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

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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.

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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 25, 2019 NuCana plc (Nasdaq: NCNA), a clinical-stage biopharmaceutical company (the "Company") focused on significantly improving treatment outcomes for patients with cancer, reported that it has withdrawn the proposed underwritten offering of American Depositary Shares ("ADSs") (Press release, Nucana BioPharmaceuticals, JAN 25, 2019, View Source [SID1234532903]). The Company believes it is not in the best interest of its shareholders to raise equity capital in the current market environment. The Company remains well capitalized with a cash position of approximately £77 million as of December 31, 2018 to fund its key programs.

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On January 25, 2019 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on its Phase 1 monotherapy and combination studies of MGD009, a B7-H3 × CD3 bispecific DART molecule (Press release, MacroGenics, JAN 25, 2019, View Source [SID1234532906]). Enrollment of new patients in the U.S. has been cleared to proceed with these trials. MacroGenics previously announced on December 7, 2018, that the FDA had placed the program on partial clinical hold following MacroGenics’ reporting of hepatic adverse events on the MGD009 trials to the FDA. During the partial clinical hold, previously enrolled study participants were allowed to continue to receive drug at their pre-assigned dose.

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"The MacroGenics team worked diligently and rapidly to provide a comprehensive response to the FDA in late December. As a result, we have been able to resolve the partial clinical hold without significant delay to this clinical program," stated Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "The partial clinical hold did not involve our other B7-H3 programs, and, in fact, during the partial hold, we completed enrollment of the first dose escalation cohort for MGC018, our B7-H3-targeted ADC."
About MGD009
MGD009 is a humanized, bispecific DART molecule that recognizes both B7-H3 and CD3 and has a prolonged serum half-life. B7-H3 is a member of the B7 family of molecules involved in immune regulation and is over-expressed on a wide variety of cancer cells, including cancer stem cells, as well as on the supporting tumor vasculature and underlying tissues, or stroma. The intended mechanism of action of MGD009 is its ability to redirect T cells, via their CD3 component, to kill B7-H3-expressing cells.

In addition to MGD009, MacroGenics’ comprehensive B7-H3 franchise includes enoblituzumab, an Fc-optimized monoclonal antibody, as well as MGC018, an antibody-drug conjugate. These clinical molecules target B7-H3. MacroGenics retains worldwide rights to its franchise of three B7-H3-based molecules.

On January 25, 2019 Oragenics, Inc. (NYSE American:OGEN), a leader in the development of new antibiotics against infectious diseases and effective treatments for oral mucositis ("OM"), reported that Alan Joslyn, Ph.D., president and CEO of Oragenics will be a featured presenter at NobleCon15 – Noble Capital Markets’ Fifteenth Annual Investor Conference on January 28th at 10:30 AM Eastern Standard Time (Press release, Oragenics, JAN 25, 2019, View Source [SID1234532908]). The conference is being held at the W Hotel, Fort Lauderdale, Florida. Dr. Joslyn will provide an overview of the company’s business model and growth strategy and will be available for one-on-one meetings.

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A high-definition, video webcast of the presentation will be available the following day on Oragenics’ web site View Source, and as part of a complete catalog of presentations available at Noble Capital Markets’ websites: www.noblecapitalmarkets.com, and www.nobleconference.com. The webcast and presentation will be archived on the company’s website and on the Noble websites for 90 days following the event.