IMMUNOTHERAPY  The Checkpoint Inhibitors The most revered news was the discovery of the checkpoint proteins on the surface of the immune system cells. The checkpoint proteins’ natural job is to put a break on the immune system cells to prevent them from attacking people’s own body cells. An immune attack on host cells can lead to disabling and life-threatening autoimmune diseases. Long before the scientists …

Exciting are the Q2 2018 reported results by Exelixis’ (EXEL) including the firm’s revenues and earnings, compared to 2017. Impressive were Cabometyx’ (cabozantinib) revenues, in addition to the milestone payments from collaborating companies and ex-USA marketing agent. Inspiring also are the efforts the firm is spending on research and development with the aim of further boosting its revenues. Of the Results Revenues and Incomes – …

ASTRAZENECA AstraZeneca’s (AZN) Checkpoint Inhibitor Imfinzi significantly improved Overall Survival (OS) for Stage III Non-Small Cell Cancer Imfinzi (durvalumab) achieved positive overall survival (OS) results for the Phase III PACIFIC trial in patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose cancer did not progress following platinum-based chemotherapy and radiation. An Independent Data Monitoring Committee concluded that the trial met the second of two primary …

Prohost Letter #420 REAL BREAKTHROUGHS - One Has Already Been Used and the Other Has Extraordinary Promises In  the  NEWS - THE POWER OF CHECKPOINT INHIBITOR IMMUNOTHERAPY WOW It is about the checkpoint inhibitors immunotherapy, which is bringing to the world of cancer a stunning revelation of a combination treatment offering an almost cure for a lung cancer...

In spite of their successes, Immuno-oncology products, which we still like to call immunotherapy for several reasons, are a work in progress. The most two highlighted approaches that enable the immune system to clear cancers are the checkpoint inhibition and the chimeric antigen receptor (CAR T) genetically engineered immune system T cells therapies. Therapeutic vaccines had some successes, but the outcome was inferior to the two approaches that have …

Yes, the title is real and correct and the condition is ASD. The US Food and Drug Administration (FDA) has granted a Breakthrough Therapy Designation for Roche’s (RHHBY) drug balovaptan developed for ASD. Balovaptan has shown the potential to improve social interaction and communication in people with ASD. Balovaptan is an investigational small molecule drug that acts as a vasopressin (V1a) receptor antagonist. Evidence from both human and animal studies implicate …

The Week in Review #13 From the Prohost Portfolio - 1. Betting on the technology - HALOZYME - As expected, the pulse of fat agreements with HALO is accelerating . . . This content is for paid subscribers. Please click here to subscribe or here to log in.

Prohost Letter #413 FROM BIOTECH TO BIOPHARMA - New research, new findings, new discoveries of trustworthy and doubtful biomarkers more understanding of genomics and proteomics, in addition to more breakthrough diagnostic procedures, are all gifts of the life-science revolution. This revolution started with molecular biology, the discovery of the DNA and its functions, which was the prelude to genomic understanding, gene sequencing, and genetic engineering and …

Following the announcement of two new licensing agreements for its ENHANZE® drug-delivery technology, Halozyme Therapeutics (HALO) raised financial guidance for 2017 as follows: - Net revenue of $245 million to $260 million, an increase of $130 million from the prior range of $115 million to $130 million, reflecting the portion of upfront payments from the new agreements expected to be recorded as revenue in 2017; - Operating expenses of $240 million …

New Discoveries in Neurodegenerative Diseases  Everyday is another day that can totally differ from the previous day with regard to increasing researchers’ capabilities of discovering new pathways of diseases and turning their new discoveries into far-reaching treatments. The tireless revolution in life sciences has uncovered treasures of knowledge that has been buried for centuries in the graves of the unknown. The wealth of knowledge being …

Prohost Letter #412 Part 3 GLIOBLASTOMA - Is There Hope? Senator John McCain was diagnosed with a malignant brain tumor, glioblastoma – the most common and aggressive form of brain cancer. The cancer is so aggressive that most surgeries did not provide survival. This brain cancer affects around 3 people out of 100,000 in the U.S., with men more than women and whites more than other …

Prohost Letter #411 SOME STOCK RALLYING NEWS - Under normal conditions, some good news should rally the stocks of the firms that the news belong to them. During the past six months, Amgen (AMGN) announced a series of good news that seem to have fallen on deaf ears. Yesterday Amgen announced some positive results from three approved and one experimental products – all the news …

Prohost Letter #410 JUNE PDUFA DAYS This month, the FDA will decide on the approvals of drugs belonging to companies that Prohost has picked for investment. Usually, granting approvals rallies the stocks of the drugs’ developing firms. Sending Complete Response Letters for demands that might delay approvals would cut a substantial percentage of the stocks’ values, while rejections would cause the stocks to falter. Let’s …

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 …

AT A GLANCE IMPORTANT NEWS A New FDA Commissioner The U.S. Senate Voted in Favor of Scott Gottlieb as the FDA Chief – Dr. Gottlieb, a medical doctor graduated from Mount Sinai – He held a high ranking position in the FDA during George W. Bush’s Presidency – Senators who voted for based their choice on Mr. Gottlieb’s knowledge of the FDA and of the …

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 …

Exelixis (EXEL) announced a new collaboration with Roche on a phase 1b dose escalation study of a combination of Exelixis cabozantinib in combination with Roche’s anti-PD-L1 immuno-therapy drug atezolizumab. The study aims at evaluating the safety and tolerability  of the combination in patients with locally advanced or metastatic solid tumors. Enrollment is scheduled to begin mid-year 2017. Exelixis will sponsor the trial, and Roche will …

Le CompaGnon Part 1 TUESDAY June 14, 2016 The Eternal Market Games Unfortunately, the fabrication and misrepresentation of reality in media articles about member firms of the biotech sector succeeded in devastating promising companies having exceptional technologies and products. The damages went far beyond investors unwarranted losses. The damages were grave as to ruin of many firms. Indeed, many promising firms were forced to declare …

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 …