PORTLAND, Ore. - Galena Biopharma Inc., a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major medical needs across the full spectrum of cancer care, today announced in a press release the Notice of Allowance of a US patent application covering methods of treating patients having any HER2/neu expressing cancer by administering NeuVax™ (nelipepimut-S) in combination with Herceptin® (trastuzumab; Genentech/Roche). NeuVax is a peptide immunotherapy for the prevention of cancer recurrence and is Galena's lead development agent in multiple ongoing and planned clinical trials.
Importantly, the allowed claims of this patent application cover all HER2/neu expressing cancer types and patient populations (e.g., patients characterized by particular fluorescence in situ hybridization (FISH)/Immunohistochemistry (IHC) levels of HER2/neu). The patent will expire in 2026, not including any patent term extensions.
"This patent is a fundamental addition to our NeuVax intellectual property portfolio as it expands our coverage footprint to a broader set of potential indications and patient populations," said Mark W. Schwartz, Ph.D., President and Chief Executive Officer. "The NeuVax patent family now covers a range of potential treatment settings. With our current ongoing and planned clinical trials of NeuVax, we have built a robust platform for targeted treatments of HER2 expressing cancers in multiple indications both as a single agent and in combination with existing agents."
NeuVax™ (nelipepimut-S) is the immunodominant peptide derived from the extracellular domain of the HER2 protein, a well-established target for therapeutic intervention in breast carcinoma. The nelipepimut-S sequence stimulates specific CD8+ cytotoxic T lymphocytes (CTLs) following binding to HLA-A2/A3 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. NeuVax is currently in an international, Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) study under a Special Protocol Assessment (SPA) granted by the U.S. Food and Drug Administration (FDA). Additional information on the PRESENT trial can be found at www.neuvax.com. A randomized, multicenter investigator sponsored, 300 patient Phase 2b clinical trial is also enrolling patients to study NeuVax in combination with Herceptin® (trastuzumab; Genentech/Roche).
Galena Biopharma, Inc. is a biopharmaceutical company developing and commercializing innovative, targeted oncology therapeutics that address major medical needs across the full spectrum of cancer care. Galena's development portfolio ranges from mid- to late-stage clinical assets, including a robust immunotherapy program led by NeuVax™ (nelipepimut-S) currently in an international, Phase 3 clinical trial. The Company's commercial drugs include Abstral® (fentanyl) Sublingual Tablets and Zuplenz® (ondansetron) Oral Soluble Film. Collectively, Galena's clinical and commercial strategy focuses on identifying and advancing therapeutic opportunities to improve cancer care, from direct treatment of the disease to the reduction of its debilitating side-effects. For more information, visit www.galenabiopharma.com.