HOUSTON, May 15, 2024 /PRNewswire/ -- Moleculin Biotech, Inc, (Nasdaq: MBRX) ('Moleculin' or the 'Company), a clinical-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced the commencement of an Investigator-initiated Phase 2 study evaluating WP1066 in combination with radiation therapy for the treatment of adults with glioblastoma (NU 21C06) in cooperation with the Company.

休斯顿，2024年5月15日/PRNewswire/--Moleculin Biotech，Inc.（纳斯达克：MBRX）（“Moleculin”或“该公司”），一家临床阶段制药公司，拥有针对难治性肿瘤和病毒的广泛候选药物组合，今天宣布开始与该公司合作进行由研究者发起的第二阶段研究，评估WP1066联合放射治疗成人胶质母细胞瘤（NU 21C06）。

The study is being conducted under Northwestern University's Investigative New Drug application (IND) which cross references the Company's own IND, which received clearance from the U.S. Food and Drug Administration (FDA) in April 2022. This trial is funded by the National Institutes of Health (NIH) and BrainUp®, a non-profit organization dedicated to bringing awareness to brain cancer..

这项研究是在西北大学的调查性新药申请（IND）下进行的，该申请交叉引用了该公司自己的IND，该IND于2022年4月获得了美国食品和药物管理局（FDA）的批准。该试验由美国国立卫生研究院（NIH）和BrainUp®资助，BrainUp®是一家致力于提高脑癌意识的非营利组织。。

Dr. Priya Kumthekar, Associate Professor and the Co-Investigator for the study commented, 'There remains a significant unmet need in the treatment of glioblastoma. Based on the data seen to date, we believe that WP1066 in combination with radiation therapy has the potential to address this need and provide patients with a much-needed treatment option.

该研究的副教授兼共同研究者Priya Kumthekar博士评论道，“胶质母细胞瘤的治疗仍然存在大量未满足的需求。根据迄今为止的数据，我们认为WP1066联合放射治疗有可能解决这一需求，并为患者提供急需的治疗选择。

We are pleased to commence this important study with Moleculin.'.

我们很高兴用Moleculin开始这项重要的研究。”。

WP1066 is Moleculin's flagship Immune/Transcription Modulator designed to stimulate the immune response to tumors by inhibiting the errant activity of regulatory T cells while also inhibiting key oncogenic transcription factors, including p-STAT3 (phosphorylated signal transducer and activator of transcription 3), c-Myc (a cellular signal transducer named after a homologous avian virus called Myelocytomatosis) and HIF-1α (hypoxia-inducible factor 1α).

WP1066是Moleculin的旗舰免疫/转录调节剂，旨在通过抑制调节性T细胞的错误活性来刺激对肿瘤的免疫反应，同时还抑制关键的致癌转录因子，包括p-STAT3（磷酸化信号转导和转录激活因子3），c-Myc（以称为骨髓细胞瘤病的同源禽病毒命名的细胞信号转导）和HIF-1α（缺氧诱导因子1α）。

These transcription factors are widely sought targets because of their role in cancer cell survival and proliferation, angiogenesis (coopting vasculature for blood supply), invasion, metastasis, and inflammation associated with tumors..

这些转录因子是广泛寻找的靶标，因为它们在癌细胞存活和增殖，血管生成（协调血液供应的脉管系统），侵袭，转移和与肿瘤相关的炎症中的作用。。

The NU 21C06 trial is a Phase 2, open-label, multi-arm trial of radiation therapy in combination with WP1066 in newly diagnosed IDH (isocitrate dehydrogenase) wild-type, MGMT-unmethylated glioblastoma patients. The primary outcome measure for the study is progression-free survival and secondary outcome measures include tumor microenvironment analysis..

NU 21C06试验是一项针对新诊断的IDH（异柠檬酸脱氢酶）野生型MGMT非甲基化胶质母细胞瘤患者的放射治疗与WP1066联合的2期开放标签多臂试验。该研究的主要结局指标是无进展生存期，次要结局指标包括肿瘤微环境分析。。

'To date, WP1066 has demonstrated significant anti-tumor activity in a wide range of tumor cell lines and increased survival in multiple animal models. The combination of WP1066 with radiation in glioma models demonstrated both therapeutic responses and compelling alteration of the immune surveillance within the gliomas which we hope will be replicated in human subjects,' according to Dr.

迄今为止，WP1066已在多种肿瘤细胞系中显示出显着的抗肿瘤活性，并在多种动物模型中提高了存活率。WP1066与放射治疗在神经胶质瘤模型中的结合证明了治疗反应和神经胶质瘤内免疫监视的引人注目的改变，我们希望这将在人类受试者中得到复制。

Amy Heimberger at Northwestern University..

西北大学的艾米·海姆伯格。。

'We are continuing to evaluate WP1066 in additional indications including for the treatment of pediatric brain tumors and look forward to its continued development,' added Mr. Walter Klemp, Chairman and Chief Executive Officer of Moleculin.

Moleculin董事长兼首席执行官Walter Klemp先生补充道：“我们正在继续评估WP1066的其他适应症，包括用于治疗小儿脑肿瘤的适应症，并期待其继续发展。”。

Glioblastoma is a common type of tumor originating in the brain. The average annual age-adjusted incidence rate of glioblastoma is 3.19 per 100,000 persons in the United States.1 Glioblastoma is the most aggressive malignant primary brain tumor with a median survival of only 15 months2. It is the most common malignant primary brain tumor making up 54% of all gliomas and 16% of all primary brain tumors.3 Despite advancements for other cancers, the survival rate for glioblastoma has not changed significantly in the last three decades.4.

胶质母细胞瘤是起源于大脑的常见肿瘤类型。在美国，胶质母细胞瘤的平均年年龄校正发病率为每10万人3.19。胶质母细胞瘤是最具侵袭性的恶性原发性脑肿瘤，中位生存期仅为15个月2。它是最常见的恶性原发性脑肿瘤，占所有胶质瘤的54%，占所有原发性脑肿瘤的16%[3]。尽管其他癌症取得了进展，但胶质母细胞瘤的生存率在过去三十年中没有显着变化。

Moleculin has received Orphan Drug Designation for WP1066 for the treatment of brain tumors, as well as Rare Pediatric Disease designation for three other pediatric indications. For more information about the NU 21C06 Phase 2 study, visit clinicaltrials.gov and reference identifier NCT05879250.

Moleculin已被指定为用于治疗脑肿瘤的WP1066孤儿药，以及用于其他三种儿科适应症的罕见儿科疾病。有关NU 21C06 2期研究的更多信息，请访问clinicaltrials.gov和参考标识符NCT05879250。

About Moleculin Biotech, Inc.

关于Moleculin Biotech，Inc。

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company with a growing pipeline, including Phase 2 clinical programs, for hard-to-treat tumors and viruses. The Company's lead program, Annamycin is a next-generation anthracycline designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity.

Moleculin Biotech，Inc.是一家临床阶段制药公司，拥有不断增长的管道，包括针对难治性肿瘤和病毒的2期临床计划。该公司的主导项目安那霉素是一种下一代蒽环类药物，旨在避免多药耐药机制，几乎没有心脏毒性。

Annamycin is currently in development for the treatment of relapsed or refractory acute myeloid leukemia and soft tissue sarcoma lung metastases..

Annamycin目前正在开发用于治疗复发或难治性急性骨髓性白血病和软组织肉瘤肺转移。。

Additionally, the Company is developing WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic and other cancers, and WP1220, an analog to WP1066, for the topical treatment of cutaneous T-cell lymphoma.

此外，该公司正在开发WP1066，一种能够抑制p-STAT3和其他致癌转录因子的免疫/转录调节剂，同时还能刺激自然免疫反应，靶向脑肿瘤，胰腺癌和其他癌症，以及WP1220，一种类似于WP1066的药物，用于局部治疗皮肤T细胞淋巴瘤。

Moleculin is also engaged in the development of a portfolio of antimetabolites, including WP1122 for the potential treatment of viruses, as well as cancer indications including brain tumors, pancreatic and other cancers..

Moleculin还参与开发抗代谢物组合，包括用于潜在治疗病毒的WP1122，以及包括脑肿瘤，胰腺癌和其他癌症在内的癌症适应症。。