BOSTON, Feb. 26, 2025 (GLOBE NEWSWIRE) -- Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company developing next-generation therapeutics for difficult-to-treat cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to PYX-201 for the treatment of adult patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) whose disease has progressed following treatment with platinum-based chemotherapy and an anti-PD-(L)1 antibody.

波士顿，2025年2月26日（GLOBE NEWSWIRE）—— Pyxis Oncology, Inc.（纳斯达克股票代码：PYXS），一家致力于开发治疗难治性癌症的下一代疗法的临床阶段公司，今日宣布美国食品药品监督管理局（FDA）已授予PYX-201快速通道资格，用于治疗曾接受铂类化疗和抗PD-(L)1抗体治疗后疾病进展的复发或转移性头颈部鳞状细胞癌（R/M HNSCC）成年患者。

PYX-201 is a first-in-concept antibody-drug conjugate (ADC) that uniquely targets Extradomain-B Fibronectin (EDB+FN), a non-cellular structural component within the tumor extracellular matrix (ECM), which is highly expressed in various tumor types..

PYX-201 是一种首创概念的抗体药物偶联物 (ADC)，它独特地靶向肿瘤细胞外基质 (ECM) 中的非细胞结构成分 extradomain-B 纤连蛋白 (EDB+FN)，该成分在多种肿瘤类型中高度表达。

“Receiving Fast Track designation for PYX-201 from the FDA marks a significant milestone for Pyxis Oncology, recognizing our potential to address the significant medical need in R/M HNSCC. This designation underscores the urgency of bringing differentiated treatment options to patients and will help accelerate the development of PYX-201 as we actively recruit patients for our trial,” said Lara S.

“PYX-201获得FDA的快速通道资格对Pyxis Oncology来说是一个重要的里程碑，这认可了我们在R/M HNSCC领域满足重大医疗需求的潜力。这一资格强调了为患者提供差异化治疗方案的紧迫性，并将有助于加速PYX-201的开发，因为我们正在积极招募试验患者，”Lara S.表示。

Sullivan, M.D., President and Chief Executive Officer. “We look forward to working with the FDA to advance this promising therapy as efficiently as possible.”.

沙利文，医学博士，总裁兼首席执行官。“我们期待与FDA合作，尽快推进这一有前景的疗法。”

Fast Track designation is an FDA program intended to facilitate and expedite the development and review of new drugs in the U.S. for the treatment of a serious or life-threatening condition. To qualify for this designation, there must be clear data demonstrating the drug has potential to address unmet medical need in the designated condition..

快速通道资格是美国食品药品监督管理局（FDA）的一项计划，旨在促进和加速用于治疗严重或危及生命状况的新药在美国的开发和审评。要获得此项资格，必须有明确的数据证明该药物有潜力满足指定适应症中未被满足的医疗需求。

About Head and Neck Squamous Cell Carcinoma (HNSCC)

关于头颈部鳞状细胞癌（HNSCC）

Head and Neck Cancer (HNC) is the sixth most common cancer in the world, with 1,464,550 new cases and 487,993 deaths from HNC globally

头颈癌（HNC）是全球第六大常见癌症，全球新增1,464,550例头颈癌病例，死亡487,993例。

. Squamous Cell Carcinoma presents as the most common subtype and is derived from the mucosal lining of the oral cavity, pharynx and larynx. Almost 50% of cases progress to recurrent or metastatic cancer post-initial treatment, presenting patients with a median overall survival of less than a year. The overall incidence of HNSCC is expected to rise, with a predicted 30% increase annually by 2030.

鳞状细胞癌是最常见的亚型，起源于口腔、咽部和喉部的黏膜上皮。大约50%的病例在初始治疗后进展为复发性或转移性癌症，患者的中位总生存期不到一年。预计头颈部鳞状细胞癌（HNSCC）的总体发病率将上升，到2030年预计每年将增加30%。

. The increase has been associated with multiple factors, including but not limited to tobacco use, alcohol consumption, a rise in HPV infections, and other environmental catalysts. With limited development outside of immunotherapy in the last decade, HNSCC remains one of the most difficult to treat carcinomas, highlighting the unmet need..

。增长与多种因素有关，包括但不限于烟草使用、酒精消费、HPV感染的增加以及其他环境催化剂。在过去的十年中，除了免疫治疗外，发展有限，HNSCC仍然是最难治疗的癌肿之一，突显了未满足的需求。

About PYX-201

关于 PYX-201

PYX-201, an antibody-drug conjugate (ADC) with a microtubule inhibitor (optimized auristatin) payload that uniquely targets Extradomain-B Fibronectin (EDB+FN), a non-cellular structural component of the tumor extracellular matrix (ECM), is the company’s lead clinical drug candidate.

PYX-201是一种抗体药物偶联物（ADC），具有微管抑制剂（优化的auristatin）载荷，独特地靶向肿瘤细胞外基质（ECM）的非细胞结构成分——额外域B纤维连接蛋白（EDB+FN），是该公司的主要临床候选药物。

Two PYX-201 trials are now actively recruiting. One trial, PYX-201-101, is designed to evaluate PYX-201 as monotherapy in patients with R/M HNSCC. A second trial, PYX-201-102, is evaluating PYX-201 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA

两个PYX-201试验正在进行积极招募。其中一个试验PYX-201-101旨在评估PYX-201作为单一疗法在R/M HNSCC患者中的效果。第二个试验PYX-201-102正在评估PYX-201与默克的抗PD-1疗法KEYTRUDA联合使用的效果。

(pembrolizumab), in patients with R/M HNSCC and other advanced solid tumors. The combination trial is part of a recently announced Clinical Trial Collaboration Agreement with Merck (known as MSD outside of the US and Canada).

（pembrolizumab），用于治疗R/M HNSCC及其他晚期实体瘤患者。该联合试验是最近宣布的与默克（在美国和加拿大以外地区称为MSD）的临床试验合作协议的一部分。

KEYTRUDA

KEYTRUDA

is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

是默克公司（Merck & Co., Inc.，位于美国新泽西州拉威市）的子公司默克夏普与多姆有限责任公司的注册商标。

About Pyxis Oncology, Inc.

关于Pyxis Oncology公司

Pyxis Oncology, Inc. is a clinical stage company focused on defeating difficult-to-treat cancers. The company is efficiently building next generation therapeutics that hold the potential for monotherapy and combination indications. PYX-201, an antibody-drug conjugate (ADC) that uniquely targets EDB+FN, a non-cellular structural component of the tumor extracellular matrix, is being evaluated in ongoing Phase 1 clinical studies in multiple types of solid tumors.

Pyxis Oncology, Inc. 是一家临床阶段公司，专注于攻克难治性癌症。该公司正在高效开发具有单药治疗和联合用药潜力的下一代疗法。PYX-201 是一种抗体药物偶联物 (ADC)，独特地靶向肿瘤细胞外基质的非细胞结构成分 EDB+FN，目前正在进行针对多种实体瘤的 1 期临床研究。

PYX-201 is designed to directly kill cancer cells and to address factors in the microenvironment that enable the uncontrolled proliferation and immune evasion of malignant tumors..

PYX-201旨在直接杀死癌细胞，并针对微环境中使恶性肿瘤不受控制地增殖和免疫逃逸的因素。