Bio-Path Holdings, Inc. BPTH announced that the FDA has cleared its investigational new drug (“IND”) application for BP1002 (liposomal Bcl-2), a novel cancer candidate targeting Bcl-2 Protein. The candidate will be evaluated as a potential treatment for refractory/relapsed acute myeloid leukemia (“AML”) patients in a phase I/Ib study.
The study will initially evaluate six patients who will be treated with BP1002 monotherapy in a standard 3+3 design, with a starting dose of 20 mg/m2. The approved treatment cycle is two doses per week over a period of four weeks. The phase Ib portion of the study, which will commence following BP1002 monotherapy cohorts, will assess the safety and efficacy of BP1002 in combination with decitabine in refractory/relapsed AML patients.
The company’s shares increased 14.9% on Aug 24, following the above news. In fact, the stock has rallied 86.9% so far this year against the industry’s 11.7% decrease.
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Currently, patients with AML who are not eligible for intensive chemotherapy are treated with AbbVie ABBV and Roche’s RHHBY partnered drug Venclexta (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. Patients who fail frontline venetoclax-based therapy have very poor prognosis, with a median overall survival of less than three months.
The IND approval is based on the data from pre-clinical studies that demonstrated the effectiveness of BP1002 combined with decitabine against venetoclax-resistant cell lines. Per the company, BP1002 is a potent BcL-2 inhibitor that targets Bcl-2 at the DNA level rather than the protein.
We inform investors that BP1002 is Bio-Path’s second candidate that is being evaluated for the treatment of blood cancers and solid tumors, including lymphoma and AML.
BP1001, the company’s lead drug, is being evaluated in a phase II study for the treatment of blood cancers. Bio-Path is in the process of filing an IND application for BP1001 across solid tumors. An IND for BP1003, a STAT3 inhibitor, is anticipated to be filed in late 2021 or 2022.
Jazz’s JAZZ Vyxeos has been approved in the United States for treating AML. In March 2021, the FDA approved Vyxeos’ label expansion to treat pediatric AML patients.
BioPath currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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