Bio-Path Holdings Inc. (BPTH) stock prices started and closed market trading on August 23rd, 2021 at USD5.69. Premarket fluctuations saw the stock skyrocket by 43.94%, bringing it up to USD$8.19.
FDA Approves IND for BP1002
August 24th 2021 saw BPTH stock announce the approval of its Investigational New Drug application for BP1002 by the U.S Food and Drug Administration. The biotechnology company leverages its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs. Liposomal Bcl-2 is the company’s second drug candidate, with the IND being for an initial Phase 1/1b clinical trial that will evaluate the ability of BP1002 to treat refractory/relapsed acute myeloid leukemia (AML) patients.
Potential of BPTH Stock’s BP1002
Patients with AML that fail frontline venetoclax-based therapy have shown very poor prognosis with a median overall survival of less than three months. Accordingly, a novel treatment modality is urgently needed for such patients. Preclinical studies have shown indicated that the BP1002 and decitabine combination is effective against venetoclax-resistant cell lines. This suggests that the combined therapy can potentially provide benefits to patients who have relapsed from venetoclax-based treatment.
BPTH Stock Ahead of the Competition
BP1002 targets Bcl-2 at the DNA level rather than the protein level, which allows it to possible overcome and prevent some of the mechanisms of resistance that affect venetoclax. Existing 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. High expression of Bcl-2 has been correlated with adverse prognosis for patients diagnosed with AML.
Scope of BPTH Stock’s Developments
Preclinical studies have shown the treatment to be a potent inhibitor against the Bcl-2 target. Its benign safety profile should enable BP1002 combination therapy with approved agents, such as decitabine. The company is excited to develop its clinical studies and is looking forward to generating data. This data supports the DNAbilize platform and brings the company one step closer to bringing these potentially lifesaving drugs to patients.
Future Outlook for BPTH Stock
The company reported a strong quarter with the IND for its BP1002 treatment being approved by the U.S FDA. BPTH stock is keen to leverage the resources at its disposal to usher in organic growth over the long term. Investors are hopeful that management will be able to facilitate significant and sustained increases in shareholder value.