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MabVax Therapeutics HuMab 5B1 Antibody Is Highlighted at Upcoming World Molecular Imaging Congress in Five Separate Presentations

On August 31, 2015 MabVax Therapeutics Holdings, Inc. (OTCQB: MBVX) aclinical stage oncology drug development company reported that the Company’s lead antibody, HuMab 5B1, will be garnering major attention as the subject of five separate presentations during the upcoming World Molecular Imaging Congress (WMIC) being held in Hawaii September 2-5, 2015 (Press release, MabVax, AUG 31, 2015, View Source [SID:1234507361]). Researchers from the Department of Radiology at Memorial Sloan Kettering Cancer Center (MSK) will present results on the use of MabVax’s lead antibody as a PET imaging agent and as a radioimmunotherapy agent targeting pancreatic cancer.

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Presenters at the WMIC include Jacob Houghton, Ph.D. of MSK, who will present results from two preclinical in vivo studies using the HuMab 5B1 antibody as an ImmunoPET imaging agent in the context of circulating antigen as well as new pretargeted methods for the immunoPET imaging of CA19.9 in murine models of pancreatic cancer. Dalya Abdel-Atti will present the results of using HuMab5B1 in ImmunoPET imaging with newly developed murine organoid models of pancreatic cancer. A third presenter, Jan-Philip Meyer, Ph.D., will present results of using HuMab 5B1 as a pre-targeting agent followed by administration of the short-lived (18F)-NOTA-labeled tetrazine radioligand for PET imaging and in vivo coupling, examining the efficiency of HuMab5B1 in imaging and the reduction in exposure to the radiolabel. All four presentations illustrate the potential utility of the antibody as a next generation imaging agent for pancreatic cancer. Lastly, Ryan Lanning, M.D. Ph.D., will present the results of using HuMab 5B1 as a radioimmunotherapy agent for treatment of pancreatic cancer.

Because five-year survival rates in pancreatic cancer are only 5% and more than half of all patients initially diagnosed already have metastatic disease, the difficulties in identifying distant metastases that often go undetected as well as developing advanced therapeutics to treat this difficult cancer are significant unmet medical needs. These researchers at MSK are on the cutting edge of this technology and may well help develop a new generation of diagnostic and therapeutic agents using HuMab 5B1. Continuing studies of HuMab 5B1 could further demonstrate the utility of a broad technology platform useful both as a imaging and therapeutic agent.

About HuMab 5B1
The fully human antibody HuMab 5B1 was recovered from patients undergoing cancer vaccine treatment at Memorial Sloan-Kettering Cancer Center. The HuMab 5B1 has demonstrated high specificity, affinity, and lack of cross-reactivity with similar antigens. The antibody has also shown potent cancer cell killing capacity and efficacy in animal models of pancreatic, colon, and small cell lung cancers. Ongoing toxicology results continue to demonstrate an acceptable profile in acute and repeat dose studies in animals. MabVax plans to initiate two complementary Phase I clinical trials in the first quarter of 2016. One clinical trial is aimed at determining the safety and potential utility of HuMab 5B1 as a therapeutic agent in subjects with metastatic pancreatic cancer. The second clinical trial is aimed at demonstrating the utility of 89Zr-HuMab 5B1, the Company’s radio-labeled HuMab 5B1 antibody, as a next-generation PET imaging agent for the diagnosis, staging, and management of pancreatic cancer.

Phase 2 Study of Advaxis’s Axalimogene Filolisbac (ADXS-HPV) in Cervical Cancer to be Presented at 2015 AGOS Annual Meeting

On August 31, 2015 Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, reported that final clinical data from Stage 1 of the ongoing two-stage Phase 2 study (GOG-0265) of Advaxis’s lead Lm Technology immunotherapy, axalimogene filolisbac (ADXS-HPV), in patients with persistent or recurrent metastatic (squamous or non-squamous cell) carcinoma of the cervix (PRmCC), will be presented at the American Gynecological & Obstetrical Society (AGOS) annual meeting in Half Moon Bay, Calif. by Tom Hertzog, M.D., Clinical Director at the University of Cincinnati Cancer Institute, on September 17, 2015, at 11:15 a.m. PDT (Press release, Advaxis, AUG 31, 2015, View Source [SID:1234507360]).

"There are limited therapies available in metastatic cervical cancer, particularly for patients who have failed at least one line of therapy," said Dr. Hertzog. "We see the potential for axalimogene filolisbac to fill a significant unmet need in the treatment of this disease and look forward to presenting these Stage 1 data at the AGOS annual meeting."

GOG-0265 is an open-label, single-arm, two-stage Phase 2 study designed to evaluate the safety, tolerability and efficacy of axalimogene filolisbac in approximately 67 patients with PRmCC who have received at least one prior line of systemic therapy. The primary efficacy endpoint is 12-month overall survival rate, with secondary efficacy endpoints of progression-free survival, overall survival and objective tumor response. The primary safety endpoints are the number of patients with dose-limiting toxicities and the frequency and severity of adverse effects.

The trial is being conducted in the United States by the Gynecologic Oncology Group (GOG), now part of NRG Oncology, under the sponsorship of the Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute (NCI). Further information about the study can be found on ClinicalTrials.gov, using Identifier NCT01266460.

About Cervical Cancer

Cervical cancer is the fourth most common cancer and the most common cause of mortality in women worldwide. In the United States, nearly 13,000 new cases are diagnosed and approximately 4,100 deaths are reported because of cervical cancer. According to the WHO/ICO Information Centre on HPV and Cervical Cancer, about 3.9 percent of women in the U.S. are estimated to harbor high-risk cervical HPV infection at a given time, and 71.7 percent of invasive cervical cancers are attributed to high-risk HPV strains.

About Axalimogene Filolisbac

Axalimogene filolisbac (ADXS-HPV) is Advaxis’s lead Lm Technology immunotherapy candidate for the treatment of HPV-associated cancers and is in clinical trials for three potential indications: invasive cervical cancer, head and neck cancer, and anal cancer. In a completed randomized Phase 2 study in recurrent/refractory cervical cancer, axalimogene filolisbac showed apparent prolonged survival, objective tumor responses, and a manageable safety profile alone or in combination with chemotherapy, supporting further development of the company’s Lm Technology.

OncoMed Pharmaceuticals Completes Enrollment of Phase 2 ALPINE Clinical Trial of Tarextumab in Pancreatic Cancer

On August 31, 2015 OncoMed Pharmaceuticals Inc. (NASDAQ:OMED), a clinical-stage company developing novel anti-cancer stem cell and immuno-oncology therapeutics, reported that it has completed patient enrollment in its Phase 2 "ALPINE" clinical trial of tarextumab (anti-Notch2/3, OMP-59R5) for the treatment of pancreatic cancer more than eight months ahead of schedule. The ALPINE study enrolled 177 patients with advanced pancreatic cancer who had not received prior treatment (Press release, OncoMed, AUG 31, 2015, View Source [SID:1234507362]). Enrollment in the randomized, double-blinded, multi-center clinical study began in July 2014.

"We are encouraged to have accrued patients in this expanded trial over eight months ahead of our original projections and by the enthusiasm of the ALPINE investigators for the potential of tarextumab in combination with chemotherapy for the treatment of patients with pancreatic cancer," said Jakob Dupont, M.D., Chief Medical Officer of OncoMed. "The ALPINE clinical study will be the first of our ongoing Phase 2 trials testing novel anti-cancer stem cell therapeutics to read out, and we expect to report data from this trial in the second half of 2016. The primary endpoint of the study is overall survival."

The Phase 2 ALPINE trial is designed to evaluate the efficacy of tarextumab in combination with Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin bound) plus gemcitabine in patients with previously untreated Stage IV pancreatic cancer. The Phase 2 clinical trial will compare the overall survival of patients receiving tarextumab 15 mg/kg every two weeks versus placebo in combination with Abraxane plus gemcitabine. Secondary and exploratory endpoints, including progression-free survival and overall response rate, pharmacokinetics, safety and other biomarkers, will also be evaluated. Overall survival, progression-free survival and overall response rates will be assessed using a predictive biomarker for high tumor Notch3 expression. Increased Notch3 expression is estimated to occur in approximately 70 percent of pancreatic tumors and is associated with poor patient outcomes.

Eileen O’Reilly, M.D., Associate Director for Clinical Research, David M. Rubenstein Center for Pancreatic Cancer Research at Memorial Sloan Kettering Cancer Center in New York, and a Principal Investigator of the ALPINE study commented, "The Notch pathway is a key biological pathway in pancreatic cancer that is associated with poor survival outcomes for patients. The ALPINE trial will help us determine whether the novel antibody tarextumab, which targets the Notch pathway, can provide clinical benefit for patients with pancreatic cancer that need better treatments, and whether the companion Notch3 biomarker can help identify the patients who might derive greater benefit with tarextumab treatment."

The protocol for the randomized Phase 2 ALPINE trial was amended in February 2015 to designate overall survival as the primary endpoint (rather than progression-free survival), and the target enrollment increased from 124 to at least 160 patients. These changes occurred based on the anti-cancer stem cell mechanism of action of tarextumab and following the review of final data from the Phase 1b portion of the ALPINE trial in 40 patients with first-line metastatic pancreatic cancer, where 24 patients received the tarextumab-Abaxane-gemcitabine combination. Analyses of the Phase 1b subjects receiving the three drug combination revealed a median overall survival of 14.6 months in patients whose tumor samples had elevated levels of Notch3 gene expression and 11.6 months in all patients regardless of Notch3 biomarker status1. By comparison, the historical overall survival using the standard-of-care in this patient population is 8.5 months2. Results from OncoMed’s Phase 1b trial of tarextumab were presented at the 2015 Gastrointestinal Cancer Symposium.

About Pancreatic Cancer

Pancreatic cancer is the third leading cause of cancer-related deaths. According to the American Cancer Society, each year in the United States there are approximately 49,000 new cases of pancreatic cancer and 41,000 deaths. The majority of patients with pancreatic cancer are diagnosed after their cancer has spread locally and/or metastasized to distant organs. The average life expectancy after the diagnosis of metastatic pancreatic cancer is less than one year3.

About Tarextumab (anti-Notch2/3, OMP-59R5)

Tarextumab (anti-Notch2/3, OMP-59R5) is a fully human monoclonal antibody that targets the Notch2 and Notch3 receptors. Preclinical studies have suggested that tarextumab exhibits two mechanisms of action: (1) by downregulating Notch pathway signaling, tarextumab appears to have anti-cancer stem cell effects, and (2) tarextumab affects pericytes, impacting stromal and tumor microenvironment. Tarextumab is currently being studied in two randomized Phase 2 clinical trials. The "ALPINE" study (Antibody therapy in first-Line Pancreatic cancer Investigating anti-Notch Efficacy and safety) is assessing tarextumab with Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin bound) plus gemcitabine in first-line advanced pancreatic cancer patients. The "PINNACLE" study (A Phase 1b/2 Study of OMP-59R5 in Combination with Etoposide and Platinum Therapy in Subjects with Untreated Extensive Stage Small Cell Lung Cancer) is testing tarextumab in combination with etoposide and cisplatin and etoposide and carboplatin in first-line extensive-stage small cell lung cancer patients. Tarextumab is part of OncoMed’s collaboration with GlaxoSmithKline (GSK). GSK has an option to obtain an exclusive license to tarextumab during certain time periods through completion of the proof-of-concept Phase 2 trials.

Bristol-Myers Squibb and QIMR Berghofer Medical Research Institute Announce Worldwide Collaboration to Discover Novel Immuno-Oncology Antibodies

On August 30, 2015 Bristol-Myers Squibb Company (NYSE:BMY) and QIMR Berghofer Medical Research Institute reported that they have signed a research collaboration and license agreement to discover novel therapeutic antibodies against an undisclosed immuno-oncology (I-O) target (Press release, Bristol-Myers Squibb, AUG 30, 2015, View Source [SID:1234507358]).

"Bristol-Myers Squibb continues to invest in strategic partnerships that accelerate the discovery and development of novel immunotherapies through innovative science and technologies," said Carl Decicco, Ph.D., Head of Discovery, R&D, Bristol-Myers Squibb. "We are excited to work with QIMR Berghofer Medical Research Institute, a partner that brings significant experience and expertise in cancer research."

"QIMR Berghofer is committed to translational research, so it is gratifying when high quality research at the Institute results in the strategic collaboration announced today," said Professor Frank Gannon, QIMR Berghofer Director and CEO. "Bristol-Myers Squibb is the ideal partner to progress these assets to the clinic, with their world-leading expertise in immuno-oncology and a proven track record developing multiple cancer therapies on the market. We look forward to a fruitful, long-term collaboration, delivering new therapies for cancer patients."

QIMR Berghofer Medical Research Institute is a world leading translational research institute focused on cancer, infectious diseases, mental health and a range of complex disorders. Bristol-Myers Squibb will be solely responsible for clinical development and commercialization of antibodies discovered through the collaboration. Financial terms were not disclosed.

Telesta Receives FDA BLA Filing Notification Letter and Priority Review Designation for MCNA(1)

On August 28 2015 Telesta Therapeutics Inc. (TSX: TST) (PNK: BNHLF) reported that it has received its BLA Filing Notification for MCNA from the U.S. Food and Drug Administration (FDA). This formal letter communicates that the FDA has completed its initial review of Telesta’s Biologics License Application (BLA) submitted on June 29, 2015 and has accepted it for filing (Press release, Telesta Therapeutics, AUG 28, 2015, View Source [SID:1234507865]). In the same letter, the FDA communicated that it has designated the file for 6 month Priority Review and has set February 27, 2016 as the review goal date for MCNA. The FDA has also advised that it will be organizing an advisory committee to discuss the BLA application.

Commenting on the FDA letter, Dr. Michael Berendt, Chief Executive Officer and Chief Scientist noted: "Today is a historic day for Telesta Therapeutics and for all of our staff and collaborators who have worked so diligently to advance our new treatment for non-muscle invasive bladder cancer towards potential regulatory approval early next year. While we recognize that the FDA must complete its full review of our BLA filing before rendering its ultimate decision, we are working extremely hard, at all levels, to prepare for commercial launch in the United States."

About MCNA

MCNA is a biologic therapy developed to provide high risk non-muscle invasive bladder cancer patients who are refractory to or relapsing from front line therapy with a therapeutic alternative to surgery. MCNA is derived from the cell wall fractionation of a non-pathogenic bacteria. Its activity is believed to be through a dual mechanism of immune stimulation and direct anti-cancer effects. MCNA was developed to be delivered as a sterile suspension for intravesical administration by urologists and urology nurses, following the same dosing paradigm as first-line bacillus Calmette-Guérin (BCG) therapy, with the advantage that it can be prepared, handled and disposed of easily and safely. The efficacy, duration of responses and safety data from MCNA’s pivotal Phase 3 trial was recently published in The Journal of Urology. The FDA has set February 27, 2016 as its review goal date for MCNA’s potential approval.

About Telesta Therapeutics Inc.

Telesta Therapeutics Inc. is a late stage therapeutics company with near term commercial potential focused on the manufacturing, marketing and licensing/acquisition of proprietary and innovative therapies for the global health market. The Company’s primary goal is to develop and commercialize products that advance human health and increase shareholder value. For more information, please visit www.telestatherapeutics.com