- Initiated SURF201 Phase 1 Study; dosed first patient with TYRA-200- - Cleared multiple dose cohorts in SURF301 and continues to dose escalate with TYRA-300-- Received FDA feedback on TYRA-300 Phase 2 ACH study: IND submission planned for 2H 2024-

-启动SURF201第一阶段研究；第一位服用TYRA-200的患者-在SURF301中清除了多剂量队列，并继续服用TYRA-300剂量递增-收到了FDA对TYRA-300第二阶段ACH研究的反馈：IND提交计划于2024年下半年提交-

CARLSBAD, Calif., Dec. 22, 2023 /PRNewswire/ -- Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, today announced that it has initiated the SURF201 Phase 1 study of TYRA-200 and provided positive updates on its oral FGFR3-selective inhibitor, TYRA-300. .

加利福尼亚州卡尔斯巴德，2023年12月22日/PRNewswire/--Tyra Biosciences，Inc.（纳斯达克：Tyra），一家临床阶段的生物技术公司，专注于开发下一代精准药物，这些药物针对成纤维细胞生长因子受体（FGFR）生物学的巨大机会，今天宣布，它已经启动了SURF201 TYRA-200的第一阶段研究，并对其口服FGFR3选择性抑制剂TYRA-300提供了积极的更新。

'As we approach the end of 2023, I believe TYRA is in our strongest position to date. We now have multiple clinical-stage programs with TYRA-300 and TYRA-200, and we believe that the emerging profile from SURF301 supports our objective to deliver a best-in-class agent with TYRA-300 to improve outcomes in children with achondroplasia and patients with cancer,' said Todd Harris, CEO of TYRA.

“随着2023年底的临近，我相信泰拉处于我们迄今为止最有利的地位。TYRA首席执行官托德·哈里斯（ToddHarris）说：“我们现在有TYRA-300和TYRA-200的多个临床阶段计划，我们相信SURF301的新兴概况支持我们的目标，即用TYRA-300提供一流的药物，以改善软骨发育不全儿童和癌症患者的预后。”。

'In 2024, we are excited to build on our recent progress and continue to advance our pipeline toward milestones that we believe will drive significant value for patients and shareholders.'.

“到2024年，我们很高兴能在最近取得的进展的基础上再接再厉，继续朝着我们认为将为患者和股东带来重大价值的里程碑前进。”。

TYRA-200

TYRA-200

TYRA initiated the SURF201 study and has dosed the first patient with TYRA-200, an FGFR1/2/3 inhibitor with potency against activating FGFR2 gene alterations and resistance mutations. The SURF201 study is currently enrolling and dosing adults with unresectable locally advanced/metastatic intrahepatic cholangiocarcinoma and other advanced solid tumors with activating FGFR2 gene alterations.

TYRA启动了SURF201研究，并给第一位患者服用了TYRA-200，这是一种FGFR1/2/3抑制剂，具有抗激活FGFR2基因改变和抗性突变的效力。SURF201研究目前正在招募和给成人服用不可切除的局部晚期/转移性肝内胆管癌和其他具有激活FGFR2基因改变的晚期实体瘤。

The Phase 1 clinical study of TYRA-200, SURF201 (Study in PrevioUsly treated and Resistant FGFR2+ Cholangiocarcinoma and Other Advanced Solid Tumors) (NCT06160752), is a multi-center, open label study designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of TYRA-200 and determine the optimal and maximum tolerated doses (MTD), as well as evaluate the preliminary antitumor activity of TYRA-200. .

TYRA-200，SURF201（先前治疗和耐药的FGFR2+胆管癌和其他晚期实体瘤研究）（NCT06160752）的1期临床研究是一项多中心，开放标签研究，旨在评估TYRA-200的安全性，耐受性和药代动力学（PK），并确定最佳和最大耐受剂量（MTD），并评估TYRA-200的初步抗肿瘤活性。

TYRA-300

TYRA-300

SURF301 Study. The SURF301 Phase 1/2 study for oncology (Study in Untreated and Resistant FGFR3+ Advanced Solid Tumors) (NCT05544552) continues to advance. The study is a multi-center, open label study designed to determine the optimal and maximum tolerated doses (MTD) and the recommended Phase 2 dose of TYRA-300, as well as to evaluate the preliminary antitumor activity of TYRA-300.

SURF301研究。SURF301肿瘤学1/2期研究（未治疗和耐药FGFR3+晚期实体瘤研究）（NCT05544552）继续取得进展。该研究是一项多中心开放标签研究，旨在确定TYRA-300的最佳和最大耐受剂量（MTD）和推荐的2期剂量，并评估TYRA-300的初步抗肿瘤活性。

The Phase 1 portion of SURF301 will provide data to inform multiple doses and schedules of TYRA-300 in future studies in metastatic urothelial carcinoma (mUC), non-muscle invasive bladder cancer (NMIBC) and achondroplasia. The SURF301 Phase 1 Part A portion continues to dose escalate and has cleared multiple dose cohorts that are above the anticipated dose(s) planned for use in the Phase 2 pediatric achondroplasia study.

SURF301的第一阶段部分将提供数据，以便在转移性尿路上皮癌（mUC），非肌肉浸润性膀胱癌（NMIBC）和软骨发育不全的未来研究中告知TYRA-300的多剂量和时间表。SURF301第一阶段A部分的剂量继续增加，并且已经清除了多个剂量组，这些剂量组高于计划用于第二阶段小儿软骨发育不全研究的预期剂量。

Current expansion cohorts in Part B are at dose level(s) anticipated to be evaluated in oncology. TYRA expects to submit initial results from its SURF301 Phase 1 portion for presentation at a scientific congress in 2024..

B部分目前的扩展队列处于预期在肿瘤学中评估的剂量水平。TYRA预计将在2024年的科学大会上提交其SURF301第一阶段部分的初步结果。。

Planned Phase 2 Achondroplasia (ACH) Study. TYRA is planning to initiate a randomized Phase 2 clinical trial with multiple dose cohorts of TYRA-300 for children with achondroplasia. The primary objective of this study will be to assess safety and tolerability in children with achondroplasia and determine the dose(s) for further development.

计划的2期软骨发育不全（ACH）研究。TYRA计划启动一项针对软骨发育不全儿童的多剂量TYRA-300随机2期临床试验。这项研究的主要目的是评估软骨发育不全儿童的安全性和耐受性，并确定进一步发展的剂量。

Secondary objectives will include evaluating change in growth velocity, growth proportionality and pharmacokinetics, as well as an assessment of quality of life and evaluation of biomarkers indicating dose-response relationships to TYRA-300. TYRA's expectation is that the study will initially evaluate treatment naïve children ages 5-12 to determine optimal dose ranges and will also include a separate analysis of children ages 5-12 with achondroplasia who have not responded to a prior growth accelerating therapy.

次要目标将包括评估生长速度，生长比例和药代动力学的变化，以及评估生活质量和评估指示TYRA-300剂量反应关系的生物标志物。TYRA的期望是，该研究将首先评估未接受治疗的5-12岁儿童，以确定最佳剂量范围，并将包括对5-12岁软骨发育不全儿童的单独分析，这些儿童对先前的生长加速疗法没有反应。

We also expect to conduct studies in younger children in additional cohorts as data on safety, pharmacokinetics, and dose become available. TYRA plans to submit an Investigational New Drug (IND) application to the US FDA in the second half of 2024 for the initiation of the Phase 2 study..

随着安全性，药代动力学和剂量数据的获得，我们还希望在其他队列中对年幼儿童进行研究。TYRA计划在2024年下半年向美国FDA提交一份研究性新药（IND）申请，以启动第二阶段研究。。

About TYRA-300

关于TYRA-300

TYRA-300 is the Company's lead precision medicine program stemming from its in-house SNÅP platform. TYRA-300 is an investigational, oral, FGFR3-selective inhibitor currently in development for the treatment of cancer and skeletal dysplasias, including achondroplasia. In oncology, TYRA-300 is being evaluated in a multi-center, open label Phase 1/2 clinical study, SURF301 (Study in Untreated and Resistant FGFR3+ Advanced Solid Tumors).

TYRA-300是该公司的领先精准医学计划，源自其内部SNÅP平台。TYRA-300是一种研究性口服FGFR3选择性抑制剂，目前正在开发中，用于治疗癌症和骨骼发育不良，包括软骨发育不全。在肿瘤学方面，TYRA-300正在一项多中心，开放标签的1/2期临床研究SURF301（未经治疗和耐药的FGFR3+晚期实体瘤研究）中进行评估。

SURF301 (NCT05544552) was designed to determine the optimal and MTD and the recommended Phase 2 dose (RP2D) of TYRA-300, as well as to evaluate the preliminary antitumor activity of TYRA-300. SURF301 is currently enrolling adults with advanced urothelial carcinoma and other solid tumors with FGFR3 gene alterations.

SURF301（NCT05544552）旨在确定TYRA-300的最佳和MTD以及推荐的2期剂量（RP2D），并评估TYRA-300的初步抗肿瘤活性。SURF301目前正在招募患有晚期尿路上皮癌和其他具有FGFR3基因改变的实体瘤的成年人。

In skeletal dysplasias, TYRA-300 has demonstrated positive preclinical results, and the Company expects to submit an IND in the second half of 2024 for the initiation of a Phase 2 clinical study in pediatric achondroplasia. In July 2023, TYRA-300 was granted Orphan Drug Designation for the treatment of achondroplasia from the FDA..

在骨骼发育不良中，TYRA-300已显示出积极的临床前结果，该公司预计将在2024年下半年提交IND，以启动小儿软骨发育不全的2期临床研究。2023年7月，TYRA-300被FDA授予用于治疗软骨发育不全的孤儿药。。

About TYRA-200

关于TYRA-200

TYRA-200 is an investigational, oral, FGFR1/2/3 inhibitor with potency against activating FGFR2 gene alterations and resistance mutations currently in development for the treatment of cancer. TYRA-200 is being evaluated in a multi-center, open label Phase 1 clinical study, SURF201 (Study in PrevioUsly treated and Resistant FGFR2+ Cholangiocarcinoma and Other Advanced Solid Tumors).

TYRA-200是一种研究性口服FGFR1/2/3抑制剂，具有抗激活FGFR2基因改变和目前正在开发用于治疗癌症的抗性突变的效力。TYRA-200正在一项多中心，开放标签的1期临床研究SURF201（先前治疗和耐药的FGFR2+胆管癌和其他晚期实体瘤的研究）中进行评估。

SURF201 (NCT06160752) was designed to determine the optimal and MTD and the RP2D of TYRA-200, as well as to evaluate the preliminary antitumor activity of TYRA-200. SURF201 is currently enrolling adults with advanced/metastatic intrahepatic cholangiocarcinoma and other advanced solid tumors with activating alterations in FGFR2..

SURF201（NCT06160752）旨在确定TYRA-200的最佳和MTD以及RP2D，并评估TYRA-200的初步抗肿瘤活性。SURF201目前正在招募患有晚期/转移性肝内胆管癌和其他FGFR2活化改变的晚期实体瘤的成年人。。

About Tyra Biosciences

关于Tyra Biosciences

Tyra Biosciences, Inc. (Nasdaq: TYRA) is a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in FGFR biology. The Company's in-house precision medicine platform, SNÅP, enables rapid and precise drug design through iterative molecular SNÅPshots that help predict genetic alterations most likely to cause acquired resistance to existing therapies.

Tyra Biosciences，Inc.（纳斯达克股票代码：Tyra）是一家临床阶段生物技术公司，专注于开发针对FGFR生物学巨大机遇的下一代精准药物。该公司的内部精密医学平台SNÅP通过迭代分子SNÅPshots实现了快速而精确的药物设计，这些分子SNÅPshots有助于预测最有可能导致对现有疗法产生获得性耐药的基因改变。

TYRA's initial focus is on applying its accelerated small molecule drug discovery engine to develop therapies in targeted oncology and genetically defined conditions. TYRA is based in Carlsbad, CA..

TYRA最初的重点是应用其加速的小分子药物发现引擎来开发靶向肿瘤学和基因定义条件下的疗法。TYRA总部位于加利福尼亚州卡尔斯巴德。。

For more information about our science, pipeline and people, please visit www.tyra.bio and engage with us on LinkedIn.

有关我们的科学、管道和人员的更多信息，请访问www.tyra.bio并在LinkedIn上与我们联系。

Forward-Looking Statements

前瞻性声明

TYRA cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to: the potential to develop next-generation precision medicines and a best-in-class agent and the potential safety and therapeutic benefits of TYRA-300, TYRA-200 and other product candidates; the ability to drive significant value for patients and shareholders; the expected timing, design (including dosing levels) and phase of clinical development of TYRA-300 and TYRA-200, including timing of a submission of an IND for TYRA-300 in pediatric achondroplasia and submission of initial results from the SURF301 Phase 1 portion of the study to a scientific congress; and the potential for SNÅP to develop therapies in targeted oncology and genetically defined conditions.

TYRA提醒您，本新闻稿中关于非历史事实的声明是前瞻性声明。前瞻性声明基于我们目前的信念和期望，包括但不限于：开发下一代精准药物和一流药物的潜力以及TYRA-300，TYRA-200和其他候选产品的潜在安全性和治疗益处；为患者和股东创造重大价值的能力；TYRA-300和TYRA-200的预期时间，设计（包括剂量水平）和临床开发阶段，包括提交TYRA-300在小儿软骨发育不全中的IND的时间以及SURF301第一阶段研究的初步结果提交给科学大会；以及SNÅP在靶向肿瘤学和遗传定义条件下开发疗法的潜力。

Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: we are early in our development efforts, have only recently begun testing TYRA-300 and TYRA-200 for oncology in clinical trials and the approach we are taking to discover and develop drugs based on our SNÅP platform is novel and unproven and it may never lead to product candidates that are successful in clinical development or approved products of commercial value; potential delays in the commencement, enrollment, and completion of preclinical studies and clinical trials; interim results of a clinical trial do not predict final results and clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data become availa.

由于我们业务中固有的风险和不确定性，实际结果可能与本新闻稿中的结果有所不同，包括但不限于：我们的开发工作刚刚起步，最近才开始在临床试验中测试TYRA-300和TYRA-200的肿瘤学，我们正在基于我们的SNÅP平台发现和开发药物的方法是新颖且未经证实的，它可能永远不会导致候选产品在临床开发或批准的商业价值产品中取得成功；临床前研究和临床试验的开始，注册和完成可能延迟；临床试验的中期结果不能预测最终结果，随着对数据进行更全面的审查以及更多患者数据的可用性，随着患者登记的继续，临床结果可能会发生重大变化。

Contact:

联系人：

Amy Conrad[email protected]

艾米·康拉德[受电子邮件保护]

SOURCE Tyra Biosciences

资料来源：Tyra生物科学