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MAIA Biotechnology (MAIA) Up on Positive Data From NSCLC Study
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MAIA Biotechnology, Inc. (MAIA - Free Report) announced positive top-line data from the completed Part A safety lead-in its phase II study, THIO-101, on lead candidate THIO in advanced non-small cell lung cancer (NSCLC). Shares gained 6% on the news.
THIO-101 is a multicenter, open-label, phase II dose-finding study designed to evaluate THIO’s potential direct anticancer and immune system activation effects in NSCLC patients by administering THIO in advance of Regeneron’s (REGN - Free Report) anti-PD-1 therapy, Libtayo (cemiplimab). This allows immune system activation and sensitivity to the PD-1 inhibitor to take effect. The primary objectives of the study are to evaluate the safety and tolerability of THIO administered as a direct anti-cancer and priming immune system agent followed by cemiplimab administration, as well as the preliminary clinical efficacy of THIO in patients with advanced NSCLC who either progressed or relapsed through the initial treatments with an immune checkpoint inhibitor alone or in combination with chemotherapy.
Part A was designed to assess the safety and tolerability of the highest dose of 360 mg/cycle in six patients. Top-line data from part A demonstrated that THIO administered in sequential combination with Regeneron’s Libtayo was generally well tolerated. Data showed no dose-limiting toxicities (DLTs) or significant treatment-related adverse events were observed.
While mild toxicities, such as grade 1 fatigue and muscle pain, were reported, as well as only one occurrence of grade 3 nausea, there were no grade 4 adverse events.
MAIA Biotechnology has commenced recruitment for Part B randomized efficacy/dose selection.
This part of the study will allow the randomization of patients to three THIO dose levels, including 60 mg, 180 mg and 360 mg, followed by cemiplimab treatment every three weeks. Safety and tolerability will continue to be monitored across all THIO doses. The objective of Part B is to determine the most efficacious and safe dose, which will guide Part C of the trial.
MAIA Biotechnology anticipates reporting preliminary efficacy data later in 2023.
THIO is being developed as a second or later line of treatment for NSCLC for patients who have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.
Shares of the company gained 9.4% in the year so far against the industry’s decline of 5%.
Image Source: Zacks Investment Research
The successful development of THIO will be a significant boost for MAIA Biotechnology, Inc.
MAIA Biotechnology is planning to conduct a second phase II trial to evaluate THIO in sequential combination with the immunotherapies Keytruda or Tecentriq, which are the most used checkpoint inhibitors in oncology.
Some well-placed stocks in the overall healthcare sector are Novo Nordisk (NVO - Free Report) and Ligand Therapeutics (LGND - Free Report) , both sporting a Zacks Rank #1 at present.
In the past 30 days, estimates for Novo Nordisk’s 2023 earnings per share have risen from $4.20 to $4.43 and estimates for 2024 have gone up by 29 cents to $5.19.
Ligand’s earnings per share estimates for 2023 increased to $4.32 from $3.30 in the past 30 days. LGND beat earnings estimates in one of the last four reported quarters and missed in the remaining three.
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MAIA Biotechnology (MAIA) Up on Positive Data From NSCLC Study
MAIA Biotechnology, Inc. (MAIA - Free Report) announced positive top-line data from the completed Part A safety lead-in its phase II study, THIO-101, on lead candidate THIO in advanced non-small cell lung cancer (NSCLC). Shares gained 6% on the news.
THIO-101 is a multicenter, open-label, phase II dose-finding study designed to evaluate THIO’s potential direct anticancer and immune system activation effects in NSCLC patients by administering THIO in advance of Regeneron’s (REGN - Free Report) anti-PD-1 therapy, Libtayo (cemiplimab). This allows immune system activation and sensitivity to the PD-1 inhibitor to take effect. The primary objectives of the study are to evaluate the safety and tolerability of THIO administered as a direct anti-cancer and priming immune system agent followed by cemiplimab administration, as well as the preliminary clinical efficacy of THIO in patients with advanced NSCLC who either progressed or relapsed through the initial treatments with an immune checkpoint inhibitor alone or in combination with chemotherapy.
Part A was designed to assess the safety and tolerability of the highest dose of 360 mg/cycle in six patients. Top-line data from part A demonstrated that THIO administered in sequential combination with Regeneron’s Libtayo was generally well tolerated. Data showed no dose-limiting toxicities (DLTs) or significant treatment-related adverse events were observed.
While mild toxicities, such as grade 1 fatigue and muscle pain, were reported, as well as only one occurrence of grade 3 nausea, there were no grade 4 adverse events.
MAIA Biotechnology has commenced recruitment for Part B randomized efficacy/dose selection.
This part of the study will allow the randomization of patients to three THIO dose levels, including 60 mg, 180 mg and 360 mg, followed by cemiplimab treatment every three weeks. Safety and tolerability will continue to be monitored across all THIO doses. The objective of Part B is to determine the most efficacious and safe dose, which will guide Part C of the trial.
MAIA Biotechnology anticipates reporting preliminary efficacy data later in 2023.
THIO is being developed as a second or later line of treatment for NSCLC for patients who have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.
Shares of the company gained 9.4% in the year so far against the industry’s decline of 5%.
Image Source: Zacks Investment Research
The successful development of THIO will be a significant boost for MAIA Biotechnology, Inc.
MAIA Biotechnology is planning to conduct a second phase II trial to evaluate THIO in sequential combination with the immunotherapies Keytruda or Tecentriq, which are the most used checkpoint inhibitors in oncology.
MAIA Biotechnology currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Some well-placed stocks in the overall healthcare sector are Novo Nordisk (NVO - Free Report) and Ligand Therapeutics (LGND - Free Report) , both sporting a Zacks Rank #1 at present.
In the past 30 days, estimates for Novo Nordisk’s 2023 earnings per share have risen from $4.20 to $4.43 and estimates for 2024 have gone up by 29 cents to $5.19.
Ligand’s earnings per share estimates for 2023 increased to $4.32 from $3.30 in the past 30 days. LGND beat earnings estimates in one of the last four reported quarters and missed in the remaining three.