Observed 67% Objective Response Rate (ORR) in frontline HR-MDS patients, primarily with TP53 mutations; initial complete remission (CR)/marrow complete remission (mCR) rate of 58% and median overall survival had not yet been reached

在一线HR-MDS患者中观察到67%的客观缓解率（ORR），主要是TP53突变；初始完全缓解（CR）/骨髓完全缓解（mCR）率为58%，中位总生存期尚未达到

Observed 43% ORR in frontline TP53m AML patients, 33% CR/complete remission with incomplete hematologic recovery (CRi) and median overall survival had not yet been reached

在一线TP53m AML患者中观察到43%的ORR，33%的CR/完全缓解，不完全血液学恢复（CRi）和中位总生存期尚未达到

SL-172154 demonstrated a manageable interim safety profile in combination with AZA

SL-172154与AZA相结合，表现出可控的临时安全性

Focuses clinical development opportunity in HR-MDS and TP53m AML; these indications may offer the fastest path to potential approval; enrollment underway in randomized, controlled HR-MDS cohort

关注HR-MDS和TP53m AML的临床发展机会；这些迹象可能为潜在的批准提供最快的途径；随机对照HR-MDS队列正在进行登记

Shattuck to host conference call and webcast today, June 14, 2024 at 7:30 a.m. ET

Shattuck将于2024年6月14日美国东部时间上午7:30主持电话会议和网络广播

AUSTIN, TX & DURHAM, NC, June 14, 2024 (GLOBE NEWSWIRE) -- Shattuck Labs, Inc. (Shattuck) (Nasdaq: STTK), a clinical-stage biotechnology company pioneering the development of bifunctional fusion proteins as a potential new class of biologic medicine for the treatment of patients with cancer and autoimmune disease, today announced updated interim data from the Phase 1B dose expansion clinical trial of SL-172154 in combination with AZA in frontline HR-MDS and TP53m AML patients.

德克萨斯州奥斯汀和北卡罗来纳州达勒姆，2024年6月14日（环球通讯社）--Shattuck Labs，Inc.（Shattuck）（纳斯达克：STTK），一家临床阶段生物技术公司，率先开发双功能融合蛋白，作为治疗癌症和自身免疫性疾病患者的潜在新型生物药物，今天宣布了SL-172154与AZA联合用于一线HR-MDS和TP53m AML患者的1B期剂量扩展临床试验的最新中期数据。

These data are to be featured in a poster presentation on June 14, 2024 at 18:00 CEST, during the European Hematology Association (EHA) 2024 Congress..

这些数据将在2024年6月14日欧洲血液学协会（EHA）2024年大会期间18:00 CEST的海报展示中展示。。

“We are pleased to present additional data from our Phase 1B dose expansion clinical trial, which further supports our differentiated mechanism of action and underscores SL-172154’s emergence as the leading CD47 inhibitor in hematologic malignancies,” said Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck.

Shattuck首席执行官Taylor Schreiber医学博士说：“我们很高兴提供1B期剂量扩展临床试验的额外数据，这进一步支持了我们的差异化作用机制，并强调了SL-172154作为血液系统恶性肿瘤中领先的CD47抑制剂的出现。”。

“This update shows that the rate of complete remission has improved since our last data release in December, with additional patients in both cohorts who continue to improve on therapy. As a result of these encouraging data, and our expectation of rapid enrollment and progress in our ongoing randomized, controlled cohort in HR-MDS, we are focusing our efforts on our opportunity in HR-MDS and TP53m AML.

“此次更新显示，自去年12月我们的上次数据发布以来，完全缓解率有所提高，两组患者中都有更多患者继续改善治疗。由于这些令人鼓舞的数据，以及我们对HR-MDS正在进行的随机对照队列的快速入组和进展的期望，我们将重点放在HR-MDS和TP53m AML的机会上。

These are indications with high unmet need, limited competition, and potential for accelerated paths to approval.”.

这些迹象表明，未满足的需求很高，竞争有限，并且有可能加速获得批准。”。

Dr. Lini Pandite, MBChB, M.B.A., Chief Medical Officer of Shattuck added, “We are encouraged by the maturing data that continues to underscore the therapeutic potential, and manageable safety profile, of SL-172154 for patients with previously untreated HR-MDS and TP53m AML. Accumulating clinical evidence now shows the pharmacodynamic contribution of CD40 activation in the peripheral blood, and an emerging correlation between clinical remission and CD40 mediated induction of certain cytokines.

。

The TP53m AML and HR-MDS patients we have treated represent a high-risk group with short duration of complete remission and overall survival when treated with azacitidine alone. Median overall survival and duration of remission have not yet been achieved, and we look forward to sharing additional durability data later this year.

。中位总生存期和缓解期尚未达到，我们期待着在今年晚些时候分享更多的耐久性数据。

Enrollment is now underway for our randomized, controlled expansion cohort in frontline HR-MDS patients, and we expect to engage in regulatory discussions later this year regarding the registrational strategy for SL-172154.”.

目前，我们正在招募一线HR-MDS患者的随机对照扩展队列，我们预计今年晚些时候将就SL-172154的注册策略进行监管讨论。”。

A copy of the EHA poster, titled “Phase 1b Study of SL-172154, a Bi-functional Fusion Protein Targeting CD47 and CD40, in Combination with Azacitidine (AZA) in Previously Untreated Acute Myeloid Leukemia (AML) and Higher-Risk Myelodysplastic Syndromes/Neoplasms (HR- MDS) Patients (pts),” will be made available under posters in the Our Science section of Shattuck’s website..

EHA海报的副本，标题为“SL-172154的1b期研究，一种靶向CD47和CD40的双功能融合蛋白，与阿扎胞苷（AZA）联合治疗先前未经治疗的急性髓细胞白血病（AML）和高危骨髓增生异常综合征/肿瘤（HR-MDS）患者（pts）”，将在Shattuck网站的“我们的科学”部分的海报下提供。。

Phase 1B Trial of SL-172154 in Frontline HR-MDS and TP53m AML

SL-172154在前线HR-MDS和TP53m AML中的1B期试验

Key takeaways: Additional interim efficacy observed for SL-172154 in combination with AZA in frontline HR-MDS and TP53m AML.

关键收获：SL-172154联合AZA在一线HR-MDS和TP53m AML中观察到额外的中期疗效。

HR-MDS: As of the data cut-off date of April 23, 2024, in 24 treated patients (21 had TP53m, 16 had complex karyotype, and seven had therapy-related MDS), the ORR was 67%.

HR-MDS：截至2024年4月23日的数据截止日期，在24名接受治疗的患者中（21名患有TP53m，16名患有复杂核型，7名患有与治疗相关的MDS），ORR为67%。

Ten (42%) patients achieved a CR with 3.6 months as the median time to CR.

10名（42%）患者达到CR，中位CR时间为3.6个月。

Nine patients are continuing on treatment (five CR, two mCR+HI, one SD+HI, one SD).

9名患者正在继续治疗（5名CR，2名mCR+HI，1名SD+HI，1名SD）。

Three patients proceeded to allogeneic hematopoietic cell transplantation (HCT), all three patients achieved CR prior to HCT.

三名患者进行了异基因造血细胞移植（HCT），所有三名患者在HCT之前均达到CR。

TP53m AML: As of the data cut-off date of June 4, 2024, in 21 treated patients (all 21 had TP53 mutations or deletion, 19 had a complex karyotype, and 14 had secondary AML) the ORR was 43%.

TP53m AML：截至2024年6月4日的数据截止日期，在21例接受治疗的患者中（所有21例均具有TP53突变或缺失，19例具有复杂的核型，14例具有继发性AML），ORR为43%。

Six (29%) patients achieved a CR. One patient achieved a CRi and two patients achieved a partial remission (PR). The median time to CR was 3.8 months and none of the responders progressed as of the data cutoff.

六名（29%）患者达到CR。一名患者达到CRi，两名患者达到部分缓解（PR）。CR的中位时间为3.8个月，截至数据截止时，没有反应者进展。

Five responders (three CR, one CRi, one PR) were taken to HCT and seven patients were still undergoing treatment, including two patients in CR. Additional patients may be bridged to transplant in the coming months.

五名应答者（三名CR，一名CRi，一名PR）被送往HCT，七名患者仍在接受治疗，其中包括两名CR患者。未来几个月可能会有更多患者接受移植。

Preliminary analysis indicates clearance of TP53 mutation in four out of five TP53m HR-MDS patients and two out of four TP53m AML patients who achieved CR and were evaluated as of the data cutoff.

初步分析表明，在五分之四的TP53m HR-MDS患者和四分之二的TP53m AML患者中，TP53突变被清除，这些患者达到了CR，并在数据截止时进行了评估。

Median duration of response for OR and CR and overall survival had not yet been reached in either HR-MDS or TP53m AML as of the respective data cutoff dates.

截至各自的数据截止日期，HR-MDS或TP53m AML尚未达到OR和CR反应的中位持续时间和总生存期。

Safety Results: As of the data cutoff date of April 23, 2024, SL-172154 showed a manageable safety profile: Infusion-related reactions (IRRs) were the most common SL-172154 treatment-emergent adverse events (TEAEs). There have been no G3 or higher IRRs when patients have been premedicated with dexamethasone.

安全性结果：截至2024年4月23日的数据截止日期，SL-172154显示出可控的安全性：输注相关反应（IRR）是最常见的SL-172154治疗紧急不良事件（TEAE）。。

There was no evidence of hemolytic (destructive) anemia..

没有溶血（破坏性）贫血的证据。。

HR-MDS:

HR-MDS：

Grade 3/4 AEs were reported in ten (42%) patients as related/possibly related to SL-172154: IRR (n=3), febrile neutropenia (n=2), anemia, alkaline phosphate increased, chondrocalcinosis, colitis, cytokine release syndrome, decreased appetite, fatigue, hypertension, left ventricular dysfunction, myocardial infarction (MI), neutropenia, pancytopenia, thrombocytopenia, troponin I increase, each in one patient..

。。

There was one death due to AE of sepsis, deemed unrelated to SL-172154, and three treatment discontinuations due to AEs, including MI (n=1), IRR (n=1) and sepsis (n=1).

。

As already reported in the Company’s May 2024 EHA abstract, a Grade 4 MI occurred in one patient who first developed sepsis on-study. This patient had a history of coronary artery disease and type II diabetes. The MI occurred eight days after the last dose of SL-172154. Although reported by the investigator as possibly related, Shattuck’s assessment is that this event was unlikely related to SL-172154..

正如该公司2024年5月的EHA摘要所报道的那样，一名在研究中首次出现败血症的患者发生了4级心肌梗死。该患者有冠状动脉疾病和II型糖尿病病史。MI发生在最后一剂SL-172154后8天。虽然调查人员报告可能与此有关，但Shattuck的评估是，这起事件不太可能与SL-172154有关。。

TP53m AML:

TP5300万反洗钱：

Grade 3/4 AEs were reported in seven patients (33%), as related/possibly related to SL-172154, including neutropenia (n=3), thrombocytopenia (n=2), leukopenia (n=2), ALT increased (n=1), AST increased (n=1), enterococcal bacteremia (n=1), fatigue (n=1), hypoxia (n=1) and pneumonia (n=1).

7例患者（33%）报告3/4级AE，与SL-172154相关/可能相关，包括中性粒细胞减少症（n=3），血小板减少症（n=2），白细胞减少症（n=2），ALT升高（n=1），AST升高（n=1），肠球菌菌血症（n=1），疲劳（n=1），缺氧（n=1）和肺炎（n=1）。

There were three deaths due to AEs deemed unrelated to SL-172154 including sepsis (n=1) and pneumonia (n=2).

由于被认为与SL-172154无关的AE导致三人死亡，包括败血症（n=1）和肺炎（n=2）。

As already reported in the Company’s December 2023 update for the ASH Annual Meeting, a Grade 5 cardiac arrest occurred in one patient with a history of significant cardiovascular disease, prior MI, prior stenting, prior arrhythmia, hypokalemia in the setting of amiodarone, additional adverse risk factors and other comorbidities.

正如该公司2023年12月ASH年会更新中所报道的那样，一名患者发生了5级心脏骤停，该患者有重大心血管疾病史，既往心肌梗死，既往支架置入术，既往心律失常，胺碘酮治疗低钾血症，其他不良风险因素和其他合并症。

Although reported by the investigator as possibly related, Shattuck’s assessment is that this event was unlikely related to SL-172154..

虽然调查人员报告可能与此有关，但Shattuck的评估是，这起事件不太可能与SL-172154有关。。

Key Takeaways from Phase 1B Trial of SL-172154 in Platinum-Resistant Ovarian Cancer (PROC)

SL-172154在铂类耐药卵巢癌（PROC）1B期试验中的关键收获

SL-172154 in combination with pegylated liposomal doxorubicin (PLD) or mirvetuximab soravtansine (Elahere)

SL-172154与聚乙二醇化脂质体多柔比星（PLD）或mirvetuximab soravtansine（Elahere）联合使用

Interim efficacy results as of April 23, 2024, showed four of 21 (19%) treated patients in our Phase 1B study of SL-172154 in combination with PLD have achieved partial responses. The Javelin-200 study reported an ORR of 4% with PLD alone. Two additional patients with stable disease showed maximum tumor reductions of 17% and 27% and were continuing on study.

截至2024年4月23日的中期疗效结果显示，在我们的SL-172154联合PLD的1B期研究中，21名（19%）接受治疗的患者中有4名获得了部分缓解。Javelin-200研究报告单用PLD的ORR为4%。另外两名病情稳定的患者肿瘤最大减少率分别为17%和27%，正在继续研究。

The Company is continuing to follow patients for progression free survival and overall survival..

该公司正在继续跟踪患者的无进展生存期和总生存期。。

In our cohort combining SL-172154 with Elahere, the Company has completed enrollment. As of the April 23, 2024 data cutoff, the Company has not observed an ORR benefit beyond Elahere alone, and the Company plans to further follow patients for progression free survival and overall survival.

在我们将SL-172154与Elahere相结合的队列中，该公司已完成注册。截至2024年4月23日的数据截止日期，该公司尚未观察到仅Elahere以外的ORR益处，该公司计划进一步跟踪患者的无进展生存期和总生存期。

Both of these combinations, SL-172154 combined with PLD and SL-172154 combined with Elahere, have shown an acceptable safety profile with IRRs as the most common treatment emergent AE as of the data cutoff.

SL-172154联合PLD和SL-172154联合Elahere这两种组合均显示出可接受的安全性，IRR是截至数据截止时最常见的治疗紧急AE。

The Company is not currently planning to conduct additional clinical development in PROC, in part due to the evolving competitive landscape in this indication. Should progression free survival or overall survival mature favorably in either PROC cohort, we would evaluate further development in PROC at that time.

该公司目前不计划在PROC中进行额外的临床开发，部分原因是该适应症的竞争格局不断变化。如果在任何一个PROC队列中无进展生存期或总生存期成熟良好，我们将评估当时PROC的进一步发展。

Shattuck will focus all current later-stage clinical development efforts in AML and HR-MDS due to the strength of the emerging efficacy results in those patient populations, the limited competition, and the potential for these indications to be the fastest path to registration..

由于这些患者群体中新兴疗效的优势，有限的竞争以及这些适应症成为注册最快途径的潜力，Shattuck将专注于AML和HR-MDS的所有当前后期临床开发工作。。

Conference Call at 7:30 a.m. ET Today

美国东部时间今天早上7:30召开电话会议

Shattuck will host a conference call today at 7:30 a.m. ET featuring lead investigator Dr. Naval Daver, MD, (Professor and the Director of the Leukemia Research Alliance Program in the Department of Leukemia and MD Anderson Cancer Center in Houston, TX) to discuss the data from the poster presentation featured at the EHA 2024 Congress, including an interim safety and efficacy update from the frontline expansion cohorts in HR-MDS and TP53m AML.

Shattuck将于美国东部时间今天上午7:30主持一次电话会议，由首席研究员Naval Daver博士（德克萨斯州休斯顿白血病和MD安德森癌症中心白血病研究联盟项目的教授和主任）主持，讨论EHA 2024年大会上海报展示的数据，包括HR-MDS和TP53m AML前线扩展队列的临时安全性和有效性更新。

To listen to the live webcast, please visit the Investor Relations page of the Shattuck Labs website here. Participants may register for the call here. While not required, interested participants are encouraged to join 10 minutes prior to the start of the event..

要收听网络直播，请访问Shattuck实验室网站的投资者关系页面。参与者可以在此处注册通话。虽然不需要，但鼓励感兴趣的参与者在活动开始前10分钟加入。。

A replay of the webcast will be available following the conclusion of the live call and will be accessible on the Company’s website.

直播结束后，将提供网络广播的重播，并可在公司网站上访问。

About SL-172154

关于SL-172154

SL-172154 (SIRPα-Fc-CD40L) is an investigational Agonist Redirected Checkpoint (ARC®) fusion protein designed to simultaneously inhibit the CD47/SIRPα checkpoint interaction and activate the CD40 costimulatory receptor to bolster an anti-tumor immune response in patients with advanced cancer. Multiple Phase 1 clinical trials are ongoing for patients with platinum-resistant ovarian cancer (NCT04406623, NCT05483933) and patients with AML and HR-MDS (NCT05275439)..

SL-172154（SIRPα-Fc-CD40L）是一种研究激动剂重定向检查点（ARC®）融合蛋白，旨在同时抑制CD47/SIRPα检查点相互作用并激活CD40共刺激受体以增强晚期癌症患者的抗肿瘤免疫应答。铂类耐药卵巢癌患者（NCT04406623，NCT05483933）和AML和HR-MDS患者（NCT05275439）正在进行多项1期临床试验。。

About Shattuck Labs, Inc.

关于Shattuck Labs，Inc。

Shattuck Labs, Inc. (Nasdaq: STTK) is a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a potential new class of biologic medicine for the treatment of patients with cancer and autoimmune disease. Compounds derived from Shattuck’s proprietary ARC® platform are designed to simultaneously inhibit checkpoint molecules and activate costimulatory molecules with a single therapeutic.

Shattuck Labs，Inc.（纳斯达克：STTK）是一家临床阶段生物技术公司，率先开发双功能融合蛋白，作为治疗癌症和自身免疫性疾病患者的潜在新型生物药物。源自Shattuck专有ARC®平台的化合物旨在同时抑制检查点分子并通过单一治疗剂激活共刺激分子。

The company’s lead SL-172154 (SIRPα-Fc-CD40L) program, which is designed to block the CD47 immune checkpoint and simultaneously agonize the CD40 pathway, is being evaluated in multiple Phase 1 trials. Shattuck has offices in both Austin, Texas and Durham, North Carolina. For more information, please visit: www.ShattuckLabs.com..

该公司的主要SL-172154（SIRPα-Fc-CD40L）计划旨在阻断CD47免疫检查点并同时激动CD40途径，正在多个1期临床试验中进行评估。。有关更多信息，请访问：www.ShattuckLabs.com。。

Forward-Looking Statements

前瞻性声明

Certain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws, including, but not limited to, statements regarding: future presentations of clinical data; clinical development plans and strategies for SL-172154; timing of anticipated clinical data; future plans for Shattuck’s pipeline; and Shattuck’s strategies.

本新闻稿中的某些声明可能构成《联邦证券法》所指的“前瞻性声明”，包括但不限于以下声明：临床数据的未来呈现；SL-172154的临床开发计划和策略；；沙塔克管道的未来计划；和Shattuck的策略。

Words such as “anticipate,” “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “develop,” “plan” or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements.

诸如“预期”、“可能”、“可能”、“将要”、“客观”、“打算”、“应该”、“可能”、“可以”、“会”、“期望”、“相信”、“设计”、“估计”、“预测”、“潜在”、“发展”、“计划”或这些术语的否定词，以及类似的表达，或关于意图、信念或当前期望的陈述，都是前瞻性陈述。

While the company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in Shattuck’s filings with the U.S.

虽然公司认为这些前瞻性陈述是合理的，但不应过度依赖任何此类前瞻性陈述，这些前瞻性陈述是基于公司在本发布之日可获得的信息。这些前瞻性声明基于当前的估计和假设，并受到各种风险和不确定性的影响（包括但不限于Shattuck向美国提交的文件中规定的风险和不确定性）。

Securities and Exchange Commission (SEC)), many of which are beyond the company’s control and subject to change. Actual results could be materially different. Risks and uncertainties which could cause such outcomes to change include: global macroeconomic conditions and related volatility; expectations regarding the initiation, progress, and expected results of Shattuck’s preclinical studies, clinical trials and research and development programs; the potential failure of a clinical trial to provide sufficient results to merit further development; expectations regarding the timing, completion and outcome .

证券交易委员会（SEC）），其中许多不受公司控制，可能会发生变化。实际结果可能会有很大不同。可能导致此类结果发生变化的风险和不确定性包括：全球宏观经济状况和相关波动；对Shattuck临床前研究、临床试验和研发计划的启动、进展和预期结果的期望；临床试验可能无法提供足够的结果以值得进一步发展；对时间、完成和结果的期望。

The Company intends to use the investor relations portion of its website as a means of disclosing material non-public information and for complying with disclosure obligations under Regulation FD.

公司打算将其网站的投资者关系部分用作披露重大非公开信息的手段，并遵守FD条例规定的披露义务。

Investor & Media Contact:

Conor Richardson

康纳·理查德森

Vice President of Investor Relations

投资者关系副总裁

Shattuck Labs, Inc.

沙塔克实验室公司。

InvestorRelations@shattucklabs.com

InvestorRelations@shattucklabs.com