On August 21, 2024 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, reported an update from the Company’s ongoing Phase 1/1b clinical trial of BP1001-A in solid tumor patients and reports continued patient progress from the Company’s ongoing Phase 2 triple combination study of prexigebersen in Acute Myeloid Leukemia (AML) (Press release, Bio-Path Holdings, AUG 21, 2024, View Source [SID1234646026]).
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"These positive responses mark a significant milestone for Bio-Path as they suggest our DNAbilize platform technology has the potential to produce multiple drug candidates capable of targetspecific protein inhibition for over-expressed, disease-causing gene products," said Peter H. Nielsen, President and Chief Executive Officer of Bio-Path. "We were thrilled to see that our first patient treated with the higher dose (90 mg/m2) in our Phase 1/1b study of BP1001-A has shown tumor regression and stable disease. We believe this is significant, particularly considering the heavily pretreated and fragile patient population involved."
"This elderly female patient with gynecologic cancer had previously been treated with multiple lines of chemotherapy along with multiple surgeries for her disease, and only now is showing positive clinical results with BP1001-A treatment. Importantly, we are not seeing the onerous side effects typically seen in patients with advanced solid tumors being treated with standard frontline therapies," continued Mr. Nielsen.
"In addition, we observed extended treatment durability in two elderly patients in our Phase 2 triple combination study of prexigebersen, venetoclax and decitabine in AML patients. These ongoing positive outcomes underscore the potential for prexigebersen to treat fragile AML patients for extended periods. We are particularly pleased with these results, as AML patients are typically unable to tolerate intensive chemotherapy and thus experience very poor clinical outcomes," concluded Mr. Nielsen.
Bio-Path’s DNAbilize Technology Platform – Bio-Path’s DNAbilize platform is a novel technology that achieves systemic delivery for target-specific protein inhibition for any gene product that is over-expressed in disease. The Company’s drug delivery and antisense technology uses P-ethoxy, which is a deoxyribonucleic acid (DNA) backbone modification intended to protect the DNA from destruction by the body’s enzymes when circulating in vivo, incorporated inside of a lipid bilayer having neutral charge. Bio-Path believes this combination allows for high efficiency loading of antisense DNA into non-toxic, cell-membrane-like structures for delivery of the antisense drug substance into cells. In vivo, DNAbilize delivered antisense drug substances are systemically distributed throughout the body to allow for reduction or elimination of target proteins in blood diseases and solid tumors. Through testing in numerous animal studies and dosing in clinical trials, the Company’s DNAbilize drug candidates have demonstrated a promising safety and efficacy profile. Bio-Path currently has four DNAbilize drug product candidates in development.
Solid Tumor Patient Response in Second, Higher Dose Cohort – Bio-Path’s first patient in the second dose cohort in its Phase 1/1b advanced solid tumor clinical trial experiencing a positive response may signal that this analog of prexigebersen has potential as a new treatment for advanced solid tumors. The patient appears to be doing well on study after failing extensive chemotherapy and surgical treatment for gynecologic cancer, demonstrating a 15% reduction in her primary tumor through six cycles of treatment. Moreover, it appears that these positive outcomes may have contributed to allow her to continue with rigorous exercise and improved quality of life.
The dose finding portion of the Phase 1/1b trial is comprised of BP1001-A monotherapy with no accompanying chemotherapy. This clinical trial of BP1001-A in patients with advanced or recurrent solid tumors has successfully completed the initial prescribed dose in the first cohort of 60 mg/m2 and began enrollment in the higher dose cohort of 90 mg/m2. The Phase 1b portion of the study is expected to commence after completion of three planned BP1001-A monotherapy dose level cohorts and is intended to assess the safety and efficacy of BP1001-A in combination with paclitaxel in patients with recurrent ovarian or endometrial tumors. Phase 1b studies are also expected to be opened in combination with gemcitabine in late-stage pancreatic cancer
AML Patients Demonstrate Extended Treatment Durability – During the Company’s recent pause for an interim analysis of results for Bio-Path’s Phase 2 clinical trial treating AML patients, attention focused on two elderly patients who demonstrated continued treatment durability. The first patient is an elderly female who has received 16 cycles of treatment over 21 months and continues in complete remission. The second patient is an elderly male who is completing his twelfth cycle of treatment over fourteen months and continues in complete remission. The clinical trial investigator treating these two patients indicated that they are both doing very well on treatment. Both patients are being treated with the triple combination of prexigebersen, decitabine and venetoclax.