Someone's Loading Up On Immune Pharmaceuticals Inc (NASDAQ:IMNP) Ahead Of A Major Update

Immune Pharmaceuticals Inc (NASDAQ:IMNP) is a big runner this week, up more than 55% on its Monday open. The company announced back on November 22 that it will host an R&D update event on December 8, and it looks as though someone is loading up big ahead of the event in anticipation of wider markets taking note, and the buy volume flooding in.So, ahead of management taking the stage, what is on the table for discussion, and what might drive speculative volume to boost the company's market capitalization near term?Let's take a look.The focus of the event is a drug called Ceplene, which is one of a couple of leads assets in the company's pipeline, with the other being bertilimumab. The latter is an ulcerative colitis indication, and investors will be hoping that management serves up some degree of insight into the progress that that drug is making through its so-far promising program. However, if the led in info is to be relied upon, chances are we won't see any major bertilimumab news. That doesn’t mean it's not going to be interesting, however. Ceplene in itself is a promising asset, and could be a big revenue generator for Immune if it can carry it through to commercialization.What's it all about?The Ceplene moniker is a brand name for the chemical histamine dihydrochloride, and it's designed to improve the efficacy of IL-2 in patients with Acute Myeloid Leukemia (AML). IL-2 is a cytokine that derives from T cells (which are basically the attack cells in the human immune system). It initiates the T cell response against cancerous cells, which would otherwise be hidden from view of the immune system as a result of the cloaking mechanism these cancerous cells employ to avoid detection and – by proxy – removal. In this specific indication, IL-2 isn't overly effective (at least, not as effective as it is in some other cancers) because it gets inhibited by what are called myeloid-cell derived reactive oxygen species (ROS). Ceplene essentially blocks these ROSs from inhibiting the IL-2, and in turn, enhances the latter's impact on T cell activation towards the cancer cells in question.It's a pretty neat mechanism of action (MOA) in that the rationale behind including Ceplene as part of a combo therapy with IL-2 in AML patients is simple, and clearly beneficial.The EMA in Europe has already cleared the drug, and its at-market right now. The US market is bigger, however, and an FDA nod is what the company is seeking with its Ceplene development program. And that's what this update is going to address – the next stage of the program.Here's what we think is going to happen.The Ceplene Scientific Advisory Board (SAB) met on Sunday to discuss the next steps ahead of the update on the 8th. At this meeting, we think the board will have put together a protocol for a pivotal phase III trial of Ceplene in combination with IL-2 in AML, and that company management are going to both confirm the agreement of, and relay the details of, this program at the update. The SAB meeting comes following FDA guidance, and with the clear loading up that's taking place ahead of management reporting on the guidance and the subsequent protocol decision, we're guessing it's pretty favorable. We're almost definitely going to see an overall survival endpoint (it's a remission maintenance study, so no other endpoint would make that much sense) and we're looking to a relatively condensed patient population as being key to getting this drug in front of the FDA by way of an NDA as soon as possible. We'll be watching the event, so stick with us and we'll bring our interpretation to the table as soon as possible.We will be updating our subscribers as soon as we know more. For the latest updates on IMNP, sign up below!Disclosure: We have no position in IMNP and have not been compensated for this article.