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December 24, 2021/eMedClub PR News/--Recently, a leading innovative global biopharmaceutical company Deqi Pharmaceuticals announced the company’s bispecific antibody (PD-L1/4-1BB) candidate product ATG-101 was administered to the first patient in the Phase 1 PROBE clinical trial in Australia, mainly for the treatment of metastatic/advanced solid tumors and B-cell non-Hodgkin’s lymphoma (B-NHL)
.
The first purpose of the pilot study is to evaluate the safety and tolerability of ATG-101, and to determine the maximum tolerated dose (MTD) and/or phase 2 dose (RP2D) of ATG-101; the second purpose is to evaluate The preliminary anti-tumor activity of ATG-101
.
ATG-101 is a new PD-L1/4-1BB bispecific antibody, which is being developed for the treatment of various cancers
.
ATG-101 is designed to block the binding of immunosuppressive PD-1/PD-L1 and induce 4-1BB stimulation, thereby activating anti-tumor immune effectors, thereby enhancing anti-tumor activity and safety
.
ATG-101 can activate depleted cells in vitro, indicating that it is possible to reverse T cell dysfunction and depletion (PD-1 cross-linking)
.
Among PD-1 overexpressing cancer cells, ATG-101 has shown significant anti-tumor activity in animal tumors that have progressed in anti-PD-1/L1 therapy, and has shown good safety in GLP toxicology studies
.
In addition, ATG-101 also exhibits significant anti-tumor activity in animal models of drug-resistant tumors and animal models of anti-PD-L1/L1 treatment
.
The PROBE trial is the first human phase 1 trial of ATG-101 in patients with metastatic/advanced solid tumors and mature B-cell non-Hodgkin's lymphoma (B-NHL).
The study will be conducted during the dose escalation phase and the dose expansion phase
.
This trial is the first global trial conducted by Deqi Pharmaceuticals on a new drug.
The trial plans to recruit patients in Australia and then expand to the United States
.
ATG-101 has obtained the IND approved by the FDA in the United States
.
Dr.
Kevin Lynch, Chief Medical Officer of Deqi Pharmaceuticals, said: “ATG-101 is specifically designed to combine the proven PD-1 inhibitory activity with the immunostimulatory activity of 4-1BB
.
Our goal is to “cold” the tumor "Hot" to further enhance the anti-tumor activity, in order to re-fight the drug-resistant and refractory diseases, which has become a growing and important medical demand
.
The first patient trial of the PROBE trial is an important milestone.
It highlights our cross-regional exploration and clinical execution capabilities
.
"PD-L1/4-1BB antibody tumor immunotherapy is a treatment method that restores or enhances the natural defenses against tumors through the human immune system
.
This treatment method targets specific biomolecules on the surface of cancer cells, such as tumor-associated antigens (TAAs), and the anti-tumor activity is achieved by directing the host immune system to TAAs, thereby establishing or inducing an adaptive immune response against cancer cells
.
4-1BB was identified as an inducible gene in 1989.
It is expressed on T cells initiated by the antigen, but not on quiescent T cells
.
4-1BB (CD137), also known as tumor necrosis factor superfamily receptor 9, is a type I transmembrane glycoprotein, which belongs to the tumor necrosis factor receptor (TNFR) superfamily member.
It consists of signal peptide, extracellular domain, hydrophobic domain and cell The inner region is composed of monomers or dimers expressed on the surface of activated T cells
.
4-1BB is mainly expressed on the surface of CD4+T and CD8+T, and can also be expressed on NK cells.
Because anti-4-1BB antibody has the ability to activate cytotoxic T cells and increase the production of interferon-γ (IFN-γ), Shows great potential in anti-cancer
.
For PD-L1, it is a ligand of PD-1, which is mainly expressed on tumor cells, which can inhibit the proliferation of CD8+ T cells in lymph nodes and help tumor immune escape
.
Looking at the world, due to the unsatisfactory therapeutic effect and safety data of monoclonal antibodies, there are still serious liver toxicity, which may be due to the excessive activation of T cells, which leads to the risk of systemic immune response
.
Therefore, bispecific antibodies with two or more specific antigen binding sites are expected to improve the effectiveness and safety of the product
.
➤ On December 7, 2021, Biocytometer's wholly-owned subsidiary, Youhe Pharmaceutical, announced that its YH004 (4-1BB monoclonal antibody) Phase I (No.
YH004002) clinical study in Australia has completed the first patient administration
.
YH004 is a humanized IgG1 monoclonal antibody (mAb) that binds to human 4-1BB with high affinity and specificity, and can stimulate 4-1BB
.
YH004 enhances anti-tumor immunity through multiple mechanisms of action
.
Antibody-mediated 4-1BB stimulation can enhance T cell costimulation, increase NK cell cytotoxicity, promote the maturation of antigen presenting cells (APC) and inhibit regulatory T cells (Tregs)
.
Recommended reading: Biocytometer/Youhe International clinical research enters a new journey: 4-1BB monoclonal antibody completes the first phase I administration in Australia ➤ On September 7, 2021, the CDE official website showed that Qilu Pharmaceutical’s PD-L1/4 The -1BB double antibody QLF31907 was approved for clinical use
.
Recommended reading: Qilu Pharmaceutical's PD-L1/4-1BB double antibody was approved for clinical useYimai Meng broke the news ➤ On July 14, 2021, the Center for Drug Evaluation accepted Nanjing Weilizhibo Biotechnology Co.
, Ltd.
's anti-tumor class 1 biological drug, Clinical application of LBL-024 for injection
.
LBL-024 is a tetravalent bispecific antibody that can simultaneously target PD-L1 and 4-1BB, which can restrict the activation of T cell 4-1BB signal only in the tumor microenvironment expressing PD-L1.
The patient's toxicity may be lower
.
Recommended reading: Wei Li Zhibo: PD-L1/4-1BB bi-antibody reported to the clinicYi Mai Meng broke the news ➤ In April 2021, Tianjing Bio and ABL Bio from South Korea jointly announced the bispecific antibody TJ-L14B jointly developed by the two parties / ABL 503 has been administered to the first patient in the Phase 1 clinical study in the United States
.
The drug is a highly differentiated bispecific antibody based on PD-L1 developed by Tianjing Bio and ABL Bio.
By blocking PD-L1 signal and stimulating 4-1BB signal, it activates T cells to produce anti-tumor synergy It can transform the "cold" tumor with weak immune response into "hot" tumor sensitive to PD-(L)1 treatment
.
Recommended reading: Biospace and ABL Bio announced that the PD-L1/4-1BB double antibody has completed the first patient dosing in the United StatesYimai Meng broke the news.
Reference materials: 1.
https:// /first-patient-dosed-in-australia-in-atg-101-first-in-human-trial/2.
https://#rd_4 Statement: The content in this article is only for exploring biology Advances in the frontiers of medicine do not constitute any medical guidance.
If necessary, please go to a regular hospital for treatment
.
Recommended recent articles
.
The first purpose of the pilot study is to evaluate the safety and tolerability of ATG-101, and to determine the maximum tolerated dose (MTD) and/or phase 2 dose (RP2D) of ATG-101; the second purpose is to evaluate The preliminary anti-tumor activity of ATG-101
.
ATG-101 is a new PD-L1/4-1BB bispecific antibody, which is being developed for the treatment of various cancers
.
ATG-101 is designed to block the binding of immunosuppressive PD-1/PD-L1 and induce 4-1BB stimulation, thereby activating anti-tumor immune effectors, thereby enhancing anti-tumor activity and safety
.
ATG-101 can activate depleted cells in vitro, indicating that it is possible to reverse T cell dysfunction and depletion (PD-1 cross-linking)
.
Among PD-1 overexpressing cancer cells, ATG-101 has shown significant anti-tumor activity in animal tumors that have progressed in anti-PD-1/L1 therapy, and has shown good safety in GLP toxicology studies
.
In addition, ATG-101 also exhibits significant anti-tumor activity in animal models of drug-resistant tumors and animal models of anti-PD-L1/L1 treatment
.
The PROBE trial is the first human phase 1 trial of ATG-101 in patients with metastatic/advanced solid tumors and mature B-cell non-Hodgkin's lymphoma (B-NHL).
The study will be conducted during the dose escalation phase and the dose expansion phase
.
This trial is the first global trial conducted by Deqi Pharmaceuticals on a new drug.
The trial plans to recruit patients in Australia and then expand to the United States
.
ATG-101 has obtained the IND approved by the FDA in the United States
.
Dr.
Kevin Lynch, Chief Medical Officer of Deqi Pharmaceuticals, said: “ATG-101 is specifically designed to combine the proven PD-1 inhibitory activity with the immunostimulatory activity of 4-1BB
.
Our goal is to “cold” the tumor "Hot" to further enhance the anti-tumor activity, in order to re-fight the drug-resistant and refractory diseases, which has become a growing and important medical demand
.
The first patient trial of the PROBE trial is an important milestone.
It highlights our cross-regional exploration and clinical execution capabilities
.
"PD-L1/4-1BB antibody tumor immunotherapy is a treatment method that restores or enhances the natural defenses against tumors through the human immune system
.
This treatment method targets specific biomolecules on the surface of cancer cells, such as tumor-associated antigens (TAAs), and the anti-tumor activity is achieved by directing the host immune system to TAAs, thereby establishing or inducing an adaptive immune response against cancer cells
.
4-1BB was identified as an inducible gene in 1989.
It is expressed on T cells initiated by the antigen, but not on quiescent T cells
.
4-1BB (CD137), also known as tumor necrosis factor superfamily receptor 9, is a type I transmembrane glycoprotein, which belongs to the tumor necrosis factor receptor (TNFR) superfamily member.
It consists of signal peptide, extracellular domain, hydrophobic domain and cell The inner region is composed of monomers or dimers expressed on the surface of activated T cells
.
4-1BB is mainly expressed on the surface of CD4+T and CD8+T, and can also be expressed on NK cells.
Because anti-4-1BB antibody has the ability to activate cytotoxic T cells and increase the production of interferon-γ (IFN-γ), Shows great potential in anti-cancer
.
For PD-L1, it is a ligand of PD-1, which is mainly expressed on tumor cells, which can inhibit the proliferation of CD8+ T cells in lymph nodes and help tumor immune escape
.
Looking at the world, due to the unsatisfactory therapeutic effect and safety data of monoclonal antibodies, there are still serious liver toxicity, which may be due to the excessive activation of T cells, which leads to the risk of systemic immune response
.
Therefore, bispecific antibodies with two or more specific antigen binding sites are expected to improve the effectiveness and safety of the product
.
➤ On December 7, 2021, Biocytometer's wholly-owned subsidiary, Youhe Pharmaceutical, announced that its YH004 (4-1BB monoclonal antibody) Phase I (No.
YH004002) clinical study in Australia has completed the first patient administration
.
YH004 is a humanized IgG1 monoclonal antibody (mAb) that binds to human 4-1BB with high affinity and specificity, and can stimulate 4-1BB
.
YH004 enhances anti-tumor immunity through multiple mechanisms of action
.
Antibody-mediated 4-1BB stimulation can enhance T cell costimulation, increase NK cell cytotoxicity, promote the maturation of antigen presenting cells (APC) and inhibit regulatory T cells (Tregs)
.
Recommended reading: Biocytometer/Youhe International clinical research enters a new journey: 4-1BB monoclonal antibody completes the first phase I administration in Australia ➤ On September 7, 2021, the CDE official website showed that Qilu Pharmaceutical’s PD-L1/4 The -1BB double antibody QLF31907 was approved for clinical use
.
Recommended reading: Qilu Pharmaceutical's PD-L1/4-1BB double antibody was approved for clinical useYimai Meng broke the news ➤ On July 14, 2021, the Center for Drug Evaluation accepted Nanjing Weilizhibo Biotechnology Co.
, Ltd.
's anti-tumor class 1 biological drug, Clinical application of LBL-024 for injection
.
LBL-024 is a tetravalent bispecific antibody that can simultaneously target PD-L1 and 4-1BB, which can restrict the activation of T cell 4-1BB signal only in the tumor microenvironment expressing PD-L1.
The patient's toxicity may be lower
.
Recommended reading: Wei Li Zhibo: PD-L1/4-1BB bi-antibody reported to the clinicYi Mai Meng broke the news ➤ In April 2021, Tianjing Bio and ABL Bio from South Korea jointly announced the bispecific antibody TJ-L14B jointly developed by the two parties / ABL 503 has been administered to the first patient in the Phase 1 clinical study in the United States
.
The drug is a highly differentiated bispecific antibody based on PD-L1 developed by Tianjing Bio and ABL Bio.
By blocking PD-L1 signal and stimulating 4-1BB signal, it activates T cells to produce anti-tumor synergy It can transform the "cold" tumor with weak immune response into "hot" tumor sensitive to PD-(L)1 treatment
.
Recommended reading: Biospace and ABL Bio announced that the PD-L1/4-1BB double antibody has completed the first patient dosing in the United StatesYimai Meng broke the news.
Reference materials: 1.
https:// /first-patient-dosed-in-australia-in-atg-101-first-in-human-trial/2.
https://#rd_4 Statement: The content in this article is only for exploring biology Advances in the frontiers of medicine do not constitute any medical guidance.
If necessary, please go to a regular hospital for treatment
.
Recommended recent articles
