C1D1 C1D8 C2D80

1

2

3

4

CD3+ T cells

Ab

so

lute

ce

ll c

ou

nts

(1

09/L

)

C1D1 C1D8 C2D80.0

0.5

1.0

1.5

2.0

2.5

CD4+ T cells

Ab

so

lute

ce

ll c

ou

nts

(1

09/L

)

C1D1 C1D8 C2D80.0

0.5

1.0

1.5

CD8+ T cells

Ab

so

lute

ce

ll c

ou

nts

(1

09/L

)

C1D1 C1D8 C2D80

5

10

15

Treg cells

Ab

so

lute

ce

ll c

ou

nts

(1

07/L

)

C1D1 C1D8 C2D80.0

0.5

1.0

1.5

2.0

CD14+ Monocyte

Ab

so

lute

ce

ll c

ou

nts

(1

09/L

)

C1D1 C1D8 C2D80.0

0.1

0.2

0.3

0.4

0.5

CD19+ B cells

Ab

so

lute

ce

ll c

ou

nts

(1

09/L

)

C1D1 C1D8 C2D80.0

0.2

0.4

0.6

0.8

CD56+ NK cells

Ab

so

lute

ce

ll c

ou

nts

(1

09/L

)

C1D1 C1D8 C2D80.0

0.5

1.0

1.5

2.0

2.5

Neutrophils

Ab

so

lute

ce

ll c

ou

nts

(1

09/L

)

• Three patients with colorectal cancer were enrolled in the first cohort (240 µg/kg) (Table 1).Table 1. Baseline Characteristics

A Phase I/IIa, Open-label, Dose-Escalation and Dose-Expansion Study to

Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics

of TJ107, a Long-acting IL-7, in Chinese Patients with Advanced Solid Tumors

Jin Li1, Ye Guo1, Wei Peng1, Junli Xue1, Wei Zhao1, Xiaoxiao Ge1, Liqiong Xue1, Wenbo Tang1, Li

Zhou2, Min Zhang2, Taylor B Guo3, Liping Wang3, Jiyuan Guo3, Feifei Cui3, Haiyun Suo3

1Dongfang Hospital, Tongji University, Shanghai, China; 2START (Shanghai) Co., Ltd ., Shanghai, China; 3I-MAB Biopharma, Inc., Shanghai, China

INTRODUCTION

METHODS

RESULTS

Patient Baseline Characteristics

Pharmacokinetic profile following first dose

Pharmacodynamic analysis after TJ107 treatment

TCR diversity analysis after TJ107 treatment

CONCLUSIONS

C

cohort Subject NO. Primary Disease M/F Age ECOG PS Metastatic lesion

240ug/kg

101001 Colorectal F 61 1 Liver, Lung

101003 Colorectal M 44 0 Liver, pelvis

101004 Colorectal M 50 1Liver, Lymph Node, Lung,

Omentum

SAFETY

• TJ107 was well tolerated and no DLTs were reported during the first cycle at this dose level.• The most common TEAEs was transient lymphocyte count decrease which is due to the TJ107

induced lymphocyte homing (Table 2).• All 3 subjects had grade 1 injection site reactions which recovered spontaneously or after local

treatment without steroid (Table 3).• The only SAE was an event of hospitalization due to melaena on a patient with colorectal cancer. The

event was considered unlikely related to TJ107 by the investigator (Table 4).

B

A

Preliminary results from the ongoing trial show that TJ107• Exhibited a good safety profile in cancer patients at the dose of 240 µg/kg

with the characteristics of rapid absorption and slow clearance.• Activated IL-7 pathway and expanded T cells in cancer patients in a similar way

to data previously reported in healthy subjects.• Increased the diversity of TCR repertoire.As a potent and selective T cell amplifier, the potential of TJ107 as a novel I/Otherapy agent warrants further clinical investigation.

BA

Figure 3. TCR repertoire was analyzed by RNA sequencing. (A). The frequency of V/J gene usage was analyzed. (B). The diversity analysis was indicated by Inverse Simpson Index.

Figure 2. (A). Absolute lymphocyte counts of each patient (240 ug/kg) were measured by hematology analyzer at indicated time points. Lymphocyte count relative to baseline over time was plotted (upper). The average ALC was indicated (below). (B). Absolute numbers of individual cell subsets in PBMC of each patient were measured by FACS. (C). The percentage of the proliferating T cell subsets was measured by Ki67 FACS staining. The average (upper) and individual percentages (lower) were shown.

ALC -- temporal profile

0 7 14 21 280

100

200

300

days

% o

f b

as

eli

ne

0.24 mpk

baseline peak0

1

2

3

4

ALC

10

6/m

L

Part A: Dose Escalation

MTD/

RP2D

Part B: Dose Expansion

Primary endpoints:• Safety and tolerability per CTCAEv5.0Secondary endpoints• Safety: MTD/MED & RP2D• PD: ALC, NLR, etc• PK: Tmax, Cmax, AUC0-t, AUC0-inf, t1/2, CL/F and Vd/F, etc.• Immunogenicity: ADA, NabsOther endpoints• PK/PD, ORR(RECIST v1.1), biomarkers, e.g. TCR, ratio of T cells and

lymphocyte subsets.

Cohort 1 n=10-12

PT term Total n (%) ≥Grade 3

Lymphocyte count decreased 3(100%) 3(100%)

Lymphocyte percentage decreased 2(66.7%) 2(66.7%)

Anemia 2(66.7%) 1(33.3%)

Platelet count decreased 2(66.7%) —

White blood cell count increased 2(66.7%) —

Aspartate aminotransferase increased 2(66.7%) —

Table 2. Treatment Related Adverse Events(in ≥ 2 subjects) Table 3. Injection Related Reaction

PT term n (%)CTC

Grade

Latency*

(day)Outcome

Injection site swelling 1(33.3%) 1 6 Recovered

Injection site pain 1(33.3%) 1 6 Recovered

Injection site discomfort 1(33.3%) 1 8 Recovered

Table 4. Serious Adverse Event

*Latency = AE start date – First study treatment date

Subject ID/ Age(year)/ Gender

PT Start Date End Date CTC

Grade Relationship to

TJ107 Action Taken to

TJ107 Outcome

101004/50/Male Melaena 06/May/2019 10/May/2019 2 Unlikely Related Not Applicable Recovered

C1D1 C1D8 C2D80

10

20

30

40

50

CD4+ T cells

Perc

en

tag

e (

%)

C1D1 C1D8 C2D80

10

20

30

40

50

CD8+ T cells

Perc

en

tag

e (

%)

C1D1 C1D8 C2D80

10

20

30

40

50

Treg cells

Perc

en

tag

e (

%)

100101

100103

100104

C1D1 C1D8 C2D8-10

0

10

20

30

40

50

CD4+ T cells

Perc

en

tag

e (

%)

C1D1 C1D8 C2D8-10

0

10

20

30

40

50

CD8+ T cells

Perc

en

tag

e (

%)

C1D1 C1D8 C2D8-10

0

10

20

30

40

50

Treg cells

Perc

en

tag

e (

%)

TRAC TRBC0

200

400

600

101001

Inv

ers

e S

imp

so

n I

nd

ex C1D1

C1D28

TRAC TRBC0

500

1000

1500

2000

101003

Inv

ers

e S

imp

so

n I

nd

ex

C1D1

C1D28

C2D28

DLT assessment at D28

240µg/kg q4w I.M

480µg/kg q4w I.M

720µg/kg q4w I.M

960µg/kg q4w I.M

1200µg/kg q4w I.M

Patients with Advanced

Solid Tumors

Recruiting

Completed

TJ107, an immuno-oncology agent also known as Hyleukin, is a T cell amplifier comprising a

homodimer of engineered human interleukin-7 (IL-7) fused with Genexine’s proprietary long-acting

platform hybrid Fc. IL-7 is a critical homeostatic factor for T cells, acting on T cells to increase their

number, diversity and functionality.

TJ107 could play a pivotal role in reconstitution and

reinvigoration of T cell immunity in cancer patients,

providing unique opportunities for immuno-oncology

combination strategies.

The aim of this study (NCT04001075) is to determine

the safety, tolerability and PKPD profile of TJ107 in

Chinese cancer patients.

Figure 1. Individual concentration-time post TJ107 first dose (240 ug/kg).

• The preliminary PK results shows that TJ107 was rapidly absorbed and reached serum peak concentration around 24 hours post-dose.

• TJ107 was slowly cleared from the body and remained detectable in serum until Day 14 post-dose.

Cohort 2 n=10-12