Company's flu vaccine, mRNA-1010, met its primary endpoint in Phase 3 trial; separate Phase 1/2 data demonstrated higher HAI titers than Fluzone HD

公司的流感疫苗mRNA-1010在3期试验中达到了主要终点；单独的1/2期数据显示HAI滴度高于Fluzone HD

Vaccine pipeline advancing rapidly with Company announcing the completion of RSV BLA filing (mRNA-1345), completion of adult enrollment in the Phase 3 trial of mRNA-1647, a first-in-class vaccine against CMV, and the Phase 3 trial of mRNA-1283, a next-generation COVID-19 vaccine

随着公司宣布完成RSV BLA申请（mRNA-1345），完成成人入选针对CMV的一流疫苗mRNA-1647的3期试验以及3期试验mRNA-1283，一种新一代COVID-19疫苗

With its partner Merck, the Company plans to begin a second Phase 3 trial of mRNA-4157, its individualized neoantigen therapy (INT), in combination with Keytruda®, for non-small cell lung cancer later this year; updated efficacy follow-up from the ongoing Phase 2 study in adjuvant melanoma expected in Q4.

与其合作伙伴默克公司计划在今年晚些时候开始mRNA-4157（其个体化新抗原治疗（INT））与Keytruda®联合用于非小细胞肺癌的第二阶段3试验；第四季度正在进行的第二阶段辅助性黑色素瘤研究的最新疗效随访。

With positive clinical data announced in mRNA-3705, a treatment for methylmalonic acidemia, the Company has three chronic rare disease medicines that have demonstrated potential for clinical benefit in patients

随着mRNA-3705（一种治疗甲基丙二酸血症的药物）公布的阳性临床数据，该公司拥有三种慢性罕见疾病药物，这些药物已证明对患者有潜在的临床益处

Over the next five years, the Company expects to launch up to 15 new products addressing high unmet needs, to bring up to 50 new candidates into clinical trials and to continue expanding the field of mRNA into new applications

在未来五年内，该公司预计将推出多达15种新产品，以满足高度未满足的需求，将多达50名新候选人纳入临床试验，并继续将mRNA领域扩展到新的应用领域

CAMBRIDGE, MA / ACCESSWIRE / September 13, 2023 / Moderna, Inc. (NASDAQ:MRNA) today announced business and clinical updates across its franchises and introduced several new development programs at the Company's annual R&D Day.

马萨诸塞州剑桥市/ACCESSWIRE/2023年9月13日/Moderna，Inc。（纳斯达克股票代码：MRNA）今天宣布其特许经营的业务和临床更新，并在公司年度研发日推出了多项新的开发计划。

'Our mRNA platform is working. With today's positive Phase 3 flu results, along with previous results in COVID and RSV, we are now three for three on advancing respiratory disease programs to positive Phase 3 data,' said Stéphane Bancel, Chief Executive Officer of Moderna. 'In the near term, we look forward to product launches in our oncology, latent, rare and infectious disease franchises.In the fourth quarter of this year, we also expect to provide data on our next-generation COVID and flu combination, mRNA-1083, and additional efficacy analysis on our Phase 2 INT study.

'我们的mRNA平台正在运作。Moderna首席执行官StéphaneBancel说，随着今天3期流感的阳性结果，以及之前COVID和RSV的结果，我们现在有三分之三的人将呼吸系统疾病项目推进到阳性3期数据在短期内，我们期待我们的肿瘤，潜伏，罕见和传染病特许产品的推出。在今年第四季度，我们还希望为我们的下一代COVID和flu组合，mRNA-1083以及我们的2期INT研究提供额外的功效分析数据。

With significant momentum across the business and our pipeline, we are excited by the near future and focused on execution.'.

随着业务和我们的渠道的巨大发展，我们对不久的将来感到兴奋，专注于执行。

Expanding the Field of mRNA Medicine

拓展mRNA医学领域

Moderna was founded and built to use nature's information molecule, mRNA, to treat and prevent disease. The premise has always been that an mRNA-based approach to making medicine could advance at the pace of information, leveraging common science, technology, and infrastructure to create medicines addressing high unmet needs at unprecedented speed and efficiency..

Moderna的成立和建设是为了利用自然界的信息分子mRNA来治疗和预防疾病。前提一直是，基于mRNA的制造药物的方法可以在信息的步伐上推进，利用共同的科学，技术和基础设施，以前所未有的速度和效率创造满足高度未满足需求的药物。。

Through more than a decade of investment in science, the Company has created the field of mRNA medicine. The Company has advanced a diverse pipeline and demonstrated the potential for clinical benefit in cancer (mRNA-4157), in three different rare diseases (mRNA-3705, mRNA-3927, mRNA-3745), and multiple infectious disease vaccines (mRNA-1273, mRNA-1345, mRNA-1010).

经过十多年的科学投资，该公司创建了mRNA医学领域。该公司已经推进了多样化的管道，并展示了癌症临床益处（mRNA-4157），三种不同的罕见疾病（mRNA-3705，mRNA-3927，mRNA-3745）和多种传染病疫苗（mRNA-1273），mRNA-1345，mRNA-1010）。

The Company has advanced six programs into late-stage development, including two approved or filed for approval, and three more that have completed Phase 3 enrollment. The Company expects to double the number of programs in Phase 3 by 2025 and launch up to 15 products in five years across cancer, rare disease, and infectious disease.

该公司已将六个项目推进到后期开发阶段，其中两个已获得批准或提交批准，另外三个已完成第三阶段注册。该公司预计到2025年第3阶段的项目数量将翻一番，并在五年内在癌症，罕见病和传染病方面推出多达15种产品。

Up to four of those launches could come by 2025..

到2025年，最多可以有四次发射。。

Staying true to its mission, over the next five years the Company will continue to invest in science to expand the field of mRNA medicine into new frontiers and expects to advance up to 50 new candidate medicines into clinical trials across established and new modalities.

为了履行其使命，在未来五年内，该公司将继续投资科学，将mRNA医学领域扩展到新的前沿，并期望通过既定和新的方式将多达50种新的候选药物推进临床试验。

Updates and recent progress include:

更新和最新进展包括：

RESPIRATORY FRANCHISE

呼吸特许经营

Moderna's respiratory pipeline continues to exhibit consistent efficacy in older adults and immunocompromised individuals. The Company is also advancing its efforts to develop multiple generations of single-virus and combination respiratory vaccines that address significant public health needs.

Moderna的呼吸管道在老年人和免疫功能低下的个体中继续表现出一致的疗效。该公司还在努力开发多代单一病毒和组合呼吸疫苗，以满足重大的公共卫生需求。

The respiratory franchise, now a seasonal business with an annual recurring revenue stream, is targeting an approximately $30 billion annual market, comprised of an approximately $15 billion COVID-19 market, a $10 billion RSV market, and a $6 billion flu market, with the potential for growth with more effective vaccines.

呼吸特许经营现在是一项季节性业务，每年都有经常性收入流，目标是每年约300亿美元的市场，包括约150亿美元的COVID-19市场，100亿美元的RSV市场和60亿美元的流感市场，更有效的疫苗有可能增长。

Respiratory products sales in 2027 are expected to be in the range of $8 billion to $15 billion, depending on vaccination rates, efficacy and Company market share, as previously communicated at Vaccines Day..

根据疫苗接种率，功效和公司市场份额，预计2027年呼吸系统产品销售额将在80亿至150亿美元之间，如之前在疫苗日所传达的那样。。

COVID-19 Vaccine Update

COVID-19疫苗更新

Following the June FDA VRBPAC meeting, the Company demonstrated potent neutralization and cross-reactivity with its monovalent XBB.1.5 vaccine, mRNA-1273.815, with similar neutralization for XBB.1.5, XBB.1.16, and XBB.2.3.2 sub-variants. Clinical trial data from research assays also confirmed mRNA-1273.815 showed an 8.7 to 11-fold increase in neutralizing antibodies against circulating variants, including BA.2.86, EG.5, and FL.1.5.1.

在6月FDA VRBPAC会议之后，该公司与其单价XBB.1.5疫苗mRNA-1273.815表现出有效的中和和交叉反应性，对XBB.1.5，XBB.1.16和XBB.2.3.2亚变体具有相似的中和作用。来自研究测定的临床试验数据也证实mRNA-1273.815显示针对循环变体（包括BA.2.86，EG.5和FL.1.5.1）的中和抗体增加8.7至11倍。

With these data, Moderna has confirmed an antibody response against current strains of concern, suggesting that the updated vaccine is well-matched for the upcoming vaccination season..

有了这些数据，Moderna已经证实了针对当前关注菌株的抗体反应，这表明更新的疫苗与即将到来的疫苗接种季节非常匹配。。

On September 11, 2023, the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) for Spikevax® for ages 12 years and above. Emergency Use Authorization (EUA) for the Moderna COVID-19 Vaccine was also received for individuals 6 months through 11 years of age.

2023年9月11日，美国食品和药物管理局（FDA）批准了Spikevax®12岁及以上的补充生物制剂许可申请（sBLA）。Moderna COVID-19疫苗的紧急使用许可（EUA）也在6个月至11岁之间收到。

Moderna's updated COVID-19 vaccine contains spike proteins for the XBB.1.5 sublineage of SARS-CoV-2 to help prevent COVID-19 in individuals 6 months of age and older. Clinical trial data confirm mRNA-1273.815 showed a strong immune response in humans against BA.2.86, EG.5 and FL.1.5.1 variants. With the U.S.

Moderna更新的新型冠状病毒肺炎疫苗含有XBB.1.5 SARS-CoV-2亚系的刺突蛋白，有助于预防6个月及以上个体的新型冠状病毒肺炎。临床试验数据证实mRNA-1273.815在人类中对BA.2.86，EG.5和FL.1.5.1变体显示出强烈的免疫应答。与美国。

FDA's decision, Moderna has begun shipping doses to vaccination sites across the U.S., with updated vaccines expected to be available in the coming days..

FDA的决定，Moderna已开始向美国各地的疫苗接种地点运送剂量，预计未来几天将有更新的疫苗。。

In addition, the Company's next-generation, refrigerator-stable COVID-19 vaccine, mRNA-1283, demonstrated encouraging results in multiple clinical studies and has now completed enrollment of its Phase 3 trial.

此外，该公司的下一代冰箱稳定型COVID-19疫苗mRNA-1283在多项临床研究中表现出令人鼓舞的结果，现已完成其3期临床试验。

Seasonal Influenza Vaccine

季节性流感疫苗

mRNA-1010 demonstrated an acceptable safety and tolerability profile across all clinical trials to date, including three Phase 3 trials (P301, P302, P303), and independent data and safety monitoring boards (DSMBs) have raised no safety concerns.

迄今为止，mRNA-1010在所有临床试验中均表现出可接受的安全性和耐受性，包括三项3期试验（P301，P302，P303），独立数据和安全监测委员会（DSMB）未提出安全性问题。

Enrollment is complete in the Company's Phase 3 safety and immunogenicity trial for the updated formulation of mRNA-1010 (P303). In an interim analysis of the P303 study,mRNA-1010 met all co-primary endpoints across all four A and B strains (A/H1N1, A/H3N2, influenza B/Yamagata, B/Victoria). Higher HAI geometric mean titers and seroconversion rates were observed for all four strains compared to a licensed comparator (Fluarix).

在公司的第3阶段安全性和免疫原性试验中完成了mRNA-1010（P303）更新配方的注册。在对P303研究的中期分析中，mRNA-1010满足所有四种A和B菌株（A/H1N1，A/H3N2，B型流感/山形，B/维多利亚）的所有共同主要终点。与许可的比较物（Fluarix）相比，观察到所有四种菌株的HAI几何平均滴度和血清转化率更高。

Local and systemic solicited adverse reactions were similar to those reported in previous mRNA-1010 studies..

局部和全身征求的不良反应与之前的mRNA-1010研究中报道的相似。。

Improved immunogenicity was observed across age groups, and importantly, was seen in older adults. mRNA-1010 also elicited higher HAI titers against A/H1N1, A/H3N2, B/Victoria, and comparable titers to B/Yamagata compared to Fluzone HD in a separate Phase 1/2 head-to-head study. Consultations with regulators on a potential licensing package are currently ongoing based on these data..

在各个年龄组中观察到改善的免疫原性，并且重要的是，在老年人中观察到。在单独的1/2期头对头研究中，与Fluzone HD相比，mRNA-1010还引发针对A/H1N1，A/H3N2，B/Victoria的更高HAI滴度以及与B/Yamagata相当的滴度。根据这些数据，目前正在与监管机构就潜在的许可一揽子计划进行磋商。。

As the previous P302 efficacy study has not accrued its target case numbers by the end of the most recent season, the Company would need to enroll a second season to accrue enough cases. In light of P303 meeting all its primary endpoints, the Company has decided not to enroll a second season in the P302 study..

由于之前的P302功效研究尚未在最近一赛季结束时累计其目标病例数，因此该公司需要报名第二季以累计足够的病例数。鉴于P303满足其所有主要终点，公司已决定不参加P302研究的第二季。。

The Company continues to advance a portfolio of influenza vaccine candidates that include additional HA antigens for broader coverage of circulating influenza A strains (mRNA-1011 and mRNA-1012) and candidates that incorporate both HA and neuraminidase (NA) antigens to target multiple proteins involved in the influenza virus lifecycle to reduce the potential of viral antigenic escape (mRNA-1020 and mRNA-1030)..

该公司继续推进一系列流感疫苗候选物，其中包括额外的HA抗原，用于更广泛地覆盖循环甲型流感病毒株（mRNA-1011和mRNA-1012），以及包含HA和神经氨酸酶（NA）抗原以靶向多种蛋白质的候选物。参与流感病毒生命周期以减少病毒抗原逃逸的可能性（mRNA-1020和mRNA-1030）。。

Respiratory Syncytial Virus (RSV) Vaccine

呼吸道合胞病毒（RSV）疫苗

Moderna has submitted marketing authorization applications globally for mRNA-1345, a vaccine for the prevention of RSV-associated lower respiratory tract disease (RSV-LRTD) and acute respiratory disease (ARD) in adults aged 60 years or older. The Company filed for a Biologics License Application (BLA) with the FDA and used a Priority Review Voucher (PRV).

Moderna已在全球范围内提交mRNA-1345上市许可申请，mRNA-1345是一种预防60岁或以上成人RSV相关下呼吸道疾病（RSV-LRTD）和急性呼吸道疾病（ARD）的疫苗。该公司向FDA提交了生物制剂许可证申请（BLA），并使用了优先审核凭证（PRV）。

The Company expects an April 2024 PDUFA date. Regulatory applications were also submitted in Europe (EMA), Switzerland (Swissmedic), Australia (TGA), Canada (Health Canada), and United Kingdom (MHRA)..

该公司预计2024年4月PDUFA日期。欧洲（EMA），瑞士（Swissmedic），澳大利亚（TGA），加拿大（加拿大卫生部）和英国（MHRA）也提交了监管申请。。

The regulatory applications are based on positive data from the pivotal ConquerRSV study, a randomized, double-blind, placebo-controlled study of approximately 37,000 adults 60 years or older. The trial met both its primary efficacy endpoints, with a vaccine efficacy (VE) of 83.7% (95.88% CI: 66.1%, 92.2%; p<0.0001) against RSV-LRTD as defined by two or more symptoms, and a VE of 82.4% (96.36% CI: 34.8%, 95.3%; p=0.0078) against RSV-LRTD defined by three or more symptoms.

监管应用基于关键征服者SV研究的积极数据，这是一项随机，双盲，安慰剂对照研究，对大约37000名60岁或以上的成年人进行了研究。该试验符合其主要疗效终点，针对由两种或更多种症状定义的RSV-LRTD的疫苗效力（VE）为83.7%（95.88%CI:66.1%，92.2%；p<0.0001），并且VE为针对由三种或更多种症状定义的RSV-LRTD的82.4%（96.36%CI:34.8%，95.3%；p=0.0078）。

No cases of Guillain-Barre Syndrome (GBS) have been reported with mRNA-1345 in the Phase 3 RSV trial. In addition to older adults, mRNA-1345 is being investigated in a fully enrolled, ongoing Phase 1 trial in pediatric populations..

在3期RSV试验中没有报道mRNA-1345的格林-巴利综合征（GBS）病例。除老年人外，mRNA-1345正在儿科人群中进行全面登记的正在进行的1期临床试验中进行研究。。

Combination Respiratory Vaccines

联合呼吸道疫苗

Moderna's development strategy for combination vaccines can provide substantial public health benefits. The Company's combination vaccine candidates address respiratory viruses associated with the largest disease burden in the category and are designed for higher compliance, increased uptake, consumer convenience and benefits to healthcare systems.

Moderna的联合疫苗开发战略可以提供巨大的公共卫生利益。该公司的联合候选疫苗针对与该类别中最大疾病负担相关的呼吸道病毒，旨在提高依从性，增加吸收率，消费者便利性和医疗保健系统的益处。

Enrollment is now complete in the following combination trials:.

现在在以下组合试验中完成注册：。

Flu/COVID-19 (mRNA-1073: mRNA-1010 + mRNA-1273) Phase 1/2

流感/COVID-19（mRNA-1073:mRNA-1010+mRNA-1273）1/2期

Flu/RSV (mRNA-1045: mRNA-1010 + mRNA-1345) Phase 1

流感/RSV（mRNA-1045:mRNA-1010+mRNA-1345）第1阶段

Flu/COVID-19/ RSV (mRNA-1230: mRNA-1010 + mRNA-1273 +mRNA-1345) Phase 1

流感/COVID-19/RSV（mRNA-1230:mRNA-1010+mRNA-1273+mRNA-1345）第1阶段

Flu/COVID-19 (mRNA-1083: mRNA-1010 + mRNA-1283) Phase 1/2

流感/COVID-19（mRNA-1083:mRNA-1010+mRNA-1283）1/2期

The Company intends to have a combination vaccine available as early as 2025 and expects to regularly update combinations with improved next-generation vaccine candidates as appropriate. The Company further expects to provide an investor update in Q4 of this year.

该公司打算早在2025年就提供组合疫苗，并希望酌情定期更新与改进的下一代候选疫苗的组合。该公司进一步预计今年第四季度将提供投资者更新。

LATENT and OTHER VIRUSES FRANCHISE

潜伏和其他病毒特许经营

Moderna is currently developing vaccines against six latent and other viruses with unmet or underserved needs, including cytomegalovirus, Epstein Barr virus, herpes simplex virus, varicella zoster virus, norovirus, and HIV. The latent and other vaccine market is a large unaddressed market estimated at approximately $10 billion to $25 billion..

Moderna目前正在开发针对六种潜伏和其他未满足或服务不足的病毒的疫苗，包括巨细胞病毒，Epstein-Barr病毒，单纯疱疹病毒，水痘带状疱疹病毒，诺如病毒和HIV。潜伏和其他疫苗市场是一个尚未解决的大型市场，估计约为100亿美元至250亿美元。。

Cytomegalovirus (CMV) Vaccine

巨细胞病毒（CMV）疫苗

The pivotal Phase 3 study of Moderna's CMV vaccine candidate (mRNA-1647), known as CMVictory, is fully enrolled with adults. The trial evaluates the efficacy, safety and immunogenicity of mRNA-1647 in the prevention of primary infection in women of childbearing age.

Moderna的CMV候选疫苗（mRNA-1647）的关键阶段3研究，称为CMVictory，已完全招募成人。该试验评估了mRNA-1647在预防育龄妇女原发感染中的有效性，安全性和免疫原性。

Norovirus (NoV)

诺如病毒（NoV）

Enteric viruses, including norovirus, are a leading cause of global acute gastroenteritis (AGE), resulting in significant morbidity and mortality worldwide, particularly among young children and older adults. Norovirus is highly contagious and the leading cause of diarrheal disease globally, associated with 18% of all diarrheal diseases worldwide, resulting in approximately 200,000 deaths per year and substantial healthcare costs..

肠道病毒，包括诺如病毒，是全球急性胃肠炎（AGE）的主要原因，导致全世界显着的发病率和死亡率，特别是在幼儿和老年人中。诺如病毒具有高度传染性，是全球腹泻病的主要原因，与全球所有腹泻病的18%相关，每年导致约20万人死亡，并产生巨大的医疗费用。。

Moderna is developing two multi-valent virus-like particle (VLP) vaccines to tackle norovirus diversity, mRNA-1403 (trivalent) and mRNA-1405 (pentavalent) for the prevention of acute gastroenteritis (AGE) from the most prevalent norovirus genotypes in young children and older adults. The Phase 1 trial of norovirus vaccine candidate, mRNA-1403, is currently enrolling participants..

Moderna正在开发两种多价病毒样颗粒（VLP）疫苗来解决诺如病毒多样性问题，mRNA-1403（三价）和mRNA-1405（五价）用于预防最常见的诺如病毒基因型的急性胃肠炎（AGE）幼儿和老年人。诺如病毒候选疫苗mRNA-1403的1期试验目前正在招募参与者。。

ONCOLOGY FRANCHISE

肿瘤特许经营

The oncology franchise includes the individualized neoantigen therapy being developed in partnership with Merck, as well as Moderna's checkpoint and triplet vaccines. The announced adjuvant indications for Phase 3 represent estimated eligible population sizes in the U.S. and E.U. of approximately 30,000 patients for melanoma and 101,000 eligible patients for non-small cell lung cancer..

肿瘤学特许经营包括与默克合作开发的个性化新抗原治疗，以及Moderna的检查点和三联疫苗。宣布的第3阶段辅助适应症代表了美国和欧盟约30000名黑色素瘤患者和101000名非小细胞肺癌合格患者的估计合格人群规模。。

Individualized Neoantigen Therapy (INT)

个体化新抗原治疗（INT）

Melanoma: Phase 2b in patients with resected high-risk melanoma (stage III/IV)

黑色素瘤：切除高危黑色素瘤患者的2b期（III/IV期）

In April 2023, Moderna and Merck reported the results from the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial evaluating mRNA-4157 (V940), an investigational individualized neoantigen therapy (INT), in combination with KEYTRUDA, Merck's anti-PD-1 therapy, in patients with resected high-risk melanoma (stage III/IV).

2023年4月，Moderna和Merck报告了2b期KEYNOTE-942/mRNA-4157-P201试验的结果，该试验评估了mRNA-4157（V940），一种研究性个体化新抗原治疗（INT），结合KEYTRUDA，Merck的抗PD-1治疗，切除高危黑色素瘤患者（III/IV期）。

In the overall intention-to-treat population, adjuvant treatment with mRNA-4157 (V940) in combination with KEYTRUDA demonstrated a statistically significant and clinically meaningful improvement in recurrence-free survival (RFS) and reduced the risk of recurrence or death by 44% (HR=0.56 [95% CI, 0.309-1.017]; one-sided p value=0.0266) compared with KEYTRUDA alone.

在总体意向治疗人群中，mRNA-4157（V940）联合KEYTRUDA的辅助治疗显示无复发生存期（RFS）具有统计学意义和临床意义的改善，并将复发或死亡风险降低44%（HR=0.56[95%CI，0.309-1.017]；单侧p值=0.0266）与单独的KEYTRUDA相比。

In June, the Company announced a statistically significant and clinically meaningful improvement in distant metastasis-free survival (DMFS) from the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial. mRNA-4157-P201/KEYNOTE-942 is the first randomized trial to demonstrate improvement in recurrence-free survival and distant metastasis-free survival with an individualized neoantigen therapy approach..

6月，该公司宣布从2b期KEYNOTE-942/mRNA-4157-P201试验中获得无远处转移生存率（DMFS）的统计学显着和临床意义的改善。mRNA-4157-P201/KEYNOTE-942是第一个通过个体化新抗原治疗方法证明无复发生存率和无远处转移生存率提高的随机试验。。

The Company expects to provide additional data from the Phase 2 study in Q4.

该公司预计将在第四季度提供第二阶段研究的额外数据。

Melanoma: Phase 3 in patients with resected high-risk melanoma (Stage IIB-IV)

黑色素瘤：切除高危黑色素瘤患者的第3阶段（IIB-IV期）

Merck and Moderna announced the initiation of a pivotal Phase 3 study (V940-001) to evaluate the safety and efficacy of mRNA-4157 (V940) in combination with KEYTRUDA in people with resected high-risk (Stage IIB-IV) melanoma compared to KEYTRUDA alone. The primary endpoint of the study is recurrence-free survival (RFS), and secondary endpoints include distant metastasis-free survival (DFMS), overall survival (OS) and safety..

默克和Moderna宣布启动一项关键的3期研究（V940-001），以评估mRNA-4157（V940）联合KEYTRUDA治疗切除高危（IIB-IV期）黑色素瘤患者的安全性和有效性。单独使用KEYTRUDA。该研究的主要终点是无复发生存期（RFS），次要终点包括无远处转移生存期（DFMS），总生存期（OS）和安全性。。

Non-small cell lung cancer (NSCLC)

非小细胞肺癌（NSCLC）

The Company presented plans to partner with Merck in an upcoming Phase 3 trial in NSCLC in patients with resected stage II-IIIB NSCLC patients who have received adjuvant chemotherapy, with no recurrence. The companies expect to initiate that trial later this year.

该公司计划与默克公司合作，在即将进行的NSCLC 3期临床试验中，对接受过辅助化疗且无复发的II-IIIB期NSCLC切除患者进行合作。这些公司预计今年晚些时候开始这个试验。

Moderna and Merck plan to expand the INT development program to additional tumor types.

Moderna和Merck计划将INT开发计划扩展到其他肿瘤类型。

Checkpoint Vaccine

检查点疫苗

Moderna's checkpoint vaccine, mRNA-4359, aims to stimulate effector T cells that target and kill suppressive immune and cancer cells that express high levels of target checkpoint antigens. mRNA-4359 is being evaluated in an ongoing Phase 1/2 study as monotherapy and in combination with pembrolizumab.

Moderna的检查点疫苗mRNA-4359旨在刺激靶向并杀死表达高水平靶检查点抗原的抑制性免疫和癌细胞的效应T细胞。正在进行的1/2期研究中评估mRNA-4359作为单一疗法并与pembrolizumab组合。

Eligible tumors included in the trial include cutaneous melanoma, NSCLC, non-muscle invasive bladder cancer, head and neck squamous cell carcinoma, microsatellite stable colorectal cancer, basal cell carcinoma, and triple-negative breast cancer..

试验中包括的合格肿瘤包括皮肤黑色素瘤，NSCLC，非肌层浸润性膀胱癌，头颈部鳞状细胞癌，微卫星稳定结直肠癌，基底细胞癌和三阴性乳腺癌。。

Triplet

三联体

Moderna's Triplet (mRNA-2752) is being evaluated in an ongoing Phase 1 study to evaluate safety and tolerability of mRNA-2752 administered alone and in combination with durvalumab, as well as an ongoing study evaluating mRNA-2752 in patients with ductal carcinoma in situ (DCIS). The dose escalation and confirmation arms enroll participants with accessible solid tumors and lymphomas, and dose expansion enrolls participants with CPI refractory melanoma.

Moderna的三联体（mRNA-2752）正在进行的第一阶段研究中进行评估，以评估单独和与durvalumab联合使用的mRNA-2752的安全性和耐受性，以及正在进行的评估原位导管癌患者mRNA-2752的研究（DCIS）。剂量递增和确认组招募具有可接近的实体瘤和淋巴瘤的参与者，并且剂量扩展招募具有CPI难治性黑素瘤的参与者。

The DCIS study is currently enrolling patients with mRNA-2752 administered as monotherapy..

DCIS研究目前正在招募作为单一疗法施用mRNA-2752的患者。。

RARE DISEASE FRANCHISE

罕见病特许经营

Moderna's rare disease portfolio, which includes therapies targeting methylmalonic acidemia (MMA), propionic acidemia (PA), glycogen storage disease (GSD1A) and Phenylketonuria (PKU) may represent a $10 billion market while also addressing significant unmet medical needs. The Company is expecting up to four rare disease product launches in the next five years..

Moderna的罕见疾病组合包括针对甲基丙二酸血症（MMA），丙酸血症（PA），糖原贮积病（GSD1A）和苯丙酮尿症（PKU）的疗法，可能代表了100亿美元的市场，同时也解决了未满足的重大医疗需求。该公司预计未来五年将推出多达四种罕见病产品。。

Methylmalonic acidemia (MMA)

甲基丙二酸血症（MMA）

MMA therapy candidate, mRNA-3705, encodes for a missing or deficient hepatic enzyme. In the Phase 1/2 study, eleven participants have been dosed, with a total of 221 doses administered. Thus far, all participants have opted to participate in the Open-Label Extension study. To date, mRNA-3705 has generally been well-tolerated with no discontinuations due to safety or meeting protocol defined dose limiting toxicity criteria..

MMA治疗候选药物mRNA-3705编码缺少或缺乏的肝酶。在1/2期研究中，已经给药了11名参与者，总共给予221剂。到目前为止，所有参与者都选择参加开放标签扩展研究。迄今为止，由于安全性或符合方案定义的剂量限制性毒性标准，mRNA-3705通常具有良好的耐受性，不会中断。。

Interim results from the global Phase 1/2 clinical trial of mRNA-3705 demonstrated encouraging initial pharmacodynamic data, with dose-dependent reductions in methylmalonic acid in Cohorts 2 and 3. Early results suggest potential decreases in annualized metabolic decompensation events (MDEs), frequency and MMA-related hospitalizations compared to pre-treatment..

mRNA-3705的全球1/2期临床试验的中期结果表明，令人鼓舞的初始药效学数据显示，队列2和3中甲基丙二酸的剂量依赖性降低。早期结果表明，与治疗前相比，年度代谢失代偿事件（MDE），频率和MMA相关住院的可能性降低。。

Propionic Acidemia (PA)

丙酸血症（PA）

Propionic acidemia is a rare, serious, inherited metabolic disorder with significant morbidity and mortality. Currently, there are no effective therapies for PA that target the underlying root cause of the disease. The global Phase 1/2 clinical trial of mRNA-3927 is enrolling patients in the dose confirmation arm.

丙酸血症是一种罕见的，严重的遗传性代谢疾病，具有很高的发病率和死亡率。目前，没有针对PA的有效疗法来针对疾病的根本原因。mRNA-3927的全球1/2期临床试验正在招募剂量确认组的患者。

Sixteen patients have been dosed with more than 280 intravenous doses of mRNA-3927 and twelve patients have received more than a year of dosing. mRNA-3927 is generally well-tolerated to date with no discontinuations due to safety and no events meeting protocol-defined dose-limiting toxicity criteria.

16名患者接受了超过280次静脉注射剂量的mRNA-3927，12名患者接受了超过一年的给药。迄今为止，mRNA-3927通常具有良好的耐受性，由于安全性而没有中断，也没有事件符合方案定义的剂量限制性毒性标准。

Enrollment is ongoing in the Phase 1/2 study with a goal to identify an optimal dose. All participants who have completed the treatment period of the main study have opted enter a long-term extension study..

在1/2期研究中正在进行注册，目标是确定最佳剂量。所有完成主要研究治疗期的参与者都选择参加长期延长研究。。

PKU

PKU

Phenylketonuria (PKU) is a rare and serious metabolic disease, affecting approximately 40,000 patients in the US and EU5 (France, Germany, Italy, Spain, and the United Kingdom). Mutations in the phenylalanine hydroxylase (PAH) gene encoding the PAH enzyme, result in the inability to metabolize the essential amino acid Phe to Tyr in the liver.

苯丙酮尿症（PKU）是一种罕见且严重的代谢性疾病，在美国和EU5（法国，德国，意大利，西班牙和英国）影响约40000名患者。编码PAH酶的苯丙氨酸羟化酶（PAH）基因突变导致无法将肝脏中的必需氨基酸Phe代谢为Tyr。

There is a high unmet medical need for patients with PKU with early and continuous treatment throughout life being fundamental to prevent the development of irreversible neuropsychiatric outcomes. mRNA-3210 is an mRNA encoding the PAH enzyme encapsulated in the same LNP as that used in MMA and PA development candidates, with the potential to address the unmet need in patients with PKU..

对于PKU患者来说，有一个高度未满足的医疗需求，在整个生命过程中进行早期和持续的治疗对于预防不可逆转的神经精神病学结局的发展至关重要。mRNA-3210是编码PAH酶的mRNA，其封装在与MMA和PA开发候选物相同的LNP中，有可能解决PKU患者未满足的需求。。

The Company has opened an Investigational New Drug Application (IND) for mRNA-3210.

该公司已为mRNA-3210开设研究性新药申请（IND）。

FINANCIAL UPDATE

财务更新

Moderna expects to add $10 billion to $15 billion in annual sales five years after launching new products in Oncology, Rare and Latent diseases by 2028. This is in addition to the previously announced $8 billion to $15 billion of expected sales from the Respiratory Franchise in 2027.

Moderna预计到2028年在肿瘤，罕见和潜伏疾病方面推出新产品五年后，年销售额将增加100亿美元至150亿美元。这是之前在2027年宣布的呼吸特许经营预期销售额80亿至150亿美元的补充。

The Company expects to support this organic growth framework by investing approximately $25 billion in research and development from 2024 through 2028.

该公司预计将通过从2024年到2028年投资约250亿美元的研发来支持这一有机增长框架。

Additionally, the Company continues to expect 2023 COVID-19 sales of $6 billion to $8 billion, dependent on U.S. vaccination rates. While 2023 cost of sales remain elevated, the Company is currently resizing its manufacturing footprint and supply base to accelerate gross margin expansion towards its longer-term target of 75-80%..

此外，根据美国的疫苗接种率，该公司继续预计2023年COVID-19销售额为60亿至80亿美元。虽然2023年的销售成本仍然上涨，但该公司目前正在调整其制造业足迹和供应基地，将利润率大幅扩张至75-80%的长期目标。。

About Moderna

关于现代人

In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale.

自成立以来的10多年中，Moderna已从一家研究阶段公司推进信使RNA（mRNA）领域的计划转变为一家拥有多种临床疫苗和治疗药物组合的企业，涵盖七种模式，广泛的知识产权组合在包括mRNA和脂质纳米颗粒制剂的领域，以及一个集成的制造工厂，可以大规模快速进行临床和商业生产。

Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic..

Moderna与广泛的国内外政府和商业合作者保持联盟，这使得追求开创性的科学和快速扩大的制造业成为可能。最近，Moderna的能力已经汇集在一起​​，可以授权使用和批准最早和最有效的针对COVID-19大流行的疫苗之一。。

Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past eight years.

Moderna的mRNA平台建立在基础和应用mRNA科学，传递技术和制造技术的不断进步的基础上，并允许开发传染病，免疫肿瘤学，罕见疾病，心血管疾病和自身免疫疾病的治疗和疫苗。Moderna在过去八年中被科学评为顶级生物制药雇主。

To learn more, visit www.modernatx.com..

To learn more, visit www.modernatx.com..

Forward-Looking Statements

前瞻性声明

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the potential for Moderna to launch up to 15 products in the next five years, and advancement of new products into clinical studies; Moderna's discussions with regulators and the potential for accelerated, conditional or other product approvals in certain markets; the expectation that INT will begin a Phase 3 study in NSCLC in 2023; clinical trial progress and results from Moderna's programs; Moderna's ability to develop combination vaccines and the benefits of those vaccines; the ability of Moderna's XBB.1.5 monovalent COVID-19 vaccine (mRNA-1283.815) to provide protection during the fall 2023/2024 season; Moderna's ability to develop updated vaccines to provide protection against evolving SARS-CoV-2 variants of concern; the safety and tolerability profile for Moderna's products; and the size of the addressable markets being targeted by Moderna's pipeline, Moderna's estimated future revenue from sales in those markets and its anticipated future margins.

本新闻稿包含经修订的1995年“私人证券诉讼改革法”含义范围内的前瞻性声明，包括以下声明：Moderna在未来五年内推出多达15种产品的潜力，以及新产品的发展进入临床研究；Moderna与监管机构的讨论以及在某些市场加速，有条件或其他产品批准的可能性；预计INT将于2023年开始NSCLC的3期研究；Moderna项目的临床试验进展和结果；Moderna开发联合疫苗的能力和这些疫苗的益处；Moderna的XBB.1.5单价COVID-19疫苗（mRNA-1283.815）在2023/2024秋季提供保护的能力；Moderna能够开发更新的疫苗，以防止不断发展的SARS-CoV-2变种；Moderna产品的安全性和耐受性概况；以及Moderna管道所针对的可寻址市场的规模，Moderna估计这些市场销售的未来收入及其预期的未来利润。

The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements.

本新闻稿中的前瞻性声明既不承诺也不保证，您不应过分依赖这些前瞻性声明，因为它们涉及已知和未知的风险，不确定性和其他因素，其中许多超出了Moderna的控制范围，可能导致实际结果与这些前瞻性陈述所表达或暗示的结果大不相同。

These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading 'Risk Factors' in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2022, filed with th.

这些风险，不确定性和其他因素包括在截至2022年12月31日的财政年度Moderna年度报告10-K表格中的“风险因素”标题下描述的风险和不确定性。

Moderna Contacts

现代接触

Media:

媒体：

Chris Ridley

Chris Ridley

Vice President, Communications

通讯副总裁

617-800-3651

617-800-3651

Chris.Ridley@modernatx.com

Chris.Ridley@modernatx.com

Investors:

投资者：

Lavina Talukdar

Lavina Talukdar

Senior Vice President& Head of Investor Relations

高级副总裁兼投资者关系负责人

617-209-5834

617-209-5834

Lavina.Talukdar@modernatx.com

Lavina.Talukdar@modernatx.com

SOURCE: Moderna, Inc.

资料来源：Moderna，Inc。

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