Date: 2016-01-21
Type of
information: Presentation of results at a congress
phase: observational
Announcement: presentation of results at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in San Francisco
Company: Galena Biopharma (USA - OR) Dr Reddy's laboratories (India)
Product: NeuVax™ (nelipepimut-S)
Action
mechanism:
- peptide/immunotherapy product. NeuVax™ (nelipepimut-S) is an immunodominant nonapeptide derived from the extracellular domain of the HER2 protein, a well-established target for therapeutic intervention in breast carcinoma. NeuVax™ has been shown to bind to HLA-A2 and A3, as well as HLA-A24 and A26 molecules. The nelipepimut-S sequence stimulates specific CD8+ cytotoxic T lymphocytes (CTLs) following binding to specific HLA molecules on antigen presenting cells (APC). These activated specific CTLs recognize, neutralize and destroy, through cell lysis, HER2 expressing cancer cells, including occult cancer cells and micrometastatic foci. The nelipepimut-S immune response can also generate CTLs to other immunogenic peptides through inter- and intra-antigenic epitope spreading leading to a broader, more robust anti-tumor immune response.
Disease: HER2 gastric cancer
Therapeutic
area: Cancer - Oncology
Country:
Trial
details:
Latest
news:
- • On January 21, 2016, Galena Biopharma presented data from an observational study in gastric cancer patients at the American Society of Clinical Oncology ( ASCO ) 2016 Gastrointestinal Cancers Symposium in San Francisco , CA. The study was conducted by Galena’s partner, Dr. Reddy’s Laboratories Ltd , under the license agreement for NeuVax™ (nelipepimut-S) which includes the commercialization rights in India . As part of the license agreement, Dr. Reddy’s will conduct a Phase 2 clinical trial of NeuVax in gastric cancer patients in India .
The planned Phase 2 clinical study will assess the effectiveness of NeuVax to prevent recurrence and the effect on the disease free survival in gastric cancer patients with all levels of HER2 expression and who are HLA A2 and/or A3 positive. The data presented demonstrated that, as expected, about 25% of the patient population suffering from gastric cancer in India are likely to be eligible for the Phase 2 trial. This study by Dr. Reddy’s supports their plans to run a Phase 2 trial in India.
This prospective, observational study was undertaken to estimate the expression of HER2 (1+, 2+, or 3+) with HLA-A2 and/or HLA-A3 type positive gastric cancer patients in the Indian population. The poster, entitled, “An observational study evaluating the expression of HER2 (1+, 2+, and 3+) with HLA A2+/A3+ in gastric adenocarcinoma patients” is being presented during today’s poster session. Of the 50 patients evaluated, 12 (24%) were positive for HER2 (1+, 2+, 3+) with HLA A2/A3 alleles. Of the 12 patients, 9 (75%) and 3 (25%) expressed HLA A2/A3, respectively, with no patient demonstrating HER2 3+ expression. Results from this study suggest patients with gastric or GE junction adenocarcinoma have HLA A2 and/or A3 expressing tumors with mostly HER2 1+, 2+ expression. The estimated incidence of HER2 3+ expression in this population may be limited by the size of the current study (n=50). Approximately 25% of the patients met the projected clinical protocol population of all levels of expression of HER2 and HLA A2+ and/or A3+ as defined for the planned NeuVax Phase 2 clinical trial. Results indicate an acceptable potential for enrollment rate, given the high incidence of gastric cancer in this population, and will inform the screen failure rate in the planned Phase 2 clinical study.
Tumor tissue samples from gastric or GE junction adenocarcinoma patients were collected from S. L. Raheja Hospital , Mumbai, India . A serum sample was collected for HLA testing by quantitative PCR (polymerase chain reaction). Immunohistochemistry (IHC) (DAKO, 1:600 dilution) was employed for detection of HER2. All patients were consented for the study.
Is
general: Yes
