- The shares of Bio-Path Holdings, Inc. (NASDAQ: BPTH) increased by over 30% pre-market. This is why it happened.
The shares of Bio-Path Holdings, Inc. (NASDAQ: BPTH) – a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs – increased by over 30% pre-market. Investors appear to be responding positively to Bio-Path Holdings announcing that the U.S. Food and Drug Administration (FDA) has reviewed and cleared the Investigational New Drug (IND) application for BP1002 (liposomal Bcl-2) – the company’s second drug candidate – for an initial Phase 1/ 1b clinical trial that will evaluate the ability of BP1002 to treat refractory/relapsed acute myeloid leukemia (AML) patients.
By targeting Bcl-2 at the DNA level rather than the protein, BP1002 may overcome and prevent some of the mechanisms of resistance that affect venetoclax. And the current standard of care for patients with AML not eligible for intensive chemotherapy is venetoclax, an oral Bcl-2 inhibitor that targets the BH3 domain of the Bcl-2 protein – in combination with a hypomethylating agent or with low-dose cytarabine.
The high expression of Bcl-2 has been correlated with adverse prognosis for patients diagnosed with AML. And preclinical studies have shown BP1002 to be a potent inhibitor against the Bcl-2 target and its benign safety profile should enable BP1002 combination therapy with approved agents like decitabine.
The Phase 1/1b clinical trial is anticipated to be conducted at several leading cancer centers in the U.S., including the Weill Medical College of Cornell University, The University of Texas MD Anderson Cancer Center and the Georgia Cancer Center. Initially, a total of 6 evaluable patients are scheduled to be treated with BP1002 monotherapy in a standard 3+3 design, with a starting dose of 20 mg/m2. And the approved treatment cycle is two doses per week over 4 weeks, resulting in 8 doses administered over 28 days. The Phase 1b portion of the study will commence after completion of BP1002 monotherapy cohorts and will assess the safety and efficacy of BP1002 in combination with decitabine in refractory/relapsed AML patients.
Gail J. Roboz, M.D. will serve as Principal Investigator for the Phase 1/1b trial. And Dr. Roboz is professor of medicine and director of the Clinical and Translational Leukemia Program at the Weill Medical College of Cornell University and the New York-Presbyterian Hospital in New York City.
The IND review process was performed by the FDA’s Office of Oncologic Diseases, Division of Hematologic Malignancies and involved a comprehensive review of data submitted by the Company covering pre-clinical studies, safety, chemistry, manufacturing and controls, and the protocol for the Phase 1/1b clinical trial.
“AML patients that fail frontline venetoclax-based therapy have very poor prognosis with a median overall survival of less than three months and a novel treatment modality is urgently needed for such patients. Preclinical studies indicate that the BP1002 and decitabine combination is effective against venetoclax-resistant cell lines, suggesting that the BP1002 and decitabine combination therapy may provide benefits to patients who have relapsed from venetoclax-based treatment.”
— Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings
“We are excited to move into these advanced clinical studies and look forward to generating data that not only support the DNAbilize platform but bring us one step closer to bringing these potentially lifesaving drugs to patients.”
— Jorge Cortes, M.D., Director of the Georgia Cancer Center and Chairman of the Bio-Path Scientific Advisory Board
Disclaimer: This content is intended for informational purposes. Before making any investment, you should do your own analysis.