On September 1, 2015 RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL) ("RedHill" or the "Company"), an Israeli biopharmaceutical company primarily focused on late clinical-stage, proprietary, orally-administered, small molecule drugs for inflammatory and gastrointestinal (GI) diseases, including gastrointestinal cancers, reported that the last patient has completed the final scheduled follow-up visit in the Phase I study evaluating YELIVA (ABC294640), the Company’s orally-administered first-in-class sphingosine kinase-2 (SK2) selective inhibitor, for the treatment of advanced solid tumors (the ABC-101 study) (Press release, RedHill Biopharma, SEP 1, 2015, View Source [SID:1234507372]).

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The ABC-101 Phase I study was conducted at the Medical University of South Carolina Hollings Cancer Center and was led by Principal Investigators Melanie Thomas, MD, and Carolyn Britten, MD. The open-label, dose-escalation, pharmacokinetic (PK) and pharmacodynamic (PD) first-in-human Phase I study of YELIVA (ABC294640) enrolled 22 patients with advanced solid tumors. The patients were continuously treated with the study drug in the absence of disease progression and evaluated for an additional period of up to one year after discontinuing treatment with YELIVA (ABC294640). The primary objectives of the study were to identify the maximum tolerated dose (MTD) and the dose limiting toxicities (DLTs) and to evaluate the safety of YELIVA (ABC294640). The secondary objectives of the study were to determine the pharmacokinetic (PK) and pharmacodynamic (PD) properties of YELIVA (ABC294640) and to assess its antitumor activity.

The study was supported by grants from the National Cancer Institute (NCI) and the FDA’s Office of Orphan Products Development (OOPD). Preliminary positive data from the Phase I study was presented by Apogee Biotechnology Corporation at the November 2013 Molecular Targets and Cancer Therapeutics meeting.

The analysis of the study is currently ongoing and top-line results are expected to be announced early in the fourth quarter of 2015. A full analysis and the final Clinical Study Report (CSR) are expected by the end of the year or early 2016.

YELIVA (ABC294640) is a proprietary, first-in-class, orally-administered sphingosine kinase-2 (SK2) selective inhibitor, with anti-cancer and anti-inflammatory activities, targeting multiple oncology, inflammatory and GI indications. SK2 is an innovative molecular target for anti-cancer therapy because of its critical role in catalyzing the formation of the lipid-signaling molecule sphingosine 1-phosphate (S1P), which is known to regulate cell proliferation and activation of inflammatory pathways. By inhibiting SK2, YELIVA (ABC294640) could potentially be effective in treating multiple oncology, inflammatory and gastrointestinal indications.

Reza Fathi, Ph.D., RedHill’s Senior VP Research & Development said: "The completion of the final follow-up visit by the last patient in the Phase I study of YELIVA (ABC294640) is an important milestone for RedHill, and we look forward to completing the analysis of the study, which includes analysis of plasma S1P levels as a potential new pharmacodynamic biomarker for anti-cancer activity of a sphingolipid targeted drug."

RedHill recently initiated a Phase I/II clinical study in the U.S. evaluating YELIVA (ABC294640) in patients with refractory/relapsed diffuse large B-cell lymphoma (DLBCL), primarily patients with HIV-related DLBCL, supported by a grant from the NCI Small Business Technology Transfer (STTR) program. Additional Phase II clinical studies are planned, including a multiple myeloma study to be conducted at Duke University and supported by the NCI, and a radioprotection study to evaluate potential prevention of mucositis in cancer patients undergoing therapeutic radiotherapy. Numerous successful pre-clinical studies were conducted with YELIVA (ABC294640) in GI, inflammation, radioprotection and oncology models.

The studies with YELIVA (ABC294640) are registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health which provides public access to information on publicly and privately supported clinical studies.

About YELIVA (ABC294640):

YELIVA (ABC294640) is a first-in-class, proprietary sphingosine kinase-2 (SK2) selective inhibitor, administered orally, with anti-cancer and anti-inflammatory activities, targeting multiple potential oncology, inflammatory and gastrointestinal indications. By inhibiting the SK2 enzyme, YELIVA (ABC294640) blocks the synthesis of sphingosine 1-phosphate (S1P), a lipid that promotes cancer growth and pathological inflammation. YELIVA (ABC294640) was originally developed by U.S.-based Apogee Biotechnology Corp. and completed multiple successful pre-clinical studies in oncology, inflammation, GI, and radioprotection models, as well as the ABC-101 Phase I clinical study in cancer patients with advanced solid tumors. A Phase I/II clinical study evaluating YELIVA (ABC294640) in patients with refractory/relapsed diffuse large B-cell lymphoma (DLBCL) has been initiated in the U.S. The development of YELIVA (ABC294640) was funded to date primarily by grants and contracts from U.S. federal and state government agencies.

On September 1, 2015 CEL-SCI Corporation (NYSE MKT: CVM) ("CEL SCI" or the "Company") reported that in the month of August it has enrolled 19 patients in its ongoing Phase 3 trial of its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) in patients with advanced primary squamous cell carcinoma of the oral cavity/soft palate, a type of head and neck cancer (Press release, Cel-Sci, SEP 1, 2015, View Source [SID:1234507373]). Total patient enrollment is now 540 as of August 31, 2015 in the world’s largest Phase 3 study in head and neck cancer.

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"A lower enrollment number in the month of August was expected since the majority of our clinical sites are in Europe and the month of August is known to be a primary vacation time in Europe. We expect enrollment in the fall to increase rapidly again with the goal of being completely enrolled by March of next year," stated CEL-SCI Chief Executive Officer Geert Kersten.

A total of 880 patients are expected to be enrolled, through approximately 100 clinical centers in over 20 countries.

About the Multikine Phase 3 Study

The Multikine Phase 3 study is enrolling just diagnosed, not yet treated patients with advanced primary squamous cell carcinoma of the head and neck. The objective of the study is to demonstrate a statistically significant improvement in the overall survival of enrolled patients who are treated with the Multikine treatment regimen plus standard of care ("SOC") vs. subjects who are treated with SOC only. Standard of care for these patients consists of the surgical removal of the tumor and any locally involved lymph nodes, followed by radiotherapy or concurrent radiochemotherapy.

About Multikine

Multikine (Leukocyte Interleukin, Injection) is an investigational immunotherapeutic agent that is being tested in an open-label, randomized, controlled, global pivotal Phase 3 clinical trial as a potential first-line treatment for advanced primary squamous cell carcinoma of the head and neck. Multikine is designed to be a different type of therapy in the fight against cancer: one that appears to have the potential to work with the body’s natural immune system in the fight against tumors.

Multikine is also being tested in a Phase 1 study under a Cooperative Research and Development Agreement ("CRADA") with the U.S. Naval Medical Center, San Diego, and at University of California, San Francisco (UCSF), as a potential treatment for peri-anal warts in HIV/HPV co-infected men and women. CEL-SCI has also entered into two co-development agreements with Ergomed Clinical Research Limited to further the development of Multikine for cervical dysplasia/neoplasia in women who are co-infected with HIV and HPV and for peri-anal warts in men and women who are co-infected with HIV and HPV.

On September 01, 2015 Ignyta, Inc. (Nasdaq: RXDX), a precision oncology biotechnology company, reported that an abstract relating to entrectinib, the company’s proprietary oral tyrosine kinase inhibitor targeting solid tumors that harbor activating alterations to TrkA, TrkB, TrkC, ROS1 or ALK, has been selected for a mini-oral presentation at the 16th World Conference on Lung Cancer on September 9, 2015 in Denver, Colorado (Press release, Ignyta, SEP 1, 2015, View Source [SID:1234507379]). The presentation, which will be made by Anna F. Farago, M.D., Ph.D., of the Center for Thoracic Cancers at Massachusetts General Hospital, details a clinical case study in which entrectinib therapy resulted in rapid clinical improvement accompanied by radiographic evidence of a systemic partial response and near complete resolution of multiple CNS metastases in a patient with non-small cell lung cancer harboring an NTRK1 gene rearrangement whose disease had progressed after multiple prior therapies.

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"We are honored that the International Association for the Study of Lung Cancer’s Scientific Program Committee for the 2015 World Lung Conference has selected this abstract detailing how entrectinib treatment helped a patient in our Phase 1 clinical trial of entrectinib," said Pratik Multani, M.D., M.S., Chief Medical Officer of Ignyta. "We are looking forward to sharing this case study in this prestigious scientific forum, and to discussing our Phase 1 data and our future clinical development plans for entrectinib with key scientific and clinical experts during the World Lung conference."

Details of the presentation are as follows:

Title: Clinical Response to Entrectinib in a Patient with NTRK1-Rearranged Non-Small Cell Lung Cancer (NSCLC) (ID number 2913)
Date/time: Wednesday, September 9, 2015, 6:30 PM – 8:00 PM, Mountain time
Location: Four Seasons Ballroom, F3/F4
Presenter: Anna F. Farago, M.D., Ph.D., Center for Thoracic Cancers, Massachusetts General Hospital
Session: New Kinase Targets

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]).

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"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.

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.