October was a full month for oncology-focused biopharmaceutical company Galena Biopharma, Inc.
The company began the month with a milestone announcement of the official U.S. product launch of its Abstral (fentanyl) Sublingual Tablets for the management of breakthrough cancer pain. The product was acquired by Galena in March of 2013 and has become the company’s first commercial product, offering relief from breakthrough pain to cancer patients who have become opioid-tolerant. Abstral can now be prescribed by healthcare professionals and is available at retail pharmacies nationwide.
Galena also traveled the conference circuit last month, presenting at the 12th annual BIO Investor Forum, which took place Oct. 9 in San Francisco, Calif., and also making a presentation at the American College of Surgeons Clinical Congress 2013, which took place Oct. 6-10 in Washington, D.C.
The company’s presentation at the American College of Surgeons Clinical Congress, titled “Predicting Clinical Benefit After Completion of Treatment with the Adjuvant Breast Cancer Vaccine NeuVax (nelipepimut-S or E75),” gave an analysis of biomarker data and clinical outcomes from the NeuVax Phase 2 trial.
A cancer immunotherapy that harnesses the immune system’s power to seek out and destroy HER2-presenting cancer cells, NeuVax is the most immunogenic peptide of the HER2 protein, which is injected into the body to allow the immune system to develop a strong HER2-directed T-cell response, creating immune memory and priming the immune system against tumor cells. This active immunotherapy is able to not only kill tumor cells that are present at the time of therapy but, with the added advantage of immune memory, primes the boosted immune system to eradicate any remaining or recurrent tumor cells in a patient.
In the company’s presentation, various variables were analyzed, including HER2 levels, the effect of boosters, induction and amplification of the NeuVax T-cell response. The data shows that induction, rather than amplification, of an anti-HER2 immune response provides optimal clinical benefit and may partially explain why NeuVax works in HER2 IHC 1+/2+ patients with low to intermediate HER2 antigen exposure. The data is consistent with previously published biomarker data that indicates a correlation between increasing NeuVax-specific T-cells after vaccination and reductions in breast cancer recurrence rates.
As Galena heads into November, the company continues efforts to advance its pipeline of products toward approval. For more information about the company, including its current clinical development efforts, visit www.galenabiopharma.com.
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