US$5 million PanCAN grant provides important support for the fifth cohort of the GOBLET study

500万美元的PanCAN赠款为GOBLET研究的第五组提供了重要支持

Study of modified FOLFIRINOX/pelareorep/atezolizumab (Tecentriq®) combination expands existing pancreatic cancer program

改良FOLFIRINOX/pelareorep/atezolizumab（Tecentriq®）组合的研究扩展了现有的胰腺癌计划

First patient expected to be enrolled in Q2 2024

预计2024年第二季度登记的第一名患者

SAN DIEGO and CALGARY, AB, May 9, 2024 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, will commence enrollment into a new GOBLET study pancreatic cancer cohort following both German regulatory and ethics approvals.

圣地亚哥和卡尔加里，AB，2024年5月9日/PRNewswire/--Oncolytics Biotech®Inc。（纳斯达克：ONCY）（TSX:ONC）是一家专注于肿瘤免疫治疗的领先临床阶段公司，在获得德国监管和道德批准后，将开始加入新的杯状研究胰腺癌队列。

This cohort will evaluate pelareorep in combination with modified FOLFIRINOX (mFOLFIRINOX) with or without the PD-L1 immune checkpoint inhibitor atezolizumab (Tecentriq®) in newly diagnosed patients with pancreatic ductal adenocarcinoma (PDAC). It is supported by a US$5M Therapeutic Accelerator Award from the Pancreatic Cancer Action Network (PanCAN), an innovative program established to accelerate the development of new treatments for pancreatic cancer.

该队列将评估pelareorep联合改良FOLFIRINOX（mFOLFIRINOX）联合或不联合PD-L1免疫检查点抑制剂atezolizumab（Tecentriq®）治疗新诊断的胰腺导管腺癌（PDAC）患者。它得到了胰腺癌行动网络（PanCAN）500万美元治疗加速器奖的支持，这是一项旨在加速开发胰腺癌新疗法的创新计划。

The chemotherapy regimens of mFOLFIRINOX or gemcitabine + nab-paclitaxel are the two most common standards of care for pancreatic cancer.1 Oncolytics has already reported data with the combination of gemcitabine and nab-paclitaxel (link to the PR, link to the poster) that surpassed historical outcomes.2-5 Positive results from a combination with mFOLFIRINOX could greatly enhance pelareorep's potential in addressing pancreatic cancer..

mFOLFIRINOX或吉西他滨+nab-紫杉醇的化疗方案是胰腺癌最常见的两种治疗标准。溶瘤药物已经报道了吉西他滨和nab-紫杉醇联合治疗的数据（链接到PR，链接到海报），超过了历史结果。2-5与mFOLFIRINOX联合治疗的阳性结果可以大大提高pelareorep治疗胰腺癌的潜力。。

'Oncolytics is pleased to announce receipt of regulatory clearance to initiate the mFOLFIRINOX cohort in patients with newly diagnosed metastatic PDAC. We appreciate the opportunity to collaborate with PanCAN, Roche, and AIO on this cohort, which is expected to initiate enrollment in the second quarter,' said Dr.

“Oncolytics很高兴宣布收到监管许可，以启动新诊断的转移性PDAC患者的mFOLFIRINOX队列。我们很高兴有机会与PanCAN、Roche和AIO在这个队列上合作，预计将在第二季度开始招生。

Matt Coffey, President and Chief Executive Officer of Oncolytics. 'We believe that working with PanCAN will help to further enrich Oncolytics' clinical relationships with the pancreatic cancer community. We are also grateful for PanCAN's Therapeutic Accelerator Award, which is enabling the evaluation of this combination therapy.'.

Oncolytics总裁兼首席执行官马特·科菲（MattCoffey）我们相信，与PanCAN合作将有助于进一步丰富溶瘤药物与胰腺癌社区的临床关系。我们也感谢PanCAN的治疗加速器奖，该奖项能够对这种联合疗法进行评估。”。

'The Therapeutic Accelerator Award program has been an important part of PanCAN's approach to advancing innovative treatments for pancreatic cancer. We incorporated input from leading scientists and clinicians in the field of pancreatic cancer to select Oncolytics as a recipient of this award,' said Anna Berkenblit, MD, MMSc, Chief Scientific and Medical Officer at PanCAN.

“治疗加速器奖计划是PanCAN推进胰腺癌创新治疗方法的重要组成部分。PanCAN首席科学和医学官、MMSc医学博士安娜·伯克恩布莱特（AnnaBerkenblit）说，我们吸收了胰腺癌领域顶尖科学家和临床医生的意见，选择了溶瘤药物作为该奖项的获得者。

'Increasing patient access to clinical trials is vital to developing improved treatment options, so we are pleased that Oncolytics has received regulatory clearance for the pelareorep/mFOLFIRINOX combination and is poised to enroll the first patient in this cohort. We hope that the results from this study lead to improved outcomes for patients with pancreatic cancer.'.

“增加患者获得临床试验的机会对于开发改进的治疗方案至关重要，因此我们很高兴溶瘤药物已获得pelareorep/mFOLFIRINOX组合的监管许可，并准备招募该队列中的第一名患者。我们希望这项研究的结果能够改善胰腺癌患者的预后。”。

Dirk Arnold, M.D., Ph.D., Director of Asklepios Tumorzentrum Hamburg and primary investigator of the GOBLET trial, commented, 'Oncolytics has taken a very strategic approach to the development of pelareorep in pancreatic cancer by focusing its clinical studies on combinations with the most widely used treatment regimens.

汉堡Asklepios Tumorzentrum的主任兼GOBLET试验的主要研究者、医学博士德克·阿诺德（Dirk Arnold）评论道：“溶瘤药物通过将临床研究重点放在与最广泛使用的治疗方案的组合上，对胰腺癌的pelareorep的发展采取了非常战略性的方法。

My experience to date with the GOBLET study, including the positive metastatic PDAC and encouraging anal cancer data reported last year, makes me enthusiastic to initiate enrollment in the mFOLFIRINOX cohort.'.

迄今为止，我在GOBLET研究中的经验，包括去年报道的阳性转移性PDAC和令人鼓舞的肛门癌数据，使我热衷于开始参加mFOLFIRINOX队列研究。”。

'We previously reported very encouraging results in pancreatic cancer patients for the combination of pelareorep, gemcitabine/nab-paclitaxel, and atezolizumab, and we plan to begin a registration-enabling study of this regimen later this year. The new pelareorep/mFOLFIRINOX cohort offers the opportunity to expand pelareorep's role in pancreatic cancer.

“我们之前报道了pelareorep，吉西他滨/纳布紫杉醇和atezolizumab联合治疗胰腺癌患者的结果非常令人鼓舞，我们计划在今年晚些时候开始对该方案进行注册研究。新的pelareorep/mFOLFIRINOX队列为扩大pelareorep在胰腺癌中的作用提供了机会。

If the mFOLFIRINOX combination shows a compelling efficacy signal, this therapeutic approach could also be advanced to a registration-enabling study, providing two opportunities for pelareorep-based treatment to benefit pancreatic cancer patients,' said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics.

Oncolytics首席医疗官托马斯·海因曼（ThomasHeineman）医学博士说，如果mFOLFIRINOX组合显示出令人信服的疗效信号，那么这种治疗方法也可以推进到注册研究，为基于pelareorep的治疗提供两个机会，使胰腺癌患者受益。

'In addition, translational research studies planned for this cohort will help to further elucidate pelareorep's mechanism of action, including its ability to shape the tumor microenvironment (TME). Notably, we will evaluate the correlation between tumor responses and the expansion of tumor-infiltrating lymphocytes (TILs) in the blood, an effect that was observed in earlier pancreatic cancer studies.

此外，为该队列计划的转化研究将有助于进一步阐明pelareorep的作用机制，包括其塑造肿瘤微环境（TME）的能力。值得注意的是，我们将评估肿瘤反应与血液中肿瘤浸润淋巴细胞（TIL）扩增之间的相关性，这是早期胰腺癌研究中观察到的效果。

We look forward to initiating enrollment into the mFOLFIRINOX/pelareorep study cohort in the second quarter of this year.'.

我们期待着在今年第二季度开始进入mFOLFIRINOX/pelareorep研究队列。”。

References

参考文献

Botta G, et al. SWI/SNF complex alterations as a biomarker of immunotherapy efficacy in pancreatic cancer. JCI Insight. 2021;6(18):e150453. https://doi.org/10.1172/jci.insight.150453

Botta G等人。SWI/SNF复合物改变作为胰腺癌免疫治疗功效的生物标志物。JCI Insight。2021年；6（18）：e150453https://doi.org/10.1172/jci.insight.150453

Von Hoff D et al. N Engl J Med 2013; 369:1691-1703 DOI: 10.1056/NEJMoa1304369

Von Hoff D等人《英国医学杂志》2013；369:1691-1703 DOI:10.1056/NEJMoa1304369

O'Reilly et al. Eur J Cancer. 2020 June; 132: 112–121. DOI:10.1016/j.ejca.2020.03.005

O'Reilly等人，《癌症杂志》。2020年6月；132:112-121。doi:10.1016/j.ejca.2020.03.005

Karasic et al. JAMA Oncol. 2019 Jul 1; 5(7):993-998. DOI: 10.1001/jamaoncol.2019.0684

Karasic等人《美国医学会杂志肿瘤学》。2019年7月1日；5(7):993-998.DOI:10.1001/jamancel.2019.0684

Tempero et al. Ann Oncol. 2021 May; 32(5):600-608. DOI: 10.1016/j.annonc.2021.01.070

Tempero等人，Ann Oncol。2021年5月；32（5）：600-608。doi:10.1016/j.annonc.2021.01.070

About GOBLET Cohort 5 The mFOLFIRINOX cohort of the Phase 1/2 GOBLET study is designed to evaluate newly diagnosed PDAC patients treated with pelareorep + mFOLFIRINOX with or without atezolizumab. There will be a three-patient safety run-in to evaluate the tolerability of each treatment arm: pelareorep + mFOLFIRINOX + atezolizumab and pelareorep + mFOLFIRINOX.

关于杯状队列5 1/2期杯状研究的mFOLFIRINOX队列旨在评估用pelareorep+mFOLFIRINOX联合或不联合atezolizumab治疗的新诊断PDAC患者。将进行三名患者的安全运行，以评估每个治疗组的耐受性：pelareorep+mFOLFIRINOX+atezolizumab和pelareorep+mFOLFIRINOX。

A total of fifteen evaluable patients will be randomized to each arm in Stage 1 of this Simon-two stage study. The co-primary endpoints are objective response rate and safety. If Stage 1 success criteria are met, one or both treatment arms may be expanded to Stage 2 in which 17 additional evaluable patients per arm will be enrolled.

在这项西蒙两阶段研究的第一阶段，共有15名可评估患者被随机分配到每只手臂。共同主要终点是客观缓解率和安全性。如果符合第一阶段的成功标准，则可以将一个或两个治疗组扩展到第二阶段，其中每个组将招募17名额外的可评估患者。

Blood and tumor samples will also be collected for translational evaluations..

还将收集血液和肿瘤样本进行转化评估。。

About GOBLET The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 12 centers in Germany and is being managed by AIO-Studien-gGmbH.

关于杯状物杯状物（探索与溶瘤呼肠孤病毒peLarEorep和抗PD-L1治疗组合的胃肠道肿瘤）研究是晚期或转移性胃肠道肿瘤的1/2期多指征研究。这项研究正在德国的12个中心进行，由AIO Studien gGmbH管理。

The co-primary endpoints of the study are objective response rate (ORR) and/or disease control rate assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers (T cell clonality and CEACAM6). The study employs a Simon two-stage design with Stage 1 comprising five treatment groups:.

该研究的共同主要终点是在第16周评估的客观缓解率（ORR）和/或疾病控制率以及安全性。关键的次要和探索性终点包括额外的疗效评估和潜在生物标志物（T细胞克隆性和CEACAM6）的评估。该研究采用西蒙两阶段设计，第一阶段包括五个治疗组：。

Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients;

Pelareorep联合atezolizumab，吉西他滨和nab-紫杉醇治疗一线晚期/转移性胰腺癌患者；

Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients;

Pelareorep联合atezolizumab治疗一线MSI（微卫星不稳定性）-高转移性结直肠癌患者；

Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients;

Pelareorep联合atezolizumab和TAS-102治疗三线转移性结直肠癌患者；

Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients; and

Pelareorep联合atezolizumab治疗二线晚期和不可切除的肛门癌患者；和

Pelareorep in combination with mFOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients.

Pelareorep联合mFOLFIRINOX联合或不联合atezolizumab治疗新诊断的转移性PDAC患者。

Any cohort meeting pre-specified efficacy criteria in Stage 1 may be advanced to Stage 2 and enroll additional patients.

任何符合第一阶段预先规定的疗效标准的队列都可以进入第二阶段并招募更多患者。

About AIOAIO-Studien-gGmbH (AIO) emerged from the study center of the medical oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally..

关于AIOAIO Studien gGmbH（AIO）来自德国癌症协会（DKG）医学肿瘤学工作组的研究中心。AIO的经营宗旨是以医学肿瘤学为重点，促进科学和研究。自成立以来，AIO已成为一家成功的赞助商和学习管理公司，并在国内外建立了自己的地位。。

About Oncolytics Biotech Inc.Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer.

关于Oncolytics Biotech Inc.Oncolytics是一家临床阶段的生物技术公司，开发静脉注射免疫治疗剂pelareorep。Pelareorep在转移性乳腺癌的两项随机2期研究和胰腺癌的1期和2期研究中显示出有希望的结果。

It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning 'cold' tumors 'hot' -- through innate and adaptive immune responses to treat a variety of cancers..

它通过诱导抗癌免疫反应来发挥作用，并通过先天性和适应性免疫反应来治疗多种癌症，从而促进发炎的肿瘤表型-使“冷”肿瘤“热”。。

Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA.

Pelareorep已证明与多种批准的肿瘤治疗具有协同作用。Oncolytics目前正在进行和计划与pelareorep在固体和血液系统恶性肿瘤中的联合临床试验，因为它在转移性乳腺癌和胰腺癌的注册研究方面取得了进展，这两种癌症都获得了FDA的快速通道指定。

For further information, please visit: www.oncolyticsbiotech.com or follow the company on social media on LinkedIn and on X @oncolytics..

欲了解更多信息，请访问：www.oncolyticsbiotech.com或在社交媒体LinkedIn和X@oncolytics上关注公司。。

This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as 'forward-looking statements').

本新闻稿包含1934年《证券交易法》第21E节所指的经修订的前瞻性声明以及适用加拿大证券法下的前瞻性信息（此类前瞻性声明和前瞻性信息在本文中统称为“前瞻性声明”）。

Forward-looking statements contained in this press release include Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; our stated goals, objectives and mission; the commencement of enrollment into our new GOBLET study pancreatic cancer cohort and the timing thereof; our belief that positive results from a combination of pelareorep and mFOLFIRINOX could greatly enhance pelareorep's potential in addressing pancreatic cancer, including potentially advancing the approach to a registration-enabling study; our plans to advance towards registrational studies in metastatic breast cancer and pancreatic cancer; and other statements related to anticipated developments in Oncolytics' business and technologies.

本新闻稿中包含的前瞻性声明包括溶瘤药物对pelareorep作为癌症治疗剂的潜力，作用机制和益处的信念；我们声明的目标、目的和使命；开始加入我们新的杯状研究胰腺癌队列及其时机；我们相信，pelareorep和mFOLFIRINOX联合使用的积极结果可以大大增强pelareorep在解决胰腺癌方面的潜力，包括潜在地推进注册研究的方法；我们计划推进转移性乳腺癌和胰腺癌的注册研究；以及其他与溶瘤药物业务和技术的预期发展有关的声明。

In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved.

在溶瘤药物对未来结果表示期望或信念的任何前瞻性声明中，这些期望或信念是真诚表达的，并且被认为有合理的基础，但不能保证该声明或期望或信念会实现。

Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatme.

此类前瞻性陈述涉及已知和未知的风险和不确定性，这可能导致溶瘤剂的实际结果与前瞻性陈述中的结果存在重大差异。这些风险和不确定性包括开展研究和开发项目的资金和资源的可用性，pelareorep作为癌症治疗药物的疗效。

Company Contact Jon Patton Director of IR & Communication jpatton@oncolytics.ca

公司联系人Jon Patton IR&Communication总监jpatton@oncolytics.ca

Investor Relations for Oncolytics Timothy McCarthy LifeSci Advisors +1-917-679-9282 tim@lifesciadvisors.com

溶瘤投资者关系Timothy McCarthy LifeSci Advisors+1-917-679-9282tim@lifesciadvisors.com

Logo: https://mma.prnewswire.com/media/2408622/Oncolytics_Biotech_Inc_Logo.jpg

Logo: https://mma.prnewswire.com/media/2408622/Oncolytics_Biotech_Inc_Logo.jpg

SOURCE Oncolytics Biotech® Inc.

SOURCE Oncolytics Biotech®公司。