10-Q – Quarterly report [Sections 13 or 15(d)]

Myriad Genetics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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Heat Biologics CEO, Jeff Wolf, to Present at the Upcoming BIO CEO & Investor Conference in New York

On February 7, 2018 Heat Biologics, Inc. ("Heat") (NASDAQ: HTBX), a biopharmaceutical company developing drugs designed to activate a patient’s immune system against cancer, will present during the BIO CEO & Investor Conference next week in New York (Press release, Heat Biologics, FEB 7, 2018, View Source [SID1234523783]). Jeff Wolf, CEO of Heat, will present at 9 a.m. ET, on Tuesday, Feb. 13, 2018, and he will also be available to participate in one-on-one meetings with investors registered to attend the conference.

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The BIO CEO & Investor Forum is a biotech investor conference focused on established and emerging, publicly traded and select private biotech companies. The event features plenary sessions, education sessions focused on therapeutic topics and business issues, company presentations, and one-on-one meetings.

TC BioPharm and the NIPRO Corporation Announce Strategic Programme Co-Developing a Novel Gamma-Delta CAR-T Product to Treat Cancer

On February 7, 2018 The NIPRO Corporation (TSE: 8086) and TC BioPharm Ltd (TCB), reported that they have formed a strategic collaboration to co-develop a novel immunotherapy product using TCB’s safe CAR-T platform, based on unique properties of modified gamma delta (γδ) T cells to selectively target cancer whilst leaving healthy cells untouched (Press release, TC Biopharm, FEB 7, 2018, http://www.tcbiopharm.com/index.php/component/content/article/96 [SID1234524275]). TCB intends to use this novel platform to develop new CAR-based immunotherapies, with the aim of treating a broad range of cancers and major viral disease.

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"TCB’s world-class GMP-compliant manufacturing facility and experienced in-house clinical team will allow us to leverage patient treatment at established cancer therapy centers throughout Europe", said TCB’s Chief Operating Officer, Angela Scott, "since commencing operations in 2014, we have treated numerous cancer patients successfully with unmodified gamma-delta T cells and built sufficient infrastructure to progress our innovative proprietary next-generation CAR-T towards phase I studies during 2018."

The NIPRO Corporation will provide non-dilutive funds in the form of up-front fees, milestone payments and research-support to progress elements of TCB’s CAR-T program to clinical studies. NIPRO cash will provide the Osaka-based company with an exclusive right to sell, and distribute CAR-T product worldwide.

TCB and NIPRO will co-develop an autologous gamma-delta CAR-T therapy directed against CD19, which is expressed in several B cell tumors such as multiple myeloma and lymphoma. Preclinical studies developing the product will be supported by a Scottish Enterprise ‘seek-and-solve’ grant which will provide £2.7m of additional non-dilutive funding. Commenting on both the grant and collaboration, Jim Watson, director of Innovation & Enterprise Services at Scottish Enterprise, said, "This particular grant is designed to encourage investment in R&D and inspire Scottish companies to partner with international players to expand market reach, it’s fantastic to see a pre-revenue company like TCB collaborating with NIPRO. TCB’s strong international mindset will help the company reap benefits of this collaboration – both in terms of financial support and the market knowledge that NIPRO brings to the table. The Seek and Solve project will allow TCB to accelerate route to market, meaning potentially quicker returns for the Scottish economy, helping establish TCB as a global leader in cancer-specific cell therapies."

TCB’s proprietary ImmuniCAR platform uses the innate ability of gamma-delta T cells to target cancer, this has allowed the Company develop a wide-range of innovative safe therapies designed to treat a variety of tumours without toxic side-effects seen in many current CAR-T products. NIPRO’s Managing Director, Toshiaki Masuda, said, "The collaboration with TC Biopharm – who has stand-alone technology in developing CAR-T products; and NIPRO – an experienced company in manufacturing cell culture products, will establish the safe and innovative cancer therapeutics for practical use in the global market."

Head of the Department of Oncology at the University of Oxford, Professor Mark Middleton noted that, "the combination of gamma delta and CAR T cell therapy gives us the opportunity to test this promising new treatment in patients for the first time.’ He added that, ‘those of us who treat solid tumors have followed use of CAR T cells in hematological malignancy with great interest, this exciting collaboration between TCB and NIPRO has potential to overcome safety challenges when developing such treatments in patients with solid tumors".

The collaboration with NIPRO is TCB’s first major pharma deal centred in Asia, and represents a strong endorsement of the therapeutic approach. Remarking on this significant milestone for the Company, Chief Executive Dr Michael Leek iterated that, "This commercial collaboration represents the cutting-edge of cell-based immunotherapy, providing clinicians and cancer patients access to next-generation, safe, innovative oncology products, we are privileged to be working alongside the NIPRO Corporation as they continue to build a formidable presence in the regenerative medicine sector ".

Chief Business Officer Dr Artin Moussavi added, "TCB has been very active over the last 12 months raising over $35m cash, sealing long-term commercial relationships with a potential combined pre-market income over $1bn. The NIPRO collaboration is our latest such deal, representing a joint-effort to build a significant immune-oncology business in Japan and Asia".

MabVax to Present at BIO CEO & Investor Conference

On February 7, 2018 MabVax Therapeutics Holdings, Inc. (NASDAQ: MBVX) ("MabVax" or the "Company"), a clinical-stage biotechnology company focused on the development of antibody-based products to address unmet medical needs in the treatment of cancer, reported that David Hansen, MabVax’s President and Chief Executive Officer will present at the BIO CEO & Investor Conference on Monday, February 12, 2018 at 11:15 a.m. EST in New York, NY (Press release, MabVax, FEB 7, 2018, View Source [SID1234523784]).

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As part of his presentation, Mr. Hansen will provide a corporate overview, including a clinical update on the Company’s two lead clinical development programs: (1) Its fully human antibody therapeutic product, MVT-5873, currently in a Phase 1 clinical study in combination with gemcitabine and nab-paclitaxel in first line therapy for the treatment of newly diagnosed pancreatic cancer patients. The Company remains on track to announce interim safety and response data from the MVT-5873 study early in the first quarter of 2018; and (2) the MVT-1075 program, a human antibody-based radioimmunotherapy ("RIT") product, currently being evaluated in a Phase 1 clinical trial for the treatment of pancreatic, colon and lung cancers. MabVax recently announced the completion of enrollment and dosing of all patients in the initial cohort of the Phase 1 MVT-1075 study and plans to report interim results from this study in the first quarter of 2018.

In addition to the presentation, management will be available to participate in one-on-one meetings with qualified members of the investor community who are registered to attend the conference. To schedule a meeting, please contact the Company through the one-on-one meeting portal.

A live audio webcast of the presentation will be available on the Events page of the Investor section of the Company’s website (www.mabvax.com). A webcast replay will be available approximately two hours after the presentation ends and will be accessible for 90 days following the live presentation.

Sanofi Delivers 2017 Business EPS(1) in line with Guidance

On February 7, 2017 Sanofi reported financial results for the fiscal year ended December 31, 2017 (Press release, Sanofi, FEB 7, 2018, View Source [SID1234523887]).

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Q4 2017 sales reflect strong Dupixent launch offset by anticipated declines in U.S. diabetes and Renagel

Net sales were €8,691 million, down 2.0% on a reported basis and up 4.1%(3) at CER. At CER/CS(3), net sales were down 1.6%.
Strong Sanofi Genzyme sales growth (up 16.8%) driven by contribution from new immunology franchise.
Sanofi Pasteur sales increased 1.2% at CER/CS impacted by order phasing effects and Dengvaxia.
CHC sales grew 2.5% at CER/CS.
Diabetes and Cardiovascular GBU sales down 19.1%.
Emerging Markets(4) sales increased 2.1% at CER/CS, driven by Pharmaceuticals which increased 4.0% at CER/CS.
Sanofi Genzyme, Sanofi Pasteur and Emerging Markets sales growth more than offset Diabetes sales decline in 2017

Net sales in 2017 were €35,055 million, up 3.6% on a reported basis and 5.6%(2) at CER. Net sales were up 0.5% at CER/CS.
Sanofi Genzyme grew 15.1% to €5,674 million while Sanofi Pasteur increased 8.3% (at CER/CS) to €5,101 million.
Emerging Markets sales were up 6.0% at CER/CS supported by strong performance in China (up 15.1% at CER/CS).
Diabetes and Cardiovascular GBU sales declined 14.3% to €5,400 million.
Sanofi meets its full-year 2017 business EPS guidance

Q4 2017 business EPS(1) decreased 8.8% at CER to €1.06, including financial impact from Dengvaxia (-€0.10).
2017 business EPS(1) of €5.54 (-0.4% at CER) and IFRS EPS of €6.71 (+83.3% on a reported basis).
Net debt was €5,229 million at the end of 2017, a decrease from €8,206 million at the end of 2016.
Board proposes dividend of €3.03, an increase of 2.4%.
2017 business net income (BNI) effective tax rate unaffected by the U.S. tax reform. In 2018, Sanofi expects the BNI effective tax rate to be around 22% primarily as a result of U.S. tax reform(5).
Sanofi progresses on its strategic priorities

Sanofi to acquire Bioverativ(6) for $11.6 billion to expand in specialty care and strengthen its leadership in rare diseases.
Sanofi to acquire Ablynx(6) for €3.9 billion to strengthen its R&D strategy with innovative Nanobody technology platform.
Agreement signed with Regeneron to accelerate and expand investments for the development of cemiplimab and dupilumab.
FDA supplemental BLA submission for dupilumab in uncontrolled persistent asthma for adults and adolescents.
2018 financial outlook

Sanofi expects 2018 business EPS(1) to grow between 2% and 5%(7) at CER, including the anticipated contribution from the recently announced acquisitions, barring unforeseen major adverse events. Applying the average December 2017 exchange rates, the currency impact on 2018 business EPS is estimated to be -3% to -4%.