On January 30, 2019 4SC AG (4SC, FSE Prime Standard: VSC) reported the enrollment of the first patient in the third dose cohort of the ongoing Phase Ib/II study SENSITIZE (Press release, 4SC, JAN 30, 2019, View Source [SID1234532963]).

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The SENSITIZE study (ClinicalTrials.gov identifier: NCT03278665) is enrolling up to 40 patients suffering from unresectable advanced-stage cutaneous melanoma who are refractory or non-responding to prior treatment with anti-PD-1 antibodies (checkpoint inhibitors).

In the first part of the study, three patient cohorts will be treated at three different dose levels of domatinostat in combination with pembrolizumab. In the second part, additional patients will be treated with the recommended dosing regimen defined in the first dose-finding part of the study. 4SC anticipates first data to be available in H1 2019.

Jason Loveridge, Ph.D., CEO of 4SC: "Enrolling the first patient in the third dose cohort of the SENSITIZE study again is a significant milestone for 4SC and the study is continuing steadily. We are convinced that the combination of domatinostat with checkpoint inhibitors is the best route to most rapidly progress domatinostat towards market approval. With this, as well as the investigator-sponsored Phase II study EMERGE in advanced gastrointestinal cancer, we continue to build momentum and execute on our plan, which is intended to lead to the initiation of a potentially pivotal trial in 2019."

On January 30, 2019 NewLink Genetics Corporation (NASDAQ:NLNK) reported that the Company’s Chairman, CEO and Chief Scientific Officer, Charles J. Link, Jr, MD, will participate in the Immuno-Oncology 360° Conference (IO360°) being held February 6 – 9, 2019 at the Crowne Plaza Times Square in New York, New York (Press release, NewLink Genetics, JAN 30, 2019, View Source [SID1234532961]).

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Dr. Link’s presentation, "IDO Changes the T-cell Balance in the Tumor Microenvironment," will occur on Wednesday, February 6th, at 9:15 AM ET, and will include a discussion of immune regulation in the tumor microenvironment and how indoximod’s mechanism of action lends itself to counter multiple elements of immune regulation.

Additional information may be found on the IO360°website. The presentation slides will be available on the NewLink Genetics website at www.newlinkgenetics.com in the "Investors & Media" section under "Events & Presentations" once the presentation has begun.

On January 30, 2019 Eli Lilly and Company (NYSE: LLY) has reported that revised the date for its fourth-quarter and full-year 2018 financial results announcement (Press release, Eli Lilly, JAN 30, 2019, View Source [SID1234532960]). The company will now announce results on Wednesday, February 6, 2019, one week earlier than previously scheduled. Lilly will also conduct a conference call on that day with the investment community and media to further detail the company’s financial performance.

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The conference call will begin at 9 a.m. Eastern time. Investors, media and the general public can access a live webcast of the conference call through a link that will be posted on Lilly’s website at View Source A replay will also be available on the website following the conference call.

On January 30, 2019 Novartis reported strong sales growth with core margin expansion, building leading advanced therapy platforms and focusing the company in 2018 (Press release, Novartis, JAN 30, 2019, View Source [SID1234532959])·

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Full year net sales up 5% (cc1, +6% USD) driven by strong performance of growth drivers:

o Pharmaceuticals BU grew 7% (cc) driven by Cosentyx USD 2.8 billion (+36% cc) and Entresto USD 1.0 billion (+102% cc)

o Oncology BU grew 9% (cc) driven by AAA2 (USD 0.4 billion) including Lutathera, Promacta/Revolade USD 1.2 billion (+35% cc) and Tafinlar + Mekinist USD 1.2 billion (+31% cc)

· Full year core1 operating income grew 8% mainly driven by higher sales and gross margin expansion

· Net income was USD 12.6 billion (+64%) including a USD 5.7 billion net gain from the divestment of OTC JV. Operating income declined 5% mainly due to M&A transactions and restructurings

· Free cash flow1 grew 12% to USD 11.7 billion driven by strong operating cash flows

· Focused the company with transformational deals during 2018:

o Consumer healthcare JV stake divested to GSK for USD 13.0 billion

o Announced proposal to spin-off Alcon Division3; on track for H1 2019

o Sandoz began transformation with reshaping the portfolio4, geographic focus and a leaner cost structure

· Built leading advanced therapy platforms:

o Gene therapy – Acquired AveXis and in-licensed Luxturna

o Radioligand therapy – Acquired AAA and Endocyte

o Cell therapy – Expanding Kymriah global manufacturing including multiple collaborations

· Four additional products reached blockbuster status in 2018; Lutathera, Aimovig and Kymriah for DLBCL were launched; additional ten key launches on track by 2020

· Alcon sales grew 5% (cc, +6% USD) and core operating income grew 10%; expanding core margin

· Sandoz sales down -3% (cc, -2% USD) due to US price pressure; Biopharmaceuticals grew 24% (cc)

· Dividend of CHF 2.85 per share, an increase of 2%, proposed for 2018

· 2019 Group guidance5:

o New focused medicines company6 – Net sales expected to grow mid single digit (cc); core operating income expected to grow mid to high single digit (cc)

o Current Group structure7 – Net sales expected to grow low to mid single digit (cc); core operating income expected to grow mid single digit (cc)

On January 30, 2019 TG Therapeutics, Inc. (NASDAQ: TGTX) reported the publication of results from the multicenter Phase 1 triple combination trial of ublituximab (TG-1101), the Company’s anti-CD20 monoclonal antibody, umbralisib (TGR-1202), the Company’s oral once-daily PI3K delta inhibitor, and ibrutinib, the oral Bruton’s tyrosine kinase (BTK) inhibitor, in The Lancet Haematology (Press release, TG Therapeutics, JAN 30, 2019, View Source [SID1234532958]).

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The paper includes safety and efficacy information from patients with relapsed or refractory B-cell malignancies, including 23 patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and 23 patients with non-Hodgkin lymphoma (NHL). Safety data was available from all 46 patients and the triple combination of ublituximab, umbralisib, and ibrutinib was well tolerated with a manageable adverse event profile, and no maximum tolerated dose achieved for the combination. Efficacy data was available from 44 patients and showed the triple combination to be highly active. The overall response rate (ORR) amongst all evaluable patients was 84%, with 100% (22 of 22) of patients with CLL/SLL achieving a response, including 36% achieving a Complete Response (CR). Among patients with NHL, 68% (15 of 22) achieved a response, including a 71% Overall Response Rate (ORR) in follicular lymphoma (FL) (n=7), a 100% ORR in marginal zone lymphoma (MZL) (n=3), and a 100% ORR in mantle cell lymphoma (MCL) (n=6).

These data are described further in the manuscript entitled, "Tolerability and activity of ublituximab, umbralisib, and ibrutinib in patients with chronic lymphocytic leukemia and non-Hodgkin lymphoma: a phase 1 dose escalation and expansion trial," which was featured as the cover article in the February issue of The Lancet Hematology published yesterday. The online version of the article can be accessed at https://www.thelancet.com/journals/lanhae/article/PIIS2352-3026(18)30216-3/fulltext

Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, stated "We want to thank Dr. Loretta Nastoupil and the MD Anderson Cancer Center, as well as each of the participating trial sites and most importantly the patients who participated in this study. Umbralisib has demonstrated unique combinability with other targeted agents, and the data included in this publication further support our goal of developing a proprietary triple combination of ublituximab, umbralisib and our own BTK inhibitor, TG-1701, for which we target commencing clinical trials later this year."