D3 Bio (Wuxi) Co. Ltd

Breakthrough Therapy Designation was granted for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) who have had prior treatment with platinum-based chemotherapy and anti-PD-(L)1 antibody but have not been previously treated with a KRAS G12C inhibitor Orphan Drug Designation was granted for treatment of colorectal cancer (CRC) harboring KRAS G12C mutant protein. SHANGHAI, Aug. 28, 2025 /PRNewswire/ -- D3 Bio, Inc, a clinical-stage oncology company focuses on discovery and development of precision oncology therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted a Breakthrough Therapy Designation to D3S-001, the company's next generation KRAS G12C-selective inhibitor, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC who have received prior chemotherapy and immunotherapy but have not been previously treated with a KRAS G12C inhibitor. Additionally, D3S-001 has been granted Orphan Drug Designation for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic CRC. The Breakthrough Therapy and Orphan Drug Designations are based on clinical data from an ongoing Phase 1/2 study (NCT05410145) evaluating D3S-001 in patients with advanced solid tumors harboring a KRAS G12C mutation. Results from this ongoing clinical trial demonstrated highly compelling and durable efficacy according to RECIST (Response Evaluation Criteria in Solid Tumors) with a favorable safety and tolerability profile. "We are very pleased to receive both Breakthrough Therapy and Orphan Drug Designations from the FDA for D3S-001, which highlights D3S-001's promising potential to address critical unmet needs in patients with KRAS G12C-mutated cancers," said George Chen, Founder and CEO of D3 Bio. "These designations also recognize D3S-001's novel profile as a next-generation KRAS G12C inhibitor. We look forward to bringing this exciting new treatment to patients with support and collaboration from health authorities." KRAS mutations are among the most common oncogenic drivers in human cancers, found in approximately 25 to 30% of all tumors. The KRAS G12C mutation occurs in approximately 12% of NSCLC cases and 3 to 4% of CRC. Patients with KRAS G12C-mutated cancers often have more aggressive disease and limited responses to standard therapies, such as immunotherapy and/or chemotherapy. About D3S-001 D3S-001 is a next-generation KRAS G12C inhibitor designed to achieve rapid and complete KRAS G12C target engagement. D3S-001 potently, selectively, and covalently binds to the oncogenic RAS (Off) form of the RAS G12C variant, functionally abolishing the nucleotide cycling between RAS (Off) and RAS (On) forms of the G12C mutant protein. In preclinical investigations, D3S-001 demonstrated high covalent potency, complete engagement of KRAS G12C at clinically relevant doses and CNS penetration properties. D3S-001 is currently under evaluation as monotherapy and in combination regimens in a Phase II global clinical trial in patients with advanced solid tumors harboring KRAS G12C mutations, including NSCLC, CRC, and other tumor types. Key publications: D3S-001, a KRAS G12C Inhibitor with Rapid Target Engagement Kinetics, Overcomes Nucleotide Cycling, and Demonstrates Robust Preclinical and Clinical Activities. Cancer Discov. (2024)14 (9):1675–1698. D3S-001 in advanced solid tumors with KRASG12C mutations: a phase 1 trial. Nat Med. 2025 Aug;31(8):2768-2777. About D3 Bio D3 Bio is a global biotechnology company focused on the discovery, development, and registration of new medicines in oncology and immunology. The company's discovery and development platforms leverage proprietary clinical insight and biomarker strategies to create novel and clinically meaningful therapies for patients in need. D3 Bio's oncology programs target driver mutations or critical immune pathways and are designed to have first-in-class or best-in-class potential. D3 Bio owns global rights for all of its programs. For more information, please visit . Contacts Media Contact: Rui Liu Head, Corporate Affairs [email protected] SOURCE D3 Bio, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Shanghai, China — April 21, 2025 — D3 Bio, a global biotechnology company that focuses on discovery, development, and registration of innovative cancer drugs, announced that its abstract highlighting clinical data for D3S-001, the company’s lead program, has been selected for an oral presentation at the 2025 American Association for Cancer Research (AACR) Annual Meeting, taking place April 25-30 in Chicago, Illinois. The presentation will be part of the Clinical Trials Minisymposium session titled “Innovative Approaches to Key Molecular Targets”, scheduled for April 29, 2025, from 2:30 PM to 4:30 PM CDT. The abstract, identified by presentation number CT266, will be published and cited with this number in the AACR meeting proceedings. D3S-001 is a new generation KRAS G12C inhibitor designed to enhance KRAS G12C target engagement. The data to be presented at AACR 2025 will highlight clinical efficacy and safety results from ongoing Phase 1/2 trials, demonstrating promising anti-tumor activity and favorable tolerability in patients with advanced or metastatic non-small cell lung cancer, who are resistant to first generation KRAS G12C inhibitors, along with PK and biomarker analyses. “We are honored to have the opportunity to present our latest clinical data for D3S-001 at the AACR Annual Meeting, one of the most prestigious forums for cancer research,” said Herbert H F Loong, Deputy Medical Director, Phase 1 Clinical Trial Centre of The Chinese University of Hong Kong. “These findings underscore the potential of D3S-001 to address significant unmet needs in cancer treatment, and we look forward to sharing our progress with the scientific and medical community.” The AACR Annual Meeting is the largest and most comprehensive cancer research event, bringing together researchers, clinicians, and industry leaders from around the world to share the latest advances in cancer science and medicine. For more information about the AACR Annual Meeting 2025, please visit https://www.aacr.org/meeting/aacr-annual-meeting-2025/. ‍ ‍ D3S-001 is a new generation KRAS G12C inhibitor designed to enhance KRAS G12C target engagement. In preclinical investigations, D3S-001 has demonstrated high covalent potency, ability to rapidly and completely engage the KRAS G12C target at clinically relevant doses, and CNS penetration properties. D3S-001 is currently in a Phase II global clinical trial in patients with advanced solid tumors harboring a KRAS G12C mutation, including Non-Small Cell Lung Cancer (NSCLC), colorectal cancer (CRC) and other tumor types. For detailed information about D3S-001, please refer to the following. Research Article published at the 2024 September issue of Cancer Discovery, titled “D3S-001, a KRAS G12C Inhibitor with Rapid Target Engagement Kinetics, Overcomes Nucleotide Cycling, and Demonstrates Robust Preclinical and Clinical Activities”, Cancer Discov (2024) 14 (9): 1675–1698. https://doi.org/10.1158/2159-8290.CD-24-0006. Phase I dose escalation data published at ESMO 2024, titled “615MO - Phase I/II study of D3S-001, a second generation KRAS G12C inhibitor in advanced/ metastatic solid tumors with KRAS G12C mutations”, https://oncologypro.esmo.org/meeting-resources/esmo-congress-2024/phase-i-ii-study-of-d3s-001-a-second-generation-kras-g12c-inhibitor-in-advanced-metastatic-solid-tumors-with-kras-g12c-mutations. D3 Bio is a global biotechnology company that focuses on the discovery, development, and registration of new medicines in oncology and immunology. The D3 Bio discovery and development platform leverages our proprietary clinical insight and biomarker strategy to guide our discovery and development efforts in creating novel and clinically meaningful new therapies for patients in need. ‍ ‍ Media Contact: Rui Liu Head, Corporate Affairs bd@d3bio.com Shanghai, China ‍

Shanghai, China—D3 Bio (Wuxi) Co. Ltd (“D3 Bio” or “The Company”), a biotechnology company that focuses on discovery, development, and registration of innovative medicines in the fields of oncology and immune-oncology, announces the following regulatory approvals and pipeline data presentation: The Company received Orphan Drug Designation (ODD) from Office of Orphan Products Development (OOPD), FDA, to D3S-001 for treatment of patients with advanced pancreatic cancer harboring KRAS p.G12C mutant protein. The Company received FDA’s IND clearance for D3S-002, a potent and selective ERK1/2 inhibitor. The Company received FDA’s IND clearance for D3L-001, a novel bispecific antibody targeting HER2 and CD47. The Company will present its pipeline research data of D3S-002 and D3L-001 in poster sessions at the upcoming AACR 2023 Annual Meeting, from April 14-19 in Orlando, Florida, USA. ‍ The two presentations are: ‍ Session Category: Clinical Research Excluding Trials Session Title: Combination Therapies for Cancer Session Date and Time: Tuesday Apr 18, 2023, 1:30 PM - 5:00 PM Location: Poster Section 38 Poster Board Number: 19 Published Abstract Number: 5501 ‍ Session Category: Immunology Session Title: Therapeutic Antibodies 1 Session Date and Time: Monday Apr 17, 2023, 9:00 AM - 12:30 PM Location: Poster Section 25 Poster Board Number: 12 Published Abstract Number: 1873 ‍ For more information about D3 Bio at AACR 2023, please go to https://www.aacr.org/meeting/aacr-annual-meeting-2023/ ‍ ‍ D3S-001 is a selective and covalent KRAS G12C small molecule inhibitor designed to enhance KRAS G12C target engagement. In preclinical investigation, D3S-001 has demonstrated high potency, CNS penetration property and capability to achieve complete KRAS G12C target engagement at predicted clinically relevant dose. It is currently in global phase 1 development as an oral therapeutic agent for the treatment of patients with advanced solid tumors harboring KRAS G12C mutation, including Non-Small Cell Lung Cancer (NSCLC), CRC and Pancreatic cancer. For detailed information about D3S-001, please refer to our recent publication at the 34th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics. ‍ D3S-002 is a small molecule kinase inhibitor of ERK1/2 that demonstrated promising activity, selectivity, and favorable safety profiles in preclinical assessment. D3S-002 has received FDA’s IND clearance and its FIH study will be initiated soon. D3L-001 is a novel HER2×CD47 bi-specific antibody (bsAb), which demonstrated potent and synergistic anti-tumor effect via HER2 guided CD47 co-blocking in both in vitro and in vivo models. D3L-001 has received FDA’s IND clearance and its FIH study will be initiated soon. ‍ D3 Bio is a globally orientated, clinical stage biotechnology company that focuses on the discovery, development, and registration of new medicines in oncology and immunology. At D3 Bio, we fully leverage our clinical insight and biomarker strategy to guide our discovery effort and compound development, aiming to create novel and clinically meaningful new therapies for patients in need. D3 Bio is funded by globally renowned investors, including Boyu Capital, Matrix Partners China, Sequoia Capital China, Temasek, and WuXi AppTec's Corporate Venture Fund. ‍ For inquiries, please contact: bd@d3bio.com