Marks Meaningful Progress Across Key Clinical Trials in Multiple Cancer Indications

标志着多种癌症适应症的关键临床试验取得了有意义的进展

Completes Development of Oncology Molecular Biomarkers and Prepares for Preclinical Obesity Studies

完成肿瘤学分子生物标志物的开发，并为临床前肥胖研究做好准备

HOUSTON, July 08, 2024 (GLOBE NEWSWIRE) -- 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, today provides an update on the Company’s clinical progress and plans for expansion..

休斯顿，2024年7月8日（环球通讯社）--Bio-Path Holdings，Inc.（纳斯达克：BPTH），一家利用其专有的DNAbilize®脂质体递送和反义技术开发靶向核酸癌症药物组合的生物技术公司，今天提供了该公司临床进展和扩张计划的最新信息。。

“The Bio-Path team continues to work diligently toward advancing our important clinical work and have made meaningful progress in a number of areas critical to each program’s success,” said Peter H. Nielsen, President and Chief Executive Officer of Bio-Path. “With the increased clinical data that we have generated, we are now able to develop the biomarkers needed to incorporate into our oncology studies.

Bio-Path总裁兼首席执行官彼得·尼尔森（PeterH.Nielsen）表示：“Bio-Path团队继续努力推进我们重要的临床工作，并在对每个项目的成功至关重要的许多领域取得了有意义的进展。”。“随着我们产生的临床数据的增加，我们现在能够开发需要纳入我们肿瘤学研究的生物标志物。

In addition, we have completed preparations for preclinical work to support advancing prexigebersen as a potential treatment for obesity. In tandem, we are designing development plans for first-in-human clinical studies in this expansive global market for weight loss.”.

此外，我们已经完成了临床前工作的准备工作，以支持推进prexigebersen作为肥胖的潜在治疗方法。同时，我们正在为这个广阔的全球减肥市场中的首次人体临床研究设计开发计划。”。

“The incremental advances that we are making across these programs collectively push our DNAbilize platform closer to delivering these medicines to patients. Moreover, we are continuing to see the broader potential of our platform beyond oncology and look forward to realizing its potential across multiple indications, starting with obesity,” continued Mr.

“我们在这些项目中取得的进步共同推动了我们的DNAbilize平台更接近于向患者提供这些药物。此外，我们继续看到我们平台在肿瘤学之外的更广泛潜力，并期待着在多种适应症中实现其潜力，从肥胖开始，”先生继续说道。

Nielsen..

尼尔森。。

Clinical Program Overview

临床计划概述

Bio-Path’s clinical development program consists of one Phase 2 clinical trial and three Phase 1 or 1/1b clinical trials. Bio-Path has developed a molecular biomarker package to accompany prexigebersen treatment and is currently expanding prexigebersen preclinical studies for the treatment of obesity..

Bio-Path的临床开发计划包括一项2期临床试验和三项1期或1/1b期临床试验。Bio-Path已经开发出一种分子生物标志物包来伴随prexigebersen治疗，目前正在扩大prexigebersen治疗肥胖症的临床前研究。。

Development of Molecular Biomarkers – Bio-Path has developed a molecular biomarker package to accompany prexigebersen treatment, the goal of which is to identify patients with a genetic profile more likely to respond to treatment, thereby improving the probability of success for this program. The emerging role of biomarkers has enhanced cancer development over the past decade and has become a more common companion to many oncology programs..

分子生物标志物的开发–Bio-Path开发了一种分子生物标志物包，用于伴随prexigebersen治疗，其目标是鉴定具有更可能对治疗有反应的遗传特征的患者，从而提高该计划的成功概率。生物标志物的新兴作用在过去十年中促进了癌症的发展，并已成为许多肿瘤学项目的更常见伴侣。。

Prexigebersen Phase 2 Clinical Trial – Bio-Path’s Phase 2 clinical trial is treating Acute Myeloid Leukemia (AML) patients. This trial is comprised of three separate cohorts of patients and treatments, each separately approvable by the FDA as a new drug indication. The first two cohorts are treating patients with the triple combination of prexigebersen, decitabine and venetoclax.

。该试验由三个独立的患者和治疗组组成，每个患者和治疗组分别被FDA批准为新药适应症。前两个队列正在用prexigebersen，地西他滨和venetoclax的三联疗法治疗患者。

The first cohort includes untreated AML patients, and the second cohort includes relapsed/refractory AML patients. Finally, the third cohort is treating relapsed/refractory AML patients, who are venetoclax-resistant or intolerant, with the two-drug combination of prexigebersen and decitabine. Based on recent interim data for safety and efficacy, the Company plans to pursue next development steps by applying molecular biomarkers to future patient selection for enrollment into the Phase 2 clinical trial.

第一组包括未经治疗的AML患者，第二组包括复发/难治性AML患者。最后，第三个队列是用普瑞昔布生和地西他滨的两种药物联合治疗复发/难治性AML患者，这些患者对venetoclax耐药或不耐受。根据最新的安全性和有效性中期数据，该公司计划通过将分子生物标志物应用于未来的患者选择以进入2期临床试验来寻求下一步的发展步骤。

Outcomes for these older patients who are unable to receive intensive chemotherapy due to the challenging side effect profile remain suboptimal with a median survival of only five to ten months..

这些由于具有挑战性的副作用而无法接受强化化疗的老年患者的结果仍然不理想，中位生存期仅为5至10个月。。

The study is currently paused for an interim analysis, amendment preparation and U.S. Food and Drug Administration (FDA) review. Bio-Path expects to complete enrollment in cohorts 1 and 2 of the study over the next eighteen months.

该研究目前暂停进行中期分析，修订准备和美国食品和药物管理局（FDA）审查。Bio-Path预计在未来18个月内完成该研究第1组和第2组的注册。

Phase 1/1b Clinical Trial in BP1001-A in Advanced Solid Tumors – A Phase 1/1b clinical trial of BP1001-A in patients with advanced or recurrent solid tumors, including ovarian and uterine, pancreatic and breast cancer, is ongoing. BP1001-A is a modified product candidate that incorporates the same drug substance as prexigebersen but has a slightly modified formulation designed to enhance nanoparticle properties.

BP1001-A在晚期实体瘤中的1/1b期临床试验-BP1001-A在晚期或复发性实体瘤（包括卵巢癌和子宫癌，胰腺癌和乳腺癌）患者中的1/1b期临床试验正在进行中。BP1001-A是一种改进的候选产品，它包含了与prexigebersen相同的药物，但具有略微改进的配方，旨在增强纳米粒子的性能。

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.

第一阶段研究已进入第二个更高剂量水平。该研究的1b期部分预计将在成功完成三个BP1001-A单药治疗剂量水平队列后开始，旨在评估BP1001-A联合紫杉醇治疗复发性卵巢或子宫内膜肿瘤患者的安全性和有效性。

Phase 1b studies are also expected to be opened in combination with gemcitabine in late stage pancreatic cancer..

预计1b期研究也将与吉西他滨联合用于晚期胰腺癌。。

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.

最近几个月，Bio-Path已达到2级剂量，预计将完成注册，以便在年底前达到3级剂量。

Phase 1/1b Clinical Trial in BP1002 in Relapsed/Refractory AML – A Phase 1/1b clinical trial for BP1002 to treat relapsed/refractory AML patients, including venetoclax-resistant patients, is ongoing. BP1002 targets the protein Bcl-2, which is responsible for driving cell survival in up to 60% of all cancers.

BP1002在复发/难治性AML中的1/1b期临床试验-BP1002治疗复发/难治性AML患者（包括venetoclax耐药患者）的1/1b期临床试验正在进行中。BP1002靶向蛋白质Bcl-2，其负责驱动高达60%的所有癌症中的细胞存活。

The drug venetoclax treats AML patients by blocking the activity of the Bcl-2 protein in AML patients. However, patients become resistant to venetoclax. BP1002 treats the Bcl-2 target by blocking the cell’s ability to produce Bcl-2, and could have the potential to eliminate the need for venetoclax. AML patients that fail frontline venetoclax-based therapy have very poor prognosis with median overall survival of less than three months.

venetoclax药物通过阻断AML患者Bcl-2蛋白的活性来治疗AML患者。然而，患者对venetoclax产生耐药性。BP1002通过阻断细胞产生Bcl-2的能力来治疗Bcl-2靶标，并且可能有可能消除对venetoclax的需求。一线venetoclax治疗失败的AML患者预后非常差，中位总生存期不到三个月。

The first dose cohort consisted of a starting dose of 20 mg/m2, and there were no dose limiting toxicities..

第一个剂量组包括20 mg/m2的起始剂量，并且没有剂量限制性毒性。。

Bio-Path recently completed the second dose cohort of 40 mg/m2 and is completing an analysis of PK/PD data to be submitted to the FDA in order to advance to the next dose level. Upon submission of data and approval from FDA, Bio-Path expects to advance to dose level 3 in the fourth quarter of 2024.

。在提交数据并获得FDA批准后，Bio-Path预计将在2024年第四季度达到剂量水平3。

Phase 1 Clinical Trial in BP1002 in Refractory/Relapsed Lymphoma and Chronic Lymphocytic Leukemia (CLL) – A Phase 1 clinical trial to evaluate the ability of BP1002 to treat refractory/relapsed lymphoma and refractory/relapsed chronic lymphocytic leukemia (CLL) patients is currently ongoing. The Phase 1 clinical trial is being conducted at the Georgia Cancer Center, The University of Texas Southwestern and New York Medical College.

BP1002在难治性/复发性淋巴瘤和慢性淋巴细胞白血病（CLL）中的1期临床试验-目前正在进行一项1期临床试验，以评估BP1002治疗难治性/复发性淋巴瘤和难治性/复发性慢性淋巴细胞白血病（CLL）患者的能力。第一阶段临床试验正在乔治亚癌症中心、德克萨斯大学西南分校和纽约医学院进行。

In January 2024, Bio-Path announced successful completion of the first dose cohort in the Phase 1 clinical trial. A total of six evaluable patients are scheduled to be treated over two dose levels with BP1002 monotherapy in a standard 3+3 design, unless there is a dose limiting toxicity which would require an additional three patients to be tested.

2024年1月，Bio-Path宣布成功完成了第一阶段临床试验中的第一个剂量队列。除非存在剂量限制性毒性，需要另外三名患者进行测试，否则共有六名可评估患者计划在标准3+3设计中接受两种剂量水平的BP1002单药治疗。

There were no dose limiting toxicities in the first dose cohort (20 mg/m2)..

第一剂量组（20 mg/m2）没有剂量限制性毒性。。

Enrollment has continued for patients in the second BP1002 dose cohort of 40 mg/m2 and the Company expects to complete enrollment and to review these data by year-end.

。

Preclinical Work for BP1003 – The Company continues to advance its drug candidate, BP1003, for the treatment of advanced solid tumors, including pancreatic cancer. BP1003 is an antisense RNAi nanoparticle targeting the STAT3 protein. Plans are to conduct a Phase 1 study of BP1003 in patients with refractory, metastatic solid tumors (pancreatic, non-small cell lung cancer)..

BP1003的临床前工作-该公司继续推进其候选药物BP1003，用于治疗晚期实体瘤，包括胰腺癌。BP1003是靶向STAT3蛋白的反义RNAi纳米颗粒。计划对难治性转移性实体瘤（胰腺癌、非小细胞肺癌）患者进行BP1003的1期研究。。

Prexigebersen as Potential Treatment for Obesity and Obesity-related Cancers – The RNAi target of prexigebersen is the Grb2 protein, which is involved in activating the RAS/ERK pathway for cell growth. By blocking the cell’s ability to produce Grb2, prexigebersen treatment may limit cell growth. In obesity, two such pathways are related to leptin and insulin.

Prexigebersen作为肥胖和肥胖相关癌症的潜在治疗方法-Prexigebersen的RNAi靶标是Grb2蛋白，它参与激活RAS/ERK途径以促进细胞生长。通过阻断细胞产生Grb2的能力，prexigebersen治疗可能会限制细胞生长。在肥胖中，两种这样的途径与瘦素和胰岛素有关。

Activation of leptin or insulin receptors can stimulate the RAS/ERK pathway via Grb2i..

瘦素或胰岛素受体的激活可以通过Grb2i刺激RAS/ERK途径。。

Bio-Path believes development of prexigebersen for the treatment for obesity and obesity-related cancers could be accelerated given the large amount of safety data from prexigebersen treatment of leukemia patients and the continued unmet medical need. The Company is preparing for preclinical development evaluating prexigebersen for the treatment of obesity and will continue thereafter to conduct additional Investigational New Drug (IND)-enabling studies with an aim to advance prexigebersen into first-in-human studies in this indication..

Bio-Path认为，鉴于prexigebersen治疗白血病患者的大量安全性数据以及持续未满足的医疗需求，可以加速prexigebersen治疗肥胖和肥胖相关癌症的发展。该公司正在准备临床前开发评估用于治疗肥胖症的prexigebersen，此后将继续进行额外的研究性新药（IND）研究，旨在将prexigebersen推进该适应症的首次人体研究。。

About Bio-Path Holdings, Inc.

关于Bio Path Holdings，Inc。

Bio-Path is a biotechnology company developing DNAbilize®, a novel technology that has yielded a pipeline of RNAi nanoparticle drugs that can be administered with a simple intravenous transfusion. Bio-Path’s lead product candidate, prexigebersen (BP1001, targeting the Grb2 protein), is in a Phase 2 study for blood cancers, and BP1001-A, a drug product modification of prexigebersen, is in a Phase 1/1b study for solid tumors.

Bio-Path是一家开发DNAbilize®的生物技术公司，这项新技术已经产生了一系列RNAi纳米颗粒药物，可以通过简单的静脉输液进行管理。Bio-Path的主要候选产品prexigebersen（BP1001，靶向Grb2蛋白）正在进行血癌的2期研究，而prexigebersen的药物产品修饰BP1001-a正在进行实体瘤的1/1b期研究。

The Company’s second product, BP1002, which targets the Bcl-2 protein, is being evaluated for the treatment of blood cancers and solid tumors, including lymphoma and acute myeloid leukemia. In addition, an IND application is expected to be filed for BP1003, a novel liposome-incorporated STAT3 antisense oligodeoxynucleotide developed by Bio-Path as a specific inhibitor of STAT3..

。此外，预计将为BP1003提交IND申请，BP1003是由Bio-Path开发的一种新型脂质体掺入STAT3反义寡核苷酸，作为STAT3的特异性抑制剂。。

For more information, please visit the Company's website at http://www.biopathholdings.com.

欲了解更多信息，请访问公司网站http://www.biopathholdings.com.

Forward-Looking Statements

前瞻性声明

This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws. These statements are based on management's current expectations and accordingly are subject to uncertainty and changes in circumstances. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements.

。这些声明基于管理层当前的期望，因此会受到不确定性和环境变化的影响。本新闻稿中包含的任何非历史事实声明的明示或暗示声明均可被视为前瞻性声明。

Any statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties, including Bio-Path’s ability to raise needed additional capital on a timely basis in order for it to continue its operations, have success in the clinical development of its technologies, the timing of enrollment and release of data in such clinical studies, the accuracy of such data, limited patient populations of early stage clinical studies and the possibility that results from later stage clinical trials with much larger patient populations may not be consistent with earlier stage clinical trials, the maintenance of intellectual property rights, that patents relating to existing or future patent applications will be issued or that any issued patents will provide meaningful protection of our drug candidates, the impact, risks and uncertainties related to global pandemics, including the COVID-19 pandemic, and actions taken by governmental authorities or others in connection therewith, and such other risks which are identified in Bio-Path's most recent Annual Report on Form 10-K, in any subsequent quarterly reports on Form 10-Q and in other reports that Bio-Path files with the Securities and Exchange Commission from time to time.

本版本中包含的任何非历史事实的陈述都是前瞻性的陈述，涉及风险和不确定性，包括Bio-Path及时筹集所需额外资金以继续运营的能力，其技术的临床开发取得成功，此类临床研究中数据的注册和发布时间，此类数据的准确性，早期临床研究的患者人数有限，以及患者人数更多的后期临床试验结果可能与早期临床试验不一致的可能性，知识产权的维护，与现有或未来专利申请相关的专利将被发布，或者任何已发布的专利将为我们的候选药物提供有意义的保护，以及与全球大流行，包括新型冠状病毒肺炎大流行，以及政府当局或其他人采取的与此相关的行动，以及Bio-Path最近的10-K表年度报告、随后的10-Q表季度报告以及Bio-Path不时向证券交易委员会提交的其他报告中确定的其他风险。

These documents are available on request from Bio-Path Holdings or at .

这些文件可从Bio-Path Holdings或。。

www.sec.gov. Bio-Path disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

www.sec.gov.Bio-Path否认任何更新或修订任何前瞻性声明的意图或义务，无论是由于新信息、未来事件或其他原因。

Contact Information:

联系方式：

Investors

投资者

Will O’Connor

威尔·奥康纳

Stern Investor Relations, Inc.

斯特恩投资者关系公司。

212-362-1200

212-362-1200

will@sternir.com

will@sternir.com

Doug Morris

道格·莫里斯

Investor Relations

投资者关系

Bio-Path Holdings, Inc.

Bio-Path控股公司。

832-742-1369

832-742-1369

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