Investor Presentaiton
HLX43 (PD-L1 ADC) Presented Excellent Preclinical Efficacy Data in ESMO
and Entered into Clinical Phase I
ESMO 2023 FPN: 693P
HLX43 shows no immunotoxicity
towards PD-L1 positive human APCs
A
Macrophage
120-
100-
% untreated
II.
Title
Preclinical activity of HLX43, a PD-L1-targeting ADC, in multiple PD-1/PD-L1
refractory/resistant models
Results
HLX43 shows no immunotoxicity towards PD-L1 positive human APCs
In in vivo efficacy studies, HLX43 induced tumor regression in in multiple PD-L1-
positive CDX & PDX models, and was well tolerated, with no major changes in body
weight of administered mice compared to control animals, across all dosing groups
As in the MDA-MB-231 model, weekly administration of HLX43 at 8 mg/kg for three weeks
induced significant tumor regression, while no body weight loss was observed
In all tested models (weak PD-L1 expression and high heterogeneity, as well as PD-1/PD-L1
nonresponsive models), HLX43 always showed superior anticancer efficacy over the anti-
PD-L1 Ab-GGFG-Dxd at equivalent doses.
Preliminary toxicity assessments in rats and cynomolgus monkeys also
demonstrated that HLX43 was safe
B
% untreated
Regulatory and Clinical Trial Progress
IND of HLX43 for the treatment of advance/metastatic solid tumors has been successively
approved by China NMPA and the US FDA during Oct. to Nov., 2023
On Nov. 24, 2023, the phase I clinical trial of HLX43 for the treatment of advance/metastatic
solid tumors has completed the first patient dosing in China
• The phase I dose escalation study is in process; the indications to be developed include but
not limited to lung cancer, esophagus cancer, liver cancer, etc.
30
30
80-
60- - HLX43
40- IgG-Linker-Payload
- HLX20
20-
→ Payload
0-
104
102
10°
102
104
Conc. (nM)
Dendritic Cell
120-
100-
80-
60-
* HLX43
40-
→ IgG-Linker-Payload
HLX20
20-
→ Payload
104
10-2
10°
Conc. (nM)
102
104
Tumor Volume (mm³)
Tumor Volume (mm³)
0
Tumor Volume (mm³)
A
HLX34 exhibits excellent anti-tumor
efficacy in vivo
MDA-MB-231 CDX Model
2500-
2000-
1500-
1000-
500-
0
10
20
30
40
Days Post Treatment (d)
B
BxPC-3 CDX model
000-
1500-
1000-
500-
10
20
30
40
Days Post Treatment (d)
Melanoma PDX model
2000-
1500-
1000-
500-
0+
0
10
20
30
Days Post Treatment (d)
Vehicle control
Payload, 0.24mpk, QW*3
HLX20, 8mpk, QW*3
HLX20-VC-MMAE, 3mpk, QW*3
HLX20-GGFG-Dxd, 3mpk, QW*3
HLX20-GGFG-Dxd, 8mpk, QW*3
HLX43, 3mpk, QW*3
HLX43, 8mpk, QW*3
HLX20, 8mpk, QW*4
HLX20-GGFG-Dxd, 3mpk, QW*4
HLX20-VC-MMAE, 3mpk, QW*4
Payload, 0.24mpk, QW*4
HLX20-GGFG-Dxd, 8mpk, QW*4
-Vehicle control
HLX43, 3mpk, QW*4
HLX43, 8mpk, QW*4
-Vehicle control
HLX20, 10mpk, QW*4
HLX43, 1.5mpk, QW*4
HLX20-GGFG-Dxd, 3mpk, QW*4
HLX43, 3mpk, QW*4
Payload, 0.24mpk, QW*4
- HLX20-GGFG-Dxd, 10mpk, QW*4
HLX43, 10mpk, QW*4
2 HenliusView entire presentation