Ceplene new data from a post hoc analysis of EpiCept's Phase 3 clinical study with Ceplene has shown positive data non-FAB-M2 subtype AML. Non-FAB-M2 AML making up roughly 70% of the total AML market. If Phase 3 trial initiated and successful IMNP expected value will increase dramatically.
Thesis & Catalyst For Immune Pharmaceuticals Inc. (OTCQB:IMNP)
IMNP is undervalued because at the AACR annual meeting, researchers out of Sweden presented data on the Phase 4 MISSION trial, designed to assess the immunomodulatory properties of Ceplene + IL-2, relating potential biomarkers with clinical outcome. Investigators found a reduction in the frequency of CD8+ T effector memory TEM cells during the first cycle of Ceplene + IL-2 prognosticated leukemia-free survival LFS HR 0.25, P=0.001 and overall survival OS HR 0.24, P=0.009. Induction of T effector cells TEFF during the first cycle also impacted favorably on patient outcome P=0.048 for OS.
A reduction in TEM cells during the first cycle of Ceplene + IL-2 led to an improvement in both LFS and OS in all patients. The results were particularly well in patients over the age of 60. Similarly, an induction of TEFF cells during the first cycle of Ceplene + IL-2 led to an improvement in both LFS and OS in all patients, again, with excellent results in patients over the age of 60.
The increase in TEFF cells and a decrease in TEM cells was the strongest predictor of complete response and improvement in LFS HR 0.19, P=0.001 and OS HR 0.13, P=0.008 in older patients, over 60 years with high risk relapsed AML.
Published data indicates that targeting different subtypes of AML for a clinical trial - all non-FAB-M2 subtypes has shown great results. It also indicates that Immune's explanation on how Ceplene + IL-2 was able to demonstrate the strongest improvement in LFS in non-FAB-M2 AML patients is due to the mechanism of action and not by chance.
Non-FAB-M2 AML making up roughly 70% of the total AML market so you can imagine market potential.
Once Ceplene + IL-2 is being used to treat AML patients, oncologists can analyze T cell phenotypic expression before and after the first cycle looking for an increase in TEFF cells and a reduction in TEM cells. With confirmed response, patients can be kept on Ceplene + IL-2 therapy. Lack of response can also be identified if the T cell expression does not relate to the altered distribution, and those patients can be moved to other medications.
Immune Pharma is currently working with principal investigators to design a Phase 3 trial in line with the FDA's guidance issued to EpiCept in 2011 and if talks with financier for Phase 3 successful present shareholders will be rewarded with expected share price of around 2$ Similar share price is indicated by analysts following the company. Also would like to be noted that after Ceplene data published insiders loaded heavily and one institutional - present investor has purchased 4M share @ 0.5$ with no warrants, no restrictive covenants, and no restrictions on use of proceeds. If you add IMNP pipeline with above described Ceplene potential even average investor can see 300-400% gain in share price.
Disclosure: I/we have no positions in any stocks mentioned, but may initiate a long position in IMNP over the next 72 hours.
Additional disclosure: All data presented are available and publicly published