Roswell Park Cancer Institute Launches Trial to Test Cuban Lung Cancer Vaccine

Excerpt:

“Roswell Park Cancer Institute launched a clinical trial that will assess CIMAvax-EGF, a novel Cuban-developed immunotherapy for lung cancer.

“This is the first time an American center received FDA authorization to sponsor a clinical trial offering a Cuban-made therapy to U.S. patients. Researchers are working to accelerate the process of this and other innovative therapies to patients worldwide through a historic new business venture with the Cuban research institute.”

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Vaccine Shows Promising Results for Early-Stage Breast Cancer Patients

Excerpt:

“Immunotherapy is a fast growing area of cancer research. It involves developing therapies that use a patient’s own immune system to fight and kill cancer. Moffitt Cancer Center is working on a new vaccine that would help early-stage breast cancer patients who have HER2 positive disease.

“The HER2 protein is overexpressed in nearly 25 percent of all breast cancer tumors and is associated with aggressive disease and poor prognosis. Moffitt researchers, led by physician-scientist Brian J. Czerniecki, M.D., Ph.D., have previously shown that immune cells are less able to recognize and target cancer cells that express HER2 as breast cancer progresses into a more advanced and invasive stage.  This suggests that strategies that can restimulate the immune system to recognize and target HER2 early during cancer development may be effective treatment options.”

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A Souvenir Smuggled Home From Cuba: A Cancer Vaccine

Excerpt:

“Zuby Malik is an unlikely candidate to violate international law. A 78-year-old mother of four with a crown of silver hair, she is a retired obstetrician-gynecologist with a penchant for order.

“But Ms. Malik is fighting for her life. After receiving a Stage 4 non-small-cell lung cancer diagnosis a year ago, she exhausted many of the treatments available to her and grappled with torturous side effects that left her itching and gasping for breath. During the summer, she decided to go to Cuba and bring back a cancer vaccine that is not approved in the United States. That she comes from a family steeped in medical training made the decision all the more difficult.”

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Personalized Vaccines May Protect Patients With High-Risk Melanoma

Excerpt:

“The field of cancer vaccines may be reinvigorated by a new understanding, and the therapeutic leveraging, of neoantigens. Researchers from Dana-Farber Cancer Institute in Boston are exploring this novel approach as a means of protecting patients with high-risk melanoma from recurrence. Early results from a phase I study were reported at the 2nd International Cancer Immunotherapy Conference by Patrick A. Ott, MD, PhD, Clinical Director of the Melanoma Center and the Center for Immuno-Oncology.”

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in a First, U.S. Trial to Test Cuban Lung-Cancer Vaccine

Excerpt:

“The Food and Drug Administration has approved the first clinical trial to test a Cuban drug in the United States — a lung-cancer vaccine developed in Havana.

“The decision on the early-stage trial was announced Wednesday by New York Gov. Andrew Cuomo (D) and officials at the Roswell Park Cancer Institute, based in Buffalo. The trial could start as soon as next month and will enroll 60 to 90 patients. It is likely to take three years to complete.

“The trial will test the CIMAvax-EGF vaccine, combined with an immunotherapy drug called Opdivo, which has already been approved in the United States. The goal is to see if the pairing improves effectiveness.”

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Cuba's Lung Cancer Vaccine: Hype or Hope?

Excerpt:

“Now that relations between the United States and Cuba are thawing, there has been a growing interest in forming medical partnerships.

“Of particular interest is a lung cancer vaccine called CimaVax, which was developed for non-small cell lung carcinoma. Available in Cuba since 2011, the vaccine has caught the attention of researchers and physicians not only in the United States but in other countries as well.

“But while intriguing, the question remains: Is it really a breakthrough in lung cancer treatment?”

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Celldex Therapeutics’ CDX-1401, CDX-301 Combination Generates Potent NY-ESO-1 Immune Responses in Patients with Melanoma

Excerpt:

“Celldex Therapeutics, Inc. (Nasdaq:CLDX) announced today results from a Phase 2 clinical study evaluating CDX‑1401 and CDX‑301 in patients with malignant melanoma, which was conducted by the Cancer Immunotherapy Trials Network (CITN) under a Cooperative Research and Development Agreement (CRADA) between Celldex and the Cancer Therapy Evaluation Program of the National Cancer Institute. CDX‑1401 is an NY‑ESO‑1-antibody fusion protein for immunotherapy, and CDX‑301 (recombinant human Flt3 ligand) is a potent hematopoietic cytokine that uniquely expands dendritic cells and hematopoietic stem cells. Results from the study were presented at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago in a poster titled ‘A Phase 2, Open-label, Multicenter, Randomized Study of CDX‑1401, a Dendritic Cell Targeting NY‑ESO‑1 Vaccine, in Patients with Malignant Melanoma Pre-Treated with CDX‑301, a Recombinant Human Flt3 Ligand.’ ”

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Expert Discusses Promise of CRS-207 Vaccine in Mesothelioma

Excerpt:

“The investigational cancer vaccine CRS-207 may improve response and survival when given with chemotherapy in patients with malignant pleural mesothelioma (MPM) according to results of a phase Ib trial.

“CRS-207, a live-attenuated, double-deleted Listeria monocytogene engineered to express the tumor-associated antigen mesothelin, was administered with chemotherapy to 38 patients with MPM. Of 34 evaluable patients, 59% (n = 20) had partial response posttreatment and 35% (n = 12) had stable disease, for an overall disease-control rate 94%. Median progression-free survival was 8.5 months and median overall survival had not been reached.

“Immunohistochemistry data from 3 patients revealed an increase in tumor-infiltrating lymphocytes (TILs) post–CRS-207. Treatment-associated changes in circulating immune cells and biomarkers were also observed.”

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Long-Term Survival Achieved in Metastatic Melanoma With Personalized Vaccine

Excerpt:

“Two patients with melanoma that had spread to the liver survived for at least 8.5 and 12 years after resection of the hepatic tumor and treatment with patient-specific immunotherapeutic vaccines. The vaccines, designed to activate the immune system against the tumor, were derived from the patients’ own dendritic cells loaded with proteins isolated from their tumors, as described in an article published in Cancer Biotherapy and Radiopharmaceuticals.

“Robert O. Dillman, MD, formerly Vice President Oncology, Caladrius Biosciences, Inc. and currently Chief Medical Officer, NeoStem Oncology (Irvine, CA) and Executive Medical and Scientific Director, Hoag Cancer Institute (Newport Beach, CA) discusses the typically poor prognosis for patients with melanoma of the eye or skin that spreads to the liver, and reports on the potential to achieve long-term survival without disease progression in a subset of patients using the eltrapuldencel-T vaccine. One patient had no disease progression for more than 4.5 years, while the other patient survived and remained disease-free for more than 12 years.”

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