CD24

ROCKVILLE, Md., Jan. 04, 2024 (GLOBE NEWSWIRE) -- OncoC4, Inc. (“OncoC4”), a late-stage biopharmaceutical company developing novel medicines for cancer, today announced its participation in the 42nd Annual J.P. Morgan Healthcare Conference being held in San Francisco, California. Yang Liu, PhD, Co-Founder, CEO and CSO of OncoC4 will present an overview of the company and its pipeline at 11 a.m. Pacific Time on Thursday, January 11, 2024, in the Mission Bay Room (32nd Floor) of The Westin St. Francis Hotel. Dr. Yang and Abid Ansari, Chief Financial Officer of OncoC4, will also participate in one-on-one meetings throughout the week. About OncoC4Based in Rockville, Maryland, OncoC4 is a privately held, late clinical-stage biopharmaceutical company developing and discovering novel immunotherapeutics targeting CTLA-4 and CD24-Siglec checkpoints to overcome cancer resistance to immunotherapy. Built on fundamental research from its co-founders, OncoC4 has developed a rich pipeline of drug candidates spanning preclinical to pivotal stage programs. Its lead clinical candidate, BNT316/ONC-392, is a Phase 3, next generation anti-CTLA-4 antibody designed to allow CTLA-4 recycling and maintain its protective function against autoimmune diseases while enhancing anti-tumor activity. BNT316/ONC-392 is part of a strategic collaboration with BioNTech announced in March 2023. OncoC4’s CD24-Siglec program develops products that target the CD24-Siglec immune checkpoint, including AI-071, a Phase 2 ready broad-based Siglec agonist for immune-related adverse events and ONC-841, a potential first-in-class anti-Siglec 10 monoclonal antibody targeting innate and adaptive immunity in the tumor microenvironment. To address multiple types of cancers, OncoC4’s CD24 oncology platform targets a unique cancer-selective CD24 epitope used by nearly 70% of tumors to evade innate immune destruction and includes monoclonal antibody, bi-specific antibody, antibody-drug conjugate, and CAR T-cell therapy approaches. To learn more, please visit www.oncoc4.com. CONTACTS OncoC4Investor Contact:Alexandra FoliasLifeSci Advisorsafolias@lifesciadvisors.comMedia Contact:Mari PurpuraLifeSci Advisorsmpurpura@lifesciadvisors.com

The Phase I PERFORM trial, taking place at four clinical trial centers across the U.S., will evaluate the safety and preliminary efficacy of ATG-031 in patients with advanced solid tumors or B-cell non-Hodgkin's lymphoma (B-NHL). ATG-031, discovered and developed in-house by Antengene, is the world's first anti-CD24 antibody to advance to the clinic in oncology. SHANGHAI and HONG KONG, Dec. 10, 2023 /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 medicines for cancer, today announced that the first patient has been dosed in the Phase I PERFORM trial of ATG-031 for the treatment of patients with advanced solid tumors or B-cell non-Hodgkin's lymphoma (B-NHL), at The University of Texas MD Anderson Cancer Center, the lead center of the study that also includes three other clinical trial centers across the U.S. The PERFORM trial is a first-in-human, multi-center, open-label, Phase I dose-finding study of ATG-031 in patients with advanced solid tumors or B-NHL. The study's primary objective is to evaluate the safety and tolerability of ATG-031 as a monotherapy, and determine the appropriate dose for Phase II studies. The secondary objective is to characterize the pharmacology, evaluate the immunogenicity, and assess the preliminary efficacy of ATG-031. "We are delighted that the PERFORM trial has successfully dosed its first patient in the U.S. CD24 is a target with great potential in regulating macrophage activities in tumor environment. Supported by the striking preclinical efficacy demonstrated by blocking CD24 in preclinical studies and a promising preclinical safety profile based on CD24's limited expression in normal tissue, Antengene has quickly initiated the PERFORM study in the U.S. to further assess the safety and tolerability of ATG-031 in late stage cancer patients," said Dr. Amily Zhang, Antengene's Chief Medical Officer. "Moving forward, we will continue to work closely with investigators at MD Anderson and three other clinical trial centers in the U.S. to bring clinical benefit to more patients as soon as possible." "With the joint persistent efforts from Antengene's internal teams, we have made great strides to the development of ATG-031, a first-in-class anti-CD24 monoclonal antibody targeting the novel 'don't eat me' pathway, while making rapid progress with the clinical development of other core assets. To date, we have established close collaboration with more than 100 clinical trial centers in the U.S., Australia, and the Mainland of China," said Dr. Jay Mei, Antengene's Founder, Chairman and CEO. "Remaining committed to our global innovation strategies and steadily expediting our clinical programs, we will focus on next generation novel treatments to address broad unmet medical needs post the current immune checkpoint inhibitors." About ATG-031 ATG-031 is a first-in-class humanized CD24 monoclonal antibody which inhibits the "don't eat me" signal and enhances macrophage-mediated phagocytosis of cancer cells. Tumor cells evade the surveillance of the human immune system by over-expressing "don't eat me" surface proteins that signal macrophages to prevent the detection and phagocytosis of cancer cells. CD24 (cluster of differentiation 24) is a prominent "don't eat me" signal that plays a significant role in tumor immune evasion by suppressing macrophage-mediated phagocytosis. Compared to CD47, another well-known "don't eat me" target, CD24 has a more restricted distribution in normal tissue and higher expression in cancerous tissue. In addition，unlike CD47，CD24 is not expressed on human red blood cells，allowing for a wider therapeutic window and minimal on-target-off-tumor toxicity as a CD24-targeted therapy. As a novel innate immune checkpoint, CD24 orchestrates immune evasion through its interaction with the inhibitory receptor Siglec-10 (sialic-acid-binding Ig-like lectin 10) expresses on tumor-associated macrophages (TAMs). Preclinical data presented in 2023 at the American Association for Cancer Research Annual Meeting (AACR 2023) demonstrated that ATG-031 can specifically bind to CD24 with nM affinity and block the interaction of CD24 and Siglec-10. Furthermore, ATG-031 induces efficient phagocytosis with a picomolar EC50 and stimulates the pro-inflammatory cytokines production by macrophages. 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, in realizing its vision of "Treating Patients Beyond Borders". Since 2017, Antengene has built a pipeline of 9 oncology assets at various stages going from clinical to commercial, including 6 with global rights, and 3 with rights for the APAC region. To date, Antengene has obtained 29 investigational new drug (IND) approvals in the U.S. and Asia, and submitted 10 new drug applications (NDAs) in multiple Asia Pacific markets, with the NDA for XPOVIO® (selinexor) already approved in Mainland of China, Taiwan China, Hong Kong China, Macau China, 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, please see the other risks and uncertainties described in the Company's Annual Report for the year ended December 31, 2022, and the documents subsequently submitted to the Hong Kong Stock Exchange. SOURCE Antengene Corporation Limited

Clinical programs, including ATG-101 (PD-L1/4-1BB bispecific antibody), ATG-022 (Claudin 18.2 antibody-drug conjugate), and ATG-037 (oral CD73 inhibitor) have shown clinical responses in cancer patients with advanced diseases. ATG-008 (dual mTORC1/2 inhibitor) continued showing strong clinical activities in the Phase II program, with promising efficacy data in cervical cancer patients compared to benchmarks. SHANGHAI and HONG KONG, Nov. 16, 2023 /PRNewswire/ -- Antengene Corporation Limited ( "Antengene" SEHK: 6996.HK), a leading commercial-stage innovative, global biopharmaceutical company dedicated to discovering, developing, and commercializing first-in-class and/or best-in-class medicines for hematology and oncology, is presenting encouraging clinical data of the Company's four key drugs in clinical development: ATG-101 (PD-L1/4-1BB bispecific antibody), ATG-022 (Claudin 18.2 antibody-drug conjugate), ATG-037 (oral CD73 inhibitor), and ATG-008 (dual mTORC1/2 inhibitor), at its 2023 R&D Day taking place today. The event will also include presentations and discussion with three well-known clinical experts from leading medical centers in the U.S. and Australia. ATG-101 (PD-L1/4-1BB bispecific antibody): Early data from the Phase I PROBE trial have shown a partial response (PR) in a patient with metastatic colon adenocarcinoma (microsatellite stability biomarker [ MSS], liver metastasis, and three prior lines of therapy) which is ongoing. Additionally, two patients have been on ATG-101 for 18 cycles and 17 cycles (Q3W), respectively, demonstrating durable stable disease (SD) with a good safety profile with no liver toxicities. This distinguishes ATG-101 as a safer drug compared to many molecules currently under development targeting 4-1BB. At present, Antengene is conducting the Phase I clinical trials with ATG-101 for the treatment of patients with solid tumors or B-cell non-Hodgkin's lymphoma (B-NHL) in Mainland of China, Australia, and the U.S. ATG-022 (Claudin 18.2 antibody-drug conjugate): Initial clinical data include a complete response (CR) and a PR in two late-stage metastatic gastric cancer patients in the Phase 1 CLINCH trial . The PR was observed in Cohort 3 (1.8 mg/kg), a dose lower than the anticipated efficacious range; while the CR was observed in Cohort 4 (2.4 mg/kg). At present, Antengene is conducting a Phase I clinical study of ATG-022 for the treatment of patients with advanced or metastatic solid tumors in Australia and Mainland of China. ATG-037 (oral CD73 inhibitor): In the dose escalation portion of the Phase I STAMINA trial, 12 patients, all previously treated with a checkpoint inhibitor (CPI, pembrolizumab or nivolumab), have received ATG-037 in combination with pembrolizumab after at least 2 cycles of ATG-037 monotherapy, with 7 patients still under treatment. PRs were observed in two melanoma patients (with prior anti-PD-1 treatment), and in one patient with non-small cell lung cancer (NSCLC) who had also undergone treatment with chemotherapy in addition to a CPI (anti-PD-1). In Australia and Mainland of China, Antengene is currently conducting a Phase I study of ATG-037 single agent and in combination with pembrolizumab for the treatment of patients with locally advanced or metastatic solid tumors. ATG-008 (dual mTORC1/2 inhibitor): Clinical efficacy data have shown promising results from the Phase II TORCH-2 study evaluating ATG-008 in combination with toripalimab (anti-PD-1 antibody) for relapsed/metastatic cervical cancer patients. The trial enrolled 54 late-stage metastatic cervical cancer patients (30 CPI-naïve and 17 CPI-pre-treated patients with at least one tumor assessment). For the CPI-naïve patients, the objective response rate (ORR) is 53.3%, accompanied by a disease control rate （ DCR ） of 86.7% and a median progression-free survival (mPFS) of 8.41 months. For the CPI-pre-treated patients, the ORR, DCR, and mPFS stands at 29.4%, 82.4%, and 4.17 months respectively. These results support the efficacy of the treatment and compare favorably with previously published benchmark data. "We are gratified that the differentiated preclinical efficacy data and benchmark comparisons for each program are being effectively translated to the clinic and encouraged to observe preliminary responses below the projected efficacious doses, according to the preliminary clinical data of ATG-022 and ATG-101. Moreover, ATG-037 and ATG-008, have progressed to combination studies and that, to date, we have already seen promising efficacy data with well tolerated safety profile. This is very encouraging." commented Dr. Amily Zhang, Antengene's Chief Medical Officer. "Finally, we look forward to the participation of the investigators for the three programs: ATG-101, ATG-022 and ATG-037, and believe their perspective will help enrich the discussion at the R&D Day." "The promising, early efficacy and good overall safety signals that we are presenting today on ATG-101, ATG-022, ATG-037 and ATG-008 are very encouraging because these programs target patients with advanced disease who had received multiple prior lines of therapy and the data further demonstrate these drugs' potential to improve the care of patients with cancer," said Dr. Jay Mei, Antengene's Founder, Chairman and CEO." In addition, we will also present the latest preclinical data of ATG-031 (anti-CD24 monoclonal antibody), our novel first-in-class CD24-targeted drug acting on the ' don't eat me ' pathway. The drug is currently being evaluated in a Phase I study of ATG-031 that is led by the MD Anderson Cancer Center and participated by other three clinical trial centers across the U.S. We were founded with the mission of bringing more transformative medicines to cancer patients around the world. Everyone at Antengene has resolute dedication to our mission and these early data affirm that we are delivering." Antengene expects that updated and detailed study results of the studies that will be presented at international scientific conferences in 2024 or later. The English session will be held virtually at 8:30 AM, November 17, 2023, Eastern Time/ 9:30 PM, Beijing Time. The Chinese session will be held in-person at the Antengene Shanghai Office and virtually at 8:30 AM, November 17, 2023, Beijing Time. We invite all investors to join Antengene's 2023 R&D Day. To attend the event, please follow instructions provided in the press release below: 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, in realizing its vision of "Treating Patients Beyond Borders". Since 2017, Antengene has built a pipeline of 9 oncology assets at various stages going from clinical to commercial, including 6 with global rights, and 3 with rights for the APAC region. To date, Antengene has obtained 29 investigational new drug (IND) approvals in the U.S. and Asia, and submitted 10 new drug applications (NDAs) in multiple Asia Pacific markets, with the NDA for XPOVIO® (selinexor) already approved in Mainland of China, Taiwan China, Hong Kong China, 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, please see the other risks and uncertainties described in the Company's Annual Report for the year ended December 31, 2022, and the documents subsequently submitted to 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