USA

美国

News Group

新闻组

News Commentary

新闻评论

Issued on behalf of Oncolytics Biotech Inc.

代表Oncolytics生物技术公司发布。

VANCOUVER, BC

加拿大温哥华

,

，

Aug. 28, 2025

2025年8月28日

/PRNewswire/ -- Federal budget cuts have

/PRNewswire/ -- 联邦预算削减已经

put pressure on cancer research

对癌症研究施加压力

efforts in

努力于

the United States

美国

, but private investment is helping to fill the gap, with oncology ventures

，但私人投资正在帮助填补这一空白，其中肿瘤学风险投资

securing hundreds of millions

确保数亿

in funding so far in 2025. The Senate's recent

截至目前，2025年的资金。参议院最近的

restoration of

恢复

$15 million

1500万美元

for the

为了

Pancreatic Cancer Research Program (PCARP)

胰腺癌研究计划 (PCARP)

was a win, yet its earlier elimination underscored the fragility of public support. Against this backdrop, investors are zeroing in on companies with standout science, solid pipelines, and clear regulatory strategies, including

是一次胜利，但其早期的淘汰也突显了公众支持的脆弱性。在此背景下，投资者正将目光聚焦在拥有突出科学实力、坚实研发管线和明确监管策略的公司上，包括

Oncolytics Biotech Inc.

Oncolytics生物技术公司

(NASDAQ:

（纳斯达克：

ONCY

ONCY

),

),

ImmunityBio, Inc.

ImmunityBio公司

(NASDAQ:

（纳斯达克：

IBRX

IBRX

),

),

Agenus Inc.

安吉纳斯公司

(NASDAQ:

（纳斯达克：

AGEN

代理商

),

),

Sutro Biopharma, Inc.

德罗生物制药公司

(NASDAQ:

（纳斯达克：

STRO

STRO

), and

)，以及

Castle Biosciences, Inc.

卡斯尔生物科学公司

(NASDAQ:

（纳斯达克：

CSTL

中国标准时间

).

）。

Major pharmaceutical companies

大型制药公司

have committed in the range of

在范围内的提交

$20 billion

200亿美元

in recent partnerships to advance next-generation immunotherapies, while

近年来，在推进下一代免疫疗法的合作中，同时

venture capital investors

风险资本投资者

continue backing innovative oncology startups despite economic headwinds. The timing couldn't be more strategic, as there are several companies demonstrating robust survival data and regulatory alignment now commanding premium valuations as big pharma races to replace expiring patents with breakthrough platforms..

尽管面临经济逆风，仍继续支持创新的肿瘤学初创公司。当前时机再战略不过了，因为有几家公司展示了强劲的生存数据和监管一致性，现在正以突破性平台获得高额估值，大型制药公司竞相以此取代即将到期的专利。

Oncolytics Biotech Inc.

Oncolytics生物技术公司

(NASDAQ:

（纳斯达克：

ONCY

ONCY

) has reached a pivotal inflection point, advancing toward what could become a registration-enabling trial for its breakthrough immunotherapy,

）已经到达了一个关键的转折点，正朝着可能成为其突破性免疫疗法的注册试验迈进，

pelareorep

佩拉雷奥雷普

, in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC).

，在一线转移性胰腺导管腺癌 (mPDAC) 中。

Recently, the company

最近，公司

confirmed

确认

active discussions with the

积极讨论

U.S. Food and Drug Administration (FDA)

美国食品药品监督管理局 (FDA)

to finalize pivotal study parameters, positioning

最终确定关键研究参数，定位

Oncolytics

溶瘤病毒

for potential initiation of trial activities by Q4 2025. This regulatory engagement represents a critical milestone, transitioning from proof-of-concept research to regulatory-stage development in one of oncology's most challenging therapeutic areas.

预计在2025年第四季度可能启动试验活动。这一监管参与代表了一个关键的里程碑，从概念验证研究过渡到肿瘤学最具挑战性的治疗领域之一的监管阶段开发。

The strategic emphasis on mPDAC builds on compelling survival data and addresses a massive unmet medical need. Pelareorep functions as a systemically delivered oncolytic virus that transforms immunologically 'cold' tumors into 'hot' targets responsive to immune-based treatments. Clinical data reveals pelareorep combinations achieved a remarkable 21.9% two-year overall survival rate in first-line pancreatic cancer patients, substantially outperforming the .

对mPDAC的战略重点建立在令人信服的生存数据之上，并解决了巨大的未满足医疗需求。Pelareorep作为一种系统递送的溶瘤病毒，能够将免疫学上的“冷”肿瘤转化为对免疫治疗有反应的“热”靶标。临床数据显示，Pelareorep联合疗法在一线胰腺癌患者中实现了显著的21.9%两年总生存率，大幅优于 。

9.2% historical benchmark

9.2% 历史基准

established by standard chemotherapy protocols.

由标准化疗方案建立。

Importantly, pelareorep demonstrated a

重要的是，pelareorep 展示了

62% objective response rate

62%的客观缓解率

when combined with chemotherapy and checkpoint inhibitors. This outcome carries particular weight given checkpoint inhibitors currently lack approval for pancreatic cancer treatment, suggesting pelareorep may unlock immunotherapy effectiveness in historically resistant tumor types.

当与化疗和检查点抑制剂联合使用时，这一结果具有特别重要的意义，因为检查点抑制剂目前尚未获准用于胰腺癌治疗，这表明 pelareorep 可能会在历史上对免疫疗法有抗性的肿瘤类型中释放其有效性。

'We have turned the corner from proof-of-concept studies and will be sprinting toward regulatory clarity for the remainder of the year,' said

“我们已经完成了概念验证研究，接下来将在今年剩余时间里全力冲刺以获得监管清晰度，”

Jared Kelly

贾里德·凯利

, CEO of

，首席执行官

Oncolytics

溶瘤病毒

. 'As we shore up our intellectual property, get a clear registration path for pelareorep, and allow our GOBLET data to mature, we will establish our position as the only platform immunotherapy in gastrointestinal tumors.'

“随着我们巩固知识产权，为pelareorep获得明确的注册路径，并让我们的GOBLET数据成熟，我们将确立自己作为胃肠道肿瘤中唯一的平台免疫疗法的地位。”

The mechanism behind these outcomes involves pelareorep's dual action profile. The virus selectively replicates within cancer cells and activates broad immune responses against tumor tissue. Translational studies from GOBLET and AWARE-1 trials demonstrate how treatment elevates PD-L1 expression, amplifies interferon signaling, and mobilizes tumor-infiltrating lymphocytes throughout the bloodstream..

这些结果背后的作用机制涉及 pelareorep 的双重作用特性。该病毒选择性地在癌细胞内复制，并激活对肿瘤组织的广泛免疫反应。GOBLET 和 AWARE-1 试验的转化研究表明，治疗如何提高 PD-L1 表达、增强干扰素信号传导，并调动遍布血液中的肿瘤浸润淋巴细胞。

'This robust data set, amassed from several studies in cancers that have historically resisted immunotherapeutic approaches, provides definitive validation of pelareorep's immune-mediated mechanism of action,'

“这一强大的数据集汇总了多项针对历史上对免疫治疗产生抵抗的癌症的研究，为pelareorep的免疫介导作用机制提供了确凿的验证。”

said

说

Dr.

博士

Thomas Heineman

托马斯·海因曼

, Chief Medical Officer of

，首席医疗官

Oncolytics

溶瘤病毒

. 'We observed tumor biopsy-confirmed virus replication, immune cell activation, and the recruitment of cytotoxic T cells into the TME - all consistent with the durable responses observed in patients with metastatic PDAC and HR+/HER2- breast cancer who were treated with pelareorep.'

“我们观察到肿瘤活检证实的病毒复制、免疫细胞激活以及细胞毒性T细胞被招募到肿瘤微环境（TME）中——这些都与接受pelareorep治疗的转移性胰腺导管腺癌（PDAC）和HR+/HER2-乳腺癌患者中观察到的持久反应一致。”

These mechanistic insights, combined with survival data from

这些机制上的见解，加上生存数据

over 1,100 patients

超过1100名患者

across multiple clinical programs, have shaped management's focus on pancreatic cancer as the lead indication for regulatory advancement.

跨多个临床项目，影响了管理层对胰腺癌作为监管推进的首要适应症的关注。

Leadership changes reflect

领导层的变化反映了

Oncolytics'

溶瘤病毒的

execution-oriented approach. CEO

以执行为导向的方法。首席执行官

Jared Kelly

贾里德·凯利

and Chief Business Officer

首席商务官

Andrew Aromando

安德鲁·阿罗曼多

both contributed to

双方都促成了

Ambrx Biopharma's

安博生物制药的

US$2 billion

20亿美元

acquisition

收购

by

通过

Johnson & Johnson

强生公司

. Kelly assumed the CEO role in

凯利担任首席执行官一职。

June 2025

2025年6月

, while Aromando joined a few weeks later to oversee business development initiatives. The company has also eliminated its At-the-Market and Equity Line facilities, signaling confidence in current cash resources to reach key development milestones.

，而阿罗曼多则在几周后加入，负责监督业务发展计划。该公司还取消了其在市场上和股票线的设施，表明对当前现金资源有信心，能够达到关键的发展里程碑。

Regulatory momentum supports accelerated development timelines. Pelareorep maintains both

监管势头支持加速发展时间表。Pelareorep维持双方

Fast Track

快速通道

and

和

Orphan Drug

孤儿药

designations from the

来自的指定

FDA

食品药品监督管理局

specifically for

专门针对

pancreatic cancer

胰腺癌

, acknowledging both therapeutic promise and critical patient need. These designations facilitate expedited review processes and can enhance partnership attractiveness with major pharmaceutical companies.

，同时承认其治疗潜力和关键的患者需求。这些指定促进了加快审查进程，并可以增强与大型制药公司的合作吸引力。

The broader market context highlights the commercial opportunity. Pancreatic cancer maintains among the lowest survival rates of common malignancies, with

更广泛的市场背景突显了商业机会。胰腺癌在常见恶性肿瘤中生存率最低，

five-year survival below 14%

五年生存率低于14%

. While immunotherapies have revolutionized treatment across multiple cancer types, mPDAC has remained largely resistant to immune-based approaches, creating substantial unmet need for effective therapeutic combinations.

虽然免疫疗法已经彻底改变了多种癌症类型的治疗，但转移性胰腺导管腺癌（mPDAC）对基于免疫的方法仍然基本无效，因此对有效的联合治疗策略存在显著的未满足需求。

During July,

七月期间，

Oncolytics

溶瘤病毒学

conducted a

进行了一个

key opinion leader event

关键意见领袖活动

featuring gastrointestinal oncology specialists who analyzed patient survival outcomes and biomarker validation studies. Expert feedback reinforced that pelareorep's immune activation mechanism addresses fundamental treatment gaps in first-line mPDAC therapy.

邀请了胃肠道肿瘤学专家，他们分析了患者的生存结果和生物标志物验证研究。专家反馈强调，pelareorep的免疫激活机制填补了一线mPDAC治疗中的基本治疗空白。

Current

当前

FDA

食品药品监督管理局

discussions center on study design parameters that could support regulatory submission for commercial approval. Should the agency accept

讨论集中在可以支持监管提交以获得商业批准的研究设计参数。监管机构是否应该接受

Oncolytics'

Oncolytics'

proposed framework emphasizing overall survival endpoints, the resulting trial would provide definitive evidence of pelareorep's clinical and commercial viability in pancreatic cancer treatment.

该框架强调总体生存终点，由此产生的试验将提供pelareorep在胰腺癌治疗中的临床和商业可行性的决定性证据。

Oncolytics

溶瘤病毒

anticipates sharing updated clinical development timelines during Q3 2025, with trial initiation activities potentially commencing by Q4 2025. With robust survival data, established regulatory plans, and experienced leadership driving strategic execution, the company appears well-positioned to advance pelareorep through its most critical development phase..

预计在2025年第三季度分享更新的临床开发时间表，试验启动活动可能在2025年第四季度开始。凭借可靠的生存数据、已制定的监管计划以及经验丰富的领导团队推动战略执行，该公司似乎具备良好的条件，能够推动pelareorep进入其最关键的开发阶段。

CONTINUED… Read this and more news for Oncolytics Biotech at:

持续更新... 请在此处阅读更多关于Oncolytics Biotech的新闻：

https://usanewsgroup.com/2023/10/02/the-most-undervalued-oncolytics-company-on-the-nasdaq/

https://usanewsgroup.com/2023/10/02/纳斯达克上最被低估的溶瘤公司/

In other recent industry developments and happenings in the market include:

其他近期行业发展和市场动态包括：

ImmunityBio, Inc.

ImmunityBio公司

(NASDAQ:

（纳斯达克：

IBRX

IBRX

) achieved

`)` 达成

groundbreaking results

开创性成果

in its pilot study for recurrent glioblastoma, reporting 100% disease control in all five patients treated with its investigational immune-boosting regimen combining ANKTIVA, NK cell therapy, and Optune Gio Tumor Treating Fields. Three of the five patients responded to treatment, with two achieving near complete responses while the remaining two maintained stable disease in this chemotherapy-free approach.

在其针对复发性胶质母细胞瘤的初步研究中，报告称所有五名接受其研究性免疫增强方案（结合ANKTIVA、NK细胞疗法和Optune Gio肿瘤治疗电场）治疗的患者均实现了100%的疾病控制。五名患者中有三名对治疗有反应，其中两名接近完全缓解，另外两名在这一无化疗方法中保持了疾病稳定。

ANKTIVA treatment increased absolute lymphocyte count in all five patients who had experienced lymphopenia after standard radiation and chemotherapy..

ANKTIVA 治疗使所有五名在标准放化疗后出现淋巴细胞减少的患者的绝对淋巴细胞计数增加。

'Although they are early, these results are very encouraging, given the high risk and low survival rates associated with GBM,' said Dr.

“尽管它们出现得较早，但鉴于GBM相关的高风险和低存活率，这些结果非常令人鼓舞，”博士说道。

Patrick Soon-Shiong

帕特里克·顺-肖恩

, Founder, Executive Chairman and Global Chief Scientific and Medical Officer at

创始人、执行主席兼全球首席科学与医学官 at

ImmunityBio

免疫生物公司

. 'There is compelling evidence that ANKTIVA's mechanism of proliferating NK and T cells plays an important role in treating patients with cancer Independent of tumor type. By activating the immune system the goal of providing durable responses is at hand.'

“有令人信服的证据表明，ANKTIVA增殖NK细胞和T细胞的机制在治疗癌症患者方面发挥着重要作用，且独立于肿瘤类型。通过激活免疫系统，提供持久应答的目标已近在咫尺。”

Based on these preliminary findings,

基于这些初步发现，

ImmunityBio

ImmunityBio

is initiating a randomized Phase 2 trial targeting second-line glioblastoma patients with recurring disease following standard care. The company also

正在启动一项随机的二期试验，针对标准治疗后疾病复发的二线胶质母细胞瘤患者。该公司还

announced

宣布

a new Phase 2 study to assess ANKTIVA in patients with long COVID, expanding its clinical research beyond cancer applications.

一项新的二期研究，以评估ANKTIVA在长期COVID患者中的应用，将其临床研究扩展到癌症应用之外。

Agenus Inc.

安吉纳斯公司

(NASDAQ:

（纳斯达克：

AGEN

代理

) reported

) 报告

significant progress

显著进展

in the second quarter of 2025 as it is advancing its botensilimab (BOT) and balstilimab (BAL) immunotherapy combination, which delivered 42% two-year survival in refractory MSS colorectal cancer.

在2025年第二季度，其推进博替西利单抗（BOT）和巴利西利单抗（BAL）免疫疗法组合的进程中，该组合在难治性MSS结直肠癌中实现了42%的两年生存率。

'Our team is committed to advancing BOT/BAL to deliver meaningful benefits to patients with treatment-resistant cancers, and we are working with regulatory agencies to expedite access through a streamlined Phase 3 trial,' said

“我们的团队致力于推进BOT/BAL，为治疗耐药性癌症患者带来有意义的益处，我们正与监管机构合作，通过简化的三期试验加快获取途径，”

Garo Armen

加罗·阿尔门

, Ph.D., Chairman and CEO of

，博士，董事长兼首席执行官

Agenus

Agenus

. 'With significant clinical progress, strategic partnerships, and prudent financial management, we are well-positioned to execute our vision of transforming cancer care.'

“凭借显著的临床进展、战略合作伙伴关系以及审慎的财务管理，我们有能力实现彻底改变癌症治疗的愿景。”

Agenus

Agenus

secured regulatory alignment for its Phase 3 BATTMAN trial initiation in Q4 2025 and expects a

已确保其三期BATTMAN试验于2025年第四季度启动的监管一致性，并预期

$91 million

9100万美元

capital infusion from

资本注入来自

Zydus Lifesciences

西德斯生命科学公司

collaboration upon closing, and anticipates several significant milestones in the second half of 2025, including the global BATTMAN Phase 3 trial launch and new BOT/BAL clinical data presentations at major oncology congresses.

在即将结束时的合作，并预计在 2025 年下半年迎来几个重要的里程碑，包括全球 BATTMAN 三期试验的启动以及在主要肿瘤学大会上展示新的 BOT/BAL 临床数据。

Sutro Biopharma, Inc.

德罗生物制药公司

(NASDAQ:

（纳斯达克：

STRO

STRØ

) delivered

）交付

exceptional revenue growth

异常的收入增长

in the second quarter of 2025, reporting

2025年第二季度，报告

$63.7 million

6370万美元

compared to

与...相比

$25.7 million

2570万美元

in Q2 2024, driven primarily by the

在 2024 年第二季度，主要受

Astellas

安斯泰来制药

collaboration and recognition of previously deferred revenue from

合作并确认之前递延的收入

Ipsen's

益普生的

decision not to advance the STRO-003 program.

决定不推进STRO-003项目。

'Over the past several months, we've generated compelling preclinical data across our entire pipeline, further supporting our candidates' best-in-class potential as well as highlighting the unique capabilities of our platform technology,' said

“在过去的几个月里，我们在整个产品线中生成了令人信服的临床前数据，进一步支持了我们候选产品的同类最佳潜力，同时也突显了我们平台技术的独特能力，”

Jane Chung

简·钟

, CEO of

，首席执行官

Sutro

苏特罗

. 'As we look to the second half of the year, we are well capitalized to meet our top priority of pipeline execution which we believe is critical to increasing shareholder value and we continue to look for ways to implement operating efficiencies and further extend our cash runway.'

“展望下半年，我们拥有充足的资金来实现我们的首要任务——管道执行，我们认为这对增加股东价值至关重要。同时，我们将继续寻找实施运营效率的方法，并进一步延长我们的现金跑道。”

Sutro's

苏特罗的

pipeline includes STRO-006, an integrin beta-6 ADC expected to enter clinical development in 2026, and a dual-payload ADC platform with an IND filing anticipated in 2027. The oncology company pioneering site-specific antibody drug conjugates maintained a strong cash position of

管线包括预计将在2026年进入临床开发的STRO-006（一种整合素β-6抗体药物偶联物），以及预计在2027年提交IND申请的双载荷抗体药物偶联物平台。这家致力于位点特异性抗体药物偶联物的肿瘤学公司保持了强劲的现金储备。

$205.1 million

2.051亿美元

and reduced operating expenses while preparing to initiate clinical trials for STRO-004, its next-generation Tissue Factor-targeting exatecan ADC, in the second half of 2025.

并在准备于2025年下半年启动其下一代靶向组织因子的exatecan ADC（STRO-004）临床试验的同时，减少了运营费用。

Castle Biosciences, Inc.

卡斯尔生物科学公司

(NASDAQ:

（纳斯达克：

CSTL

中国标准时间

) announced the

`) 宣布了`

publication of new evidence

新证据的公布

supporting the use of its DecisionDx-SCC test in guiding treatment pathway decisions for NCCN high-risk cutaneous squamous cell carcinoma patients. A new validation study demonstrates that DecisionDx-SCC significantly outperforms current staging systems in predicting risk of local recurrence and metastasis, while a clinician survey confirms test results align with treatment decision-making thresholds for adjuvant radiation therapy and surveillance imaging..

支持将其DecisionDx-SCC测试用于指导NCCN高危皮肤鳞状细胞癌患者的治疗路径决策。一项新的验证研究表明，DecisionDx-SCC在预测局部复发和转移风险方面显著优于当前的分期系统，而一项临床医生调查证实，测试结果与辅助放疗和监测影像学治疗决策阈值相符。

'These new data indicate that DecisionDx-SCC test results provide individualized risk predictions that doctors can use to guide risk-aligned escalation or de-escalation of care in their NCCN high-risk SCC patients,' said Dr. Désirée Ratner, Mohs micrographic surgeon and clinical professor of dermatology at the .

“这些新数据表明，DecisionDx-SCC测试结果提供了个性化的风险预测，医生可以利用这些预测来指导对NCCN高风险SCC患者的治疗进行风险对应升级或降级。”莫尔斯显微外科医生、皮肤病学临床教授德西蕾·拉特纳博士表示。

NYU Grossman School of Medicine

纽约大学格罗斯曼医学院

. 'The ability of the test to reliably identify those patients with NCCN high-risk SCC at risk of developing local recurrence or metastasis is not only practice-changing for physicians who treat SCC, but also life-changing for their patients.'

“该测试能够可靠地识别那些有NCCN高风险SCC且有局部复发或转移风险的患者，这不仅对治疗SCC的医生来说是实践上的改变，对他们的患者来说也是命运的改变。”

The 40-gene expression profile test uses a patient's tumor biology to predict individual risk of cutaneous squamous cell carcinoma metastasis and stratify patients into Class 1 (low), Class 2A (higher), or Class

40基因表达谱测试利用患者的肿瘤生物学特性来预测皮肤鳞状细胞癌转移的个体风险，并将患者分为1类（低风险）、2A类（较高风险）或

2B

2B

(highest) risk categories.

（最高）风险类别。

Castle Biosciences

卡塞尔生物科学公司

continues expanding clinical evidence for its genomic tests, with DecisionDx-SCC now validated for predicting local recurrence in addition to metastatic risk and likelihood of benefit from adjuvant radiation therapy.

持续扩展其基因组测试的临床证据，DecisionDx-SCC现已验证可用于预测局部复发，以及转移风险和辅助放疗获益的可能性。

Source:

源代码：

https://usanewsgroup.com/2024/09/21/is-oncolytics-biotech-the-markets-most-undervalued-cancer-opportunity/

https://usanewsgroup.com/2024/09/21/溶瘤生物技术是市场最被低估的癌症机会吗/

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新闻集团是市场IQ媒体集团（MIQ）的全资子公司。MIQ已从Oncolytics Biotech Inc.直接获得广告和数字媒体费用。可能有第三方持有Oncolytics Biotech Inc.的股份，并可能抛售其股票，这可能会对股价产生负面影响。

This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc.

这种补偿构成了我们对公司概况进行客观沟通的能力上的利益冲突。由于这一冲突，强烈建议个人不要将本出版物作为任何投资决策的依据。MIQ的所有者/运营者持有Oncolytics Biotech Inc.的股份。

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这些股份是在公开市场上购买的，并保留买卖的权利，将随时买入和卖出Oncolytics Biotech Inc.的股票，立即开始并不再另行通知。我们还预计将获得进一步的报酬，作为持续的数字媒体推广工作以提高公司知名度，不再另行通知，但请以此免责声明作为通知：所有材料，包括本文，均由MIQ发布并已获Oncolytics Biotech Inc.批准；这是一则付费广告，我们目前持有Oncolytics Biotech Inc.的股份。

and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles..

并将在公开市场上或通过私募方式和/或其他投资工具买卖公司股票。

While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results.

虽然所有信息都被认为是可靠的，但我们不保证其准确性。个人应假设我们通讯中包含的所有信息均不可信，除非通过他们自己的独立研究进行核实。此外，由于事件和情况往往不会按预期发生，任何预测与实际结果之间可能会存在差异。

Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment..

在做出任何投资决定之前，请务必咨询持有执照的投资专业人士。要格外小心，证券投资具有高度风险，您可能会损失部分或全部投资。

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