Metastatic colon cancer

LIÈGE, Belgium & GRENOBLE, France--( BUSINESS WIRE )--PDC*line Pharma, a clinical stage biotech company developing a new class of potent and scalable active immunotherapies for cancer, announces today the selection of the PDC*neo+ project for funding by the Walloon region and BioWin, the health cluster for Wallonia. This is the result of a call for proposals on R&D projects in the field of Advanced Therapy Medicinal Products (ATMP). Members of the project consortium will receive €8.1M ($8.9M) in funding, including €4.7M ($5.1M) for PDC*line Pharma. The total budget is €12.5M ($13.7M). The project aims to develop PDC*neo+, a personalized therapeutic vaccine for colorectal cancer using PDC*line Pharma's innovative PDC*line technology. Targeting unique neoantigens in each colorectal cancer patient, PDC*neo+ represents a groundbreaking approach in cancer immunotherapy. Globally, colorectal cancer (CRC) is among the most prevalent and deadly cancers , with a high recurrence rate post-surgery and chemotherapy. PDC*neo+ is designed as an adjuvant treatment to prevent relapses in high-risk patients with stages II, III and certain stage IV CRCs. Its action post-chemotherapy potentially makes it a pioneering treatment in CRC. This project is a collaborative effort involving several key partners. OncoDNA contributes its expertise in personalized medicine and liquid biopsies, focusing on neoantigen identification and circulating tumor DNA analysis. salamanderU is developing a compact isolator for decentralized vaccine production to bring manufacturing closer to the clinical centers. Academic centers UCLouvain – IREC (Institut de Recherche Expérimentale et Clinique)/MIRO (Molecular Imaging, Radiotherapy and Oncology) and ULB-BCTL (Breast Cancer Translational Research Laboratory) offer essential support in translational research and clinical trial execution. The main goal of the project is to confirm the clinical feasibility and safety of PDC*neo+ in a phase I trial. This initiative is expected to have a significant impact on CRC patient care, alongside broader economic and societal benefits. Over its three-year duration, across all partners, it is estimated to create or maintain around 34 full-time jobs. “We are very happy that our project has been selected by the Walloon region. The subsidies and collaborative effort of the partners in the consortium will speed-up the launch of a first phase I clinical trial with PDC*neo+, the personalized vaccine based on PDC*line cells loaded with neoantigens to treat CRC patients, positioning our technology in the very promising field of neoantigen-based cancer vaccines,” said Eric Halioua, CEO of PDC*line Pharma. “We are very thrilled to be part of this innovative project and clinical trial. It acknowledges our recent proficiency in the discovery of neoantigens and our robust experience in liquid biopsy monitoring by detection of circulating tumor DNA (ctDNA)," said Jean-Pol Detiffe, founder and chief strategy and innovation officer at OncoDNA. “We are very enthusiastic about participating in this collaborative project and bringing the production of PDC*Neo+ closer to the patient. Through this project, salamanderU strengthens its position as a designer and manufacturer of innovative isolators for the manufacture of ATMP,” said Claude Dedry, CEO of salamanderU. “We are very pleased and motivated to take part in this exciting and collaborative project. With our expertise, we will contribute to characterizing the immunogenicity of colorectal cancers and to the development and recruitment of patients for this clinical trial,” said Marc Van den Eynde and Jean-Pascal Machiels, oncologists at UCLouvain (Cliniques universitaires St-Luc). “We are delighted to be involved in this interesting collaborative project. Leveraging our expertise in various ‘omics’ technologies, such as single-cell RNA sequencing and spatial transcriptomics, we will delve into the tumor microenvironment of colorectal cancers. Our objective is to develop predictive biomarkers for vaccine response and actively contribute to patient recruitment for the clinical trial," said Christos Sotiriou, head of the BCTL at ULB and Francesco Sclafani, gastrointestinal oncologist and clinical researcher at Institut Jules Bordet, Hopital Universitaire de Bruxelles (HUB) and Bordet Cancer Research Laboratory. About PDC*line Pharma Founded in 2014 as a spin-off of the French Blood Bank (EFS), PDC*line Pharma is a Belgian-French clinical-stage biotech company that develops an innovative class of active immunotherapies for cancers, based on a GMP-grade allogeneic therapeutic cell line of Plasmacytoid Dendritic Cells (PDC*line). PDC*line is much more potent than conventional dendritic cell-based vaccines in priming and boosting antitumor antigen-specific cytotoxic T-cells, including the T-cells specific for neoantigens, and is synergistic with checkpoint inhibitors. The technology can potentially be applied to any type of cancer. Following a first-in-human phase I feasibility study in melanoma, PDC*line Pharma is now focused on the development of PDC*lung01, its candidate for Non-Small-Cell Lung Cancer (NSCLC), currently in phase I/II trials, and PDC*neo with neoantigens, in preclinical development. The company has a staff of 42, with an experienced management team. It has raised more than €61M in equity and non-dilutive funding. In March 2019, PDC*line Pharma granted the LG Chem Life Sciences company an exclusive license in South Korea and an exclusive option in other Asian countries for the development and commercialization of the PDC*lung01 cancer vaccine for lung cancer. The total deal is worth €108M, plus tiered royalties on net sales in Asia. www.pdc-line-pharma.com About OncoDNA OncoDNA is a leading genomic and theranostic company specializing in precision medicine for the treatment of cancer and genetic diseases. The company helps clinicians, academic researchers, and biopharma companies to outsmart molecular complexity with the mission of delivering the promise of precision medicine. The company not only provides clinical guidance for the treatment and real-time monitoring of late-stage cancer patients, but also supports research and drug development in cancer and genetic diseases. Since its early days in 2012, OncoDNA grew into a corporate group of companies with world-renowned expertise. The Group offers a unique portfolio that combines NGS services, biomarker testing, data analysis software and clinical decision support tools. OncoDNA is headquartered in Belgium, and its entities – BioSequence and IntegraGen – are based in Spain and France. OncoDNA employs over 115 employees across 9 countries, works with an international network of 35 distributors and collaborates with European-based accredited laboratories. OncoDNA is keen to meet laboratory partners and oncologists who would like to benefit from our expertise and work in partnership with us for the benefit of oncologists and their patients. Visit www.oncodna.com About salamanderU salamanderU is a technology company made up of a multidisciplinary team of business experts in the life sciences, pharmaceutical engineering and IT industries. We enhance our clients’ competitive advantage by increasing the robustness and the efficiency of their operational pharmaceutical processes. salamanderU develops and commercializes both technical and digital solutions: technical with acrylic resin isolators, and digital with voice-controlled electronic batch record and manufacturing execution system software. www.salamanderu.com About UCLouvain IREC/MIRO and Cliniques universitaires Saint-Luc UCLouvain is one of the most important universities in Belgium. The IREC-MIRO-Oncology laboratory (UCLouvain) and the Cancer and Hematology Roi Albert II Institute at Cliniques universitaires Saint-Luc have expertise in clinical, translational and fundamental research in oncology. Through the conduct of several academic studies, we have characterized the tumor microenvironment of several cancers and investigated the effectiveness of different combinations of targeted and immune therapies. Our phase 1 research unit is internationally recognized in the investigation of innovative therapies such as novel immune and genetic treatments. www.uclouvain.be About IJB The Institut Jules Bordet (IJB) is the only Comprehensive Cancer Centre in Belgium and is part of the Hopital Universitaire de Bruxelles (HUB) and of the Université Libre de Bruxelles (ULB). The strength of IJB is built upon its integration of three missions: excellence of care, innovative research and a high level of education. The Institute has participated in the creation of several international networks, including the European Organization for Research and Treatment of Cancer (EORTC), the Breast International Group (BIG), Accelerating Oncology Drug Development and Innovative Strategies in Clinical Trials (Oncodistinct) and the Organization of European Cancer Institutes (OECI). The Breast Cancer Translational Research Laboratory (BCTL), headed by Prof. Sotiriou, is an academic laboratory at the ULB faculty of medicine located within the Institut Jules Bordet. The main research focus of BCTL consists of improving the molecular understanding of breast cancer biology, disease dissemination and progression using state-of-the art ‘omics’ technologies as well as identifying novel prognostic and predictive biomarkers. The ultimate goal of this laboratory is to accelerate the translation into the clinic of basic science discoveries dedicated to breast cancer. www.bordet.be

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

Dive Brief:The Food and Drug Administration on Wednesday approved a new targeted therapy for metastatic colon cancer, granting an OK to Furzaqla from Takeda.The drug is cleared for adults with previously treated metastatic colorectal cancer, regardless of what protein markers their tumors express. Takeda claims its the first drug that targets all three subtypes of an important cellular regulator known as VEGF.Known scientifically as fruquintinib, Fruzaqla won its clearance several weeks ahead of the FDAs target Nov. 30 decision date. Its already approved for colon cancer in China, where its marketed as Elunate by original developer Hutchmed.Dive Insight:Takeda made a bet on Fruzaqla when it licensed the drug from Hutchmed for $400 million upfront in January. The deal was a step toward bolstering the pharmaceutical companys oncology business as its top-selling multiple myeloma drug Velcade came under pressure from generic competition.Fruquintinib won approval in China five years ago, drawing the interest and support of Eli Lilly, which partnered with Hutchmed to market the therapy there.Takedas deal covers rights to the drug outside of China and promises as much as $730 million in additional payments if certain milestones are met. Takeda is also seeking approvals in Europe and Japan.The FDAs approval was based on two late-stage trials of Fruzaqla: a colon cancer study in China that enrolled just over 400 patients, and a larger multi-regional study that was run across 14 countries. Results from both showed a statistically significant increase in survival among Fruzaqla-treated patients compared to those given placebo.Colorectal cancer is one of the most tumor types and the second leading cause of cancer-related deaths in the world, according to the World Health Organization. While early-stage colon cancer can be treated with surgery, metastatic disease has fewer treatment options. '