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주요파이프라인개발현황업데이트
2020. 05. 06.
2
㈜제넥신개요
회장/대표이사
• 성영철 Ph.D.
설립/상장• 1999년포스텍학내벤처㈜제넥신설립
• 2009년코스닥시장상장
핵심기반기술
• hyFc 항체융합기술
• DNA 백신기술
중점개발분야
• 면역항암제
• 희귀질환치료제
• DNA 백신
임직원수 • ~163 명 (MD 1, Ph.D 24, MS 68)
시가총액 • ~1조 5천억원
위치 • 판교코리아바이오파크
“Focused on the Development of Innovative Immunotherapeutics and
Saving the lives of Patients.”
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제넥신개발파이프라인
GX-E4 (EPO)
GX-G3 (G-CSF)
GX-27, GX-P10
GX-210, GX-19
GX -188 (DNA vaccine)
Hyleukin-7 (T cell amplifier)
GX-H9 (hGH)
Best-in-classInnovative drugs
GX-G6 (GLP-1)
Early Stage ( Phase 1 )
GX-G8 (GLP-2)
Late Stage ( Phase 2 3 ) Early Stage ( Phase 1 / 2 )
Preclinical Stage: 4 pipelines
BioBetter drugs
First-in-class
GX-P1 ( Long-acting PD-L1 )
KGBIO
ILKOGEN
HANDOK
CSPC Dual-TargetingFc Fusion Protein
DNA Vaccine
1.
3.
2.
4.
5.
Papitrol-188 (GX-188E)HPV 치료 DNA 백신
인유두종바이러스(HPV) 유래자궁경부암
4
5
두 클래스의 HPV 유래 질환
Source: CDC, hpvcentre.net, WHO IARC
Globally 530,000 new cases/yr
270,000Deaths/yr
HPV 16/18Related 70%
Globally 142,387 new cases/yr
97,940 Death/yr
HPV 16Related 63%
Globally 44,480
new cases/yr
6,000Deaths/yr
HPV 16Related 72%
US/EU 600,000
new cases/yr
Chance to Cancer30%
HPV 16/18Related 52%
US/EU2,800,000
new cases/yr
HPV 16/18Related 26%
Reference: Grand View Research, ICO/IARC Information Centre on HPV and Cancer
$10.6B in 2025, CAGR 5.0% (2017-2025)
Cervical Cancer Treatment Market
6
GX-188E, HPV 16/18 유래질환 치료를 위한 DNA백신
Rationally designed DNA vaccine to enhance HPV 16/18, E6- and E7-specific CD8+ T cell responses
MHC I
HPV 16-/18-specific
CD8+ T-cell ACTIVATION
SECRETED HPV 16/18
E6, E7 ANTIGEN
MHC II
CD4+ T-cell ACTIVATION
MYOCYTETRANSFECTION
DENDRITIC cells
Electroporation
tPA Flt3L E6/E7 of HPV types 16 & 18
GX-188In pGX27
high-expression Vector
Lancet Oncol. 2019 Dec;20(12):e671
전이 또는 재발된 말기 자궁경부암의 표준치료요법 현황
7
1 NCCN Guideline Version 4.20192 J Clin Oncol. 2019; 37(17):1470-1478
1
Pembrolizumab received accelerated approval for PD-L1 positive or MSI-H/dMMR tumors with ORR of 14.6% after Ph2 (Keynote158)
Pembrolizumab only
ORR12.2% 2
CPS ≥ 1 ORR 14.6% CPS < 1 ORR 0
Sooyoung Hur1, Jong Sup Park2, Yong-Man Kim3, Myong Cheol Lim4, Jae Hong No5, Byoung-Gie Kim6, Jae-Kwan Lee7, Chi Heum Cho8, Yoon-Jeong Choi2, You Suk Suh2, Jung Won Woo2, and Young Chul Sung2
1The Catholic University of Korea, Seoul St. Mary's Hospital, Seocho-gu, Seoul, Korea, Republic of; 2Genexine, Inc., Bundang-gu,
Seongnam-si, Gyeonggi-do, Korea, Republic of; 3Asan Medical Center, Songpa-gu, Seoul, Korea, Republic of; 4National Cancer
Center, Ilsandong-gu, Goyang-si, Gyeonggi-do, Korea, Republic of; 5Seoul National University Bundang Hospital, Bundang-gu,
Seongnam-si, Gyeonggi-do, Korea, Republic of; 6Samsung Medical Center, Gangnam-gu, Seoul, Korea, Republic of; 7Korea
University Guro Hospital, Guro-gu, Seoul, Korea, Republic of; 8Keimyung University Dongsan Medical Center, Dalseo-gu, Daegu,
Korea, Republic of
Efficacy and safety results of GX-188E DNA vaccination combined with pembrolizumab administration in patients with HPV 16- and/or 18- positive advanced cervical cancer: Phase II interim analysis results
Abstract #10121
April 27th, 2020
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Rationale of HPV-therapeutic vaccine + anti-PD-1
HPV therapeutic vaccine
• Facilitate T cell priming, expansion and lesion infiltration
Before
PD-L1 PD-L1
After
CD8 CD8
Complementary therapeutic benefits
Pre-operative MEDI0457 monotherapy in HPV+ HNC
Aggarwal, C., et al. (2019) Clin Cancer Res 25(1): 110-124.
• Invigorate and deploy HPV-specific CD8+ T cells into the TME
Anti-PD-1
• Facilitate T cell priming (expansion of anti-HPV T cells) Hui, E., et al. (2017). Science 355(6332): 1428-1433.
ORR in anti-PD-1
37-57%11-42%
12-35%0-9%TMB
T-cell inflamed Gene Expression Profile(GEP)
TMBlo GEPhiTMBlo GEPlo
TMBhi GEPhiTMBhi GEPlo
“Cold” tumor “Hot” tumor
Vaccine
Cristescu, R., et al. (2018). Science 362(6411).
Discussant:
Nina Bhardwaj M.D., Ph.D.
Director of Immunotherapy,
Tisch Cancer Institute,
Icahn School of Medicine at Mt Sinai,
Ward-Coleman Chair in Cancer Research,
Professor of Hematology and Oncology,
New York, NY
10
GX-188E + Keytruda 병용요법의 면역반응 유도 및 치료반응 결과
PD-L1-positive: 50%, HPV16: 47%, Suamous cell carcinoma: 45% 의치료반응율보임.
PD-L1-negative 에서도치료반응관찰됨.
78%의환자에서 HPV 특이적면역반응이효율적으로유도됨.
안전성및내약성이뛰어남 (병용임에도부작용발생율이 Keytruda 단일요법과유사한수준임)
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Type of vaccine Target NCT number Phase Cancer types Combinations
Peptide vaccine(ISA101b)
HPV16, E6/E7NCT02426892NCT03669718
IIrII
HPV16+ Solid tumors1
HPV16+ Oropharyngeal CancerNivolumabCemiplimab or placebo
Poxvirus vaccine(TG4001)
HPV16, E6/E7 NCT03260023 I/II HPV16+ Cancers2 Avelumab
DNA vaccine(MEDI0457)
HPV16, 18 E6/E7NCT03162224 NCT03439085
I/IIII
HPV-associated Head and Neck CancerHPV-associated Cancers
Durvalumab
DNA vaccine(GX-188E)
HPV16, 18 E6/ E7 NCT03444376 I/II HPV16+ +/- 18+ Cervical cancer Pembrolizumab
Selected clinical trials of HPV-targeted cancer vaccines + anti-PD-1/PD-L1
1. Massarelli, E., et al. (2019). JAMA Oncol 5(1): 67-73.2. C. Tourneau et al.(2019) Ann Oncol 30 (suppl_5): v475-v532.
Lowy, D. R. and J. T. Schiller (2012). Cancer Prev Res (Phila) 5(1): 18-23.
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HPV-therapeutic vaccine + anti-PD-1 ab vs. anti-PD-1 ab alone
ISA101b + Nivolumab1
HPV+ Oropharyngeal Cancer cases, N=22Nivolumab alone (Checkmate141)2
HPV+ Head and Neck Cancer cases, N=63
ORR, n(%) 8 (36) 10 (16)
Median PFS [mo.] 2.66† 2.0‡
Median OS [mo.] 17.5† 9.1
TRAEs ≧ grade3 (%) 8.3† 13.1‡
†Among all cancer type(22 oropharyngeal cancer, 1 cervical cancer, 1 anal cancer)‡Among all population (both patients with HPV+ and HPV-)
GX-188E + Pembrolizumab(current study), N=26
Pembrolizumab monotherapy3
(Keynote158), N=98
ORR, n(%) 11 (42.3) 12 (12.2)
DCR, n(%) 15 (57.7) 30 (30.6)
Median PFS [mo.] 5.0 2.1
TRAEs ≧ grade3 (%) 10.7* 12.2
ISA101b + Nivolumab vs. Nivolumab alone
GX-188E + Pembrolizumab vs. Pembrolizumab alone
* Safety set (n=28)
1. Massarelli, E., et al. (2019). JAMA Oncol 5(1): 67-73.2. Ferris, R. L., et al. (2016). N Engl J Med 375(19): 1856-1867.3. Chung, H. C., et al. (2019). J Clin Oncol 37(17): 1470-1478.
HPV 16/18 유래 암에 대한 임상협업관련 문의 및 논의 활발
개발 일정
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Cervical Cancer
with CPI & Hyleukin-7
Oropharyngeal Cancer
with CPI & Hyleukin-7
GX-210*
*Next Generation of HPV DNA Vaccine: semi-personalized vaccine
Phase 1b/2
Phase 1b/2
Indication 2018 2020 2022 2024 2026
Cervical Cancer
with KEYTRUDA®
Phase 2
Cancer Vaccine
GX-188
Phase 3 (optional)
1차 평가변수 결과 확보(N=60, Best ORR≤24w)
Phase 2Phase 1b
AACR 2020BD 추진
ASCO 2021L/O 목표
국내 조건부 승인자료 제출 및2022년 국내 최초 허가 목표
GX-188E+Hyleukin-7+CPI 병용의 시너지 효과
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Hyleukin-7
HPV+ Pre-cancer( CIN)
( Cervical, Oro-pharyngeal, & Anogenital Cancers )
HPV+ Cancer
기술이전 잠재적 타겟 회사: anti-PD-1 또는 anti-PD-L1 등 면역관문억제제 보유사
15
국립항암신약사업단및미리어드생명과학과협업으로진행중
Target market
Company PD-(L)1 inhibitor(Trade name)
Dev. Stage(Marketed)
Company PD-(L)1 inhibitor Dev. Stage(Clinical)
Global Merck(MSD) Keytruda Marketed BeiGene Tislelizumab Approved in CN
BMS/Ono Opdivo Marketed Novartis Spartalizumab Ph3
Roche Tecentriq Marketed Incyte/MacroGenics MGA012 Ph2/3
Merck Serono/Pfizer
Bavencio Marketed Tracon/3D Medicines /Alphamab
Envafolimab Ph3
AstraZeneca/Celgene Imfinzi Marketed Curis/Aurigene CA-170 Ph2
Regeneron/Sanofi Libtayo Marketed CheckpointTX/TGTX Cosibelimab Ph1
Innovent/Eli Lilly Tyvyt Marketed in CN ImmuneOncia IMC-001 Ph1
CN Junshi Tuoyi Marketed in CN Henlius HLX10 Ph3
HengRui AiRuiKa Approved in CN
GX-19SARS-CoV-2 예방 DNA 백신
SARS-CoV-2 감염질환
16
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COVID-19: Its Impact and Vaccine Development Timeline
• 전세계적으로 약 23만 명의 사망자 발생 , 확진자 약 230만명
• 세계적으로 경제적 피해가 심각해지고 있음
18
Pipeline of COVID-19 vaccine candidates by technology platform
* Ref: Le TT (2020) Nat Rev Drug Dis Apr.09
It will take 12 to 18 months to get a coronavirus vaccine in the US. - Fauci A (NIAID)
*
COVID-19 예방백신경쟁사임상현황
Platform Type of vaccine Developer Current StageSame platform for non-coronavirus
RNAvaccine
LNP-encapsulatedmRNA
ModernaPh 1 (NCT04283461)Ph 2 (IND)
Multiple candidates
Non-replicatingviral vector
Adenovirus Type 5 vector
CansinobioPh 1 (NCT04313127)Ph 2 (NCT04341389)
Ebola
DNA vaccine
DNA plasmid vaccine with electroporation
inovio Ph 1 (NCT04336410) Multiple candidates
Inactivated inactivated + alum SinovacPh1/2 (NCT04352608)
SARS
Non-replicatingviral vector
ChAdOx1 Oxford Univ.Ph1/2 (NCT04324606)
MERS, influenza, TB, Chikungunya, Zila, MenB, plague
RNA 3 LNP-mRNAs BiontechPh 1/2 (NCT04368728)
Inactivated Inactivated SinopharmPh 1/2(ChiCTR2000031809)
Inactivated Inactivated SinopharmPh 1/2(ChiCTR2000032459)
19
다양한 백신 플랫폼기술의 특성종류 특성
DNA백신
• 동일한 백신 분자 대비 더 많은 항원 단백질을 생산
• 전달 벡터에 대한 면역 반응 생성의 우려가 없음
• 항체 반응과 함께 강력한 세포 면역반응을 유도
• 자체 면역증강효과
• 필요시 유전자 형태로 면역증강 유전자를 넣어줄 수 있음
• 백신의 제작이 빠르고 간편하며, Ecoli를 이용하여 생산비가 낮음
RNA백신 • DNA백신과 비교하여 임상 사례가 많지 않아 더 검증 필요
바이러스벡터 백신 • 전달되는 유전자 외에 전달 바이러스 단백질에 대한 원치 않은 면역반응이 생길 수 있음
Subunit 백신 • 항체 반응 유도에는 유리하지만, 세포면역반응 유도는 상대적으로 불리하기 때문에 면역증강제를 함께 사용해야 함
장단점 RNA vaccine DNA vaccine
Manufacturing in vitro E.coli
# of protein antigen produced per molecules of nucleic acids Medium High
Integration into chromosome No Practically No
Localization for expression Need to escape endosome Need to enter nucleus
Optimization of formulation/Delivery device Challenging Challenging, but solved
Toxicity Potential toxicity No
Manufacturing cost High Medium
GX-19: COVID-19 예방 DNA백신
pCMV S-antigen poly A
GX-19
In pGX27 high-expression
Vector
20
GX-19: COVID-19 예방 DNA백신
GX-19
In pGX27 high-expression
Vector
21
• GX-19
- 항체면역반응과 함께 세포면역반응을 동시에 유도가능
- 원숭이에서 항체반응과 T세포 반응 모두 효율적으로 유도됨을 확인
중화항체 생성능 확인: COVID-19을 효과적으로 예방할 수 있을 것으로 예상
- 설계 당시 알려진 45개의 COVID-19 서열을 분석하여 후보물질 도출
현재 보고되는 대부분의 코로나19 변종에 적용이 가능할 것으로 기대
pCMV HPV antigens poly A
pCMV COVID-19 antigens poly A
GX-188
GX-19
22
Members of Consortium
• Evaluation of Vaccine-inducedImmune Responses in Mice
• Management of Preclinical & Clinical Development
• Operation of Clinical Study
• Evaluation of Immune Responses by using clinical samples
• Evaluation of Vaccine Efficacy in Monkey model
• Neutralizing antibody assay with animal & human blood
• MCB Manufacturing• GMP Production of DNA Vaccine
GX-19
23
Development Timeline (2020)
개발내역 연구기관2020년
3월 4월 5월 6월 7월 8월 9월
GX-19 백신후보도출및
비임상시료생산
영장류에서안전성및면역원성평가
중화능력평가
임상시료생산
(GMP)
IND/IRB 제출및승인제넥신/바이넥스
식약처/임상기관
임상시험
(안전성/면역원성/중화능력 평가)
Phase 1 Phase 2/3
24
COVID-19 Current Incidence Update
Source: https://coronaboard.kr
GX-I7Interleukin-7-hyFc
Cancer and Lymphopenia
GX-I7지속형인터루킨-7 (IL-7-hyFc)
암및림프구감소증
25
26
Hyleukin-7 (GX-I7) : 지속형 인터루킨-7의 차별성
hyFc
N-terminal engineering
No cytotoxicity on target cells- No ADCC of IgD & No CDC of IgG4
Higher protein stability due to N-terminal engineering
Higher productivity+ than IL-7 protein by hyFc fusion
Longer in vivo half-life than IL-7 protein due
to FcRn-mediated recycling of IgG4 &
Reduced renal clearance.
Comparison of Hyleukin-7 with IL-7 protein
1. Pauken KE et al, Science 2016 Dec 2;354(6313)2. In house data, Trafficking and infiltration by upregulating chemokine receptors and
overcoming immune-suppressive tumor microenvironment
Increased TILs Enhanced anti-
tumor activity
APC Naïve T cell
Antigen Presentation
Tumor
Effector T cell
Exhausted T cell
Memory T cell
Priming & Activation
Expansion with clonal diversity & longevity
(CD4 & CD8)Expansion with clonal diversity & longevity
(CD4 & CD8)
Tumor Recognitionand Killing
Antigen specific functional T cells
Trafficking and Infiltration
TILs
27
Hyleukin-7: 작용기전
T 세포증식및활성유지에유일무이한필수사이토카인
T cell Amplifier
T cell Activator Blockade of T cell Suppressor
- IL-7, Hyleukin-7 (GX-I7)- Under clinical trials actively
- anti-PD-1, anti-PD-L1- anti-CTLA4- anti-TIM-3, anti-TIGIT- anti-TGF-beta
- Cancer vaccine - IL-2, IL-15, IFN-alpha- CD137 L, OX40 L, ICOSL- TLR agonists, etc
28
Hyleukin-7: 면역항암치료의핵심인 T 세포수를늘릴수있는유일한약물
29
높은 ALC 수치와 OS(Overall Survival)의 상관관계 (Chemo/Radiotherapy)
Melanoma (ALC < 1000/mm3)
Delyon et al. Annals of Oncology, 2013
Prospective study, 73 unresectable Stage III and IV melanoma patients receiving four courses of ipilimumab q3w
N=25
N=48
Retrospective review, 34 R/M HNSCC patients who received either nivolumab or pembrolizumab
N= total 48
HNSCC (ALC < 600/mm3)
Ho et al., J Immnotherapy Cancer, 2018 F. Huemer et. Al., J. Clin. Med. 2019
N=100
N=41
Retrospective study, multivariate analysis, 142 advanced NSCLC receiving anti-PD-1/PD-L1 treatment (nivolumab, pembrolizumab, or atezolizumab)
Adv. NSCLC (ALC < 930/mm3)
Does low anti-PD-1/PD-L1 response attribute to low level of T lymphocytes?
30
높은 ALC 수치와 면역관문억제제 반응성과의 상관관계
BufferCPA + Anti PD-1CPA + Anti PD-1 + Hyleukin-7
BufferCPA + Anti PD-L1CPA + Anti PD-L1 + Hyleukin-7
BufferCPA + Anti CTLA4CPA + Anti CTLA4 + Hyleukin-7
0 5 10 15 200
500
1000
1500
2000
Tum
or v
olum
e (m
m3 )
0 5 10 15 200
500
1000
1500
Tum
or v
olum
e (m
m3 )
0 5 10 15 200
500
1000
1500
2000
2500
Tum
or v
olum
e (m
m3 )
0 20 40 600
25
50
75
100
******
Sur
viva
l (%
)
0 20 40 600
25
50
75
100
*****
Sur
viva
l (%
)
0 20 40 600
25
50
75
100
******
Sur
viva
l (%
)
Days post-treatment start
Time(Days) Time(Days)
[Lee SW et. al. AACR 2019]
Hyleukin-7 ICI
*ICI: Immune checkpoint inhibitor
31
PD-1/PD-L1 저해제의 항암 효과 강화
DiPersio J. et . al. ASH 2018
32
GX-I7와 CAR-T 병용 용법
GX-I7 enhances CAR-T efficacy
GX-I7 enhances CAR-T expansion and persistence
GX-I7 only
GX-I7
+ GX-I7
GX-I7
GX-I7 GX-I7GX-I7
• 2018 AACR 동물실험을통한작용기전및병용항암효과확인
단독투여에서용량의존적으로종양성장억제
종양침윤 T세포 (TIL)의증가확인
항암제 (CPA) 병용투여시항종양효과증가
• 2019 AACR 동물모델에서병용항종양기전확인
세포증식및활성화를통한 CD8+ T 세포항상성유지
TIL의증가및면역에유리한종양환경유도
면역치료제와의병용투여시유의한증가확인
33
GX-I7: 선행연구 결과
2019 SITC 고형암환자대상작용기전및항암병용가능성확인
환자대상으로고용량에서안전성 (Safety)확인
용량의존적인약동학과 T세포및 Subset (Naïve, CM, EM, EMRA)의증가확인
T 세포면역계재구성을통한면역항암제와의우수한병용치료효과기대
34
GX-I7: TIL 증가 및 면역관문억제제의 치료효능 증대 시너지?
[Ribas et al. Science 359: 1350–1355. 2018][ Emens et al, JAMA Onc, 2018; Adams et al, Ann Onc, 2018 ]
Cervical cancer
ColorectalmTNBC
5.5. %
5.3% ORR 12.2%Pembro
Hot tumorCold Tumor
Novel approach ?
35
GX-I7: 고형암 1b상 Tumor-infiltrating lymphocyte (TIL)
Confidential
36
GX-I7: 항종양평가를 위한 병용임상 개발 현황 (국내/국외)
Phase 1b/2a
Indication
r/r TNBC, SIT (KR)with KEYTRUDA®
(n=~83)
2016 2018 2020 2022 2024
Skin cancer, SIT (US)with Tecentriq®
(n=84)
Phase 1b/2
New GBM (CN)with Chemo
(n=160)Phase 2
Elderly cancer survivor (US)with Vaccines
(n=35)Phase 1b
Basket trial* (US)with CPI
IND opened on 04/15 after no issue on pre-IND
Phase 2
*TNBC, NSCLC, SCLC, PanCA, MSS-CRC
Drug:
Fund:ASCO 2020 포스터 발표
Item Description
Population • metastatic TNBC* regardless of PD-L1 expression level
PD-L1 level • All included
Lines of treatment • 2nd line or later (anthracycline/taxane treated)
ORR • 5.3% , 2 CR(1.2%), 7 PR(4.1%)
Results of Pembrolizumab Monotherapyin Ph2 Study with mTNBC(KN086, N=170)Adams S. Et. Al. Ann Oncol. 2019 Mar 1;30(3):397-404.
Checkpoint InhibitorAnti-PD-1, Anti-PD-L1
Anti-TIM3, Anti-LAG3…
Chemotherapy& chemo/radiotherapy
Cancer VaccinesDNA, RNA
Peptide, Viral
Cell TherapyCAR-TTCR-T
Monotherapy
GX-I7: 잠재적 시장 규모
Lymphopenia correction
Immune Checkpoint Inhibitors MarketThe global immune checkpoint inhibitors market was valued at $10.5 Billion in 2017, and is projected to reach $56.5 Million by 2025, registering a CAGR of 20.1% from 2018 to 2025.
https://www.alliedmarketresearch.com/immune-check-point-inhibitors-market
GX-H9지속형성장호르몬
성인및소아성장호르몬결핍증
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일 1회제형
365투여/1년
주 1회/월 2회제형
52/26투여/1년vs
Daily •투여시기불이행•매일주사의고통•치료효과감소
Weekly/ Twice-Monthly•매일주사의부담감해소•편리성증대및삶의질개선•치료효과향상
치료대상소아연령대:
5 -12 세
평균치료기간:
2-7 년
PLoS ONE Jan. 2011 Vol 6 Issue 1 e16223
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일일 제형 성장 호르몬의 Unmet Needs
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성장호르몬치료제시장
2021년전세계성장호르몬치료제시장규모 USD 3.6 B 예측 (연평균성장률 7.6%)
* Reference: Global Data, Koncept Analytics
제품별시장규모비율
PGHD
AGHD
대상환자규모비율(110K, 2018)
PGHD
AGHD
시장규모비율(총 $3.1B, 2018)
소아(30%)
성인(30%)
소아(86%)
성인(14%)
Company
Drug GX-H9 ACP-001 MOD-4023 NNC0195-0092
Long-acting Technology
hyFc TransCon PEG CTP Albumin
# of PatientsIMP vs Reference
-Pivotal P3: 161105 vs 56 (2:1)
Pivotal P3: 224112 vs 112 (1:1)
P2: 59 (1:1:1:1)P3: 192 (ratio?)
FrequencyWeekly
Twice-monthlyWeekly Weekly Weekly
Stage
Adult Phase 2 completed Phase 2 completed Phase 3 failed Phase 3 On-going
PediatricPreparing for Phase 3 IND
Completes Pivotal Phase 3 Completes Pivotal Phase 3Ongoing Phase 3
(initiated in 3Q 2019)
Height Velocity
Ph2 12 month0.8mg/kg 10.5cm/yr
1.2mg/kg 11.76cm/yr2.4mg/kg 11.03cm/yr(EOW)
Geno 0.03mg/kg 9.14cm/yr
Ph3 12 month0.24mg/kg 11.2cm/yr
Geno 0.034mg/kg 10.3cm/yr
Ph3 12 month0.66mg/kg 10.12cm/yr
Geno 0.034mg/kg 9.78cm/yr
Ph2 12 month0.04mg/kg 7.8cm/yr0.08mg/kg 9.7cm/yr
0.16mg/kg 11.5cm/yrNord 0.034mg/kg 10.0cm/yr
CMC Genetic fusion Chemical conjugation Genetic fusion Chemical conjugation
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지속형성장호르몬경쟁사개발현황
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GX-H9: 지속형 성장호르몬 데이터
Confidential
Confidential
GX-E4지속형 Erythropoietin (EPO-hyFc)
만성신부전증유래빈혈
43
44
GX-E2 (GX-E4) 임상 개발 현황 (국내/국외)
Indication
HD&PD, SIT (KR)vs NESP, Mircera
(n=250)
2016 2018 2020 2022 2024
Phase 2
Pre-dialysis, SIT(ASEAN, AUS)
(n=386)Phase 3
Confidential
Phase 3
• 국내임상1상및임상2상완료 (2014~2017) 및임상3상승인 (2018)
가격경쟁력제고:생산공정변경및제조시설이전 (녹십자→ 인도네시아)
• 임상3상승인 (아세안/오스트레일리아)
Kick-off Meeting (Jan, 2020, 발리)
다국가임상3상개시 (총7개국*)
*대한민국, 오스트레일리아, 인도네시아, 말레이시아, 대만, 필리핀, 태국
Study start (FPI): Mar 2020Target date from FPI to LPO: Mar 2020- Q3 2021Estimated Enrollment: 386 ptsNCT04155125
공정최적화
2027년전세계 EPO 시장규모 USD 12.3 B 예측 (연평균성장률 4.4%)
Biosimilar/Biobetter 시장규모 USB 3.3 B 예측 (시장점유율 27%)
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GX-E4 : EPO 시장 규모 및 차별성
* Reference: IMS + Global Data(HIF-PHi) + Roche Data Base + VIFOR Annual Report + Amgen Annual Report
• GX-E4 차별성
가격경쟁력: 높은생산성에기반
안전성: 장기투여에따른심혈관계(CV) 부작용감소
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제넥신개발파이프라인
GX-E4 (EPO)
GX-G3 (G-CSF)
GX-27, GX-P10
GX-210, GX-19
GX -188 (DNA vaccine)
Hyleukin-7 (T cell amplifier)
GX-H9 (hGH)
Best-in-classInnovative drugs
GX-G6 (GLP-1)
Early Stage ( Phase 1 )
GX-G8 (GLP-2)
Late Stage ( Phase 2 3 ) Early Stage ( Phase 1 / 2 )
Preclinical Stage: 4 pipelines
BioBetter drugs
First-in-class
GX-P1 ( Long-acting PD-L1 )
KGBIO
ILKOGEN
HANDOK
CSPC Dual-TargetingFc Fusion Protein
DNA Vaccine
1.
3.
2.
4.
5.
Companies for Joint Venture Companies for Equity Investment Companies for Clinical Research Collaboration
47
글로벌파트너쉽을통한협력개발
감사합니다~!
Genexine, Inc.Korea Bio Park, Bldg. B,
700 Daewangpangyo-ro, Bundang Gu, Seongnam Si, Gyunggi Do, 463-400 Korea
ContactIR/PR
[email protected]+82-31-628-3242
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![Venusaur & Snivy {GX} Венузавр и Снайви {GX} · Vileplume {GX} HP: 240 Pokémon Energy Type: Stage 2/GX Pokémon Evolves from Gloom [Ability] Fragrant Flower Garden](https://img.pdfslide.tips/doc/110x75/5e8c904e15bf165d0954aecc/venusaur-snivy-gx-f-gx-vileplume-gx-hp.jpg)
