Immune Pharmaceuticals Inc (fka IMNPQ)

[Investor100]

Immuno Oncology R&D Update, December 2016

For those that missed the interview today.

http://www.immunepharma.com/investor-information/investor-events/immuno-oncology-rd-update-december-2016/


http://www.immunepharma.com/focus-on-acute-myeloid-leukemia-at-the-american-society-of-hematology/

Focus on Acute Myeloid Leukemia at the American Society of Hematology

The Immune Pharma team traveled this weekend to the annual meeting of the American Society of Hematology (ASH) in San Diego. This was an opportunity to learn about the latest developments in Acute Myeloid Leukemia(AML) and to hold a Scientific Advisory Board for our AML drug, Ceplene®. Acute Myeloid Leukemia (AML) is the most frequent form of leukemia in adults. An estimated 19,950 patients were diagnosed in 2016 with AML in the US, with a 26.6% 5-year survival rate (2006-2012) and an estimated 10,430 deaths in 2016. This is a stern reminder of the urgent need for new therapies.

The bi-partisan Congress 21st Century Cures, provides additional funding to the FDA to accelerate approval of needed therapies, to help fund the Cancer Moonshot initiatives, and to enable acceleration of cancer research programs. New data is promising and comes from a mix of novel breakthrough approaches, such as targeting specific cytogenetic characteristics. Molecular genetic analysis of the Flt3 gene, CEBPA, and NPM1 among others is becoming the standard of care for the diagnosis, prognostic understanding, and treatment guidance in AML. Targeted therapies, such as Agios IDH1 and IDH2 inhibitors also reported favorable early clinical data.

Vyxeos (CPX-351) is a new 5+1 liposomal formulation of the 7+3 cytarabine-daunorubicin standard of care in induction therapy. After a disappointing phase 2 study, Celator (now part of Jazz Pharmaceuticals) conducted a phase 3 study that has demonstrated impressive overall survival benefit and should lead to approval in 2017. Mylotarg, which targets CD33, was the first Antibody Drug Conjugate and was developed for AML. However, toxicity led to its withdrawal from the market. Seattle Genetics is now targeting CD33 but with a novel toxin and linker system, vadastuximab talirine, where phase 1b data appears to support further development.

While new induction or consolidation approaches show promise, a gap remains in remission maintenance of AML patients, which is also being explored with vadastuximab and with Celegene’s oral azacitidine. Ceplene in combination with low dose Interleukin 2 (IL2) is approved in Europe to maintain remission in AML patients. Ceplene enables IL2 growth factor-like activity on T-Cells and NK cells, helping prevent relapse of leukemia blasts post first remission (CR1). The over 1500 patient Ceplene clinical trial data includes a positive pivotal phase 3 Leukemia Free Survival study published in Blood, ASH’s weekly medical journal, and a phase 4 study presented at the American Academy of Cancer Research earlier this year. Now Immune Pharmaceuticals is planning a global pivotal Overall Survival (OS) study which will compare Ceplene+ IL2 to IL2 in AML patients post CR1. The primary end point will be OS at 2 years while intermediary end points will be assessed at 1 year. The Ceplene SAB included pioneers of Ceplene+IL2 therapy like Kristoffer Hellstrand, MD (Gotenborg, Sweden) and Jacob Rowe (Jerusalem, Israel) as well as several of the leading US key opinion leaders, Martin Tallman ( MSK, New York), Elihu Estey ( Fred Hutchinson, Seattle), Gail Roboz ( Weill Cornell, New York), Janice Dutcher (Cancer Research Foundation, New York), Selina Luger ( University of Pennsylvania, Philadelphia) and Jessica Altman ( Northwestern University, Chicago). We are grateful for their guidance and their passion to bring new therapies to AML patients.

Immune Pharmaceuticals is committed to fully funding the further development of Ceplene through a recently announced new immuno-oncology company, Cytovia Oncology.

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