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.

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.

On April 27, 2021 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported its business update for the quarter ending March 31, 2021, and provides an update on the progress of its portfolio of clinical trials (Press release, Transgene, APR 27, 2021, View Source [SID1234578576]).

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Since January 2021, Transgene has achieved significant milestones on all candidates of its clinical portfolio, with:

ü the first patients dosed with TG4050, the individualized therapeutic vaccine against cancer based on Transgene’s myvac technology – the first data from the two ongoing Phase I clinical trials are expected in 4Q 2021;

ü regulatory clearance received in the United States, in France and in Spain, which are expected to allow enrolment of patients with HPV-positive anogenital cancers in the randomized Phase II trial of TG4001 + avelumab versus avelumab alone in 2Q 2021;

ü first patients dosed in the Phase I trial evaluating BT-001, an oncolytic virus based on the Invir.IO platform – first data are expected in 1H 2022;

ü TG6002 initial data, presented at AACR (Free AACR Whitepaper), providing the clinical proof of concept of the intravenous administration of an oncolytic virus. After intravenous administration, TG6002 reached the tumor, multiplied within tumor cells, and induced the local expression of its payload (the FCU1 gene). These data also suggest that candidates derived from Transgene’s unique Invir.IO platform could also be given intravenously, extending the use of these therapies to a broad range of solid tumors – Next data with TG6002 are expected in 2H 2021 (intra-hepatic artery route).

SUMMARY OF KEY ONGOING CLINICAL TRIALS
AND EXPECTED MILESTONES

myvac

TG4050

Phase I

NCT03839524

Targets: tumor neoantigens

Ovarian cancer – after surgery and first-line chemotherapy

ü Trial ongoing in the United States and in France

ü Inclusions and patient dosing progressing in line with forecast

Ü First data expected in 4Q 2021

myvac

TG4050

Phase I

NCT04183166

HPV-negative head and neck cancer – after surgery and adjuvant therapy

ü Trial ongoing in the United Kingdom and in France

ü First patient treated in Jan. 2021 – Inclusions and patient dosing progressing in line with forecast

Ü First data expected in 4Q 2021

TG4001

+ avelumab
Phase II

NCT03260023

Targets: HPV16 E6 and E7 oncoproteins

Recurrent/metastatic anogenital HPV-positive – 1st and 2nd line

ü A Phase II randomized trial comparing the efficacy of TG4001 + avelumab versus avelumab single-agent benefits from the extended clinical collaboration with Merck KGaA and Pfizer, for the supply of avelumab

ü Regulatory authorizations received in the Unites States, Spain, and France

Ü Patient enrollment in the randomized trial expected to start in 2Q 2021

Ü First data from the randomized trial are expected around the end of 2022. This timeline is based on patient enrollment starting in 2Q 2021 and there being no major impact on recruitment from the Covid-19 pandemic.

Invir.IO

BT-001

Phase I/IIa

NCT04725331

Payload: anti-CTLA4 antibody and GM-CSF cytokine

Solid tumors

ü Co-development with BioInvent

ü Trial ongoing in France and Belgium

ü First patient enrolled in February 2021 – Inclusions and patient dosing progressing in line with forecast

Ü US IND expected in 2021

Ü First Phase I data expected in 1H 2022

TG6002

Phase I/IIa

NCT03724071

Payload: FCU1 for the local production of a 5-FU chemotherapy

Gastro-intestinal cancer (colorectal cancer for Phase II) – Intravenous (IV) administration

ü Multicenter trial ongoing in Belgium, France and Spain

ü Poster presentation at AACR (Free AACR Whitepaper) 2021 on initial data of the trial, demonstrating the clinical proof of concept of the intravenous route of administration

Ü Phase I part ongoing

TG6002

Phase I/IIa

NCT04194034

Colorectal cancer with liver metastasis – Intrahepatic artery (IHA) administration

ü Multicenter trial ongoing in the United Kingdom

Ü First observations expected in 2H 2021

During the first quarter of 2021, revenue from collaborative and licensing agreements was mainly composed of the revenue from the collaboration with AstraZeneca.

As of March 31, 2021, government financing for research expenditures mainly consisted of 25% of the research tax credit expected for 2021 (€1.5 million in the first quarter of 2021, in line with the same period in 2020).

CASH, CASH EQUIVALENTS

AND OTHER FINANCIAL ASSETS

Cash, cash equivalents and other financial assets stood at €19.1 million as of March 31, 2021, compared to €26.3 million as of December 31, 2020. In the first quarter of 2021, Transgene’s cash burn was €7.2 million, compared to €8.0 million for the same period in 2020.

In addition, Transgene has access to a €15 million credit line available from Natixis, the maturity date of which has been extended to April 15, 2023. The Company holds shares of Tasly BioPharmaceuticals valued at €32.3 million at the end of December 2020.

As a result, the Company has a financial visibility until the second half of 2022.

On April 27, 2021 Alligator Bioscience reported that Interim report January-March 2021 (Press release, Alligator Bioscience, APR 27, 2021, View Source [SID1234578593])

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High activity during the first quarter

"So far, 2021 has been characterized by high activity, with a research collaboration that validates our Discovery concept, and good progress of our clinical programs, with ATOR-1017 and mitazalimab entering clinical efficacy studies this year."

Malin Carlsson, Interim CEO Alligator Bioscience AB

SIGNIFICANT EVENTS JANUARY-MARCH

Pipeline:

New preclinical data were released in an abstract for a poster presentation at the AACR (Free AACR Whitepaper) Annual Meeting 2021, demonstrating that mitazalimab synergizes with chemotherapy.
Company:
Søren Bregenholt was appointed as new CEO to strengthen Alligator’s business development activities and clinical progress on an international level.
Oversubscribed rights issue generated proceeds of SEK 86 million before transaction costs.
SIGNIFICANT EVENTS AFTER THE END OF THE PERIOD

Alligator and the US biopharmaceutical company MacroGenics entered into a joint research collaboration to develop Neo-X-PrimeTM, next generation immune oncology therapy building on Alligator’s CD40 expertise.
The Annual General meeting was postponed to June 1, 2021.
The Nomination Committee proposed that the Annual General Meeting 2021 re-elects Anders Ekblom and Graham Dixon as board members, and that Hans-Peter Ostler, Eva Sjökvist Saers and Veronica Wallin are elected as new board members.
FINANCIAL SUMMARY

January–March 2021

Net sales, SEK 0.6 million (0)
Operating result, SEK -32.5 million (-44.9)
Result for the period, SEK -32.7 million (-42.9)
Earnings per share before and after dilution, SEK -0.38 (-0.60)
Cash flow for the period, SEK 40.4 million (108.4)
Cash and cash equivalents, incl. interest-bearing securities, SEK 143.7 million (103.3)