Celonic AG

近日，mRNA新冠疫苗公司相继公布了最新的临床数据，Moderna公布，其疫苗接种一年后的保护率达到了87%。与Moderna不同，位于美国的另一家mRNA疫苗公司CureVac宣布其开发的第一代mRNA新冠肺炎疫苗CVnCoV在临床2b/3期试验中疫苗保护力仅为47%，但该公司还正在与GSK合作开发 第二代新冠疫苗CV2CoV，临床试验将于第四季度开始。 在全世界都大规模接种新冠疫苗、mRNA技术被热捧的当下，Moderna和BioNTech已经尝尽甜头，后进场者，甚至在效果并不具优势的情况下，能分到多大的市场值得深思。 01 Moderna疫苗接种一年有效率达87% 9月16日，Moderna公布了其新冠疫苗临床三期最新的数据，显示相较于后期的接种者，接种日期越靠前的人疫苗保护力越强。 目前最新的统计数据显示，该疫苗接种一年后的保护力为87%。同日Moderna还与抗体公司AbCellera达成合作，将透过AbCellera的人工智能(AI)抗体开发平台，加速多项适应证「mRNA编码抗体疗法」的开发。 根据Moderna公布的三期临床试验「COVE」最新数据，今年7~8月期间接种疫苗约一年的14746名受试者中，诊案例数为162例(每千人有77.1例)；而接种疫苗约8个月的11431名受试者，确诊案例数为88例(每千人有49.0例)。 另据加州研究机构Kaiser Permanente Southern California近期统计，接种Moderna新冠疫苗一年后，受试者预防确诊的有效性为87%，预防重症住院的有效性更高达96%。而根据美国CDC的最新数据，6~8月期间Moderna疫苗对预防染疫后须接受紧急护理或急诊的有效性为92% ，而对预防重症住院的有效性为95%。 同一天，Moderna还与AbCellera达成一项合作协议，两公司将针对多达6项疾病开发治疗性抗体，并由Moderna创建出可让人体自行制造这些抗体的mRNA。 AbCellera公司是一家人工智能驱动的抗体发现公司。其技术平台通过汇集高通量微流控技术，机器视觉和人工智能技术，能够在单细胞水平对B细胞进行筛选，从而提高发现抗体候选疗法的速度和效率。AbCellera将获得研究资金，并有资格获得后续临床试验和商业里程碑付款、以及产品净销售额的特许权使用费。Moderna将有权开发和商业化合作产生的抗体。 02 mRNA新冠疫苗效果差！CureVac终止疫苗生产合同 日前，总部位于德国图宾根的生物制药公司CureVac宣布，其开发的第一代mRNA新冠肺炎疫苗CVnCoV在临床2b/3期试验中疫苗保护力仅为47%。CureVac宣布调整其mRNA产品线的欧洲制造网络，决定终止与Wacker、Celonic的疫苗生产合同。不过，其同时宣称与Rentschler Biopharma和诺华达成的mRNA生产和配方协议合同不受任何影响。 CureVac表示，这一决定是为了应对疫苗短期需求峰值下降。同时表示产能变化不会影响与葛兰素史克合作研发的第二代新冠疫苗CV2CoV临床试验。据悉，CV2CoV的临床试验预计将于2021年第四季度开始。 今年早些时候，CureVac与诺华签署了初步生产协议，计划到 2022年常能达到2亿剂。该公司当时曾表示正在考虑更多生产合作，总产能在明年达到6亿剂，以满足欧洲的大量供应订单。6月份CVnCoV未能通过第三阶段试验，之后被欧洲联邦卫生部踢出了疫苗采购清单，但Curevac并没有放弃继续寻求欧洲对该疫苗的授权。 就在一个月前，CureVac在其最新的财务报告中透露，该公司与勃林格殷格翰的肺癌项目也已经终止。此举结束了双方7年前签署的高达5亿欧元的合作伙伴关系。2014年双方曾达成协议共同开发CureVac处于早期临床开发阶段的、用于治疗肺癌的治疗性疫苗CV9202。 该公司表示，尽管CureVac决定终止与勃林格殷格翰在该项目上的合作伙伴关系，两家公司仍将继续寻找其他合作方式，以其他方式将CureVac的RNA技术应用于其他潜在的治疗目的。 CureVac首席执行官Franz-Werner Haas在一份声明中表示，“虽然CureVac希望获得更强劲的中期结果，但CureVac认识到在这种前所未有的病毒广泛变异中，保持疫苗疗效高效是具有挑战性的。此外，随着新病毒变种不断出现，变种丰富的环境也凸显了开发下一代疫苗的重要性。”

CureVac and Celonic have entered a commercial supply agreement to manufacture over 100 million doses of the former’s mRNA-based Covid-19 vaccine candidate CVnCoV. As an optimised, non-chemically modified mRNA, CVnCoV encodes the prefusion stabilised full-length spike protein of the SARS-CoV-2 and is formulated within lipid nanoparticles. The vaccine candidate will be produced at Celonic’s commercial manufacturing facility for biologics and advanced therapy medicinal products in Heidelberg, Germany. The companies intend to produce over 50 million doses of CVnCoV before the end of this year. According to the initial agreement, technology and knowledge transfer are progressing. The manufacturing of the mRNA drug substance and the LNP formulation of the bulk drug product are included in the commercial supply agreement. CureVac confirmed a potential output capacity of its extensive European manufacturing network of up to 300 million doses this year. CureVac chief production officer Dr Florian von der Mülbe said: “The manufacturing of sufficient quantities of vaccine is critical to combating the Covid-19 pandemic. “With this partnership, we are further extending our integrated European manufacturing network, reinforcing the overall production capacity for our Covid-19 vaccine candidate CVnCoV.” Thematic Reports Are you worried about the pace of innovation in your industry? GlobalData's TMT Themes 2021 Report tells you everything you need to know about disruptive tech themes and which companies are best placed to help you digitally transform your business. Find out more According to phase I interim data, CVnCoV was generally well tolerated across all tested doses and prompted robust antibody responses apart from showing signs of T cell activation. The quality of the immune response was similar to recovered Covid-19 patients, imitating the immune response after a natural infection. CureVac commenced a phase IIb/III HERALD study of a 12µg dose of CVnCoV last December and began a rolling submission with the European Medicines Agency (EMA) for the vaccine candidate last month. Celonic CEO Dr Konstantin Matentzoglu said: “We have invested heavily to support our partners in bringing novel Covid-19 therapeutics and vaccines to patients at an accelerated pace.” Earlier this month, Novartis entered an initial agreement with CureVac to manufacture the mRNA and bulk drug product for CVnCoV.

Paris, March 12, 2010 – Cellectis (Alternext: ALCLS), the French genome engineering specialist, today published its consolidated financial results according to International Financial Reporting Standards (IFRS) for the year ending December 31, 2009. Key financial figures: - Total operating revenues increased by 14% between 2008 and 2009 from €10.6 million to €12.1 million. This was driven by several major deals (Limagrain, Monsanto, Bayer Healthcare and BASF Plant Science) and progress with existing partners. In 2008, revenues had been driven primarily by a single contract (over €7 million from Regeneron Pharmaceuticals), which represented nearly 70% of total operating revenues. - Total operating expenses rose by 48% between 2008 and 2009, up from €14.0 million to €20.8 million. This was due to increased investment in the company’s therapeutic programs in general and preclinical activities in particular. - Operating activities consumed €4.9 million in cash in 2009, compared with a cash increase of €1.4 million in 2008. However, Cellectis strengthened its overall, year-on-year cash position by €16.9 million, up from €28.7 million at the end of 2008 to €45.6 million at the end of 2009 (mainly as a result of a successful capital increase in October 2009). Commenting on the results, Cellectis Chief Financial Officer Marc Le Bozec said: "2009 was a banner year for Cellectis, as we continued to transform the company from a research hub founded 10 years ago to an organization fully committed to maximizing the value of its technology. We have laid important groundwork for growth and we plan to build on these foundations in the year ahead. We will achieve this by increasing our presence in the research tools market, securing recognition of our strong intellectual property via the signature of additional commercial agreements, growing our plant sciences subsidiary and advancing the development of meganucleases for therapeutic applications. Our strategy is to remain focused on the applications which have the greatest potential for shareholder value creation." Highlights for 2009: - Production capacity: Significantly increased meganuclease production capacity, with ninety-six highly specific meganucleases produced for given genomic targets (compared with twelve in 2008). By constantly improving its engineering processes, Cellectis significantly raised both the quality and activity standards of its engineered products. - Cellectis bioresearch: Launched five new kits for use in research and production and acquired a commercial license to Celonic’s Cemax® technology for accelerating product development and portfolio expansion. Additionally, a new collaboration was signed with tebu-bio for the distribution of Cellectis bioresearch’s targeted integration kits throughout Europe, a deal which is expected to further expand the technology's user network. - Agrobiotechnology: Completed three major deals, the most significant being a non-exclusive research and commercial license agreement with Monsanto, which included an upfront payment and an equity investment as well as milestone payments and royalties in the longer term. - Therapeutic applications: Generated strong animal safety data supporting proof of concept for therapeutic applications of meganucleases. Results showing the potential of engineered meganucleases in drug discovery and gene therapy were published in major peer-reviewed scientific journals. ? Licensing and intellectual property: Initiated over twenty licensing discussions in Japan, Europe and USA. Reinforced the company's intellectual property estate with the filing of fifteen new patent applications, the grant of four patents and the acquisition of the Vectocell® technology and its nine new patent families. Cellectis will today hold a conference call and webcast, in English, to discuss its financial results for 2009 (5.00 pm CET; 4.00 pm GMT; 11.00 am EST) About Cellectis Cellectis is a pioneer in the field of genome engineering. The company designs and markets innovative tools -meganucleases. These molecular scissors enable targeted modifications to DNA, with applications in the research, biomanufacturing, agrobiotechnology and therapeutic sectors. To date, Cellectis has formed over 20 academic research partnerships and has established more than 50 agreements with pharmaceutical laboratories, seed producers and biotech companies across the world. The company holds exclusive rights to a portfolio of over 260 patents granted or pending. Since 2007, Cellectis has been listed on the NYSE-Euronext Alternext market (code : ALCLS) in Paris and has secured over €70 million in funding since inception. More information at