(Filing, 10-K, MEI Pharma, SEP 2, 2015, View Source [SID:1234507383])

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On August 31, 2015 Bio-Path Holdings, Inc., (NASDAQ: BPTH) (Bio-Path), a biotechnology company developing a liposomal delivery technology for nucleic acid cancer drugs, reported the formation of its inaugural Scientific Advisory Board comprised of leading oncology experts (Filing, 8-K, Bio-Path Holdings, SEP 1, 2015, View Source [SID:1234507371]). Jorge Cortes, M.D., renowned leukemia expert from The University of Texas MD Anderson Cancer Center, will join as Chairman, where he will provide clinical and scientific guidance, and work with Bio-Path to identify and attract additional oncology thought leaders to join the Company’s growing Scientific Advisory Board. Amy P. Sing, M.D., a member of Bio-Path’s board of directors and Senior Director of Medical Affairs at Genomic Health, Inc., will also join as a founding member.

"We are honored to have attracted such esteemed oncology experts to join our Scientific Advisory Board," said Peter Nielsen, President and Chief Executive Officer of Bio-Path. "The creation of this board is a testament to the level of confidence in Bio-Path’s pipeline of nucleic acid therapies and lipid-based delivery technology. Dr. Sing and Dr. Cortes’ vast expertise in oncology and the treatment of blood cancers will be invaluable as Bio-Path continues clinical development of our lead candidate, Liposomal Grb-2. We look forward to benefitting from their contributions and expanding our board in the future."

Dr. Cortes joins Bio-Path’s Scientific Advisory Board as a well-established expert in oncology and hematology. He currently holds several positions at The University of Texas MD Anderson Cancer Center, including Jane and John Justin Distinguished Chair in Leukemia Research, Chief of the AML (acute myeloid leukemia) and CML (chronic myelogenous leukemia) sections, and Deputy Chair of the Department of Leukemia.

Over the course of his 25-year career specializing in leukemia research, Dr. Cortes has held several prestigious academic appointments at the University of Texas, including associate professor in the Department of Leukemia at the Graduate School of Biomedical Sciences and Chair of the CML section at the MD Anderson Cancer Center.

Dr. Cortes has also lent his experience as a consultant to leading pharmaceutical companies such as AstraZeneca on the development of prenyltransferase inhibitors, GlaxoSmithKline on the use of topotecan in MDS (myelodysplastic syndromes) and CMML (chronic myelomonocytic leukemia), and Rhône-Poulenc Rorer on the use of PEG-Asparaginase in adult ALL (acute lymphoblastic leukemia).
Dr. Cortes earned his M.D. from la Facultad de Medicina, Universidad Nacional Autónoma de México and a B.S. from el Centro Universitario México. He currently serves on the National CML Society’s Medical Advisory Board, as well as on numerous other executive committees and scientific advisory boards for organizations such as the Leukemia & Lymphoma Society and the International CML Foundation.

"As a hematologist and clinical researcher, I have dedicated my career to improving cancer outcomes and discovering better therapies for blood cancers such as AML and CML," said Dr. Cortes. "I have the utmost confidence in Bio-Path’s executive leadership and its novel liposomal Grb-2. I look forward to helping guide the Company as it makes meaningful strides in developing and strengthening its pipeline of products using liposomal delivery technology."

Dr. Sing joins the Scientific Advisory Board as a member of Bio-Path’s board of directors, where she has served since November 2014. She is the Senior Director of Medical Affairs at Genomic Health, Inc., a global health company focused on improving the quality of cancer treatment through a genomic-based approach. Dr. Sing has more than 20 years of experience working in the oncology space in various roles. Earlier in her career, she served as Senior Medical Director at Genentech, Inc., where she played an integral role in the Avastin program. Earlier, Dr. Sing served as the Senior Director of Medical and Regulatory Affairs at Seattle Genetics, at which she managed clinical programs for the company’s various antibody drug conjugates for the treatment of cancers.

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Dr. Sing earned an M.D. from the Stanford University School of Medicine, and conducted research at notable medical institutes, including the Dana Farber Cancer Institutes and Fred Hutchinson Cancer Research Center. She also holds a B.A. from Amherst College.

"Bio-Path has a unique and potentially best-in-class approach to treating cancer," said Dr. Sing. "I am honored to join the Scientific Advisory Board and am eager to lend my expertise as the Company continues its mission."

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