As the project Supporter, BLA congratulates Leads Biolabs on receiving IND may proceed letter for LBL-033 project
Gaithersburg, MD (June 22, 2023) – BLA Regulatory, LLC, a full-service biopharma regulatory consultancy, congratulates Leads Biolabs on receiving US FDA IND may proceed letter to initiate its first-in-human Phase 1 clinical trial of LBL-033, an anti-MUC16/CD13 bispecific antibody, for the treatment of ovarian cancer and other malignant tumors[1].
About BLA Regulatory, LLC
BLA Regulatory, LLC, is a full-service drug regulatory consultancy focusing on the US with global reach to other major markets. BLA provides comprehensive regulatory strategy and operation services from pre-IND strategic planning, IND preparation & submission, all the way to submission and approval of BLA/NDA. Our goal is to help move your product through the development cycle efficiently. With credits of 300+ INDs and 50+ NDAs/BLAs to our senior consultants, BLA brings clients a broad range of experiences from Big Pharma, CROs, and the FDA. Our services expand across regulatory, CMC, nonclinical, clinical, biostatistics, scientific writing, project management, eCTD publishing, and submission. We have extensive experience across therapeutic areas such as oncology, respiratory, addiction, autoimmune, inflammatory, metabolic, and cardiovascular diseases.
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Reference
[1] Leads Biolabs“The U.S. FDA Approved the PhaseⅠ/ⅡClinical Trial Application to Evaluate LBL-033, An Anti-MUC16/CD3 Bispecific Antibody Developed by Leads Biolabs, in Advanced Solid Tumors Including Ovarian Cancer” 12 June. 2023,
https://en.leadsbiolabs.com/The-U-S-FDA-Approved-the-Phase-I-II-Clinical-Trial-Application-to-Evaluate-LBL-033-An-Anti-MUC16-CD3-Bispecific-Antibody-Developed-by-Leads-Biolabs-in-Advanced-Solid-Tumors-Including-Ovarian-Cancer-id45938527.html