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D3 Bio Received IND Clearance from FDA to Initiate Phase I Clinical Trial for D3S-001

May 27, 2022

Shanghai, China—D3 Bio (Wuxi) Co. Ltd (“D3 Bio” or “Company”) is a biotechnology company that focuses on discovery, development and registration of innovative medicines in the fields of oncology and immune-oncology. Today, D3 Bio announced that the company received IND (Investigational New Drug) clearance from US FDA for D3S-001, a potent and selective small molecule inhibitor for the mutant KRAS G12C protein at the end of March. The planned Phase I clinical trial is now ready for initiation in patients with advanced solid tumors harboring the KRAS G12C mutation globally.  

The pre-clinical data of D3S-001 will be published in 2022 ASCO in two abstracts. The data provide supportive evidence to the notion that a more effective and complete KRAS G12C blockage will lead to a deeper response in the treatment of non-small cell lung cancer (NSCLC) and other tumors driven by this oncogenic mutation. In addition, the drug is expected to prolong the duration of the response and delay the development of resistance to KRAS inhibition.

"We feel very excited about obtaining IND clearance from FDA for D3S-001.This is D3 Bio’s first IND approval by US FDA, which reflects the company's strong R&D capability and excellent execution.” said George Chen, Founder, Chief Executive Officer, and Chairman of the company.

“D3S-001 is a highly selective, potent, and differentiated KRAS G12C covalent inhibitor discovered by D3 Bio through internal and external collaborations. In our preclinical studies, D3S-001 has demonstrated exceptional potency and selectivity. Importantly, the molecule delivers a rapid and efficient KRAS G12C target engagement, which we believe is a unique feature that allows the achievement of complete target blockage at clinically relevant doses. In additional, the compound has a favorable ADME and Tox profile that will allow superior therapeutic benefits either as a monotherapy or for potential combination strategies. We are also encouraged by the excellent CNS penetration property of D3S-001 in preclinical models. We plan to further explore its clinical efficacy in patients with brain metastasis during phase 1 expansion. D3S-001 has now entered clinical phase globally with a focused development path in NSCLC, CRC, and other solid tumors. We are looking forward to the upcoming trials.” said Jing Zhang, Head of Small Molecule Drug Discovery.

Abstracts to be published at 2022 ASCO Annual Meeting

Abstract Title: Preclinical characterization of D3S-001, a highly potent, selective, and differentiated covalent inhibitor of KRAS G12C

Number: e15102

Abstract Title: D3S-001, a highly potent, selective, and differentiated covalent inhibitor of KRAS G12C: Human dose prediction and first‐in‐human (FIH) trial design

Number: e15087

The full article will be available on May 26, 2022 via the ASCO online library with the link https://meetinglibrary.asco.org/

About D3S-001

D3S-001 is a small molecule inhibitor that selectively and irreversibly inhibits the KRAS G12C mutant protein, blocking its interaction with downstream effectors, such as the RAF serine/threonine protein-kinase, thereby preventing the propagation of oncogenic signaling. Based on comprehensive preclinical characterization, D3S-001 could deliver more rapid and efficient KRAS G12C target engagement. Together with its favorable ADME and tox profiles, D3S-001 is predicted to have the potential of bringing superior therapeutic benefits and an advancement in the treatment of tumors driven by the KRAS G12C mutation.


About D3 Bio

D3 Bio is a globally orientated biotechnology company that focuses on the discovery, development and registration of new medicines in oncology and immunology. At D3 Bio, our new approach is fundamentally differentiated. We do not start with drug discovery in the lab. Instead, we start from pinpointing the greatest unmet medical and market needs: the unsatisfactory clinical outcomes of standard-of-cares. We then take these insights into the laboratory to guide the discovery process in the identification of fit-for-purpose molecules as well as to tailor and refine our drug development path. 

D3 Bio has also created an infrastructure that enables us to build a robust portfolio that comprises assets carrying “back-bone” property for developing future therapies in multiple indications. This cycle of innovation is the heart of D3 Bio. In fact, it underlies our name: Development leading to Discovery that leads back to more Development, or D3 Bio.

D3 Bio is backed by renowned investors who believe in the Company. Major investors include Boyu Capital, Matrix Partners China, Sequoia Capital China, Temasek, and WuXi AppTec's Corporate Venture Fund.


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