Shanghai Antengene Corporation Limited

SHANGHAI and HONG KONG, Dec. 6, 2022 /PRNewswire/ -- 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, recently announced that Amily Zhang has been appointed as the Company's Chief Medical Officer, succeeding Dr. Kevin Lynch who will continue working with Antengene in a senior advisory role. Before joining Antengene, Ms. Zhang served in various key leadership positions in clinical development at Jiangsu Hengrui Pharmaceuticals (or "Hengrui Pharma"), including Vice President, Head of Clinical Development - Oncology, Corporate Vice President and Chief Medical Officer for Oncology. Under her leadership, Hengrui Pharma successfully obtained multiple Investigational New Drug (IND) approvals in China and the U.S., as well as numerous New Drug Application (NDA) approvals in China, in nearly three and a half years. Building on strong expertise in oncology and a wealth of experience in the pharmaceutical industry, Ms. Zhang will spearhead Antengene's global clinical development strategy and continue to build out the Company's medical team. Ms. Zhang will be based in both New Jersey, the United States, and Shanghai, China. "I am pleased to welcome Amily Zhang as our new Chief Medical Officer. As a seasoned pharmaceutical executive, Ms. Zhang brings invaluable insights in the clinical development of cancer drugs and medical affairs which will help to further accelerate the development of Antengene's product pipeline, supporting our global expansion and ongoing transition into a leading multinational biopharmaceutical company with a portfolio of commercialized products," said Dr. Jay Mei, Antengene's Founder, Chairman and CEO. "I would also like to thank Dr. Lynch for his service and tremendous contributions to Antengene. He will move to a new role as Senior Medical Expert to continue to support Antengene's global clinical development programs and clinical/medical affairs operations." Amily Zhang commented, "Antengene is emerging as a formidable global biopharmaceutical leader known for its innovation, vibrance, and unique business model. I am deeply honored to join the Company at this time and be a part of this exciting growth story. I look forward to working with my colleagues to create additional value for the company's pipeline. Together, we will strive to develop more breakthrough therapies and support the clinical adoption of innovative medicines to improve the lives of cancer patients around the world." Amily Zhang has over 20 years of experience in the field of oncology and pharmaceutical industry, including 7 years of clinical practice as a medical oncologist and medical hematologist, nearly 18 years in oncology clinical development and medical affairs in the pharmaceutical industry, and over 10 years in leadership positions. Prior to Hengrui Pharma, Ms. Zhang worked for Novartis China and Bayer in both the United States and China for over 12 years during which she was promoted to the position of Global Clinical Leader (GCL)-Oncology and played instrumental roles in the registration of Exjade® and Nexavar®, as well as the clinical development of Xofigo® and Stivarga®, and the development of multiple early-stage compounds. About Antengene 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, driven by its vision of "Treating Patients Beyond Borders". Since its founding in 2017, Antengene has built a broad and expanding pipeline of 15 clinical and preclinical assets, including 10 assets with global rights and 5 with rights for Asia Pacific markets including the Greater China region. To date, Antengene has obtained 26 investigational new drug (IND) approvals in Asia and the U.S., and submitted 7 new drug applications (NDAs) in multiple Asia Pacific markets, with the NDA for XPOVIO® (selinexor) already approved in mainland China, Taiwan, South Korea, Singapore and Australia. Forward-looking statements 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. For more information, please contact: Investor Contacts: Donald Lung E-mail: Donald.Lung@antengene.com Mobile: +86 18420672158 PR Contacts: Peter Qian E-mail: Peter.Qian@antengene.com Mobile: +86 13062747000 View original content to download multimedia: SOURCE Antengene Corporation Limited Company Codes: HongKong:6996

An objective response rate (ORR) of 52.4% was observed in relapsed or metastatic cervical cancer in Phase I/II TORCH-2 Study of ATG-008 (onatasertib) in combination with toripalimab, regardless of PD-L1 status Study builds on promising results of Phase II TORCH monotherapy study in HBV+ patients with unresectable hepatocellular carcinoma (HCC) which demonstrated an ORR of 16.7% in the 45 mg per day dosing cohort Activity also seen in patients with prior CPI treatment Antengene plans to meet with the Center for Drug Evaluation (CDE) of China and move forward to pivotal study in cervical cancer as soon as possible SHANGHAI and HONG KONG, Nov. 15, 2022 /PRNewswire/ -- 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 highlighted preliminary positive results from the TORCH-2 study of ATG-008 (onatasertib) used in combination with toripalimab (PD-1 antibody) in relapsed/metastatic cervical cancer patients (NCT04337463). The combination therapy demonstrated an ORR of 52.4% (based on all treated patients) regardless of PD-L1 status. The results are based on early data from 21 patients, including 10 patients who reached partial response (PR) and 1 patient who achieved a complete response (CR). Five out of the ten responders are still responding, and two patients who are currently in stable disease (SD) still remain on treatment. The median progression free survival (PFS) for these patients is currently 5.5 months. Notably, in the TORCH-2 study, the ORR for PD-L1 positive subjects was 77.8% (7/9). In addition, 1 out of 2 CPI-exposed patients also reached PR. Antengene also highlighted data from the 45 milligram (mg) per day monotherapy dosing cohort of the open-label Phase II TORCH Trial in subjects with Hepatitis B positive (HBV+) unresectable HCC who have received at least one prior line of systemic therapy (NCT03591965). ATG-008 monotherapy demonstrated a 16.7% ORR based on 3 confirmed PRs out of 18 patients in this cohort. The median duration of response (DOR) for these patients is 4.3 months. In the TORCH study, 2 of the 3 patients with PRs were previously treated with a PD-1/PD-L1 antibody. Treatment with ATG-008 monotherapy and in combination with toripalimab was associated with manageable side effects, similar to observations in previous global studies with ATG-008. ATG-008's pharmacokinetic profiles were comparable between ATG-008 monotherapy and the combination with PD-1 antibody and across Asia Pacific (including Greater China) and the U.S. populations. "The 52.4% ORR from the TORCH-2 study with ATG-008 and toripalimab in patients with relapsed/metastatic cervical cancer, coupled with a manageable safety profile, is an exciting result that provides a potential guide to a registration program for ATG-008. Antengene intends to review the data with the Chinese CDE and move forward into pivotal studies as quickly as possible." said Dr. Jay Mei, Antengene's Founder, Chairman and CEO. Dr. Mei continued, "Data from the TORCH and TORCH-2 studies have also demonstrated activity of ATG-008 in patients who have failed previous CPI treatments. This is an important signal that warrants further investigation in a group of patients where there is a desperate need. Importantly, observation of a 16.7% ORR as a monotherapy in the TORCH study is a strong validation of ATG-008's single agent activity." The updated and detailed study results of the TORCH and TORCH-2 will be presented at international scientific conferences in 2023. About the TORCH-2 Trial The TORCH-2 trial (NCT04337463) was designed to evaluate the safety and efficacy of ATG-008 combined with toripalimab (PD-1 antibody) in subjects with advanced solid tumors. Promising signals in several tumor types were observed, especially in advanced cervical cancer. As of the Oct 21, 2022 efficacy evaluation, 21 cervical cancer patients had been dosed with the ATG-008/toripalimab combination including 9 patients (42.9%) who were PD-L1 positive. Initial results of the TORCH-2 study were presented at the 2022 American Society of Clinical Oncology (ASCO 2022) Annual Meeting. About the TORCH Trial The TORCH trial was designed as a multi-regional clinical trial to evaluate the pharmacokinetics, safety, tolerability and efficacy of oral ATG-008 in hepatitis B positive (HBV+) hepatocellular carcinoma (HCC) who had failed at least one prior line of systemic therapy. ATG-008 was administered daily until radiological disease progression (according to RECIST 1.1 criteria) or intolerable toxicity. A total of 73 subjects from mainland China, Taiwan, and South Korea were enrolled in the trial in four dosing cohorts (15 mg per day, 30 mg per day, 20 mg twice a day and 45 mg per day). In the 18 subjects of the 45 mg per day dosing cohort, ATG-008 demonstrated a 16.7% ORR, based on 3 confirmed partial responses (PRs), validating the single agent activity of ATG-008. Notably, 2 of the 3 confirmed PRs were previously treated with a PD-1/PD-L1 antibody. About ATG-008 ATG-008 (onatasertib) is an orally available mTORC 1/2 inhibitor. ATG-008 inhibits the activity of mTOR, which may result in the induction of tumor cell apoptosis and a decrease in tumor cell proliferation. mTOR, a serine/threonine kinase that is upregulated in a variety of tumors, has an important role in the PI3K/AKT/mTOR signaling pathway, which is frequently dysregulated in human cancers. ATG-008 has been studied in clinical trials to treat a broad range of tumor types including multiple myeloma (MM), glioblastoma (GBM), hepatocellular carcinoma (HCC), non-small cell lung cancer (NSCLC), diffuse large B-cell lymphoma (DLBCL), etc. About Antengene 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, driven by its vision of "Treating Patients Beyond Borders". Since its founding in 2017, Antengene has built a broad and expanding pipeline of 15 clinical and preclinical assets, including 10 assets with global rights and 5 with rights for Asia Pacific markets including the Greater China region. To date, Antengene has obtained 26 investigational new drug (IND) approvals in Asia and the U.S., and submitted 6 new drug applications (NDAs) in multiple Asia Pacific markets, with the NDA for XPOVIO® (selinexor) already approved in mainland China, Taiwan, South Korea, Singapore and Australia. Forward-looking statements 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. For more information, please contact: Investor Contacts: Donald Lung E-mail: [email protected] Mobile: +86 18420672158 PR Contacts: Peter Qian E-mail: [email protected] Mobile: +86 13062747000 SOURCE Antengene Corporation Limited

- Oral presentation highlights preclinical data with ATG-031, an in-house discovered anti-CD24 monoclonal antibody, tracking to an investigational new drug (IND) filing in H1:2023 - Three poster presentations showcase preclinical data with three programs developed or discovered in-house, ATG-101, a PD-L1/4-1BB bispecific antibody (in Phase I studies), ATG-018, an ATR inhibitor (in Phase I studies), and ATG-027, a B7H3/PD-L1 bispecific antibody (in preclinical testing) - Antengene has global rights to these pipeline assets SHANGHAI and HONG KONG, Nov. 10, 2022 /PRNewswire/ -- 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 it has presented posters from preclinical studies of four pipeline assets, ATG-031, ATG-101, ATG-018, and ATG-027 at the 37th Society for Immunotherapy of Cancer Annual Meeting (SITC 2022), taking place on November 8-12, in Boston, Massachusetts (the United States), via in person/virtual attendance. As the world's largest and most anticipated academic gathering in the field of immuno-oncology, the SITC Annual Meeting is designed to promote scientific exchanges and cooperation for improving treatment outcomes for cancer patients. "We are very pleased to share this segment of our early stage portfolio with the oncology community. This year's presentations highlight the breadth of Antengene's internal research capabilities, evidenced by agents based on different modalities, including small molecules, monoclonal antibodies and bi-specific antibodies," said Dr. Jay Mei, Antengene's Founder, Chairman and CEO. "These programs have shown promising data across a range of cell-based assays to confirm target affinity, appropriate in vitro cell and immune activation and strong in vivo anti-tumor activity, with differentiated performance compared to bench-mark compounds, as well as our growing expertise in the identification and validation of biomarkers and companion diagnostics to guide and support clinical development." Oral Presentation ATG-031 (anti-CD24 monoclonal antibody) Title: ATG-031, a first-in-class anti-CD24 antibody, showed potent preclinical anti-tumor efficacy by blocking "don't-eat-me" signal Abstract#: 482 By overexpressing anti-phagocytic surface proteins, often known as"don't eat me" signals, cancer cells can evade macrophage-mediated elimination. CD24, a GPI-anchored, highly glycosylated surface protein interacting with Siglec-10 on innate immune cells, was reported to be a novel "don't eat me" protein. CD24 is over-expressed in multiple tumor types. And unlike CD47, another well-known "don't eat me" target, CD24 is not expressed on human red blood cells (hRBC). ATG-031 is a first-in-class, humanized anti-CD24 antibody. ATG-031 potently binds to CD24-postive tumor cells, while showed no binding with hRBC. ATG-031 blocks the interaction between CD24 and Siglec-10 and inducesd potent macrophage-dependent tumor cell phagocytosis. Upon phagocytosis, M2 macrophages start to release M1-like cytokines suggesting a repolarization from M2 macrophages to M1 macrophages. ATG-031 significantly inhibited in vivo tumor growth and demonstrated synergism with immune checkpoint inhibitor (ICI) and chemotherapies. ATG-031 was well tolerated in preclinical toxicity studies in non-human primates. Also, a companion diagnostic antibody has been developed by Antengene as a patient selection tool. In conclusion, these findings support further evaluation of ATG-031 in mono or combination therapy settings for patients with solid tumors or hematologic cancers. The Company intends to file an IND for ATG-031 in H1:2023. Poster Presentations ATG-101 (PD-L1/4-1BB bispecific antibody) Title: ATG-101, a tetravalent PD-L1×4-1BB BsAb, demonstrates potent in vivo anti-tumor efficacy in Immune Checkpoint Inhibitor (ICI)-resistant or refractory mouse tumor models Abstract#: 1150 ATG-101's anti-"ICI-resistant or refractory tumors" activity was assessed in both in vitro and in vivo models. In the presence of PD-L1 positive cells, ATG-101 enhanced the IL2 and INF-γ production by the terminally exhausted T cells and progenitor exhausted T cells. The in vivo efficacy of ATG-101 was tested in 4-1BB humanized mouse bearing syngeneic B16F10 (Melanoma), EL4 (Lymphoma) or Pan02 (Pancreatic) tumors, all of which have been suggested to be ICI-resistant. ATG-101 was well tolerated and significantly inhibited tumor growth compared with control group. Furthermore, ATG-101 induced growth inhibition or regression in MC38 tumors that had progressed on atezolizumab, revealing a significant survival advantage over atezolizumab or the control group. TIL analysis suggested that ATG-101 increases the infiltration, proliferation and activation of CD8+ T cells, the infiltration of natural killer T cells and the CD8+/Treg ratio in TILs. In conclusion, by cross linking 4-1BB with PD-L1, ATG-101 has the potential to activate exhausted T-cells and overcome ICI resistance. As the first PD-L1/4-1BB bispecific antibody entering clinical development in Australia, ATG-101 is currently being evaluated in a Phase I study in Australia, China, and the U.S. ATG-018 (ATR small molecule inhibitor) Title: Discovery of blood pharmacodynamic biomarkers for ATR inhibitors Abstract#: 76 Antengene presented the results of studies to identify validated PD biomarkers based on Antengene ATR's inhibitor, ATG-018. To demonstrate this, Antengene first evaluated gene expression changes induced by ATG-018 on human peripheral blood mononuclear cells (PBMCs) by assessing PBMCs from three donor samples treated with different concentrations of ATG-018. NanoString technology was used to develop a high throughput gene expression profile at the transcriptome level. This work was validated by treating wild type mice with ATG-018 to define the expression of PD markers in plasma using Meso Scale Discovery's technology. Through these studies, results showed that ATG-018 inhibited the expression of a set of chemokine genes (CCL2, CCL3/1 and CCL4) and that they could be detected in unmanipulated blood samples. In conclusion, the expression of three chemokine genes that were inhibited by ATG-018 could have potential as clinically-relevant peripheral blood PD biomarkers to guide the development of ATG-018 and other ATR inhibitors in the clinic. ATG-027 (B7H3/PD-L1 bispecific antibody) Title: ATG-027, a first-in-class B7-H3/PD-L1 bispecific antibody, shows potent T cell activation capability and in vivo anti-tumor efficacy Abstract#: 1397 ATG-027 is a B7-H3/PD-L1 bispecific antibody which enables key immune effects including immune checkpoint blocking, antibody-dependent cytotoxicity (ADCC) andand antibody-dependent cellular phagocytosis (ADCP). In the poster, results were presented from in vitro studies to evaluate the immune function and in vivo studies to assess the anti-tumor efficacy of ATG-027 using mice bearing syngeneic colorectal cancer cells overexpressing human B7-H3. Results showed that ATG-027 binds to B7-H3 and PD-L1 expressing cells with high affinity. ATG-027 demonstrated higher ADCC and ADCP activity compared with anti-PD-L1 and anti-B7-H3 parental antibodies. Interestingly, in a Mixed Lymphocyte Reaction (MLR) experiment to assess the T cell activation, ATG-027 and the B7-H3 parental antibody induced robust IL-2 and IFNγ production, indicating T cell activating function of tested antibodies. Besides, ATG-027 can potently block PD1/PD-L1 interaction. At in vivo studies, ATG-027 demonstrated superior anti-tumor activity compared to individual parental antibodies and induced tumor shrinkage or complete regression. In conclusion, ATG-027's dual functionality, from binding both B7-H3 and PD-L1, shows promising anti-tumor efficacy in preclinical models by enabling T-cell activation and powerful immune properties, ADCC and ADCP. About Antengene 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, driven by its vision of "Treating Patients Beyond Borders". Since its founding in 2017, Antengene has built a broad and expanding pipeline of 15 clinical and preclinical assets, including 10 assets with global rights and 5 with rights for Asia Pacific markets including the Greater China region. To date, Antengene has obtained 26 investigational new drug (IND) approvals in Asia and the U.S., and submitted 6 new drug applications (NDAs) in multiple Asia Pacific markets, with the NDA for XPOVIO® (selinexor) already approved in mainland China, Taiwan, South Korea, Singapore and Australia. Forward-looking statements 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. For more information, please contact: Investor Contacts: Donald Lung E-mail: [email protected] Mobile: +86 18420672158 PR Contacts: Peter Qian E-mail: [email protected] Mobile: +86 13062747000 SOURCE Antengene Corporation Limited