CD24

Merger expands OncoC4’s wholly owned immunotherapy pipeline and establishes in-house clinical manufacturing capabilities Adds IND-ready AI-081, a PD-1/VEGF bispecific antibody with best-in-class potential and clinical-stage assets including next-generation siglec agonist AI-071 Both companies are co-founded by CEO, Yang Liu and CMO, Pan Zheng and have a similar shareholder base ROCKVILLE, Md., Sept. 25, 2024 (GLOBE NEWSWIRE) -- OncoC4, Inc., a late-stage biopharmaceutical company developing novel medicines for cancer, and AcroImmune, a biopharmaceutical company developing immunotherapy drugs for malignant tumor and inflammatory disease, today announced that the companies, which are under common control, have entered into a definitive merger agreement to combine in an all-stock transaction (the Merger). Under the terms of the agreements, OncoC4 will acquire 100% of the outstanding equity interests of AcroImmune. Upon completion of the Merger, the combined company is expected to operate under the name OncoC4, Inc., will be headquartered in Rockville, Maryland, and led by Yang Liu, PhD, Co-Founder, Chief Executive Officer (CEO). Both OncoC4 and AcroImmune were co-founded by Drs. Yang Liu and Pan Zheng and have a similar shareholder base. “This Merger seamlessly bolsters OncoC4’s wholly owned immunotherapy pipeline and adds investigational new drug (IND)-ready PD-1/VEGF bispecific antibody AI-081 with best-in-class potential and clinical stage assets with near-term catalysts including next-generation siglec agonist AI-071,” said Yang Liu, PhD, Co-Founder, CEO and Chief Scientific Officer (CSO) of OncoC4. “Additionally, the Merger will also expand OncoC4’s geographical footprint and establish in-house clinical manufacturing capabilities including R&D, clinical, and manufacturing sites in China.” Dr. Liu continued, “Collectively, these synergies further strengthen the potential of OncoC4 to deliver differentiated and novel immunotherapies spanning multiple modalities for difficult to treat solid tumors and hematological malignancies. We look forward to continued advancement across our innovative pipeline with several upcoming early and late-stage clinical milestones over the next 12 months.” Dr. Pan Zheng, MD, PhD, OncoC4’s Chief Medical Officer (CMO) and cofounder of OncoC4 and AcroImmune added, “A bispecific targeting PD-1 and VEGF holds potential to broaden the horizon of checkpoint therapy across cancers. AI-081 consists of fully owned and high affinity binding motifs to PD-1 and VEGF that are designed to be best in-class among an emerging class of potentially transformative cancer therapies. We are very excited to file an IND application for AI-081 in the fourth quarter of the year.” OncoC4’s Pipeline Programs and Expected Upcoming Milestones Newly Added Wholly Owned Programs AI-081 – A potentially best-in-class bispecific antiboy against PD-1 and VEGF that has demonstrated high potency and in vivo anti-tumor activity in preclinical models IND filing expected in Q4 2024 AI-071 – A Phase 2 ready, next-generation siglec agonist that is designed for broad siglec coverage with potential application across immunotherapy treated indications. Siglec is a novel innate immune checkpoint discovered by OncoC4 founders with broad application for cancer and excessive inflammation. Initiation of Phase 2 trial for acute respiratory failure expected in Q4 2024Initiation of Phase 2 trial for immune related adverse events expected in Q1 2025 Legacy OncoC4 Wholly Owned Programs CD24 Siglec Program – Novel innate immune checkpoint discovered by OncoC4 founders with broad application for the treatment of cancer and excessive inflammation. ONC-841 – First-in-class anti-Siglec 10 mAb designed for broader impact across innate and adaptive immunity in tumor microenvironment Initiated Phase 1 trial in solid tumors in Q3 2024 Cancer Specific CD24 Platform Program – CD24 is a potent ‘don’t eat me’ signal used by tumors to evade innate immune destruction and an oncogene overexpressed in 70% of all human cancers. OncoC4’s cancer-specific mAb targets a neo-CD24 epitope with application across multiple therapeutic modalities. ONC-782 – CAR-T cell therapy for solid and hematological malignancies Initiation of Phase 1 Investigator Initiated Trial in China expected in 2H 2024 ONC-783 – Bispecific mAb for hematological malignancies IND enabling studies initiated in Q2 2024 ONC-784 – ADC for solid tumors IND enabling studies to be initiated in Q1 2025 Partnered Programs Gotistobart (BNT316/ONC392) is a next-generation anti-CTLA-4 antibody candidate in joint late-stage clinical development with BioNTech as a monotherapy and in combination in multiple ongoing solid tumor indications. Designed for improved toxicity and ability to overcome immune suppression in the tumor microenvironment by depleting regulatory T cells to turn immunologically cold tumors hot. About OncoC4 Based in Rockville, Maryland, OncoC4 is a privately held, late-stage biopharmaceutical company that is actively engaged in the discovery and development of novel biologicals for cancer treatment. Its lead clinical candidate is gotistobart (BNT316/ONC-392), a next generation anti-CTLA-4 antibody that allows CTLA-4 to recycle and maintain its protective function against autoimmune diseases while enhancing anti-tumor activity at the same time. In March 2023, OncoC4 announced a strategic collaboration with BioNTech to co-develop and commercialize ONC-392 in multiple solid tumor indications. OncoC4 received $200M upfront and is eligible to receive development, regulatory, and commercial milestone payments in addition to double digit royalties. In addition, OncoC4 has a pipeline of first-in-class and best-in-class assetstargeting both novel and well validated oncology targets. For more information, please visit www.oncoc4.com. Investor Contact: Alexandra FoliasLifeSci Advisorsafolias@lifesciadvisors.com Media Contact: Kristin Politi, Ph.D. LifeSci Communicationskpoliti@lifescicomms.com

ONC-841 is a potential first-in-class SIGLEC10 antibody with broad application in oncology Designed to break tumor evasion of the immune system, ONC-841 can rejuvenate anti-tumor T cells, NK cells and macrophages within the tumor microenvironment Initial Phase 1 safety, pharmacokinetics, and clinical activity data for ONC-841 monotherapy are expected in 2025 ROCKVILLE, Md., Sept. 04, 2024 (GLOBE NEWSWIRE) -- OncoC4, Inc. (“OncoC4”), a late-stage biopharmaceutical company developing novel medicines for cancer and immunological diseases, today announced the first patient has been dosed in the first-in-human Phase 1 ONC-841-002 trial (NCT06352359) evaluating ONC-841, a potential first-in-class SIGLEC10 blocking antibody for the treatment of solid tumors. “Dosing the first patient in this first-in-human trial for ONC-841 marks an important step for our SIGLEC program which holds promise to treat a range of malignancies,” said Yang Liu, PhD, Co-Founder, CEO and CSO of OncoC4. “Targeting a novel SIGLEC10 immune checkpoint, ONC-841 is designed to block tumor evasion of the immune system by activating anti-tumor immunity within the tumor microenvironment. We are very excited at the broad therapeutic potential of ONC-841 and look forward to initial Phase 1 data in 2025.” ONC-841-002 is a Phase 1 open label, dose-escalation trial evaluating the safety, efficacy and pharmacokinetics of ONC-841 as a single agent in patients with advanced and or metastatic solid tumors. The study will assess seven dose levels of intravenous ONC-841 once every 4 weeks at multiple clinical centers throughout the United States. The trial principal investigator is Dr. Tianhong Li of the University of California, Davis Comprehensive Cancer Center. OncoC4 enrolled its first patient under the care of site investigator Dr. John Hamm, of Norton Cancer Institute in Louisville, Kentucky. Initial data on the safety, pharmacokinetics, and clinical activity of ONC-841 monotherapy are expected in 2025. Dr. Hamm added, “It is very exciting to be part of this journey. As oncologists we know we need better answers and through clinical trials like this, especially in the past 5 years, we have seen rapid improvements in cancer care and treatment.” Discovered in house, ONC-841 is a humanized antagonist anti-SIGLEC10 monoclonal antibody. To our knowledge, it is the first SIGLEC10 antagonist to enter clinical development. Siglec10 is an inhibitory receptor gene broadly expressed in tumor-infiltrating immune cells that plays an important role in tumor evasion of the immune system through its interaction with CD24 present on tumor cells. ONC-841 blocks this interaction, enabling anti-tumor activation of immune cells including NK cells, macrophages and T cells. SIGLEC10 has an authentic immunoreceptor tyrosine-based inhibitory motif, which is distinct from other siglecs such as SIGLEC15. In preclinical studies ONC-841 has been shown increased phagocytosis of cancer cells and improved function of tumor-infiltrating T cells and innate cells, as well as enhanced antibody-dependent CD16a signalling, a surrogate for antibody-dependent cell mediated cytotoxicity (ADCC). About OncoC4Based in Rockville, Maryland, OncoC4 is a privately held, late clinical-stage biopharmaceutical company that is actively engaged in the discovery and development of novel biologics for the treatment of cancer and immunological diseases. Its most advanced program is BNT316/ONC392 (gotistobart), a Phase 3, next generation anti-CTLA-4 antibody that is designed to allow CTLA-4 to recycle and maintain its protective function against autoimmune diseases while enhancing anti-tumor activity at the same time. In addition, OncoC4 is targeting CD24-Siglec pathway, an innate immune checkpoint discovered by its cofounders. OncoC4 has two first-in-class clinical stage SIGLEC programs, including AI-071, a Phase 2 ready SIGLEC agonist designed for difficult to treat immune related adverse events, and ONC-841, a Phase 1 SIGLEC10 antagonist for the treatment of solid tumors. OncoC4’s portfolio also includes preclinical programs targeting the CD24 cancer immune evasion pathway. More information: www.oncoc4.com. CONTACTS OncoC4Investor Contact:Alexandra FoliasLifeSci Advisorsafolias@lifesciadvisors.comMedia Contact:Kristin PolitiLifeSci Advisorskpoliti@lifescicomms.com About Norton Cancer InstituteAs the leading provider of cancer care in Louisville and Southern Indiana, Norton Cancer Institute’s mission is to blend comprehensive treatment and services with compassion, hope and healing for patients and their families. Through a multidisciplinary approach, its team offers patients the latest in treatments and technology focused on cancer prevention, diagnosis, care and survivorship. The institute’s specialists cover a broad range of oncology subspecialties, including behavioral, breast medical and radiation, gastrointestinal medical and radiation, genitourinary medical and radiation, gynecologic, head and neck medical and surgical, neurologic, orthopedic, sarcoma and connective tissue medical, and thoracic medical and radiation oncology, as well as cancer genetics, hematology and oncologic dermatology. Norton Cancer Institute offers state-of-the-art medical, surgical and radiation therapies, including minimally invasive robotic surgery, stereotactic radiosurgery (Novalis Tx and TrueBeam STx) and advanced brachytherapy. Patients have access to groundbreaking research through its participation in dozens of innovative National Cancer Institute and industry-sponsored clinical trials. Extensive educational, physical and emotional support services, including support groups, seminars, art and music therapy, massage therapy, yoga and nutritional counseling are available through five Norton Cancer Institute Resource Centers. Norton Cancer Institute is designated by the American College of Surgeons Commission on Cancer as the only accredited Integrated Network Cancer Program in Kentucky. More information is available at NortonCancerInstitute.com. CONTACTS Norton Cancer InstituteLynne ChoatePublic Relations managerLynne.choate@nortonhealthcare.org

SHANGHAI and HONG KONG, Aug. 23, 2024 /PRNewswire/ -- Antengene Corporation (6996.HK) today announced its interim results for the period ending June 30, 2024, along with several significant milestones achieved in recent months. Dr. Jay Mei, Antengene's Founder, Chairman, and CEO, stated, "In the first half of 2024, the company has made significant progress in both R&D and commercialization. Our four global rights assets — ATG-022 (Claudin 18.2 ADC), ATG-037 (CD73 small molecule), ATG-101 (PD-L1/4-1BB bispecific antibody), and ATG-031 (CD24 monoclonal antibody) have all advanced steadily as planned. Among them, ATG-022, currently in Phase II dose expansion stage, has demonstrated efficacy not only in gastric cancer patients with moderate-to-high Claudin 18.2 expression but also in those with low and ultra-low expression levels. This unprecedented data reinforces our belief that ATG-022 is poised to become a globally best-in-class molecule targeting Claudin 18.2. While we remain focused on building a differentiated and innovative pipeline, the company has also established a robust self-sustaining revenue-generating capability. XPOVIO® has achieved three significant milestones within the past six months, including a supplementary new drug approval (NDA) for diffuse large B-cell lymphoma (DLBCL) in the Mainland of China, National Health Insurance Service Approval for Reimbursement in South Korea, and NDA approvals for multiple myeloma (MM) in Malaysia. To date, XPOVIO® has been approved for marketing in eight countries and regions across the Asia-Pacific markets and included in the national health insurance of four of these markets, generating product revenue of RMB 60.8 million in the first half of 2024." Dr. Mei continued, "Antengene's innovative R&D capabilities, strategic approach to drug discovery and development, and rigorous cost-efficiency measures ensure the company is well positioned for sustained operations and growth in the coming years. With a cash and bank balance of RMB 1.024 billion, we have sufficient runway to provide strong support to the continuous growth, development, and operations of Antengene. We look forward to sharing more of our progress in the second half of 2024, with a key highlight being the latest research results of ATG-037, which will be presented in a mini oral presentation at the ESMO Annual Meeting on September 16." 1. Global Rights Assets with Advancing Steadily at Clinical Stage ATG-022 (Claudin 18.2 Antibody-Drug Conjugate, ADC): Currently at Phase II Dose Expansion Stage, Effectively Targeting Gastric Cancer with both High and Ultra-low Claudin 18.2 (CLDN18.2) Expression ATG-022 is a highly differentiated asset demonstrating activity across a wide range of CLDN18.2 expression levels, including both high and low/ultra-low expression level. ATG-022 has received two Orphan Drug Designations (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of gastric cancer and pancreatic cancer. The Phase I CLINCH dose escalation study was completed earlier this year, 2.4 mg/kg was selected as the recommended Phase II dose (RP2D). ATG-022 has now progressed to the Phase II monotherapy dose expansion stage. As of Aug 21st 2024, Data from the on-going Phase II CLINCH dose expansion study, shows that 21 CLDN18.2 positive gastric cancer patients have been treated with ATG-022. Among the 12 patients who at least underwent their first tumor assessment after study treatment, 5 achieved partial response (PR), resulting in an overall response rate (ORR) of 41.7% (including one patient with ultra-low CLDN18.2 expression), and a disease control rate (DCR) of 100%. The Phase II CLINCH study is currently progressing smoothly in China and Australia. ATG-037 (CD73 Small Molecule Inhibitor): Demonstrated Potential in Reversing Resistance to anti-PD-1 Therapies during Dose Escalation Inhibiting CD73 is intended to stop the production of adenosine, a key immunosuppressive molecule in the tumor microenvironment. As a small molecule inhibitor of CD73, ATG-037 has demonstrated pre-clinically the ability to overcome the "hook effect" that can limit efficacy and is commonly seen in anti-CD73 antibodies. Antengene entered into a global clinical collaboration with MSD and is currently evaluating this molecule in combination with the anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with locally advanced or metastatic solid tumors. ATG-037 demonstrated an excellent safety profile during the dose escalation stage. Notably, four partial responses in patients previously treated with a checkpoint inhibitor were observed — two in melanoma patients and two in non-small cell lung cancer patients. With the Phase I dose escalation now complete, the company plans to initiate the Phase II dose-expansion of the STAMINA study in China and Australia in the third quarter of 2024. ATG-101 (PD-L1/4-1BB Bispecific Antibody): Durable Responses and Preliminary Efficacy in "Cold Tumors" Observed at Low Doses Without Off-target Liver Toxicity ATG-101's differentiated approach to targeting PD-L1 resistant cancers incorporates the conditional activation of the T-cell co-stimulatory receptor 4-1BB. The bispecific antibody utilizes high PD-L1 affinity and conditional 4-1BB activation, to reduce the risk of hepatotoxicity. ATG-101 is currently undergoing dose-escalation studies in the US, the Mainland of China, and Australia. The treatment has demonstrated excellent tolerability, with no significant liver toxicity observed to date. Encouragingly, durable stable disease has been observed even at low dose levels, as along with a partial response in a patient with microsatellite stable (MSS) colorectal cancer. The Phase I dose escalation phase is on track for completion by the first half of 2025. ATG-031 (Anti-CD24 Monoclonal Antibody): First-in-Class Macrophage Activator Targeting CD24 ATG-031 is the first-in-class humanized anti-CD24 monoclonal antibody to enter clinical trials for cancer in the U.S. ATG-031 works by blocking CD24-Siglec10 and enhancing macrophage-mediated phagocytosis of cancer cells. Key study sites of ATG-031 include four renowned cancer centers in the United States: MD Anderson Cancer Center at the University of Texas, University of California, San Francisco (UCSF), University of Colorado, and Yale Cancer Center. In the Phase I PERFORM study, 19 late-stage cancer patients have been treated with early low doses in the dose escalation segment, with no dose-limiting toxicities (DLTs) observed. Observations include stable disease (SD), objective tumor shrinkage, and clinical improvements among enrolled patients. The company targets a Phase I data readout in the first half of 2025. Promising Pre-clinical Programs: Antengene is committed to advancing its proprietary "2+1" T-cell engager platform, AnTenGagerTM. T cell engagers developed from this platform are designed to induce disease-associated antigen (DAA)-dependent T-cell binding and activation, delivering strong therapeutic activity while minimizing the risk of cytokine release syndrome (CRS). The development of preclinical candidates, including ATG-042, a selective PRMT5 inhibitor targeting MTAP-null tumors, and ATG-201, a CD19 x CD3 T-cell engager, is ongoing. 2. Expanding APAC Presence with Inclusion in Multiple National Health Insurance Programs In June 2024, South Korea's National Health Insurance Service (NHIS) has approved the reimbursement of XPOVIO®, effective from July 1, 2024. This marks the fourth Asia-Pacific market, following the Mainland of China, Australia, and Singapore, where the company has secured reimbursement/insurance coverage for XPOVIO®. The company is actively working to secure health insurance inclusion for XPOVIO® in more Asia-Pacific markets. In July 2024, XPOVIO® received approval for a new indication in the Mainland of China, offering a new treatment option for patients with DLBCL. This is the second indication approved for XPOVIO® in the Mainland of China, following its approval for relapsed/refractory multiple myeloma (R/R MM). In August 2024, XPOVIO® was officially approved for marketing in Malaysia. To date, XPOVIO® has received multiple new drug approvals across eight countries and regions in the Asia-Pacific market (the Mainland of China, Taiwan, Hong Kong, Macau, Australia, South Korea, Malaysia, and Singapore). The company has also submitted NDA for XPOVIO® in other ASEAN markets such as Thailand and Indonesia, with approvals expected later this year. Since being included in the National Reimbursement Drug List (NRDL) in December 2023, XPOVIO® has shown impressive revenue performance in the first half of 2024. As of June 30, 2024, XPOVIO® sales revenue has reached RMB 60.8 million. 3. Strong Cash and Bank Balance to Support Strategic Objectives As of June 30, 2024, the company held RMB 1.024 billion in cash and bank balance. The steady growth in revenue, strong cash and bank balance coupled with careful spending, will provide strong support to the continuous growth, development, and operations of Antengene. For more details on the 2024 interim financial results, please refer to the full announcement available in the "Investor Relations" section of the company's official website. 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, Malaysia 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, 2023, 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