Press release – No. 6 / 2024

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Zealand Pharma announces positive CHMP opinion for dasiglucagon for treatment of severe hypoglycemia in diabetes from European Medicines Agency

MDNA11 demonstrates durable response in pancreatic cancer patient with 100% regression of target and non-target lesions for over 104 weeks and continues to show remission 4 months after stopping treatment

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Medicenna To Present Evidence of Durable Single Agent Activity and Potent Immune Effector Response with MDNA11 in the Dose Escalation Portion of Phase...

Châtillon, France, May 31, 2024

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DBV Technologies Announces Plan to Implement ADS Ratio Change

Saint Herblain (France), May 31, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending authorization of Valneva’s single-dose vaccine for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older.

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Valneva Receives EMA’s Positive CHMP Opinion for its Chikungunya Vaccine

COPENHAGEN, Denmark, May 31, 2024 – Bavarian Nordic A/S (OMX: BAVA) today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of a freeze-dried formulation of JYNNEOS® for prevention of smallpox and mpox disease in adults 18 years of age and older.

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Bavarian Nordic Submits Supplemental BLA Seeking U.S. FDA Approval of Freeze-Dried Formulation of Smallpox and Mpox Vaccine

PRESS RELEASE

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AB Science is providing a summary of the live webcast held on May 30, 2024, giving an update on the application for conditional marketing...

CAMBRIDGE, Mass. and ROSTOCK, Germany and BERLIN, May 31, 2024 (GLOBE NEWSWIRE) -- CENTOGENE N.V. (Nasdaq: CNTG) (the “Company”), the essential life science partner for data-driven answers in rare and neurodegenerative diseases, today announced the voting results of the Company’s 2024 Annual General Meeting. Shareholders voted in favor of all proposals.

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CENTOGENE Announces Adoption of All Resolutions Tabled at 2024 Annual General Meeting

Objective response rate of 39% with manageable safety profile in patients with non-small cell lung cancer (NSCLC) harboring EGFR Exon 20 insertion mutations treated with zipalertinib who had progressed after prior amivantamab treatment Objective response rate of 39% with manageable safety profile in patients with non-small cell lung cancer (NSCLC) harboring EGFR Exon 20 insertion mutations treated with zipalertinib who had progressed after prior amivantamab treatment

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Cullinan Therapeutics Announces Positive Initial Data from Pivotal Phase 2b REZILIENT1 Study of Zipalertinib

Immunocore reports updated Phase 1 data of brenetafusp (IMC-F106C), an ImmTAC bispecific targeting PRAME, in immune checkpoint pre-treated cutaneous melanoma patients at ASCO 2024

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Immunocore reports updated Phase 1 data of brenetafusp (IMC-F106C), an ImmTAC bispecific targeting PRAME, in immune checkpoint pre-treated cutaneous...

BERKELEY, Calif. and MAINZ, Germany, May 31, 2024 (GLOBE NEWSWIRE) -- Mainz Biomed N.V. (NASDAQ: MYNZ), a molecular genetics diagnostic company specializing in the early detection of cancer, held its annual general meeting (“Annual General Meeting”) on Friday, May 31, 2024 in Amsterdam, The Netherlands. Holders of 2,431,947 ordinary shares, representing approximately 10.9% of our outstanding shares on May 3, 2024, the record date for the Annual General Meeting, were present at such meeting, which constituted a quorum under Dutch law. Each of the matters presented at the Annual General Meeting received the requisite shareholder approval as set below:

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Mainz Biomed Reports Results of 2024 Annual General Meeting

NEW YORK, June 01, 2024 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel radioimmunotherapy and antibody-based therapeutic products for the treatment of cancer, today announced new interim data from the Phase 2 Trial 201 of naxitamab in combination with granulocyte-macrophage colony-stimulating factor (“GM-CSF”) in patients with relapsed or refractory high-risk neuroblastoma with residual disease limited to bone and/or bone marrow. The results are summarized in poster presentations scheduled to be presented today, June 1, 2024, at the 2024 American Society of Clinical Oncology (“ASCO”) Annual Meeting in Chicago, IL.

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Y-mAbs Announces New Interim Analysis of Phase 2 Data for Naxitamab at 2024 ASCO Annual Meeting

KT-253 demonstrates initial clinical proof of concept in patients with tumor types shown to be sensitive in preclinical models, including responses in MCC and AML

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Kymera Therapeutics Presents New Clinical Data from Ongoing Phase 1 Trial of MDM2 Degrader KT-253 at ASCO Annual Meeting

Immunocore presents KIMMTRAK clinical data demonstrating that patients with stable disease and confirmed tumor reduction have similar clinical outcomes to patients with partial response

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Immunocore presents KIMMTRAK clinical data demonstrating that patients with stable disease and confirmed tumor reduction have similar clinical...

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Ultimovacs Announces Poster Presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting

-  WTX-124 was shown to be clinically active and generally well-tolerated in patients who were relapsed/refractory to immune checkpoint inhibitor therapy -

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Werewolf Therapeutics to Present Data from Ongoing Phase 1/1b Clinical Trial of WTX-124 as Monotherapy and in Combination with Pembrolizumab in Solid...

NEW YORK, June 01, 2024 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel radioimmunotherapy and antibody-based therapeutic products for the treatment of cancer, today announced the publication of preclinical GD2-SADA data at the 2024 American Society of Clinical Oncology (“ASCO”) Annual Meeting, taking place May 31 through June 4, 2024, in Chicago, IL.

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Y-mAbs Announces Publication of Preclinical GD2-SADA Data at 2024 ASCO Annual Meeting

Results from Phase 1 dose escalation trial of BDTX-1535 in GBM patients demonstrated a favorable safety and tolerability profile, and encouraging anti-tumor activity and duration of treatment

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Black Diamond Therapeutics Presents Promising BDTX-1535 Clinical Data in Patients with Recurrent Glioblastoma at 2024 American Society of Clinical...

NORWOOD, Mass., June 01, 2024 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), announced today, that the Poster [#296] Clinical Update Related to the First-In-Human Trial of SYS6002 (CRB-701), A Next-Generation Nectin-4 Targeting Antibody Drug Conjugate, has been presented at American Society of Clinical Oncology (ASCO) Annual Conference by Dr. Jian Zhang, Chief Physician (Oncology), Deputy Director of Administration, Clinical director of Phase 1 Centre, Fudan University Shanghai Cancer Center.

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SYS6002 (CRB-701) A Next-Generation Nectin-4 Targeting Antibody Drug Conjugate Continues to Demonstrate Encouraging Safety and Efficacy Observed in...

Media Release

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Investigational Acasunlimab (DuoBody® -PD-L1x4-1BB) in Combination with Pembrolizumab Demonstrates Meaningful Clinical Activity in Phase 2 Trial in...

MANNHEIM, Germany, June 01, 2024 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced longer follow-up data from the EGFRwt cohort and initial clinical efficacy data from the EGFRmut cohort from the on-going AFM24-102 study in NSCLC.

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Affimed Provides Follow-up Data of AFM24 plus Atezolizumab Showing Durable Responses in Heavily Pretreated NSCLC EGFR Wild-type Patients and Positive...