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 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 Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) reported that it will present at NobleConXV – Noble Capital Markets’ Fifteenth Annual Investor Conference at the W Hotel, Fort Lauderdale, Florida on Tuesday, January 29th at 12:30 pm EST (Press release, Actinium Pharmaceuticals, JAN 25, 2019, View Source [SID1234532902]). Actinium is the only company with a multi-disease, multi-target, drug development pipeline focused on targeted conditioning via its ARC or Antibody Radiation Conjugate Approach. Details of Actinium’s presentation are as follows:

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Date: Tuesday, January 29th
Time: 12:30 PM ET
Room: Studio 4
Venue: W Hotel, Fort Lauderdale, Florida

Members of Actinium’s Executive team will be available for 1-on-1 meetings with conference attendees. Those interested in scheduling a meeting with Actinium may do so through the conference’s system View Source or by contacting Steve O’Loughlin, Actinium’s Principal Financial Officer via email to [email protected].

On January 25, 2019 Allergan plc (NYSE: AGN) reported that its Board of Directors has approved an increase in the Company’s quarterly cash dividend for 2019 to $0.74 per ordinary share (Press release, Allergan, JAN 25, 2019, View Source [SID1234532901]). The Board declared a cash dividend for the first quarter of 2019 to be paid on March 15, 2019 to shareholders of record at the close of business on February 15, 2019.

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"Allergan’s increased dividend for 2019 demonstrates our confidence in our long-term business strategy and our commitment to executing on our capital allocation priorities. We remain committed to increasing our dividend annually," said Brent Saunders, Chairman and CEO of Allergan.

Allergan also announced that its 2019 Annual General Meeting of Shareholders will be held on May 1, 2019 in Dublin, Ireland. The Company’s Board of Directors has set the close of business on March 5, 2019 as the record date for determining shareholders eligible to vote at the meeting.

On January 25, 2019 Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported that two presentations highlighting the potential of Advaxis vectors to generate T cell responses to a large percentage of neoantigens and to promote antigen spreading and potentially slow progression of prostate cancer, were presented at the 2019 Keystone Symposia on Cancer Vaccines, held January 19-24 in Vancouver (Press release, Advaxis, JAN 25, 2019, View Source [SID1234532900]).

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The first presentation, "Neoantigen prioritization for use in a Listeria monocytogenes cancer vaccine" delivered by Brandon Coder, Ph.D., Associate Director Research & Development at Advaxis, shows the impact of CD8+ T cell responses generated to a large proportion of neoantigens, including those that were not immunogenic as peptide vaccines as well as large frameshift mutations (FSMs) that generated tumor-infiltrating lymphocytes that controlled tumor growth in preclinical CT-26 and MC-38 mouse models. The data presented support the potential of Advaxis vectors to be among the most efficient and effective at generating CD8+ T cell responses to neoantigens, including some that are not immunogenic by alternative methods of vaccination.

The second presentation, "Magnitude of anti-PSA T cell response is associated with antigen spreading and slowing in PSA and PAP velocity in ADXS-PSA treated mCRPC patients," was delivered by Robert G. Petit, Ph.D., Chief Scientific Officer and Executive Vice President of Advaxis. These data are from 13 patients treated in the ADXS-PSA monotherapy arm of Advaxis’ Phase 1/2 clinical trial of men with metastatic, castration-resistant prostate cancer (mCRPC). The presentation focused on the 56% of ADXS-PSA monotherapy patients (5/9) who exhibited a greater than three-fold increase above baseline in the magnitude of their PSA-specific T cell responses. All nine ADXS-PSA patients who received three or more treatments showed T cell responses against one or more prostate cancer antigens not included in ADXS-PSA, providing evidence of antigen spreading. Additionally, a greater magnitude of the PSA-specific T cell responses in ADXS-PSA-treated mCRPC patients was associated with more antigen spreading than those with a less than three-fold increase. Similarly, those patients with a greater than three-fold increase in PSA-specific T cells also exhibited a significant slowing in PSA and PAP velocities, which could support the potential for delaying progression and improving survival in larger studies. As previously reported, ADXS-PSA monotherapy showed a manageable safety profile with Grades 1–2 chills/rigors and fever in all patients and Grade 3 and Serious Adverse Events in five and two patients, respectively.

"These presentations highlight some of the potential benefits of the drug constructs from our proprietary Lm platform, namely the efficient generation of CD8+ T cell responses against neoantigens as well as the potential improvement of clinical endpoints due to the magnitude of these T cell responses and antigen spreading. The data directly support our ongoing investigations of the ADXS-NEO and ADXS-PSA constructs as well as future studies of the various drug constructs from our ADXS-HOT program," said Dr. Petit.