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Precisgen宣布了PRGN-2012在复发性呼吸道乳头状瘤病患者中的突破性关键研究数据,其中超过一半的患者获得了完全缓解

Precigen Announces Groundbreaking Pivotal Study Data for PRGN-2012 in Patients with Recurrent Respiratory Papillomatosis in Which More than Half of Patients Achieved Complete Response

BioSpace 等信源发布 2024-06-03 11:28

可切换为仅中文


–   Phase 1/2 pivotal study met the primary safety and efficacy endpoints –

–1/2期关键研究符合主要安全性和有效性终点–

–   51% (18 out of 35) of patients achieved Complete Response, requiring no surgeries after treatment with PRGN-2012; complete responses have been durable beyond 12 months with median duration of follow up of 20 months as of data cutoff –

–51%(35名患者中有18名)获得了完全缓解,在接受PRGN-2012治疗后不需要手术;完整的反应持续了12个月以上,截至数据截止时,中位随访时间为20个月-

–   86% of patients (30 out of 35) had a decrease in surgical interventions in the year after PRGN-2012 treatment compared to the year prior to treatment; RRP surgeries reduced from a median of 4 pre-treatment to 0 post-treatment –

–与治疗前一年相比,PRGN-2012治疗后一年,86%的患者(35名患者中有30名)的手术干预减少;RRP手术从治疗前的中位数4减少到治疗后的中位数0–

–   PRGN-2012 was well-tolerated with no dose-limiting toxicities and no treatment-related adverse events greater than Grade 2 –

–PRGN-2012耐受性良好,无剂量限制性毒性,无大于2级的治疗相关不良事件–

–   PRGN-2012 treatment induced HPV 6/11-specific T cell responses in RRP patients with a significantly greater expansion of peripheral HPV-specific T cells in responders compared with non-responders –

–PRGN-2012治疗诱导RRP患者的HPV 6/11特异性T细胞反应,与无反应者相比,有反应者的外周HPV特异性T细胞扩增明显更大–

–   PRGN-2012 significantly (p < 0.0001) improved Derkay and quality of life scores in complete responders –

–PRGN-2012显著(p<0.0001)改善了完全缓解者的Derkay和生活质量评分-

–   RRP is a rare, devastating HPV-mediated chronic disease characterized by growth of benign tumors for which the current standard-of-care is repeated surgeries; if approved, PRGN-2012 has the potential to be the first FDA-approved therapeutic for the treatment of RRP –

–RRP是一种罕见的破坏性HPV介导的慢性疾病,其特征是良性肿瘤的生长,目前的护理标准是重复手术;如果获得批准,PRGN-2012有可能成为FDA批准的第一种治疗RRP的药物-

–   Clinical data associated with favorable safety, strong efficacy, ease of administration, and immunological responses, position PRGN-2012 to potentially be the preferred treatment-of-choice for RRP –

–与良好的安全性,强大的疗效,易于管理和免疫反应相关的临床数据,将PRGN-2012定位为RRP的首选治疗方法–

–   PRGN-2012 rolling BLA submission, under an accelerated approval pathway, is anticipated in the second half of 2024 –

–根据加速批准途径,PRGN-2012滚动BLA提交预计将于2024年下半年提交–

–   Precigen to host webcast event today at 6:00 PM CT / 7:00 PM ET –

–正好是今天下午6点CT∙东部时间下午7点举办的网络直播活动–

GERMANTOWN, Md., June 3, 2024 /PRNewswire/ -- Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, today released positive Phase 1/2 pivotal study results for the investigational PRGN-2012 off-the-shelf (OTS) AdenoVerse® gene therapy in patients with recurrent respiratory papillomatosis (RRP).

GERMANTOWN,Md.,2024年6月3日/PRNewswire/--Precigen,Inc.(纳斯达克:PGEN),一家专门开发创新基因和细胞疗法以改善患者生活的生物制药公司,今天发布了针对复发性呼吸道乳头状瘤病(RRP)患者的研究性PRGN-2012现成(OTS)AdenoVerse®基因疗法的阳性1/2期关键研究结果。

Results were presented in a late-breaking oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting by Scott M. Norberg, DO, Associate Research Physician, Center for Immuno-Oncology, Center for Cancer Research, National Cancer Institute and a lead investigator for the PRGN-2012 clinical study.

在2024年美国临床肿瘤学会(ASCO)年会上,斯科特·M·诺伯格(ScottM.Norberg,DO)作为副研究医师、免疫肿瘤学中心、国家癌症研究所癌症研究中心和PRGN-2012临床研究的首席研究员,在最新的口头报告中介绍了研究结果。

The Company will host a webcast event today at 6:00 PM CT / 7:00 PM ET to detail the results presented at ASCO..

该公司将于今天下午6:00 CT/7:00 ET举办网络直播活动,详细介绍ASCO会议的结果。。

'We are thrilled with the results of the Phase 1/2 pivotal study showing more than half of patients were surgery free–Complete Response–and 86% of patients had a significant reduction in the need for surgeries after PRGN-2012 treatment. Based on the efficacy, safety, and ease of administration, we believe PRGN-2012 is a game-changer for RRP patients and has the potential to be the preferred treatment-of-choice for RRP,' said Helen Sabzevari, PhD, President and CEO of Precigen.

“我们对1/2期关键研究的结果感到兴奋,该研究显示,超过一半的患者无需手术-完全缓解-86%的患者在PRGN-2012治疗后手术需求显着减少。Precigen总裁兼首席执行官海伦·萨布泽瓦里(HelenSabzevari)博士说,基于疗效、安全性和易用性,我们认为PRGN-2012是RRP患者的游戏规则改变者,有可能成为RRP首选治疗方法。

'We look forward to sharing these results with the FDA as part of a rolling Biologics License Application submission under an accelerated approval pathway. We have ramped up our commercial readiness efforts in anticipation of a potential launch in 2025 and are excited by the potential to bring a long overdue new treatment option to the RRP community.'.

“我们期待着与FDA分享这些结果,作为加速批准途径下滚动生物制剂许可证申请提交的一部分。我们已经加大了商业准备工作的力度,预计2025年将有可能推出,并对为RRP社区带来一种早该推出的新治疗选择感到兴奋。”。

Pivotal Study Design and Endpoints

关键研究设计和终点

The Phase 1/2 clinical study (clinical trial identifier: NCT04724980) evaluated safety and efficacy of PRGN-2012. The study design included an initial 3+3 dose escalation cohort to identify the recommended Phase 2 dose (RP2D). Adult RRP patients who had three or more surgeries in the prior 12 months were eligible for the study.

1/2期临床研究(临床试验标识符:NCT04724980)评估了PRGN-2012的安全性和有效性。研究设计包括最初的3+3剂量递增队列,以确定推荐的2期剂量(RP2D)。在过去12个月内接受过三次或三次以上手术的成年RRP患者有资格参加该研究。

The Phase 1/2 study enrolled a total of 38 patients. Of these, 3 patients received four administrations of PRGN-2012 at 1x 1011 particle units (PU)/dose and 35 patients received four administrations of PRGN-2012 at RP2D (5 x 1011 PU/dose) over a 12 week treatment period via subcutaneous injection..

1/2期研究共招募了38名患者。其中,3名患者在12周的治疗期间通过皮下注射接受了4次1x 1011粒子单位(PU)/剂量的PRGN-2012给药,35名患者接受了4次RP2D(5 x 1011 PU/剂量)的PRGN-2012给药。。

Primary endpoints included safety and Complete Response rate defined as the percentage of patients who require no RRP surgeries in the 12-month period after PRGN-2012 treatment completion. Key secondary endpoints included HPV-specific immune responses, extent of papilloma growth as measured by Derkay scoring, and quality of life measurement as measured by Vocal Handicap Index-10 (VHI-10)..

主要终点包括安全性和完全缓解率,定义为PRGN-2012治疗完成后12个月内不需要RRP手术的患者百分比。关键的次要终点包括HPV特异性免疫反应,通过Derkay评分测量的乳头状瘤生长程度,以及通过嗓音障碍指数-10(VHI-10)测量的生活质量。。

Patient Characteristics

患者特征

Baseline patient characteristics of the 35 adult patients included a median age of 49 years (range: 20-88); 20 of the patients were male and 15 were female. Patients had a median of 4 surgeries (range: 3-10) in the 12 months before PRGN-2012 treatment initiation. Average years since RRP diagnosis was 20 (range: 1-65) with 12 and 23 patients with juvenile and adult onset RRP, respectively..

35名成年患者的基线患者特征包括中位年龄49岁(范围:20-88);其中男性20例,女性15例。在PRGN-2012治疗开始前的12个月内,患者的中位数为4次手术(范围:3-10)。自RRP诊断以来的平均年数为20(范围:1-65),分别有12例和23例青少年和成人RRP患者。。

Clinical Efficacy

临床疗效

Primary efficacy endpoint analysis demonstrated that 51% (18 out of 35) (95% CI: 34-69) patients achieved Complete Response, defined as no need for RRP surgeries in the 12-month period following completion of PRGN-2012 treatment. The Complete Response rate was 50% (6 out of 12) and 52% (12 out of 23) in the Phase 1 and Phase 2 portions of the study, respectively (TABLE 1).

主要疗效终点分析显示,51%(35名患者中的18名)(95%CI:34-69)患者达到完全缓解,定义为在PRGN-2012治疗完成后的12个月内不需要RRP手术。在研究的第一阶段和第二阶段,完全缓解率分别为50%(12/12)和52%(23/12)(表1)。

Complete Responses were durable. Median durability of response has not yet been reached with median follow up of 20 months as of the data cutoff date of May 20, 2024. PRGN-2012 treatment significantly (p < 0.0001) reduced the need for surgeries in RRP patients compared to pre-treatment history (FIGURE 1).

完整的回答是持久的。截至2024年5月20日的数据截止日期,中位随访时间为20个月,尚未达到中位反应持久性。与治疗前病史相比,PRGN-2012治疗显着(p<0.0001)减少了RRP患者的手术需求(图1)。

PRGN-2012 treatment reduced the need for RRP surgeries in 86% (30 out of 35) of patients compared to their pre-treatment history. RRP surgeries were reduced from a median of 4 (range: 3-10) in the 12 months pre-treatment to 0 (range: 0-7) in the 12 months post PRGN-2012 treatment completion. .

与治疗前的病史相比,PRGN-2012治疗减少了86%(35名患者中的30名)的RRP手术需求。RRP手术从治疗前12个月的中位数4(范围:3-10)减少到PRGN-2012治疗完成后12个月的0(范围:0-7)。

PRGN-2012 treatment showed significant (p < 0.0001) improvement in anatomical Derkay scores, a tool used for research purposes to quantify RRP severity based on involvement of laryngeal structures, with mean Derkay scores reducing from 9 (range: 5-19) at baseline to 1 (range: 0-5) at 24 weeks post-treatment in patients with Complete Response.

PRGN-2012治疗显示解剖Derkay评分有显著改善(p<0.0001),这是一种用于研究目的的工具,用于根据喉结构受累程度量化RRP严重程度,平均Derkay评分从基线时的9分(范围:5-19分)降至完全缓解患者治疗后24周的1分(范围:0-5分)。

Quality of life, as evaluated using the validated VHI-10, significantly (p < 0.0001) improved from a mean of 25 (range: 12-38) at baseline to 7 (range: 0-30) at 24 weeks post PRGN-2012 treatment in patients with Complete Response. PRGN-2012 treatment induced HPV 6/11-specific T cell responses in RRP patients with a significantly greater expansion of peripheral HPV-specific T cells observed in responders compared with non-responders..

使用经过验证的VHI-10评估的生活质量,在PRGN-2012治疗后24周,完全缓解患者的生活质量从基线时的平均25(范围:12-38)显着提高(p<0.0001),达到7(范围:0-30)。PRGN-2012治疗在RRP患者中诱导HPV 6/11特异性T细胞应答,与无应答者相比,在应答者中观察到的外周HPV特异性T细胞的扩增显着更大。。

TABLE 1: Clinical Efficacy Summary

表1:临床疗效总结

Total Patients (N=35)

患者总数(N=35)

Phase 1

第1阶段

(N=12)

(N=12)

Phase 2

第2阶段

(N=23)

(N=23)

Phase 1/2 Total

第1/2阶段总计

(N=35)

(N=35)

Complete Response

完整响应

No surgeries needed during 12 months post-treatment

治疗后12个月内无需手术

50% (6/12)

50% (6/12)

52% (12/23)

52% (12/23)

51% (18/35)

51% (18/35)

Decrease in Rate of Surgery

手术率下降

12 months post-treatment compared to 12 months pre-treatment

治疗后12个月与治疗前12个月相比

83% (10/12)

83% (10/12)

87% (20/23)

87% (20/23)

86% (30/35)

86% (30/35)

Safety

安全

PRGN-2012 treatment was well-tolerated with no dose-limiting toxicities and no treatment-related adverse events (TRAEs) greater than Grade 2 (TABLE 2). All patients received four administrations of PRGN-2012 at the intended dose levels. TRAEs were mostly mild with no treatment-related serious adverse events reported.

PRGN-2012治疗耐受性良好,无剂量限制性毒性,无治疗相关不良事件(TRAEs)大于2级(表2)。所有患者均以预期剂量水平接受了四次PRGN-2012给药。TRAE大多为轻度,未报告与治疗相关的严重不良事件。

The most common TRAE was injection site reaction. Other common TRAEs occurring in more than one subject were fatigue, chills, and fever. There was no meaningful anti-drug antibody response with repeat administrations of PRGN-2012..

最常见的TRAE是注射部位反应。在一个以上的受试者中发生的其他常见TRAE是疲劳,寒战和发烧。PRGN-2012的重复给药没有有意义的抗药物抗体反应。。

TABLE 2: Treatment-related Adverse Events Occurring in More Than 1 Patient

表2:1名以上患者发生的治疗相关不良事件

Total Patients (N=38)

患者总数(N=38)

Event

事件

1 x 1011 PU

1 x 1011 PU

(N = 3)

(N=3)

5 x 1011 PU

5 x 1011 PU

(N=35)

(N=35)

Grade 1

1级

Grade 2

2级

Grade 1

1级

Grade 2

2级

(N, %)

(N,%)

(N, %)

(N,%)

(N, %)

(N,%)

(N, %)

(N,%)

Chills

寒战

-

-(笑声)

-

-(笑声)

25 (71 %)

25 (71 %)

-

-(笑声)

Fatigue

疲劳

-

-(笑声)

-

-(笑声)

28 (80 %)

28 (80 %)

2 (6 %)

2 (6 %)

Fever

发烧

-

-(笑声)

-

-(笑声)

24 (69 %)

24 (69 %)

-

-(笑声)

Headache

头痛

2 (6 %)

2 (6 %)

Hyperhidrosis

多汗症

-

-(笑声)

-

-(笑声)

2 (6 %)

2 (6 %)

-

-(笑声)

Injection site reaction

注射部位反应

3 (100 %)

3 (100 %)

-

-(笑声)

34 (97 %)

34 (97 %)

-

-(笑声)

Myalgia

肌痛

-

-(笑声)

-

-(笑声)

9 (26 %)

9 (26 %)

2 (6 %)

2 (6 %)

Nausea

恶心

-

-(笑声)

-

-(笑声)

8 (23 %)

8 (23 %)

-

-(笑声)

Vomiting

呕吐

-

-(笑声)

-

-(笑声)

2 (6 %)

2 (6 %)

-

-(笑声)

About RRP

关于RRP

RRP is a rare, difficult-to-treat and sometimes fatal neoplastic disease of the upper and lower respiratory tracts that is caused by infection with HPV 6 or HPV 11.1-4 RRP is classified based on age of onset as juvenile or adult. Currently, there is no cure for RRP and the current standard-of-care is repeated endoscopic debulking with ablation or excision of papillomatous lesions.3,4 Recurrence of papilloma after surgical removal is very common and repeated procedures are required to debulk and monitor the disease, which exposes patients to anesthetic and surgical risks, and emotional distress.

RRP是一种罕见的,难以治疗的,有时是致命的上呼吸道和下呼吸道肿瘤性疾病,由HPV 6或HPV 11.1-4感染引起。RRP根据发病年龄分为青少年或成人。目前,RRP尚无治愈方法,目前的护理标准是反复内镜下切除或切除乳头状瘤病变[3,4]。手术切除后乳头状瘤复发非常常见,需要重复手术来切除和监测疾病,这会使患者面临麻醉和手术风险以及情绪困扰。

RRP morbidity and mortality results from the effects of papilloma mass on the vocal cords, trachea, and lungs, which may cause voice changes, stridor, airway occlusion, loss of lung volume, and/or post-obstructive pneumonia.5 Although rare, one to three percent of RRP cases can transform into invasive squamous cell carcinoma.6,7.

RRP的发病率和死亡率是由乳头状瘤肿块对声带,气管和肺部的影响引起的,这可能导致声音改变,喘鸣,气道阻塞,肺容量减少和/或阻塞后肺炎[5]。虽然罕见,但1%至3%的RRP病例可转化为浸润性鳞状细胞癌[6,7]。

AdenoVerse®

腺病毒®

Precigen's AdenoVerse platform utilizes a library of proprietary adenovectors for the efficient gene delivery of therapeutic effectors, immunomodulators, and vaccine antigens designed to modulate the immune system. Precigen's gorilla adenovectors, part of the AdenoVerse library, have potentially superior performance characteristics as compared to current competition.

Precigen的AdenoVerse平台利用专有的腺载体库,有效地传递治疗效应物,免疫调节剂和疫苗抗原,以调节免疫系统。Precigen的大猩猩腺载体是AdenoVerse文库的一部分,与当前的竞争对手相比,具有潜在的优越性能。

AdenoVerse gene therapies have been shown to generate high-level and durable antigen-specific T-cell immune responses as well as an ability to boost these responses via repeat administration. Superior performance characteristics and high yield manufacturing of AdenoVerse vectors leveraging UltraVector® technology allows Precigen to engineer cutting-edge investigational gene therapies to treat complex diseases..

AdenoVerse基因疗法已被证明可以产生高水平和持久的抗原特异性T细胞免疫应答,以及通过重复给药增强这些应答的能力。利用UltraVector®技术,AdenoVerse载体具有优异的性能特征和高产率制造,使Precigen能够设计尖端的研究性基因疗法来治疗复杂疾病。。

About PRGN-2012 AdenoVerse® Gene Therapy

关于PRGN-2012 AdenoVerse®基因治疗

PRGN-2012 is an investigational off-the-shelf AdenoVerse gene therapy designed to elicit immune responses directed against cells infected with human papillomavirus (HPV) 6 or HPV 11 for the treatment of RRP. PRGN-2012 was the first to receive Breakthrough Therapy Designation and an accelerated approval pathway for RRP from the US Food and Drug Administration (FDA).

PRGN-2012是一种研究性现成的腺病毒基因疗法,旨在引发针对感染人乳头瘤病毒(HPV)6或HPV 11的细胞的免疫反应,用于治疗RRP。PRGN-2012是第一个获得突破性治疗指定和美国食品和药物管理局(FDA)RRP加速批准途径的药物。

PRGN-2012 received Orphan Drug Designation from the FDA and from the European Commission. Results from the Phase 1 portion of the Phase 1/2 study were published in the peer-reviewed journal, Science Translational Medicine, a leading publication from the American Association for the Advancement of Science (AAAS)..

PRGN-2012获得了FDA和欧盟委员会的孤儿药指定。1/2期研究第一阶段的结果发表在同行评审期刊《科学转化医学》上,该期刊是美国科学促进会(AAAS)的主要出版物。。

AdenoVerse® Clinical Programs

AdenoVerse®临床计划

Precigen's AdenoVerse platform is currently under clinical investigation in a Phase 1/2 study of PRGN-2009 alone or in combination with an anti-PDL1/TGF-Beta Trap in patients with HPV-associated cancers (NCT04432597), a Phase 2 study of PRGN-2009 in combination with pembrolizumab in newly diagnosed patients with HPV-associated oropharyngeal squamous cell carcinoma (OPSCC) (NCT05996523), a Phase 2 study of PRGN-2009 in combination with pembrolizumab in patients with recurrent or metastatic cervical cancer (NCT06157151), and a Phase 1/2 study of PRGN-2012 in patients with recurrent respiratory papillomatosis (RRP) (NCT04724980).

Precigen的AdenoVerse平台目前正在进行PRGN-2009单独或联合抗PDL1/TGF-β陷阱治疗HPV相关性癌症(NCT04432597)的1/2期临床研究,PRGN-2009联合pembrolizumab治疗新诊断的HPV相关性口咽鳞状细胞癌(OPSCC)的2期临床研究(NCT05996523),PRGN-2009联合pembrolizumab治疗复发或转移性宫颈癌(NCT06157151)的2期临床研究,以及PRGN-2012治疗复发性呼吸道乳头状瘤病(RRSCC)的1/2期临床研究P)(NCT04724980)。

PRGN-2012 has been granted Orphan Drug Designation and Breakthrough Therapy Designation in patients with RRP by the FDA and Orphan Drug Designation by the European Commission. .

PRGN-2012已被FDA授予RRP患者的孤儿药指定和突破性治疗指定,并被欧盟委员会授予孤儿药指定。。

Precigen: Advancing Medicine with Precision™

Precigen:用Precision™推进医学

Precigen (Nasdaq: PGEN) is a dedicated discovery and clinical stage biopharmaceutical company advancing the next generation of gene and cell therapies using precision technology to target the most urgent and intractable diseases in our core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases.

Precigen(纳斯达克股票代码:PGEN)是一家专注于发现和临床阶段的生物制药公司,利用精密技术推进下一代基因和细胞疗法,以针对我们免疫肿瘤学,自身免疫性疾病和传染病等核心治疗领域中最紧迫和最棘手的疾病。

Our technologies enable us to find innovative solutions for affordable biotherapeutics in a controlled manner. Precigen operates as an innovation engine progressing a preclinical and clinical pipeline of well-differentiated therapies toward clinical proof-of-concept and commercialization. For more information about Precigen, visit www.precigen.com or follow us on X @Precigen, LinkedIn or YouTube..

我们的技术使我们能够以可控的方式为负担得起的生物治疗药物找到创新的解决方案。Precigen作为一个创新引擎,致力于将分化良好的治疗方法的临床前和临床管道推向临床概念验证和商业化。有关Precigen的更多信息,请访问www.Precigen.com或在X@Precigen、LinkedIn或YouTube上关注我们。。

Trademarks

商标

Precigen, AdenoVerse, UltraVector and Advancing Medicine with Precision are trademarks of Precigen and/or its affiliates. Other names may be trademarks of their respective owners.

Precigen、AdenoVerse、UltraVector和Advanced Medicine with Precision是Precigen和/或其附属公司的商标。其他名称可能是其各自所有者的商标。

Cautionary Statement Regarding Forward-Looking Statements

关于前瞻性声明的警示声明

Some of the statements made in this press release are forward-looking statements. These forward-looking statements are based upon the Company's current expectations and projections about future events and generally relate to plans, objectives, and expectations for the development of the Company's business, including the timing and progress of preclinical studies, clinical trials, discovery programs and related milestones, the promise of the Company's portfolio of therapies, and in particular its CAR-T and AdenoVerse therapies.

本新闻稿中的一些声明是前瞻性的声明。这些前瞻性陈述基于公司目前对未来事件的期望和预测,通常与公司业务发展的计划、目标和期望有关,包括临床前研究、临床试验、发现计划和相关里程碑的时间和进展,公司治疗组合的承诺,特别是其CAR-T和AdenoVerse疗法。

Although management believes that the plans and objectives reflected in or suggested by these forward-looking statements are reasonable, all forward-looking statements involve risks and uncertainties and actual future results may be materially different from the plans, objectives and expectations expressed in this press release.

尽管管理层认为这些前瞻性声明中反映或建议的计划和目标是合理的,但所有前瞻性声明都涉及风险和不确定性,未来的实际结果可能与本新闻稿中表达的计划、目标和期望有重大差异。

The Company has no obligation to provide any updates to these forward-looking statements even if its expectations change. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. For further information on potential risks and uncertainties, and other important factors, any of which could cause the Company's actual results to differ from those contained in the forward-looking statements, see the section entitled 'Risk Factors' in the Company's most recent Annual Report on Form 10-K and subsequent reports filed with the Securities and Exchange Commission..

即使公司的预期发生变化,公司也没有义务对这些前瞻性声明进行任何更新。本警示声明明确限定了所有前瞻性声明的全部内容。有关潜在风险和不确定性以及其他可能导致公司实际业绩与前瞻性报表中所含结果不同的重要因素的更多信息,请参阅公司最新年度报告(表10-K)中题为“风险因素”的部分以及随后提交给证券交易委员会的报告。。

Investor Contact:

投资者联系人:

Steven M. Harasym

史蒂文·M·哈拉西姆

Vice President, Investor Relations

投资者关系副总裁

Tel: +1 (301) 556-9850

电话:+1(301)556-9850

investors@precigen.com

investors@precigen.com

Media Contacts:

媒体联系人:

Donelle M. Gregory

多内尔·M·格雷戈里

press@precigen.com

press@precigen.com

Glenn Silver

格伦·西尔弗

Lazar-FINN Partners

Lazar FINN合伙人

glenn.silver@finnpartners.com

glenn.silver@finnpartners.com

References

参考文献

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1 Mounts,P等人(1982年)。'青少年和成人喉鳞状乳头状瘤的病毒病因美国国家科学院院刊79(17):5425-5429。

2 Smith, E et al. (1993). 'Human papillomavirus infection in papillomas and nondiseased respiratory sites of patients with recurrent respiratory papillomatosis using the polymerase chain reaction.' Arch Otolaryngol Head Neck Surg 119(5): 554-557.

2 Smith,E等人(1993年)。'使用聚合酶链反应在复发性呼吸道乳头状瘤病患者的乳头状瘤和非患病呼吸道部位感染人乳头状瘤病毒耳鼻咽喉头颈外科119(5):554-557。

3 Derkay, CS et al. (2008). 'Recurrent respiratory papillomatosis: a review.' Laryngoscope 118(7): 1236-1247.

3 Derkay,CS等人(2008年)。'复发性呼吸道乳头状瘤病:综述喉镜118(7):1236-1247。

4 Derkay, CS et al. (2019). 'Update on Recurrent Respiratory Papillomatosis.' Otolaryngol Clin North Am 52(4): 669-679.

4 Derkay,CS等人(2019)。'复发性呼吸道乳头状瘤病的最新进展耳鼻喉科临床北Am 52(4):669-679。

5 Seedat, RY (2020). 'Juvenile-Onset Recurrent Respiratory Papillomatosis Diagnosis and Management - A Developing Country Review.' Pediatric Health Med Ther 11: 39-46.

5西达特,RY(2020年)。'青少年发作的复发性呼吸道乳头状瘤病的诊断和管理-发展中国家综述。”儿科健康医学杂志11:39-46。

6 Dedo, HH et al. (2001). 'CO(2) laser treatment in 244 patients with respiratory papillomas.' Laryngoscope 111(9): 1639-1644.

6 Dedo,HH等人(2001年)。'244例呼吸道乳头状瘤的CO(2)激光治疗喉镜111(9):1639-1644。

7 Silver, RD et al. (2003). 'Diagnosis and management of pulmonary metastasis from recurrent respiratory papillomatosis.' Otolaryngol Head Neck Surg 129(6): 622-629.

7 Silver,RD等人(2003年)。'复发性呼吸道乳头状瘤病肺转移的诊断和治疗耳鼻咽喉头颈外科129(6):622-629。

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SOURCE Precigen, Inc.

SOURCE Precigen公司。

Company Codes: NASDAQ-NMS:PGEN

公司代码:NASDAQ-NMS:PGEN