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The study will evaluate ATG-101, a PD-L1/4-1BB bispecific antibody independently developed by Deqi Pharmaceuticals.
The trial will enroll patients with metastatic/advanced solid tumors and B-cell non-Hodgkin’s lymphoma.
Shanghai, China And Hong Kong, December 20, 2021-Deqi Pharmaceutical Co.
, Ltd.
(abbreviated as "Deqi Pharmaceutical", Hong Kong Stock Exchange stock code: 6996.
HK) today announced that ATG-101 in Australia was used to treat metastatic disease.
/The first phase I human trial (PROBE study) of advanced solid tumors and B-cell non-Hodgkin's lymphoma (B-NHL) has completed the first patient dosing
.
The main purpose of the study is to evaluate the safety and tolerability of ATG-101, and to determine the maximum tolerable dose (MTD) and/or phase II recommended dose (RP2D) of ATG-101
.
The secondary purpose is to evaluate the preliminary anti-tumor activity of ATG-101
.
As a new PD-L1/4-1BB bispecific antibody, ATG-101 can block the immunosuppressive PD-L1/PD-1 binding and conditionally activate the 4-1BB costimulatory signal, thereby activating anti-tumor Immune effector cells enhance the safety while enhancing the efficacy of the drug
.
ATG-101 has shown potent anti-tumor activity in animal tumor models that are resistant and relapse after receiving anti-PD-1/L1 treatment
.
In addition, in the GLP toxicology study for the drug, no liver toxicity was observed in cynomolgus monkeys with doses up to 100 mg/kg
.
Dr.
Charlotte Lemech, medical director of the Scientia Clinical Research Center in Sydney, Australia, said: “As many patients with malignant tumors are resistant to existing chemotherapeutics, targeted drugs and monoclonal antibody drugs, or after receiving treatment The phenomenon of recurrence, so these patients urgently need innovative drugs that can change the status quo of treatment
.
Increasing evidence shows that bispecific antibodies will become pivotal and innovative treatments in tumor treatment
.
We are very pleased to have the opportunity to develop ATG-101.
The first clinical study of a new PD-L1/4-1BB bispecific antibody, and will cooperate with many senior researchers in the study
.
ATG-101 has a high affinity for PD-L1 and can achieve 4-1BB The activation of the conditions is expected to bring about a lower risk of liver toxicity
.
I hope this bispecific antibody drug can show better efficacy and safety, and bring a new treatment plan for these patients in the near future
.
" Chief Medical Officer Dr.
Kevin Lynch said: "ATG-101 is a drug specially designed and developed to combine the inhibitory effect of PD-1 with the immune activation effect of 4-1BB
.
Its purpose is to transform the tumor from'cold' 'Heat' strengthens the efficacy of tumor immunotherapy, so that patients who cannot benefit from anti-PD-1/L1 monotherapy can get better treatment results, and help patients who have developed resistance to these drugs achieve effective Disease control
.
PROBE is the first global research conducted by Deqi Pharmaceuticals for its independent research and development of innovative drugs
.
Currently, the research has been approved in Australia and the United States, and patient enrollment has been initiated in Australia, followed by the United States
.
At the same time, we are advancing a clinical application called PROBE-CN study in China
.
The first patient drug delivery is an important milestone, once again demonstrating the company's cross-regional drug development and clinical research capabilities
.
I am very grateful to all subjects, researchers and staff of the research center for their support and dedication to this research
.
It is hoped that ATG-101 can bring a breakthrough to the current status of tumor treatment
.
"About the PROBE study PROBE is the first phase I human trial of ATG-101 for the treatment of patients with metastatic/advanced solid tumors and B-cell non-Hodgkin's lymphoma (B-NHL)
.
The study is divided into dose climbing.
The main purpose is to evaluate the safety and tolerability of ATG-101, and to determine the MTD and/or RP2D of ATG-101
.
The
secondary purpose is to evaluate the preliminary anti-tumor activity of ATG-101
.
In addition The study will also evaluate a number of pharmacological, immunological and biomarker indicators
.
About ATG-101 ATG-101 is a new PD-L1/4-1BB bispecific antibody that is being developed for the treatment of a variety of tumors
.
the ATG-based cell 101 may be formed - antibody - trimeric cell structure, block the binding of PD-L1 / PD-1 and activation 4-1BB costimulatory signals to activate antitumor immune effector cells, and effectively reduce Hepatotoxicity
.
ATG-101 can activate depleted immune cells in in vitro studies, showing its potential to reverse T cell dysfunction and cell depletion (under PD-1 cross-linking conditions)
.
For tumors with PD-L1 overexpression Cells, ATG-101 has shown significant anti-tumor activity in animal tumor models that relapse after receiving anti-PD1/L1 treatment, and has shown excellent safety in GLP toxicology studies
.
Deqi Pharmaceutical reported the results of these studies and the development of a unique computational semi-mechanical pharmacology model at the recent annual meeting of the Society for Tumor Immunotherapy (SITC)
.
About Deqi Pharmaceuticals Deqi Pharmaceuticals Co.
, Ltd.
(“Deqi Pharmaceuticals” for short, Hong Kong Stock Exchange stock code: 6996.
HK) is a leading R&D-driven biopharmaceutical company, committed to providing the most advanced products for patients in Asia-Pacific and even the world.
Therapies to treat tumors and other life-threatening diseases
.
Since its official operation in 2017, Deqi Pharmaceuticals has established a rich product pipeline that extends from pre-clinical to clinical stages through cooperative introduction and independent research and development
.
At present, Deck Pharmaceuticals has 15 products under development, of which 5 products have Asia-Pacific rights including the Greater China market, and 10 products have global rights
.
Deck Pharmaceuticals has obtained 20 clinical approval documents (IND) in the United States and multiple Asia-Pacific markets, and submitted 6 new drug listing applications (NDA), of which Celiniso has been approved for new drug listing applications in China and South Korea
.
With the vision of "Doctors have no boundaries, innovation and sustainability", Deqi Pharmaceuticals will focus on the early R&D, clinical research, drug production and commercialization of the first and best-in-class therapies to solve urgent clinical needs
.
The trial will enroll patients with metastatic/advanced solid tumors and B-cell non-Hodgkin’s lymphoma.
Shanghai, China And Hong Kong, December 20, 2021-Deqi Pharmaceutical Co.
, Ltd.
(abbreviated as "Deqi Pharmaceutical", Hong Kong Stock Exchange stock code: 6996.
HK) today announced that ATG-101 in Australia was used to treat metastatic disease.
/The first phase I human trial (PROBE study) of advanced solid tumors and B-cell non-Hodgkin's lymphoma (B-NHL) has completed the first patient dosing
.
The main purpose of the study is to evaluate the safety and tolerability of ATG-101, and to determine the maximum tolerable dose (MTD) and/or phase II recommended dose (RP2D) of ATG-101
.
The secondary purpose is to evaluate the preliminary anti-tumor activity of ATG-101
.
As a new PD-L1/4-1BB bispecific antibody, ATG-101 can block the immunosuppressive PD-L1/PD-1 binding and conditionally activate the 4-1BB costimulatory signal, thereby activating anti-tumor Immune effector cells enhance the safety while enhancing the efficacy of the drug
.
ATG-101 has shown potent anti-tumor activity in animal tumor models that are resistant and relapse after receiving anti-PD-1/L1 treatment
.
In addition, in the GLP toxicology study for the drug, no liver toxicity was observed in cynomolgus monkeys with doses up to 100 mg/kg
.
Dr.
Charlotte Lemech, medical director of the Scientia Clinical Research Center in Sydney, Australia, said: “As many patients with malignant tumors are resistant to existing chemotherapeutics, targeted drugs and monoclonal antibody drugs, or after receiving treatment The phenomenon of recurrence, so these patients urgently need innovative drugs that can change the status quo of treatment
.
Increasing evidence shows that bispecific antibodies will become pivotal and innovative treatments in tumor treatment
.
We are very pleased to have the opportunity to develop ATG-101.
The first clinical study of a new PD-L1/4-1BB bispecific antibody, and will cooperate with many senior researchers in the study
.
ATG-101 has a high affinity for PD-L1 and can achieve 4-1BB The activation of the conditions is expected to bring about a lower risk of liver toxicity
.
I hope this bispecific antibody drug can show better efficacy and safety, and bring a new treatment plan for these patients in the near future
.
" Chief Medical Officer Dr.
Kevin Lynch said: "ATG-101 is a drug specially designed and developed to combine the inhibitory effect of PD-1 with the immune activation effect of 4-1BB
.
Its purpose is to transform the tumor from'cold' 'Heat' strengthens the efficacy of tumor immunotherapy, so that patients who cannot benefit from anti-PD-1/L1 monotherapy can get better treatment results, and help patients who have developed resistance to these drugs achieve effective Disease control
.
PROBE is the first global research conducted by Deqi Pharmaceuticals for its independent research and development of innovative drugs
.
Currently, the research has been approved in Australia and the United States, and patient enrollment has been initiated in Australia, followed by the United States
.
At the same time, we are advancing a clinical application called PROBE-CN study in China
.
The first patient drug delivery is an important milestone, once again demonstrating the company's cross-regional drug development and clinical research capabilities
.
I am very grateful to all subjects, researchers and staff of the research center for their support and dedication to this research
.
It is hoped that ATG-101 can bring a breakthrough to the current status of tumor treatment
.
"About the PROBE study PROBE is the first phase I human trial of ATG-101 for the treatment of patients with metastatic/advanced solid tumors and B-cell non-Hodgkin's lymphoma (B-NHL)
.
The study is divided into dose climbing.
The main purpose is to evaluate the safety and tolerability of ATG-101, and to determine the MTD and/or RP2D of ATG-101
.
The
secondary purpose is to evaluate the preliminary anti-tumor activity of ATG-101
.
In addition The study will also evaluate a number of pharmacological, immunological and biomarker indicators
.
About ATG-101 ATG-101 is a new PD-L1/4-1BB bispecific antibody that is being developed for the treatment of a variety of tumors
.
the ATG-based cell 101 may be formed - antibody - trimeric cell structure, block the binding of PD-L1 / PD-1 and activation 4-1BB costimulatory signals to activate antitumor immune effector cells, and effectively reduce Hepatotoxicity
.
ATG-101 can activate depleted immune cells in in vitro studies, showing its potential to reverse T cell dysfunction and cell depletion (under PD-1 cross-linking conditions)
.
For tumors with PD-L1 overexpression Cells, ATG-101 has shown significant anti-tumor activity in animal tumor models that relapse after receiving anti-PD1/L1 treatment, and has shown excellent safety in GLP toxicology studies
.
Deqi Pharmaceutical reported the results of these studies and the development of a unique computational semi-mechanical pharmacology model at the recent annual meeting of the Society for Tumor Immunotherapy (SITC)
.
About Deqi Pharmaceuticals Deqi Pharmaceuticals Co.
, Ltd.
(“Deqi Pharmaceuticals” for short, Hong Kong Stock Exchange stock code: 6996.
HK) is a leading R&D-driven biopharmaceutical company, committed to providing the most advanced products for patients in Asia-Pacific and even the world.
Therapies to treat tumors and other life-threatening diseases
.
Since its official operation in 2017, Deqi Pharmaceuticals has established a rich product pipeline that extends from pre-clinical to clinical stages through cooperative introduction and independent research and development
.
At present, Deck Pharmaceuticals has 15 products under development, of which 5 products have Asia-Pacific rights including the Greater China market, and 10 products have global rights
.
Deck Pharmaceuticals has obtained 20 clinical approval documents (IND) in the United States and multiple Asia-Pacific markets, and submitted 6 new drug listing applications (NDA), of which Celiniso has been approved for new drug listing applications in China and South Korea
.
With the vision of "Doctors have no boundaries, innovation and sustainability", Deqi Pharmaceuticals will focus on the early R&D, clinical research, drug production and commercialization of the first and best-in-class therapies to solve urgent clinical needs
.
