Dricenta Weekly Updates

Temab-A (c-Met ADC) secured dual FDA BTD in refractory mCRC (with bevacizumab) and previously treated EGFR WT, c-Met+ NSQ NSCLC (Monotx); strengthen Temab-A’s regulatory and clinical positioning

FDA cleared CR-002 (PD-L1 ADC) IND; global Ph1/2 APOLLO trial targets solid tumors including NSCLC and HNSCC, with initial data expected in H2’2027

China’s NMPA approved Enhertu in adj HER2+ eBC and Datroway in PD-(L)1-ineligible TNBC, strengthening DXd ADC penetration across curative-intent and metastatic settings (Source1, Source2)

FDA cleared IND for MC001, a FIC FRα-targeted dimeric chemoimmunotherapy ADC; advancing ADoBind™ into Ph1 evaluation for pancreatic cancer

Posted Ph2 SHR-A2009-203 evaluating SHR-A2009 (HER3 ADC)-based perioperative combos with adebrelimab/almonertinib in resec NSCLC

Registered Ph1/2 evaluating REGN13089-M404-M2980 (MET ADC) in previously treated MET+ solid tumors, including NSCLC and CRC

Posted the Ph3 RAINFOL-10 study evaluating Rina-S (FRα ADC) + SoC as maintenance tx following 1L chemo in high-grade epithelial OC who are not candidates for PARPi maintenance per local SoC

Initiated a Ph2a/2b trial of BL-M09D1 (CEACAM5 ADC) in LA/met UC & other solid tumors in China (Unverified Source)

OB-001 (P-gp/BCRP dual efflux-pump inhibitor) preclinical data support P-gp/BCRP inhibition to reverse SN-38, DM4 and DXd ADC resistance, with clinical PoC planned

Announced $86.6M PIPE financing and conditional debt/royalty restructuring, cash runway into 2029 and support ZYNLONTA (CD19 ADC) development, including Ph3 DLBCL and MZL programs

Implements FDA-aligned New Approach Methodologies (NAMs) to de-risk BiTAC-TCE/ADC pipelines, potentially reducing NHP testing, preclinical timelines and costs.

Agreed €1M Hammenhög facility divestment to Immunrise, freeing resources for nature-sourced ADC payload development, pending financing and due diligence

Launched Hyderabad’s 15,000-sq-ft OEB-6 high-potency platform, targeting 600 kg annual API capacity and future ADC/PDC manufacturing expansion

Invested in Hirono linker-payload manufacturing, targeting 2028 operations to establish Japan’s first integrated, end-to-end ADC CDMO service

Expands Japan’s integrated CRO–CDO–CMO strategy, leveraging CFD-based ADC scale-up to ensure consistent quality and capture APAC multimodality demand

Convened its SAB to review OMTX705’s (FAP ADC) Ph1b/2 progress; advances FAP-targeted Quantum ADCs, superlinkers, bispecific designs, and AI-enabled R&D strategy

Doubles UK bioconjugation capacity with new 500L GMP suite, strengthening late-stage and commercial ADC manufacturing, analytical capabilities and high-potency containment

Selected for Korea’s 2026 World Class Plus Project, securing up to 4 yrs of government R&D support to advance innovative drugs & ADC platform technologies

Pivots internal R&D toward immunology, earlier licensed NN3201 (c-Kit ADC) for up to $553M, pursuing capital-efficient oncology monetization

Secured U.S. patent through 2043 for DOR-targeting technology spanning ADCs and cellular therapies, strengthening IP protection for its strategy to overcome tumor immunosuppression and immunotherapy resistance

Completed its $2B equity investment in Summit to accelerate development of ivonescimab (PD-1×VEGF bsAb) with ADCs across tumor types, building on collaborations evaluating Sone-Ve + ivonescimab and Datroway + ivonescimab