On May 29, 2020 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, reported the presentation of a poster highlighting the clinical trial design of its Phase 2 study of BP1001 (prexigebersen) at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place virtually from May 29-31, 2020 (Press release, Bio-Path Holdings, MAY 29, 2020, View Source [SID1234558691]).
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The poster, titled, "A Phase II Study of BP1001 (liposomal Grb2 antisense oligonucleotide) in Patients with Hematologic Malignancies," was presented virtually by Dr. Maro Ohanian, Department of Leukemia, University of Texas M.D. Anderson Cancer Center. The poster describes the Phase 2 study design of BP1001 (liposomal Grb2 antisense), the Company’s lead drug candidate, in combination with decitabine as a potential treatment for patients diagnosed with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS).
"This innovative trial design for BP1001 is unique in that it allowed us to adjust our treatment to include newly approved therapies that we believed would be enhanced from combination with our DNAbilize technology. We believe this robust design will provide for the best outcomes for patients and will be the most expeditious route to bringing BP1001 to market. We are delighted to have the design presented and expect that it will enhance visibility for our DNAbilize platform and its versatility among an audience dedicated to bringing new cancer treatments to patients," stated Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings.
The Phase 2 clinical trial is a multi-center, open label study with two parallel cohorts of BP1001 in combination with decitabine in untreated AML and high risk MDS patients or refractory/relapsed AML and high risk MDS patients who are ineligible or unwilling to receive intensive induction therapy. The primary objective of the study is to assess whether BP1001 in combination with decitabine provides higher response rates than decitabine alone in AML or high risk MDS patients. In addition, a six-patient safety run-in of BP1001 and decitabine was completed with no dose adjustment required.
BP1001 is a neutral liposome incorporated with nuclease-resistant, hydrophobic P-ethoxy antisense oligodeoxynucleotides targeted to Grb2 mRNA. Grb2 is an adaptor protein that links oncogenic tyrosine kinases with downstream kinases, such as ERK and AKT, which are critical to cell proliferation and survival. Preclinical results showed that BP1001 enhanced the inhibitory effects of cytarabine or decitabine against AML cells.
The poster also describes future development plans for BP1001 in AML. Preclinical results suggest that BP1001 plus venetoclax plus decitabine triple combination could be more efficacious than the BP1001 + decitabine combination against AML cells. Venetoclax will be added to the study, thus exploring three-drug combinations of BP1001, venetoclax and decitabine. There will be three patient cohorts in the study:
•Untreated AML patients will be treated with BP1001 plus venetoclax plus decitabine.
•Refractory/relapsed AML patients will be treated with BP1001 plus venetoclax plus decitabine.
•A third cohort of BP1001 + decitabine will be offered to refractory/relapsed AML patients who are venetoclax resistant or intolerant, or not considered by the investigator as optimal candidates for venetoclax-based therapy.