Biotech small cap MAIA jumps on positive trial data for its cancer drug
Quotes on the small-cap MAIA Biotechnology jumped almost 6% yesterday, Tuesday, February 4, after the company revealed phase II clinical trial results for its drug that is said to offer a fundamentally new approach to cancer treatment. The therapy has proved to be superior to existing treatments, MAIA claims, and the chances of U.S. regulatory approval are «stronger than ever.»
Details
Yesterday, MAIA stock advanced almost 6% to close at $2.00 per share before adding another 4.5% in after-hours trading. It has given back about 1% in premarket trading today as of this writing. Over the last 12 months, MAIA is up approximately 41%. Still, MAIA is currently trading at about 60% below its peak last summer, with its highest close at $5.10 per share on June 3.
Yesterday, MAIA announced that its cancer drug THIO-101 had shown greater efficacy than existing treatments in phase II clinical trials. The company combined THIO-101 with another drug — Regeneron’s cemiplimab (marketed as Libtayo) — and administered it to patients with advanced non-small-cell lung cancer who had already failed at least two therapies.
The results showed median overall survival of 16.9 months among 22 patients who received at least one dose of THIO. This measure indicates how long half of the patients survived with their respective diagnoses. For context, chemotherapy typically has median overall survival of five to six months, according to MAIA.
«Treatment with THIO now shows a 99% probability that overall survival will extend past chemotherapy’s measure by a wide margin… With our latest overall survival results, our outlook for potential FDA commercial approval of THIO is stronger than ever,» MAIA founder and CEO Vlad Vitoc was quoted as saying in the press release.
MAIA believes there might be a chance for accelerated Food and Drug Administration approval of THIO, but this will depend on the final trial results.
About MAIA
MAIA Biotechnology was founded in 2018 by Romanian-born Vlad Vitoc. That same year, the company obtained a global exclusive license for THIO from the University of Texas Southwestern Medical Center. The drug targets telomeres — «protective caps» on the ends of chromosomes — causing them to break apart and the cancer cell DNA to unwind, leading to the tumor cell’s death, Vitoc explained in an interview with professional platform Oncology Compass.
The MAIA CEO believes the efficacy of THIO will improve if it is used with another drug — a checkpoint inhibitor. Checkpoint inhibitors block signaling through immune checkpoints in a cell. Under normal conditions, these signals prevent immune responses from becoming overly aggressive, but in cancer treatment, they can be an obstacle. Blocking them allows the body to fight cancer more effectively.
MAIA is currently studying THIO for several indications, including non-small-cell lung cancer — which accounts for 85% of all lung cancer cases — as well as the rarer but more aggressive small-cell lung cancer, liver cancer, and glioblastoma, an aggressive brain cancer. The FDA has granted THIO orphan drug designation for the latter three indications. This designation provides drugmakers with financial incentives and a seven-year market exclusivity period after regulatory approval. Typically, the FDA grants orphan designation to a drug for only one indication, Vitoc pointed out.
However, MAIA is still loss-making: for the first nine months of 2024, it posted a net loss of $19.7 million, up almost 46% year over year.
According to MarketWatch, MAIA is covered by a single analyst, who rates it a «buy» with a target price of $14.00 per share, implying 600% upside.
