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 …

Merck’s (MRK) anti-PD-1 drug Keytruda® (pembrolizumab) is approved for many, many cancers. Yet, it is fair to say that this checkpoint inhibitor drug will not be effective in all cancers. This is especially true now that yesterday, the U.S. Food and Drug Administration (FDA) has placed a clinical hold on KEYNOTE-183, KEYNOTE-185 and KEYNOTE-023, three combination studies of Keytruda® with Celgene’s products Pomalyst Pomalidomide and …

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 …

Prohost Letter #409 ASCO The American Society of Clinical Oncology (ASCO) meeting is around the corner. The Meeting, which will begin on Friday June 2, 2017 and will end on Monday 5, 2017 will be different than the past years for many reasons, including the following: -­ Checkpoint inhibition as Immunotherapy for cancer treatment moved from wishful thinking a decade ago, to promising cancer treatments …

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 …

MERCK Merck (MRK) has beaten analysts’ expectations generating $9.4 billion for revenues in the first quarter of 2017. Its GAAP EPS was $0.56 for the first quarter of 2017 and the Non-GAAP EPS $0.88 for the first quarter of 2017. The outperformance occurred in spite of the declining sales of some aging drugs, which is a normal recurrent phenomenon especially with the increase in break-through …

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 …

CANCER IMMUNOTHERAPY Nonstop Improvements and Nonstop Discoveries Checkpoint inhibitors and CAR-T immunotherapy are created to stay and succeed and change the way cancer has been treated for decades. The reason is that the successful results from some early attempts to enable the immune system to attack and fight cancers through these new immunotherapy approaches were unmatched in the history of cancer treatments. These successes, though, …

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 …

Vertex (VRTX) entered into a licensing agreement with Merck KGaA, Darmstadt, Germany for the worldwide development and commercialization of four research and development programs that the firm believes represent novel approaches to cancer treatment Merck KGaA will license two clinical-stage programs targeting DNA damage and repair, along with two additional novel pre-clinical programs. Upon the agreement Vertex will receive an upfront payment of $230 million, …

Prohost Letter #402 Antisense Proof of Concept and Feasibility EYE ON INVIVA (INVA) Sales of The Ellipta Inhalers Started to Pick up AND ON THERAVANCE BIOPHARMA (TBPH) See Below AND WE WILL NOT LOSE FOCUS ON ARIAD (ARIA), EXELIXIS (EXEL), ARRAY (ARRY), PORTOLA (PTLA), NEKTAR (NKTR), THERAVANCE BIOPHARMA (TBPH), INVIVA (INVA), MERCK (MRK) AND SEE THE TABLES IONIS (IONS) The . . . This content is for paid …

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 …

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 …

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 …

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 …

Biotech NEWS   AGENUS Agenus’ First Checkpoint Inhibitor to reach Clinical Trial The first patient has been dosed in Agenus (AGEN) Phase 1 clinical trial of its checkpoint inhibitor product AGEN1884. The open-label, multicenter trial in patients with advanced or refractory cancer is designed to evaluate the safety of AGEN1884 and determine the estimated maximum tolerated dose. AGEN1884 is an anti-CTLA-4 (cytotoxic T-lymphocyte antigen-4) checkpoint …