Slide 1: THIO-101 Supporting Deck ASCO 2024
THIO-101 SUPPORTING DECK ASCO 2024
Slide 2: Introduction
INTRODUCTION • Despite recent approvals for the first-line treatment of advanced Non-Small Cell Lung Cancer (NSCLC), long-term prognosis remains poor with a 5-year survival rate of 28%1 and limited options exist in patients refractory or resistant to immune checkpoint inhibitors (ICI). • THIO (6-thi
Slide 3: Methods
METHODS • Using a modified 3+3 design, the safety lead-in (Part A) enrolled 10 patients who received THIO 360 mg IV (120 mg QD, D1–3), followed by 350 mg cemiplimab on D5, Q3W. • Following completion of Part A, enrollment was opened in the dose-finding portion of the study (Part B). • Using a Simon
Slide 4: THIO-101 Study Schema
THIO-101 STUDY SCHEMA Part A: Part B: Safety Efficacy / safety / dose selection Every 3 weeks Every 3 weeks THIO 60 mg Immune activation Immune activation Best RANDOMIZE ORR, dose Stage 2 Libtayo® Libtayo® THIO THIO DCR, selected THIO 360 mg 180 mg Safety Nov 23: 180 mg 180 mg THIO 360 mg • Primary
Slide 5: Baseline Characteristics
BASELINE CHARACTERISTICS • At the time of data cut-off (30 April 2024), 79 patients with advanced NSCLC had received ≥1 dose of THIO. • All patients had previously failed ≥1 prior line of ICI ± chemotherapy in the advanced setting and had documented disease progression at study entry. • 34% of patie
Slide 6: Safety Findings
SAFETY FINDINGS • THIO + cemiplimab has so far been well tolerated in a heavily pre-treated population, with most events being Grade 1–2 in severity. • Most TEAEs were laboratory value elevations, except nausea (11.4% overall and 2.4% at the 180 mg dose) and decreased appetite (5.1% overall and 2.4%
Slide 7: Safety Findings: Related TEAEs by dose level
SAFETY FINDINGS Related TEAEs by dose level reported in ≥2 patients 60 mg 180 mg 360 mg Total Preferred term (n=24) (n=41) (n=14) (N=79) Aspartate aminotransferase increased 6 (25.0%) 10 (24.4%) 4 (28.6%) 20 (25.3%) Alanine aminotransferase increased 6 (25.0%) 8 (19.5%) 3 (21.4%) 17 (21.5%) Nausea 1
Slide 8: Safety Findings: Related Grade ≥3 TEAEs
SAFETY FINDINGS Related Grade ≥3 TEAEs 60 mg 180 mg 360 mg Total Preferred term (n=24) (n=41) (n=14) (N=79) Alanine aminotransferase increased 3 (12.5%) 4 (9.8%) 2 (14.3%) 9 (11.4%) Aspartate aminotransferase increased 5 (20.8%) 2 (4.9%) 2 (14.3%) 9 (11.4%) Neutropenia 2 (8.3%) 0 (0.0%) 0 (0.0%) 2 (
Slide 9: Efficacy Findings
EFFICACY FINDINGS • 69 evaluable patients had completed ≥1 post-baseline assessment at the time of data cut-off (45 in 2L, 20 in 3L, 4 in 4L+). • Partial Responses (PRs) per RECIST 1.1 were observed in 9 patients (6 in 2L, 3 in 3L), with 6 PRs confirmed (3 in 2L, 3 in 3L) by a 2nd scan per Investiga
Slide 10: Efficacy Second-Line
EFFICACY SECOND-LINE Patients receiving THIO as 2L treatment (n=45)* Subject Treatment Follow-Up Stable Disease (SD) Partial Response (PR) Progressive Disease (PD) Death Withdrawal Others *Includes all patients with ≥1 post-baseline response assessment. 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 PFS (2L)
Slide 11: Efficacy Third-Line
EFFICACY THIRD-LINE Patients receiving THIO as 3L treatment (n=20)* Subject Treatment Follow-Up Stable Disease (SD) Partial Response (PR) Progressive Disease (PD) Death Median Survival Follow-Up Withdrawal 9.1 months Others *Includes all patients 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 with ≥1 post-ba
Slide 12: Efficacy Third-Line - 180 mg Dose
EFFICACY THIRD-LINE - 180 MG DOSE Patients receiving THIO as 3L treatment, 180 mg dose (n=8)* Treatment Follow-Up Subject Stable Disease (SD) Partial Response (PR) Progressive Disease (PD) Death Median Survival Follow-Up Withdrawal 9.1 months Others 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 PFS (3L) = 2
Slide 13: Biomarker Findings
BIOMARKER FINDINGS • TIF (Telomere dysfunction Induced Foci) analysis demonstrated the intended on-target mechanism of action: modification of telomeres in circulating tumor cells (CTCs) by THIO. Cumulative TIF TIF by dose level p=0.0004468 0.01193 0.01885 100 100 60 mg n=16 n=29 180 mg TIF gammaH2A
Slide 14: Conclusions
CONCLUSIONS • The combination of THIO + cemiplimab is very active in this hard-to-treat patient population (CPI resistant and chemotherapy resistant progressors). • The ORR in the 3L setting with the 180 mg dose is 38%, which compares favorably with response rates reported of ~6% for other currently
Slide 15: Authors
AUTHORS T. Jankowski,1 T. Csoszi,2 L. Urban,3 T. Nagy,4 N. Chilingirova,5 M. Cholakova,6 R. Joshi,7 M. Moore,8 R. Ramlau,9 S. Soter,10 M. Kotlarski,11 K.D. Koynov,12 A. Mruk,13 B. Seidl,14 V. Minchev,15 V. Muller,16 V. Vitoc,17 S. Gryaznov,17 O. Tudos,17 V. Zaporojan17 1Medical University Lublin, Lu
Slide 16: References
REFERENCES 1. https://www.cancer.net/cancer-types/lung-cancer-non-small-cell/statistics 2. Shay JW, Bacchetti S. Eur J Cancer 1997;33:787–91. 3. Tahara H, et al. Cancer Res 1995;55:2734–6. 4. Mender I, et al. Cancer Disc 2015 Jan;5(1):82-95. 5. Mender I, et al. Cancer Cell 2020;38:400–11. 6. https:/
Slide 17: Acknowledgements
ACKNOWLEDGEMENTS • This study is sponsored by MAIA Biotechnology, Inc. • The authors would like to thank the patients and research staff who contributed to this study. • The sponsor would like to send a special thanks to REGENERON, CROMOS and NOVA-CLIN for their exceptional contribution to this stud