Indeed, updated data from the ongoing Phase 2 NLG2103 study of NewLink Genetics (NLNK) IDO inhibitor immunotherapy product indoximod in combination with the PD-1 pathway inhibitor, KEYTRUDA (pembrolizumab) demonstrate positive results in advanced melanoma. The news rallied the stock that has been cremated following news that the same drug Indoximoll has failed to meet the endpoint in mid-phase trials on breast cancer in combination with …

EXELIXIS Exelixis’ (EXEL) shareholders know well how good are the firm’s announced financial results for the second quarter of 2017. They also know well how good is the update presented by the firm about the progress made towards fulfilling its commercial and clinical development milestones. Exelixis report left no reason for complaining, criticizing or downgrading the firm’s stock. As a matter of fact, the presentation …

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 …

FROM ARRAY Array’s Drug Binimetinib in Combination Therapy with Merck’s Drug Keytruda for METASTATIC FOR COLORECTAL CANCER   On May 8, 2017, Array BioPharma and Merck announced entering into a clinical trial collaboration to investigate the safety and efficacy of Array's MEK inhibitor, binimetinib, with Merck's anti-PD-1 therapy, Keytruda® (pembrolizumab), in metastatic colorectal cancer patients with microsatellite stable tumors (MSS CRC). The decision on this …

As we wrote yesterday, immunotherapy checkpoint inhibitors represent a great advancement and big changes in the management of cancer. It is pertinent, though, to keep in mind that these immuno-oncology products will not be successful with all cancers. Immune checkpoint inhibitors Keytruda (Merck) and Obdivo, Bristol-Myers Squibb and others are already approved around the world for several cancers. We also know that these immunotherapy products …

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 …

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 …