Boan Bio's anti-PD-L1/TGF-β innovative double antibody BA1201 was approved for clinical use

Luye Pharmaceutical Group announced that the anti-PD-L1/TGF-β bispecific antibody BA1201 independently developed by its holding subsidiary Boan Biologics has been approved by the Drug Evaluation Center of the China National Medical Products Administration to conduct clinical trials
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BA1201 is an anti-PD-L1/TGF-β bispecific antibody fusion protein for the treatment of advanced solid tumors and other indications
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This product is also Boan's first new drug under development for bispecific antibodies that has been approved to enter the clinic
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The approved clinical trial is a phase I clinical study evaluating the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BA1201 in patients with advanced solid tumors
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Different from the single target of monoclonal antibodies, bispecific antibodies can bind to two antigens at the same time to regulate two signal pathways related to the treatment of cancer, which has unique advantages in tumor immunotherapy
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BA1201 is a bifunctional antibody fusion protein with TGF-βRII fused to the C-terminus of the PD-L1 antibody.
It can simultaneously inhibit the PD-L1/PD-1 signaling pathway and the TGF-β/TGF-βRII signaling pathway, thereby releasing immune suppression in the body , And restore the body's immune killing ability, which has stronger anti-tumor potential than traditional PD-L1 monoclonal antibodies
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In the tumor microenvironment, programmed cell death ligand-1 (PD-L1) and transforming growth factor-β (TGF-β) are usually highly expressed
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PD-L1 binds to PD-1 on the surface of lymphocytes to inhibit the proliferation and activation of lymphocytes and induce their apoptosis, leading to immune escape of tumor cells; and TGF-β not only drives tumorigenesis, but is also an important factor in immunosuppression , Can mediate the primary drug resistance of tumor cells against PD-L1 monoclonal antibody
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Blocking the two immunosuppressive signals of PD-L1 and TGF-β at the same time can produce a synergistic anti-tumor effect, potentially improving the current low response rate of PD-L1/PD-1 inhibitors
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The results of pre-clinical studies show that the PD-L1 end antibody of BA1201 has excellent affinity and exhibits good anti-tumor activity in multiple mouse models; compared to the standard product, its binding sensitivity on PD-L1 positive cells is better Good (IC50 value is three times lower); it shows good stability and long half-life in mice and cynomolgus monkeys, and the risk of cardiotoxicity is low
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Dr.
Dou Changlin, President and Chief Operating Officer of Boan Biosciences, said: "The development complexity and technical barriers of bispecific antibodies are higher than those of monoclonal antibodies.
Boan Biosciences has accumulated advantages in technology platforms and efficient and collaborative innovation capabilities over the years.
I believe this will help us accelerate the development of BA1201 and more subsequent double-antibody drug candidates, continuously optimize our own antibody development technology, and add more blockbuster products to the company's product line
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" About Boan BioBoan Bio is Luye Pharmaceutical The holding subsidiary of the group is a comprehensive biopharmaceutical company, specializing in the development, production and commercialization of therapeutic antibodies, focusing on tumors, autoimmune, pain and endocrine diseases
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The company's antibody discovery activities revolve around three platforms, namely, fully human antibody transgenic mice and phage display technology platform, bispecific T-cell Engager technology platform and antibody conjugated drug (ADC) technology platform
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At present, Boan Bio has built a portfolio of more than 10 innovative antibodies with international intellectual property protection and 7 biosimilar drugs.
Its first biosimilar product Boyouno® (bevacizumab injection) has been Listed in China
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Boan Biology has a complete integrated industrial chain from antibody production and lead optimization, cell line establishment and process development, technology transfer, pilot production and commercial production
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In addition, the company is also actively deploying around cutting-edge technologies.
Its cell therapy products use non-viral vectors to prepare advanced solid tumor CAR-Ts, and deploy a new generation of universal and controllable CAR-Ts to rapidly develop safer, effective, and affordable CAR-Ts.
CAR-T products
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In addition to China, Boan Bio is also engaged in the development of biopharmaceutical products in the US and EU markets
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