“MimiVax LLC, a clinical-stage biotechnology company developing immunotherapeutics and targeted therapies for cancer treatment, today announced positive interim results from a multicenter Phase II study of SurVaxM in patients with newly diagnosed glioblastoma (nGBM). These promising interim results support further development of SurVaxM in combination with standard therapy as a potential treatment for glioblastoma. A randomized trial of SurVaxM in glioblastoma is planned, pending completion of this study and review at the end of Q4 2018.”
“An Independent Data and Safety Monitoring Board (DSMB) unanimously recommended that the Phase 1/2 clinical trial evaluating VBI Vaccines’ VBI-1901 continue to enroll patients with recurrent glioblastoma (GBM) in a second study arm.
“The positive review recommended the study continue without modification, after scanning through all safety data from the first group of patients, who received the lowest VBI-1901 dose. Enrollment now has commenced for the second, intermediate-dose study arm.”
“Carboxyamidotriazole orotate (CTO) in combination with temozolomide (Temodar), with or without radiotherapy, produced positive safety and efficacy results in a phase Ib study of patients with glioblastoma (GBM) or anaplastic gliomas.
“Forty-two patients were divided into 2 cohorts and received treatment. Cohort 1 included 27 patients with recurrent, temozolomide-refractory anaplastic gliomas or GBM. Twenty-one patients were assigned to a regimen of 219 to 812.5 mg/m2 of once-daily CTO in escalating doses and 6 were assigned to a fixed daily dose of 600 mg of CTO. All 27 patients received 150 mg/m2 of temozolomide on days 1 to 5 of each 28-day cycle.”
“As immunotherapies continue to make up a larger share of new cancer drugs, researchers are looking for the most effective ways to use these cutting edge treatments in combination with each or with other pre-existing options. New studies from the Abramson Cancer Center of the University of Pennsylvania are providing fresh clues on potentially effective combinations with CAR T therapy in brain cancer as well as a novel therapeutic target in head and neck cancer, and also providing greater understanding of the mechanisms of resistance in pancreatic cancer. All three studies will be presented as late breaking abstracts at the American Association for Cancer Research Annual Meeting in Chicago.”
“Healthcare informatics firm Massive Bio has enrolled its first patient in a global registry it launched as part of a new clinical trial matching system that seeks to connect patients to appropriate biomarker-based clinical trials using information such as clinical history and genomic testing results.
“Previously, Massive Bio offered its clinical trial matching capability as part of a broader oncology clinical decision support system through which it provides treatment guidance and expert recommendations primarily to oncologists working in community practices. By separating the clinical trial matching component, the company hopes to broaden its market reach, said Massive Bio CEO and Cofounder Selin Kurnaz. The company also hopes the new tool will appeal to contract research organizations, molecular diagnostics companies, and patients themselves.”
“At first glance, a bill passed by the House of Representatives this week seems like the kind of thing anyone could get behind.
“Known as the “Right to Try” legislation, it would allow terminally ill patients access to experimental drugs without the approval of the Food and Drug Administration.
“But the bill and a similar one passed last summer by the Senate do little to address the main barrier that patients face in getting unapproved treatments: permission from the drug companies themselves.”
“NovoCure (NASDAQ: NVCR) announced today that the National Comprehensive Cancer Network (NCCN) has updated its clinical practice guidelines to recommend Optune® in combination with temozolomide as a category 1 treatment for newly diagnosed glioblastoma (GBM) in its globally recognized Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Central Nervous System Cancers.
“NCCN panel members designated alternating electric field therapy, or Optune, as a Category 1 treatment recommendation for patients with newly diagnosed GBM in conjunction with temozolomide after maximal safe resection and completion of radiation therapy in patients with newly diagnosed GBM.”
“The Centers for Medicare & Medicaid Services, which administers the federal Medicare insurance program, will begin covering FDA-approved diagnostic tests that scan tumors for a range of genetic mutations. The news is a boost for companies like Foundation Medicine and Thermo Fisher Scientific, who are among the few firms with such tests on the market.
“Late Friday, the CMS said that, going forward, it will start to reimburse for tests that use DNA sequencing technology to map the tumors of patients with advanced cancers once approved by the FDA. Two of the already-approved tests fitting this description are FoundationOne CDx, from Cambridge, MA-based Foundation, and Oncomine Dx Target Test, from Waltham, MA-based Thermo Fisher Scientific (NYSE: TMO). FoundationOne CDx looks for 324 cancer-related alterations in patients’ DNA. Foundation amasses a report based on the results and sends it to doctors, who use the data to suggest possible treatments. Oncomine detects 23 genetic alterations associated with non-small cell lung cancer.”
“Investigators are seeking to determine whether the combination of eflornithine (alphadifluoromethylornithine) with lomustine can improve survival for patients with recurrent anaplastic astrocytoma (AA). A rare form of brain tumor, AA occurs more often in adults aged 30 to 50 years and accounts for 17% of primary malignant brain tumors. This tumor type is even more rare when it recurs, according to Victor A. Levin, MD, emeritus professor of neurooncology at The University of Texas MD Anderson Cancer Center in Houston and a clinical professor at the University of California, San Francisco, School of Medicine.”