Additional data from pivotal METEOR trial underscore clinically meaningful benefit of Exelixis’ (EXEL) drug Cabometyx™ for patients with Advanced RCC AT the ASCO Meeting: ABSTRACT #4557, #4558 Cabometyx’™ benefit was robust and consistent regardless of prior treatment, location and extent of tumor metastases Positive data will be presented at the 2016 American Society of Clinical Oncology (ASCO) from subgroup analyses of the pivotal METEOR trial. …

Enrollment has been completed in all the three ongoing clinical trials comprising the firm’s Phase 3 program for Theravance Biopharma’s (TBPH) revefenacin (TD-4208). The drug is an investigational long-acting muscarinic antagonist (LAMA) for chronic obstructive pulmonary disease (COPD). The three revefenacin Phase 3 program are meant to support the registration of the product in the U.S. More than 2,300 patients have been enrolled and Top-line …

Biomarin Pharmaceutical’s (BMRN) decision to withdraw its DMD drug Kyndrisa™ (drisapersen) Marketing Authorization Application (MAA) from the European Medicines Agency (EMA) means more than pressuring the FDA to approve Sarepta’s DMD product eteplirsen. As we see from Biomarin press release, its decision was based on several reasons, including the discussions at the May 2016 Committee for Medicinal Products for Human Use (CHMP) meeting, which clearly …

Ionis Pharmaceuticals (IONS) stock plummeted when GlaxoSmithKline (GSK) stopped pursuing a late stage trial of Ionis-TTR the TTR amyloidosis called familial amyloid polyneuropathy (FAP). This product represents one wagon in Ionis train, which has several wagons representing the firm’s pipeline products. GSK is still occupying one of these wagons known as the familial amyloid cardiomyopathy (FAC). All the other BIG names riding Ionis’ train are still there, no …

GlaxoSmithKline and Innoviva: The COPD inhaler Relvar® Ellipta® (known as Brio Ellipta in the United States) Demonsterates Superiority Over Usual Care. According to GlaxoSmithKline plc (GSK) and Innoviva (INVA), the results came fromSalford lung study, which demonstrated that Relvar® Ellipta® 100/25mcg (fluticasone furoate ‘FF’/vilanterol ‘VI’ or ‘FF/VI’) achieved a superior reduction in exacerbations versususual care   in patients with chronic obstructive pulmonary disease COPD, in an everyday …

Yes, indeed, the good news has come from the randomized CABOSUN phase 2 trial with Exelixis’ (EXEL) drug cabozantinib. The news is indirectly telling us that Cabozantinib may soon become the first-line treatment for previously untreated advanced renal cell carcinoma (RCC). We say that because the randomized CABOSUN trial that was conducted on advanced renal cell carcinoma patients who have not been treated before has shown a …

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 …

Notwithstanding the unrelenting improvements being constantly made in managing blood coagulation’s problems, conventional anticoagulants still have thrombotic incidents (clots) in patients taking anticoagulants (blood thinners) and bleeding remained the most feared side effect of these indispensable life-saving drugs. In recent years, several novel anticoagulants demonstrating obvious advantages over conventional anticoagulants have been created, developed and marketed. Their advantages over conventional anticoagulants have been validated through …

COLLABORATIONS Preparing for the Future, Biogen Signs a Lucrative Collaborative Agreements While Highlighting the Small Firm REGENXBIO Pursuing gene therapy, Biogen (BIIB) announced collaborations with two gene therapy experts from the University of Pennsylvania as well as a gene therapy technology licensing deal with THE small gene therapy firm RegenxBio (RGNX). The deal will allow Biogen to license RegenxBio proprietary NAV Technology Platform for the …

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 …

Seres Therapeutics (MCRB), is microbiome therapeutics platform company. It focuses on developing a novel class of biological drugs that are designed to treat disease by restoring the function of a dysbiotic microbiome, where the natural state of bacterial diversity and function is imbalanced. Seres’ programs comprise: SER-109: This product has completed a Phase 1b/2 study with results showing a clinical benefit in patients with recurring …

GILEAD After years of controversial refraining, official India reversed course and granted Gilead Sciences its patent rights to Sovaldi hepatitis C treatment. More than a victory for Gilead, it was the prevalence of fairness after years of underestimating the power to fairness to keep resurfacing until reinstated. The Indian Patent Office had rejected Gilead’s patent application based on a notion that it did not demonstrate …

By June, which is next month, Incyte (INCY) will be the owner of the European operations of Ariad (ARIA). That’s what both firms have announced yesterday. Among other details, the firms decided on signing a licensing agreement for exclusive development and commercialization rights to Ariad’s Iclusig (ponatinib) in the European Union and 22 other countries, including Switzerland, Norway, Turkey, Israel and Russia. Iclusig is approved …

EXELIXIS AGAIN They said: Sell EXEL, as no partner is interested in the firm’s FDA approved cabozantinib to date. What really happened: It did not take long for IPSEN to come forward and take the responsibility of marketing cabozantinib abroad and pay $200 million upfront payment to Exelixis. They said: Although the FDA approved Cabometyx (cabozantinib) for advanced renal cell carcinoma (RCC), the drug will …

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 …

GILEAD SCIENCES The people who cause the selloff of Gilead’s (GILD) stock because it missed 5 cents are the same who continue to complain about the high price of its HCV drug. This is intriguing because those who advocated selling the stock said that the reason for the miss is the huge discounts the firm is making on the drug price. Gilead is the undisputed …

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 …

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 …

Congratulations.   The FDA approved Exelixis’ (EXEL) drug Cabometyx™ (cabozantinib) tablets for advanced renal cell carcinoma (RCC) patients who have received prior anti-angiogenic therapy. RCC is the most common form of kidney cancer in adults. Cabometrix is the first drug to demonstrate robust and clinically meaningful improvements in a phase 3 trial in patients with advanced RCC. The drug satisfied all key efficacy parameters — …

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 …