Cellular Biomedicine Group Inc
Cellular Biomedicine — Corporate Update (July 2020)
32 slides from Cellular Biomedicine's corporate update, Jul 13, 2020
Slide 1: CBMG Research & Development Update
CBMG Research & Development mpc ate July 13, 2020 Cellular Biomedicine Group
Slide 2: Safe Harbor
Safe Harbor ;/ CBMG Cellular Biomedicine Group SS Statements in this presentation relating to plans, strategies, trends, specific activities, investments, and other statements that are not descriptions of historical facts, including our expectations regarding our immuno-oncology and regenerative med
Slide 3: Agenda
Agenda / CBMG Cellular Biomedicine Group ™ CEO Opening remarks @ Leading Immuno-oncology (IO) Pipeline Updates m Leading Regenerative Medicine Pipeline Updates
Slide 4: CBMG Current Clinical Pipeline
CBMG Current Clinical Pipeline PRODUCT INDICATION PRECLINICAL PHASE 1 PHASE 2 Anti-BCMA CAR, MM o— CAR-T | Anti-BCMA,CD19BiICAR = MM ry Anti-CD20 CAR R/R NHL O= TCR-T | Anti-CD19, CD20 BICAR NHL O= AFP TCR-T HCC Cy TIL TILI (combo w/ anti-PD-1) NSCLC _—— TIL2 (combow/anti-P0-1) Solid Tumors —= NHL =
Slide 5: CBMG Core Strategy
CBMG Core Strategy Strive for Speedy Del y of Quality Drugs to Pa Develop Key Building Blocks: > Relevant and strong RnD expertise in cell and gene therapies. Aim for potentially best in class and/or among first three to the market Translational medicine for target patient population selection & und
Slide 6: Seeking BLA in China and Partnership in the US
Seeking BLA in China and Partnership in the US 7cBMG Cellular Biomedicine Group we ‘e *e, Pre-clinical GMP IND Clinical China +Research Manufacture // Submission // Development NMPA Filing °e: 2,@ © on saa Cc... => = > a") Loni Investigator Initiated Trial it) Positive US IND Clinical n > Early Safe
Slide 7: Investigator Initiated Trial (IIT) in China
Investigator Initiated Trial (IIT) in China 7CBMG Cellular Biomedicine Group SS > Only cell, gene and stem cell therapies are allowed to explore IIT path in China, and encouraged by both NMPA and NHC. » The sponsor and Pls work together to obtain scientific board and IRB approval. The hospital then
Slide 8: Anti-BCMA CAR (C-CAR088) is the 2nd generation 4-1BB anti-BCMA CAR
Anti-BCMA CAR (C-CAR088) is the 2nd JCBMG generation 4-1BB anti-BCMA CAR with Human scFv Eeluiar Bomectcine Group + scFv of C-CAR088 specific target epitome cluster E3 in BCMA extra-cellular domain 1 10 *S 20 30°5 a0 54 MLOMAGOCSONEYFDSLLHACI PCOLRCSSNTPPLTCORYCNASWVTNSVKGTNA es ot a £1:1-7 £2:8-21
Slide 9: C-CAR088 Shows Robust in vitro Anti-tumor Activity
C-CAR088 Shows Robust in vitro Anti-tumor Activity Anti-BCMA CAR Expression — 7CBMG Cellular Biomedicine Group BCMA Expression on Target Cells Cell Killing Assays NT ® Positive control a ~* CBM.BCMA it NH929 too, NH929-BCMA too, MM.1S 2 2 2 ‘o 75: ig 75: ‘iS 1 $ $ $ s 50- S 50- S 50- é 25: 3 25- 3 2
Slide 10: C-CAR088 Shows Dose Dependent in vivo Anti-tumor Activity
C-CAR088 Shows Dose Dependent in vivo Anti-tumor Activity 7CBMG Cellular Biomedicine Group proccc foo -------------------------------------------- 7 ' Control Tcells C-CAR088 2.5x10° cells 1 : 2500. 2500- 2500- 1 1* q soo H ' E 2000- — 2000. é H 1 2 1500. 2 100 1500 q 12 Z 1 | 3 1a 3 s00 3 so | | E
Slide 11: Phase I Study in R/R Multiple Myeloma (IIT)
Phase | Study in R/R Multiple Myeloma (IIT) C-CAR088 C-CAR088 Apheresis Manufacturing &QC. ICR Screening f assosss 21d “1d “Sd -4d -3d Flu: 30 mgimid Cy: 300mgimid 7CBMG Cellular Biomedicine Group infusion fl Clinical monitoring and biomarker studies Day0 D4 D7 Dio W2 W3 W4 We Wi2 Wi6 W20 M6 M9 iz F
Slide 12: Summary for C-CAR088
Summary for C-CAR088 / CBMG Cellular Biomedicine Group Vv Vv In preclinical studies, C-CARO88 shows strong antitumor activity both in vitro & in vivo. No Grade 4 or higher CRS was observed in 17 patients. No Grade 2 or higher neurotoxicity and DLTs observed. Cytopenia mostly related to Cy/Flu lympho
Slide 13: In vitro and in vivo Activity of Anti-CD20-CD19 Bi-specific CAR (C-CAR039)
In vitro and in vivo Activity of Anti-CD20-CD19 Fea G Bi-specific CAR (C- CAR039) £,CBMG C-CAR039 Structure Cell Killing Experiment on Target Cell Lines FMC63 scFv | mw | COP [4188 | cps: | A. Detect the killing level of cells released by LDH C-CAR039 cell activation and cytokine release tee coceale
Slide 14: C-CAR039 Phase I Study in r/r B-NHL (IIT)
C-CAR039 Phase 1 Study in r/r B-NHL (IIT) ; CBMG Cellular Biomedicine Group Dose Escalation of CAR+ T Cells 4.0x10%/Kg 2.5x108/Kg [range: + 20% of the target dose] Key Eligibility Criteria : [ais expansion cohort determine RP2D > CBMG + 18-75 years of age + t/t B-NHL including i oer DLBCL,FL,MCL [er
Slide 15: Summary for C-CAR039
Summary for C-CAR039 / CBMG Cellular Biomedicine Group > Pr C-CAR039 is a novel bi-specific CAR-T, targeting both CD19 and CD20. C-CAR039 showed reactivity against both single positive and double positive tumors in vitro and in vivo, can potentially be the best-in-class of CAR-T cell therapies for B
Slide 16: Treating HCC with AFP TCR-T Therapy
Treating HCC with AFP TCR-T Therapy + Alpha-fetoprotein (AFP) is being explored as a promising immunotherapy target due to its high expression in HCC and restricted expression in normal tissues. tireteeeid + Nine independent TCRs from AFP specific T Normal Tissue 7CBMG Cellular Biomedicine Group “ET
Slide 17: CBMG Has Promising TCRs against AFP
CBMG Has Promising TCRs against AFP Identified AFP specific TCRs by immunizing HLA-A2 transgenic AAD mice with AFP, <6. tes (FMNKFIYE1) Selectively cloned nine independent TCRs from AFP specific lymphocytes 7CBMG Cellular Biomedicine Group A AFP iss peptide+ AFP-Ly-prime+ 2 2% Naive AFP-Lv-primed ——
Slide 18: Human AFP TCR-T Specifically Recognize HLA-A2* Presented Epitope
Human AFP TCR-T Specifically Recognize HLA-A2* FoR Presented Epitope in vitro and in vivo # CBMG TCR expressing recombinant lv EFlapromoter {aan 1004 EEE AFP. HepG2 1 Mock ‘TORT 1 t 030% aa 1 204 EI AFPeHepc2 t ig 1 H 1 go Ht | = t 1 z% 1 ce |, } 1 8 : Tetiss Tetiss i H ¢ She? 1 °. 1 1-30 1 Mock TOR
Slide 19: No Reactivity of AFP TCR2 Detected to Human Primary Cells
No Reactivity of AFP TCR2 Detected to Human HLA-A*02:01 Primary Cells from Essential Organs Hepatocyte a Hepatocyte b Huh7 HepG2 Donor A Donor B UT TCR2 UT TCR2 fo [eo] fo [or] fo [oo] fo [or | | Fie PO silo PO foo |o0| o [or] 0 [oo fo |oo | | | t t t yey Nw ON ob ON foo [00] fo [oo] po |oo) fo |oo
Slide 20: No Allo-reactivity of AFP TCR2 Detected for >90% Chinese HLA Serotypes
7CBMc No Allo-reactivity of AFP TCR2 Detected for >90% Chinese HLA Serotypes iscadanncanas mm TCR Our SRIRRLSTEE LEEL-OLPL 8SE8-9PEL qo é & = 2 © (uy6u) Nat Bs ° Helse 2}5]3) 3 sg : Fi F Ratats glelals] 3 : 3 ass Hil tested lj not tested 20
Slide 21: AFP TCR2 Displays No Cross-reactivity with Other Proteins
AFP TCR2 Displays No Cross-reactivity with Other Proteins in Human Genome by X-scan FMNKFIYE Post Pos2 Pos3 15; Plu ble indi 6 Poss Poss Pos6 : hat! Mh l | ill I i Mun ratio Pose Muth ratio a — = = >90% decrease of IFN-g release over amino acid replacement in AFP 459.466 indicates that position 4 an
Slide 22: C-TCR055 Phase I Clinical Design
C-TCR055 Phase | Clinical Design / CBMG Cellular Biomedicine Group PE Dose Escalation Study, Dose Group 1: 5x10’, Group 2: 5x10%, Group 3: 2.5 — 10x10° T-CRT cells | - | Screening — Baseline] ioe Follow up Lier C-TCROS55 Production Safety Assessments Biopsy A. -4W -5D -4D -3D -2D -1D DO D4 D7 D10 W2
Slide 23: Summary for C-TCR055
Summary for C-TCRO55 / CBMG Cellular Biomedicine Group > C-TCR055 is CBMG's proprietary clinical lead of TCR-T which specifically recognizes the HLA-A*02:01 restricted AFP js.. 166 Peptide that is highly expressed in HCC and other solid tumors. > Preclinical studies suggest that C-TCR055 has optimal
Slide 24: Development of TIL as a Treatment for Immunogenic Solid Cancers
Development of TIL as a Treatment for Immunogenic Solid Cancers + Til therapy is a potent and well tolerated treatment for immunogenic cancers + Multiple TIL manufacturing processes available + Traditional TIL (NCI) + Young TIL (fast TIL) + Neoantigen-reactive TIL (NCI, licensed by CBMG) * Top poten
Slide 25: Benefits of TIL Technology
Benefits of TIL Technology Challenges 7CBMG Cellular Biomedicine Group TIL enables and enhances robust immune responses 25
Slide 26: Lung Cancer TIL Study Design & Patient Disposition
Lung Cancer TIL Study Design & Patient Deposition: FCBMG rir NSCLC Patients Post Nivolumab Treatment Responders Group > If progression -> treat with TIL Qbwxt yr Select TIL & Freeze PRCR ——pRicR teeoso 4 a? 5 Screening 87 63 49-35 2 8 7454324 0 ( ta Tumor Nivo Harvest t 2 2 ta Nwo _Nivo Cellular Bio
Slide 27: TIL Therapy: Clinical Results in Advanced NSCLC
TIL Therapy: Clinical Results in Advanced NSCLC Patients who Failed Nivolumab Therapy PE Tumor response before and after TIL Summary 7CBMG Cellular Biomedicine Group rn 1. TIL can be produced in 95% (19/20) of NSCLC rE . patients. ik _ 2. Durable responses were observed with TIL therapy. hy BO Dry B
Slide 28: CBMG TIL Strategy
CBMG TIL Strategy / CBMG Cellular Biomedicine Group > Improve the next TIL clinical trial by addressing key issues from previous studies. > Invest in TIL process development in both US and China. > Sponsor and initiate TIL1 trial in the US in 2021 for stage IIIB and IV NSCLC patients (excluding EGFR
Slide 29: CBMG Current Clinical Pipeline
CBMG Current Clinical Pipeline PRODUCT INDICATION PRECLINICAL PHASE 1 PHASE 2 Anti-BCMA CAR, MM Oo— CAR-T | Anti-BCMA,CD19BiICAR = MM ry Anti-CD20 CAR R/R NHL O= TCR-T | Anti-CD19, CD20 BICAR NHL O= AFP TCR-T HCC o: TIL TILI (combo w/ anti-PD-1) NSCLC — TIL2 (combow/anti-P0-1) Solid Tumors —= NHL =
Slide 30: AlloJoin & Re-Join Phase II trials approved in China
AlloJoin® & Re-Join® Phase Il trials approved in China 7CBMG Pre-clinical POC clinical | Phase I/ll(*lITs) | Phase II/II AlloJoin® Re-join® “IITs, investigator initiated trials + AlloJoin® Phase I! Trial kicked off in Q3 2019 and has enrolled patients in 6 hospitals. ¥ Study design: Multi centers, R
Slide 31: Brief of Re-Join Early Clinical Studies (IITs)
Brief of Re-Join® Early Clinical Studies (IITs) 7CBMG Cellular Biomedicine Group + Re-Join® IIT clinical studies on autologous haMPCs Approved by the Ethics Committee in Renji hospital of Shanghai Jiao Tong University Conducted by CBMG clinical development team under the supervision of the new drug
Slide 32: Saving Life, Revitalizing Life
Saving Life Revitalizing Life www.cellbiomedgroup.com
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