On December 1, 2015 Syndax Pharmaceuticals reported the initiation of the entinostat clinical program in Japan by its partner Kyowa Hakko Kirin, Co., Ltd (Press release, Syndax, DEC 1, 2015, View Source [SID:1234508552]). Entinostat, an oral, small molecule drug candidate that targets both cancer cells and immune regulatory cells, is being developed by Syndax as an immuno-oncology therapeutic and evaluated as a treatment for advanced hormone receptor positive (HR+) breast cancer in an ongoing Phase 3 clinical trial (designated E2112) in the United States. In September 2013, entinostat was granted breakthrough therapy designation by the U.S. Food and Drug Administration in advanced HR+ breast cancer following positive results from the Phase 2b clinical trial, ENCORE-301.

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"In addition to the entinostat immuno-oncology combination regimens entering clinical development in the U.S., we are pleased to see continued clinical progress for entinostat in advanced breast cancer both in the U.S. and Japan," said Briggs Morrison, M.D., Chief Executive Officer of Syndax. "We view this milestone as an important step towards potentially providing new treatment options to breast cancer patients globally and look forward to continuing our collaboration with our valued partner Kyowa Hakko Kirin."

In January 2015, Syndax announced completion of a license agreement with Kyowa Hakko Kirin for the exclusive rights to develop and commercialize entinostat in Japan and Korea. Kyowa Hakko Kirin has now dosed the first patient in Japan in a Phase 1 clinical trial investigating the safety of entinostat (designated KHK2375 by Kyowa Hakko Kirin) as a monotherapy and in combination with exemestane in advanced or metastatic HR+ breast cancer patients previously treated with a nonsteroidal aromatase inhibitor. Secondary endpoints include pharmacokinetic parameters and preliminary efficacy.

On December 1, 2015 MabVax Therapeutics Holdings, Inc. (OTCQB: MBVX), a clinical-stage oncology drug development company, reported it has filed an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration (FDA) for the Company’s lead fully human antibody product HuMab 5B1 as a therapeutic agent (Filing, 8-K, Telik, DEC 1, 2015, View Source [SID:1234508380]). Subject to FDA acceptance, MabVax plans to initiate the Phase I clinical trial early in 2016.

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The planned Phase I trial will evaluate the safety, tolerability and pharmacokinetics of HuMab 5B1 as a single agent or in combination with the current standard of care chemotherapy regimen in subjects with metastatic pancreatic cancer. The first cohort of patients to be enrolled in the planned clinical trial will be enrolled in a traditional dose escalation regimen to assess safety and determine the optimal dose of the antibody. A second patient cohort will establish the safety and optimized dose of the antibody when administered with standard of care chemotherapy and a third patient cohort will be administered the optimized dose of antibody as a single agent for the treatment of patients with advanced cancer.

David Hansen, MabVax’s President and Chief Executive Officer, said, "The filing of the first of two planned INDs for our novel HuMab 5B1 antibody is a significant achievement for MabVax. Pending FDA acceptance of the IND, we will begin the dose escalation portion of this Phase I trial as early in 2016 as possible and anticipate reporting on the early safety assessment and determination of a maximum tolerated dose in mid-year 2016. Achievement of this important interim milestone will enable us to move into the combination therapy and monotherapy portions of the trial where we could learn much more about the pharmacological effects of this new therapy. The milestone could also have a positive impact on our future commercial and corporate development activities. We currently anticipate having full enrollment of all three patient cohorts sometime before the end of 2016."

MabVax plans to file a second IND application this month for its HuMab 5B1-based PET imaging agent and, subject to FDA acceptance, will begin this Phase I trial as early as possible in 2016. When the antibody is combined with a radio-label as a novel PET imaging agent, the 89Zr-HuMab 5B1 product has demonstrated high image resolution of tumors in established xenograft animal models, making it attractive as a potential companion diagnostic for the HuMab 5B1 therapeutic product.

"We believe the data generated in the early portions of these two Phase I trials will help demonstrate the initial safety, targeting specificity, and utility of the HuMab 5B1 antibody in this devastating disease," added Mr. Hansen. "We are excited about the potential applicability of our dual-product development approach in other cancers with HuMab 5B1, as well as with follow-on antibodies under development at MabVax."

About HuMab 5B1:
MabVax’s HuMab 5B1 antibody is fully human and was discovered from the immune response of cancer patients vaccinated with an antigen-specific vaccine during a Phase I trial at Memorial Sloan Kettering Cancer Center. In preclinical research, the 5B1 antibody has demonstrated high specificity and affinity, and has shown potent cancer cell killing capacity and efficacy in animal models of pancreatic, colon and small cell lung cancers. The antigen the antibody targets is expressed on more than 90% of pancreatic cancers making the antibody potentially broadly applicable to most patients suffering from this type of cancer.

On December 1, 2015 CEL-SCI Corporation (NYSE MKT: CVM) ("CEL SCI" or the "Company") reported that in the month of November it has enrolled 27 patients in its ongoing Phase 3 trial of its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) in patients with advanced primary head and neck cancer (Press release, Cel-Sci, DEC 1, 2015, View Source [SID:1234508376]). Total patient enrollment is now 635 as of November 30, 2015 in the world’s largest Phase 3 study in head and neck cancer.

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"This fall we have been enrolling patients at an average of rate one per day. We expect this rate will significantly increase in the first quarter of 2016 based on the number of new clinical centers that are now being activated," stated CEL-SCI CEO Geert Kersten.

The current study goal is to enroll 880 patients through approximately 100 clinical centers in over 20 countries.

About the Multikine Phase 3 Study

The Multikine Phase 3 study is enrolling 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.

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. Dr. Joel Palefsky, a world renowned scientist and Key Opinion Leader (KOL) in human papilloma virus (HPV) research and the prevention of anal cancer, is the Principal Investigator at UCSF, which was added to the study in July 2015.

CEL-SCI has also entered into two additional co-development agreements for up to $3 million each 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 December 1, 2015 ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that develops targeted anticancer therapeutics using its antibody-drug conjugate (ADC) technology, reported the presentation of new preclinical data with the Company’s experimental therapies IMGN529 and IMGN779 to be made at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting to be held December 5-8, 2015 in Orlando, FL (Press release, ImmunoGen, DEC 1, 2015, View Source [SID:1234508374]).

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"ImmunoGen is advancing experimental therapies expected to make a meaningful difference for patients with cancer, and we believe the preclinical data being presented at ASH (Free ASH Whitepaper) with our IMGN529 and IMGN779 help demonstrate the potential significance of these programs," said Dr. Charles Morris, Executive Vice President and Chief Development Officer. "In preclinical assessments, IMGN529 demonstrates marked synergy with rituximab – a widely used therapy for non-Hodgkin lymphoma – which informed our decision to assess this combination clinically. The IMGN779 data being reported relate to its novel mechanism of action, which we believe could help patients with acute myeloid leukemia, and we expect to start clinical testing of this experimental therapy in early 2016."

In addition to these data presentations on ImmunoGen’s wholly owned compounds, clinical data will be presented with Sanofi’s CD38-targeting antibody isatuximab (SAR650984), which was developed in a research collaboration with ImmunoGen.

Title: "IMGN529, a Novel Antibody-Drug Conjugate (ADC) Targeting CD37 Shows Synergystic Activity with Rituximab in Non-Hodgkin Lymphona (NHL) Models"

Poster session #625: Saturday, Dec. 5, 5:30-7:30 pm ET. Abstract #1548.
Title: "IMGN779, a CD33-Targeted Antibody-Drug Conjugate (ADC) with a Novel DNA-Alkylating Effector Molecule, Induces DNA Damage, Cell Cycle Arrest, and Apoptosis in AML Cells"

Poster session #616: Saturday, Dec. 5, 5:30-7:30 pm ET. Abstract #1366.
Title: "A Dose Finding Phase II Trial of Isatuximab (SAR650984, Anti-CD38 mAb) As a Single Agent in Relapsed/Refractory Multiple Myeloma"

Oral presentation #653: Mon., Dec. 7, 8:00 am. Abstract #509.

Additional information can be found at www.hematology.org, including abstracts.

On December 1, 2015 Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) reported that the first patient has been treated in an investigator-sponsored pilot study of vosaroxin and cytarabine in adult patients age 60 years and older with previously untreated acute myeloid leukemia (AML) (Press release, Sunesis, DEC 1, 2015, View Source [SID1234508373]). The trial is being conducted at the Melvin and Bren Simon Cancer Center at Indiana University under the direction of Seyed Hamid Sayar, M.D., Assistant Professor of Clinical Medicine.

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"Achieving a complete remission with induction therapy is directly correlated with prolonged survival in the frontline treatment of AML," said Dr. Sayar. "Yet anthracyclines, a current backbone of induction therapy, are well known to be cardiotoxic, a toxicity that is of particular concern in older patients. New regimens, such as vosaroxin and cytarabine, with potentially less toxicity would be highly appealing not only in daily practice, but also to serve as a backbone for novel combinations."

The pilot efficacy assessment trial is expected to enroll approximately 17 previously untreated patients with AML who are age 60 and older who will receive up to 4 cycles of treatment (2 induction, 2 consolidation). Each 5-day cycle will include 10-minute infusions of vosaroxin (90mg/m2 for induction 1 and 70mg/m2 for subsequent cycles) on days 1 and 4, and 2-hour infusions of cytarabine (1g/m2) on days 1-5, followed by a variable interval required to achieve hematologic recovery (defined as absolute neutrophil count). The primary endpoint of the study is rate of complete remission, including complete remission with incomplete blood count recovery. Secondary objectives are safety of the combination in induction therapy of older patients previously unexposed to intensive chemotherapy, progression-free survival, length of stay in hospital for induction, and 30- and 60-day mortality rate.

"We are encouraged by the initiation of a new vosaroxin study in the frontline induction setting," said Daniel Swisher, Chief Executive Officer of Sunesis. "Vosaroxin is active and well tolerated in this population, both as a single agent, as seen in the REVEAL-1 study, and in combination with decitabine, as seen in our ongoing MD Anderson Cancer Center-sponsored study. We look forward to seeing results from these investigator-led studies, including data from the MD Anderson study later this year, while we continue to focus our internal resources on submitting our European Marketing Authorization Application for vosaroxin as a treatment for relapsed/refractory AML by the end of this year."

About QINPREZO (vosaroxin)
QINPREZO (vosaroxin) is an anti-cancer quinolone derivative (AQD), a class of compounds that has not been used previously for the treatment of cancer. Preclinical data demonstrate that vosaroxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Both the U.S. Food and Drug Administration (FDA) and European Commission have granted orphan drug designation to vosaroxin for the treatment of AML. Additionally, vosaroxin has been granted fast track designation by the FDA for the potential treatment of relapsed or refractory AML in combination with cytarabine. Vosaroxin is an investigational drug that has not been approved for use in any jurisdiction.
The trademark name QINPREZO is conditionally accepted by the FDA and the EMA as the proprietary name for the vosaroxin drug product candidate.