false 0001878313 0001878313 2024-06-03 2024-06-03
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
Current Report
Pursuant to Section 13 or 15(d)
of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): June 3, 2024
MAIA Biotechnology, Inc.
(Exact name of registrant as specified in its charter)
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Delaware |
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001-41455 |
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83-1495913 |
(State or other jurisdiction of incorporation) |
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(Commission File Number) |
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(IRS Employer Identification No.) |
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444 West Lake Street, Suite 1700 |
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Chicago, IL |
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60606 |
(Address of principal executive offices) |
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(Zip Code) |
(312) 416-8592
(Registrant’s telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
Common Stock |
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MAIA |
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NYSE American |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 7.01 Regulation FD Disclosure.
1. MAIA Biotechnology, Inc. (the “Company”) has prepared a poster (the “Poster”) showing the efficacy data from its Phase 2 THIO-101 clinical trial evaluating THIO sequenced with the immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in patients with advanced non-small cell lung cancer (NSCLC) who failed 2 or more standard-of-care therapy regimens. The Poster was originally displayed at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting on June 3, 2024 and will also be posted to the Company’s website on June 3, 2024, a copy of which is filed as Exhibit 99.1 to this Current Report on Form 8-K (this “Report”) and is hereby incorporated by reference.
2. The Company has prepared a supporting deck (the “Supporting Deck”) showing the efficacy data from its Phase 2 THIO-101 clinical trial evaluating THIO sequenced with the immune checkpoint inhibitor (CPI) cemiplimab (Libtayo®) in patients with advanced non-small cell lung cancer (NSCLC) who failed 2 or more standard-of-care therapy regimens, which was posted to the Company’s website on June 3, 2024, a copy of which is filed as Exhibit 99.2 to Report and is hereby incorporated by reference.
The information contained in each of the Poster and the Supporting Deck is summary information that should be considered in the context of the Company’s filings with the Securities and Exchange Commission and other public announcements the Company may make by press release or otherwise from time to time. Each of the Poster and the Supporting Deck speaks as of the date of this Report. While the Company may elect to update the Poster and/or the Supporting Deck in the future to reflect events and circumstances occurring or existing after the date of this Report, the Company specifically disclaims any obligation to do so.
Each of the Poster and the Supporting Deck contains forward-looking statements, and as a result, investors should not place undue reliance on these forward-looking statements.
The information set forth in this Report, including, without limitation, the Poster and the Supporting Deck, is not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be incorporated by reference into a filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific reference in such a filing. This Report (including the exhibits hereto) will not be deemed an admission as to the materiality of any information required to be disclosed solely to satisfy the requirements of Regulation FD.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
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Exhibit No. |
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Description |
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99.1 |
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Poster |
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99.2 |
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Supporting Deck |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Dated: June 3, 2024
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MAIA BIOTECHNOLOGY, INC. |
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By: |
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/s/ Vlad Vitoc |
Name: |
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Vlad Vitoc |
Title: |
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Chief Executive Officer |
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A Phase 2, Multi-Center, Open-Label,
Dose-Optimization Study Evaluating Telomere-Targeting Agent THIO Sequenced with Cemiplimab in Patients with Advanced NSCLC: Updated Results Abstract 8601 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, Lublin, Poland; 2Hetenyi Geza Korhaz, Onkologiai
Kozpont, Szolnok, Hungary; 3Matrai Gyogyintezet, Matrahaza, Hungary; 4Orszagos Onkologiai lntezet, Budapest, Hungary; 5Medical Oncology Clinic, Heart & Brain Hospital, Pleven, Bulgaria; 6Synexus Medical Center, Sofia, Bulgaria; 7Cancer Research
of South Australia; Adelaide, SA, Australia; 8St. Vincent’s Hospital Melbourne, Fitzroy, VIC, Australia; 9Oncology Department Poznan University of Medical Sciences, Poland; 10Koranyi National Institute of Pulmonology, Budapest, Hungary;
11Centrum Medyczne Pratia, Poznan, Poland; 12MHAT Serdika, Sofia, Bulgaria; 13Centrum Medyczne Mrukmed, Rzeszow, Poland; 14University of Sunshine Coast Queensland, Australia; 15UMHAT Sofiamed, Sofia, Bulgaria; 16Semmelweis Egyetem Pulmonologiai
Klinika Budapest, Hungary; 17MAIA Biotechnology, Chicago, IL, USA 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'-deoxyguanosine, also known as 6-thio-dG) is a small molecule, first-in-class direct cancer telomere targeting agent that selectively
kills telomerase positive (TERT+) cancer cells: Over 80% of all cancers and approx. 78-83% of all NSCLC types are TERT+.2,3 THIO is incorporated into de novo synthesized telomeres leading to chromatin uncapping, generation of DNA damage signals, and
rapid apoptosis.4 Sequential treatment of THIO and ICIs showed a potent and durable antitumor activity in preclinical models.5 Preliminary trial results in NSCLC indicates that low doses of THIO induce sensitivity to ICIs when administered prior to
an ICI in tumors which otherwise are resistant or do not respond to an ICI. Here we describe a phase 2 dose-optimization study (NCT05208944) for adult patients with advanced NSCLC who progressed or relapsed after 1–4 prior treatment lines
including first-line ICI alone or in combination with platinum chemotherapy. Introduction 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-stage design, 79 patients were assigned to one of the THIO doses: 360, 180, or 60 mg followed by
cemiplimab Q3W for up to 1 year in Part B. Disease status is assessed at Cycle 3 Day 1, Cycle 5 Day 1 and every 9 -12 weeks thereafter. The trial completed enrollment in February 2024. We report here data from the 79 patients enrolled on the study,
who received at least one dose of the treatment. An expansion cohort is planned based on data from Part B (n=100). Characteristic 60 mg (n=24) 180 mg (n=41) 360 mg (n=14) Total (N=79) Median age (range), years 67 (52–85) 68 (45–81) 68
(50–75) 67 (45–85) Sex, n (%) Female 10 (42) 11 (27) 7 (50) 28 (35) Male 14 (58) 30 (73) 7 (50) 51 (65) Number of prior lines, n (%) 1 17 (71) 30 (73) 5 (36) 52 (66) 2 6 (25) 10 (25) 6 (43) 22 (28) 3 1 (4) 0
(0) 2 (14) 3 (4) 4 0 (0) 1 (2) 1 (7) 2 (3) ECOG PS, n (%) 0 6 (25) 8 (20) 7 (50) 21 (27) 1 18 (75) 33 (80) 7 (50) 58 (73) Histology, n (%) Non-Squamous cell carcinoma 15 (63) 25 (61) 8 (57) 48
(60) Squamous cell carcinoma 9 (37) 16 (39) 6 (43) 31 (40) Brain metastases, n (%) 1 (4) 1 (2) 2 (14) 4 (5) Liver metastases, n(%) 4 (17) 5 (12) 3 (21) 12 (15) Table 1. Baseline characteristics Baseline characteristics Efficacy findings 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 had ≥2 prior treatment lines at study entry. 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 the 180 mg dose). No study drug-related Grade 5 events have been reported. No study drug-related
Grade 4 events have been reported at the 180 mg dose. No DLTs have been reported in the Part A safety lead in. A related Grade ≥3 ALT increase was reported in 9 patients (11.4%), including 2 patients receiving 360 mg, 4 at 180 mg, and 3 at 60
mg. No clinical symptoms were associated with the elevated laboratory values, and all returned to baseline or normal without sequelae. All other related Grade ≥3 events occurred in <5% of patients. Following an event of Grade 4 LFT
elevation in a patient receiving 360 mg in Part B, enrollment into the 360 mg arm was paused. Enrollment was completed in Part B at the selected dose of 180 mg/cycle in February 2024. With currently available chemotherapy in this patient population,
Grade 5 events are expected in 5% of cases, Grade 4 events in 23.8% and Grade 3 in 42.4%.6,7 Conclusions Biomarker 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' assessment. 5 patients have survival follow-up for >12 months (3 with treatment
ongoing). In the 3L setting: DCR was 85% for THIO vs. standard of care 25–35% for chemotherapy.8 13/20 (65%) patients crossed the 5.8-month OS threshold.9 17/20 (85%) patients crossed the 2.5-month PFS threshold.10-11 The median survival
follow-up time is currently 9.1 months (n=20). In the 3L setting with THIO at 180 mg: Median PFS: 5.5 months (24.1 weeks); OS rate at 6 months: 75%. ORR 38% (3/8) vs. standard of care 6–10% for chemotherapy.9 6/8 (75%) patients crossed the
5.8-month OS threshold.9 7/8 (88%) patients crossed the 2.5-month PFS threshold.10-11 The median survival follow-up time is currently 9.1 months (n=8). Table 2. Related TEAEs by dose level reported in ≥2 patients Table 3. Related Grade
≥3 TEAEs TIF (Telomere dysfunction Induced Foci) analysis demonstrated the intended on-target mechanism of action: modification of telomeres in circulating tumor cells (CTCs) by THIO (see Figures 4 and 5). Figure 5. Cumulative TRF1 Figure 6.
TRF1 by dose level 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 available treatments for heavily pre-treated patients. Median survival follow-up in the 3L setting has surpassed 9.1 months. TIF in CTCs shows on-target effect. THIO + cemiplimab has so
far been well-tolerated in a heavily pre-treated population. The safety profile of THIO has the potential to be far better than chemotherapy. Treatment has the potential to be given for longer, which usually translates into longer survival. The
ongoing Phase 2 study selected the best dose of THIO in November 2023. The 180 mg dose has shown better safety and superior efficacy compared with other doses: to date, 9.8% of patients receiving the 180 mg dose reported related Grade
≥3 AEs. There were no reported related Grade 4 and 5 AEs in the 180 mg dose. 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/hcp/nsclc-treatment/revel-trial-safety https://clinicaltrials.gov/study/NCT01168973?tab=results
Matsumoto H, et al. Transl Lung Cancer Res 2021;10:2278–89. Girard N, et al. J Thorac Onc 2009;12:1544-1549. Shepherd F, et al. N Engl J Med 2005;353:123-132. Fossella F, et al. J Clin Oncol 2000;18(12):2354-62. 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. Presenting author contact Tomasz Jankowski, M.D. (e-mail: tjankowski.onkolog@wp.pl) Scan QR Code to access our presentation and a digital version of the poster Figure 1. THIO-101 study schema Figure 4. Patients receiving
THIO as 3L treatment, 180 mg dose (n=8)* Figure 3. Patients receiving THIO as 3L treatment (n=20)* Figure 2. Patients receiving THIO as 2L treatment (n=45)* *Includes all patients with ≥1 post-baseline response assessment. PFS (2L) = 4.5
months7 OS (2L) = 10.5 months7 Subject Months PFS (3L) = 2.5 months10-11 OS (3L) = 5.8 months9 Subject Subject Months Months Enrollment completed Feb 24 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 endpoints: Safety, ORR, DCR (CR, PR and SD). Secondary
endpoints: DoR; PFS; OS. Exploratory endpoints: PK and PD (activity of THIO in circulating tumor cells measured by specific biomarkers). May 31 – June 4, 2024 Chicago, IL & Online 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 (4.2%) 1 (2.4%) 7 (50.0%) 9 (11.4%) Anemia 0 (0.0%) 2 (4.9%) 1 (7.1%) 3
(3.8%) Neutropenia 2 (8.3%) 1 (2.4%) 0 (0.0%) 3 (3.8%) Pyrexia 0 (0.0%) 2 (4.9%) 1 (7.1%) 3 (3.8%) Decreased appetite 0 (0.0%) 1 (2.4%) 2 (14.3%) 3 (3.8%) Blood alkaline phosphatase increased 1 (4.2%) 1 (2.4%) 0 (0.0%) 2 (2.5%) Blood bilirubin
increased 0 (0.0%) 1 (2.4%) 1 (7.1%) 2 (2.5%) Gamma-glutamyltransferase increased 0 (0.0%) 2 (4.9%) 0 (0.0%) 2 (2.5%) Leukopenia 1 (4.2%) 0 (0.0%) 1 (7.1%) 2 (2.5%) Asthenia 0 (0.0%) 2 (4.9%) 0 (0.0%) 2 (2.5%) Erythema 0 (0.0%) 2 (4.9%) 0 (0.0%) 2
(2.5%) Hypothyroidism 0 (0.0%) 2 (4.9%) 0 (0.0%) 2 (2.5%) Infusion-related reaction 0 (0.0%) 2 (4.9%) 0 (0.0%) 2 (2.5%) 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 (2.5%) Blood alkaline phosphatase increased 0 (0.0%) 1 (2.4%) 0 (0.0%) 1 (1.3%) Gamma-glutamyltransferase
increased 0 (0.0%) 1 (2.4%) 0 (0.0%) 1 (1.3%) Lipase increased 1 (4.2%) 0 (0.0%) 0 (0.0%) 1 (1.3%) Nausea 0 (0.0%) 0 (0.0%) 1 (7.1%) 1 (1.3%) Hyperkalemia 1 (4.2%) 0 (0.0%) 0 (0.0%) 1 (1.3%) Median Survival Follow-Up 9.1 months Median Survival
Follow-Up 9.1 months Copies of this poster obtained through QR Code are for personal use only and may not be reproduced without permission from ASCO® or the author of this poster Treatment Follow-Up Stable Disease (SD) Partial Response (PR)
Progressive Disease (PD) Death Withdrawal Others Treatment Follow-Up Stable Disease (SD) Partial Response (PR) Progressive Disease (PD) Death Withdrawal Others 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 months9 Exhibit 99.1
THIO-101 Supporting DECK ASCO 2024
Exhibit 99.2
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'-deoxyguanosine, also known as 6-thio-dG) is a small molecule, first-in-class direct cancer telomere targeting agent that selectively kills telomerase positive (TERT+) cancer cells: Over 80% of all cancers and approx. 78-83% of
all NSCLC types are TERT+.2,3 THIO is incorporated into de novo synthesized telomeres leading to chromatin uncapping, generation of DNA damage signals, and rapid apoptosis.4 Sequential treatment of THIO and ICIs showed a potent and durable antitumor
activity in preclinical models.5 Preliminary trial results in NSCLC indicates that low doses of THIO induce sensitivity to ICIs when administered prior to an ICI in tumors which otherwise are resistant or do not respond to an ICI. Here we describe a
phase 2 dose-optimization study (NCT05208944) for adult patients with advanced NSCLC who progressed or relapsed after 1–4 prior treatment lines including first-line ICI alone or in combination with platinum chemotherapy.
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.
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-stage design, 79 patients were assigned to one of the THIO doses: 360, 180, or 60 mg followed by cemiplimab Q3W for up to 1 year in Part B. Disease status is assessed at Cycle 3 Day 1, Cycle 5 Day 1 and every 9 -12 weeks thereafter.
The trial completed enrollment in February 2024. We report here data from the 79 patients enrolled on the study, who received at least one dose of the treatment. An expansion cohort is planned based on data from Part B (n=100).
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 endpoints: Safety, ORR, DCR (CR, PR and SD). Secondary endpoints: DoR; PFS; OS. Exploratory endpoints: PK and PD (activity of THIO in circulating tumor cells measured by specific biomarkers).
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 had ≥2 prior treatment lines at study entry. Characteristic 60 mg (n=24) 180 mg (n=41) 360 mg (n=14) Total (N=79) Median age (range), years 67 (52–85) 68 (45–81) 68 (50–75) 67
(45–85) Sex, n (%) Female 10 (42) 11 (27) 7 (50) 28 (35) Male 14 (58) 30 (73) 7 (50) 51 (65) Number of prior lines, n (%) 1 17 (71) 30 (73) 5 (36) 52 (66) 2 6 (25) 10 (25) 6 (43) 22 (28) 3 1 (4) 0 (0) 2 (14) 3 (4) 4
0 (0) 1 (2) 1 (7) 2 (3) ECOG PS, n (%) 0 6 (25) 8 (20) 7 (50) 21 (27) 1 18 (75) 33 (80) 7 (50) 58 (73) Histology, n (%) Non-Squamous cell carcinoma 15 (63) 25 (61) 8 (57) 48 (60) Squamous cell
carcinoma 9 (37) 16 (39) 6 (43) 31 (40) Brain metastases, n (%) 1 (4) 1 (2) 2 (14) 4 (5) Liver metastases, n(%) 4 (17) 5 (12) 3 (21) 12 (15)
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 the 180 mg dose). No study drug-related Grade 5 events have been reported. No study drug-related Grade 4 events have been reported at the 180 mg dose. No DLTs have been reported in the Part A safety lead in. A related Grade
≥3 ALT increase was reported in 9 patients (11.4%), including 2 patients receiving 360 mg, 4 at 180 mg, and 3 at 60 mg. No clinical symptoms were associated with the elevated laboratory values, and all returned to baseline or normal without
sequelae. All other related Grade ≥3 events occurred in <5% of patients. Following an event of Grade 4 LFT elevation in a patient receiving 360 mg in Part B, enrollment into the 360 mg arm was paused. Enrollment was completed in Part B at
the selected dose of 180 mg/cycle in February 2024. With currently available chemotherapy in this patient population, Grade 5 events are expected in 5% of cases, Grade 4 events in 23.8% and Grade 3 in 42.4%.6,7
https://www.cyramza.com/hcp/nsclc-treatment/revel-trial-safety https://clinicaltrials.gov/study/NCT01168973?tab=results
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 (4.2%) 1 (2.4%) 7 (50.0%) 9 (11.4%) Anemia 0 (0.0%) 2 (4.9%) 1 (7.1%) 3 (3.8%) Neutropenia 2 (8.3%) 1 (2.4%) 0 (0.0%) 3 (3.8%) Pyrexia 0 (0.0%) 2 (4.9%) 1 (7.1%) 3 (3.8%) Decreased appetite 0 (0.0%) 1 (2.4%) 2 (14.3%) 3 (3.8%)
Blood alkaline phosphatase increased 1 (4.2%) 1 (2.4%) 0 (0.0%) 2 (2.5%) Blood bilirubin increased 0 (0.0%) 1 (2.4%) 1 (7.1%) 2 (2.5%) Gamma-glutamyltransferase increased 0 (0.0%) 2 (4.9%) 0 (0.0%) 2 (2.5%) Leukopenia 1 (4.2%) 0 (0.0%) 1 (7.1%) 2
(2.5%) Asthenia 0 (0.0%) 2 (4.9%) 0 (0.0%) 2 (2.5%) Erythema 0 (0.0%) 2 (4.9%) 0 (0.0%) 2 (2.5%) Hypothyroidism 0 (0.0%) 2 (4.9%) 0 (0.0%) 2 (2.5%) Infusion-related reaction 0 (0.0%) 2 (4.9%) 0 (0.0%) 2 (2.5%)
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 (2.5%) Blood alkaline phosphatase increased 0 (0.0%) 1 (2.4%) 0 (0.0%) 1 (1.3%) Gamma-glutamyltransferase increased 0 (0.0%) 1 (2.4%) 0 (0.0%) 1 (1.3%) Lipase increased 1 (4.2%) 0 (0.0%) 0 (0.0%) 1 (1.3%) Nausea 0 (0.0%) 0 (0.0%) 1
(7.1%) 1 (1.3%) Hyperkalemia 1 (4.2%) 0 (0.0%) 0 (0.0%) 1 (1.3%)
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' assessment. 5 patients have survival follow-up for >12 months (3 with treatment ongoing). In the 3L setting: DCR was 85% for THIO vs. standard of care 25–35% for chemotherapy.8 13/20 (65%) patients crossed the
5.8-month OS threshold.9 17/20 (85%) patients crossed the 2.5-month PFS threshold.10-11 The median survival follow-up time is currently 9.1 months (n=20). In the 3L setting with THIO at 180 mg: Median PFS: 5.5 months (24.1 weeks); OS rate at 6
months: 75%. ORR 38% (3/8) vs. standard of care 6–10% for chemotherapy.9 6/8 (75%) patients crossed the 5.8-month OS threshold.9 7/8 (88%) patients crossed the 2.5-month PFS threshold.10-11 The median survival follow-up time is currently 9.1
months (n=8). Matsumoto H, et al. Transl Lung Cancer Res 2021;10:2278–89. Girard N, et al. J Thorac Onc 2009;12:1544-1549. Shepherd F, et al. N Engl J Med 2005;353:123-132. Fossella F, et al. J Clin Oncol 2000;18(12):2354-62.
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 months7 OS (2L) = 10.5 months7 Subject Months Treatment Follow-Up Stable Disease (SD) Partial Response (PR) Progressive Disease (PD) Death Withdrawal Others *Includes all patients with ≥1 post-baseline response
assessment.
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 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. *Includes all patients with
≥1 post-baseline response assessment.
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 months9 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. *Includes all
patients with ≥1 post-baseline response assessment.
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
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 available treatments for heavily pre-treated patients. Median survival follow-up in the 3L setting has surpassed 9.1 months. TIF in CTCs shows on-target effect. THIO + cemiplimab has so far been well-tolerated in a heavily
pre-treated population. The safety profile of THIO has the potential to be far better than chemotherapy. Treatment has the potential to be given for longer, which usually translates into longer survival. The ongoing Phase 2 study selected the best
dose of THIO in November 2023. The 180 mg dose has shown better safety and superior efficacy compared with other doses: to date, 9.8% of patients receiving the 180 mg dose reported related Grade ≥3 AEs. There were no reported related
Grade 4 and 5 AEs in the 180 mg dose.
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, Lublin, Poland; 2Hetenyi Geza Korhaz, Onkologiai Kozpont, Szolnok, Hungary; 3Matrai Gyogyintezet, Matrahaza, Hungary; 4Orszagos Onkologiai lntezet, Budapest, Hungary; 5Medical Oncology Clinic, Heart & Brain Hospital, Pleven,
Bulgaria; 6Synexus Medical Center, Sofia, Bulgaria; 7Cancer Research of South Australia; Adelaide, SA, Australia; 8St. Vincent’s Hospital Melbourne, Fitzroy, VIC, Australia; 9Oncology Department Poznan University of Medical Sciences, Poland;
10Koranyi National Institute of Pulmonology, Budapest, Hungary; 11Centrum Medyczne Pratia, Poznan, Poland; 12MHAT Serdika, Sofia, Bulgaria; 13Centrum Medyczne Mrukmed, Rzeszow, Poland; 14University of Sunshine Coast Queensland, Australia; 15UMHAT
Sofiamed, Sofia, Bulgaria; 16Semmelweis Egyetem Pulmonologiai Klinika Budapest, Hungary; 17MAIA Biotechnology, Chicago, IL, USA
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/hcp/nsclc-treatment/revel-trial-safety https://clinicaltrials.gov/study/NCT01168973?tab=results Matsumoto H, et al. Transl Lung Cancer Res 2021;10:2278–89. Girard N, et al. J Thorac Onc
2009;12:1544-1549. Shepherd F, et al. N Engl J Med 2005;353:123-132. Fossella F, et al. J Clin Oncol 2000;18(12):2354-62.
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.
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Grafico Azioni Maia Biotechnology (AMEX:MAIA)
Storico
Da Nov 2024 a Dic 2024
Grafico Azioni Maia Biotechnology (AMEX:MAIA)
Storico
Da Dic 2023 a Dic 2024