The platelet derived growth factor receptor-α (PDGFRα) monoclonal antibody, olaratumab (IMS-3G3) by Eli Lilly, received Priority Review from the FDA on the strength of data from its Phase II trial in patients with soft tissue sarcoma (STS). The drug already received Orphan Drug, Breakthrough Therapy, and Fast Track designations from the agency. Continue reading
In the 1920’s Otto Warburg first discovered that tumor cells bypass normal cellular respiration i.e. glucose converted to pyruvate through glycolysis, and the sequential oxidation of pyruvate through the Krebs Cycle in the mitochondria. Instead tumor cells divert pyruvate to lactate dehydrogenase (LDH), which reduces pyruvate into lactate. This type of metabolism, referred to as The Warburg Effect, is normally observed in cells in hypoxic or anaerobic environments, in cells that are proliferating, or in cells in which the accumulation of pyruvate exceeds the capacity of the mitochondria. Continue reading
In the last several months, three novel drugs that we have been following on this blog failed in late stage clinical trials. The drugs have diverse mechanisms of action:
Baxalta, the biopharmaceutical spinoff of Baxter, entered into a $1.7 B deal with Precision BioSceinces for 6 CAR-T (Chimeric Antigen Receptor T-cell) projects, and Saronic Biotechnology announced positive data in preclinical studies of its autologous dendritic cell vaccine for hepatocellular carcinoma. Continue reading
An independent data monitoring committee (IDMC) has recommended the continuation of Argos’ pivotal phase 3 ADAPT clinical trial of AGS-003 for the treatment of metastatic renal cell carcinoma (mRCC) based on results of the committee’s second planned interim data analysis. The next planned interim analysis will be in 6 months. Continue reading
Two companies announced news last week regarding their efforts to treat cancer by administering treatments that become activated by physiological conditions specific to the tumor microenvironment. Threshold Pharmaceuticals announced data from Phase III clinical trials of evophosphamide (TH-302), and BioAtla announced an antibody development deal with Pfizer. Continue reading
Elotuzumab (Empliciti) is now the second monoclonal antibody (Mab) approved by the FDA for multiple myeloma (MM). Darzalex (daratumumab), the first Mab for MM, was approved by the FDA just 3 weeks ago. Continue reading
Celldex’s vaccine against the mutated epidermal growth factor receptor (EGFRvIII), reduced the risk of death from the disease by 47% in a 73-patient randomized Phase 2 study called ReACT. In addition, the survival rate at two years was 25% for patients given the vaccine versus none in the control group. It marks the first time an immunotherapy treatment has improved survival in a randomized trial of glioblastoma patients, researchers said. It is also among the first cancer vaccines to show a survival benefit. Continue reading
An experimental therapy made of genetically-modified donor T-cells cured a baby with incurable leukemia: Continue reading
Two new companies have received substantial funding to pursue neo-antigens for cancer immunotherapy: Gritstone Oncology raised $102MM to pursue lung cancer and Neon Therapeutics raised $55MM to develop neoantigen-based therapeutic vaccines and T cell therapies to treat cancer. Continue reading