Positive results were announced from Array’s (ARRY) Part 2 of the Phase 3 COLUMBUS study evaluating the firm’s MEK inhibitor drug binimetinib, and its BRAF inhibitor drug encorafenibin in patients with BRAF-mutant advanced, unresectable or metastatic melanoma. The part 2 of the Phase 3, which intended to compare progression free survival (PFS) in patients treated with binimetinib plus encorafenib (COMBO300) to patients treated with encorafenib …

Novartis signed two different separate licensing agreements with two development-stage firms, Bluebird (BLUE) and Celyad (CYAD). The signing of the agreements, enabled Novartis to license the two firm’s proprietary technologies, both related to improving Novartis’ genetically engineered immunooncology CAR- T cells. CELYAD The Celyad/Novartis Agreement Celyad announced a non-exclusive license agreement with Novartis for its US patents issued for the production of allogeneic CAR-T cells. …

MIGRAINE Migraine might have a new potent preventive treatment on the market in the near future. The new breakthrough approach towards migraine treatment aims at targeting and inhibiting calcitonin gene–related peptide (CGPR). Four drug developing firms have ongoing clinical trials with drugs targeting CGPR. These are Amgen/Novartis product erenumab (AMG334); Alder Pharmaceuticals’’ product ALD403 and Teva Pharmaceuticals’ product TEV-48125. Each of the monoclonal antibodies has …

CANCER IMMUNOTHERAPY 2 Nonstop Improvements and Nonstop Discoveries In CAR-T Immunotherapy As we said in the article about checkpoint inhibition as cancer immunotherapy, the approaches that aim at enabling the immune system to fight cancer cells were created to stay and improve and become the gold standard for cancer treatment. Chimeric antigen receptor T cell (CAR-T) therapeutics are speeding their way towards approval in 2017. …

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, …

Agenus (AGEN) is reorganizing its business and operations. The reasons the firm cited comprise sharpening of its focus on clinical development of its two checkpoint inhibitor antibodies and vaccine program. Among others are: - Closing its Basel site and consolidate key functions to its Cambridge, UK and Lexington, MA facilities, - Phasing out approximately 50 positions across the organization. Robert Stein, M.D., Ph.D., President of …

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 …

AMGEN Amgen’s (AMGN) cholesterol lowering drug Repatha is the only drug that has demonstrated protection against heart attack and stroke in high risk patients. Prior to the FOURIER trial, which confirmed the effect of Repatha in lowering cardiovascular events, including heart attack and stroke, other clinical trial data led to the FDA approval of Repatha limited to the following indications: 1) adjunct to diet and …

Nektar Therapeutics (NKTR) announced positive results from the SUMMIT-07 Phase 3 efficacy study of its painkiller drug known as NKTR-181. The drug, which is a first-in-class opioid analgesic is a new chemical entity (NCE). It is the first full mu-opioid agonist molecule designed to provide potent pain relief without leading to abuse and addiction. The FDA has granted NKTR-181 Fast Track designation for moderate to …

Akcea Therapeutics, a wholly owned subsidiary of Ionis Pharmaceuticals (IONS), announced positive results from the pivotal Phase 3 APPROACH study of the drug volanesorsen. The results demonstrate that the drug met its primary endpoint of reducing triglyceride levels in patients with familial chylomicronemia syndrome (FCS). The Disease familial chylomicronemia syndrome (FCS) is a severe, rare genetic metabolic disorder characterized by an inability of the body …

An approved rheumatoid arthritis drug developed and sold by Sanofi could become a new treatment for aggressive cancers. The news came in a Mount Sinai press release announcing that researchers have discovered that a rheumatoid arthritis drug can block a metabolic pathway that occurs in tumors with a common cancer-causing gene mutation. The discovery offers a new possible therapy for aggressive cancers with few therapeutic …

We keep reiterating that CAR-T cancer immunotherapy was created to stay. More frequent updates about the CAR-T approach further solidified our conviction. Almost every week we are getting news eliminating layer by layer of the true problems about CAR-T therapy that transplanted skepticism in investors’ minds towards a successful outcome of this novel immunotherapy approach to cancer treatment. The two essential problems that instilled the …

Incyte Announces a Multi-year Research Collaboration with the Abramson Cancer Center at the University of Pennsylvania. The aim of the agreement with Abramson Cancer Center at the University of Pennsylvania as Incyte (INCY) stated in the press release is to bring together the knowledge and expertise of both collaborators scientists. This cooperation will enable conducting collaborative research in order to advance the understanding of cancer …

Making Sure that CAR-T Therapy for Cancer Succeeds Academic Researchers Identify a New Process to Raise Natural Armies of Cancer-Targeting T Lymphocytes Outside the Body Unleashing More Power to the Immune System to Fight All Types of Cancers GOOD NEWS FOR CAR-T IMMUNOTHERAPY DEVELOPERS Researchers from Mayo Clinic and the University of Washington have developed a new culture process to improve the efficacy of engineered …

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 …