Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM) just put out an update that has markets wishing to pile into the company and pick up shares in anticipation of near-term positive strength.
Here is a look at what happened and what it means for the company.
So, Bellicum – what happened?
The news that was just reported relates to a drug called BPX-501, which the company is trying to get approved in a target indication of patients undergoing stem cell transplants.
For those unfamiliar with this program, BPX-501 is an adjunct T-cell therapy administered after allogeneic HSCT, comprising genetically modified donor T cells incorporating Bellicum’s CaspaCIDe safety switch. This safety switch is designed to reduce the potential for a negative response to the stem cell transplant, by (essentially) acting as a breaker switch for when things start to go wrong. To put this another way, if the body looks as though it is set to reject cells, which is a major concern when it comes to stem cell transplant therapy, the breaker switch activates and turns off the stem cell in question, theoretically neutralizing the host immune system’s response to the cells.
The latest news, then, details that the Food and Drug Administration (FDA) in the US has lifted a clinical hold on the program as of yesterday. The clinical hold was in place on the back of an announcement that hit the press back on January 30, following three cases of encephalopathy deemed as possibly related to BPX-501 in the trial that was set up to demonstrate the safety and efficacy of the drug.
As is generally accepted in this population, risk factors for encephalitis/encephalopathy after allogeneic stem cell transplants include prolonged immunodeficiency, selected medications, infections, and inflammatory processes such as graft versus host disease.
That the three cases of this condition could be related to treatment, therefore, was not deemed as too much of a stretch of the imagination and the hold was put in place more as a precautionary measure than anything else.
Since this hold was put in place, Bellicum has been working hard on two fronts – the first, on the shareholder front, to try and quash any concerns relating to the tenability of the program going forward. The second, on the regulatory front, based in efforts to try and demonstrate to the FDA that the treatment is safe and that the encephalitis came about as a standard risk factor to stem cell treatment as opposed to on the back of the involvement of Bellicum’s investigative assets in the process.
And as mentioned, on this latter front, the company has been successful.
As per the announcement, the decision to lift the hold follows consultation with the FDA and agreement on amendments to the study protocols including guidance on monitoring and management of neurologic adverse events.
Basically, Bellicum just has to monitor patients a little more closely to ensure that those who are at risk of encephalitis developing are treated responsively to this risk as opposed to letting the condition develop unmanaged.
Again as per the announcement, Bellicum will be working with US clinical sites to resume patient recruitment based on the amended protocols and it’s worth noting that the FDA clinical hold did not affect the BP-004 registrational trial in Europe, which is fully enrolled.
As might be expected, then, markets are responding very favorably to this announcement and the company is picking up strength on the back of the news.
At the close of play on Wednesday, subsequent to the development hitting press, Bellicum traded for a close to 2% premium to its preannouncement market capitalization but the real action has come pre-market on Thursday, with the company looking set to open the session today at a nearly 30% premium to the price at which it closed out on Wednesday. There is a good chance that we will see this strength continue moving into the bell on Thursday and as standard participation gets underway.
Market attention now turns to the continuation of the study as well as the outcome of the registrational study in Europe.
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