NovaBridge Biosciences · NASDAQ:NBP
NovaBridge Biosciences — I-Mab — Investor Presentation (August 2024)
25 slides from NovaBridge Biosciences's investor presentation, Aug 28, 2024
Slide 1: Transforming Potential into Reality
Transforming Potential into Reality I-Mab Biopharma August 28, 2024
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: Advancing a Differentiated Pipeline
Asset PHASE 1 PHASE 2 PHASE 3 MARKET OPPORTUNITY STATUS/POTENTIAL NEXT STEPS PARTNERSHIPS Uliledlimab CD73 mAb 1L mNSCLC: Target population of 300k+ patients2 1H 2025: First patient dosed in pembrolizumab + chemo combination for 1L mNSCLC 2H 2025: Phase 2 PFS data from ongoing TJBio study (China-onl
Slide 4: Uliledlimab (targeting CD73)
Uliledlimab (targeting CD73) Initial development focused on 1L mNSCLC with potential to expand across multiple indications in combination with immune checkpoint inhibitors Anti-CD73 CD73 Biology Key Advantages CD73 is the rate-limiting enzyme that converts AMP into immunosuppressive adenosine Uliled
Slide 5: 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 6: Uliledlimab: A Differentiated CD73 Antibody
CD73 enzyme activity inhibition Dose-dependent CD73 inhibition without the “hook effect” Uliledlimab: A Differentiated CD73 Antibody Open conformation (inactive) Closed conformation (active) Oleclumab1 Intra-dimer binding mode Inter-dimer binding mode Open conformation (inactive) Closed conformation
Slide 7: Uliledlimab May Completely Inhibit CD73 Function in vitro Whereas Competitor Antibody Does Not
Partial inhibition by inter-dimer binding mode Complete inhibition by intra-dimer binding mode Uliledlimab May Completely Inhibit CD73 Function in vitro Whereas Competitor Antibody Does Not Astra Zeneca is evaluating oleclumab in a Phase 3 study in patients with Stage III NSCLC Oleclumab (MEDI9447)
Slide 8: Inhibition of CD73 Activity & Tumor Growth is Dose-Dependent for Uliledlimab
Inhibition of CD73 Activity & Tumor Growth is Dose-Dependent for 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 Dose-dependency not observed for olecl
Slide 9: Uliledlimab + Toripalimab Data Supports Patient Selection Based on CD73 Expression
Safety profile of combination comparable to CPI monotherapy studies Uliledlimab + Toripalimab Data Supports Patient Selection Based on CD73 Expression and Shows Manageable Toxicity Notes: ORR = objective response rate; MTD = maximally tolerated dose; Q3W = every three weeks; AE = adverse events; CPI
Slide 10: Most Tumors Decrease in Size
Most Tumors Decrease 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 11: Most Responses are Durable
Most Responses are Durable 18 of 21 patients with an objective response remain on treatment with a median follow-up of 10.8 months Notes: Response definitions per iRECIST criteria. PR = partial response; SD = stable disease; PD = progressive disease; iUPD = unconfirmed progressive disease Source: AS
Slide 12: Rationale to Support Uliledlimab + Pembro + Chemotherapy in 1L mNSCLC
Rationale to Support Uliledlimab + Pembro + Chemotherapy in 1L mNSCLC Samanta D, Park Y, Ni XH, Semenza G. 2017. Chemotherapy induces enrichment of CD47+/CD73+/PDL1+ immune evasive triple-negative breast cancer cells. PNAS Vol. 115, No 6. Notes: mNSCLC = metastatic non-small cell lung cancer; IO = I
Slide 13: Uliledlimab Development Plan: Randomized Study Design
Uliledlimab Development Plan: Randomized Study Design for Combination with Pembrolizumab + Chemotherapy Notes: mNSCLC = metastatic non-small cell lung cancer; R = randomized; ECOG PS = ECOG Performance Status Scale; TPS = tumor proportion score; ORR = objective response rate; PFS = progression free
Slide 14: Givastomig (targeting Claudin 18.2 and 4-1BB)
Molecular Design Key Differentiation Binding 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 compared to reference antibody Zolbetuximab Localized T cell activation in TME to minimize
Slide 15: Early Phase Responses in Heavily Pretreated Patients
Early Phase 1 Responses in Heavily Pretreated Patients Provides 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: 20 efficacy evaluable patients with CLDN18.2+ GC/GEJ/EAC Three median lines of prior treatment (range 1-10)
Slide 16: Safety: Treatment Related AEs
Safety: Treatment Related AEs Preferred Term (all numbers are n(%)) Grade 1 Grade 2 Grade 3 Grade 4 Grade 5 All Grades Nausea 10 (18.2) 3 (5.5) - - - 13 (23.6) Vomiting 7 (12.7) 2 (3.6) - - - 9 (16.4) Fatigue 7 (12.7) 1 (1.8) - - - 8 (14.5) Anemia 1 (1.8) 4 (7.3) 1 (1.8) - - 6 (10.9) Abdominal pain
Slide 17: Givastomig Yields Better Monotherapy Responses Compared to Zolbetuximab
Givastomig Yields Better Monotherapy Responses in Patients with Low to High CLDN18.2 Expression Compared to Phase 1/2 Zolbetuximab Studies Drug Givastomig (bi-specific) Zolbetuximab (mAb) Phase Phase 1 Phase 1 Phase 2 CLDN18.2 – Expression of the Study Group IHC ≥1+ in ≥1% cells IHC ≥1+ in ≥1% cells
Slide 18: Potential Differentiations of Givastomig from Other Claudin 18.2 Competitors
Potential Differentiations of Givastomig from Other Claudin 18.2 Targeted Competitors Givastomig Zolbetuximab ADC – CMG9013 Mechanism of Action CLDN18.2 dependent T cell activation in tumor 4-1BB agonism to increase T cell expansion in tumor and reinvigorate exhausted T cells Bi-specific antibody de
Slide 19: Unique Design to Enable Potential Wide Use Plus Favorable Initial Safety Profile
Unique Design to Enable Potential Wide Use Plus Favorable Initial Safety Profile Encouraging Responses in Previously Treated Patients, Including Those with Low CLDN18.2 Expression Levels Dose Expansion Data and New Nivolumab + Chemotherapy Combo Study Ongoing Unique Bispecific Design Properties and
Slide 20: Ragistomig (targeting PD-L1 and 4-1BB)
Molecular Design Target Drug Profile Molecule binds to PD-L1 to inhibit PD-1/PD-L1 interaction Targeting PD-L1+ tumor cells Blocking PD-L1/PD-1 immune inhibitory signaling PD-L1-dependent 4-1BB activation at the tumor site Potent tumor-directed 4-1BB activation to enhance anti-tumor immunity Enhance
Slide 21: Phase 1 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 22: 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 23: 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 24: Financial Information and Upcoming Milestones
Cash, cash equivalents and short-term investments as of June 30, 2024 were $207.5M Expected cash runway into 2027 supporting multiple potential inflection points Issued and outstanding ordinary shares of 187.3M representing the equivalent of 81.4M ADSs1 Financial Information and Upcoming Milestones
Slide 25: Stay connected
Stay connected I-Mab Biopharma IR Contact Tyler Ehler Sr. Director, Investor Relations [email protected]