NuCana plc (NASDAQ:NCNA) and PHARMA MAR (OTCMOTH:PHMMF) are two big biotech movers heading into the start of a fresh week in the space, with both companies attracting volume based on the release of fresh data.
Here is a look at the data from each and what it means for developing programs of the companies going forward.
This first one is rooted in a trial called ABC-08, which NuCana set up to investigate the impact of a drug called Acelarin in patients with advanced biliary tract cancer. It was a phase 1B trial and the data that just hit press (which came by way of a presentation at the 2018 ASCO Gastrointestinal Cancer Symposium) is a predefined interim release.
Biliary tract cancer is one of those cancers that doesn’t get a lot of attention from big pharmaceutical companies, with the lack of attention primarily rooted in the fact that it’s a relatively uncommon cancer, accounting for just 2% of all cancer diagnoses. It’s a cancer that affects the bile duct, which is what carries bile from the liver and gallbladder through the pancreas to the duodenum.
The fact that this is a relatively uncommon cancer far from negates its potential as a revenue driver for a company that can get an effective asset to market, however.
The idea behind this treatment is that it can overcome one of the problems currently associated with the standard of care treatments in the space – the buildup of resistance. One of the most widely used assets in solid tumor cancers (and the first-line treatment for bile duct cancer, albeit generally off-label) is called gemcitabine. It is the chemotherapy agent and it works well but, in many cases, the patient receiving treatment builds up a resistance over time and this can cause a regression in efficacy.
From a composition perspective, Acelarin is a most identical to gemcitabine, however, through the use of a proprietary technology, NuCana has been able to help overcome the process that generally leads to resistance in solid tumor cancer patients.
If the company is able to prove this mechanism of action as part of its ongoing development program, Acelarin has the potential to not only be used as an alternative to gemcitabine inpatient that have developed a resistance to the latter, but also potentially as a first-line therapy in tough to treat solid tumor cancers.
So what did the latest data show us?
As per the release, of the eight patients that were studied in the phase 1b trial, a complete radiological response was achieved in one patient and a partial response in three patients, when the drug was combined with cisplatin (another standard of care chemo agent).
Further, the combination of Acelarin and cisplatin was well-tolerated with no unexpected adverse events and no dose-limiting toxicities.
So what’s next?
This trial is ongoing in a few other cancer types but was designed to inform a maximum tolerable dose with which the company could carry forward into a phase 2 (pivotal) study for each cancer type one by one. As such, the next step is to carry Acelarin and cisplatin as a combination therapy into said pivotal in biliary tract cancer, which the company expects to do before the end of 2018.
This one is also rooted in a data release but, unfortunately for the company and the shareholders, the trial outcome wasn’t favorable.
The data derived from a phase 3 study looking at an asset called Zepsyre (lurbinectedin) in platinum-resistant ovarian cancer patients. The trial compared Zepsyre to an already approved ovarian cancer drug called topotecan, with the company looking to demonstrate that Zepsyre could both achieve an improved rate of efficacy in this patient population and maintain or improve on the safety and tolerability associated with treatment.
While the latter of these aims was met – the company highlighted an improved safety profile for the drug over control – the primary endpoint of efficacy, which was rooted in PFS (Progression Free Survival), was not met.
The company expects to present data from this study in some more detail at an upcoming oncology event but, for now, it’s probably safe to say that this development spells the end for this program in ovarian cancer.
Looking at PharmaMar’s wider pipeline, however, things aren’t as gloomy as the market response to the news (the company is down more than 30% on its preannouncement capitalization) suggests.
This same asset, Zepsyre, is currently also in a phase 3 trial for non-small cell lung cancer and a phase 2 trial for metastatic breast cancer, both of which should report data before the end of this year.
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