Immunotherapy for Cancer Blueprint Medicines Blueprint Medicines (BPMC) entered into a worldwide collaboration and exclusive license agreement with F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. (collectively, Roche) for the discovery, development and commercialization of up to five small molecule therapeutics targeting kinases believed to be important in cancer immunotherapy. Under the terms of the agreement, Blueprint Medicines will receive an upfront cash payment of $45 million …

First therapy to demonstrate statistically significant improvement in overall survival and induction response rate in a pivotal Phase 3 trial in high-risk Acute Myeloid Leukemia (AML)   NDA submission for VYXEOS planned for later this year   Celator Pharmaceuticals (CPXX) announced positive results from Phase 3 trial of VYXEOS™ (cytarabine: daunorubicin) Liposome for Injection (also known as CPX-351) in patients with high-risk (secondary) acute myeloid leukemia (AML) compared to the standard …

London, UK, 14 March 2016:  GW Pharmaceuticals (GWPH), is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform. The firm announced the positive results of the first pivotal Phase 3 study of its investigational medicine Epidiolex®(cannabidiol or CBD) for the treatment of Dravet syndrome. In this study, the firm’s product, Epidiolex, achieved the primary endpoint of a significant reduction in convulsive …

The Diagnosed Dead Is Far from Dying Xoma (XOMA): Stock rallied following report announcing an upfront payment from Novartis, which multiplied the firm’s revenues 10 times over 2014. Novartis paid Xoma $37 million, Novo Nordisk paid $5 million and Pfizer paid the firm a little less than $4 million. CEO John Varian said, “Novel antibodies and technologies created by XOMA scientists to target diseases such as …

Of the Upcoming Game-Changing Actions THE EXPECTED FDA APPROVAL OF JAZZ DRUG DEFIBROTIDE On March 31, the FDA is expected to decide on the approval of Jazz Pharmaceuticals’ (JAZZ) drug defibrotide. The drug is for patients with hepatic veno-occlusive (VOD), also known as sinusoidal obstruction syndrome (SOS), with multi-organ failure (MOF) post-hematopoietic stem-cell transplantation (HSCT). Optimism about the FDA decision is prevailing among analysts and observers as the results of the …

As we kept describing it, Illumina’s (ILMN) is the engine behind the biological revolution reflected in the current existence of treatments, which aim at targets that were unknown before this firm enabled discovering them. Illumina’s establishing and launching the independent company, Grail, will speed the successful outcome of the war against cancer. It will contribute to advancing the diagnosis of cancer through a tremendous increase in the sensitivity …

Prohost Letter #393 IMMUNOTHERAPY - PROHOST PORTFOLIO - NEW PICKS? - A Brief Reminder of the CAR T –TCR Immunotherapy Approaches In this issue we continue our journey inside the territory of cancer immunotherapy. We remind that in the Prohost Letter issue #391, we dealt with the immunotherapy based on genetically engineered T Cells, enabling them to seek out, attack and neutralize cancer cells. The immune system’s T …

Preparing a Prohost Letter dedicated to immunotherapy and the firms that are behind the promising novel approaches towards enabling the immune system to treat, or cure diseases if possible, we fell on other genius approaches. In recent Prohost Letters, we discussed the CAR T immunotherapy approach for the management of advanced, or metastatic cancers and in the upcoming Issue, which was due two days ago, …

Agenus (AGEN) is a project in the making since the firm has decided to play an integral part in immuno-oncology, doing everything possible towards building checkpoint modulator antibodies, in addition to its protective and therapeutic vaccines. Missing analysts’ expectation by one cent, which leads to stocks’ punishment has become an accepted routine, satisfying daily traders and other investors. The substance, however, which  interests us, is in …

Exelixis’ (EXEL) quarterly results beat analysts’ expectations, which was the least of our concerns. The details of the firm’s actions during the past year, however, confirmed our conviction that the recently approved products will be taken care of responsibly by the firm that created them and believed in them against all pessimistic opinions. Indeed, more important than the firm’s current revenues and spending was the firm’s ability …

Prohost Letter #392 February 28, 2016 - How could it be possible for any genius to make intelligent guesses about the market's next moves when highly regarded experts, including Nobel Prize winners in economics, remained quizzical about the recent horrifying performances of publicly traded stocks? Since the beginning of 2016, the stock market has been made to look as if a runaway train with many passengers …

Baxalta (BXLT) and Precision BioSciences a genome editing company announced a global collaboration to develop a broad series of allogeneic chimeric antigen receptor (CAR) T cell therapies directed towards areas of major unmet need in multiple cancers. CAR T elegant genetically engineered approach that enables the T cells to pinpoint and neutralize cancer cells was created to succeed and Baxalta’s decision to enter this immunotherapy program demonstrates how …

Recent Breakthrough Designated Products CANCER Acute Myeloid Leukemia PKC412 (midostaurin) developed by Novartis AG (NVS) is an oral, multi-targeted kinase inhibitor for acute myeloid leukemia (AML) with FLT3 mutations. It is also being studied for aggressive systemic mastocytosis/mast cell leukemia. FMS-like tyrosine kinase-3 (FLT3) is a cell-surface receptor for tyrosine kinase, which has a role in the upsurge of certain blood cell types. The drug has positive data …

AMGEN AND OSTEOPOROSIS Amgen And UCB Announce Positive Top-Line Results From The Phase 3 Study of Romosozumab In Postmenopausal Women With Osteoporosis The FRAME Study Met All Primary Endpoints by Reducing the Incidence of New Vertebral Fracture Through 12 and 24 Months Amgen (AMGN)and UCB (Euronext Brussels: UCB): Top-line results from the Phase 3 placebo-controlled FRActure study in postmenopausal woMen with ostEoporosis (FRAME). The results  showed …

On February 4, 2015, we wrote an article titled, “Aerie Pharmaceuticals is speeding towards improving the treatment of glaucoma”, posted under News & Comments at the Prohost website, we wrote the following: YOUNG BUT STRONG COMPETITOR IN THE GLAUCOMA HUGE MARKET Aerie Pharmaceuticals has eye drops that could become a game changer in the management of glaucoma. The firm’s lead drug, Rhopressa™, is a one drop once-daily …

Regulus Pharmaceuticals (RGLS) a biopharmaceutical company that discovers, designs and develop treatments targeting microRNAs announced interim results from one of the company’s ongoing Phase 2 studies of its hepatitis C virus (HCV) product RG-101.  The study was designed to evaluate a shortened, four-week treatment regimen containing a subcutaneous administration of 2 mg/kg of RG-101 at Day 1 and Day 29, in combination with 4 weeks of once/daily approved anti-viral …

Gilead Sciences Gilead (GILD) Shareholders wouldn’t expect to watch short investors make billions of dollars going against Gilead during this firm’s most glorious times. We never imagined negative analysts could have the capability of persuading millions of shareholders to sell and cause a selloff of the most productive, most growing, most achieving and extremely well run biotech company. Gilead reported quarterly earnings and revenue on …

Yes. Dana-Farber Cancer Institute and Array Pharmaceuticals (ARRY) announced an immuno-oncology collaboration with potential applicability in a wide range of cancer indications. Who are these people, meaning Danna-Faber Cancer institute? Founded in 1947, Dana-Farber Cancer Institute in Boston, Massachusetts has been providing cancer patients, including adults and children, with the best treatment available today, while developing tomorrow’s cures through cutting-edge research. The Institute is one of the world’s leading …

Prohost Letter #391 Frightened by the Market and Politicians’ Debates, Not the Drug Industry, Investors are Fleeing the Biotechnology Sector  1. A fruitless debate over the high prices of drugs 2. The low price of oil, the world’s dream for decades, is now considered a disaster for the world economy? 1. The High Drug Price Debate Again, as in past presidential debates, politicians have chosen an …

Incyte: A Good Company Facing Irrelevant Investors’ Reaction  Incyte decided to stop an early ongoing trial of a combination treatment ruxolitinib (Incyte) plus regorafenib (Bayer) for colon cancer after observing the combination wasn’t working. Both drugs are approved for different indications and both are doing well in the market. At this moment in the market chaos, this news looked as if a terrible thing that must cause an unwarranted …