Teneobio Announces Us Fda Clearance Of Investigational New Drug Application For Tnb-486 And The Initiation Of Phase I Clinical Studies In Patients Wit

Teneobio Announces Us Fda Clearance Of Investigational New Drug Application For Tnb-486 And The Initiation Of Phase I Clinical Studies In Patients Wit

By, Admin 5 October 2020

Teneobio, Inc. And Its Affiliate Teneotwo, Inc. Announced Today That Their Investigational New Drug Application (Ind) For Tnb-486, A Bispecific T-Cell Engaging Antibody For The Treatment Of B-Cell Non-Hodgkin&Rsquo;S Lymphoma (B-Nhl) Was Cleared For The Initiation Of Phase I Clinical Studies By The Us Food And Drug Administration (Fda) On September 30, 2020.Tnb-486 Is A Fully Human Bispecific Antibody That Binds Cd19 With One Arm And Incorporates A Unique Anti-Cd3 On The Other. In Preclinical Studies, Tnb-486 Induced T-Cell Dependent Killing Of Cd19-Positive B-Cell Leukemia And Lymphoma Cells While Inducing Minimal Cytokine Secretion, A Feature That Could Limit Immune Mediated Toxicities While Retaining Cytotoxic Activity.Benjamin Buelow, Cmo Of Teneobio, Inc., Added, &Ldquo;We Are Excited To Bring Our Differentiated T-Cell Engager Therapy To Relapsed And/Or Refractory Lymphoma Patients, For Whom A Safe And Effective Therapeutic Option Remains An Unmet Need. The Unique Anti-Cd3 Arm In Teneobio&Rsquo;S T-Cell Engagers Uncouples Toxic Cytokine Release From Tumor Cell Killing And Is Designed To Maximize The Therapeutic Window For This Class Of Therapies. Tnb-486 Also Has A Predicted Half-Life Of Over Two Weeks That Enables A Patient- And Provider-Focused Dosing Schedule. An Off-The-Shelf Cd19-Targeted Therapy With A Convenient Dosing Regimen Will Be A Tremendous Boon To The Fight Against This Terrible Disease.&Rdquo;About Teneobio, Inc.Teneobio, Inc. Is A Clinical Stage Biotechnology Company Developing A New Class Of Biologics, Human Heavy-Chain Antibodies (Uniab&Reg;), For The Treatments Of Cancer, Autoimmunity, And Infectious Diseases. Teneobio&Rsquo;S Discovery Platform, Teneoseek, Comprises Genetically Engineered Animals (Unirat&Reg; And Omniflic&Reg;), Next-Generation Sequencing, Bioinformatics And High-Throughput Vector Assembly Technologies. Teneoseek Rapidly Identifies Large Numbers Of Unique Binding Molecules Specific For Therapeutic Targets Of Interest. Versatile Antibody Variable Domains (Unidab&Reg;) Derived From Uniab&Reg; Can Be Assembled Into Multi-Specific And Multivalent Therapeutic Proteins, Surpassing Limitations Of Conventional Antibody Therapeutics. Teneobio&Rsquo;S &Ldquo;Plug-And-Play&Rdquo; T-Cell Engaging Platform Includes A Diverse Set Of Anti-Cd3 Antibodies For Therapeutics With Optimal Efficacy And Reduced Toxicity.

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