Antengene Announces First Patient Dosed in the PROBE-CN Study of ATG-101
-ATG-101 is a novel PD-L1/4-1BB bispecific antibody. It is Antengene’s first in-house developed molecule with global rights.
-ATG-101 demonstrates potent in vivo efficacy in anti-PD-1/PD-L1 resistant mouse tumor models.
Shanghai and Hong Kong, PRC, August 3, 2022 — Antengene Corporation Limited (“Antengene” SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, today announced that the first patient has been dosed in the Phase I PROBE-CN trial to evaluate ATG-101 as a monotherapy in patients with advanced/metastatic solid tumors or B-cell non-Hodgkin lymphoma (B-NHL) in China.
Shanghai East Hospital of Tongji University is the lead site for the study, which will be conducted at four centers across China. This open-label, multicenter Phase I study is designed to assess the safety and tolerability of intravenously administered ATG-101 monotherapy in patients with advanced/metastatic solid tumors and B-NHL. The study will be conducted in two parts (dose-escalation and a dose-expansion).
ATG-101 is a novel PD-L1/4-1BB bispecific antibody that was designed to block the binding of immunosuppressive PD-1/PD-L1 and conditionally induce 4-1BB stimulation, thus activating anti-tumor immune effectors, while delivering enhanced anti-tumor activity, with an improved safety profile. In preclinical studies, ATG-101 demonstrated significant anti-tumor activity in animal models of resistant tumors as well as those that progressed on anti-PD-1/L1 treatment. Furthermore, ATG-101 has also shown an excellent safety profile in Good Laboratory Practice (GLP) toxicology studies.
“Since many patients with advanced cancer are resistant to existing chemotherapy, targeted drugs, and monoclonal antibodies or relapse in a short time after receiving treatment, there is an urgent need for innovative therapies that can improve treatment options. Increasing evidence suggests that bispecific antibodies will become a critical component of cancer therapy. We are excited to have the opportunity to collaborate with a number of prominent investigators in China to conduct the first clinical study of ATG-101, a novel PD-L1/4-1BB bispecific antibody,” said Professor Ye Guo, Deputy Director of Medical Oncology at Shanghai East Hospital of Tongji University, Director of the hospital’s center for Phase I trials, and principal investigator of the study. “ATG-101 has a high affinity for PD-L1 and can achieve conditional activation of 4-1BB agonist, which is expected to bring a lower risk of systemic toxicity, particularly the hepatotoxicity that has been seen with previous agonists of 4-1BB. We hope that ATG-101 will demonstrate efficacy and safety, and bring a new treatment option to patients with resistant or relapsed cancers.”
“The development of novel therapies to improve and advance the care of patients with resistant, relapsed, or advanced cancers is central to Antengene’s mission. Compounds that combine the well-established efficacy of inhibition of the PD-1/PD-L1 axis with activation of 4-1BB represent a fascinating opportunity in oncology. In our view, ATG-101’s ability to activate exhausted T-cells and render ‘cold tumors’ hot has the potential to open the door to wide applicability in resistant/relapsed diseases. These qualities,together with a robust preclinical data package, position ATG-101 to be a potentially best-in-class molecule.” said Dr. Kevin Lynch, Antengene’s Chief Medical Officer.
ATG-101 is a novel PD-L1/4-1BB bi-specific antibody being developed for the treatment of advanced/metastatic solid tumors and B-cell non-Hodgkin lymphoma (B-NHL). ATG-101 was designed to activate anti-tumor immune effectors by forming a cell-antibody-cell trimer to simultaneously block the binding of PD-L1/PD-1 and induce 4-1BB stimulation. In PD-L1 over-expressing cancer cells, ATG-101 has shown potent PD-L1 crosslinking-dependent 4-1BB agonist activity, with the potential for delivery of enhanced therapeutic efficacy whilst mitigating the risk of hepatoxicity.
Data presented at the Annual Meeting of Society for Immunotherapy in Cancer (SITC) in 2021 showed that ATG-101 was active in anti-PD-L1 resistant and relapsed tumor models. ATG-101’s unique safety and efficacy properties make it a promising potential therapy for solid tumors and hematological cancers. To date, ATG-101 has received regulatory clearances in Australia, U.S., and China to enter a Phase I clinical study for the treatment of advanced/metastatic solid tumors and NHL. The study has already been initiated in Australia and China and is in the process of initiation in the U.S.
Antengene Corporation Limited (“Antengene”, SEHK: 6996.HK) is a leading commercial-stage R&D-driven global biopharmaceutical company focused on the discovery, development, manufacturing and commercialization of innovative first-in-class/best-in-class therapeutics for the treatment of hematologic malignancies and solid tumors, in realizing its vision of “Treating Patients Beyond Borders”.
Since 2017, Antengene has built a broad and expanding pipeline of 15 clinical and preclinical assets, of which 10 are global rights assets, and 5 came with rights for Asia Pacific markets including the Greater China region. To date, Antengene has obtained 24 investigational new drug (IND) approvals in the U.S. and Asia, and submitted 6 new drug applications (NDAs) in multiple Asia Pacific markets, with the NDA for XPOVIO® (selinexor) already approved in mainland China, South Korea, Singapore and Australia.
The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, see the section titled “Risk Factors” in our periodic reports filed with the Hong Kong Stock Exchange and the other risks and uncertainties described in the Company’s Annual Report for year-end December 31, 2021, and subsequent filings with the Hong Kong Stock Exchange.
Antengene Announces Five Upcoming Presentations at the 2022 American Association for Cancer Research Annual MeetingLearn more
Antengene Announces IND Approval in China for the Phase I Study of ATG-101 for the Treatment of Solid Tumors and Non-Hodgkin LymphomaLearn more
Antengene Announces IND Approval in China for a Phase II Study of Eltanexor (ATG-016) in Patients with High-Risk Myelodysplastic SyndromesLearn more
Antengene Announces XPOVIO® Regulatory Approval in SingaporeLearn more
Antengene Announces XPOVIO® Approved by the TGA in Australia for the Treatment of Relapsed and/or Refractory Multiple Myeloma and Triple Class-Refractory Multiple MyelomaLearn more
Antengene to Present at the 40th Annual J.P. Morgan Healthcare ConferenceLearn more
Antengene Announces HREC Approval in Australia for the Phase I Trial of the Small Molecule CD73 Inhibitor ATG-037Learn more
Antengene’s Pivotal “MARCH” Study to Evaluate Selinexor (ATG-010) in Relapsed or Refractory Multiple Myeloma Published in BMC MedicineLearn more
Antengene Announces Latest Clinical Trial Data of ATG-008 (onatasertib) to be presented in the upcoming 2022 American Society of Clinical Oncology Annual MeetingLearn more
Antengene Announces Publication of Five Posters at the 2022 American Association for Cancer Research (AACR) Annual MeetingLearn more
Antengene Announces Submission to the Human Research Ethics Committee in Australia for a Phase I Trial of ATG-018Learn more
Antengene and XtalPi Announce AI-Driven R&D CollaborationLearn more
Antengene Announces Clinical Collaboration with Bristol Myers Squibb to Evaluate ATG-017 in Combination with Opdivo (nivolumab) in Advanced Solid TumorsLearn more
Antengene Presents Results of Phase 1b TOUCH Trial of Selinexor (ATG-010) for the Treatment of T and NK-Cell Lymphoma at the 2021 American Society of Hematology (ASH)Learn more
First Patient Dosed in Australia in ATG-101 First-in-Human TrialLearn more
Antengene Announces First Patient Dosed in REACH Study of ATG-016 for the Treatment of Advanced Solid TumorsLearn more
Antengene Announces NDA Approval by NMPA for XPOVIO®, China’s First XPO1 inhibitor, for the Treatment of Adults with Relapsed or Refractory Multiple MyelomaLearn more
Antengene Included in the MSCI Global Small Cap Indexes – MSCI China Index Constituent StocksLearn more
Antengene Presents Compelling Preclinical Data on Two Programs at the Society for Immunotherapy of Cancer (SITC) Annual Meeting on November 12, 2021Learn more
Antengene to Release Preliminary Results of Phase 1b TOUCH Trial of Selinexor (ATG-010) for the Treatment of Peripheral T-Cell Lymphoma and NKT-Cell Lymphoma at the 2021Learn more
Antengene Announces IND Approval in China for a Phase I II Study of Selinexor (ATG-010) in Patients with Non-Hodgkin LymphomaLearn more
Antengene Receives FDA Approval of IND for Phase 1 Trial of ATG-101 (PD-L14-1BB bispecific antibody) in Solid Tumors and Non-Hodgkin LymphomaLearn more
Antengene Granted IND Approval in China for the Phase Ib Study of ATG-008 (Onatasertib) in Combination with ATG-010 (Selinexor) in Patients with Diffuse Large B-Cell LymphomaLearn more
Treating Patients Beyond Borders - Antengene Successfully Hosted Its First R&D DayLearn more
Antengene Announces Research Collaboration with CelularityLearn more
“Research collaboration and introduction of new drugs will continue in South Korea, regarded as an attractive market”Learn more
Domestic biopharmaceutical companies will have strong presence globallyLearn more
Antengene to Participate in Three Upcoming Investor Conferences in May&JuneLearn more
Antengene Announces Addition of Multiple XPOVIO® Treatment Regimens for Myeloma and Lymphoma in 2022 CSCO GuidelinesLearn more
Antengene Announces XPOVIO® (selinexor) Data to be Presented at the Upcoming 2022 European Hematology Association Hybrid CongressLearn more
Antengene Announces Commercial Availability of XPOVIO® (Selinexor) Prescribed for the First Time Across Mainland ChinaLearn more
Antengene Announces XPOVIO® Treatment Regimens Included for the First Time in the Guidelines for the Diagnosis and Management of Multiple Myeloma in ChinaLearn more
Antengene Announces First Patient Dosed in the Phase I II SWATCH Study of XPOVIO® (Selinexor) for the Treatment of B-Cell Non-Hodgkin LymphomasLearn more
Antengene to Present Clinical Results of ATG-008 (Onatasertib) at the 2022 American Society of Clinical Oncology Annual MeetingLearn more
Antengene Announces HREC Approval in Australia for the Phase I Trial of the Small Molecule ATR Inhibitor ATG-018Learn more
Antengene Announces First Patient Dosed in the Phase I STAMINA-001 Study of ATG-037 for the Treatment of Patients with Locally Advanced or Metastatic Solid TumorsLearn more
Antengene Announces Clinical Trial Collaboration with BeiGene to Evaluate Selinexor in Combination with Tislelizumab in T and NK-Cell LymphomaLearn more