MAIA Biotechnology Inc. Stock Price, News & Analysis

MAIA Biotechnology (NYSE American: MAIA) has announced positive interim survival updates from its Phase 2 THIO-101 study for advanced non-small cell lung cancer (NSCLC). The study evaluates THIO, a telomere-targeting treatment, sequenced with Regeneron's immune checkpoint inhibitor cemiplimab (Libtayo®). Key highlights include:

• 16 patients surpassed 12-month survival follow-up
• Median survival follow-up in third-line treatment was 10.6 months
• THIO's survival benefit in third-line treatment surpasses comparable standard-of-care overall survival of 5.8 months
• Previous data showed 38% overall response rate and 88% disease control rate in third-line treatment

The company expects to release full efficacy results of THIO-101 this year.

MAIA Biotechnology (NYSE American: MAIA) will present new Phase 2 clinical trial data for its lead candidate THIO at the H.C. Wainwright 26th Annual Global Investment Conference in September 2024. The presentation will focus on the THIO-101 trial, which combines THIO with the immune checkpoint inhibitor cemiplimab for advanced non-small cell lung cancer (NSCLC) patients who have failed multiple standard treatments.

Key highlights include:

• Presentation scheduled for September 10, 2024, at 08:00 am ET
• Updates on response rates and survival follow-up
• THIO's mechanism as a telomere-targeting agent with direct DNA damage and immune response induction
• Exceptional efficacy demonstrated in NSCLC to date
• Long-term efficacy results expected before year-end

THIO-101 is anticipated to be the first completed clinical study of a telomere-targeting agent in cancer treatment.

MAIA Biotechnology (NYSE American: MAIA) has announced positive updates from its Phase 2 THIO-101 trial, evaluating THIO sequenced with cemiplimab in advanced non-small cell lung cancer (NSCLC) patients who failed multiple standard therapies. Key highlights include:

1. Six patients have continued treatment for over 12 months, completing up to 21 cycles.
2. The THIO-cemiplimab combination shows significantly lower toxicity compared to standard treatments.
3. Treatment longevity suggests safety, efficacy, and ongoing benefits of MAIA's novel telomere-targeting therapy.
4. Current second-line NSCLC treatments typically last 3-4 months, while THIO patients are showing much longer treatment durations.

These results indicate THIO's potential as a durable and effective treatment for advanced NSCLC patients with options.

MAIA Biotechnology announced the FDA's approval of imetelstat, a telomerase inhibitor for treating myelodysplastic syndromes. This approval supports MAIA's approach to telomere-targeting therapies for cancer.

CEO Vlad Vitoc highlighted that telomere targeting is critical in treating specific cancers, noting their lead candidate, THIO, is in Phase 2 trials for high-risk non-small cell lung cancer (NSCLC). THIO has shown promising results in patients resistant to other treatments.

Telomerase, present in over 85% of human cancers, aids cancer cell proliferation. THIO disrupts telomere function, leading to rapid tumor cell death, underscoring the potential of telomere-targeting therapies.

MAIA Biotechnology announced significant milestones and clinical progress for their anticancer agent, THIO. Key achievements include more than $12 million in funding year-to-date, with $7.4 million raised in Q2'24. Recent Phase 2 clinical trial data demonstrated THIO's exceptional efficacy in treating non-small cell lung cancer (NSCLC), with a 38% overall response rate and a 5.5-month median progression-free survival, outperforming current treatments. The company secured a high-value clinical supply agreement for cemiplimab used in the trial. The median survival follow-up time reached 9.1 months. The cash position improved to $8.7 million as of March 31, 2024, bolstered by continued insider investment and strategic fundraising activities. MAIA's positive data at ASCO 2024 generated significant interest among oncologists.

MAIA Biotechnology announced new data from its Phase 2 THIO-101 clinical trial, showing promising results for the drug THIO when combined with cemiplimab (Libtayo®) in advanced non-small cell lung cancer (NSCLC) patients who have failed 2 or more standard-of-care therapies.

The trial reports a favorable overall response rate (ORR) of 38% and a disease control rate (DCR) of 85%, significantly surpassing the standard-of-care DCR of 25-35%. Median progression-free survival (PFS) for patients treated with THIO was 5.5 months, with a median survival follow-up time of 9.1 months.

Furthermore, 65% of patients crossed the 5.8-month overall survival (OS) threshold, and 85% crossed the 2.5-month PFS threshold. The data was presented at the ASCO 2024 Annual Meeting.

Full enrollment for the trial was completed ahead of schedule on February 19, 2024, and the company anticipates full efficacy data by the second half of the year. The treatment has been generally well tolerated by patients.

MAIA Biotechnology (NYSE American: MAIA), a clinical stage company specializing in telomere-targeting immunotherapies for cancer, will participate in the BIO International Convention from June 3-6, 2024, in San Diego. The event gathers over 20,000 biotech industry leaders globally. CEO Vlad Vitoc, M.D., will present findings from the Phase 2 THIO-101 clinical trial, which assesses the efficacy of THIO, a telomere-targeting agent, combined with the immune checkpoint inhibitor cemiplimab (Libtayo®) in treating advanced non-small cell lung cancer. This trial could mark the first completion of a telomere-targeting agent study in cancer treatment. Dr. Vitoc’s presentation is set for June 5 at 11:30 a.m. PDT in the San Diego Convention Center. The MAIA team will also hold meetings with key industry stakeholders during the event.

MAIA Biotechnology announced that an abstract from its Phase 2 THIO-101 clinical trial has been accepted for a poster presentation at the ASCO 2024 Annual Meeting. The trial involves the investigation of THIO, a telomere-targeting agent, sequenced with cemiplimab in treating advanced non-small cell lung cancer (NSCLC). The poster presentation is scheduled for June 3, 2024, from 1:30 pm to 4:30 pm CST in Chicago. MAIA emphasizes the uniqueness of THIO as the first cancer treatment of its kind in clinical development. Additional details will be accessible online on the ASCO website a week before the conference and on MAIA's website on the day of the presentation.

MAIA Biotechnology, Inc. announced that director Adelina Louie purchased 19,665 shares and warrants in a private placement of common stock, showing confidence in the company's mission of developing cancer immunotherapies. Louie, a top MAIA investor, has a background in finance and banking, with 30 years of experience at HSBC Group.