Maia Biotechnology, Inc. · AMEX:MAIA
Maia Biotechnology — ASCO 2024
17 slides from Maia Biotechnology's conference presentation, Jun 3, 2024
Slide 1: THIO-101 Supporting Deck ASCO 2024
THIO-101 Supporting DECK ASCO 2024 Exhibit 99.2
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-thio-2
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 2-stag
Slide 4: THIO-101 Study Schema
THIO-101 Study Schema THIO 60 mg ORR, DCR, Safety Best dose selected Nov 23: 180 mg THIO 360 mg THIO 180 mg Immune activation RANDOMIZE Every 3 weeks Part B: Efficacy / safety / dose selection Part A: Safety THIO 360 mg Libtayo® Every 3 weeks Immune activation Libtayo® Stage 2 THIO 180 mg Primary en
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 patients ha
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% at
Slide 7: Safety findings: Related TEAEs by dose level
Safety findings Related TEAEs by dose level reported in ≥2 patients Preferred term 60 mg (n=24) 180 mg (n=41) 360 mg (n=14) Total (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 Preferred term 60 mg (n=24) 180 mg (n=41) 360 mg (n=14) Total (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 Investigators
Slide 10: Efficacy Second-Line
EFFICACY Second-Line Note: This is a snapshot including ongoing subjects and data pending full verification. Due to short duration of treatment and/or follow up, data subject to change; Clinical data presented from 30Apr2024 data cut. Patients receiving THIO as 2L treatment (n=45)* PFS (2L) = 4.5 mo
Slide 11: Efficacy Third-Line
EFFICACY Third-Line Patients receiving THIO as 3L treatment (n=20)* PFS (3L) = 2.5 months10-11 OS (3L) = 5.8 months9 Subject Months Median Survival Follow-Up 9.1 months Treatment Follow-Up Stable Disease (SD) Partial Response (PR) Progressive Disease (PD) Death Withdrawal Others Note: This is a snap
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)* Subject Months Median Survival Follow-Up 9.1 months Treatment Follow-Up Stable Disease (SD) Partial Response (PR) Progressive Disease (PD) Death Withdrawal Others PFS (3L) = 2.5 months10-11 OS (3L) = 5.8 mo
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
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 ava
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 https://www.cancer.net/cancer-types/lung-cancer-non-small-cell/statistics Shay JW, Bacchetti S. Eur J Cancer 1997;33:787–91. Tahara H, et al. Cancer Res 1995;55:2734–6. Mender I, et al. Cancer Disc 2015 Jan;5(1):82-95. Mender I, et al. Cancer Cell 2020;38:400–11. https://www.cyramza.com/h
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 study.