On October 5, 2015 CEL-SCI Corporation (NYSE MKT: CVM) ("CEL SCI" or the "Company") and its Clinical Research Organization (CRO) Ergomed plc (AIM: ERGO) reported that they have expanded their co-development agreement with increased activities to be undertaken by Ergomed (Press release, Cel-Sci, OCT 5, 2015, View Source [SID:1234507641]). Pursuant to the expanded co-development agreement, Ergomed’s contribution to the Phase 3 study will increase from $10,000,000 to $12,000,000. The companies are undertaking the Phase 3 trial of CEL-SCI’s investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) in patients with advanced primary 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!

Under the extended agreement, Ergomed will contribute up to $12,000,000 towards the cost of performing clinical services for the Phase 3 study in exchange for a single digit percentage of milestone and royalty payments, up to a specified maximum amount. Well over 500 patients have been enrolled in the world’s largest Phase 3 trial for head and neck cancer.

Ergomed CEO Miroslav Reljanovic stated, "At this point in the clinical trial we have decided to increase our investment in the development of Multikine, as we believe that it holds the potential to treat head and neck cancer in a new way. Our potential returns from this agreement will increase in line with our investment."

CEL-SCI CEO Geert Kersten added, "Working with a skilled CRO, our Phase 3 trial is making significant progress towards completing study enrollment goals. We are pleased to enter into this expanded co-development agreement with Ergomed. It further aligns Ergomed’s goals with CEL-SCI’s as Ergomed will be rewarded for its $12,000,000 co-development investment from the commercialization of the drug."

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 the 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.

On October 5, 2015 Argos Therapeutics Inc. (Nasdaq:ARGS) ("Argos"), an immuno-oncology company focused on the development and commercialization of fully individualized immunotherapies based on the Arcelis technology platform, reported the company will host a special briefing conference call focused on the current clinical research landscape in metastatic renal cell carcinoma (mRCC) (Press release, Argos Therapeutics, OCT 5, 2015, View Source [SID:1234507642]). The briefing will feature Dr. Charles Drake, co-director of the division of immunology, professor of medical oncology, immunology, and urology at the Johns Hopkins Sidney Kimmel Cancer Center. The conference call is scheduled for Wednesday, October 7, 2015 at 4:30pm ET.

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!

During the briefing, Dr. Drake will review data presented during the 40th Congress of the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) held September 25-29, 2015 in Vienna, Austria, and will discuss the implications for clinical research in mRCC moving forward.

In addition to the presentation by Dr. Drake, Dr. Charles Nicolette, Argos’ chief scientific officer and vice president of research and development, will also provide an update on the company’s lead product candidate, AGS-003, and the pivotal ADAPT phase 3 clinical trial for the treatment of mRCC.

To participate by telephone, please dial (855) 433-0930 (Domestic) or (484) 756-4271 (International). The conference ID number is 55129797. A live and archived audio webcast can be accessed through the Investors section of the Company’s website at www.argostherapeutics.com. The archived webcast will remain available on the Company’s website for fourteen (14) days following the call.

About the Arcelis Technology Platform

Arcelis is a fully individualized immunotherapy technology that captures mutated and variant antigens that are specific to each patient’s disease. It is designed to overcome immunosuppression by producing a durable memory T-cell response without adjuvants that may be associated with toxicity. The technology is potentially applicable to a wide range of different cancers, and is designed to overcome many of the manufacturing and commercialization challenges that have impeded other personalized cancer immunotherapies. The Arcelis process uses only a small tumor or blood sample and the patient’s own dendritic cells, which are optimized from cells collected by a single leukapheresis procedure. The proprietary process isolates RNA from the patient’s disease sample to program the optimized dendritic cells to present disease specific antigens to circulating T-cells in vivo. The antigen-loaded dendritic cells are also activated with CD40L, a critical co-stimulatory factor, then combined with the patient’s plasma and administered via intradermal injection, resulting in the activation, differentiation and proliferation of memory and tumor-specific killer T-cells. The high-yield process enables multiple doses to be created from a single patient cell collection.

On October 5, 2015 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported that there will be seven poster presentations featured at American Society for Human Genetics (ASHG) meeting being held Oct. 6 to 10, 2015 in Baltimore, Md (Press release, Myriad Genetics, OCT 5, 2015, View Source [SID:1234507643]).

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!

"At Myriad, we are passionately committed to providing the most accurate hereditary cancer tests through extensively validated laboratory and variant interpretation processes. We have spent almost two decades of research to provide the most sophisticated and comprehensive variant classification program," said Rick Wenstrup, M.D., chief medical officer, Myriad Genetics. "We look forward to presenting these seven new studies at ASH (Free ASH Whitepaper)G as we continue to advance the state-of-the-art in variant classification with innovative new approaches."

A list of the Myriad presentations at ASH (Free ASH Whitepaper)G (#ASHG15) follows:

Poster Presentations

Title: RNA functional studies for the classification of germline variants of uncertain significance that may impair splicing.
Date: Wednesday, Oct. 7, 2015: 5:00 to 6:00 p.m. ET.
Location: Poster 2639W.

Title: No evidence for a difference in the severity of cancer history for carriers of missense versus truncating pathogenic variants in ATM.
Date: Thursday, Oct. 8, 2015: 12:00 to 1:00 p.m. ET.
Location: Poster 2750T.

Title: Detection of large rearrangements in a pan-cancer gene panel using next generation sequencing.
Date: Thursday, Oct. 8, 2015: 12:00 to 1:00 p.m. ET.
Location: Poster 2018T.

Title: Comparison of a literature search algorithm and curated publication database with the literature content of other locus specific databases.
Date: Thursday, Oct. 8, 2015: 12:00 to 1:00 p.m. ET.
Location: Poster 1739T.

Title: Analytical validation of a saliva collection and DNA extraction protocol increases accessibility to hereditary pan-cancer panel testing.
Date: Thursday, Oct. 8, 2015: 12:00 to 1:00 p.m. ET.
Location: Poster 1985T.

Title: Identification of retrotransposon insertion mutations in hereditary cancer.
Date: Thursday, Oct. 8, 2015: 12:00 to 1:00 p.m. ET.
Location: Poster 2592T.

Title: Does this patient need to be tested for Lynch Syndrome? Assessing the reliability of family history for ascertainment.
Date: Friday, Oct. 9, 2015: 11:45 a.m. to 12:45 p.m. ET.
Location: Poster 2082F.
For more information about these presentations, including a complete list of abstracts and posters, please visit the ASH (Free ASH Whitepaper)G website at www.ashg.org/2015meeting/pages/online-planner.shtml.

On October 5, 2015 The U.S. Food and Drug Administration reported they approved an expanded indication for the Optune device to treat patients with newly-diagnosed glioblastoma multiforme (GBM), an aggressive form of brain cancer (Press release, , OCT 5, 2015, View Source [SID:1234507650]). It is given along with the chemotherapy drug temozolomide (TMZ) following standard treatments that include surgery, chemotherapy, and radiation therapy.

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!

Nearly 23,000 Americans will be diagnosed with brain or other nervous system cancers in 2015, according to the National Cancer Institute, and more than 15,000 will die from them. GBM accounts for about 15 percent of all brain tumors, and typically occurs in adults ages 45 to 70. Patients survive less than 15 months on average following diagnosis, because the tumor tends to be highly resistant to standard treatments.

"Patients newly diagnosed with this challenging and aggressive form of brain cancer now have another treatment option available," said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. "While the treatment is not a cure, it can increase survival by several months."

In the clinical study used to support the expanded indication, patients treated with the device and TMZ lived on average three months longer than those treated with the drug alone.

Optune was initially approved in 2011 to treat patients with GBM that recurred or progressed after chemotherapy. With this expanded indication, Optune can be used as part of a standard treatment for GBM before the disease progresses.

For newly diagnosed GBM, Optune is not intended to be used as a substitute for standard treatments, but rather as an adjunct therapy, and should not be used without a physician’s supervision.

When using Optune, a health care professional places electrodes on the surface of the patient’s scalp to deliver low-intensity, alternating electrical fields called "tumor treatment fields" (TTFields). The unique shape and special characteristics of rapidly dividing tumor cells make them susceptible to damage when exposed to TTFields, which could halt tumor growth.

The device is portable and can be powered with batteries or plugged into an electrical outlet. Patients can use the device at home or work, allowing them to continue their normal daily activities.

The FDA based its approval of the expanded indication of the Optune device on results from a clinical trial involving 695 patients newly diagnosed with GBM that compared those who used Optune with TMZ to those receiving TMZ alone. Patients who used the device along with TMZ lived, on average, about seven months with no disease progression compared to four months for those who had the drug alone. The Optune plus TMZ group survived for an average of 19.4 months after diagnosis compared to 16.6 months for those who were treated with only TMZ.

Optune for newly diagnosed GBM was reviewed under the FDA’s priority review program, which provides for an expedited review of certain devices that treat life-threatening conditions.

The most common side effect experienced with Optune was skin irritation. Clinical trial participants also experienced a slightly higher incidence of neurological side effects, including convulsions and headaches, compared to subjects receiving TMZ alone.

Patients should not use the Optune system if they have an active implanted medical device or a skull defect, have an underlying skin condition involving the scalp or have a known sensitivity to conductive hydrogels, such as those used on electrocardiogram stickers.

The Optune System is made by Novocure Inc. of Portsmouth, New Hampshire.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

On October 2, 2015 Incyte Corporation (Nasdaq:INCY) reported that new data from its investigational immuno-oncology portfolio will be presented at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 30th Anniversary Annual Meeting & Associated Programs, November 4–8, 2015 at the Gaylord National Resort & Convention Center in National Harbor, MD (Press release, Incyte, OCT 2, 2015, View Source;p=RssLanding&cat=news&id=2092622 [SID:1234507633]). Safety and efficacy data from a Phase 1/2 study evaluating epacadostat, Incyte’s selective IDO1 inhibitor, in combination with pembrolizumab, an anti-PD-1 therapy, will be presented as a late-breaking oral presentation. Additionally, data from INCB50465, Incyte’s selective PI3Kδ inhibitor, will be presented as a poster.

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!

"We are very pleased that data for both epacadostat and INCB50465 have been selected for presentation at the SITC (Free SITC Whitepaper) Annual Meeting next month," stated Hervé Hoppenot, President and Chief Executive Officer of Incyte. "We look forward to sharing the progress of our immuno-oncology portfolio, which reflects our commitment to developing new medicines that may improve the lives of patients with cancer."

Incyte abstracts to be presented at SITC (Free SITC Whitepaper) include:

Preliminary results from a phase 1/2 study of epacadostat (INCB024360) in combination with pembrolizumab in patients with selected advanced cancers (Abstract #142)

Friday, November 6, 2015, 12:00-12:15 PM EST
Maryland Ballroom
Pharmacological inactivation of PI3Kδ in the tumor microenvironment enhances efficacy of other immunotherapeutic agents (Poster #394)

Friday, November 6, 2015, 6:15–7:30 PM ET and Saturday, November 7, 2015,
12:45–2:00 PM EST
Prince George’s Exhibition Hall A
Full session details and data presentation listings for SITC (Free SITC Whitepaper) 2015 can be found at: View Source

About Epacadostat

Indoleamine 2,3-dioxygenase 1 (IDO1) is an immunosuppressive enzyme that has been shown to induce regulatory T cell generation and activation, and allow tumors to escape immune surveillance. Epacadostat is an orally bioavailable small molecule inhibitor of IDO1 that has nanomolar potency in both biochemical and cellular assays and has demonstrated potent activity in enhancing T lymphocyte, dendritic cell and natural killer cell responses in vitro, with a high degree of selectivity. Epacadostat has shown proof-of-concept clinical data in patients with unresectable or metastatic melanoma in combination with the CTLA-4 inhibitor ipilimumab, and is currently in four proof-of-concept clinical trials with PD-1 and PD-L1 immune checkpoint inhibitors in a variety of cancer histologies.

About Pembrolizumab

Pembrolizumab, marketed in the U.S. by Merck under the brand name KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2.