On January 30, 2019 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported that Drug Design, Development and Therapy has published an article titled, "Targeting the A3 Adenosine Receptor to Treat Cytokine Release Syndrome in Cancer Immunotherapy (Press release, Can-Fite BioPharma, JAN 30, 2019, View Source [SID1234532965])." The article presents data from numerous studies that show adenosine’s role in inhibiting inflammatory cytokine production. Can-Fite’s Piclidenoson, a Phase III drug candidate, and Namodenson, a Phase II drug candidate, both target the A3 adenosine receptor (A3AR), which the Company believes may treat cytokine release syndrome (CRS) while also promoting an anti-cancer effect.

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CRS is a potentially life threatening side effect of cancer immunotherapies including CAR-T. The market for CAR-T drugs is estimated to reach approximately $5.4 Billion in 2024 according to Evaluate Pharma.

"While CAR-T and other cancer immunotherapies are saving lives, as their use increases, there is growing concern about the drugs’ life threatening side effects including the high incidence of CRS. With the publication of this article in Drug Design, Development and Therapy, we are advancing the scientific community towards delivering immunotherapies that offer a high degree of efficacy with a greater degree of safety for the patient. Our platform technology, through Namodenoson, has already displayed its anti-cancer effects in humans, and therefore it is a candidate to not only protect patients from CRS, but to also boost the body’s fight against cancer," stated Dr. Pnina Fishman, Can-Fite’s CEO. "We look forward to implementing our development strategy for our drugs in the treatment of CRS."

Can Fite’s platform technology selectively targets A3AR, which plays a central role in mediating the mechanism of inflammation by reducing elevated levels of pro-inflammatory cytokines such as IL-6, IL-1β, NF-Kβ, TNF-α, and more.

On January 30, 2019 BioInvent International AB (OMXS: BINV) reported that the U.S. Food and Drug Administration (FDA) has granted the Company orphan designation for its proprietary antibody BI-1206 for the treatment of mantle cell lymphoma (MCL) (Press release, BioInvent, JAN 30, 2019, View Source [SID1234532964]).

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Orphan designation is intended to support companies developing treatments that target rare medical conditions and are expected to provide significant therapeutic advantage over existing medicines. The orphan designation from the FDA provides certain incentives to BioInvent, including a 7-year market exclusivity in the U.S once a New Drug Application (NDA) or Biologics License Application (BLA) has been approved, and also availability of grants exclusively for orphan drug products.

BioInvent is currently conducting a dose escalation, consecutive-cohort, open-label Phase I/IIa study of BI-1206 with approximately 30 patients across sites in the EU and the U.S. The trial evaluates BI-1206 in combination with rituximab in patients with indolent relapsed or refractory B-cell non-Hodgkin’s lymphoma (NHL). MCL is one of the targeted sub-indications, along with follicular lymphoma (FL) and marginal zone lymphoma (MZL).

"This orphan designation for BI-1206 is very good news for BioInvent, and most importantly for patients suffering from this very serious condition. There is a significant unmet medical need, as there are presently few treatment options for patients suffering from mantle cell lymphoma. We are looking forward to generating data from our Phase I/IIa trial to support the use of BI-1206 in combination with rituximab in this indication," says Martin Welschof, CEO of BioInvent.

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.