosed with breast cancer in the US in their lifetime, and the current available treatments are debilitating and severe. A company that can bring a treatment to market that is neither severely toxic (as is the case with radiotherapy and chemotherapy) or invasive (as with removal surgery or mastectomy) has the potential to target a large market, and one with a clear multi billion-dollar return. Two companies just updated markets as to their progress in a type of breast cancer called triple negative breast cancer (TNBC), which affects between 20-30% of all sufferers. Here’s a look at the updates, and what they mean for the companies in question going forward.
Corcept Therapeutics Incorporated (NASDAQ:CORT)
First up, Corcept. This California based company just announced it intends to kick off a phase II to test its lead TNBC candidate, Mifepristone, in conjunction with Celgene Corporation’s (NASDAQ:CELG) already approved treatment, Abraxane. The trial is set to kick off before the close of the year.
Some reading might already be familiar with Mifepristone. It’s the drug used to bring on abortions (the oral administration version), and as such, is steeped in controversy in the US. It’s part of a family of what are called antiprogestogens. The mechanism of action of this one means it will always be required as a combination therapy (it wont be approved on its own, for reasons we will discuss shortly), so the end result wont greatly reduce the chemo-associated toxicity mentioned in the introduction to this piece, but it may be able to magnify the impact of chemo drugs on a selective basis. Why? The drug is designed to target cortisol; which scientists believe plays a role in activating pathways that increase tumor cells’ resistance to chemo. Through inhibiting cortisol’s role in survival, the theory is that that the addition of Mifepristone to current SOC chemo drugs can improve upon efficacy.
It’s early days (the phase II is kicking off based on very limited data), but it’s an interesting space to watch going forward. The company already markets another product – Korlym – so there is an element of risk mitigation associated with an exposure at this stage. As is generally the case in early stage dev biotech, finance is likely the major risk factor going forward.
Medivation Inc (NASDAQ:MDVN)
Moving on, let’s look at Medivation. Medivation just announced it will be kicking off a pivotal trial in its lead TNBC candidate, Enzalutamide, at some point during the fourth quarter of 2016. The drug is already approved in a prostate cancer indication, and the trial that the company undertakes is seeking to expand this indication to breast cancer, with a target completion date of some point between end 2017 and early 2018. It’s part of a family of drugs that are called antiandrogens, or androgen blockers, which we first discovered in the 1960s. Androgens are are hormones (the most well known is testosterone, but there are many others) and are often required for the growth and replication of cancerous cells. In prostate cancer, they play a key role in severity, and their presence, in turn, in prognosis.
Medivation is attempting to demonstrate that through the inhibition of the process that leads to androgen production (using its antiandrogen, Enzalutamide) it can play a role in reducing the rate of spread of breast cancer.
Again, this is a bit of a long shot. The company has some decent phase II results that suggest efficacy, and safety shouldn’t be too much of an issue since the drug already has approval in another indication (although, in that indication there have been concerns regarding long term impact, so it will definitely come in to play).
It’s a long shot, but its also definitely one to keep an eye on. Medivation has a pretty solid track record in oncology to date, and we wouldn’t be surprised if it can come up with another blockbuster indication for Enzalutamide before the end of the decade.
Risks here lie in efficacy rather than financing, so it’s probably the lower risk allocation of the two companies discussed.