News
Company News: ISA Pharmaceuticals’ ISA101 Studied in Phase II Combination Trial with Checkpoint Inhibitor Nivolumab
– Trial in patients with HPV16-positive, incurable solid tumors initiated by MD Anderson Cancer Center in collaboration with ISA and Bristol-Myers Squibb
ISA Pharmaceuticals B.V., a clinical-stage immunotherapy company focusing on rationally designed immunotherapeutics against cancer and persistent viral infections, today announced the start of a Phase II combination trial, which will be conducted at The University of Texas MD Anderson Cancer Center (Houston, TX).
The goal of the open-label Phase II study is to investigate whether a combination of ISA101 with Nivolumab can help to control cancer that has spread in the body. The safety of the study drugs will also be evaluated. Nivolumab, a PD-1 immune checkpoint inhibitor, is marketed by Bristol-Myers Squibb as Opdivo for the treatment of various cancers.
The study will enroll approximately 28 patients with HPV16-positive, incurable solid tumors. Patients will receive three subcutaneous administrations of ISA101 at three week intervals, and Nivolumab intravenously every 2 weeks, beginning on day 8 after receiving the first ISA101 dose.
The primary endpoint of the study is overall response rate (ORR) at 11 weeks, defined as the sum of patients with complete response (CR) and partial response (PR) divided by the number of evaluable subjects at 11 weeks from start of treatment. RECIST 1.1 criteria will be used for assessment. Further details of the study can be found at https://clinicaltrials.gov/ct2/show/NCT02426892. The study is expected to be completed in late 2018.
Funding is being provided in part by MD Anderson’s Moon Shots Program, which was launched in 2012 to dramatically improve survival for patients diagnosed with several types of cancer over the next decade. Additional funding for the trial comes from the Stiefel Oropharyngeal Research Fund in support of MD Anderson’s Oropharynx Program, which treats and conducts research on cancers that occur in the portion of the throat behind the mouth.
The trial is open to all HPV16-related cancers regardless of organ of origin.
Company News: NEO New Oncology AG’s blood test NEOliquid finds targeted therapy for cancer patient
– Researchers from Kantonsspital Luzern and NEO New Oncology AG publish case study on patient benefiting from comprehensive blood-based diagnostics –
Researchers from Kantonsspital Luzern and NEO New Oncology AG jointly published a report in the December issue of the Journal of Thoracic Oncology describing the clinical efficacy of NEO New Oncology AG’s novel liquid biopsy assay NEOliquid.
NEOliquid is a non-invasive blood test that identifies clinically relevant, cancer-specific point mutations, insertions, deletions and gene fusions in circulating cell-free DNA down to an allele frequency of 0.1%. In addition, NEOliquid is able to detect copy number alterations in tiny amounts of circulating tumor DNA.
In the case study, conventional tissue diagnostics had not been able to detect the relevant mutation in a patient with metastatic lung adenocarcinoma, who had been extensively pretreated with EGFR-inhibitors, chemotherapy, neurosurgery, and brain radiation.
NEOliquid identified EGFR T790M conferring resistance to the previously applied drugs in a simple blood sample. As a result, the patient was treated with the third-generation EGFR-inhibitor AZD9291. The disease rapidly responded to the treatment, with both the primary tumor and metastases shrinking, and the patient’s condition improving. Follow up controls with NEOliquid every 2 weeks showed a gradual decrease of the resistance mutation in the patient’s blood over time, confirming the efficacy of the drug. As of today, the clinicians observed no clinical, radiological or genomic signs of progression, and the patient remains well and on treatment.
Company News: NEO New Oncology AG launches liquid biopsy test “NEOliquid” for comprehensive cancer diagnostics from a single blood sample
NEO New Oncology AG announced today the commercial launch of “NEOliquid”, a non-invasive cancer diagnostics test. NEOliquid is uniquely able to detect all therapeutically relevant point mutations, small insertions and deletions, translocations and copy number changes from a single blood sample, offering a painless and low-risk alternative to a tissue biopsy. NEOliquid comprises 39 genes relevant for the treatment of solid tumors, offering the physician with a rational decision making guide to match their patient with the best targeted treatment. NEO New Oncology AG is the only European provider performing comprehensive routine molecular cancer diagnostics in both clinical tissue samples and blood.
NEOliquid identifies clinically relevant, cancer-specific point mutations, insertions, deletions and gene fusions in circulating cell-free DNA down to an allele frequency of 0.1%. In addition, NEOliquid is able to detect copy number alterations in tiny amounts of circulating tumor DNA.
NEOliquid enables indirect analysis of both the primary tumor as well as its metastases, capturing the entire heterogeneity of the disease. The test can be applied to reveal additional possible therapeutic options for the patient, e.g. in the case of relapse or if the patient’s tumor has become resistant to targeted therapy. NEOliquid is suited for therapy control and therapy decisions for cancer patients experiencing recurrence of cancer, avoiding risk-prone and painful re-biopsies. NEOliquid is applicable to patients with solid tumors, such as lung, skin, breast, stomach, intestinal or ovarian cancer, or in childhood malignancies such as neuroblastoma. As little as 18 milliliters of blood are required for NEOliquid analysis. Samples can be shipped at room temperature via standard mail or courier service.
Company News: Molecular Health Raises €25 Million in Private Financing
– Proceeds to further build commercial infrastructure and drive product adoption
Molecular Health, a leader in cloud-based healthcare decision support technology to enable evidence-based treatment decisions and improved outcomes, today announced that it has raised €25 million in private financing to expand commercial adoption of its healthcare decision engine. The round was led by current investor dievini, an investor in global life and health sciences companies. With the completion of this round of financing, Molecular Health has raised a total of approximately €100 million.
“Big data is largely driving decision-making for today’s physicians, diagnostic labs, and pharmaceutical companies. However, the sheer volume of data that exists today and its continuous, rapid expansion makes it increasingly complicated to digest and apply in a practical way,” said Lutz Voelker, Chief Executive Officer of Molecular Health. “Our platform integrates these data into the most comprehensive biomedical data warehouse in the world and quickly interprets information to generate accurate and actionable insights that drive important healthcare decisions, leading to both personalized treatment and more efficient therapy development. We greatly appreciate the continued support of dievini and look forward to expanding the company’s commercial infrastructure and driving adoption of our solutions.”
“Medicine is in one of its biggest changes ever, as molecular data and information are becoming the new currency in healthcare,” said Friedrich von Bohlen, Chairman of the Board of Directors and Managing Director of dievini. “We recognized long ago that Molecular Health was one of the most forward-thinking organizations in healthcare, with the unique potential to improve outcomes and health through the power of integrative computing and IT-based interpretation. We are excited to expand our support of Molecular Health, who are at the forefront of modern medicine, helping people in healthcare organizations improve understanding, interpretation and decision making.”