D3 Bio Announces Receiving an Orphan Drug Designation and Two IND Clearances from FDA for Its Compounds and Presentation of Pipeline Data at Upcoming AACR 2023

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:

1. 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.
2. The Company received FDA’s IND clearance for D3S-002, a potent and selective ERK1/2 inhibitor.
3. The Company received FDA’s IND clearance for D3L-001, a novel bispecific antibody targeting HER2 and CD47.
4. 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.

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The two presentations are:

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Title: Vertical inhibition of the MAPK pathway with D3S-002, a potent and selective ERK1/2 inhibitor, to improve anti-tumor activity of and overcome resistance to KRAS G12C inhibitors

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

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Title: D3L-001, a novel bispecific antibody targeting HER2 and CD47, demonstrates potent preclinical efficacy in solid tumors

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

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For more information about D3 Bio at AACR 2023, please go to https://www.aacr.org/meeting/aacr-annual-meeting-2023/

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About D3S-001

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.

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About D3S-002

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.

About D3L-001

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.

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About D3 Bio

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.

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For inquiries, please contact:
bd@d3bio.com