On January 22, 2018 SillaJen, Inc., (KOSDAQ:215600), a clinical-stage, biotherapeutics company focused on the development of oncolytic immunotherapy products for cancer, and ABL Europe, an ABL, Inc. company providing dedicated viral vector GMP services for gene therapy, oncolytic products and vaccines for all stages of clinical supply, reported that thay have expanded their strategic manufacturing collaboration (Press release, Advanced BioScience Laboratories, JAN 22, 2018, View Source [SID1234565002]). Under the current agreement, ABL is currently manufacturing Pexa-Vec (formerly JX-594) for SillaJen’s multinational, randomized Phase 3, open-label study of Pexa-Vec in patients with advanced liver cancer. Under the expanded agreement, ABL will also provide development, manufacturing & QC release testing services for SillaJen’s pipeline product, JX-970.

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"Based on SillaJen’s established partnership with ABL, we are pleased to further expand our agreement to include another exciting product in our pipeline," stated Georg Roth, Ph.D, Senior Vice President, Technical Operations at SillaJen. "ABL has significant experience in virus manufacturing, and we are glad to be able to utilize their expertise in order to continue to expedite the development of these important oncolytic virus therapies."

"We are excited about the significant potential of SillaJen’s oncolytic immunotherapy products and are pleased to further expand our agreement with an additional product," stated Patrick Mahieux, Ph.D., General Manager of ABL Europe. "Our primary focus is ultimately to safely help patients in need, and so we look forward to applying our twenty-plus years of experience in virus manufacturing to these exciting oncolytic products."

Pexa-Vec Clinical Development Program and SOLVE Platform
Pexa-Vec is the most advanced product candidate from SillaJen’s proprietary SOLVE (Selective Oncolytic Vaccinia Engineering) platform. The vaccinia strain backbone of Pexa-Vec has been used safely in millions of people as part of a worldwide vaccination program. This strain naturally targets cancer cells due to common genetic defects in cancer cells; Pexa-Vec was engineered to enhance this by deleting its thymidine kinase (TK) gene, thus making it dependent on the cellular TK expressed at persistently high levels in cancer cells. Pexa-Vec is also engineered to express the immunogenic GM-CSF protein. GM-CSF complements the cancer cell lysis of the product candidate, leading to a cascade of events resulting in tumor necrosis, tumor vasculature shutdown and sustained anti-tumoral immune attack.

The ongoing Phase 3 study, named the PHOCUS trial, is designed to enroll 600 patients who have not received prior systemic treatment for their cancer. To learn more about the trial, please visit: View Source

About JX-970
JX-970 is an oncolytic virus that is derived from a Western Reserve strain vaccinia virus, and its tumor selectivity has been optimized through deletion of thymidine kinase (TK) and vaccinia growth factor (VGF). In addition, it expresses GM-CSF to stimulate immune responses. In nonclinical studies, the JX-970 backbone exerted a tumor debulking effect and at the same time demonstrated a selective preference for tumor tissues.

On January 22, 2018 Redx Pharma Plc (LON:REDX) reported that it has appointed a chief medical officer ahead of the imminent launch of phase I clinical trials of its lead drug (Press release, Redx Pharma, JAN 22, 2018, View Source [SID1234524742]).

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Dr Andrew Saunders has 25 years in the cancer field and was recruited from Lytix Biopharma, a Norwegian immuno-oncology firm, where he held the same role.

He will work with the research and development team at Redx, "fronting" the clinical development of RXC004.

This is a potentially potent small molecule drug called a porcupine inhibitor that targets Wnt pathway.

Chairman Iain Ross said he was "very pleased" to announce Saunders’ appointment.

"He brings to the company a wealth of relevant experience and expertise in the clinical development of oncology drugs," Ross explained.

"This will be invaluable as the company transforms into a clinical stage company with the anticipated commencement of the first phase I study on lead compound RXC004 in the coming weeks.

"We are very excited by the potential of RXC004 to make a major difference in cancer treatment.

"We intend to progress RXC004 in the clinic both as a monotherapy and in combination with a checkpoint inhibitor. Therefore, we envisage that Andrew’s recent experience in immuno-oncology combination trials will be particularly pertinent to the design and execution of future clinical trials with RXC004."

Porcupine inhibitors such as RXC004 are a new and potentially breakthrough method of fighting the killer disease.

They work by targeting cancer stems cells that can often lie dormant after traditional treatment and are associated with a recurrence of the illness. Kill the stem cells and you have a chance of eradicating the disease completely.

Clinical trials of the new Redx drug commence in the "coming weeks".

On January 22, 2018 Enzo Biochem, Inc. (NYSE:ENZ), an integrated diagnostics company, reported validation of a cervical cancer biomarker detection test that provides a highly robust and cost-efficient solution for anatomical pathology (Press release, Enzo Biochem, JAN 22, 2018, View Source [SID1234523414]).

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Specifically, Enzo’s validated p16, a marker used extensively as a key diagnostic and prognostic biomarker of several cancers, is the latest addition to the company’s growing immunohistochemistry pipeline, including, among others, Ki-67, Her2 and p53.

Enzo’s validated p16 provides clear detection of tissue abnormalities in the field of cancer diagnostics, including cervical cancer’s progression. It complements the company’s POLYVIEW immunochemistry detection, the recent subject of a favorable article in the prestigious peer-reviewed Annals of Diagnostic Pathology. The article cited POLYVIEW as having no false-positives in tests unlike some of the leading products in the field, which were found to have large percentages of false-positives that could lead to unnecessary, costly and time-consuming interventions.

With current mounting cost and reimbursement pressures, Enzo’s new p16 test provides a highly cost-effective alternative. Other p16 tests on the market have of late become unaffordable as a result of increasing reagent costs outweighing average reimbursements. When p16 is used in combination with Enzo’s POLYVIEW detection system’s reduction of false-positives, the economics are substantially enhanced. This and other similar compounds comprise a $200 million market.

In an era of high product costs and shrinking reimbursements, Enzo has positioned itself as a growing provider of high quality, cost-effective tests that provide value in bolstering diagnostics profit margins.

"We launched our immunohistochemistry tests in response to market leaders raising prices," said Elazar Rabbani, Ph.D., Enzo CEO and Chairman. "By developing our own p16, Ki-67, and p53 tests, among others, and the fact that we have a truly unique integrated capability to develop, evaluate and manufacture these and other diagnostics, we believe we can alleviate pressure on clinical labs by providing low cost, clinically relevant products and services, which is what we are engaged in doing."

The expanded Anatomical Pathology global program at Enzo offers cost-effective clinically relevant solutions, enhances Enzo’s ongoing collaborations with clinical partners, and expands the company’s clinical and reference services nationwide. This complements Enzo’s long standing position within the women’s health field with a focus on cervical cancer testing dating back to the launch of the first in situ HPV cervical cancer detection system in the early 1980’s. In addition to these products, Enzo’s portfolio includes a line of assays for identification of women’s health infectious diseases as well as for the quantification of viral load in serum or plasma specimens.

On January 21, 2018 Laminar Pharma, a pioneering clinical stage biopharmaceutical company developing a new generation of products modulating metabolism of membrane lipids based on the groundbreaking MLT platform, reported that the European Commission has awarded a 6,15M€ grant to the CLINGLIO consortium, lead by Laminar Pharma, to execute the project entitled "A Clinical Phase IIB trial with 2OHOA in patients with newly-diagnosed malignant glioma" (Press release, Laminar Pharma, JAN 21, 2018, View Source [SID1234562095]).

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The CLINGLIO project was evaluated as a Research and Innovation Action (RIA) within the call H2020-SC1-2017-Two-Stage-RTD, Topic SC1-PM-08-2017 (New therapies for rare diseases), part of the Health, Demographic Change and Well-being Work Programme of the H2020. Total budget available for this H2020-SC1-2017-Two-Stage-RTD call was 173M€, of which 65M€ were assigned to topic SC1-PM-08-2017. Overall, 668 proposals were submitted to this call, of which 37 were pre-selected for funding across the four topics of the call (5,5% of the initial proposals). In the New Therapies for Rare Diseases topic, the EC will select for funding up to 11 proposals with an average budget per project of around 6M€.

The grant has been awarded to a multinational, well balanced consortium formed by 5 leading clinical research institutions in the UK (Royal Marsden Hospital and Northern Institute for Cancer Research, University ofNewcastle upon Tyne), France (Institut Gustave Roussy), Italy (Istituto Neurologico Carlo Besta) and Israel (Hadassah Medical Organization), two universities in Spain (Universitat de les Illes Balears, UIB) and Italy (Universita degli Studi di Salerno) and 4 specialized SMEs from The Netherlands (SMS Oncology, clinical CRO), Hungary (Lipodom Kft, lipidomic analysis), USA (LMBRI, pharmacoeconomics and market access) and Spain (Praxis Pharmaceutical, Drug product manufacturing and commercialization, and Laminar Pharma, coordinator and sponsor of the clinical trial).

The main objective of the CLINGLIO project is to execute a randomised, double-blind, placebo-controlled adjuvant trial in primary newly diagnosed glioblastoma patients to assess the efficacy and safety of 2OHOA in combination with radiotherapy and temozolomide. This study is a phase IIB adaptive trial with interim dose selection, sample size reassessment and biomarker threshold/omics signature determination. It is anticipated that around 15 clinical research hospitals across Europe and Israel will recruit 150 patients in the first part of the study, distributed in three arms: 1) control, with Standard of Care (SoC) plus placebo, 2) SoC plus 2OHOA "low dose" and 3) SoC plus 2OHOA "high dose". An interim analysis will take place after 75 events (Disease Progression) occurs and depending on the results of this interim analysis 60 to 120 additional patients will be enrolled in the second part of the study. The primary endpoint will be Progression Free Survival, according to RANO criteria, and Overall Survival will be a key secondary endpoint.

If the results of this clinical trial are positive, Laminar Pharma plans to apply for a conditional approval of 2OHOA in Europe for the treatment of newly diagnosed GBM patients, in combination with radiotherapy and temozolomide

On January 21, 2018 SymBio Pharmaceuticals Limited (Headquarters: Tokyo, "SymBio") (JASDAQ: 4582) reported that it has initiated a Phase 1 study in Japan for oral TREAKISYM in patients with progressive solid tumors (Press release, SymBio Pharmaceuticals, JAN 21, 2018, View Source [SID1234523465]).

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SymBio holds approval for TREAKISYM injectables which are already used for the treatment of three indications of malignant lymphoma (first-line and relapsed/refractory low-grade B-cell non-Hodgkin’s lymphoma and mantle cell lymphoma, and chronic lymphocytic leukemia). The purpose of the Phase 1 study is to evaluate the recommended dose, dosage regimen, the tolerability1 and the safety of oral TREAKISYM, as it is a new formulation, and to identify types of solid tumors that show promise for treatment.

Based on the efficacy and safety data related to TREAKISYM injectables that were demonstrated in the treatment of malignant lymphoma, the purpose of this study is also to provide a new treatment option for patients by developing the new oral formulation leveraging superior traits and fewer adverse events, including alopecia, compared with existing chemo therapy. Furthermore, SymBio will evaluate safer dosage regimes with no adverse effect on efficacy by leveraging the pharmacokinetic traits of the oral formulation, specifically, lowering Cmax and administration in lower doses during the treatment period. Oral formulation drugs can also be taken at home, eliminating the need for the patient to visit the hospital for intravenous infusion and reducing the treatment burden on the patient.

The development of oral TREAKISYM is part of SymBio’s strategy to develop a "TREAKISYM platform." For TREAKISYM injectables, the Phase III study for the indication of relapsed/refractory diffuse large B-cell lymphoma is underway. Although DLBCL accounts for the largest segment of malignant lymphoma in terms of patient numbers, currently only multiple drug therapies are available for r/r DLBCL. In addition, SymBio is deploying a sustainable growth strategy and will maximize the value of TREAKISYM by significantly extending the product life through the development of TREAKISYM liquid formulations (TREAKISYM Ready-to-dilute and TREAKISYM Rapid Infusion).2

1. Tolerability refers to the degree to which overt adverse effects of a drug can be tolerated by a human subject.
2. Please see SymBio’s press release of September 21, 2017: "Eagle Pharmaceuticals Licenses Japanese Rights for Bendamustine Hydrochloride Ready-to-dilute and Rapid Infusion Injection Products to SymBio Pharmaceuticals Limited."

About TREAKISYM

TREAKISYM (non-proprietary name: bendamustine hydrochloride), a cytocide anti-cancer drug first used in Germany in the 1970s, is now widely used in more than 50 countries with indications for low-grade non-Hodgkin’s lymphoma, mantle cell lymphoma, and chronic lymphocytic leukemia.

Bendamustine is a unique compound having chemical properties of both an alkylating agent3 and a metabolic antagonist4, and a mode of action different from other anti-cancer drugs. It is expected that bendamustine, given its unique properties, could be effective for the treatment of solid tumors as well as malignant lymphoma. A number of clinical studies of bendamustine injectables have been conducted outside of Japan to explore this potential, with clinical efficacy reported for certain solid tumors, including breast cancer, small-cell lung cancer, and soft tissue sarcoma. Furthermore, clinical studies of oral bendamustine for multiple myeloma, low-grade non-Hodgkin’s lymphoma, and chronic lymphocytic leukemia have indicated favorable results with respect to both safety and tolerability3 of oral formulation.

TREAKISYM Intravenous Infusion 100 mg was approved in October, 2010 for manufacturing and marketing for the indication of relapsed/refractory low-grade B-cell non-Hodgkin’s lymphoma and mantle cell lymphoma in Japan.
TREAKISYM was approved for the additional indication of chronic lymphocytic leukemia in Japan in August, 2016.
TREAKISYM Intravenous Infusion 25 mg, a standard low-dose product, was approved for manufacturing and marketing in Japan in September, 2016.
TREAKISYM was approved for the additional indication of first-line treatment of low-grade B-cell non-Hodgkin’s lymphoma and mantle cell lymphoma in Japan in December, 2016.
TREAKISYM has been marketed through Eisai Co., Ltd. since December, 2010.

3. An alkylating agent is a type of cytotoxic anti-cancer drug. Alkylating agents inhibit DNA replication by attaching alkyl group sites to the DNA chain.
4. A metabolic antagonist is a type of cytotoxic anti-cancer drug. Metabolic antagonists prevent DNA replication and the growth and division of tumor cells by interfering with the utilization of substances produced in the metabolic process.