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Delcath Announces First Patient Treated In ICC Cohort Of Global Phase 2 HCC Trial Program

On October 15, 2015 Delcath Systems, Inc. (NASDAQ: DCTH), a specialty pharmaceutical and medical device company focused on oncology with an emphasis on the treatment of primary and metastatic liver cancers, reported that the first treatment with the Delcath Hepatic CHEMOSAT Delivery System for Melphalan (CHEMOSAT) has been performed in the intrahepatic cholangiocarcinoma (ICC) cohort of the Company’s global Phase 2 clinical trial program for treatment of patients with unresectable hepatocellular carcinoma (primary liver cancer or HCC) and ICC (Press release, Delcath Systems, OCT 15, 2015, View Source;p=RssLanding&cat=news&id=2097545 [SID:1234507719]). A team led by Prof. Thomas J. Vogl, M.D., Director of the Institute for Diagnostic and Interventional Radiology of Johannes Wolfgang Goethe University Hospital, Frankfurt, Germany, treated its first patient on October 13, 2015.

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ICC is a tumor in the bile duct that arises within the liver. It is the second most common primary liver tumor and represents approximately 15% of new HCC cases diagnosed annually. Surgical resection, the standard of care, is not possible for an estimated 80% to 90% of patients diagnosed with ICC.

The ICC cohort of the Phase 2 program is designed to investigate the efficacy and safety of CHEMOSAT treatment in patients with unresectable ICC confined to the liver. The study is being conducted at the same hospitals in Europe participating in the Company’s Phase 2 HCC trial. The global Phase 2 HCC/ICC program is evaluating tumor response (objective response rate) as measured by modified Response Evaluation Criteria in Solid Tumor (mRECIST), and will assess progression-free survival and safety. Additional analyses will be conducted to characterize the systemic exposure of melphalan administered by CHEMOSAT, as well as to assess patient-reported clinical outcomes, or quality-of-life.

"Our team has been involved with CHEMOSAT since February 2012," said Prof. Vogl. "The results we’ve seen in a non-clinical setting certainly warrant formal investigation of this therapy’s potential in cancers like HCC and ICC, and we’re pleased to be working with our colleagues at major European cancer centers on the Delcath global Phase 2 HCC/ICC program."

"ICC patients currently face limited treatment options," said Jennifer K. Simpson, Ph.D., MSN, CRNP, President and CEO of Delcath Systems. "We believe that a positive efficacy signal in this tumor type and good safety profile may support a regulatory path to a U.S. registration trial, and that consolidated safety data from the HCC and ICC cohorts of this global Phase 2 trial will be valuable information for us to provide to the FDA."

ABLYNX ACHIEVES FIRST MILESTONE IN IMMUNO-ONCOLOGY COLLABORATION WITH MERCK & CO., INC.

On October 15, 2015 Ablynx [Euronext Brussels: ABLX; OTC: ABYLY] reported that it has achieved pre-clinical proof-of-concept with a Nanobody construct as part of its immuno-oncology collaboration with Merck & Co., Inc. ("Merck") [known as MSD outside the United States and Canada], triggering a €3.5 million milestone payment to Ablynx (Press release, Ablynx, OCT 15, 2015, View Source [SID:1234507728]). This collaboration with Merck includes the discovery and development of up to 17 Nanobody programmes against individual protein targets and target combinations (mono-specific and multi-specific Nanobodies) for application in immuno-oncology indications.

This Nanobody construct is a selective bi-specific molecule that potently binds to two different immune modulators, proteins believed to be targets for the development of important cancer immunotherapies.

The results from the pre-clinical study in relevant tumour models demonstrated that this bi-specific Nanobody construct potently inhibits tumour growth.

Dr Edwin Moses, CEO of Ablynx, commented:
"Combination therapies are the next generation in immuno-oncology and this is where our Nanobody technology offers major advantages. In particular, the ability to rapidly produce single constructs which can bind to multiple target combinations is a very powerful characteristic of our Nanobody platform. It is a very significant achievement to have already reached our first pre-clinical milestone just 20 months after the start of our collaboration with Merck. We look forward to further advancing programmes within this collaboration to potentially develop drugs which could transform the treatment of many cancers and the lives of patients."

Generex Announces Memorandum of Understanding in respect of a Phase II Clinical Trial for the Antigen Express Prostate Cancer Vaccine

On October 15, 2015 Generex Biotechnology Corporation (www.generex.com) (OTCQB: GNBT) reported that its wholly-owned immunotherapeutics subsidiary, Antigen Express, Inc. (www.antigenexpress.com), has entered into a Memorandum of Understanding with CompanDX Ltd to conduct a Phase II clinical trial of the Antigen Express proprietary prostate cancer vaccine (Press release, Generex, OCT 15, 2015, View Source [SID:1234507726]). CompanDX is located in the BioCity business incubator (www.biocity.co.uk) in Nottingham, England.

A number of studies conducted by Antigen Express on its AE37 immunotherapeutic cancer vaccine have shown promising results. Long term follow up of a Phase I study in prostate cancer patients showed that a robust, target-specific immune response persisted in patients for at least three years following treatment. A Phase II study in early stage breast cancer patients showed encouraging results in terms of disease-free survival, particularly in patients who were not eligible for treatment with Herceptin.

CompanDX has established expertise in the biological monitoring of patients and personalized medicine. The importance of monitoring and biomarker identification is paramount in the emerging field of cancer immunotherapy. CompanDX has established a subsidiary, TumourVac, Ltd., for the administration of the Phase II AE37 prostate cancer study.

Antigen Express has developed technology for the specific and robust activation of critical T cell subsets important in generating an anti-cancer immune response. While checkpoint inhibitors have shown great success in treating 20% to 30% of patients with various cancers, it is likely that many of those not responding do not have sufficiently activated T cells to take advantage of the immunosuppression afforded by checkpoint inhibitors and kill tumor cells. The collaboration will yield critical information on the optimization of cancer immunotherapy while advancing the clinical development of AE37.

Under the terms of the Memorandum agreement, milestone payments and royalties will be paid to Antigen Express in exchange for the rights to AE37 for the treatment of prostate cancer.

ArQule Announces Publication of Manuscript Highlighting Activity of AKT Inhibitor ARQ 092 and Next Generation AKT Inhibitor ARQ 751 in Oncology

On October 15, 2015 ArQule, Inc. (NASDAQ:ARQL) reported the publication of a paper detailing the pre-clinical profile of ARQ 092 and ARQ 751, orally available selective pan-AKT inhibitors (Press release, ArQule, OCT 15, 2015, View Source [SID:1234507724]). The findings, published on-line by PLOS ONE, View Source, demonstrate that ARQ 092 and ARQ 751 potently and selectively inhibit both the active and inactive forms of AKT.

Both ARQ 092 and ARQ 751 demonstrated signal abrogation and efficacy in pre-clinical in vitro and in vivo models harboring AKT1 and PI3K mutations. These data support the clinical advancement of ARQ 092 in a biomarker enriched population, and the filing of an investigational new drug (IND) application for ARQ 751 as a next generation AKT inhibitor.

“These data strongly support the current phase 1b biomarker-driven trial we are conducting with ARQ 092 in oncology,” said Brian Schwartz, M.D., Head of Research and Development and Chief Medical Officer at ArQule. “Preliminary evidence of clinical efficacy was recently presented at ESMO (Free ESMO Whitepaper), where we highlighted four partial responses out of 25 patients from our on-going phase 1b trial, in follicular lymphoma (AKT1 E17K mutation), breast cancer (AKT1 E17K mutation) and endometrial cancer (PIK3CA H1047R mutation), validating the pre-clinical hypothesis generated in this publication.”

ArQule continues to enroll patients in the phase 1b study for ARQ 092 in oncology and expects to file an IND application for ARQ 751 by the end of 2015.

About ARQ 092 and the AKT Pathway

ARQ 092 is an orally available, selective small molecule inhibitor of the AKT kinase. The AKT pathway when abnormally activated is implicated in multiple oncogenic processes such as cell proliferation and apoptosis. This pathway has emerged as a target of potential therapeutic relevance for compounds that inhibit its activity, which has been linked to a variety of cancers as well as to select non-oncology indications.

ARQ 092, the lead compound in ArQule’s AKT program, has completed Phase 1a clinical testing and has advanced into Phase 1b expansion testing in cohorts of patients with endometrial cancer, lymphoma and tumors harboring either AKT or PI3K mutations. A number of next-generation compounds in the Company’s AKT program are in early to late stages of pre-clinical development.

Kite Pharma Receives Positive Opinions for Orphan Drug Designation in the European Union (EU) for KTE-C19 in Three Additional Hematological Indications

On October 15, 2015 Kite Pharma, Inc. (Nasdaq:KITE), a clinical-stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT) products for the treatment of cancer, reported that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has adopted positive opinions recommending KTE-C19 for designation as an orphan medicinal product for the treatment of ALL, CLL/SLL, and FL. KTE-C19 is an investigational therapy in which a patient’s T cells are genetically modified to express a chimeric antigen receptor (CAR) designed to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias (Press release, Kite Pharma, OCT 15, 2015, View Source [SID:1234507720]).

Kite previously received orphan drug designation for KTE‑C19 for the treatment of diffuse large B‑cell lymphoma (DLBCL) in both the US and the EU, as well as COMP positive opinions for orphan drug designation in the EU for primary mediastinal B-cell lymphoma (PMBCL) and mantle cell lymphoma (MCL).

"The orphan drug designation is an important regulatory milestone as we further our development of KTE-C19 in advanced hematological cancers, where there are limited treatment options," said Arie Belldegrun, M.D., FACS, Chairman, President, and Chief Executive Officer. "We are excited by the progress of our ongoing Phase 1/2 clinical trial (ZUMA-1) of KTE-C19 in patients with refractory, aggressive non-Hodgkin lymphoma, including DLBCL, PMBCL and transformed follicular lymphoma (TFL), for which we anticipate presenting top-line Phase 1 data later this year."

The COMP adopts an opinion on the granting of orphan drug designation, after which the opinion is submitted to the European Commission (EC) for endorsement of the opinion. Orphan drug designation by the EC provides regulatory and financial incentives for companies to develop and market therapies that treat a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the EU, and where no satisfactory treatment is available. In addition to a 10-year period of marketing exclusivity in the EU after product approval, orphan drug designation provides incentives for companies seeking protocol assistance from the EMA during the product development phase, and direct access to the centralized authorization procedure.