Author Archives: Joseph Gulfo

Tazemetostat Histone Methyltransferase Inhibitor for Hematologic and Solid Tumors

Tazemetostat is a small molecule inhibitor of EZH2 being developed by Epizyme, Inc for the treatment of patients with Non-Hodgkin Lymphoma, including germinal center and non-germinal center diffuse large B-cell lymphoma and follicular lymphoma, as well as genetically-defined solid tumors. In many human cancers, misregulated EZH2 enzyme activity results in misregulation of genes that control cell proliferation—without these control mechanisms, cancer cells are free to grow rapidly.  Continue reading →

ROCA Ovarian Cancer Test for Early Detection

Each year, about 20,000 women in the United States get ovarian cancer. Among women in the United States, ovarian cancer is the eighth most common cancer and the fifth leading cause of cancer death, after lung and bronchus, breast, colorectal, and pancreatic cancers. In 2012 (the most recent year numbers are available)— 20,785 women in the United States were diagnosed with ovarian cancer, and 14,404 women in the United States died from ovarian cancer. Continue reading →

Exploiting the Tumor Microenvironment – Threshold, Bioatla, Pfizer

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 →

Second Multiple Myeloma Antibody Approved – Empliciti

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 →

Glioblastoma Update – Celldex Anti-EGFRvIII Vaccine and Improves Survival; Optune Device Reduces Risk of Death

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 →

Darzalex for Refractory Multiple Myeloma

Darzalex (daratumumab), and anti-CD38 monoclonal antibody for the treatment of patients with multiple myeloma who had already undergone at least three prior standard treatments, received FDA approval. The product was developed by J&J and Genmab. Continue reading →

Ignyta’s Cancer Drug Inhibitor of Hedgehog Smoothened Pathway Licensed from Lilly

Eli Lilly has licensed exclusive worldwide rights to Ignyta’s Phase I taladegib oncology development program, in a deal the San Diego biotech said could generate up to $53 million-plus. Taladegib is an oral bioavailable small molecule hedgehog/smoothened antagonist. The compound has achieved clinical proof-of-concept and a recommended Phase II dose based on earlier clinical studies. Continue reading →

Neo-antigens for Cancer Immunotherapy

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 →