ANTENGENE CORPORATION · pipeline drugs, including ATG-008, ATG-010, ATG-016, ATG-019 and ATG-527...

ANTENGENE CORPORATION Treating Patients Without Borders

Dr. Jay Mei, Founder & CEO

June 7th, 2019, New York

2 | Business Confidential | June 7th, 2019 New York

Forward-looking Statements

This prospectus contains forward-looking statements that reflect our current expectations and views of future events, including those regarding the therapeutic potential of and potential clinical development plans and commercialization for Antengene’s pipelines, including the timing of initiation of certain trials, of the reporting of data from such trials, of the submissions to regulatory authorities and of potential commercial launches, the potential availability of accelerated approval pathways, the potential size of the markets for HBV+HCC or multiple myeloma drugs and Antengene’s strategic and financial plans and expectations as well as financial projections for Antengene.

You can identify some of these forward-looking statements by words or phrases such as “may,” “will,” “expect,” “anticipate,” “aim,” “estimate,” “intend,” “plan,” “believe,” “is/are likely to,” “potential,” “continue” or other similar expressions. We have based these forward-looking statements largely on our current expectations and projections about future events that we believe may affect our financial condition, results of operations, business strategy and financial needs. These forward-looking statements include statements relating to: our goals and strategies; our future business development, financial conditions and results of operations; the expected growth of the pharmaceutical industry in China; our expectations regarding demand for and market acceptance of our products and services; our expectations regarding our relationships with [our distributors, customers, business partners and our other stakeholders]; competition in our industry; and relevant government policies and regulations relating to our industry.

Although we believe that our expectations expressed in these forward-looking statements are reasonable, our expectations may later be found to be incorrect. Our actual results could be materially different from our expectations. Known and unknown risks, uncertainties and other factors may cause our actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. For example, any of Antengene’spipeline drugs, including ATG-008, ATG-010, ATG-016, ATG-019 and ATG-527 will successfully complete necessary preclinical and clinical development phases or that development of any of Antengene’s pipeline drugs will continue. Further, even if Antengene receives marketing approval for ATG-008, ATG-010 or another pipeline drug, there can be no assurance that Antengene will be able to successfully commercialize that pipeline drug. Management’s expectations and, therefore, any forward-looking statements in this presentation could also be affected by risks and uncertainties relating to a number of other factors, many of which are beyond Antengene’s control, for example: Antengene’s results of clinical trials and preclinical studies, including subsequent analysis of existing data and new data received from ongoing and future studies; the content and timing of decisions made by the CFDA and other national regulatory authorities, investigational review boards at clinical trial sites, including with respect to the need for additional clinical studies; the ability of Antengene or its third party collaborators or successors in interest to fully perform their respective obligations under the applicable agreement and the potential future financial implications of such agreement; unplanned cash requirements and expenditures; development of drug candidates by Antengene’s competitors for diseases for which Antengene is currently developing its pipelines; that the markets for HBV+ HCC or multiple myeloma drugs will grow as predicted; and Antengene’s ability to obtain, maintain and enforce patent and other intellectual property protection for any pipeline drugs it is developing. You should read thoroughly this prospectus and the documents that we refer to with the understanding that our actual future results may be materially different from and worse than what we expect. We qualify all of our forward-looking statements by these cautionary statements.

The forward-looking statements made in this prospectus relate only to events or information as of the date on which the statements are made in this prospectus. Except as required by law, Antengene disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this prospectus and the documents that we refer to in this prospectus and have filed as exhibits to the registration statement, of which this prospectus is a part, completely and with the understanding that our actual future results may be materially different from what we expect.


Table of Content

PART I Introduction to Antengene Corporation

PART II Antengene Pipeline and Development Plan

PART III Track Record in Financing and IPO Plan


Antengene Corporation

• Sino-American clinical and commercial stage biopharmaceutical company

• Founded by Dr. Jay Mei, a Celgene, Johnson & Johnson, Novartis and U.S. National Cancer Institute (NCI)

veteran with over 25 years of experience in clinical development of oncology therapeutics globally

• Antengene Corporation currently operates in both China and the U.S., with the clinical development centers in

Shanghai and Beijing, and the manufacturing facilities in Shaoxing, an adjacent city

• Antengene’s mission is to become a life science ambassador, develop and introduce cutting-edge treatments

to China and other Asian markets, and to “Treat Patients Without Borders”

August 2017: Series A

financing of USD 21 million

December 2018: Series B

financing of USD 120 million

Doylestwon, PABeijing

Shanghai

Shaoxing


Our Vision: To Become an Innovator in Drug Development and Bridge

the Gulf between Bench and Bedside

Clinical Development in Asian Markets• Leveraging clinical development and regulatory expertise in China and other Asian

markets to enable international business partners to expand footprints in these markets

Commercialization in Asian Markets• Utilizing knowledge and experience with local markets and stakeholders to optimize

the value of innovative products for unmet medical needs

Proprietary Drug Discovery• Building a unique drug discovery platform by combining clinical development expertise

and insights with early stage research → from development to discovery


Efficient Execution to Drive Fast Regulatory Submission and International Trial Initiation in Multiple Regions in Asia

▪ Multiple IND submissions in Asia

− 3 IND approvals in 2018 (mainland China, Taiwan, South Korea)

− 2 IND approvals in 2019 (mainland China)

− 6 other INDs planned for 2019-2020 (mainland China and other Asian

countries/regions)

− 3 (s)NDAs planned for 2020-2022

▪ Seamless cross-functional (clinical, regulatory, CMC, etc.) collaboration and fast

trial initiation

▪ Strong clinical team across various therapeutic areas, particularly oncology and

well-established working relationship with clinical trial centers and KOLs globally,

especially in Asia

▪ One of the very few Chinese companies well experienced in managing multi-

regional clinical trials

− Currently conducting a multi-regional clinical trial in treatment of HBV+

hepatocellular carcinoma (HCC) patients in mainland China (16 sites), Taiwan (5

sites) and South Korea (6 sites)


Table of Content





Our Pipeline: A Broad Portfolio of Clinical-stage Assets Across Various Therapeutic Areas, with Specific Focus in Oncology

Oncology Programs Non-oncology Programs

* Include mainland China, Hong Kong, Taiwan, Macau, South Korea, Singapore, Malaysia, Indonesia, Vietnam, Laos, Cambodia, the Philippines, Thailand and Mongolia

Programs Discovery Lead Identification Pre-clinical Phase I Phase II Phase III Territories Partners

ATG-008 (CC-223)

Dual TORC1/2 InhibitorAsian Countries/Regions*

ATG-010 (Selinexor)

SINE XPO1 AntagonistMainland China and Macau

ATG-016 (Eltanexor)

SINE XPO1 AntagonistMainland China and Macau

ATG-527 (Verdinexor)

SINE XPO1 Antagonist

Mainland China, Macau, Taiwan,

Hong Kong, South Korea, and the

ASEAN Countries

ATG-019 (KPT-9274)

PAK4 & NAMPT

Dual Inhibitor

Mainland China, Macau, Taiwan,

Hong Kong, South Korea, and the

ASEAN Countries

Undisclosed target Worldwide

Undisclosed target Worldwide

Multiple Myeloma

Endometrial Cancer

MDS, CRC, PrC. GI, EGJ cancer

Solid Tumors & Lymphoma

EBV, CMV, Lupus, Post-transplant Lymphoproliferative Disease, etc.

Glioblastoma

Diffuse Large B-cell Lymphoma

Liposarcoma

Hepatocellular Carcinoma

Neuroendocrine Tumor

Diffuse Large B-cell Lymphoma

T-cell Lymphoma

GI Cancer, etc.

Non-small Cell Lung Cancer, etc.


ATG-008: A Novel Second Generation TORC1/2 Inhibitor

Mechanism of Action of ATG-008

• Mammalian target of rapamycin (mTOR), a core

component of two structurally distinct protein complexes

(mTORC1 and mTORC2), regulates different cellular

processes and is upregulated in multiple types of tumors

• mTOR is a well validated target for oncology indications

with two first-generation TORC1 inhibitors on market for

treatment of various cancer types including renal cell

carcinoma, breast cancer, neuroendocrine tumor, etc.

• ATG-008 is a second generation mTOR inhibitor,

targeting both TORC1 and TORC2, currently in clinical

study for treatment of hepatocellular carcinoma (HCC)

Source: HBV supports mTORC2 and YAP activation and is associated with sensitivity to mTOR kinase inhibition in hepatocellular carcinoma, John D. Gordan et al., Liver Center

Annual Symposium; Hepatitis B Virus X Protein Upregulates mTOR Signaling through IKKβ to Increase Cell Proliferation and VEGF Production in Hepatocellular Carcinoma,

Chia-Jui Y. et al. doi: 10.1371/journal.pone.0041931


ATG-008 Completed Clinical Studies: Six Clinical Studies Completed in the U.S., U.K., France and Spain

Trials Subjects

ST-001 (Dose escalation and

cohort expansion)226

NSLC-001 combination study 74

DLBCL-001 combination study 102

CP-001 (Healthy volunteers) 18



TOTAL

452

(including

50 healthy

subjects)

• CC-223-CP-001 (Formulation study: Tablet vs

API in capsule)

• CC-223-CP-002 (ADME and food effect study)

• CC-223-CP-003 (Drug-drug interaction study)

Three clinical pharmacology studies in

50 healthy subjects 02

Three clinical trials enrolled 402 subjects

with seven different types of solid and

hematologic malignancies 01

• CC-223-ST-001 (Dose escalation and expansion

study in multiple tumor types)

• CC-223-NSCL-001 (Combination study in NSCLC)

• CC-223-DLBCL-001 (Combination study in DLBCL)


HBV infection is a Major Cause of Hepatocellular Carcinoma in China and Most Asian Regions

Source: Goh GB, Best Practice & Research Clinical Gastroenterology 2015;29(6):919-928, Zhu RX, Gut Liver 2016;10(3):332-339

• Asia has approximately 531,000 new

liver cancer cases annually, accounting

for over two-thirds of cases worldwide

• Over 450,000 new HCC cases

diagnosed in China annually

• Unlike other regions in the world,

hepatocellular carcinoma is commonly

associated with viral hepatitis B

(HBV) infection in China and most

part of Asia


HBV Infection is Associated with Poor Prognosis of HCC Patients

Source: Goh GB, Best Practice & Research Clinical Gastroenterology 2015;29(6):919-928, Zhu RX, Gut Liver 2016;10(3):332-339

• Asia has approximately 531,000 new liver cancer cases

annually, accounting for over two-thirds of cases worldwide

• Over 450,000 new HCC cases diagnosed in China annually

• Unlike other regions in the world, hepatocellular carcinoma is

commonly associated with viral hepatitis B (HBV)

infection in China and most part of Asia

• HBV+ HCC patients typically showed worse prognosis compared with HBV- patients

HBV- HCCN=97

HBV+ HCCN=319

Overall Survival (HBV+ vs. HBV-）


ATG-008 Efficacy in HBV+ HCC: CC-223-ST-001 Trial Indicated Clinical Benefits of ATG-008 in Treatment of HCC Patients with HBV

► Median overall survival (mOS) of HCC patients from HBV+ subgroup is 12.1 months

Surv

iva

l P

rob

ab

ility

0.0

0.2

0.4

0.6

0.8

1.0

0 3 6 9 12 15 18 21 24 27 30 33 36 39 42

Median OS and 95% CI in months:

HBV+ 12.07 (5.88 to 20.52)

HBV- 5.16 (3.55 to 11.54)

Log-rank P value: 0.1897

HBV Status

HBV+

HBV-

Censored

months

Overall Survival (CC-223-ST-001)


Everolimus (TORC1i) HCC Study (EVOLVE): HBV Positive Patients are the Only Subgroup that Showed OS Benefits in the EVOLVE Study

Source: JAMA. 2014 Jul 2;312(1):57-67. doi: 10.1001/jama.2014.7189


ATG-008 Clinical Development Plan for HCC

Second Line

Monotherapy

Second Line

Combo Therapy

with anti-PD-1

First Line

Combo Therapy

with anti-PD-1*

ATG-008 Clinical Development Plan in HCC

* Subject to efficacy of ATG-008 and anti-PD-1 combo therapy in 2L study(ies) and availability (label and timeline) of anti-PD1 in authorized

Asian markets

• Antengene will explore fast-to-market opportunities for ATG-008 in HCC in two areas:

1) As a monotherapy in 2L and above setting

2) As a combo therapy with anti-PD-1 in 2L and/or 1L setting


ATG-008: Asia Trial Design of HCC Monotherapy Study (TORCH)

Major Inclusion Criteria:

1) Previously treated, advanced,

unresectable HCC subjects

2) Measurable disease as defined

by RECIST 1.1

3) ECOG performance status

score of 0 or 1

4) Child-Pugh score ≤ 7 with no

encephalopathy

Primary Endpoints:

• ORR

• Safety

Secondary Endpoints:

• PK

• DoR

• DCR

• PFS

• OS

ATG-008 ATG-008

Primary Endpoints:

• ORR


• DoR

• DCR

• PFS

• OS

• Safety

Dose

Escalation

Dose

Expansion


ATG-008 and Anti-PD-1 Combo Therapy (TORCH-2)

PD-1/PD-L1

Association

with HCC

PD-1 is predominantly expressed on immunocompetent cells of the hematopoietic

lineage, and that PD-L1, the PD-1 ligand, which is expressed on HCC cells, is

significantly associated with tumor aggressiveness and postoperative recurrence in

human hepatocellular carcinoma1,2,3

PD-1

Association

with mTOR

Pathway

PD-1 plays an important role in promoting tumor growth by physically associating

with S6 and eIF4E, downstream mTOR effectors, and modulating their

phosphorylation and activating mTOR signaling pathways1

Anti-PD-1

plus mTOR

Inhibitor

Therapy

Findings from previous pre-clinical study suggests that antibody blockade of PD-1 in

combination with mTOR inhibitor inhibits HCC growth in vitro and immunodeficient mice

and results in more durable and synergistic tumor regression than either single agent

alone1

Sources: 1 Li, H., et al. (2017). "Programmed cell death-1 (anti-PD-1) checkpoint blockade in combination with a mammalian target of rapamycin inhibitor restrains hepatocellular

carcinoma growth induced by hepatoma cell-intrinsic anti-PD-1." Hepatology 66(6): 1920-1933.2 Topalian SL, Drake CG, Pardoll DM. Targeting the anti-PD-1/B7-H1(PD-L1) pathway to activate anti-tumor immunity. Current opinion in immunology. 2012;24(2):207-123 Gao Q, et al. Overexpression of PD-L1 significantly associates with tumor aggressiveness and postoperative recurrence in human hepatocellular carcinoma. Clinical cancer

research: an official journal of the American Association for Cancer Research. 2009;15(3):971-9.

Scientific Rationale of ATG-008 and Anti-PD-1 Combo Therapy for HCC Treatment


ATG-008: Asia Trial Design of HCC Combo Study with Anti-PD1 (TORCH-2)


1) Previously treated, advanced,

unresectable solid tumor/HCC

subjects

2) Measurable disease as defined

by iRECIST

3) ECOG performance status

score of 0 or 1

4) Child-Pugh score ≤ 7 with no

encephalopathy

Primary Endpoints:

• PK

• RP2D

• Safety


• ORR

• DoR

• DCR

• PFS

• OS

ATG-008 in

Advanced

Solid

Tumors

ATG-008 in

Advanced

HCC

Primary Endpoints:

• ORR


• BOR

• DoR

• DCR

• PFS

• OS

• Safety

Dose

Escalation

Dose

Expansion


ATG-010, ATG-016 & ATG-527: Novel Selective Inhibitor of Nuclear Export (SINE) Compounds

• SINE compounds inhibit nuclear export through covalent binding to cysteine 528 (Cys528) in

the cargo-binding pocket of Exportin 1 (XPO1/CRM1) and promote cancer cell death through

apoptosis

• The XPO1 inhibitors block the

nuclear export of tumor suppressor

proteins (TSP), which exert anti-

neoplastic effects in the nucleus,

and other growth regulatory

proteins, leading to accumulation

of these proteins in the nucleus

and enhancing their anti-cancer

activity through apoptosis

• Additionally, SINE compounds

have potential synergistic effects

with other anti-cancer drugs (by

keeping tumor suppressor proteins

in nucleus)Source: https://www.karyopharm.com/sine-technology/

SINE Mechanism of Action


Treatment Landscape of Multiple Myeloma in China

▪ Multiple myeloma patients are currently treated with three categories of medications in China

− Chemotherapy

− Proteasome inhibitors (PIs)

− Immunomodulatory drugs (IMiDs)

1 Carfilzomib is another proteasome inhibitor currently available in the US but have not launched in China yet2 Ixazomib (in combination with Revlimid® and dexamethasone) was approved for treatment of patients who have received at least one prior line of therapy(ies) in April 2018 in China3 Pomalidomide is another immunomodulatory drug currently available in the US but have not launched in China yet4Anti-body (i.e., daratumumab) has been approved for the treatment of multiple myeloma in the U.S., but not yet available in China

Medications Available in China4

Chemotherapy Cyclophosphamide, Doxorubicin, Cisplatin, etc.

Proteasome inhibitors1 Bortezomib, Ixazomib2

Immunomodulatory drugs3 Thalidomide, Lenalidomide


ATG-010 (Selinexor) in Treatment of Multiple Myeloma (1/2)

Trial

NameTitle

Country/

RegionEnrollment

Primary

Completion

Date

STORM

A Phase 2b, Open-Label, Single-Arm Study of

Selinexor plus Dexamethasone in Patients Exposed

to Bortezomib, Carfilzomib, Lenalidomide and an

Anti-CD38 Monoclonal Antibody (mAb) Daratumumab

and Refractory to Glucocorticoid, an IMiD, a PI and

an Anti-CD38 Monoclonal Antibody

US

~202

(Part 1: 79,

Part 2: ~123)

April 2018

STOMP

A Phase 1b/2 Study of Selinexor (KPT-330) in

Combination With Backbone Treatments for

Relapsed/Refractory Multiple Myeloma

US,

Canada321 March 2019

BOSTON

A Phase 3 Randomized, Controlled, Open-label

Study of Selinexor, Bortezomib, and Dexamethasone

(SVd) Versus Bortezomib and Dexamethasone (Vd)

in Patients With Relapsed or Refractory Multiple

Myeloma (RRMM)

Global 364 June 2020

Completed and Ongoing Clinical Studies of ATG-010 in Treatment of Multiple Myeloma


ATG-010 (Selinexor) in Treatment of Multiple Myeloma (2/2)

Trial Name EnrollmentPrimary

Completion DateExperimental arm(s) Efficacy data

STORM

~202

(Part 1: 79,

Part 2: ~123)

April 2018 Selinexor + dexPenta-refractory patients: ORR

26.2% (CR 2, 1.6%)

STOMP 321 March 2019

Selinexor + bortezomib

+ dex

• PI naïve/relapsed ORR: 84%

(CR: 2, 11%)

• PI refractory ORR: 43%

Selinexor +

lenalidomide + dex

• Len naïve (all) ORR: 92%

• Len naïve and ≤ 2 prior

treatment ORR: 100%

• Len relapsed or refractory ORR:

50%

Selinexor +

pomalidomide + dexOverall ORR 50%

Selinexor +

Daratumumab + dex

• Overall ORR 74%

• Dara naïve ORR: 82%

BOSTON 364 June 2020Selinexor + bortezomib

+ dex

N/A (Enrollment expect to

complete by end of 2018; top-line

data from the Phase 3 BOSTON

study is anticipated in 2019)


ATG-010 (Selinexor): China Trial Design of R/R MM (MARCH)


1) Subjects must have previously received at

least 2 regimens including Lenalidomide

and Bortezomib, And Patients must be

refractory or resistant to most recent anti-

MM regimens prior to Cycle 1 Day 1.

2) Any clinically significant non-hematological

toxicities that patients experienced from

treatments in previous clinical studies must

have resolved to Grade ≤ 2 by Cycle 1 Day

1.

3) ECOG Performance Status of 0-2

4) Measurable MM based on IMWG guidelines

as defined by at least one of the following:

− Serum M-protein ≥ 0.5 g/dL by serum

electrophoresis (SPEP)

− Urinary M-protein excretion ≥ 200 mg/24

hours

− FLC ≥ 100 mg/L, provided that the FLC

ratio is abnormal

Primary Endpoints:

• ORR


• PK

• Overall survival at

month 6, 9, 12, 18

• TTP

• CBR

• PFS

• DOR

• DCR

• Safety

Selinexor + low-dose dexamethasone


Durability of Response:• Median DoR was 9.2 months

• Most responses at first scan (~2 months)

ATG-010 (Selinexor) in Treatment of Diffuse Large B-cell Lymphoma (DLBCL)

Best Responses† in Evaluable SADAL mITT Patients as of November 15, 2018

Category N ORR (%) CR (%) PR (%) SD (%) PD/NR (%) Pending*

All Patients 115 34 (29.6%) 11 (9.6%) 23 (20.0%) 8 (7.0%) 73 (63.5%) 12

GCB Subtype 53 18 (34.0%) 5 (9.4%) 13 (24.5%) 5 (9.4%) 30 (56.6%) 6

Non-GCB Subtype 57 12 (21.1%) 6 (10.5%) 6 (10.5%) 3 (5.3%) 42 (73.7%) 6

Unclassified

Subtype5 4 (80.0%) -- 4 (80.0%) -- 1 (20.0%) --

†Responses were adjudicated according to the Lugano Classification, Cheson 2014 by an Independent Central Radiological Review. ORR=Overall Response Rate

(CR+PR), CR=Complete Response, PR=Partial Response, SD=Stable Disease, PD=Progressive Disease, NR=No Response Recorded. *Pending patients are

currently on treatment but have not yet had a response assessment, not included in total N. Responses as of November 15, 2018 based on interim unaudited data.

Source: Karyopharm Therapeutics 2018 ASH Presentation

Category Median OS 95% CI

All Patients 9.1 Months (6.2, 15.4)

CR/PR Patients 29.7 Months (12.6, NE)

SD Patients 18.3 Months (NE, NE)

PD/NR Patients 3.2 Months (2.5, 7.0)

SADAL Overall Survival by Group


ATG-010 (Selinexor): China Trial Design of R/R DLBCL (SEARCH)


1)Eastern Cooperative Oncology

Group (ECOG) performance

status of ≤ 2

2)Pathologically confirmed de

novo DLBCL

3)Objective, documented evidence

of disease progression on study

entry

4)Have previously received at

least 2 but no more than 5

previous systemic regimens for

the treatment of DLBCL Have

measurable disease

Primary Endpoints:

• ORR


• DoR

• DCR

• PFS

• OS

• safety

Selinexor

Selinexor

approval for R/R

DLBCL in ChinaSelinexor +

ATG-008

Primary Endpoints:

• ORR


• DoR

• DCR

• PFS

• OS

• safety


ATG-010 (Selinexor): Trial Design of T-cell Lymphoma (TOUCH)

Primary Endpoints:

• ORR


• DoR

• DCR

• PFS

• OS

• Safety


1) Histologically confirmed T-cell

lymphomas and natural-killer/T-

cell lymphoma based on the

World Health Organization

(WHO) classification of tumors

of hematopoietic and lymphoid

tissues

2) Previously treated

3) ECOG performance status of

0-1

4) Adequate bone marrow and

organ function

1:1

Selinexor + ifosfamide,

carboplatin and

etoposide (ICE)

Placebo + ifosfamide,

carboplatin and

etoposide (ICE)


ATG-010 (Selinexor): Trial Design of Endometrial Cancer (SIENDO)

Primary Endpoints:

• PFS


• Time to First Subsequent

Therapy (TFST)

• PFS after consecutive

treatment (PFS2)

• Time to Second Subsequent

Treatment (TSST)

• Disease Specific Survival

(DSS)

• DCR

• OS

• Safety


1) Histological confirmed endometrial cancer

of the endometrioid, serous, or

undifferentiated type

2) Patients who have relapsed after primary

therapy and have completed taxane -

carboplatin combination for at least 12

weeks or 4 cycles for primary relapse and

are in partial or complete remission

according to RECIST 1.1

3) Patients must be started on study

treatment between 3 and 8 weeks after

completion of their final dose of the

chemotherapy

4) Patients may have undergone primary

surgery

5) ECOG performance status of 0-1

2:1

Selinexor

Placebo


ATG-010 China Clinical Development Plans

Multiple

Myeloma

Diffuse Large B-

cell Lymphoma

Other Cancer

Types

• ATG-010 in combination with dexamethasone for treatment of

relapsed/refractory multiple myeloma

• ATG-010 in combination with bortezomib and dexamethasone for

treatment of relapsed/refractory multiple myeloma

• ATG-010 as a single oral agent, as well as in combination with ATG-008,

respectively, for treatment of relapsed/refractory DLBCL

• ATG-010 in combination with chemotherapy or R-CHOP in treatment of

relapsed/refractory or newly diagnosed DLBCL

• Liposarcoma (SEAL)

• Endometrial cancer (SIENDO)

• T-cell lymphoma (TOUCH)

• Acute myeloid leukemia

• Nasopharyngeal carcinoma

• Gastric cancer…


ATG-019 Overview

• KPT-9274 is an oral, small molecule

modulator of PAK4 (p21 activated kinase)

and NAMPT (nicotinamide

phosphoribosyltransferase)

• PAK4 is a major player in cell morphology

and WNT/β-catenin signaling

• NAMPT is the rate-limiting enzyme in NAD

biosynthesis

• Co-inhibition of these targets leads to

synergistic anti-tumor effects through energy

depletion, inhibition of DNA repair, cell cycle

arrest, and ultimately apoptosis

• Cells can utilize niacin to make NAD through

an alternative pathway using NAPRT1, which

is often absent in tumors making it a

potential response biomarker

• KPT-9274 demonstrates potent anti-tumor

activity pre-clinically and in patient dogs with

cancer


ATG-019: Trial Design of Solid Tumors and Non-Hodgkin’s Lymphoma


1) Patients with histologically or

cytologically confirmed, advanced

solid tumors or NHL which have

progressed despite standard

therapy, for whom no standard

therapy exists, or who have refused

standard therapy

2) Patients must have objective

evidence of progressive disease on

study entry:

a) Advanced solid tumors:

Measurable disease as defined

by RECIST 1.11

b) NHL: Measurable disease

including target lesion(s) as

defined by the Lugano

Classification2 for initial

evaluation and staging

3) ECOG performance status of ≤ 1

Primary Endpoints:

• RP2D

• Safety


• PK

• ORR

• DOR

• DCR

• PFS

• OS

• TTP

Primary Endpoints:

• ORR


• DOR

• DCR

• Duration of disease control

• PFS

• OS

• TTP

• Safety

Dose

Escalation

Dose

Expansion

ATG-019 +

Niacin ER

ATG-019

ATG-019 +

Niacin ER

ATG-019


Our Progress: Efficient Execution to Drive Fast Regulatory Submission and Multi-regional Trial Initiation

ATG-008 Ph2 HCC

(TORCH) IND filing

ATG-008+Anti-PD1 Ph2 HCC

Trial (TORCH-2) IND filing

ATG-008+ATG-010 Ph2 Lymphoma

and Solid Tumor Trial IND filing

ATG-008 TORCH-2

preliminary data readout

ATG-010 Registration MM

Trial (MARCH) IND filing

ATG-010 Registration DLBCL

Trial (SEARCH) IND filing

ATG-010 MARCH

NDA filingATG-010 SEARCH

NDA filing

ATG-010+chemo Ph2

TCL Trial IND filing

ATG-010+chemo TCL


ATG-527 Ph1/2

PTLD Trial IND filing

ATG-016 Ph1/2 Solid

Tumor Trial IND filing

Undisclosed Targets Ph1

Solid Tumor Trial IND filing

ATG-010 Ph3 Endometrial

Cancer (SIENDO-China)

Trial IND filing

2018 2019 2020+

ATG-019 Ph1/2 Solid

Tumor Trial IND filing

ATG-008 TORCH


NDA filingIND/CTA filing Preliminary data readouts IND approved


Table of Content





Antengene Has a Strong Shareholder Base from the Industry and Investors

August 2017: Series A financing of USD 21 million

December 2018: Series B financing of USD 120 million

❖ Well funded and supported by renowned industry partners and established investors


Antengene Plan for IPO

Antengene is targeting IPO in 2020

or

Thank You

ANTENGENE CORPORATION · pipeline drugs, including ATG-008, ATG-010, ATG-016, ATG-019 and ATG-527...

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