NEWTOWN, Pa., Oct. 12, 2023 (GLOBE NEWSWIRE) -- (GLOBE NEWSWIRE) -- Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”, the “Company”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that a late-breaking abstract studying rigosertib in patients with recessive dystrophic epidermolysis bullosa (RDEB), associated with advanced/metastatic squamous cell carcinoma (SCC), will be presented today in the Late Breaking News session at the European Academy of Dermatology and Venereology (EADV) in Berlin, Germany, by Professor Dr.

宾夕法尼亚州纽敦，2023年10月12日（GLOBE NEWSWIRE）--（GLOBE NEWSWIRE）-Onconova Therapeutics，Inc。（纳斯达克股票代码：ONTX），（“Onconova”，“该公司”），一家临床阶段生物制药公司专注于为癌症患者发现和开发新产品，今天宣布，与晚期/转移性鳞状细胞癌（SCC）相关的隐性营养不良性大疱性表皮松解症（RDEB）患者中研究rigosertib的最新摘要将于今天在欧洲皮肤病学会的最新新闻会议上发表。性病学（EADV）在德国柏林，由Dr.Dr。

Johann Bauer, from the University Hospital Salzburg, Dermatology and Allergology of the PMU, Salzburg, Austria, an Investigator on the investigator-led study (IST)..

来自萨尔茨堡大学医院的Johann Bauer，奥地利萨尔茨堡PMU的皮肤病学和变态反应学，研究者领导的研究（IST）的研究人员。。

“RDEB-associated SCC is a devastating disease with few if any treatment options for advanced patients. We are very pleased for additional data on the potential use of rigosertib in patients with RDEB-associated SCC to be presented as a ‘late breaker’ at EADV 2023,” said Steven Fruchtman, M.D., President and CEO of Onconova.

“RDEB相关SCC是一种破坏性疾病，对于晚期患者几乎没有任何治疗选择。我们非常高兴有关RDEB相关SCC患者可能使用rigosertib的其他数据，这些数据将在EADV 2023中作为'后期破坏者'呈现出来，”Onconova总裁兼首席执行官Steven Fruchtman说。

“We believe that rigosertib’s profile and impact on key cell signaling pathway targets, including PLK-1 kinase, could make rigosertib a very attractive approach for this indication and other cancers. We are employing an “investigator-sponsored trial” strategy to evaluate rigosertib and believe the data that are being presented at EADV 2023 highlight the potential clinical utility of the compound.”.

“我们相信rigosertib的概况和对关键细胞信号通路靶点（包括PLK-1激酶）的影响可能使rigosertib成为该适应症和其他癌症的非常有吸引力的方法。我们正在采用“研究者赞助的试验”策略来评估rigosertib并相信EADV 2023上提供的数据突出了该药物的潜在临床应用复合。

Professor Bauer commented, “I have been working with patients and their families affected by RDEB and the devastating sequalae of squamous cell carcinoma. I am pleased to share the initial encouraging patient experience with rigosertib at this conference. We are keen to further enroll other potential patients on this study.”.

鲍尔教授评论说：“我一直在与受RDEB和鳞状细胞癌破坏性后果影响的患者及其家属一起工作。我很高兴在这次会议上与rigosertib分享最初令人鼓舞的患者经验。我们希望进一步招募其他人本研究的潜在患者“。

Presentation Details

演示细节

Date:

日期：

Thursday, October 12, 2023

2023年10月12日星期四

Time:

时间：

4:00 to 4:15 p.m. in Germany/10:00 to 10:15 a.m. ET

德国下午4:00至4:15/东部时间上午10:00至10:15

Abstract Title:

摘要标题：

Efficacy and Safety of Rigosertib in Patients with Recessive Dystrophic Epidermolysis Bullosa (RDEB) Associated Advanced/Metastatic Squamous Cell Carcinoma (SCC)

Rigosertib治疗隐性营养不良性大疱性表皮松解症（RDEB）相关晚期/转移性鳞状细胞癌（SCC）的疗效和安全性

Presenter:

节目主持人：

Prof. Dr. Johann Bauer, M.D., MBA

Johann Bauer教授，医学博士，工商管理硕士

Session:

会议：

D2T01.3: Late breaking news

D2T01.3：最新消息

Abstract Details

抽象细节

The abstract outlines promising results from an open-label, single arm safety and efficacy study of four patients with recessive dystrophic epidermolysis bullosa (RDEB) associated advanced/metastatic squamous cell carcinoma (SCC) treated with intravenous/IV or oral rigosertib. Two patients achieved complete cutaneous responses of 12 months or more, one patient experienced metastatic disease progression, and one patient remains on study.

摘要概述了4例隐性营养不良性大疱性表皮松解症（RDEB）相关晚期/转移性鳞状细胞癌（SCC）静脉/静脉或口服rigosertib治疗的开放标签，单臂安全性和有效性研究的有希望的结果。两名患者达到了12个月或更长时间的完全皮肤反应，一名患者经历了转移性疾病进展，一名患者仍在研究中。

Responding patients included one patient who achieved both cutaneous and histological remission of 16 months. The patient’s rigosertib dose was reduced following the report of a grade 2 adverse event (irritative cystitis), which led to symptomatic relief. The other responding patient achieved a complete cutaneous remission and completed the protocol-specified 12-months of therapy.

响应患者包括一名皮肤和组织学缓解16个月的患者。在报告2级不良事件（刺激性膀胱炎）后，患者的rigosertib剂量减少，导致症状缓解。另一位反应患者达到完全皮肤缓解并完成了12个月治疗方案。

The authors suggest that the preliminary study results indicate rigosertib as a potential treatment for RDEB-associated SCC. Additional patients are being sought for the trial..

作者建议，初步研究结果表明，rigosertib可作为RDEB相关SCC的潜在治疗方法。正在寻求其他患者进行试验。。

A copy of the Abstract will be available on the Scientific Presentations section of the Onconova website following the Presentation.

演示后，摘要副本将在Onconova网站的科学演示部分提供。

About Onconova Therapeutics, Inc.

关于Onconova Therapeutics，Inc。

Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company’s product candidates, narazaciclib and rigosertib, are proprietary, targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation..

Onconova Therapeutics是一家临床阶段的生物制药公司，专注于为癌症患者发现和开发新产品。该公司的候选产品narazaciclib和rigosertib是专有的靶向抗癌药物，旨在破坏对癌细胞增殖至关重要的特定细胞通路。。

Narazaciclib, Onconova’s novel, multi-kinase inhibitor (formerly ON 123300), is being evaluated in a Phase 1/2 combination trial with the estrogen blocker letrozole, in advanced endometrial cancer (NCT05705505). Based on preclinical and clinical studies of CDK 4/6 inhibitors, Onconova believes narazaciclib has broad potential and is also evaluating opportunities for combination studies with narazaciclib and letrozole in additional indications, including breast cancer..

Onconova的新型多激酶抑制剂Narazaciclib（以前称为123300）正在与晚期子宫内膜癌（NCT05705505）的雌激素阻滞剂来曲唑进行1/2期联合试验。基于CDK 4/6抑制剂的临床前和临床研究，Onconova认为narazaciclib具有广泛的潜力，并且还在评估与narazaciclib和来曲唑联合研究其他适应症（包括乳腺癌）的机会。。

Rigosertib is being studied in an investigator-sponsored trial strategy to evaluate the product candidate in multiple indications, including a dose-escalation and expansion Phase 1/2a study of oral rigosertib in combination with nivolumab in patients with KRAS+ non-small cell lung cancer (NCT04263090), a Phase 2 program evaluating oral or IV rigosertib monotherapy in advanced squamous cell carcinoma complicating recessive dystrophic epidermolysis bullosa (RDEB-associated SCC) (NCT03786237, NCT04177498), and a Phase 2 trial evaluating rigosertib in combination with pembrolizumab in patients with metastatic melanoma (NCT05764395)..

Rigosertib正在一项研究者赞助的试验策略中进行研究，以评估多种适应症的候选产品，包括KRAS+非小细胞肺癌患者口服Rigosertib联合nivolumab的剂量递增和扩展阶段1/2a研究（NCT04263090），评估口服或静脉注射rigosertib单药治疗晚期鳞状细胞癌并发隐性营养不良性大疱性表皮松解症（RDEB相关SCC）（NCT03786237，NCT04177498）的2期临床试验和2期临床试验评估rigosertib联合pembrolizumab治疗转移性黑色素瘤NCT05764395）。。

For more information, please visit www.onconova.com.

欲了解更多信息，请访问www.onconova.com。

Forward Looking Statements

前瞻性声明

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties.

本版本中的一些陈述是1933年“证券法”（修订版）第27A条，1934年“证券交易法”（修订版）第21E条以及“私人证券诉讼改革法”1995年，涉及风险和不确定性。

These statements relate to Onconova’s expectations regarding its clinical development and trials, its product candidates, its business and financial position. Onconova has attempted to identify forward-looking statements by terminology including 'believes,' 'estimates,' 'anticipates,' 'expects,' 'plans,' 'intends,' 'may,' 'could,' 'might,' 'will,' 'should,' “preliminary,” “encouraging,” 'approximately' or other words that convey uncertainty of future events or outcomes.

这些陈述涉及Onconova对其临床开发和试验，产品候选人，业务和财务状况的期望。Onconova试图通过包括“相信”，“估计”，“预期”，“期望”，“计划”，“意图”，“可能”，“可能”，“可能”，“将会”，“应该”，“初步”，“鼓励”，“大约”或其他表达未来事件或结果不确定性的词语。

Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Onconova's clinical trials, investigator-initiated trials and regulatory agency and institutional review board approvals of protocols, Onconova’s collaborations, market conditions and those discussed under the heading 'Risk Factors' in Onconova's most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q.

尽管Onconova认为此类前瞻性声明中反映的预期截至日期是合理的，但预期可能证明与此类前瞻性声明所表达或暗示的结果存在实质性差异。这些陈述只是预测，涉及已知和未知的风险，不确定性和其他因素，包括Onconova临床试验的成功和时间，研究者发起的试验和监管机构以及机构审查委员会批准的方案，Onconova的合作，市场状况以及Onconova最新的10-K年度报告和10-Q表格季度报告中“风险因素”标题下讨论的情况。

Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated .

本版本中包含的任何前瞻性声明仅在其日期之前发表。Onconova不承担更新本版本中包含的任何前瞻性声明的义务，以反映其日期之后发生的事件或情况或反映意外事件的发生。

Company Contact:

公司联系人：

Mark Guerin

Mark Guerin

Onconova Therapeutics, Inc.

Onconova Therapeutics，Inc。

267-759-3680

267-759-3680

ir@onconova.us

ir@onconova.us

https://www.onconova.com/contact/

https://www.onconova.com/contact/

Investor Contact:

投资者联系：

Bruce Mackle

Bruce Mackle

LifeSci Advisors, LLC

LifeSci Advisors，LLC

646-889-1200

646-889-1200

bmackle@lifesciadvisors.com

bmackle@lifesciadvisors.com