Double 叒叕! Xinda BioLAG-3/PD-L1 double anti-declaration clinical.

Today, China's State Drug Administration Drug Review Center (CDE) recently announced that Xinda Bio-declared class 1 bio-new drug IBI323 clinical trial application was accepted.
this is a new LAG-3/PD-L1 dual-specific antibody, but also the secondary anti-CD47/PD-L1 dual anti-IBI322, anti-PD-1/PD-L1 dual anti-I After products such as BI318, anti-PD-1/HER2 dual anti-IBI315, and anti-VEGF/complement dual anti-IBI302, Xinda Bio has another new drug with dual-specific antibody that is about to enter the clinical stage.
Screenshot Source: CDE Website Dual-Specific Antibody Therapy is another way to kill tumors using T-cells from the patient's immune system.
is different from the single target of single resistance, dual-specific antibodies contain 2 specific antigen binding points, which can stimulate specific biological functions such as guided immune response by binding to different mesotypses.
can be seen from Xinda Bio in the pipeline, dual-specific antibodies are one of the company's key research and development areas.
According to public information, the company currently has at least eight dual-specific antibodies, mostly innovative "first-in-class" products, including tumor cells and immune cell products, immune cell double target suppression and tumor cell double target suppression.
the product in an antho-section of this article.
(1) IBI323: LAG-3/PD-L1 This is a LAG-3/PD-L1 dual-specific antibody with the potential to become a "first-in-class" new drug.
is the first time that IBI323 has been declared clinically in China for cancer treatment.
, it has shown in preclinical studies that its in vitro efficacy and in vivo efficacy are superior to anti-LAG-3 monoantial and anti-PD-L1 monoantial combination therapy.
tumor micro-environment, cancer cells avoid recognition and attack by raising the level of PD-L1 expression.
, known as lymphocyte activation gene-3, is an immune checkpoint subject that affects the surface expression of T cells and regulatory T cells.
studies have shown that inhibiting LAG-3 allows T-cells to regain cytotoxic activity and reduces the ability to regulate T-cells' ability to suppress immune responses, thereby enhancing the effectiveness of tumor damage.
It is worth mentioning that Xinda Bio already has an anti-LAG-3 monoclonal antibody in its research product that is undergoing clinical studies, including a clinical study in China to evaluate the treatment of advanced malignancies with IBI110 monodrings or combined PD-1 antibodies.
(2) IBI322:CD47/PD-L1 This is a potential first recombinant anti-CD47/PD-L1 dual-specific antibody developed by Xinda Bio, which has been approved by China's State Drug Administration and the FDA's IND and is currently under global development.
August 3, Xinda Bio announced that phase 1 clinical studies of IBI322 had completed the first patient drug treatment in China.
This is a phase 1a/1b clinical study conducted in China to evaluate the treatment of patients with advanced malignancies with the main purpose of evaluating the safety, tolerance and initial anti-tumor activity of IBI322 in patients with advanced malignancies who failed standard treatment.
CD47 (recombinant all-human source anti-differentiation antigen cluster 47) protein is an overexpressed immunomodulation molecule on cancer cells, unlike PD-1, PD-L1, CTLA-4 and other immuno checkpoint inhibitors acting on T cells, CD47 mainly inhibits the phagocytorapy mechanism of macrophages by regulating protein α (SIRP alpha) with inhibitory subject signaling.
IBI322 is expected to enhance the body's ability to kill tumor cells by targeting cd47 and PD-L1 path roads.
preclinical studies have shown that IBI322 can effectively block the binding of SIRP-α to CD47, inducing macrophages to act as phagocytosphagy on tumor cells expressed together with CD47 and PD-L1.
, on the other hand, IBI322 effectively blocks the binding of PD-1 to PD-L1 and activates CD4-T lymphocytes.
According to the announcement, the product has the pioneering potential of molecules, more affinity with tumor tissue, thereby reducing the toxicity of the target to normal tissue and delaying the occurrence of drug resistance, it is expected to provide more effective treatment for cancer patients.
(3) IBI315:PD-1/HER2 IBI315 is a recombinant all-human IgG1 anti-PD-1/HER2 dual-specific antibody developed by Xinda Bio in China.
preclinical studies have shown that IBI315 can improve anti-tumor activity by bridging T lymphocytes expressing PD-1 and tumor cells expressing HER2 through two-target-specific binding bridging.
November 2019, the two sides jointly announced that phase 1 clinical studies of IBI315 had completed the first patient drug treatment in China.
This is a phase 1 clinical study conducted in China to evaluate the IBI315 treatment of patients with advanced solid malignancies expressed by HER2, with the aim of evaluating the safety, tolerance, initial effectiveness and recommended dose (RP2D) of IBI315 monodrative and combination chemotherapy in patients with advanced solid malignant tumors.
IBI315 is the world's first PD-1/HER2 dual-specific antibody to enter clinical development, according to Xinta Bio.
(4) IBI318: PD-1/PD-L1 IBI318 is a recombinant all-human source IgG1 anti-PD-1 developed by Xinda Bio and Eli Lilly and Company 1/PD-L1 dual specific antibody, by blocking PD-1 and PD-L1/PD-L2 signaling path, and blocking PD-L1 in combination with CD80 signaling path, to restore T cell activation and anti-tumor function.
IBI318, through its dual-specific properties, bridges the expression of PD-1 T cells and the expression of PD-L1 tumor cells, so that the two form immune synapses, which is expected to improve anti-tumor activity and efficacy.
at the ASCO meeting in June 2020, Xinta Bio presented the preliminary results of phase 1a clinical studies of IBI318 in the form of a wall report.
this is a Phase 1 clinical study in China to evaluate the treatment of advanced malignancies with IBI318 to assess the safety, tolerance and anti-tumor activity of IBI318 in patients with advanced tumors.
preliminary research data show that IBI318 has acceptable security.
(5) IBI302: VEGF/complement According to Xinda Bio-website, IBI302 is an anti-VEGF/complement dual-specific antibody injection with VEGF and C3b, C4 b is the target point, combined with vascular endosthort growth factor (VEGF) and complement two targets, by blocking VEGF signaling path and complement activity, inhibit the growth of lesions of new blood vessels, and then eliminate the etopathy from the source, to achieve the effect of both specimen and treatment.
China Drug Clinical Trial Registration and Information Disclosure Platform shows that Xinda Bio is conducting two clinical trials on IBI302: a Phase 1 clinical study with increasing doses to assess IBI302-related macular degeneration (AM) at wet age D) Single dosage tolerance and safety in patients, and another clinical study for dose increment, designed to assess the tolerance and safety of IBI302 multiple dosages in neurovascular age-related macular degeneration (nAMD) subjects.
(6) Other dual-specific antibodies in the study in addition to the above-mentioned products, Xinda Bio also has a number of dual-specific antibodies in the study of products, including IBI319, IBI321, IBI327 and so on.
, IBI319 is a dual-specific antibody that binds to the main chain of anti-PD-1, IBI321 is a dual-specific antibody that targets PD-1 and another undeclodied target, and IBI327 is an anti-PD-L1/OX40 dual-specific antibody.
: The preliminary results of a clinical study of anti-PD-1/PD-L1 dual-specific antibody IBI318 Ia were published by Xinda Bio. Retrieved June 02, 2020, June 2, 2020.
: Anti-PD-1/HER2 Dual-Specific Antibody Phase I Clinical Study Completes First Patient Prescription in China. Retrieved Nov. 27, 2019, from s3 s anti-CD47/PD-L1 tyro-resistant anti-tyroidal phase 1bed study completed in China's first patient. Retrieved Aug. 3, 2020, from the 4th Xinda Bio first welcomed the "investor open day", sailing a new starting point, hand in hand to create the future. Retrieved Sep. 23, 2019, from Thyda Biometrics Original title: ! Xinda bioLAG-3/PD-L1 dual anti-declaration clinical, other in the study of dual-specific antibodies and these ...