On January 28, 2019 Evelo Biosciences, Inc. (Nasdaq: EVLO) ("Evelo"), a biotechnology company developing monoclonal microbials, a new modality of oral biologic medicines, reported that the University of Chicago has dosed the first patient in an investigator-sponsored Phase 2a clinical trial evaluating EDP1503 in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy (Press release, Evelo Biosciences, JAN 28, 2019, View Source [SID1234532941]). EDP1503 is an orally delivered monoclonal microbial product candidate being developed for the treatment of cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This open-label clinical trial, led by Dr. Jason J. Luke, M.D., FACP, will evaluate the safety, tolerability, and efficacy of EDP1503 in combination with KEYTRUDA in up to 70 patients with metastatic melanoma who are previously untreated or who have relapsed following treatment with an anti-PD-1 inhibitor. Evelo will provide and retain all rights to EDP1503.

Patients will receive daily EDP1503 monotherapy for two weeks followed by treatment with daily EDP1503 in combination with KEYTRUDA. The study will evaluate biomarkers identified from paired biopsies taken before and after the two-week run-in, as well as clinical outcomes observed over the course of the trial, and potential alterations to the intestinal microbiome. Evelo anticipates initial clinical data from the trial in the second half of 2020.

In preclinical studies orally delivered EDP1503 shows activation of multiple clinically validated systemic immune pathways which are complementary to and potentially synergistic with checkpoint inhibitors. Effects include increased CXCL9 and CXCL10 production in the tumor microenvironment, augmentation of NK and T cell infiltration to the tumor site as well as upregulation of MHC Class I expression in tumors.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

On January 28, 2019 Physicians’ Education Resource (PER), a leading resource for continuing medical education (CME), reported that it will host its 23rd annual International Congress on Hematologic Malignancies: Focus on Leukemias, Lymphomas, and Myeloma from Thursday, Feb. 28 to Sunday, March 3 at the Eden Roc Miami Beach in Florida (Press release, Physicians’ Education Resource, JAN 28, 2019, View Source [SID1234532924]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This dynamic Winter Hematology congress will be co-chaired by Andre Goy, M.D., M.S., the chairman and executive director of the lymphoma division and chief of the John Theurer Cancer Center at Hackensack University Medical Center, chief science officer and director of research and innovation of the Regional Cancer Care Associates; Sagar Lonial M.D., FACP, a professor and executive vice chair in the department of hematology and medical oncology at Emory School of Medicine, and chief medical officer of Winship Cancer Institute of Emory University; and Jorge Eduardo Cortes, M.D., the D.B. Lane Cancer Research Distinguished Professor for Leukemia Research, deputy chair and professor of medicine, and an internist in the department of leukemia, division of cancer medicine at The University of Texas MD Anderson Cancer Center.

"Our winter hematology congress continually offers the latest updates and insights in the evolving field of hematologic oncology," said Phil Talamo, president of PER. "With all the recent advancements this past year, this conference will discuss new data and challenge participants to apply new information they have learned, reflect on new practices they can bring back to their clinics to share with their peers, and ultimately improve patient outcomes."

The 23rd annual congress is a three-and-a-half-day engaging and highly interactive meeting that provides community-based hematologists and medical oncologists interested in the treatment of hematologic malignancies with the opportunity to interact with internationally renowned experts in the management of leukemias, lymphomas, myeloma, myelodysplastic syndromes, myeloproliferative neoplasms, and benign hematologic malignancies. During the congress, faculty experts will review latest information on pressing topics for 2019, including the expanding role of new immunologic approaches, including CAR T cells and checkpoint inhibitors, the emergence of molecular-based therapies and new cytotoxic formulations in patients with acute leukemias, new approaches for treatment and duration of therapy among patients with myeloproliferative neoplasms and more. The meeting will also feature several engaging Medical Crossfire discussion panels interspersed throughout the meeting to allow attendees to explore some of the most challenging clinical situations in the management of hematologic malignancies.

On January 28, 2019 UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of urology, with a focus on uro-oncology, reported the closing of its previously announced public offering of 4,207,317 ordinary shares, including 548,780 shares sold pursuant to the full exercise of the underwriters’ option to purchase additional shares (Press release, UroGen Pharma, JAN 28, 2019, View Source [SID1234532925]). All of the ordinary shares were sold at a price to the public of $41.00 per share. The net proceeds of the public offering are approximately $162.1 million, after deducting the underwriting discounts and commissions but before payment of other offering expenses. All ordinary shares sold in the offering were offered by the Company.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Goldman Sachs & Co. LLC, J.P. Morgan and Jefferies acted as joint book-running managers for the offering. Oppenheimer & Co. acted as lead manager for the offering.

A shelf registration statement relating to the ordinary shares was previously filed with the Securities and Exchange Commission (the "SEC") and declared effective on October 26, 2018. A final prospectus supplement and accompanying prospectus relating to the offering was filed with the SEC and is available on the SEC’s website at View Source Copies of the final prospectus supplement and accompanying prospectus may be obtained by contacting:

Goldman Sachs & Co. LLC, c/o: Prospectus Department, 200 West Street, New York, New York 10282, or via telephone at 866-471-2526, or via email: [email protected]; or
J.P. Morgan Securities LLC, c/o: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717 or via telephone at 866-803-9204, or via email: [email protected]; or
Jefferies LLC, c/o: Equity Syndicate Prospectus Departments, 520 Madison Avenue, 2nd Floor, New York, New York 10022, or via telephone at 877-821-7388, or via email: [email protected].
This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

On January 26, 2019 MorphoSys AG (FSE: MOR; Prime Standard Segment, MDAX & TecDAX; NASDAQ: MOR) reported that in its lawsuit against Janssen Biotech and Genmab A/S, the United States (U.S.) District Court of Delaware, based on a hearing held November 27, 2018, has ruled in a Court Order on January 25, 2019, that the asserted claims of three MorphoSys patents with U.S. Patent Numbers 8,263,746, 9,200,061 and 9,758,590 are invalid (Press release, MorphoSys, JAN 26, 2019, View Source [SID1234532974]). The Court thus granted a motion for Summary Judgement of invalidity filed by Janssen Biotech and Genmab, A/S against the three patents held by MorphoSys. As a result of this decision, the jury trial scheduled for February 2019 to consider defendants’ alleged infringement and the validity of the MorphoSys patents will now not take place.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

MorphoSys’s management is disappointed with the decision and is considering all of its options. The company has the right to appeal this judgement to the Federal Circuit.

On April 4, 2016 MorphoSys had filed a lawsuit in the United States (U.S.) District Court of Delaware against Janssen Biotech, and Genmab, A/S for patent infringement of U.S. Patent Number 8,263,746. In 2017, a second and a third patent with US Patent Numbers 9,200,061 and 9,758,590 were added to the lawsuit. MorphoSys sought redress for infringement by Janssen’s and Genmab’s daratumumab, a CD38-directed monoclonal antibody for the treatment of multiple myeloma.

This court decision has no bearing upon the composition of matter patent protection for MorphoSys’s own CD38 antibody MOR202 and thus MorphoSys’s ability to develop MOR202 in various indications.

On January 26, 2019 Genmab A/S (Nasdaq Copenhagen: GEN) reported that the U.S. District Court of Delaware has declared the three U.S. patents (Nos. 8,263,746, 9,200,061, and 9,758,590), asserted by MorphoSys AG against Genmab and Genmab’s collaboration partner Janssen Biotech, Inc. (Janssen) are invalid by summary judgment (Press release, Genmab, JAN 26, 2019, View Source [SID1234532904]). The patent infringement lawsuit was initiated by MorphoSys against Genmab and Janssen in April 2016 asserting that activities with DARZALEX (daratumumab) in the United States infringe its U.S. patents, and the case has been pending before the U.S. District Court of Delaware. The summary judgment order declared all three patents invalid due to lack of enablement. As a result of this decision, the jury trial scheduled for February 2019 will not take place. MorphoSys has the opportunity to appeal the district court decision to the U.S. Court of Appeals for the Federal Circuit (CAFC). In addition, during the case a further claim by Janssen and Genmab was included in the case that the three MorphoSys patents were unenforceable due to inequitable conduct by MorphoSys. That issue remains to be decided

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!