Watching the outperformance of the new approaches for cancer immunotherapies, especially the checkpoint inhibitors and other immunotherapy successful attempts, oncologists recognized that the ultimate efficacy of empowering the immune system to fight cancer will be reached when immunotherapy products are combined with other suitable products. In this respect, researchers and oncology specialists seem to believe that targeted therapeutics could be among the most fitting products …

About the CRISPR/Cas9 Gene Editing Patent Shareholders of biotechnology firms specialized in CRISPR gene editing technology are in a state of confusion regarding the technology's patents. The confusion is caused by the U.S. Patent and Trademark Office (USPTO) decision to sustain the intellectual property awarded to the Broad Institute of MIT and Harvard. This ruling has caused the stock of the firm Editas (EDIT), which …

Incyte (INCY) and Agenus (AGEN) announced an amendment of the License, Development and Commercialization Agreement that was originally agreed upon by the two firms on January 9, 2015. The amended converts the ongoing antibodies targeting GITR and OX40 programs from co-funded development and profit-sharing arrangements to royalty-bearing programs. In the 2015 agreement, both firms decided to work together on the INCAGN1876 (anti-GITR agonist) and INCAGN1949 …

Gilead Sciences (GILD) was subjected to what we believe is an exaggerated stock selloff following the announcement of its 2016 financial reports, which comprised its projections made for 2017. Investors seemed to have focused only on the HCV sales’ revenues while ignoring the sales’ revenues of Gilead’s HIV franchise and other products, which outperformed? Investors ignored assessing the firm’s pipeline investigational products’ values especially those …

XOMA Establishes Proof-of-Concept for 358 in Congenital Hyperinsulinism and Hypoglycemia Post-Bariatric Surgery Congenital Hyperinsulinism Phase 2 study completed and multi-dose study protocol approved in the United Kingdom. Xoma initiates multi-dose study in hypoglycemic Post-Bariatric Surgery patients The NEWS A few days ago, Xoma announced news about trial results that the firm believes were promising and successful in establishing proof-of-concept for its . . . This …

Incyte and Calithera Biosciences Announce Global Collaboration to Develop and Commercialize CB-1158, a Small Molecule Arginase Inhibitor                         Incyte (INCY) and Calithera Biosciences (CALA) announced a global collaboration and license agreement for the research, development and commercialization of Calithera’s first-in-class, small molecule arginase inhibitor CB-1158 in hematology and oncology. CB-1158 is currently being studied in …

A few months ago, we heard news that a Belgium firm called Celyad (CYAD) has concluded a deal worth over $300 million with Ono Pharmaceutical. The deal gives Ono the rights to Celyad’s allogeneic NKR-2 T-cell immunotherapy in Japan, Korea and Taiwan. This news did not mean a lot to investors as Celyad had yet to recover from a heartbreaking  setback in a late phase trial …

Amgen (AMGN) The Journal of the American Medical Association (JAMA) published findings from three Phase 3 studies of Parsabiv (etelcalcetide), an investigational intravenous calcimimetic agent in the U.S. The studies evaluated Amgen’s drug Parsabiv in more than 1,700 adults with secondary hyperparathyroidism on hemodialysis and showed that the drug produced statistically significant and clinically meaningful reductions in serum parathyroid hormone (PTH) levels, a key marker …

GILEAD (GILD) One analyst who aimed at bringing only the negatives about biotech has finally succeeded in convincing other critics and media bloggers that Gilead would not be good for investment until the firm acquires a company that can expand its meager oncology franchise. His story became the melody hummed by every blogger, ignoring the fact that the firm’s revenues and income have doubled overnight …

Hi and Happy New Year 2017 In a couple of days, you will receive the NEW Year 2017 issue #404 of the Prohost Letter where we will set out our prediction regarding breakthrough achievements that we believe will change the way diseases will be treated. Our long article tackles great technological capabilities that we expect will advance products to the market and improve state-of-the-art approaches …

Observing the biotech sector’s stock prices post losses yesterday, Wednesday, Dec. 21 convinced us that investors and traders in the biotech sector might have wrongly interpreted a bipartisan Senate report regarding the high price of drugs. The report is the outcome of a study that forms the basis of a recommendation that would enable the Congress take the right action against unjustified increases in the …

Ionis Pharmaceuticals (IONS) has further good news with a new revelation from Akcea Therapeutics, a wholly-owned subsidiary of Ionis Pharmaceuticals that the Phase 3 COMPASS study met its primary endpoint. COMPASS is a randomized, double-blind, placebo-controlled, 26-week Phase 3 study evaluating the firm’s drug volanesorsen in 113 patients with severe hypertriglyceridemia.   The average incoming triglyceride level of patients in the study was 1,261 mg/dl. …

Today we have good news and bad news. The good news is coming from Regeneron (REGN)through two sources: The first is the European Medicines Agency accepting Regeneron’s and Sanofi’s (SNY) Filing for the approval of Dupixent (dupilumab) for moderate to severe atopic dermatitis. A probable second source could be the bad news about the failure of Ophthotech’s (OPHT) drug Fovista® combo with Lucentis in demonstrating superiority …

Bellicum Pharmaceuticals (BLCM) announced results from the BP-004 multicenter clinical trial for children with Primary Immune Deficiencies (PIDs) and hemoglobinopathies. The candidates received an add-back of Bellicum’s BPX-501 modified T cells following a haploidentical, T cell-depleted hematopoietic stem cell transplant (haplo-HSCT). The data were presented in oral and poster sessions today during the 58th Annual Meeting of the American Society of Hematology (ASH). Results: All …

Prohost Biotech On   ARRAY PHARMACEUTICALS Under the title “Halozyme has Good News and Array Too”, we wrote the following about Array On Nov. 5, 2015. Array’s (ARRY) internal, broad based drug discovery and research technological capabilities is behind the creation of its small molecule therapeutics. Array’s know-how and expertise led it to build a library of therapeutics for advanced cancers and other diseases. Array’s library’s therapeutic molecules are expected …

The U.S. Food and Drug Administration (FDA) has removed the partial clinical hold it put on Adaptiimmune’s (ADAP) planned study of its NY‑ESO SPEAR™ (Specific Peptide Enhanced Affinity Receptor) T-cell therapy in myxoid round cell liposarcoma (MRCLS). The move cleared Adaptimmune to start enrolling patients with the MRCLS cancer in a trial of NY‑ESO T-cell therapy partnered with GlaxoSmithKline (GSK) Adaptimmune will initiate a study …

The media failure to forecast the results of the Presidential election has become the talk of the town and of the failed media itself. The New York Times’ article about this forecast fiasco titled “How Data Failed Us In Calling An Election” was great, showing that forecasting science is still immature to bring accurate results. The article stated that the failure in predicting the winner …

Biogen (BIIB) and Ionis (IONS) announced that Spinraza (nusinersen), an antisense drug designed and developed by Ionis met its primary endpoint in Phase 3 trial of the CHERISH Study in later-onset spinal muscular atrophy (SMA). This was the second positive Phase 3 study that provides evidence of Spinraza’s efficacy and favorable safety. The data demonstrate statistically significant and clinically meaningful results.   Children receiving Spinraza …

Ariad Pharmaceuticals (ARIA): Good news from the U.S. Food and Drug Administration (FDA) affirmed that the agency accepted for review Ariad’s New Drug Application (NDA) for its investigational oral anaplastic lymphoma kinase (ALK) inhibitor, brigatinib for patients with metastatic ALK-positive (ALK+) non-small cell lung cancer (NSCLC) who have progressed after being treated with crizotinib. The NDA submission includes clinical data from its Phase 1/2 and …

Results from trials were negative in two phase 2 studies for Gilead (GILD) experimental drug GS-4997 (selonsertib) intended to treat pulmonary arterial hypertension (PAH) and diabetic kidney disease (DKD). But the same drug selonsertib showed it might hit the jackpot when results demonstrated it succeeded in treating nonalcoholic steatohepatitis (NASH), which is also known as non-alcoholic fatty liver disease, where, according to Gilead, it showed …