On April 27, 2021 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported the publication of a peer-reviewed article titled "COM902, a Novel Therapeutic Antibody Targeting TIGIT Augments Anti-Tumor T Cell Function in Combination with PVRIG or PD-1 Pathway Blockade" in Cancer Immunology, Immunotherapy (Press release, Compugen, APR 27, 2021, View Source [SID1234578592]). The preclinical data discussed in the paper highlight the potential of COM902, Compugen’s anti-TIGIT therapeutic antibody, to enhance anti-tumor immune responses.

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Article highlights include:

Development and characterization of COM902, a fully human anti-TIGIT antibody which binds specifically to TIGIT and disrupts the binding of TIGIT with PVR, the cognate ligand of TIGIT
Expression of TIGIT, a checkpoint within the DNAM-1 axis discovered in 2009 by Compugen and others, is induced on lymphocytes infiltrating the tumor microenvironment, including Tregs, effector T cells, and NK cells in diverse solid tumors
PVR is expressed in a large set of solid tumors
COM902, designed to have reduced Fc receptor engagement to avoid potential depletion of TIGIT-expressing effector T cells, does not demonstrate T cell depletion activity in-vitro or in-vivo, making it unlikely to elicit direct depletion of TIGIT-expressing effector T cells, which are important for anti-tumor activity
Blockade of TIGIT/PVR binding by COM902 enhances human T and NK cell function in vitro. This effect can be increased by dual blockade of COM902 with either an anti-PVRIG antibody, COM701, or an anti-PD-1 antibody
In vivo, in murine tumor models, COM902 combined with anti-PVRIG or anti-PD-L1 antibodies enhances anti-tumor lymphocyte responses and inhibits tumor growth
"This publication offers further validation of TIGIT as a potential novel target for cancer immunotherapies," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "These published data answer fundamental questions regarding TIGIT’s biology and demonstrate potential synergies with other immune checkpoints. Excitingly, we have observed the amplification of anti-tumor immune responses after dual blockade of TIGIT with either PVRIG or PD-1, which validates our clinical strategy to pursue combination approaches targeting these checkpoints. Furthermore, these data provide additional support that COM902 has the potential to improve outcomes for patients with advanced malignancies, expanding the reach of checkpoint inhibitors."

COM902 is currently being studied as monotherapy in a Phase 1 trial of patients with advanced malignancies (NCT04354246). The trial, which was initiated in 2020, is on track to report initial data in Q4 2021. In addition, the initiation of the dual combination study of COM701 with COM902 is expected as planned in H2 2021.

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On April 27, 2021 Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) reported that it will report its financial results for the first quarter of 2021, on Tuesday, May 4, 2021, before the U.S. financial markets open (Press release, Concert Pharmaceuticals, APR 27, 2021, View Source [SID1234584683]). The Company will host a conference call and webcast at 8:30 a.m. ET to discuss its first quarter 2021 financial results and provide a business update. Individuals interested in participating in the call should dial (855) 354-1855 (U.S. and Canada) or (484) 365-2865 (International).

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A live webcast of the conference call may be accessed in the Investors section of the Company’s website at www.concertpharma.com. Please log on to the Concert website approximately 15 minutes prior to the scheduled webcast to ensure adequate time for any software downloads that may be required. A replay of the webcast will be available on Concert’s website for three months.

On April 27, 2021 Immunomic Therapeutics, Inc. (ITI) reported that it will participate at the World Vaccine Congress Washington being held virtually May 4-6, 2021. CEO and Co-Founder Bill Hearl, Ph.D., will present a talk titled, "Adaptive T-cell immunotherapy for newly diagnosed glioblastoma: Using targeted antigen presentation to enhance immune responses," at 15:00 on May 4, 2021 (Press release, Immunomic Therapeutics, APR 27, 2021, View Source [SID1234578543]).

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In addition, Immunomic Therapeutics’ Why We Vax, a non-profit whose mission is to help educate communities with research backed facts on vaccines, board member, Dr. Michael Miller will be participating on a panel titled, "Vaccinating Against Misinformation," at 14:00 on May 6, 2021.

"Vaccines are one of the safest, most widely-adopted health care practices in the world. Why We Vax will help spread the message that vaccines are rigorously tested and provide the best defense against diseases, particularly indicative during this unprecedented time," said Dr. William Hearl, Why We Vax Chairman, Immunomic Therapeutics CEO, and experienced vaccinologist.

The World Vaccine Congress Washington is a multi-faceted conference experience with over 300 industry leading speakers, exclusive interviews, world leading presentations, live panel debates, and virtual face to face meetings.

Presentation details are as follows:

Dr. Bill Hearl Presentation:
Title: Adaptive T-cell immunotherapy for newly diagnosed glioblastoma: Using targeted antigen presentation to enhance immune responses
Track: Cancer Immunotherapy
Date and Time: Tuesday, May 4, 2021 15:00

Why We Vax’ Board Member Michael Miller Panel Participation:
Title: Vaccinating Against Misinformation
Track: Vaccine Safety
Date and Time: Thursday, May 6, 2021 14:00

About UNITE

ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, works by fusing pathogenic antigens with the Lysosomal Associated Membrane Protein, an endogenous protein in humans, for immune processing. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach could put UNITE technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. UNITE is currently being employed in Phase II clinical trials as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of UNITE in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for UNITE therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.

About ITI-1000 and the Phase 2 (ATTAC-II) Study

ITI-1000 is an investigational dendritic cell vaccine therapy currently in a Phase 2 clinical trial (ATTAC-II) for the treatment of GBM. ITI-1000 was developed using Immunomic’s proprietary investigational lysosomal targeting technology, UNITE, in the context of cell therapy. In May 2017, Immunomic exclusively licensed a patent portfolio from Annias Immunotherapeutics for use in combination with UNITE and ITI-1000, allowing Immunomic to combine UNITE with a patented and proprietary CMV immunotherapy platform. The ATTAC-II study (NCT02465268) is a Phase II randomized, placebo-controlled clinical trial enrolling patients with newly diagnosed GBM that will explore whether dendritic cell (DC) vaccines, including ITI-1000, targeting the CMV antigen pp65 improves survival. This study is enrolling up to 120 subjects at 3 clinical sites in the United States. For more information on the ATTAC-II study, please visit www.clinicaltrials.gov.

On April 27, 2021 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that the Company has submitted its Marketing Authorization Application ("MAA") to the European Medicines Agency for omburtamab for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma (Press release, Y-mAbs Therapeutics, APR 27, 2021, View Source [SID1234578560]). Omburtamab is an investigational, monoclonal antibody that targets B7-H3 and is radiolabeled before intraventricular central nervous system ("CNS") administration. B7-H3 is an immune checkpoint molecule that is widely expressed in tumor cells of several cancer types.

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"We believe omburtamab is on track to potentially become the first EMA approved targeted therapy for pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma," said Thomas Gad, founder, Chairman and President at Y-mAbs. "With this submission to EMA, Y-mAbs is continuing to advance the omburtamab program to potentially provide access to this innovative therapy to pediatric patients globally as quickly as possible."

In addition, Y-mAbs recently concluded a Type B meeting with the U.S. Food and Drug Administration ("FDA") regarding omburtamab and the Company continues to be in close dialog with the FDA and maintains its aim of resubmitting the Biologics License Application ("BLA") to the FDA late in the second quarter or in the third quarter of 2021.

Dr. Claus Moller, the Company’s Chief Executive Officer, continued, "We are excited to submit the MAA for omburtamab, and very pleased about the progress we are making. We believe omburtamab can potentially address a significant unmet medical need for children with CNS/leptomeningeal metastasis from neuroblastoma. We also are continuing to work closely with the FDA to resubmit the omburtamab BLA."

Researchers at Memorial Sloan Kettering Cancer Center ("MSK") developed omburtamab, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interest related to the compound and Y-mAbs.