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Investor 100
A Personalized Approach to Treating Autoimmune Disease
http://www.futureofpersonalhealth.com/prevention-and-treatment/a-personalized-approach-to-treating-autoimmune-disease?utm_source=arrow&utm_medium=previous
“It’s a targeted treatment with the best efficacy-safety ratio,” says Dr. Daniel Teper, the founder and CEO of IMMUNE Pharmaceuticals. “It’s a treatment where both the physicians and the patients will have greater confidence in the drug right from the first time.”
Investor 100
Immune Presents Biomarker Data On Ceplene at AACR
A team of researchers from Gothenburg University in Sweden presented data from a Phase 4 study on Ceplene® earlier this week at the American Association for Cancer Research (AACR) Annual Meeting in New Orleans, LA. These data could have a profound impact on future use of the drug in elderly patients with Acute Myeloid Leukemia (AML). Ceplene®, whose rights in the U.S. belong to Immune Pharmaceuticals (IMNP), is already approved in Europe and Israel. Immune plans to use these data to attract a development partner for Ceplene®, as the company prepares to advance the drug towards regulatory approval in the U.S.
Quick Background on Ceplene
Ceplene® is a drug Immune acquired in 2013 with the takeover of EpiCept. Until recently, Ceplene® sat on the back-burner at Immune. However, recent data has piqued the interest of management and now it seems as though there is a potential to monetize Ceplene® through a partnership that aims to fund clinical studies designed to gain regulatory approval in the U.S. Ceplene® was approved in the EU in October 2008. EU rights are controlled by Swedish-based Meda Pharmaceuticals. Meda recently refocused its business on respiratory, dermatology, and pain / inflammation products, so the company does not actively promote the product. As such, it is likely that any company interested in the U.S. rights to Ceplene® may also be interested in acquiring the EU rights as well. This presents an interesting in-licensing / out-licensing opportunity for Immune.
Ceplene® (histamine dihydrochloride), in combination with interleukin-2 (IL-2), is believed to work by activating T and Natural Killer (NK) cells into a tumor killing mode. Ceplene® binds to the histamine H2 receptors (H2R) that are predominantly expressed on FAB subtypes with monocytic differentiation. Binding to H2R results in down-regulation of NOX2, which results in decreased production of Reactive Oxygen Species (ROS), and subsequent protection of deleterious immune cells from deactivation and death.
Phase 3 data with Ceplene® used in combination with IL-2 demonstrated an improvement in leukemia-free survival (LFS) in patients with AML. Specifically, complete remission patients in the post-consolidation phase of treatment for AML receiving Ceplene® plus IL-2 achieved a 3-year LFS rate of 40% vs. only 26% for a no treatment control (Brune et al., 2006). Both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have granted Ceplene® orphan drug status for the treatment of AML.
Phase 4 Data At AACR
Earlier this week, 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® plus IL-2, and to correlate potential biomarkers with clinical outcome. In the Phase 4 international study, 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). Similarly, induction of T effector cells (TEFF) during the first cycle also impacted favorably on patient outcome (P=0.048 for OS).
The figure below, taken from the AACR Poster (Sander FE, et al., 2016), shows that a reduction in TEM cells during the first cycle (21 days) of Ceplene® + IL-2 was evident and statistically significant in non-relapsing AML patients (n=18), but not evident in relapsing patients (n=26). Data also show an increase in the frequency of TEFF cells during the first cycle of Ceplene® + IL-2 for non-relapsing AML patients (n=18) but not in relapsing patients (n=26).
As further evidence by the MISSION data, 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 prominent 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 particular prominence in patients over the age of 60.
The concomitant 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 (> 60 years) with high risk relapsed AML.
Thus, the altered distribution of cytotoxic T cells during the first cycle (21 days) treatment with Ceplene® + IL-2 significantly prognosticated LFS and OS, especially within the group of elderly patients. These data provide a potential personalized approach for treating therapy-resistant older AML patient populations, in addition to the selection of the population most likely to benefit by FAB subtype. Keeping AML patients in remission post-consolidation is a major challenge, so Immune plans to explore further the combination of Ceplene®+ IL-2 formulations in 2016.
A Place For Ceplene In The Market
Recent breakthroughs in immuno-oncology (e.g. CAR-T, checkpoint inhibitors, liposomal 7+3, etc...) have significantly changed the potential treatment paradigm for AML, so the future for a drug like Ceplene® is likely in combination with newer advanced therapeutics. In this regard, the company is seeking a new patent for the combination of Ceplene® and checkpoint inhibitors. The new invention provides methods of treating cancer by administration of Ceplene® in combination with immune checkpoint inhibitors, as well as methods for predicting the efficacy of Ceplene® and IL-2 therapy in patients with AML.
The biomarker data presented at AACR suggests an interesting potential personalized approach to the selection of patients who are most likely to benefit from Ceplene® + IL-2 maintenance therapy in AML. AML is a horrible disease with little in terms of breakthrough treatments approved over the past decade. Recently, Celator Pharmaceuticals (CPXX) posted some positive Phase 3 top-line results with Vyxeos® as an induction therapy. Celator shares are up over 1,000% from that news. Ceplene® + IL-2 as a maintenance therapy looks to add to the recent success in treating AML patients.
For example, oncologists can analyze T cell phenotypic expression before and after the first cycle of Ceplene® + IL-2 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 used along with immunotherapy with checkpoint inhibitors or other personalized approaches. Lack of predictive response can also be identified if the T cell expression does not correlate to the ideal altered distribution, and those patients can be moved to alternative medications.
Immunes I/O Strategy Intrigues
As noted in previous articles, Immune is expecting to enter into a transaction in the coming months to create an immune-oncology subsidiary separate from the company's focus on inflammation and dermatology with bertilimumab. A transaction that brings about significant funding to the company should help return investor interest to the story. I see a lot of potential for Immune's drug candidates in inflammation, dermatology, and immune-oncology, but funding for these programs and remains a key area of investor concern. New data on drugs like Ceplene® and advancing programs wth NanomAbs® and bi-specific antibodies has the potential to attract much-needed capital and turn around the shares of Immune Pharmaceuticals.
http://www.bionapcfa.com/2016/04/immune-presents-biomarker-data-on.html
More dips more purchases....
Investor 100
Nice 6% gainer today!!!
Going much higher!
Investor 100
Adding more shares on this dip!!
Investor 100
Pleased be an investor here as the run begins!
Investor 100
Analysis Ratings @ IMNP..
http://www.marketbeat.com/stocks/NASDAQ/IMNP/?RegistrationCode=SocialMedia-StockTwits
Investor 100
New Data on Ceplene® Cancer Immunotherapy to be Presented at the 2016 AACR Annual Meeting
http://www.marketwatch.com/story/new-data-on-ceplene-cancer-immunotherapy-to-be-presented-at-the-2016-aacr-annual-meeting-2016-03-17-15183530
Immune Pharmaceuticals Inc. IMNP, +12.77% announced today that new clinical pharmacology and outcomes data with Ceplene (histamine dihydrochloride) will be presented by Prof. Kristoffer Hellstrand, Dr. Anna Martner and their scientific colleagues from the University of Gothenburg, Sweden and Università di Roma, Italy, at the upcoming American Association of Cancer Research (AACR) annual conference to be held April 16-20 in New Orleans.
Investor 100
ImmunoCellular Therapeutics Announces 2015 Financial Results
ICT-107 Phase 3 Registration Trial Underway; Collaborations to Enhance Dendritic Cell and Stem Cell Platform Progressing
https://finance.yahoo.com/news/immunocellular-therapeutics-announces-2015-financial-201500612.html
Took a starter position on IMUC..been on watchlist for weeks.
Investor 100
Alder Presents Preclinical Data for ALD1613 at ENDO 2016
-ALD1613 Administration Reduces Plasma Corticosterone in Multiple Preclinical Models-
http://finance.yahoo.com/news/alder-presents-preclinical-data-ald1613-171500565.html
Key Points:
In vitro, ALD1613 inhibits ACTH-induced cortisol secretion in a mouse adrenal cell line.
ALD1613 administration in rats with artificially elevated ACTH and corticosterone levels resulted in a rapid and durable reduction of plasma corticosterone levels.
In non-human primates, ALD1613 demonstrated stable and durable reductions in plasma cortisol levels by >50%.
Randall C. Schatzman, Ph.D., President and Chief Executive Officer of Alder, said, “Existing therapeutic options for patients with congenital adrenal hyperplasia and Cushing's disease comprise treatments that provide limited disease control and involve significant side effects. We believe these limitations indicate a clear need for new therapies such as ALD1613, which targets ACTH to diminish the overproduction of cortisol. The data presented today demonstrate the capacity of ALD1613 to reduce corticosteroid levels in preclinical settings. We intend to use these studies as part of an IND filing that we plan to submit to the FDA in the second half of 2016.”
Investor 100
Congrats to those holding through approval - plan to sell today from an $18 entry!
Investor 100
Monster Run On Huge News Up 57%
http://seekingalpha.com/news/3169667-alder-bios-migraine-candidate-ald403-successful-mid-stage-study-shares-9-percent-premarket
Investor 100
Immune Pharmaceuticals Announces Publication of Preclinical Data in Support of Its Bispecific Antibody Platform in The Journal of Immunology
Focus on Development of New Drug Candidates targeting Immune Checkpoints
https://finance.yahoo.com/news/immune-pharmaceuticals-announces-publication-preclinical-113000840.html
Dr. Boris Shor, Ph.D., Executive Director R&D, Immune stated: "We believe that this therapeutic platform provides Immune with a basis for developing innovative modalities targeting immune checkpoint proteins in a variety of cancer indications. Our future goal is to develop novel classes of antibody-based therapeutics for clinically-validated and novel targets. In 2016, we expect to complete initial validation of several bispecific antibody candidates for further development based on new data generated by our R&D team and supported by new intellectual property filed by Immune.
Investor 100
New Data on Ceplene® Cancer Immunotherapy to be Presented at the 2016 AACR Annual Meeting
Overall Survival was Predicted by Re-Distribution of Cytotoxic T-Cell Subsets During Therapy with Ceplene in Patients with Acute Myeloid Leukemia
Ceplene is a first-in-class histamine receptor agonist in cancer immunotherapy and there are no other drugs approved for remission maintenance in AML. These new data significantly expand our knowledge of the immunological activation pathway following Ceplene/IL-2 therapy in patients suffering from AML and will provide a personalized approach for getting the right treatment to the right patients" said Dr. Miri Ben-Ami, President, Immune Pharmaceuticals (Israel) and Immune's EVP, Global Oncology.
https://finance.yahoo.com/news/data-ceplene-cancer-immunotherapy-presented-113000935.html
Investor 100
mmune Pharmaceuticals and The International Pemphigus & Pemphigoid Foundation (IPPF) Celebrate Rare Disease Day
https://finance.yahoo.com/news/immune-pharmaceuticals-international-pemphigus-pemphigoid-123000862.html
Investor 100
Immune Pharmaceuticals Names Dr. Jeff Paley to its Board of Directors
https://finance.yahoo.com/news/immune-pharmaceuticals-names-dr-jeff-123000462.html
Dr. Jeff Paley brings over 19 years of experience in the healthcare industry to his new role. Dr. Paley has been an active clinician and consultant for over 30 analysts and portfolio managers in the biotechnology, pharmaceutical, specialty pharmaceutical and medical technology arenas, reviewing the clinical, preclinical and regulatory pedigrees of numerous therapeutics and devices. Dr. Paley has also consulted for several biotechnology and specialty pharmaceutical companies, most notably in the areas of clinical development and business development and he has engineered transactions worth over $600 million. Dr. Paley founded Access Medical Associates in 2003, after spending five years on the full-time academic faculty of Weill Cornell Medical College, where he served as a Director of Clinical Research at the Cornell Internal Medicine Associates. At Weill Cornell, Dr. Paley was a Principal or Co-Principal Investigator on several studies of diabetes, hypertension, and cholesterol disorders. He has served as a Director of Kellbenx and Retrophin and currently serves as a Director of Kalytera, Avenue Therapeutics and Remote Radiology Inc. Dr. Paley trained at Harvard Medical School and completed a residency in Internal Medicine at Massachusetts General Hospital.
Investor 100
Immune Pharmaceuticals Announces Publication of New Data on Eotaxin-1 in IBD; Patient Enrollment in Phase II UC Trial Continues
https://finance.yahoo.com/news/immune-pharmaceuticals-announces-publication-data-123000678.html
Professor Goldin, the principal investigator for the study, stated: "The observational clinical study shows that tissue eotaxin-1 correlates with disease severity in both UC and CD. Additionally, the classic DSS-mouse IBD model demonstrated that administration of anti-eotaxin-1 resulted in improvement in the inflammation and disease course of these mice. Professor Goldin continued, "We believe that the results obtained in the clinical study support the role of eotaxin-1 as a target in IBD, a therapeutic area in which over half of patients fail to sustain remission. A first-in-class alternative to currently available therapies will offer a new treatment option.
Investor 100
ACAD @ Stockcharts
Looks like bottom is in...lookin to enter on any dip next week!
News in 2016:
ACADIA Pharmaceuticals Announces FDA Advisory Committee Meeting to Review NUPLAZID™ (Pimavanserin) for the Treatment of Parkinson’s Disease Psychosis
Advisory Committee Meeting Scheduled for March 29, 2016
The Prescription Drug User Fee Act (PDUFA) action date for completion of FDA review of the NUPLAZID NDA is May 1, 2016. The FDA has granted the NUPLAZID NDA Priority Review status and designated NUPLAZID for the treatment of psychosis associated with Parkinson’s disease as a Breakthrough Therapy.
http://www.marketwatch.com/story/acadia-pharmaceuticals-announces-fda-advisory-committee-meeting-to-review-nuplazidtm-pimavanserin-for-the-treatment-of-parkinsons-disease-psychosis-2016-01-29
Investor 100
Immune Highlights Catalysts and Goals for 2016
Expanding Efforts in Immuno-Oncology
http://www.bionapcfa.com/2016/02/immune-highlights-catalysts-and-goals.html (February 11th,2016 )
Over the past few months, Immune Pharma has been working vigorously to expand development within its immuno-oncology division. This is a relatively new focus for the company. The division is being headed up by Dr. Miri Ben-Ami, MD, Immune's new EVP and head of Oncology. Dr. Ben-Ami joined Immune in November 2015. Also in November 2015, Dr. Monica E. Luchi, MD joined as the company's Chief Medical Officer. Recall that in September 2015, Dr. Boris Shor, Ph.D., joined Immune to head up the research laboratory at the Alexandria Center for Life Science in New York City. Dr. Shor joined the company from the Pfizer Oncology Research Unit where he led internal and external collaboration project teams to develop novel antibody-drug conjugates (ADCs) for the treatment of cancer. It is clear through these new hires that Immune is gearing up to make a strong push into immuno-oncology.
While BP represents the most near-term shot on goal for Immune and is an interesting orphan drug opportunity for the company, UC is the blockbuster indication. According to GlobalData, there are approximately 650,000 Americans with active UC, and another 765,000 in France, Germany, Italy, Spain, the UK, Canada, and Japan. Worldwide sales of pharmaceutical products to treat IBD are expected to exceed $14 billion by 2019, with the UC market approximately 35% of that total (source: EvaluatePharma, April 2015). If approved, Bertilimumab would represent a new mechanism of action and offer an patients and physicians an alternative treatment option to the modest efficacy of the TNF-a drugs. Data from the ongoing Phase 2 study is expected in 2017.
Bullous Pemphigoid is a chronic autoimmune skin disease that involves the formation of blisters, known as bullae, at the space between the epidermis and dermis layers of the skin. There is no cure, and current treatment options primarily consist of class-1 anti-inflammatory agents (e.g., corticosteroids, tetracyclines, and clobetasol). While somewhat effective in knocking down flare-ups, long-term use of high-dose corticosteroids results in significant side effects, including weight gain, glaucoma, diabetes, high blood pressure, hormone imbalances, osteoporosis, and edema and thus is not suitable for patients with severe or recurrent BP (Mayo Clinic).
There are an estimated 65,000 patients in the U.S. and Europe with BP; thus, both agencies recognize BP as an Orphan Disease. If the open-label Phase 2a study above is successful, Immune will likely push forward into a Phase 2/3 clinical trial in 2017. Because BP is an Orphan Disease, it seems logical to assume that this next trial will count as one of the required pivotal studies required prior to U.S. FDA approval. As noted above, I'm expecting data in the second half of the year.
Investor 100
Investors @ IMNP
Two noted instiutional investment firms Discover Growth Fund and Hercules Technology Growth display a strong vote of confidence!
October 1,2015
Immune Pharmaceuticals Receives Second Tranche of $3 Million from Discover Growth Fund
Company Has Now Secured $16.5 Million Gross Proceeds out of the $21.5 Million July 2015 Financing
(IMNP) ("Immune or the "Company") announced today that Immune has received an additional $3 million in gross proceeds from Discover Growth Fund pursuant to the agreement previously disclosed in the Company's Current Report on Form 8K filed on July 29, 2015. This financing was in addition to the gross proceeds of $9 million already received from Discover at the same $2.50 conversion price and terms and the $4.5 million from Hercules Technology Growth Capital. Hercules also provided Immune the option to draw down additional capital under the term loan of up to $5 million in gross proceeds subject to clinical milestones and other conditions. The additional $3 million from Discover was received upon an effective "resale" registration statement pertaining to the Series D Preferred and stockholders approval on Friday, September 25, 2015.
Dr. Daniel Teper, CEO of Immune stated, "Immune has now received $16.5 million gross proceeds of the potential $21.5 million. We believe that the financing provided by Hercules and Discover is a vote of confidence in the Immune pipeline and will allow Immune the ability to execute on its clinical milestones."
***CEO owns over 4M shares on IMNP!
http://openinsider.com/search?q=imnp
Investor 100
Executives @ IMNP
I think the company is turning the page with some additional changes to its exceutive ranks that will provide better results in 2016
December 7th,2015
G. John Mohr Joins Immune Pharmaceuticals as Senior Vice President of Business Development
https://finance.yahoo.com/news/g-john-mohr-joins-immune-123000868.html
John Mohr has served in the pharmaceutical business for over twenty years in multiple functions including business development, strategic planning and marketing. Prior to joining Immune, he was managing director at the consulting firm BioAsset Advisors advising public and private companies on strategic partnering and licensing activities. John Mohr previously served as senior vice president with CV Therapeutics, a publicly traded drug company focused on innovative cardiovascular therapeutics, and he lead several major global transactions with Menarini and Astellas. In addition, he was instrumental in the $1.4 billion sale of the company to Gilead in 2009. Prior to that, he was the chief operating officer for Topigen Pharmaceuticals, a clinical stage company developing innovative therapeutics in the respiratory field. He was senior vice president with Atherogenics and President of Fournier Pharma US, where he delivered billion dollar deals with AstraZeneca and Abbott. John is a graduate of Drexel University in Finance and Accounting, a CPA and certified licensing executive.
February 3,2016
Immune Pharmaceuticals Names John Neczesny to its Board of Directors
https://finance.yahoo.com/news/immune-pharmaceuticals-names-john-neczesny-123000987.html
Mr. Neczesny brings over 27 years of investment banking and corporate experience to this role. Mr. Neczesny has been a Managing Director at Oberon Securities, LLC, a boutique investment bank, since 2012, where he advises on and executes M&A and financing transactions principally for healthcare companies. Previously, he was Vice President, Corporate Development at Par Pharmaceutical Companies from 2009 to 2011. From 1998 to 2008, Mr. Neczesny was an investment banker at Bear Stearns & Co. Inc. in the Healthcare group, where he rose to Managing Director and was involved in numerous M&A and capital markets transactions for pharmaceutical, biotechnology and medical technology companies. Mr. Neczesny earned an MBA in Finance from New York University Stern School of Business and a Bachelor of Science degree in Chemistry from the University of Delaware.
December 9th,2015
Immune Pharmaceuticals CEO Updates Shareholders On Company Progress
Additional Insider Buying Confirms Board and Management Confidence
https://finance.yahoo.com/news/immune-pharmaceuticals-ceo-updates-shareholders-135300932.html
The Company secured financing allowing us to execute the development plan for our lead drug candidate, bertilimumab, through Phase II clinical trials data, and relocated corporate headquarters to New York City at the Alexandria Center for Life Sciences, the heart of the NYC medical and biotech corridor. Immune has hired a new leadership team with a proven track record of execution in both pharma and fast growth biotech companies: Monica Luchi, M.D., our new Executive Vice President and Chief Medical Officer, formerly at Novartis, Incyte and Mesoblast; Miri Ben Ami, M.D., Executive Vice President, Oncology and President Immune Pharmaceuticals Ltd., formerly at Teva and Aposense; G. John Mohr, Senior Vice President, Business Development, formerly at Merck and CV Therapeutics. The Company is now committed to further strengthening its board of directors with the addition of members with successful leadership experience at public biotech companies.
http://www.immunepharma.com/
Investor 100
IMMUNE PHARMACEUTICALS: February 2016 Investor Presentation Dr. Daniel Teper , Ceo
2016 shaping up to be a strong year!
http://www.conferencecalltranscripts.org/8/summary/?id=2404187
Investor 100