On December 11, 2015 CEL-SCI Corporation (NYSE MKT: CVM) ("CEL SCI" or the "Company") reported financial results today for the fiscal year ended September 30, 2015 (Press release, Cel-Sci, DEC 11, 2015, View Source [SID:1234508549]). The Company also reported key clinical and corporate developments achieved during and subsequent to fiscal 2015.

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!

Clinical and Corporate Developments Included:

CEL-SCI raised net proceeds of approximately $21.15 million during fiscal 2015 and an additional $10.6 million subsequent to the end of the fiscal year, to finance its expanding Phase 3 trial in the treatment of head and neck cancer.

During fiscal year 2015 we added 7 countries to our Phase 3 study and we enrolled another 304 patients in the study. This represented a 115% increase in enrollment over fiscal year 2014. We are continuing this trend in the first quarter fiscal 2016.
We had 2 very important corporate developments that suggest our Phase 3 trial is going well and that we have a strong case in our $50+ million arbitration against the former Clinical Research Organization ("CRO"):

In October 2015 Ergomed, the new CRO running our Phase 3 trial, added another $2 million to its existing $10 million investment in our Phase 3 clinical trial, for a total investment of $12 million. Ergomed will receive its funds back only from a successful drug.
Also in October 2015, we signed a funding agreement with Lake Whillans, a firm that specializes in litigation funding. Pursuant to the agreement, CEL-SCI will receive up to $5.0 million in funding for litigation expenses to support arbitration claims against the former CRO. This case is scheduled for "hearing" (trial) in the spring of 2016. Lake Whillans will get its funds back only from the proceeds derived from the arbitration. CEL-SCI now spends $0 on this arbitration.

CEL-SCI expanded the ongoing Phase 1 study with Multikine in HIV/HPV co-infected men and women by adding a another clinical site and a world renowned key opinion leader in the field. Dr. Joel Palefsky of the University of California, San Francisco (UCSF) joined the study in July 2015 as a Principal Investigator. The study is also being conducted under a Cooperative Research and Development Agreement (CRADA) with the U.S. Navy at the San Diego Naval Medical Center.

CEL-SCI reported an operating loss of ($34.30) million in fiscal year 2015 versus an operating loss of ($27.57) million in fiscal year 2014. Of the 2015 fiscal operating loss, the cash used by the company totaled $23.8 million. The legal expenses for the arbitration were $3.6 million and those expenses will not be repeated in 2016 since the company signed an agreement with the litigation funding firm Lake Whillans to fund any remaining arbitration legal fees. This will allow CEL-SCI to focus its expenditures on the Phase 3 trial.

CEL-SCI’s net loss available to common shareholders for the quarter ended June 30, 2015 was ($4,429,137) or ($0.05) per basic share, versus ($2,444,480) or ($0.04) per basic share during the quarter ended June 30, 2014. The net loss available to common shareholders for the nine months ended June 30, 2015 was ($24,830,691) or ($0.32) per basic share, versus ($21,261,925) or ($0.38) per basic share during the same nine months ended June 30, 2014. The increase in net loss for the three and nine month periods of 2015 as compared to the same periods in 2014 was primarily attributable to the increase in operating loss and the non-cash charge for the loss on a debt extinguishment off-set by the gain reported of the non-cash charge for the change in value of derivative instruments caused by a decrease in the Company’s common stock.

The rise in operating loss was largely attributable to an increase in research and development expenses to $20.95 million in fiscal year 2015 compared to $17.0 million in fiscal year 2014. This expense increased based on the additional activity level of the Phase 3 clinical trial, including more clinical centers joining the study and more patients enrolled.

Geert Kersten, CEL-SCI’s Chief Executive Officer said, "We are rapidly enrolling patients in our Phase 3 trial in head and neck cancer and the trial date for our arbitration is near. Both of these efforts are proceeding well, and we look forward to a positive 2016."

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.

(Filing, 10-K, Cel-Sci, DEC 11, 2015, View Source [SID:1234508540])

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!

On December 11, 2015 ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) reported that it will continue negotiations with the Economic Committee on Health Care Products in France regarding pricing and reimbursement for Iclusig (ponatinib) into 2016 (Press release, Ariad, DEC 11, 2015, View Source;p=RssLanding&cat=news&id=2121970 [SID:1234508534]). The Company had previously anticipated reaching agreement by year-end 2015. As a result, ARIAD now expects its global product revenue for Iclusig in 2015 to be $110 million to $115 million, excluding France, compared to our previous guidance of $130 million to $140 million. The Company estimates shipments of Iclusig to patients in France for 2015 to be approximately $9 million, and the cumulative value of shipments through year-end 2015 to be approximately $26 million.

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 pleased with the continued growth of our business in France as evidenced by increasing product shipments and look forward to successful resolution of price," stated Marty J. Duvall, executive vice president and chief commercial officer of ARIAD. "We continue to promote and sell Iclusig in France with the objective of helping patients and driving long-term brand value for key stakeholders."

ARIAD’s previously stated revenue guidance for 2015 assumed the completion of pricing and reimbursement negotiations in France by year-end. ARIAD will record revenue related to cumulative shipments in France upon completion of pricing and reimbursement negotiations, net of any amounts that will be refunded to the French health authorities as a result of these negotiations, which we now anticipate will be completed in 2016.

About Iclusig (ponatinib) tablets

Iclusig is a kinase inhibitor. The primary target for Iclusig is BCR-ABL, an abnormal tyrosine kinase that is expressed in chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Iclusig was designed using ARIAD’s computational and structure-based drug-design platform specifically to inhibit the activity of BCR-ABL. Iclusig targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs.

Iclusig is approved in the U.S., EU, Australia, Switzerland, Israel and Canada.

In the U.S., Iclusig is a kinase inhibitor indicated for the:

Treatment of adult patients with T315I-positive chronic myeloid leukemia (chronic phase, accelerated phase, or blast phase) or T315I-positive Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL).
Treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia or Ph+ ALL for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated.
These indications are based upon response rate. There are no trials verifying an improvement in disease-related symptoms or increased survival with Iclusig.

IMPORTANT SAFETY INFORMATION, INCLUDING THE BOXED WARNING

WARNING: VASCULAR OCCLUSION, HEART FAILURE, and HEPATOTOXICITY

See full prescribing information for complete boxed warning

Vascular Occlusion: Arterial and venous thrombosis and occlusions have occurred in at least 27% of Iclusig treated patients, including fatal myocardial infarction, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, and the need for urgent revascularization procedures. Patients with and without cardiovascular risk factors, including patients less than 50 years old, experienced these events. Monitor for evidence of thromboembolism and vascular occlusion. Interrupt or stop Iclusig immediately for vascular occlusion. A benefit risk consideration should guide a decision to restart Iclusig therapy.
Heart Failure, including fatalities, occurred in 8% of Iclusig-treated patients. Monitor cardiac function. Interrupt or stop Iclusig for new or worsening heart failure.

Hepatotoxicity, liver failure and death have occurred in Iclusig-treated patients. Monitor hepatic function. Interrupt Iclusig if hepatotoxicity is suspected.

Please see the full U.S. Prescribing Information for Iclusig, including the Boxed Warning, for additional important safety information.

About ARIAD

On December 11, 2015 CytomX Therapeutics, Inc. (Nasdaq:CTMX), a biopharmaceutical company developing investigational Probody therapeutics for the treatment of cancer, reported that it has selected its second clinical candidate from its Probody therapeutic pipeline (Press release, CytomX Therapeutics, DEC 11, 2015, View Source;p=irol-newsArticle&ID=2121979 [SID:1234511333]). The candidate, CX-2009, is a first-in-class Probody drug conjugate targeting CD166. CX-2009 utilizes ImmunoGen, Inc. conjugate technology.

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!

"CD166 is highly and homogeneously expressed in the majority of patients with a variety of solid tumors," said Michael Kavanaugh, M.D., chief scientific officer. "Despite high expression of CD166 in normal tissues, our Probody technology is designed to concentrate CX-2009 only in tumor tissue. As such, we believe that CX-2009 is uniquely positioned to deliver on the promise of CD166 as a target. We look forward to testing CX-2009 in patients and are on track to file the IND in 2017."

In October, CytomX researchers presented preclinical safety and efficacy data for the CD166 Probody drug conjugate program at the AACR (Free AACR Whitepaper)-NCI-EORTC International Conference on Molecular Targets. The data showed that CytomX’s CD166-directed Probody drug conjugates were efficacious in xenograft tumor models at doses equal to or below the predicted human dose. The therapeutics were also well-tolerated in preclinical studies at a dose predicted to be therapeutically relevant.

Therapeutics developed with CytomX’s Probody platform are designed to be active in the tumor while sparing healthy tissue. By restricting activity to the tumor microenvironment, Probody therapeutics directed against both validated and novel targets have been shown pre-clinically to enable anti-tumor efficacy with a significantly enhanced safety window, relative to traditional antibody-based therapies. CytomX’s preclinical pipeline of wholly-owned and partnered programs includes Probody cancer immunotherapies, Probody drug conjugates and T-cell engaging Probody bispecifics.

On December 11, 2015 Prima BioMed Ltd (ASX: PRR; NASDAQ: PBMD) reported important progress in its collaboration with NEC Corporation and Yamaguchi University in Japan (Filing, 6-K, Prima Biomed, DEC 11, 2015, View Source [SID:1234508536]). In this collaboration, first announced in May 2015, Prima’s IMP321 Antigen Presenting Cell activator (APC) is being combined with a therapeutic vaccine for different carcinoma types that was developed at Yamaguchi University.

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!

The Yamaguchi/Prima collaboration resulted from evidence that IMP321 at low doses can be used as a T cell adjuvant for cancer vaccines because of IMP321’s ability to activate dendritic cells1. Under the original May 2015 agreement, scientists at Yamaguchi University and NEC have designed and conducted in vivo studies of the combination, in work supported by NEC Corporation.
Favourable safety data from these studies has now resulted in a decision to progress the vaccine into clinical research. Under a new Material Transfer Agreement (MTA), Yamaguchi University will now work towards clinical research in cancer patients, which will be initiated in Japan in the first quarter of 2016. As with the in vivo work, this proof-of-concept research will be supported by NEC Corporation.

Marc Voigt, Chief Executive of Prima, welcomed the signing of the new MTA: "We are very pleased with the progress our collaborators at Yamaguchi University have made in just six months of work. We see significant upside from this work for cancer patients, given the current limited treatment options for many tumour types and the ease with which we think IMP321 can be used in combination with other therapies".

Yamaguchi University President Dr Masaaki Oka commented, "I am proud of our teams’ work in cancer vaccines, given the increasing importance of immuno-oncology to the future of cancer medicine. We thank Prima BioMed and NEC Corporation for their support and look forward to continued progress".

About IMP321
IMP321, a first-in-class Antigen Presenting Cell (APC) activator based on the immune checkpoint LAG-3, represents one of the first proposed active immunotherapy drugs in which the patient’s own immune system is harnessed to respond to tumour antigenic debris created by chemotherapy. As an APC activator IMP321 boosts the network of dendritic cells in the body that can respond to tumour antigens for a better anti-tumour CD8 T cell response. IMP321 has been shown in an open-label Phase I study to be able to double the expected six-month response rate in HER-2 negative metastatic breast cancer patients receiving standard-of-care paclitaxel, from a 25% historic response rate (RECIST criteria)2 to 50% when combined with IMP3213.