NovaBridge Biosciences · NASDAQ:NBP
NovaBridge Biosciences — I-Mab — Investor Presentation (January 2025)
27 slides from NovaBridge Biosciences's investor presentation, Jan 13, 2025
Slide 1: Transforming Potential into Reality
Transforming Potential into Reality I-Mab Biopharma January 2025
Slide 2: Legal Disclaimer
Legal Disclaimer. This presentation has been prepared by I-Mab (the “Company”) solely for informational purposes. Certain of the information included herein was obtained from various sources, including certain third parties, and has not been independently verified by the Company. By viewing or acces
Slide 3: Positioning Company for Accelerated Growth, with Focus on Precision Immuno-Oncology
Defined strategy for three clinically active programs Claudin 18.2 bispecific givastomig leads the pipeline Completed divestiture of China operations in 2024 Executing on clinical strategy via disciplined capital approach Positioning Company for Accelerated Growth, with Focus on Precision Immuno-Onc
Slide 4: Clinical development pipeline
Asset PHASE 1 PHASE 2 PHASE 3 CLINICAL DEVELOPMENT STATUS/POTENTIAL NEXT STEPS PARTNERSHIPS Givastomig1 CLDN18.2 X 4-1BB Bispecific Ab 1L GC, GEJ, EAC: Target population of ~137k patients2 2H 2025: Phase 1b dose escalation data in combination with nivolumab + chemo 1H 2026: Phase 1b dose expansion d
Slide 5: First asset to be tested with immuno-chemotherapy standard of care in 1L gastric cancer
First asset to be tested with immuno-chemotherapy standard of care in 1L gastric cancer Molecular Design Key Differentiation Clinical activity demonstrated across various levels of CLDN18.2 expression Exhibits CLDN18.2 binding even on low expressing tumor cells Higher-affinity binding to CLDN18.2 co
Slide 6: Monotherapy Responses in Heavily Pretreated Patients Provide Support for Further Studies
Phase 1 Monotherapy Responses in Heavily Pretreated Patients Provide Support for Further Studies 5 mg/kg 8 mg/kg 12 mg/kg 15 mg/kg Numbers: CLDN18.2 % > Treatment Ongoing PD SD PR Patient Overview: 43 efficacy evaluable patients with CLDN18.2+ GC/GEJ/EAC A median of three prior lines of systemic the
Slide 7: Givastomig adverse event table
Preferred Term (all numbers are n(%)) Grade 1 Grade 2 Grade 3 Grade 4 Grade 5 All Grades Nausea 6 (14.0) 4 ( 9.3) 1 ( 2.3) - - 11 (25.6) Anemia 2 ( 4.7) 5 (11.6) 3 ( 7.0) - - 10 (23.3) White blood cell count decreased 4 ( 9.3) 3 ( 7.0) 3 ( 7.0) - - 10 (23.3) Vomiting 4 ( 9.3) 2 ( 4.7) 1 ( 2.3) - - 7
Slide 8: Givastomig Yielded Responses Across Broader Claudin 18.2 Expression
Givastomig Yielded Responses Across Broader Claudin 18.2 Expression Drug Givastomig (bi-specific) Zolbetuximab (CLDN18.2 targeted mAb) Phase Phase 1 Phase 1 Phase 2 CLDN18.2 – Expression (Study Group) IHC ≥1+ in ≥1% cells IHC ≥1+ in ≥1% cells IHC ≥ 2+ in ≥ 50% cells Diagnosis Previously treated GC/G
Slide 9: Potential Differentiation of Givastomig from Other Claudin 18.2 Targeted Competitors
Potential Differentiation of Givastomig from Other Claudin 18.2 Targeted Competitors Givastomig (bi-specific) Zolbetuximab (mAb)1 CMG901 (ADC)2 Mechanism of Action Bi-specific antibody designed to have 4-1BB activation in the presence of CLDN18.2 4-1BB agonism increases T cell expansion in the TME a
Slide 10: Phase 1b trial design with nivolumab and chemotherapy
Eligibility: 1L unresectable or metastatic GC/GEJ/EAC HER2-negative CLDN18.2 ≥1+ on ≥1% of tumor cells Endpoints: Primary: Safety Secondary: Response rate: ORR, BoR, DoR Survival: PFS, OS PK/PD Dose Escalation Lead-In (n=5) Giva dose level 1 + nivo + mFOLFOX6 Q2W Dose Escalation (n=17) Dose Expansio
Slide 11: Givastomig Potentially FIC & BIC: 1L HER2-negative Gastric Cancer Landscape
Givastomig Potentially FIC & BIC Givastomig Potentially BIC Zolbetuximab4 Gastric Cancer HER2-negative2 CLDN18.2-positive3 250k 195k 137k PD-L1 CPS CLDN18.2 Level 100% >75% >1% 1L HER2-negative Gastric Cancer Therapeutic Landscape CLDN18.2 Gastric Cancer Market Opportunity Approximately 250,000 pati
Slide 12: Significant Opportunity for CLDN18.2 Asset Class Beyond Gastric Cancer
Markets include U.S., 5 E.U., and Japan by 2030 based on Data Monitor Biomed Tracker Pancreatic Cancer Market Size, Share, and Trends 2024 to 2034 Olympus Research Global and Wall Street Equity Research Represents CLDN18.2 prevalence within population; Ventana Assay Validation Report on file Ventana
Slide 13: Givastomig, a Potential Best-in-Class Claudin 18.2 Therapeutic
Givastomig, a Potential Best-in-Class Claudin 18.2 Therapeutic First CLDN18.2 asset tested with immuno-chemotherapy standard of care in 1L gastric cancer 4-1BB scFv CLDN18.2 Notes: scFv = single chain Fragment-variable region; 1L = first line High CLDN18.2 affinity with conditional 4-1BB activation
Slide 14: Uliledlimab (Targeting CD73)
Uliledlimab (Targeting CD73) A potential best-in-class CD73 therapeutic Anti-CD73 CD73 Biology: CD73 is the rate-limiting enzyme and best target in the adenosine immunosuppressive pathway Key Advantages: Uliledlimab completely inhibits CD73 activity and the production of adenosine without the “hook
Slide 15: CD73 is the Rate-Limiting Enzyme in the Adenosine Immunosuppression Pathway
CD73 is the Rate-Limiting Enzyme in the Adenosine Immunosuppression Pathway All AMP pathways converge at CD73 to generate adenosine Advantages of targeting CD73 for cancer therapy: blocking CD73 activity leads to complete inhibition of the adenosine pathway. Known potential escape pathways (ATP, cyc
Slide 16: Uliledlimab Designed to Inhibit CD73, Without a Hook Effect
CD73 enzyme activity inhibition Dose-dependent CD73 inhibition without the “hook effect”2 Uliledlimab Designed to Inhibit CD73, Without a Hook Effect Open conformation (inactive) Closed conformation (active) Oleclumab1 Intra-dimer binding mode Inter-dimer binding mode Open conformation (inactive) Cl
Slide 17: Uliledlimab May Completely Inhibit CD73 Function in vitro
Partial inhibition by inter-dimer binding mode Complete inhibition by intra-dimer binding mode Uliledlimab May Completely Inhibit CD73 Function in vitro Notes: Astra Zeneca is evaluating oleclumab in a Phase 3 study in patients with Stage III NSCLC Oleclumab (MEDI9447) was internally produced based
Slide 18: Dose-Dependent Inhibition of CD73 and Tumor Growth by Uliledlimab
Dose-Dependent Inhibition of CD73 and Tumor Growth by Uliledlimab Inhibition of CD73 activity and tumor growth in vivo is limited by oleclumab’s hook effect biology Inhibition of CD73 activity and tumor growth in vivo by uliledlimab is dose-dependent Source: Data on file (IMAB), based on in vivo stu
Slide 19: Uliledlimab + Toripalimab Data Support Patient Selection Based on CD73 Expression
Safety profile of combination comparable to CPI monotherapy studies Uliledlimab + Toripalimab Data Support Patient Selection Based on CD73 Expression and Show Manageable Toxicity Well tolerated up to the highest doses tested (45mg/kg Q3W), without MTD Most TRAEs/AEs were Grade 1 or 2 ORR% (n) PD-L1
Slide 20: Most Tumors Decreased in Size
Most Tumors Decreased in Size Notes: Response definitions per iRECIST criteria. PR = partial response; SD = stable disease; PD = progressive disease; BOR = best overall response Source: ASCO 2023 Poster Early Phase 2 Data in Treatment-Naïve NSCLC Patients
Slide 21: Most Responses were Durable
18 of 21 treatment naïve NSCLC patients with an objective response remained on treatment with a median follow-up of 10.8 months Most Responses were Durable Notes: Response definitions per iRECIST criteria. PR = partial response; SD = stable disease; PD = progressive disease; iUPD = unconfirmed progr
Slide 22: Ragistomig (ABL503) targeting PD-L1 and 4-1BB
Molecular Design: Molecule binds to PD-L1 for activation of 4-1BB in the TME Implications: Mitigation of liver toxicity and systemic immune response Enhancement of anti-tumor immunity and re-invigoration of exhausted T cells1 Development: Co-development with ABL Bio Combinations will require maximiz
Slide 23: Data Support Further Development as a Monotherapy and in Combination
Phase 1 Data Support Further Development as a Monotherapy and in Combination with Other Agents Overview: 44 efficacy evaluable patients (53 enrolled) with advanced or relapsed/refractory solid tumors (NCT04762641) 64.2% (34/53) of patients enrolled had at least three prior lines of systemic anti-can
Slide 24: Manageable Safety Profile
Manageable Safety Profile MTD established with 7 mg/kg every two-week dosing Most common TRAEs were increased ALT and increased AST None of the transaminase elevations were accompanied by clinically significant, treatment-related bilirubin increases Grade ≥ 3 ALT or AST increases occurred in 24.5% (
Slide 25: Ragistomig Results Compared to Acasunlimab
Ragistomig Results Compared to Acasunlimab Phase 1 Ragistomig (ABL503) Acasunlimab (GEN1046) Phase Phase 1 (NCT04762641) Phase 1 (NCT03917381) Treatment Monotherapy 0.7 mg – 10 mg/kg, Q2W Monotherapy 25 – 1,200 mg, Q3W Diagnosis Advanced or refractory solid tumors Advanced or refractory solid tumors
Slide 26: Selected Financial Information and Anticipated Upcoming Milestones
Cash, cash equivalents and short-term investments as of September 30, 2024, were $184.4M Cash position expected to fund givastomig Phase 1b studies and further development initiatives into 2027 Issued and outstanding ordinary shares of 187.5M representing the equivalent of 81.5M ADSs1 as of Septembe
Slide 27: I-Mab Biopharma IR Contact
I-Mab Biopharma IR Contact Tyler Ehler Sr. Director, Investor Relations [email protected] Stay connected