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 …

As we wrote in Prohost Letter #409, a transformation in this year’s American Society of Clinical Oncology meeting (ASCO) is further elaborating on Checkpoint inhibition and chimeric antigen receptor T-cell (CAR-T) approaches’ limitations. Both are attempts towards making Immunotherapy for cancer a successful treatment. Checkpoint inhibitors have reached the market at the hands of Merck, Bristo-Myers Squibb and Roche, with other firms coming forward with products …

Array Biopharma (ARRY) and Bristol-Myers Squibb (BMY) announced a clinical research collaboration to investigate the safety, tolerability and efficacy of Array’s investigational MEK inhibitor, binimetinib in combination with BMY’s checkpoint inhibitor immunotherapy drug Opdivo (nivolumab) and Opdivo Plus Yervoy (ipilimumab). The combinations are for the  potential treatment for metastatic colorectal cancer in patients with microsatellite stable tumors. According to Ron Squarer, CEO Array BioPharma the …

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 #407 AT A GLANCE - Firms Added to Prohost Portfolio PROHOST IS PICKING NEUROCRINE BIOSCIENCES   On March 27, a few days before the FDA approves Neurocrine’s (NBIX) drug Ingrezza, (valbenazine) capsules for adults with tardive dyskinesia (TD), we posted an article titled “Time for Transformation and Achievements”. In the article, we stated that Neurocrine Sciences Ingrezza will highlight Neurocrine Biosciences and its …

Eli Lilly (LLY) and Incyte (INCY) announced that the FDA has issued a complete response letter for the New Drug Application (NDA) of baricitinib for moderate-to-severe rheumatoid arthritis (RA). The FDA letter indicated that additional clinical data are required to determine the most appropriate doses. The FDA also stated that additional data are necessary for further characterization of safety concerns across treatment arms. The timing …

Everybody knows Bristol-Myers Squibb (BMY), but just a few may know anything about CytomX Therapeutics (CTMX), or about its Probody Program. CytomX is a small, develop-ment-stage firm that created platform known as the Probody Program, which leads to the creation of first in class Probody therapeutics. These therapeutics are meant to overcome safety and efficacy problems encountered by the antibodies that are currently used in …

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 …

ANOTHER MISLEADING STORY  This article was corrected after being posted. Read our apology at the end of the article. Forecasting exaggerated impact of negative-looking news has stricken GlaxoSmithKline (GSK) shareholders today, while enchanting Merck’s (MRK) shareholders. GSK said that: “Used as a single therapy”, its checkpoint immunotherapy drug Opdivo has failed a trial for newly diagnosed lung cancer patients. GSK said that the Checkmate-026 study has not met its primary …

PsiOxus Therapeutics’ adenovirus product in combination with Opdivo (nivo-lumab) for late-stage cancers.     Bristol-Myers Squibb (BMY) and PsiOxus Therapeutics (PsiOxus) announced an agreement to evaluate PsiOxus’ drug enadenotucirev, a systemically administered oncolytic adenovirus therapeutic, in combination with Bristol-Myers Squibb’s checkpoint inhibitor opdivo (nivolumab) for a range of tumor types in late-stage cancer patients. Enadenotucirev is designed to have immune stimulating effects while Opdivo is designed …

Le CompaGnon Part 2 Wednesday June 22, 2016 From the  American Society of  Clinical  Oncology (ASCO)               Checkpoint inhibitors the CAR T Approach Adoptive cell therapy Oncolytic virus therapy Therapeutic vaccines Cytokines. Le CompaGnon Part 1 dealt with: - The two firms, MERK and BMY, who were the first to get approvals of their checkpoint inhibitors. These two . . . This content is for paid …

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 …

CANCER Everyday something new is discovered that explains cancer behavior, including proliferation, response to treatment, resistance to treatment, metastasis, recurrence, etc. Today we have several news, including one that might have cleared a puzzle regarding a continuous growth of colon cancer after oncologists block a well known signaling molecule recognized as playing a major role in making, not breaking the cancer. We also have news …

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 …

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 …

Prohost Letter #388 TOPICS - 1. AN INDISPENSABLE SHORT INTRODUCTION 2. GENE EDITING 3. GENE THERAPY 4. CANCER IMMUNOTHERAPY 1. GENE EDITING Exon Skipping: Biomarin (BMRN); Sarepta (SRPT); These firms are waiting FDA approvals for Duchenne Muscular Dystrophy (DMD) Gene Editing Technology Competitors: Cellectis S.A. (CLLS); CRISPR; PTC Therapeutics (PTCT) Firms Using Different Approaches For DMD Treatment (see Below) Zink Finger Tech: Sangamo (SGMO); RNAi …

Prohost Letter #378 Part 2 2015 ASCO ANNUAL MEETING What a Big Revolution in Oncology! The ASCO meeting projected the huge advancement in the understanding, diagnosing and treating cancer. What looked as if a sudden explosion has brought in the big change, the change was, in fact a slow, deep-rooted evolution, built up over a long period of trial and error with the failures constituting …

Prohost Letter #376 WHILE LOOKING AT THE BIOTECHS SCIENTIFIC FUNDAMENTALS We keep an eye on other factors That influence the stocks Investors who pick their stocks based on the firms’ solid scientific fundamentals, technological capabilities and pipeline products’ promises are mostly long-termers. They usually keep the stock they meticulously picked until they reach the goals that motivated them to pick it in the first place. …

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, …