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BioSpecifics Technologies Corp. to Present at the NobleCon14 Conference

On January 22, 2018 BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company that originated and continues to develop collagenase based-therapies with a first in class collagenase-based product marketed as XIAFLEX in the U.S. and Xiapex in Europe, reported that BioSpecifics’ President, Tom Wegman, will present a corporate overview at the upcoming at NobleCon14 – Noble Capital Markets’ Fourteenth Annual Investor Conference in Fort Lauderdale, Florida on Monday, January 29th at 2:00pm E.T (Press release, BioSpecifics Technologies, JAN 22, 2018, View Source [SID1234523409]).

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A live webcast of the presentation can be accessed under "Events and Presentation" in the Investors section of the Company’s website at www.biospecifics.com or at View Source

Altimmune to Participate at the Noble Capital 14th Annual Investor Conference

On January 22, 2018 Altimmune, Inc. (Nasdaq:ALT), a clinical-stage immunotherapeutics company, reported that Bill Enright, President and Chief Executive Officer, will provide a corporate overview at NobleCon14 – Noble Capital Markets’ Fourteenth Annual Investor Conference, being held January 29-30, 2018 at the W Hotel, Fort Lauderdale, Florida (Press release, Altimmune, JAN 22, 2018, View Source [SID1234523403]).

14th Annual Investor Conference Presentation Details
Date: Tuesday, January 30, 2018
Time: 2:30pm Eastern Time
Location: W Hotel, Ft. Lauderdale, Florida, Studio 2
Webcast: View Source
A high-definition, video webcast of the presentation will be available the following day on the Company’s web site www.altimmune.com and as part of a complete catalog of presentations available at Noble Capital Markets’ websites: www.noblecapitalmarkets.com, and www.nobleconference.com. You will require a Microsoft SilverLight viewer (a free download from the presentation link) to participate. The webcast and presentation will be archived on the company’s website and on the Noble websites for 90 days following the event.

Laminar Pharma awarded a 6,15M€ grant by the H2020 Programme to conduct a PIIb trial with 2OHOA in patients with newly-diagnosed glioblastoma

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]).

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

Initiation of Phase I Clinical Trial for Oral TREAKISYM® in Progressive Solid Tumors

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]).

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.

http://www.bivictrix.com/#news

On January 20, 2017 BiVictriX Therapeutics ("BVX") has reported the completion of a successful fundraise to develop a new class of targeted cancer drugs (Press release, BiVictriX Therapeutics, JAN 20, 2018, View Source [SID1234526189]). The company’s ‘Dual Targeting Approach’ is designed to give superior selectivity towards blood cancers.

Approximately £0.5m has been raised from a syndicate comprising Alderley Park Ventures, Finance Wales and high net worth individuals;

Funds to be used to establish Proof of Principle on the Company’s technology in two lead programmes;

Acceleris Capital Ltd (Manchester UK) provided corporate finance advice to the Company.

Founded in 2016 by serial life sciences entrepreneur Dr Peter Jackson and BVX CEO Tiffany Thorn, the company is focused on developing and licensing novel Antibody Drug Conjugates ("ADCs"), which have been coined as the new ‘Magic Bullet’ therapeutics in the field of oncology. The Company has developed a novel strategy, ‘The Dual Targeting Approach’ that improves ADC selectivity towards cancer cells. The lead and back-up candidate are in the areas of Acute Myeloid Leukaemia ("AML") and a specific type of agressive Non-Hodgkin Lymphoma, respectively. These areas have been targeted due to a combination of unmet clinical need, market size and the specificity of the targeted antigens.

BVX will focus on developing a platform technology to produce next generation bispecific ADCs with superior tumour selectivity. By exploiting its novel therapeutic strategy, the ‘Dual Targeting Approach’, the Company expects to significantly reduce off-target side effects on healthy tissues. This approach differentiates BVX from mainstream ADC developers by improving selectivity and minimising side effects, which can be significant hurdles in the development of these drugs.

The new investors include Alderley Park Ventures and Finance Wales who both look to back innovative, high-technology companies. The principal use of funds will be to initiate early scientific research to demonstrate Proof of Principle for our approach ahead of establishing technical Proof of Concept and selection of a lead therapeutic candidate.

Commenting on the fundraise, BVX’s CEO Tiffany Thorn said, "We are delighted to close our fundraising with a very strong syndicate of investors who are able to support BVX as we commence operations and look to grow. The Company is now looking forward to demonstrating Proof of Principle for our approach over the next 12 months and have selected a strong panel of service providers to assist in our development now that we have the necessary funds to grow."

David Youngman, Corporate Finance Director at Acceleris Capital and Non-executive director of BVX, said:

"Acceleris Capital has been delighted to work with BVX to pull together the funding plan and syndicate to allow BVX to commence operations. We are very excited by the potential applications of the ‘Dual Targeting Approach’ in this exciting area of oncology therapeutics."

Finance Wales Investment Executive Carmine Circelli, said:

"This is an exciting company with strong growth potential. Tiffany and the team have an innovative proposition and we look forward to seeing them commercialize successfully. We’re also pleased to be working with an experienced team of fellow co-investors to support BVX’s expansion in Wales."

The DWF Corporate team in Manchester acted as legal advisers to the Company in the transaction.