On March 27, 2017 Endocyte, Inc. (NASDAQ:ECYT), a leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy, reported that eight posters will be presented by Endocyte scientists at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2017 to be held in Washington, DC, April 1 – 5, 2017 (Press release, Endocyte, MAR 27, 2017, View Source [SID1234518281]).

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Key presentations during the meeting include a late-breaking poster presentation of new research from investigators and faculty at the Purdue University Center for Drug Discovery on the application of Endocyte’s SMDC technology in a chimeric antigen receptor (CAR) therapy setting. Additionally, the company will present several posters with preclinical data relating to Endocyte’s SMDC technology, including developments in combination therapies and novel proPBD warheads.

The presentation materials will be available on Endocyte’s website following presentation at the conference.

Presentations are as follows:

Abstract #: 2057
Title: Evaluation of anti-tumor efficacy of EC1456 in low-passage and pre-treated patient-derived xenograft models of triple-negative breast cancer
When: Monday, April 3, 1 p.m. – 5 p.m. CDT
Session Title: Drug Resistance: Other Topics
Location: Halls A-C, Poster Section 3


Abstract #: 2133
Title: Pre-clinical studies of EC2629, a highly potent FR targeted DNA crosslinking agent
When: Monday, April 3, 1 p.m. – 5 p.m. CDT
Session Title: New Targets 2
Location: Halls A-C, Poster Section 6


Abstract #: LB-187
Title: New methods for controlling CAR T-cell mediated cytokine storms
When: Tuesday, April 4, 8 a.m. – 12 p.m. CDT
Session Title: Late-Breaking Research: Immunology
Location: Poster Section 35


Abstract #: 3670
Title: Treatment of epithelial ovarian cancer with folate receptor (α/β) targeted chemotherapy is enhanced by CTLA-4 blockage: Learning from animal models
When: Tuesday, April 4, 8 a.m. – 12 p.m. CDT
Session Title: Dendritic Cells as Critical Immune Targets
Location: Halls A-C, Poster Section 27


Abstract #: 3228
Title: Development and characterization of in vitro assays to detect and quantitate tubulysin B hydrazide in biological samples
When: Tuesday, April 4, 8 a.m. – 12 p.m. CDT
Session Title: Novel Molecular Targets 2
Location: Halls A-C, Poster Section 8


Abstract #: 4017
Title: Development and application of an immunohistochemistry-based assay for evaluating functional and accessible folate receptor expression in vivo
When: Tuesday, April 4, 1 p.m. – 5 p.m. CDT
Session Title: Assay Technology
Location: Halls A-C, Poster Section 1


Abstract #: 4574
Title: Combinatorial strategies of folate receptor-targeted chemotherapy guided by improved understanding of tumor microenvironment and immunomodulation
When: Tuesday, April 4, 1 p.m. – 5 p.m. CDT
Session Title: Clinical Immunotherapy, Viruses, and bacteria
Location: Halls A-C, Poster Section 25


Abstract #: 5147
Title: Novel warheads for targeted therapies of cancer: The concept and design of proPBDs
When: Wednesday, April 5, 8 a.m. – 12 p.m. CDT
Session Title: Novel Drug Delivery Technology
Location: Halls A-C, Poster Section 5
About Endocyte’s SMDC Bi-Specific Adaptors

Endocyte’s SMDC bi-specific adaptors represent a novel approach that makes possible the engineering of a single universal CAR T-cell, designed to bind with high affinity to fluorescein isothiocyanate (FITC). This universal CAR T-cell can be specifically directed to cancer cells through the administration of a tumor targeted FITC-containing SMDC, known as a bi-specific adaptor that acts to bridge the universal CAR T-cell with the cancer cells to cause localized T-cell activation. This approach has been shown pre-clinically to address three key CAR T-cell issues by: (i) avoiding hyper-activation of CAR T-cells leading to a cytokine storm, (ii) enabling termination of CAR T-cell activity upon eradication of the tumor, and (iii) potentially enabling elimination of all cancer cells in heterogeneous solid tumors. In March 2017, Endocyte entered into a research collaboration with Seattle Children’s Research Institute and Dr. Michael Jensen for the development of Endocyte’s SMDC platform in the chimeric antigen receptor T-cell (CAR T-cell) immunotherapy setting through the use of Endocyte’s proprietary SMDC bi-specific adaptor molecules.

On March 27, 2017 Delcath Systems, Inc. (NASDAQ:DCTH), an interventional oncology Company focused on the treatment of primary and metastatic liver cancers, reported it has reached a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) for the design of Delcath’s pivotal trial of Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) to treat patients with intrahepatic cholangiocarcinoma (ICC) (Press release, Delcath Systems, MAR 27, 2017, View Source [SID1234518278]). The SPA agreement indicates that the pivotal trial design adequately addresses objectives that, if met, would support regulatory requirements for approval of Melphalan/HDS.

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The pivotal trial is titled "A Randomized, Controlled Study to Compare the Efficacy, Safety and Pharmacokinetics of Melphalan/HDS Treatment Given Sequentially Following Cisplatin/Gemcitabine versus Cisplatin/Gemcitabine (Standard of Care) in Patients with Intrahepatic Cholangiocarcinoma." Under the SPA, the study will enroll approximately 295 ICC patients at approximately 40 clinical sites in the U.S. and Europe. The primary endpoint is overall survival (OS) and secondary and exploratory endpoints include safety, progression-free survival (PFS), overall response rate (ORR) and quality-of-life measures. The Company expects to initiate the study in the Fall of 2017.

Full details of the registration trial will be made public upon the launch of the study and will be available at www.clinicaltrials.gov.

"We look forward to initiating this important study in ICC under a SPA with the FDA," said Jennifer K. Simpson, Ph.D., MSN, CRNP, President and Chief Executive Officer of Delcath. "The promising outcomes and observations in this tumor type identified by European investigators at our global Key Opinion Leader Forum last year were discussed at length with the agency, and provide us with considerable confidence in the potential of our therapy as a treatment for ICC. A manuscript of the European investigator data will be submitted to a peer-reviewed journal for publication."

"This pivotal study in ICC is designed to be cost effective and pursued in a financially prudent manner. Given the sequential nature of the trial design, Delcath’s investment in this study will be modest in 2017 as the Melphalan/HDS segment of the study will not occur until late in the year," added Dr. Simpson.

Separately, the Company announces that it intends to file financial results for the three and 12 months ending December 31, 2016 on Form 10-K with the U.S. Securities and Exchange Committee on or before March 30, 2017.

About Special Protocol Assessments
The Special Protocol Assessment (SPA) process is a procedure by which the FDA provides official evaluation and written guidance on the design and size of proposed protocols that are intended to form the basis for a new drug application. Final marketing approval depends on the results of efficacy, the adverse event profile and an evaluation of the benefit/risk of treatment demonstrated in the Phase 3 clinical program. The SPA agreement may only be changed through a written agreement between the sponsor and the FDA, or if the FDA becomes aware of a substantial scientific issue essential to product efficacy or safety.

About Intrahepatic Cholangiocarcinoma
Intrahepatic cholangiocarcinoma is the second most common primary liver tumor and represents approximately 10-20% of new hepatocellular carcinoma (primary liver cancer or HCC) cases diagnosed annually, or approximately 3,100 new cases every year in the U.S.1 Surgical resection, the standard of care, is not possible for an estimated 80% to 90% of patients diagnosed with ICC.

On March 27, 2017 ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company focused on new immunotherapies, reported the receipt of positive guidance from an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for its lead gene therapy product candidate, Ad-RTS-hIL-12 plus orally administered veledimex (V), to harness and control IL-12 production for the investigational treatment of recurrent glioblastoma (GBM), an aggressive form of brain cancer with few treatment options (Press release, Ziopharm, MAR 27, 2017, View Source [SID1234518275]).

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"We are pleased with our productive interactions with the FDA and the valuable direction we received at the End-of-Phase 2 meeting. Our controlled approach utilizing the RheoSwitch platform represents the next-generation of gene therapy enabling IL-12 to be regulated through a transcriptional switch. We appreciate the FDA’s feedback surrounding our plans to advance Ad-RTS-hIL-12-based therapy to a pivotal registration study for patients with recurrent GBM in 2017 and look forward to establishing the benefits of this novel therapeutic approach," said Laurence Cooper, M.D., Ph.D., Chief Executive Officer of ZIOPHARM.

"The median overall survival remains very promising and continues to be greater than 12 months for these heavily compromised patients," said Francois Lebel, M.D., Chief Medical Officer of ZIOPHARM. He added, "After positive meetings with both FDA and European regulators, the Company is working towards finalization of the optimal pathway for our pivotal trial for Ad-RTS-hIL-12 + veledimex."

In collaboration with its investigators and regulators, the Company is currently assessing its protocol design options for the pivotal trial, including the potential for a single-arm study comparing Ad-RTS-hIL-12 + V to historical controls in a subpopulation of patients with recurrent GBM. Details of the pivotal Phase 3 trial will be made available following evaluation and completion of discussions with clinical advisors as well as regulators.

About Glioblastoma:
GBM represents approximately 15% of all primary brain tumors and remains a high unmet clinical need that affects roughly 74,000 people worldwide annually. GBM is an aggressive form of brain cancer with recurrence rates near 90%, and prognosis for patients is poor with treatment often combining multiple approaches including surgery, radiation, and chemotherapy. Median overall survival (OS) is only 6 to 7 months in patients who have experienced multiple recurrences, and the prognosis is even poorer for patients who have failed temozolomide and bevacizumab, or equivalent salvage chemotherapy with a median OS of approximately 3 to 5 months.

On March 27, 2017 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, reported that AGI-134, an immunotherapy for the treatment of multiple cancers, obtained through its recently announced acquisition of Agalimmune Ltd., will be featured at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Washington, DC to be held on April 1-5, 2017 (Filing, 6-K, BioLineRx, MAR 27, 2017, View Source [SID1234518274]).

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An abstract titled "The novel α-Gal-based immunotherapy AGI-134 invokes CD8+ T cell-mediated immunity by driving tumor cell destruction, phagocytosis and tumor-associated antigen cross-presentation via multiple antibody-mediated effector functions" was accepted for a poster presentation at the T-Cell Immunity to Cancer: New Progress session on April 2nd, 2017.

About AGI-134
AGI-134 is a synthetic alpha-Gal immunotherapy in development for solid tumors. AGI-134 harnesses the body’s pre-existing, highly abundant anti-alpha-Gal antibodies to induce a systemic, specific anti-tumor response to the patient’s own tumor neo-antigens. This response not only kills the tumor cells at the site of injection, but also brings about a durable, follow-on, anti-metastatic immune response. AGI-134 has completed numerous pre-clinical studies, demonstrating robust protection against the development of secondary tumors in a model of melanoma with a single dose only. Synergy has also been demonstrated in additional pre-clinical studies when combined with a PD-1 immune checkpoint inhibitor, offering the potential to broaden the utility of such immunotherapies, and improve the rate and duration of responses in multiple cancer types. AGI-134 is in near-clinical development and is expected to commence a first-in-man study in patients with solid tumors in the first half of 2018.