Eye Of The Cytokine Storm

Emily BurkeBiologics, Biotech Basics, Cancer, Clinical Trials, Drug Development, Drug Targets, Mechanism of Action, Small Molecule Drugs, The WEEKLY

THE FLASH OF THE FIRST CAR-T Last week’s much anticipated FDA approval of the first chimeric antigen receptor T-cell (CAR-T) therapy for acute lymphocytic leukemia hails as the first gene therapy on the US  market. Classified as a “cell-based gene therapy,” Novartis’ (Basel, Switzerland) Kymriah works by removing patients’ T-cells, using a viral vector to introduce a gene that will allow the … Read More

Putting The CAR-T Before The Horse

Emily BurkeThe WEEKLY

THE STORY BEHIND CAR-T The hottest cancer therapy in the pipeline — chimeric antigen receptor therapy (CAR-T) — got a big boost last month when an FDA advisory panel unanimously recommended approval of the treatment for children and young adults with a severe form of leukemia who have run out of other options. Developed by Novartis (Basel, Switzerland), this elegant … Read More

Eye Of The Cytokine Storm

Emily BurkeBiologics, Biotech Basics, Cancer, Clinical Trials, Drug Development, Drug Targets, Mechanism of Action, Small Molecule Drugs

Understanding CAR-T Safety Chimeric antigen receptor therapy (CAR-T) is our top technology pick of 2016, blazing trails in drug development with its innovative approach of using engineered immune cells to fight cancer. Despite its success in clinical trials, safety concerns remain. Serious adverse events, including death, have occurred as a result of “cytokine storms” during CAR-T treatments. We reviewed the basics of CAR-T in last week’s … Read More

The Top Tech Of 2016

Emily BurkeBiotech Basics, Cancer, Clinical Trials, Drug Targets, FDA, Mechanism of Action

CAR-T Primer The hottest cancer therapy in the pipeline — chimeric antigen receptor therapy (CAR-T) — continued to mature in 2016 with its first FDA approval for blood cancer patients set to arrive this year. What’s next in the world of CAR-T? A whole lot: Additional cancer and autoimmune disease indications in preclinical development. Added safety features. More affordable “off … Read More

Next-Generation CAR-T

Emily BurkeBiologics, Business of Biotech, Cancer, Clinical Trials, Drug Development, Drug Targets, Genomics, Mechanism of Action, Monoclonal Antibodies, The WEEKLY

The Race Is On Our last WEEKLY—Hacking the Immune Response—unveiled the science behind CAR-T and TCR, two immunotherapies under the microscope of the mainstream press. The well-deserved media attention highlights the ability of these “living drugs” to recognize and obliterate cancers. With all of the early phase clinical success, a few challenges have popped up: • Safety: CAR-T and TCR can … Read More

Two Monoclonal Antibodies Walk Into The Market

Emily BurkeBiologics, Clinical Trials, Drug Approvals, Drug Development, Drug Targets, Easily Confused, Mechanism of Action, Monoclonal Antibodies, Small Molecule Drugs, Term of the Week, The WEEKLY

Attacking Asthma & Pushing Out Psoriasis Two new monoclonal antibodies debuted on the market thanks to FDA approvals last month. Both treat chronic inflammatory conditions: Lilly’s (Indianapolis, IN) Taltz for psoriasis and Teva’s (Petah Tikva, Israel) drug Cinqair for severe asthma. Interestingly enough, having psoriasis is associated with an increased risk of developing asthma according to a study in the British Journal of Dermatology. While these two conditions … Read More

Et Tu, Immune System?

Emily BurkeBusiness of Biotech, Deoxyribonucleic Acid (DNA), Drug Development, Drug Targets, Easily Confused, The WEEKLY

Autoimmune Disorders: A Story Of Betrayal “Et tu, Brute?” The famous line spoken by Shakespeare’s Julius Caesar is synonymous with unexpected betrayal by a close friend. A once trusted member of the inner circle, Marcus Brutus joined the coup and turned on Caesar. The 23.5 million Americans suffering from autoimmune disorders also have a Brutus in their midst—their own immune … Read More

A Health Crisis In The Making

Emily BurkeBusiness of Biotech, Clinical Trials, Drug Development, Drug Targets, Easily Confused, FDA, Mechanism of Action, Small Molecule Drugs, The WEEKLY

The Race Against Nash A silent epidemic creeping upon the Western world pushed the headline grabbing acquisition of a Phase 1 non-alcoholic steatohepatitis (NASH) drug last week. Boehringer Ingelheim (Ingelheim, Germany) acquired Pharmaxis (Sydney, Autralia) due to the promise of PXS4728A. Several other companies also have NASH drugs in development, such as Intercept, Genfit, Gilead, Galmed, Conatus, Raptor, and Galectin Therapeutics. With no approved treatment on the market and liver transplant … Read More