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MabVax Therapeutics HuMab-5B1 Based Diagnostic Imaging and Radioimmunotherapy Programs Featured at the 2016 World Molecular Imaging Congress

On September 26, 2016 MabVax Therapeutics Holdings, Inc. (NASDAQ: MBVX), a clinical-stage oncology drug development company, reported that its lead antibody development program, HuMab 5B1, was featured in three separate presentations at the recently held World Molecular Imaging Congress (WMIC) in September (Press release, MabVax, SEP 26, 2016, View Source [SID:SID1234515400]). The presentations were made by investigators from the Department of Radiology at Memorial Sloan Kettering Cancer Center (MSK) describing the novel use of MabVax’s lead antibody as a PET imaging agent and as a radioimmunotherapy agent targeting pancreatic and bladder cancer.

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Summaries of the investigator presentations and key points made are as follows:

"Utilizing antibody fragments for same-day pre-targeted immunoPET imaging in preclinical pancreatic cancer" – Investigators demonstrated that the MabVax HuMab-5B1 antibody can be successfully produced as a smaller fragment called a F(ab’)2 and coupled to multiple imaging agents without impacting immunoreactivity. This smaller fragment was coupled with Zirconium and Copper-based PET imaging agents, and a commonly used fluorescence imaging agent. All three constructs produced promising results for rapid immunoPET or immunofluorescent imaging. The potential advantage of using a smaller fragment is that imaging results could be obtained more rapidly and perhaps within the same day, giving physicians more real-time information and providing increased convenience for patients. This work was led by Jacob Houghton, Ph.D. of the Department of Radiology at MSK.
"Bioorthogonal click chemistry for the development of 225 Ac-radioimmunoconjugates and its application to pretargeting" – Investigators demonstrated that the MabVax HuMab-5B1 antibody was successfully conjugated to the radioimmunotherapy agent 225Actinium without losing immunoreactivity. Actinium has received increased interest among investigators as a potential therapeutic modality because of its alpha particle radiation has a limited range in tissue of a few cell diameters and a greater energy release for selectively killing cancer cells. This work was led by Sophie Poty, Ph.D. from the Department of Radiology and the Molecular Pharmacology Program at MSK.

"Tumor-specific PET Imaging in a Bladder Cancer Model" – The investigators demonstrated that the 89Zirconium-labeled HuMab-5B1 labeled antibody can specifically bind to xenograft tumors of human bladder cancer in animal models, potentially leading to use as an immunoPET radiotracer. There is a large unmet medical need for new treatments for bladder cancer, with an estimated 76,900 new cases each year. MabVax’s 89Zirconium-labeled HuMab-5B1 antibody (MVT-2163) is now in a phase I clinical trial for evaluation as a PET imaging agent for pancreatic cancer targeting the CA19.9 epitope, which is expressed on one-third to one-half of bladder cancers. This work was led by Jeffrey Steckler and Jacob Houghton, Ph.D. of the Department of Radiology at MSK.
David Hansen, CEO of MabVax Therapeutics, said, "We are grateful to Jason S. Lewis, Ph.D. and his team for their continued pioneering work using the HuMab-5B1 platform. They are taking important steps in expanding the clinical utility of our HuMab-5B1 antibody, including (1) demonstrating that smaller fragments of our full-length antibody could provide significant advantages in speeding tumor imaging, (2) demonstrating the utility of our full length antibody with a new radioimmunotherapy approach, (3) helping MabVax to evaluate additional CA19-9 expressing cancers for which our antibody development program may have utility beyond our current focus on pancreatic cancer, and (4) completing investigations supporting our radioimmunotherapy product for which we plan to submit an Investigational New Drug Application later this year."

CEL-SCI Reports Clinical Hold on Head and Neck Cancer Study

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.

FIRST PATIENT DOSED IN CANBRIDGE’S CAN-008 PHASE I/II TRIAL IN NEWLY-DIAGNOSED GLIOBLASTOMA

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.

Cellerant Therapeutics, Inc. Awarded $1.5 Million SBIR Contract for Development of Novel Antibody-Based Therapeutic Against IL1RAP

On September 26, 2016 Cellerant Therapeutics, Inc., a clinical-stage company developing innovative cell- and antibody-based immunotherapies for hematologic malignancies (blood cancers) and other blood-related disorders, reported that the National Cancer Institute has awarded the Company a $1.5 million Small Business Innovation Research (SBIR) Phase II contract to support preclinical development of CSC012-ADC, a novel antibody drug-conjugate to treat acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) (Press release, Cellerant Therapeutics, SEP 26, 2016, View Source [SID:SID1234515417]). CSC012-ADC targets the interleukin 1 receptor accessory protein (IL1RAP), which has been shown to be expressed on leukemic cancer stem cells, but not on normal hematopoietic stem cells. The award will fund preclinical studies and other activities over the next two years which, if successful, will position the Company to pursue an Investigational New Drug application for CSC012-ADC.

"We are very pleased to receive this award to support the development of CSC012-ADC and address a high unmet medical need," said Ram Mandalam, Ph.D., President and Chief Executive Officer of Cellerant. "Our studies to date show IL1RAP to be a promising target for the treatment of AML and MDS, which are aggressive diseases with low survival rates, particularly among elderly patients. We believe our approach of targeting and killing the leukemic cancer stem cells with an IL1RAP antibody drug-conjugate has the potential to improve outcomes for AML and MDS patients."

This contract was awarded by the National Cancer Institute under the Small Business Research Innovation Research Program Contract Topic 326, "Development of Novel Therapeutic Agents that Target Cancer Stem Cells." IL1RAP has been shown to be expressed on leukemic cancer stem cells and on tumors from several solid cancers. The Company was previously awarded an SBIR Phase 1 contract to support research and development of IL1RAP antibodies.

ERYTECH Completes Patient Enrollment in Phase 2 Trial of eryaspase (GRASPA®) for Pancreatic Cancer

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]).

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.