Whalatane
4月前
Well while waiting for the FDA update on UNCY ...did some more DD on MAIA and can see why its fast tracked and has an NIH grant
Efficacy Highlights (180 mg Dose)
As of the mid-2025 data cutoffs, the 180 mg dose sequenced with cemiplimab demonstrated:
Progression-Free Survival (PFS): An estimated median PFS of 5.6 months. This is more than double the historical standard-of-care (SOC) threshold of approximately 2.5 months for this population.
Overall Survival (OS): An estimated median OS of 17.8 months across third-line patients, with high confidence levels (95% CI lower bound of 12.5 months). This significantly exceeds the typical SOC survival of 5–8 months.
Response Rates: An Overall Response Rate (ORR) of 38% and a Disease Control Rate (DCR) of 85% in the 3L setting. For comparison, typical SOC chemotherapy ORRs in similar settings are roughly 6–10%.
Durability: Some patients have completed over 33 cycles of therapy, indicating long-term benefit and potential for extended dosing.
Safety & Mechanism
Tolerability: The 180 mg dose was chosen for its superior safety profile compared to the 360 mg dose, with most adverse events being Grade 1 or 2 (mild to moderate).
Biomarker Activity: Treatment at this dose level induced a 1.73-fold increase in telomere dysfunction-induced foci (TIFs), confirming that ateganosine is successfully targeting telomeres in cancer cells as intended.
The positive results from this 180 mg cohort are the primary driver for the Part C expansion and the upcoming Phase 3
Enrolling 300 patients in a Phase 3 oncology trial like THIO-104 is a major financial undertaking, typically costing between $20 million and $60 million in total, depending on trial complexity and geographical distribution.
Now they just need $ to complete a P 3 trial which requires them to enroll 300 patients ......or best case scenario..enough for a successful interim analysis which probably requires around 200 enrolled. .
These guys are burning cash as they set up these clinical trial sites
Good luck
Kiwi
tw0122
8月前
... $1.51 “The posters showcased at ESMO 2025 featured exceptional extended survival in third-line NSCLC patients. In addition, as of September 17, 2025, a patient that began therapy in March 2023 has shown survival of 30 months, or 912 days, an outstanding measure relative to many of the high-risk cancers,” said MAIA CEO Vlad Vitoc, M.D. “Very few options exist for patients who are refractory or resistant to immune checkpoint inhibitors (ICI). We believe that a survival of over two years is a clear signal of ateganosine’s role in effectively targeting and eliminating NSCLC tumor cells.”
Volcano
2年前
CHICAGO--(BUSINESS WIRE)--May 16, 2024--MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that an abstract about its Phase 2 THIO-101 clinical trial named “A phase 2, multicenter, open-label, dose-optimization study evaluating telomere-targeting agent THIO sequenced with cemiplimab in patients with advanced NSCLC: Updated results” was accepted for poster presentation at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting, to take place May 31-June 4, 2024, in Chicago, Illinois. The poster is scheduled for presentation on June 3, 2024, from 1:30pm to 4:30pm CST.
“We are proud to accept ASCO’s invitation to present at its 2024 Annual Meeting, the most significant gathering of oncology professionals worldwide,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. “We look forward to revealing the newest efficacy results from THIO-101 and discussing our pioneering telomere targeting science underlying THIO, the first and only cancer treatment of its kind in clinical development.”
MAIA’s abstract will be available online at the ASCO Annual Meeting 2024 website during the week prior to the conference start date, and the poster will be published on maiabiotech.com on the day of the presentation, June 3, 2024.
tw0122
2年前
3/22 news On March 11, 2024, MAIA entered into a Securities Purchase Agreement with certain accredited investors for the issuance and sale in a private placement of 2,043,587 shares of the Company’s common stock, and warrants to purchase up to 2,043,587 shares of the Company’s common stock, at a price per share of $1.17. The combined gross proceeds from the private placement, closed on March 14, 2024, were approximately $2.9 million, prior to deducting offering expenses payable by the Company.
Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer, commented, “The participation in our private placement from five of our independent directors points to their confidence in the science and clinical pathways for our immuno-oncology therapies targeting difficult-to-treat cancers.”
Stan V. Smith, Ph.D., added, “I have participated in every round of financing and I am a big believer in MAIA’s telomere-targeting approach to cancer and its potential to disrupt the field of research and development for cancer therapies, for the benefit of all humankind.”
Dr. Smith is president of Smith Economics Group, Ltd. in Chicago, providing economic and financial consulting nationwide. Trained at the University of Chicago and specializing in litigation economics, Dr. Smith co-authored the first textbook on the subject of economic damages. Dr. Smith has served as an adjunct professor at the University of Chicago and at DePaul University College of Law where he created the first course in the United States in forensic economics.
About MAIA Biotechnology, Inc.
MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.