On October 31, 2018 Epigenomics AG (FSE: ECX, OTCQX: EPGNY) reported the Veterans Administration New York Harbor Healthcare System (VA-Manhattan) is commencing a study to assess the adherence impact of offering a blood-based colorectal cancer screening test and colonoscopy completion in patients who have refused colonoscopy and fecal immunochemical test (FIT) (Press release, Epigenomics, OCT 31, 2018, View Source [SID1234530405]).

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The VA-Manhattan has received grants from the American Society for Gastrointestinal Endoscopy (ASGE) and New York Society for Gastrointestinal Endoscopy (NYSGE) to assist in the performance of this study. The study will be managed through The Narrows Institute. Epigenomics will provide testing and budgetary support for testing.

Colorectal cancer (CRC) is the fourth most common cancer and the second deadliest cancer in the US. However, CRC is a preventable condition with screening being one of the most impactful public health contributions to prevention. Screening rates are suboptimal due to patient barriers to colonoscopy or stool-based testing. Unscreened patients contribute to approximately 43% of new CRC cases, 70% of CRC deaths, and 76% of CRC treatment expenditures.

The goal of the VA-Manhattan study is to assess the potential of a blood-based test as an acceptable alternative for these screen-resistant individuals. If the proposed study shows high acceptance of the blood test as well as reliable colonoscopy follow up for positive tests, then the blood test could play an important adjunctive role in improving overall screening rates.

"Some people simply don’t want colonoscopy or stool-based colorectal cancer screening, so we need to understand how effective alternative methods such as a blood-based test are at engaging these individuals," said Dr. Peter Liang, the study principal investigator and a gastroenterologist at the VA-Manhattan.

"Unscreened patients contribute significantly to new CRC cases, deaths, and treatment costs," said Greg Hamilton, CEO of Epigenomics AG. "Addressing the unscreened challenge with a blood test could unquestionably have an impact to colorectal cancer management. We look forward to the study outcomes as they have the potential to support the use of a blood test on screening-resistant patients."

On October 31, 2018 Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX: AEZS) reported that it will announce its third quarter 2018 financial and operating results after market close on Tuesday, November 6, 2018 (Press release, AEterna Zentaris, OCT 31, 2018, View Source [SID1234530472]). The Company will host a conference call to discuss these results on Wednesday, November 7, 2018 at 8:30 a.m. Eastern Time.

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Participants may access the conference call by telephone using the following numbers:

Toll-Free: 877-407-8029, Confirmation #13684540
Toll: 201-689-8029, Confirmation # 13684540
A replay will also be available on the Company’s website for a period of 30 days.

On October 31, 2018 GeneQuantum Healthcare and Biocytogen reported that reached a Strategic Cooperation Agreement focusing on the development of next generation bioconjugates for tumor immunotherapy in Beijing on October 29, 2018 (Press release, GeneQuantum Healthcare, OCT 31, 2018, View Source [SID1234553996]). Based on their mutually beneficial complementary advantages, both companies agreed to integrate GeneQuantum Healthcare’s world-class bio-conjugation platform and Biocytogen’s tumor immunotherapy antibody drug development and evaluation platform to jointly develop a series novel bioconjugates for tumor immunotherapy and precision medicine.

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Dr. Gang Qin from GeneQuantum Healthcare remarked: "GeneQuantum Healthcare has built a diverse and innovative platform in order to face challenges in the biopharmaceutical field. GeneQuantum Healthcare has developed the intelligent ligase-dependent conjugation (iLDC) system based on the independently developed ligase-dependent conjugation (LDC) technology, which provides a systematic solution toward manufacturing next generation bioconjugates. On the other hand, Biocytogen has developed an efficient animal model production platform to screen and develop high-throughput antibody drugs for tumor immuno-oncology. We are excited to collaborate with Biocytogen, a partner that possesses unique features and top-level technologies that are extremely valuable in the process of developing next generation bioconjugates for tumor immunotherapy and targeted therapies to meet the yet unsatisfied clinical demands cancer patients worldwide. We believe this mutual win-win cooperation between these two emerging biotech companies will set a precedent and an example for biomedical intelligent manufacturing in China."

"Through the development of customized gene-edited animal models, Biocytogen can provide clients with high-quality services, including pharmacological efficacy evaluation and R&D of antibody drugs. The unique large-scale in vivo drug efficacy evaluation platform with tailored animal models and the efficient pilot antibody drug discovery process enable Biocytogen to provide pharmaceutical companies with fast and efficient services toward novel antibody drug discovery. Biocytogen is committed to becoming a world-class comprehensive CRO company specialized in biomedical R&D to advance human health. GeneQuantum Healthcare’s independent, innovative and world-class intelligent bioconjugate development platform is a leader in the industry," Dr. Yuelei Shen from Biocytogen said. "We hope to harness the integrated advantages of both GeneQuantum Healthcare and Biocytogen to jointly develop new and efficient anti-tumor drugs to satisfy the needs of patients in China and other countries."

On October 30, 2018 City of Hope reported that Women with HER2-positive breast cancer that has spread to the brain need more treatment options, and City of Hope and Mustang Bio Inc. are meeting that challenge (Press release, Mustang Bio, OCT 30, 2018, View Source [SID1234530429]). A new City of Hope chimeric antigen receptor (CAR) T cell trial – the first to focus on HER2-positive breast cancer patients with brain metastases – is now enrolling potential participants.

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The phase 1 trial will be conducted in an outpatient setting and will also be the first to use intraventricular delivery of CAR T cells directly to the brains of these patients. It will test the safety and effectiveness of the CAR T cell therapy for patients who have tried other types of treatment that are no longer effective. HER2 refers to a cancer-causing protein called human epidermal growth factor receptor-2, which is found on the cell surface of breast cancer cells, as well as some lung, colon and other cancer cells, and some melanoma cells. About 20 percent of breast cancer patients are HER2-positive, according to the American Cancer Society.

"For a woman who already has breast cancer, learning that a brain tumor has developed can be a frightening diagnosis because there are few treatment options available. CAR T cell therapy may be another tool in our fight against this devastating disease," said Jana Portnow, M.D., City of Hope associate clinical professor in the Department of Medical Oncology & Therapeutics Research and associate director of the Brain Tumor Program. Portnow and Saul Priceman, Ph.D., assistant research professor in City of Hope’s T cell immunotherapy program, who conducted preclinical research that led to the trial’s development, are leading the CAR T cell trial.

"Our hope is that the HER2-specific CAR T cell therapy will target and kill HER2-positive cancer cells, and safely and effectively treat brain metastases in these patients," Priceman added.

CAR T cell therapy is a type of cell-based immunotherapy in which a patient’s own T cells are reprogrammed to actively seek out and destroy cancerous cells. For this trial, the patient’s T cells will be isolated from the blood and genetically engineered to express a CAR that allows these immune cells to target and eradicate HER2-positive cancer cells.

City of Hope, a recognized leader in CAR T cell therapies, has treated more than 200 patients since its CAR T program started in the late 1990s. The institution continues to have one of the most comprehensive CAR T cell clinical research programs in the world – it currently has 16 ongoing CAR T clinical trials, including a trial that opened recently for patients with primary glioblastoma that expresses the HER2 protein. The institution plans to open a trial in the coming months for patients with bone metastatic prostate cancer.

Mustang Bio Inc. (NASDAQ: MBIO), a company focused on the development of novel immunotherapies based on proprietary CAR T technology and gene therapies for rare diseases, licensed the HER2 technology from City of Hope in 2017.

The HER2 trial meets a crucial need – it is estimated that nearly half of all women with HER2-positive breast cancer will eventually develop brain metastases. The current standard of care for treating brain metastases uses HER2-targeted drugs and/or radiation.

"Targeted agents don’t always work because of the blood-brain barrier, a semipermeable membrane that often prevents easy access of potentially effective therapeutic drugs to the tumors," Portnow said. "Likewise, radiation has its limitations in durably controlling disease. These patients are in desperate need of safe and more effective therapies."

City of Hope researchers were the first to use intraventricular delivery of CAR T cells in patients with glioblastoma, one of the deadliest types of brain tumors. They found that injecting engineered CAR T cells locally into a patient’s brain, or regionally through infusion in the ventricular system, has the potential to eradicate brain tumors.

"Because this type of CAR T cell delivery was found to be safe, City of Hope will now also use this route of administration for patients on this trial," Priceman added.

The trial’s key investigators also include Stephen J. Forman, M.D., the Francis & Kathleen McNamara Distinguished Chair in Hematology and Hematopoietic Cell Transplantation; Christine Brown, Ph.D., the Heritage Provider Network Professor in Immunotherapy; and Behnam Badie, M.D., chief of City of Hope’s Division of Neurosurgery and director of its Brain Tumor Program.

On October 30, 2018 Immune Design (Nasdaq: IMDZ), an immunotherapy company focused on next-generation therapies in oncology, reported that it will report third quarter 2018 financial results after the close of U.S. financial markets on Tuesday, November 6, 2018 (Press release, Immune Design, OCT 30, 2018, View Source [SID1234530353]). Immune Design management will host a webcast conference call at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time on November 6, 2018 to discuss the financial results and provide a corporate update.

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The live call may be accessed by dialing 844-266-9538 for domestic callers and 216-562-0391 for international callers. A live webcast of the call will be available online from the investor relations section of the company website at View Source and will be archived there for at least 30 days. A telephone replay of the call will be available for five days by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference code: 1359112.