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ArQule to Present at Oppenheimer’s 29th Annual Healthcare Conference on March 20, 2019

On March 13, 2019 ArQule, Inc. (Nasdaq: ARQL) reported that Peter Lawrence, President and Chief Operating Officer, and Brian Schwartz, MD, Chief Medical Officer and Head of Research and Development, of ArQule will present at Oppenheimer’s 29th Annual Healthcare Conference on March 20, 2019 at 10:20 a.m. ET at the Westin New York Grand Central in New York City (Press release, ArQule, MAR 13, 2019, View Source [SID1234534276]).

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The live webcast of the presentation will be available via the "Investors & Media" section of ArQule’s website, www.arqule.com, under "Events & Presentations." A replay of the webcast will be available shortly after the conclusion of the presentation.

Investment Presentation March 2019

On March 13, 2019 Bellicum Pharmaceuticals presented an Investor Presentations (Press release, Bellicum Pharmaceuticals, MAR 13, 2019, View Source [SID1234534271]).

Transgene – NEOVIVA project supporting the development of myvac™ awarded a €5.2 million grant from Bpifrance’s “Investments for the Future” programme

On March 13, 2019 Transgene (Euronext Paris:TNG), a biotech company that designs and develops virus-based immunotherapies against cancers and infectious diseases, reported that the NEOVIVA project was selected by the "Investments for the Future" (IFP) Programme (Programme d’Investissements d’Avenir) operated by Bpifrance for the development of an industrial sector focused on Transgene’s individualized immunotherapy platform myvac (Press release, Transgene, MAR 13, 2019, View Source [SID1234534268]). Under the agreement, the NEOVIVA project will receive €5.2 million over the five-year duration of the program from Bpifrance, of which Transgene will receive €2.6 million.

Transgene holds the intellectual property of the myvac platform and is actively working to further develop this innovative technology in collaboration with its three French partners participating in the NEOVIVA project: HalioDx in Marseille, Traaser in Evry and the Curie Institute in Paris. The NEOVIVA project complements the already existing collaboration between Transgene and the Japanese company NEC focused on the clinical validation of an individualized immunotherapy based on artificial intelligence.

The goal of the NEOVIVA project is to develop and validate a manufacturing approach that would provide all solutions needed for the development of individualized immunotherapies. These are designed to stimulate the patient’s immune system to recognize and kill cancer cells by using their own genetic mutations. Two proof of concept clinical trials are being prepared in Europe and US for the treatment of HPV-negative head and neck cancers and ovarian cancer. These are expected to start in H2 2019.

"We would like to thank Bpifrance for its financial support which will accelerate the development of myvac. This funding is a further recognition of the myvac platform and reinforces our ambition to stand as a world leader in the development of individualized viral-vector (MVA) based immunotherapies. We believe the synergies among our partners and their respective teams are highly complementary and harness creativity which will lead to the success of our project. We are delighted to have access to our partners’ expertise through the NEOVIVA project," said Philippe Archinard, CEO and Chairman of Transgene.

Aïcha Douhou, Leader of the Health sector at the innovation department, Bpifrance commented: "We are delighted to support Transgene and its partners HalioDX, Traaser and the Curie Institute in their innovative approach for the design and development of individualized immunotherapy against solid tumors. We expect this project to further boost the development of Transgene bioproduction manufacturing unit for this individualized immunotherapy."

This consortium which combined bio-engineering, bioIT and a recognized know-how in viral vectorisation will be led by Transgene and each partner will contribute to the project as follows:

Transgene will be responsible for the project’s strategy and the clinical development plan. The product design for each patient will be generated in collaboration with NEC which will provide bioIT predictions needed to finalise the immunotherapy. Transgene will also manufacture the myvacTM clinical batches in its pilot manufacturing unit on the short timelines required for the treatment;
Traaser will be in charge of the interpretation of the genomic profiles determined by DNA sequencing. This will be used to facilitate, guide and secure the study of the individualized virotherapy artificial intelligence algorithms results;
HalioDx will study biomarkers to monitor and maximize the clinical efficacy of myvacTM with Immunogram, a high-tech clinical research platform that includes a suite of proprietary tests including Immunosign and the Immunoscore assay suite;
The Curie Institute (Immunotherapy Cancer Centre, led by Dr Amigorena) will contribute to the project in generating translational data and characterizing the therapy’s mechanism of action.

Sanofi successfully prices EUR 2 billion of bond issues

On March 13, 2019 Sanofi reported that it has successfully priced its offering of EUR 2 billion of notes (the "Notes") across 3 tranches (Press release, Sanofi, MAR 13, 2019, View Source [SID1234534266]):

€850 million fixed rate notes, due March 2022, bearing interest at an annual rate of 0.0%
€650 million fixed rate notes, due March 2029, bearing interest at an annual rate of 0.875%
€500 million fixed rate notes, due March 2034, bearing interest at an annual rate of 1.25%

The Notes are being issued off the company’s Euro Medium Term Note Programme.

The transaction enables the company to lower its average cost of debt and extend the average maturity of its debt.

Sanofi intends to use the net proceeds of the offering for general corporate purposes.

BofA – Merrill Lynch and Natixis acted as Global Coordinators and Bookrunners, alongside ING and Santander which acted as Bookrunners for the offering.

Moleculin Files with FDA for Expedited Approval Pathway for Annamycin

On March 13, 2019 Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, reported that it has submitted a request for Fast Track Designation with the US Food and Drug Administration (FDA) for its drug, Annamycin, for the treatment of relapsed or refractory acute myeloid leukemia (AML) (Press release, Moleculin, MAR 13, 2019, View Source [SID1234534272]).

"Now that we have some traction in our clinical trials of Annamycin for the treatment of relapsed or refractory AML," commented Walter Klemp, Moleculin’s Chairman and CEO, "we believe it is appropriate to request Fast Track designation for Annamycin. Importantly, this is a valuable first step in ultimately qualifying for Accelerated Approval and Priority Review."

A drug that receives Fast Track designation is eligible for some or all of the following:

More frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval
More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers
Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA