prexigebersen-A (BP1001-A) / Bio-Path - LARVOL DELTA

Bio-Path Holdings Achieves Third Pre-Clinical Milestone Confirming Potential of BP1001-A as Treatment for Obesity in Type 2 Diabetes Patients (GlobeNewswire) - "Bio-Path Holdings...reported the achievement of a third milestone from recent preclinical studies of BP1001-A that provide additional support for its potential as a treatment for obesity. These studies showed BP1001-A rescues the decrease in AKT activity in liver cells and prevents cells from becoming insulin resistant, confirming its potential as a treatment for obesity and related metabolic diseases in Type 2 diabetes patients....In the final step of pre-clinical testing, Bio-Path will use a mouse model to assess the impact of BP1001-A on animal weight and its effect on insulin sensitivity and glucose tolerance. If successful, Bio-Path anticipates filing an Investigational New Drug (IND) application in 2025 to initiate a first-in-human Phase 1 clinical trial."

IND • Preclinical • Obesity • Type 2 Diabetes Mellitus

Bio-Path Holdings Announces Pre-Clinical Results Signaling Increased Potential for BP1001-A as Treatment for Obesity in Type 2 Diabetes Patients (GlobeNewswire) - "Updated results from BP1001-A obesity and Type 2 diabetes testing from the second stage of pre-clinical testing are as follows: Skeletal muscle fiber cell models now confirm BP1001-A also increases insulin sensitivity in C2C12 myotubes. High fat diet rich in saturated fatty acids can lead to insulin resistance. Palmitic acid, the most common saturated fatty acid in a high fat diet, has been shown to impair insulin signaling. Recent pre-clinical work showed that BP1001-A attenuated palmitic acid-induced insulin resistance and restored insulin sensitivity in C2C12 myoblasts and myotubes."

Preclinical • Obesity • Type 2 Diabetes Mellitus

BP1001-A-101-GynOnc: BP1001-A in Patients With Advanced or Recurrent Solid Tumors (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: Bio-Path Holdings, Inc. | Trial completion date: Oct 2024 ➔ Oct 2027 | Trial primary completion date: Jul 2024 ➔ Jul 2027

Trial completion date • Trial primary completion date • Breast Cancer • Endometrial Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Prostate Cancer • Solid Tumor

Solid Tumor Patient Response in Second, Higher Dose Cohort (GlobeNewswire) - PI/Ib | N=50 | NCT04196257 | Sponsor: Bio-Path Holdings, Inc. | "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...As of January 2025, this patient continues doing well on treatment, recently completing nine cycles and is now in her tenth treatment cycle...This clinical trial of BP1001-A...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 late-stage pancreatic cancer."

P1 data • Trial status • Endometrial Cancer • Ovarian Cancer • Pancreatic Cancer

Bio-Path Holdings Outlines Rationale for Development of BP1001-A as Potential Treatment for Obesity in Type 2 Diabetes Patients (GlobeNewswire) - "Bio-Path Holdings, Inc...today outlined the growing body of scientific evidence that Bio-Path believes supports the development of BP1001-A for the treatment for obesity and related metabolic diseases in Type 2 diabetes patients...'The rationale for initiating our development program for BP1001-A for the treatment of obesity is rooted in substantial scientific literature providing evidence that downregulating Grb2 expression affects insulin signaling, ultimately, leads to lower blood glucose levels. BP1001-A has been shown to downregulate Grb2 expression in preclinical models and has been shown to be safe and well-tolerated across a multitude of human clinical studies, giving us confidence in its potential to treat Type 2 diabetes and obesity'...'We look forward to completing Investigational New Drug (IND)-enabling testing in the fourth quarter of 2024 and to advancing this important metabolic program in 2025.'"

IND • Preclinical • Obesity • Type 2 Diabetes Mellitus

Bio-Path Holdings Initiates Development of Therapeutic Program for Treatment of Obesity (GlobeNewswire) - "Bio-Path Holdings, Inc...today announced the initiation of a therapeutic program to develop BP1001-A for the treatment of obesity and related metabolic diseases. This program marks the first application of DNAbilize technology for development of a non-cancer application, which highlights the broad therapeutic potential of this technology...Bio-Path expects downregulating Grb2 expression with BP1001-A will enhance insulin sensitivity. The Company expects to begin preclinical studies to confirm these assumptions in the fourth quarter of 2024."

Pipeline update • Preclinical • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Bio-Path Holdings Reports Solid Tumor Patient Response Supporting BP1001-A’s Compelling Potential as Treatment for Advanced Solid Tumors (GlobeNewswire) - P1/1b | N=50 | NCT04196257 | Sponsor: Bio-Path Holdings, Inc. | "Bio-Path Holdings, Inc...provides 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)....'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'....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."

P1 data • Trial status • Endometrial Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Pancreatic Cancer

Bio-Path Holdings Provides Clinical Update and Expansion Plans (GlobeNewswire) - "Phase 1/1b Clinical Trial in BP1001-A in Advanced Solid Tumors....The Phase 1 study has advanced to the second, higher dose level. The Phase 1b portion of the study is expected to commence after successful completion of the three 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. In recent months, Bio-Path advanced to dose level 2 and expects to complete enrollment in order to advance to dose level 3 by year-end."

Trial status • Endometrial Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor

Bio-Path Holdings Provides 2024 Clinical and Operational Update (GlobeNewswire) - "Based on positive interim data for safety and efficacy, the Company plans to pursue FDA Fast Track designation for the accelerated approval of prexigebersen for the treatment of fragile AML patients who are unable to tolerate intensive chemotherapy and thus experience very poor clinical outcomes....The Phase 1b portion of the study is expected to commence after successful completion of the three 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 Stage 4 pancreatic cancer and combination therapy in breast cancer."

Fast track • Trial status • Acute Myelogenous Leukemia • Endometrial Cancer • Fallopian Tube Cancer • Gynecologic Cancers • Hematological Malignancies • Leukemia • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

Bio-Path Holdings Announces Successful Completion of First Dose Cohort in Phase 1/1b Clinical Trial of BP1001-A in Solid Tumors (GlobeNewswire) - "Bio-Path Holdings...announced completion of the first dose cohort of the dose escalation portion of its Phase 1/1b clinical trial of BP1001-A (liposomal Grb2) in patients with solid tumors, including ovarian, endometrial, pancreatic and breast cancer....'Importantly, this achievement enables us to advance to the second cohort of this important study in solid tumor cancers, for which we hope to complete enrollment by year end 2023'....Three patients were enrolled into the first dose cohort of BP1001-A at 60 mg/m2 at three different centers in the study, including one patient with hepatic lesions (and lung metastases) and two with advanced gynecologic lesions."

Trial status • Breast Cancer • Endometrial Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • Uterine Cancer

Bio-Path Holdings Reports First Quarter 2023 Financial Results (GlobeNewswire) - "Important Near-Term Clinical Milestones - BP1001-A Phase 1/1b Clinical Trial in Solid Tumors: Important trial with advanced or recurrent solid tumors, including ovarian and uterine, pancreatic and breast cancer with initial cohort completion and data readout currently expected mid-year. BP1002 Phase 1/1b Clinical Trial in Relapsed/Refractory AML: Focus on patients who relapsed on venetoclax treatment with initial cohort completion and readout expected mid-year."

P1 data • Trial status • Acute Myelogenous Leukemia • Endometrial Cancer • Fallopian Tube Cancer • Gynecologic Cancers • Hematological Malignancies • Leukemia • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

Bio-Path Holdings Reports Full Year 2022 Financial Results (GlobeNewswire) - "Important Near-Term Clinical Milestones - BP1001-A Phase 1/1b Clinical Trial in Solid Tumors: Important trial with advanced or recurrent solid tumors, including ovarian and uterine, pancreatic and breast cancer with initial cohort completion and data readout expected before mid-year. BP1002 Phase 1/1b Clinical Trial in Relapsed/Refractory AML: Focus on patients who relapsed on venetoclax treatment with initial cohort completion and readout expected in the second quarter of 2023."

P1 data • Trial status • Acute Lymphocytic Leukemia • Breast Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Hematological Malignancies • Leukemia • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • Uterine Cancer

Bio-Path Holdings Announces First Patient Dosed in Phase 1/1b Clinical Trial of BP1001-A in Solid Tumors (GlobeNewswire) - "Bio-Path Holdings...announced the enrollment and dosing of the first patient in a Phase 1/1b clinical trial of BP1001-A (liposomal Grb2) in patients with solid tumors, including ovarian, endometrial, pancreatic and breast cancer....The dose escalation portion of the Phase 1/1b clinical trial is planned to be conducted at more than six leading cancer centers in the United States, including The University of Texas MD Anderson Cancer Center, The Mary Crowley Cancer Research Center, and Karmanos Cancer Center."

Trial status • Breast Cancer • Endometrial Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • Uterine Cancer

Bio-Path Holdings Reports Third Quarter 2022 Financial Results (GlobeNewswire) - "We look forward to initiating our Phase 1 study of BP1001-A for the treatment of solid tumors later this year and to filing an Investigational New Drug (IND) application for BP1003, a novel liposome-incorporated STAT3 antisense oligodeoxynucleotide, in the first half of 2023."

IND • Trial status • Oncology • Solid Tumor

BP1001-A in Patients With Advanced or Recurrent Solid Tumors (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: Bio-Path Holdings, Inc. | Not yet recruiting ➔ Recruiting | Trial completion date: Oct 2023 ➔ Oct 2024 | Trial primary completion date: Jul 2023 ➔ Jul 2024

Enrollment open • Trial completion date • Trial primary completion date • Breast Cancer • Endometrial Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Prostate Cancer • Solid Tumor

Bio-Path Holdings Reports Second Quarter 2022 Financial Results (GlobeNewswire) - "...'We look forward to initiating our Phase 1 studies of BP1001-A, a drug product modification of prexigebersen, for the treatment of solid tumors and of BP1002 to treat relapsed/refractory acute myeloid leukemia (AML), including venetoclax resistant patients, in the coming weeks'..."

Trial status • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • Solid Tumor

BP1001-A in Patients With Advanced or Recurrent Solid Tumors (clinicaltrials.gov) - P1; N=50; Not yet recruiting; Sponsor: Bio-Path Holdings, Inc.; Trial completion date: Oct 2022 ➔ Oct 2023; Trial primary completion date: Jul 2022 ➔ Jul 2023

Clinical • Trial completion date • Trial primary completion date • Breast Cancer • Endometrial Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • MRI