On September 26, 2016 CEL-SCI Corporation (NYSE MKT: CVM) reported that it has received verbal notice from the U.S. Food and Drug Administration (FDA) that its Multikine (Leukocyte Interleukin Injection) Phase 3 clinical trial in advanced primary head and neck cancer has been placed on clinical hold (Press release, Cel-Sci, SEP 26, 2016, View Source [SID:SID1234515419]). Pursuant to this communication from FDA, patients currently receiving study treatments can continue to receive treatment, and patients already enrolled in the study will continue to be followed. CEL-SCI was also told to expect a formal letter from the FDA within 30 days and will work diligently with the FDA to obtain the release of the clinical hold. The study currently has about 926 patients enrolled.

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On September 26, 2016 CANbridge Life Sciences, a biopharmaceutical company focused on developing Western drug candidates in China and North Asia, reported that the first patient was dosed in the Phase I/II trial of its lead candidate, CAN-008, for the treatment of newly-diagnosed glioblastoma multiforme (GBM), in Taiwan (Press release, CANbridge Life Sciences, SEP 26, 2016, View Source [SID:SID1234515418]). The patient was treated at Linkou Chang Gung Memorial Hospital, in Taipei, Taiwan. CAN-008, CANbridge’s lead candidate, is an immunotherapy that enhances the immune system response to cancer and inhibits tumor cell growth. The combined Phase I/II trial will consist of an open-label, dose-escalation Phase I portion, with a primary endpoint of safety. Phase II will consist of a multi-center, double-blind, randomized, placebo controlled trial, with the primary endpoint and secondary efficacy endpoints of progression free survival, overall survival and safety, respectively. Overall, the trial will enroll a total of 55 patients. CANbridge expects to report Phase I safety data after mid-2017.


"CANbridge is now a clinical stage company, delivering on our mission to develop Western drug candidates for Asian markets, " said James Xue, CANbridge CEO. "It is of particular value to us that CAN-008 shows promise in glioblastoma multiforme, a terrible cancer that has had no new front-line treatments approved, anywhere in the world, since 1999. We are proud to bring a potentially new treatment option to this underserved group of patients."

"I am honored to lead this well-designed, high-quality clinical trial, " said principal investigator (PI) Kuo-Chen Wei (MD), Professor of Neurosurgery,Vice Chairman of Cancer Center, and Director of Brain Tumor Division, Linkou Chung Gung Memorial Hospital. "We look forward to doing all we can to explore CAN-008’s potential to make a meaningful difference in the treatment of GBM patients"

About CAN-008
CAN-008 is a fully human fusion protein that inhibits the CD95 ligand, a member of the tumor necrosis factor (TNF) family. By blocking it, CAN-008 restores the immune system’s anti-tumor response and inhibits invasive tumor cell growth. In a European Phase II trial in patients with recurrent glioblastoma, conducted by the drug’s developer, privately-held Apogenix, patients with biomarkers for the CD95 ligand experienced the greatest benefits. In July 2015, CANbridge acquired an exclusive license to develop, manufacture and commercialize CAN-008 for GBM and other indications, in China, Hong Kong and Macau, which was recently expanded to include Taiwan.

On September 26, 2016 ERYTECH Pharma (Paris:ERYP) (ADR:EYRYY) (Euronext Paris: ERYP), a French biopharmaceutical company developing ‘tumor starvation’ treatments for acute leukemia and other oncology indications with unmet medical needs, reported the final patient has been enrolled in its Phase 2 trial of eryaspase, also known as ERY-ASP or GRASPA, for the treatment of pancreatic cancer (Press release, ERYtech Pharma, SEP 26, 2016, View Source [SID:SID1234515415]).

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The multicenter, randomized Phase 2 trial is evaluating eryaspase as a second-line treatment of patients with metastatic pancreatic cancer. In the study conducted in France, eryaspase was added to the standard of care (currently Gemcitabine or FOLFOX regimen) and then compared to the standard of care alone in a 2-to-1 randomization. The primary endpoint of the trial is progression-free survival (PFS) at four months.

The trial has completed enrollment of 139 patients and we expect to report primary results from this trial by early 2017.

"The Phase 2 trial of eryaspase for pancreatic cancer is, to our knowledge, the largest cohort of solid tumor patients treated with an asparaginase-based product to date," said Gil Beyen, Chairman and CEO of ERYTECH. "Previously, deprivation of asparagine has shown to limit growth of pancreatic and other solid tumors in preclinical models, but clinical proof of concept has not yet been established. We believe a positive efficacy signal in this trial could open a potentially large application area for asparagine depletion in certain solid tumors."

About pancreatic cancer:

Pancreatic cancer is a disease in which malignant (cancer) cells are found in the tissues of the pancreas. Every year there are about 150,000 new cases of pancreatic cancer diagnosed in Europe and the United States. Pancreatic cancer is a particularly aggressive cancer, with a five-year survival rate of less than 10% and is currently the fourth most common cause of cancer death in the EU for men and women. Pancreatic cancer could be a suitable indication for eryaspase because it involves a large proportion of tumors that are believed to be sensitive to asparagine depletion, allowing it to potentially have an impact.

On September 26, 2016 Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform, reported that it has today presented new preclinical data demonstrating in vivo efficacy of its lead 4-1BB (CD137)-based bispecific cancer immunotherapeutic drug candidate, PRS-343, at the 2016 CRI-CIMT-AACR International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) – Translating Science into Survival, taking place in New York City (Press release, Pieris, SEP 26, 2016, View Source [SID:SID1234515414]).

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The in vivo data show that treatment of HER2-positive tumor-bearing animals with PRS-343 provided dose-dependent, dual anti-tumor activity by increasing the frequency of tumor-infiltrating lymphocytes via bispecific targeting of 4-1BB and HER2, as well as mediating tumor growth inhibition by direct antagonism of HER2 on tumor cells. In contrast, an agonistic anti-4-1BB benchmark monoclonal antibody (mAb) displayed neither tumor growth inhibition nor enhanced lymphocyte infiltration into tumors compared to an isotype control mAb, but preferentially activated T cells systemically, resulting in significant toxicity. A copy of the poster can be viewed and downloaded by clicking View Source

Louis Matis, M.D., Pieris SVP and Chief Development Officer, commented, "These new data support a differentiated mode of action for PRS-343 and demonstrate the potential benefits of tumor microenvironment-localized costimulatory T cell activation for both reduced systemic toxicity and higher efficacy in comparison to conventional agonistic anti-4-1BB mAbs. We look forward to the initiation of our phase 1 clinical trial of PRS-343 for the treatment of cancer patients planned for the first half of 2017."

About PRS-343
PRS-343 is a bispecific monoclonal antibody/Anticalin fusion protein comprised of a HER2 tumor-targeting mAb genetically linked to a potent anticalin specific for the immune costimulatory TNF family receptor 4-1BB (CD137). PRS-343 is being developed as the first 4-1BB based therapeutic to mediate the activation of tumor-specific T lymphocytes selectively within the tumor microenvironment (TME). 4-1BB is a potent costimulatory immunoreceptor and an established marker for tumor-specific infiltrating T lymphocytes (TILs), and is therefore, an attractive target for cancer immunotherapy. In in vivo preclinical tumor models, PRS-343 has demonstrated potent T lymphocyte activation localized to the TME of established HER2-positive tumors, indicating the potential for both enhanced safety and efficacy.