Slide 1: Jacobio Pharma 2023 Interim Results Presentation
Jacobio Pharma 2023 Interim Results Presentation Aug 2023 1167.HK
Slide 2: Disclaimer
Disclaimer This presentation includes forward-looking statements. All statements contained in this presentation other than statements of historical facts, including statements regarding future results of operations and financial position of Jacobio Pharmaceuticals (“Jacobio” “we,” “us” or “our”), ou
Slide 3: Key Milestones and Catalyst Events
Key Milestones and Catalyst Events
Slide 4: 2023 Interim Results
2023 Interim Results Core products Data Publications Financial Performance Glecirasib（KRAS G12Ci, JAB-21822) 2023 JAC-AACR As of June 30, 2023: • Bank Balances: RMB 1.3 billion • NSCLC monotherapy pivotal trial • Glecirasib plus cetuximab in CRC • Cash Runway: 24 months Patient enrollment to complet
Slide 5: 2023 H2 - 2024 H1 Key Milestones and Catalyst Events (1/2)
2023 H2 - 2024 H1 Key Milestones and Catalyst Events (1/2) Event Expected Timing NDA Glecirasib (JAB-21822) monotherapy in NSCLC pre-NDA submission (CMC portion) ● 2023 Q4 Glecirasib (JAB-21822) monotherapy in NSCLC NDA submission ● 2024 H1 Pivotal Trials Glecirasib (JAB-21822) monotherapy in PDAC –
Slide 6: 2023 H2-2024 H1 Key Milestones and Catalyst Events (2/2)
2023 H2-2024 H1 Key Milestones and Catalyst Events (2/2) Event Expected Timing New INDs JAB-23400 (KRASmulti ) ● 2024 H1 JAB-30300 (P53 Y220C) ● 2023 Q4 Data publication ESMO • Clinical data of JAB-3312 (SHP2i) plus Glecirasib ● October 2023 ASCO GI (plan to submit) • Glecirasib monotherapy in PDAC
Slide 7: The Dilemma of Oncology Drug Development in the Past Decade
The Dilemma of Oncology Drug Development in the Past Decade Target Therapy Immuno-oncology In the last 15 years since 2001, the easier After the successful development of the therapeutic targets have been largely anti-PD-1 antibody in 2013, there have developed, shifting the focus to previously been
Slide 8: Our Strategy and Pipeline Layout (1/2)
Our Strategy and Pipeline Layout (1/2) Leveraging our IADD Platform for Developing Novel Drugs toward Undruggable Targets and Serving as Payloads for iADC Development toward undruggable targets for classic pathways Development toward undruggable targets for classic oncogenic pathways • KRAS Pathway
Slide 9: Our Strategy and Pipeline Layout (2/2)
Our Strategy and Pipeline Layout (2/2) Leveraging our IADD Platform for Developing Novel Drugs toward Undruggable Targets and Serving as Payloads for iADC iADC Development in Immuno-oncology • iADC JAB-X400 HER2-STING agonist JAB-X1800 CD73-STING agonist … • Downstream targets of STING JAB-26766 PAR
Slide 10: Our Pipeline
Our Pipeline Global China Asset Target Pathway Stage IND Indications Note Ranking* Ranking JAB-3312 NSCLC, ESCC, SHP2 RAS&I/O Phase II 2018 2 1 JAB-3068 other solid tumor NSCLC, CRC, JAB-21822 KRAS G12C RAS Phase II 2021 PDAC, other solid 2 Submit NDA in 2024 tumor solid tumor, MF, The same target p
Slide 11: Targeted Therapy Programs - KRAS Pathway
Targeted Therapy Programs - KRAS Pathway
Slide 12: Advancing Glecirasib in NSCLC
Advancing Glecirasib in NSCLC Regimen Indications IND Phase I Phase IIa Phase IIb Mono NSCLC China trial (pivotal trial) 1L, 2L+ and KRAS G12Ci Combo w/JAB-3312 China trial resistant NSCLC 1L NSCLC w/ STK11 Mono China trial co-mutation Combo w/PD-1 mAb NSCLC China trial Mono NSCLC Global trial Robus
Slide 13: Glecirasib has Superior Efficacy and Safety Profile in NSCLC
Glecirasib has Superior Efficacy and Safety Profile in NSCLC Efficacy Patients with KRAS G12C mutant NSCLC • In the early dose esc/exp trial, ORR was observed 56.3% (18/32) in NSCLC (2022 ASCO abstract). • Promising response data in the frontline NSCLC was observed for JAB-21822+JAB-3312 trial (2023
Slide 14: Glecirasib has the BIC Potential in CRC
Glecirasib has the BIC Potential in CRC Efficacy and Safety shows superior advantage cross the competitors • JAB-21822 has encouraging single agent activity in advanced CRC • Both single agent and combination therapy are safety and well tolerated. - ORR 33.3% (11/33), DCR 90.9% (30/33) and mPFS of 6
Slide 15: Glecirasib in Pancreatic Cancer Development
Glecirasib in Pancreatic Cancer Development Monotherapy Clinical Development Update - The single arm pivotal trial in patients with PDAC harboring KRAS G12C mutation was approved by the CDE. Site is expected to be activated in September 2023. - In August, Glecirasib was granted BTD for 2L + KRAS G12
Slide 16: SHP2 inhibitor
SHP2 inhibitor
Slide 17: SHP2 Protein Phosphatase
SHP2 Protein Phosphatase SHP2 effects are upstream of RAS and Programmed cell death protein 1 (PD-1) Immune checkpoint in T cells KRAS pathway in tumor cells RTK PD-1 BTLA Others… EGFR, ALK, MET, KIT… P SOS ITIM P P P P SHP2 RAS AMG-510 P SHP2 P P MRTX849 ITSM RAF Vemurafenib TCR inhibition MEK Tram
Slide 18: Clinical Application of SHP2 Inhibitors - SHPi+X combination therapy
Clinical Application of SHP2 Inhibitors - SHPi+X combination therapy SHP2 Inhibition Sensitizes Diverse Oncogene-Addicted Solid Tumors to Re-treatment with Targeted Therapy • SHP2 inhibitor overcome bypass-signaling-mediated resistance when combined with inhibitors of various oncogenic drivers 1. Co
Slide 19: JAB-3312 is the only second-generation SHP2i
JAB-3312 is the only second-generation SHP2i First-generation SHP2i Second-generation SHP2i JAB-3068 JAB-3312 other clinical-stage compounds Biochemical assay IC50: ~10nM Biochemical assay IC50: ~1.5nM Cell viability IC50 ~100nM Cell viability IC50: ~4nM Clinical dose up to 100-300mg/day Clinical do
Slide 20: Global Development Plan of SHP2 Inhibitors
Global Development Plan of SHP2 Inhibitors Asset Regimen Indications Phase I Phase II KRAS G12C mut China trial Combination with JAB-21822 solid tumors KRAS G12C multi Global trial Combination with sotorasib NSCLC JAB-3312 Combination with Global trial NSCLC, ESCC Pembrolizumab (PD-1 mAb) Osimertini
Slide 21: JAB-23400: An Oral KRAS multi Inhibitor
JAB-23400: An Oral KRAS multi Inhibitor • 23% of human cancers harbor KRAS mutations1. KRAS G domain Hypervariable • 2,700,000 new cases per year with KRAS 12 61 Region mutations in worldwide2 1 30 40 58 72 188 Differentiation of JAB-23400 P loop Switch I Switch II • JAB-23400 inhibits multiple KRAS
Slide 22: JAB-23400: An Oral KRAS multi Inhibitor
JAB-23400: An Oral KRAS multi Inhibitor JAB-23400 Profile Inhibition of KRAS mutation profile pERK, Cell Viability, Cell lines • JAB-23400 inhibits the activity of multiple KRAS IC50, nM IC50, nM AGS (KRAS G12D) mutants (G12D, V, A, R, G13D, Q61H) in both RAS KRAS Mutation SW620 (KRAS G12V) <5 < 20
Slide 23: Targeted Therapy Programs - MYC Pathway
Targeted Therapy Programs - MYC Pathway JAB-8263 Clinical Progress • The Phase I dose escalation in solid tumors and hematological malignancies is ongoing in the U.S. and China simultaneously. • Excellent safety and positive therapeutic signals. • RP2D is expected to be determined in the second half
Slide 24: Targeted Therapy Programs - P53 Pathway
Targeted Therapy Programs - P53 Pathway
Slide 25: P53: Most Frequently Mutated Gene in Tumors
P53: Most Frequently Mutated Gene in Tumors Frequency of P53 Y220C in solid tumors P53 Hotspot mutation Frequency Y220C 1.80% R249S 2.00% G245S 2.10% R282W 2.80% R273C 3.30% R248W 3.50% R273H 4.00% R248Q 4.40% R175H 5.60% • P53 is a key tumor suppressor that regulates various cell processes such as
Slide 26: JAB-30300: An Oral P53 Y220C Activator
JAB-30300: An Oral P53 Y220C Activator JAB-30300 Preclinical Profile Strong Antitumor Effect • JAB-30300 is 2-3 folds more potent than the competitor (double digit nanomolar biochemical IC50) • JAB-30300 demonstrates >40% bioavailability in mouse, rat, dog and monkey, and more than 3 folds higher ex
Slide 27: Immuno-oncology
Immuno-oncology Clinical stage - STING downstream target PARP7 inhibitor Pre-clinical - iADC：Sting agonist as a Novel Payload
Slide 28: JAB-26766: An Oral PARP7 Inhibitor
JAB-26766: An Oral PARP7 Inhibitor Role of PARP7 JAB-26766 Preclinical Profile • PARP7 is frequently amplified in squamous cell carcinoma histologies, and inhibition of PARP7 restores the type I IFN response in tumor cells. • JAB-26766 displays 3 folds higher potency in cellular assay, and 3-17 fold
Slide 29: JAB-27670: STING Agonist as iADC Payload
JAB-27670: STING Agonist as iADC Payload Rationale • STING agonist produces antitumor cytokine IFNs and T cell chemokine CXCL10, turning “cold” tumors into “hot” tumors. • Tumor-targeted delivery of STING agonist is warranted to avoid toxicity by systemic administration. JAB-27670 Preclinical Profil
Slide 30: Stability of STING iADC agonists in plasma
Stability of STING iADC agonists in plasma Benchmark Payload H2N O O Stability in human plasma O O N O NH N O 100 N H O JAB-BX400 JAB-BX400 (HER2-27670) O H2N N N 80 Payload release% N O ADC1 ADC1 (M HER2-iADC) O O N N O 60 53.8 H N O NH O O O O O OH OH 40 N H N H N H N O O O O H N OH N N N O O O O
Slide 31: Our iADC Products
Our iADC Products High potency and Synergistic effect with anti-PD-1 In pre-clinical studay, BX400 (HER2-27670) is hCD73-MC38 syngeneic (Colon, CD73- positive) effective to DS8201 resistance tumor models hCD73- C57BL/6 mice We are developing multiple STING iADCs with HER2 and other potential targets
Slide 32: On Target to Capture the Global Market
On Target to Capture the Global Market
Slide 33: Financial Summary
Financial Summary R&D Costs 1 Cash, Bank Balances and Bank Credit 231 219 2022/12/31 1300 5.5% 2023/6/30 1298 180 1,478 cash, bank balances and 2022H1 2023H1 （RMB mm） bank credit （RMB mm） Cash and Bank Balances Bank Credit 1. R&D costs = Cost of revenue + Research and development expenses. All R&D c
Slide 34: Company Strategy
Company Strategy Full Function FIC & Global Top 3 In-house R&D Global Market Pharma Key projects on validated Focus on in-house R&D by Commercialization Explore MNC partnership oncogenic signaling leveraging our IADD platform in China to capture global market pathways are among rather than relying o
Slide 35: http://www.jacobiopharma.com/
http://www.jacobiopharma.com/