Bio-Path Holdings Advances in Clinical Trials and Expands into Obesity Treatment

Bio-Path Holdings, Inc., a biotechnology company specializing in targeted nucleic acid cancer drugs, has provided an update on its clinical progress and expansion plans. The company has made meaningful progress in its clinical trials across multiple cancer indications and is preparing for preclinical studies to explore the use of prexigebersen as a potential treatment for obesity.

Clinical Program Overview Bio-Path's clinical development program includes one Phase 2 clinical trial and three Phase 1 or 1/1b clinical trials. The company has developed a molecular biomarker package to accompany prexigebersen treatment, aiming to identify patients more likely to respond to treatment. This approach is expected to improve the probability of success for the program.

Prexigebersen Phase 2 Clinical Trial The Phase 2 trial focuses on treating Acute Myeloid Leukemia (AML) patients, with three separate cohorts. The trial is currently paused for an interim analysis, amendment preparation, and FDA review. Bio-Path expects to complete enrollment in cohorts 1 and 2 over the next eighteen months.

Phase 1/1b Clinical Trials

• BP1001-A in Advanced Solid Tumors: A Phase 1/1b clinical trial for BP1001-A, targeting advanced or recurrent solid tumors, is ongoing. The trial has advanced to the second dose level, with plans to assess BP1001-A in combination with paclitaxel for recurrent ovarian or endometrial tumors.
• BP1002 in Relapsed/Refractory AML: A Phase 1/1b clinical trial for BP1002, targeting relapsed/refractory AML patients, is ongoing. The trial has completed the second dose cohort and is analyzing PK/PD data for FDA submission.
• BP1002 in Refractory/Relapsed Lymphoma and CLL: A Phase 1 clinical trial for BP1002, targeting refractory/relapsed lymphoma and chronic lymphocytic leukemia (CLL), is ongoing. The trial has successfully completed the first dose cohort.

Preclinical Work for BP1003 Bio-Path is advancing BP1003, an antisense RNAi nanoparticle targeting the STAT3 protein, for the treatment of advanced solid tumors. Plans include conducting a Phase 1 study in patients with refractory, metastatic solid tumors.

Prexigebersen as Potential Treatment for Obesity Bio-Path is preparing for preclinical development of prexigebersen for the treatment of obesity and obesity-related cancers. The company believes the development could be accelerated due to the large amount of safety data from prexigebersen treatment of leukemia patients and the unmet medical need in obesity treatment.

Bio-Path Holdings continues to leverage its DNAbilize® liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, with plans to expand into new indications, including obesity.