1stOncology™: Cancer Intelligence Service – Page 17524 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

CEL-SCI REPORTS MONTHLY PATIENT ENROLLMENT IN NOVEMBER FOR ITS PHASE 3 HEAD AND NECK CANCER TRIAL

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

"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.

ImmunoGen, Inc. Announces Data Presentations at Upcoming 57th ASH Annual Meeting and Exposition

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]).

"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.

Sunesis Pharmaceuticals Announces First Patient Treated in Indiana University Pilot Study of Vosaroxin and Cytarabine in Adults Age 60 Years and Older With Previously Untreated AML

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.

"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.

Genmab to Hold R&D Update on Company’s Progress in 2015

On December 1, 2015 Genmab A/S (Nasdaq Copenhagen: GEN) reported it will hold its annual R&D Update focused on the company’s latest developments in antibody innovation on December 8, 2015 from 8:00 PM to 10:00 PM CET (Press release, Genmab, DEC 1, 2015, View Source [SID:1234508372]). The update will include presentations by key opinion leaders describing data from studies of daratumumab presented at the 57th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) as well as information on Genmab’s pipeline product HuMax-TF-ADC. Genmab will also discuss the company’s pre-clinical pipeline, the proprietary DuoBody and HexaBody technologies and will present its 2016 Key Goals.

The following cancer experts and senior Genmab staff will attend the event:

Daratumumab Key Opinion Leaders:

Professor Thierry Facon, Professor of Hematology, Head of the Department of Hematology, Lille University Hospital, Lille, France
Professor Maria Victoria Mateos, Associate Professor of Medicine, University Hospital of Salamanca, Salamanca, Spain
Professor Torben Plesner, Department of Hematology, Vejle Hospital, Vejle, Denmark
Dr. Peter Voorhees, M.D., Associate Professor, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, US

HuMax-TF-ADC Key Opinion Leader:

Professor Johann de Bono, Director of the Drug Development Unit & Head of Prostate Cancer Targeted Therapy Group, Professor of Experimental Cancer Medicine & Honorary Consultant in Medical Oncology, The Institute of Cancer Research, Surrey, UK

Genmab:

Dr. Jan van de Winkel, President and CEO, Genmab
David Eatwell, Executive Vice President and CFO, Genmab

ASH abstracts to be discussed during the event include:

Management of Infusion-related Reactions Following Daratumumab Monotherapy in Patients with ≥3 Lines of Prior Therapy or Double Refractory Multiple Myeloma (MM): 54767414MMY2002 (Sirius)
Clinical Efficacy of Daratumumab Monotherapy in Patients with Heavily Pretreated Relapsed or Refractory Multiple Myeloma
Daratumumab in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed or Relapsed and Refractory Multiple Myeloma: Updated Results from a Phase 1/2 Study (GEN503)
Open-label, Multicenter Phase 1b Study of Daratumumab in Combination with Pomalidomide and Dexamethasone in Patients with ≥2 Lines of Prior Therapy and Relapsed or Relapsed and Refractory Multiple Myeloma (MM)

The R&D Update is taking place at the Hyatt Regency Orlando in Orlando, Florida. Those wishing to attend in person should email [email protected]

The event can be attended via webcast. To view this webcast visit: View Source Webcast viewers may submit questions during the Q&A portion of the live webcast via the webcast player. An archive of the webcast will be available on Genmab’s website. The webcast will be conducted in English.
This meeting is not an official program of the ASH (Free ASH Whitepaper) Annual Meeting.

CytRx Announces the Completion of Enrollment in Pivotal Global Phase 3 Trial Ahead of Schedule

On December 1, 2015 CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, reported that it has reached its enrollment target of 400 patients for the company’s pivotal global Phase 3 clinical trial of aldoxorubicin in patients with previously treated soft tissue sarcoma (STS) (Press release, CytRx, DEC 1, 2015, View Source;p=RssLanding&cat=news&id=2119175 [SID:1234508371]). Enrollment was originally estimated to be completed in Q1 2016. The Phase 3 trial is a randomized, comparative trial being conducted under a Special Protocol Assessment from the FDA at 79 sites in the United States, Canada, Israel, Australia, Western & Eastern Europe and Chile.

"It is a true testament to the dedicated work of our clinical team, the enthusiasm of our participating physicians, and the willingness of patients to participate in our study that enrollment in our global pivotal Phase 3 clinical trial was completed ahead of schedule," said Steven A. Kriegsman, Chairman and CEO of CytRx. "We now expect to report the primary endpoint of top-line progression-free survival (PFS) in the first half of 2016, and pre-commercial launch activities are underway."

"As a member of the sarcoma research community, I am very excited to see the overwhelmingly positive response from my colleagues to this pivotal trial," said Sant P. Chawla, M.D., F.R.A.C.P., Principal Investigator and Director of the Sarcoma Oncology Center. This trial is the first to compare a single agent, aldoxorubicin, to five of the most commonly used treatment options for STS patients that have received prior chemotherapy. The rapid timeframe in which this Phase 3 trial reached its targeted enrollment reflects the desire of practitioners for more efficacious therapies."

Trial Design

This is a multicenter, randomized, open-label Phase 3 clinical trial designed to enroll approximately 400 late-stage patients with metastatic, locally advanced or unresectable soft tissue sarcomas who have either not responded to, or who have progressed following treatment with one or more systemic regimens of nonadjuvant chemotherapies. Trial patients are randomized 1:1 to be treated with aldoxorubicin or the investigator’s choice of an approved chemotherapeutic regimen, including doxorubicin, ifosfamide, dacarbazine, pazopanib (Votrient), or gemcitabine plus docetaxel. The primary endpoint of the study is PFS and will be calculated after 191 events occur. Secondary endpoints include overall survival, response rates and safety. In January 2014, CytRx announced that it received approval from the FDA to amend the Phase 3 protocol to continue dosing patients with aldoxorubicin until disease progression as defined by RECIST 1.1 criteria. The ability to dose until disease progression creates the potential for substantially improved Phase 3 efficacy results.

About Soft Tissue Sarcoma

Soft tissue sarcoma is a cancer occurring in muscle, fat, blood vessels, tendons, fibrous tissues and connective tissue, and can arise anywhere in the body at any age. According to the American Cancer Society, there are approximately 50 types of soft tissue sarcomas. In 2013 more than 11,400 new cases were diagnosed in the U.S. and approximately 4,400 Americans died from this disease. In addition, approximately 40,000 new cases and 13,000 deaths in the U.S. and Europe are part of a growing underserved market.

About Aldoxorubicin

The widely used chemotherapeutic agent doxorubicin is delivered systemically and is highly toxic, which limits its dose to a level below its maximum therapeutic benefit. Doxorubicin also is associated with many side effects, especially the potential for damage to heart muscle at cumulative doses greater than 450 mg/m2. Aldoxorubicin combines doxorubicin with a novel single-molecule linker that binds directly and specifically to circulating albumin, the most plentiful protein in the bloodstream. Protein-hungry tumors concentrate albumin, thus increasing the delivery of the linker molecule with the attached doxorubicin to tumor sites. In the acidic environment of the tumor, but not the neutral environment of healthy tissues, doxorubicin is released. This allows for greater doses (3 ½ to 4 times) of doxorubicin to be administered while reducing its toxic side effects. In studies thus far there has been no evidence of clinically significant effects of aldoxorubicin on heart muscle, even at cumulative doses of drug well in excess of 2,000 mg/m2.