CELGENE Good news from Celgene (CELG) announced  that the FDA approved the firm’s targeted drug Idhifa (enasidenib) for adults with relapsed or refractory acute myeloid leukemia (AML) associated with isocitrate dehydrogenase-2 (IDH2) mutations. Good news also announced that the FDA approved the RealTime IDH2 companion assay, which pinpoints the IDH2 mutations. Richard Pazdur, MD, of the FDA Office of Hematology and Oncology Products, said in a statement. …

GENE EDITING Sangamo Biosciences: Is it a Comeback? Genome editing allows the creation of therapeutics that can modify the genome in a living cell, providing unprecedented reach that would help the creation of treatments for genetic diseases. The dream about emerging solutions through genome editing techniques, which could correct genetic mutations causing diseases seems to be turning into reality. Among the innovative firms in this …

Prohost Letter #405 Synthetic Biology (3) We have already decided upon becoming shareholders the day synthetic biology firm called Synthetic Genomics turns public. We reiterate that firms specialized in synthetic biology are numerous private and publicly traded. Some are promising, others are walking in place and a few have plummeted. With the general underperformance of synthetic biology stocks, many shareholders abandoned ship. Investors felt that …

MANUFACTURING ISSUES?!  Why PORTOLA Stock Rallied? On Aug. 17, 2016, we learned that the FDA sent a Complete Response Letter (CRL) to Portola Pharmaceuticals (PTLA) regarding its Biologics License Application (BLA) for AndexXa™ (andexanet alfa), which is an antidote important for the safety use of several new Factor Xa inhibitors anticoagulants aimed at replacing Coumadin (warfarin). The Factor Xa inhibitors anticoagulants have many advantages over …

Prohost Letter #403 Part 2 Continued From Wednesday Instead of continuing yesterday article about Agenus, we decided to post it all so that the reader can find it in one place. Important changes and additions have been made especially under the headline “Near-­Term Priorities, Possibilities and Catalysts”, which are important to read. Learning More About AGENUS Since its inception, Agenus (AGEN), previously known as Antigenics, …

The FDA announced what made Clovis Oncology (CLVS) shareholders believe that the bad times might have ended for the firm and a new era is beginning. The announcement was about the FDA decision not to hold an advisory committee meeting to discuss the company’s New Drug Application (NDA) for drug rucaparib aimed at treating advanced ovarian cancer. The regulatory agency had already granted rucaparib a …

GILEAD & GENMAB To Access Genmab’s (GEN) bispecific antibody technology, Gilead (GILD) signed a new agreement with Genmab. The King of HIV treatment objective is to use its exclusive license from Genmab to produce an HIV bispecific monoclonal antibody therapeutic. Gilead is paying around $5 million in upfront payment and up to $277 million in milestones. Genmab will also be entitled to one-digit royalty of …

We do expect some selling of Array today after AstraZeneca’s announced negative results from Phase 3 SELECT-1 trial of the MEK inhibitor, selumetinib, in combination with docetaxel chemotherapy as 2nd-line treatment for KRAS mutation-positive (KRASm) locally-advanced or metastatic non-small cell lung cancer (NSCLC). The results did not meet the trial’s primary endpoint of progression-free survival (PFS), and did not demonstrate overall survival (OS). These results, …

Important news is the news that informs about successful achievements that make a difference in treating life-threatening diseases, chronic diseases and diseases with no available treatments. Sometime you might not have a personal interest in one, or another or even all the mentioned firms in the news. For investors in the biotech sector, however, it is good to know the successful treatments that might be …

Underestimating the Value of Drugs that Disrupt the DNA Repair Mechanisms in Cancer Cells. AstraZeneca’s (AZN) Chief Executive Pascal Soriot said that while DNA damage response was under-recognized by investors, oncologists were already “very excited” by its potential of the drugs targeting DNA repair mechanisms inside cancer cells. According to AstraZeneca, drugs that disrupt the DNA repair mechanisms inside cancer cells are showing tangible promise for …

Prohost Letter #395 On the Road TO DEFEATING CANCER - Results of cancer treatment with novel immunotherapy drugs suggest that the hope of conquering cancer has improved from doubtful to conceivable. Immunotherapy treatments are scoring unprecedented successes against a wide variety of malignancies, including liquid cancers, solid cancers, cancers with DNA mutations caused by viruses and other cancer-causing agents. The two Immunotherapy approaches are currently occupying …

Medivation is a Target for Acquisition The Question is: Who Will Acquire Medivation? Sanofi has made a bid to acquire Medivation for $9.3 billion (£6.37B). Sanofi is expected to pay $52.50 per share in cash for Medivation. Why Medivation? Sanofi's chief executive Olivier Brandicourt said, "Thanks to Medivation's excellent prostate cancer treatments, we believe that a merger with Medivation would benefit patients and, at the same time, create value …

The AACR 2016 meeting presentations differed substantially from previous meetings. The  2016 meeting has brought near certainty that, indeed, defeating cancer is a reachable objective. The road is lengthy, but the speed in analyzing the data and acting upon them towards improvement is unprecedented. You will find the most important information about the AACR cancer meeting in the upcoming Prohost Letter. In the NEWS TAPIMMUNE …

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 …

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 …

Prohost Letter #390 COMPANIES USING CRISPR GENE EDITING TOOLS - The Firms Launched with CRISPR Patents Either Pending or Disputed! What Does This Mean? What are these Firms’ Priorities? But First: A Reminder In the last issue, Prohost #389, we pinpointed the gene editing technologies and techniques and demonstrated the difference between gene editing, which is genetic engineering, i.e., making changes in the genes themselves, and antisense …

In The NEWS IMMUNOTHERAPY MIRATI THERAPEUTICS Mirati Therapeutics (MRTX) is an oncology company focusing on genetic and epigenetic drivers of cancer. The firm’s clinical stage product candidates include MGCD265, a multi-targeted kinase inhibitor that is in Phase 1b clinical development trials for the treatment of solid tumors, including lung, head and neck, and gastric cancers; MGCD516, a kinase inhibitor, which is in Phase 1 clinical …

Prohost Letter #375 Part 1 BIOTECHNOLOGY: THE BEGINNING OF A NEW ERA STATE- OF-THE-ART APPROACHES FOR THE MANAGEMENT OF CHRONIC AND DEADLY DISEASES ARE IN HUMAN CLINICAL TRIALS We are encouraged by some novel treatments for chronic diseases and cancer and we are optimistic about results coming from their early- and late-phase trials. Picking advanced therapeutics is the magic word Sesame in the formula “Open Sesame”, which, …