Aston SCI

A New Vaccine Approach for Ovarian Cancer Patients SEOUL, South Korea, Sept. 12, 2023 /PRNewswire/ -- Aston Sci. is proud to announce that it has received Phase 2 Clinical Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) for its innovative cancer vaccine, AST-201, designed specifically for ovarian cancer. This milestone achievement, known as the CornerStone-004 program, marks a significant step forward in Aston Sci.'s fight against women's cancers. Study Highlights and the Primary Objective: The study is a randomized controlled trial designed to assess the clinical efficacy and safety of the plasmid-based DNA vaccine AST-201 when administered alongside standard adjuvant chemotherapy (Paclitaxel/Carboplatin), for patients with newly diagnosed Stage III advanced ovarian cancer following surgical intervention. The primary objective of this study is to evaluate the clinical efficacy of AST-201 compared to a placebo, as measured by the progression-free survival (PFS) rate. Aston Sci.'s Pipeline Expansion: With this milestone, Aston Sci.'s pipeline has expanded to include two drug candidates in multinational Phase 2 clinical trials: AST-201 for ovarian cancer and AST-301 for breast and gastric cancer. This milestone underscores Aston Sci.'s position as a frontrunner in the field, with a total of four drugs in advanced clinical stages. Aston Sci. is currently conducting or planning four CornerStone clinical programs in the United States, Taiwan, Korea and Europe. A New Vaccine Approach for Ovarian Cancer Patients: "In a global environment where approved immunotherapies for ovarian cancer remain scarce, our dedicated efforts are focused on delivering a safer and more advanced treatment option for ovarian cancer patients. We are committed to sharing our results at the earliest opportunity," said Dr. Hun Jung, Head of R&D Division at Aston Sci. Inc. "We will expand clinical research across various indications and reaffirm our expertise in the field of cancer vaccine development." About Aston Sci. Inc. Aston Sci. Inc. is a clinical-stage biopharmaceutical company led by a team of global pharmaceutical experts. Specializing in innovative immunotherapies, including therapeutic cancer vaccines, Aston Sci. focuses on enhancing T-cell immune responses against specific antigens, triggering cancer cell apoptosis. Central to our mission is the Th-Vac® platform. This platform, grounded in immune informatics, facilitates continuous epitope discovery, serving as the cornerstone of our ongoing efforts in therapeutic vaccine development. Headquartered in Seoul, South Korea, with a U.S. office in Seattle, Washington, Aston Sci. is deeply committed to delivering advanced treatments and preventing cancer recurrence, ultimately striving for safer and more effective options for cancer patients worldwide. Media Contact: Kevin KP Jang Public Affairs Manager [email protected] SOURCE Aston Sci. Inc.

当下，全球生物医药产业的交融仍在继续，各种合作形式亦在持续开拓。尤其在当前一级市场投资情绪不高、节奏明显放缓的情况下，合作共赢或成破局之道，将有限的产业资源放到更熟悉的领域，竭尽全力地转化创新的果实。从全球层面，将现有的管线，以互利共赢的形势，放到更能够发挥价值的地方，更好解决未被满足的临床需求。无论是生物技术公司，大药厂还是投资机构，若能在这一点上达成一致，就能产生更多的合作，挺过“寒流”，共登彼岸。为此，8月10日，由猎药人俱乐部、E药经理人主办，U Chem 、凯莱英医药集团支持的韩国前沿创新生物药项目投融资路演交流会在上海猎药人俱乐部举办，在精准化对接、咨询、服务等方式，与生物技术公司、商业化制药企业、投资机构一道探讨创新价值，增进了解，促成合作，帮助极具临床价值的创新药械项目与头部制药企业实现高效对接与赋能，助力生物技术公司产业融资与制药企业转型升级。本次韩国前沿创新生物药项目投融资路演交流会现场看点颇多，参与大会的有AbTis、Aston Science、DigmBio、Aptamer Science、Immunoforge株式会社、 lmmuse Therapeutics等多家韩国药企，涉及ADC、CGT、HPV、小核酸药物、COPD、DMD等诸多前沿项目。场上有投资人评价，“韩国生物创新有看点！”01中国生物制药市场面临的机遇与挑战开场，波士顿咨询全球合伙人胡奇聪率先做了《Opportunities and  Challenges facing Biopharma markets in China》的主题报告，介绍了在中国生物制药市场的主要发展趋势，同时强调需要积极拥抱市场全球化。就市场规模而言，中国制药市场已经位居全球第二，相对于其他发达市场，预计将强劲增长。而创新趋势同样势不可挡，在他看来，目前中国生物技术创新正处于拐点，向创新2.0和3.0快速发展。从“快速跟进”已验证或临床目标的创新1.0阶段，再到新靶点/技术改进的创新2.0阶段，联合治疗、BsAb、ADC等开始生长；而今，则朝着如CGT、mRNA等前沿目标/新技术蓬勃发展的创新3.0前进。一个趋势愈发明显。相比小分子、单克隆抗体等传统技术，而今技术创新如RNAi、mRNA、细胞和基因治疗，以及技术/治疗改进如组合、BsAb、ADC、创新交付新技术领域发展势头较猛。不可否认的是，制药行业已从小分子发展到了生物制剂、CGT和RNA时代。其中CGT预计将享受最高的增长，但生物制剂仍然是主要的生长方式。随着小分子和生物制剂的成熟，业内对RNA治疗也投入了重要的临床兴趣，从2014年到2022年，RNA治疗药物在药物批准量和销售收入方面亦出现了快速增长。目前，虽然中国创新药市场覆盖较全球创新药市场差距仍然存在，但近年来随着一系列政策的出台，中国推出的创新药物数量显著增加。会上分享的一组数据显示，2021年全球创新药市场约8300亿美元，其中美国创新药占比超一半；中国创新药占全国药品销售额约1/10，远低于发达国家。不过自2018年以来，中国推出创新药物的速度显著提高，2021年批准的创新药物超过了FDA。此外，由于MAH改革、生物制剂管线的快速增长和生物加工能力的缺乏，中国的生物制剂CDMO市场正在快速增长。与此同时，中国制药公司也正在积极开展生物仿制药全球化；过程中问题同样也较为明显，中国生物制剂市场高度同质，专注于几个过热的目标，从而使同质化药物在IND注册和BLA批准方面面临挑战。在投资和融资活动方面，会上透露，2022年投融资仍然活跃，与2021年的一些交易数量相当；但对生物技术公司、医疗设备和供应商的资本投资经历了大幅下降。而今，中国生物科技股正经历着先前市场过热后的低迷，随着国家证券交易所提高了非盈利生物技术IPO的门槛，导致新上市生物技术公司减少。“不过，生物技术资本市场是周期性的，根据历史数据，可能需要3-4年才能完全恢复。”在胡奇聪看来。02韩国前沿创新生物药项目百花齐放在如此局面下，“合作共赢”或成当下产业“破局”刚需。在本次路演项目中，诸多韩国前沿项目亮相，涉及了HPV、Car-T、ADC、小核酸药物、COPD等较多新技术领域。如在国内外热火朝天的ADC领域中，一家韩国ADC新药研发公司AbTis带来了专有的下一代ADC接头技术使特定数量的有效载荷能够结合到特定位点，而无需抗体工程。成立于2011年的韩国Aptamer Science公司也正在中国寻找各种战略伙伴关系机会。成立以来，从适体发现到各种应用的集成技术平台，它开发了一系列用于靶向递送的适体（TfR、ASGPR等），逐渐成为全球领先的适体玩家。据透露，Aptamer Science与多家制药公司合作研究也正在进行中，一些基于专有的ApDC平台的治疗管线产品正如火如荼开发，并且第一个临床试验将于2024年年初展开。“适体与抗体技术相比具有关键的优势，有望成为下一代蛋白结合物。”场内有人如是评价。成立于2017年的Immunoforge株式会社，旗下已基于ELP平台研发了多款药物，如PF1801、 PF1804等；还涉及了耐药性慢性髓性白血病KF1601，治疗肌肉萎缩性侧索硬化症 (ALS)、帕金森病PF1802等。目前体量不算太大的DigmBio公司管线却涵盖了肿瘤、神经退行性变、纤维化、NASH等多领域，靶点涉及PARP-1、KRAS G12D、TASR、Mast cell、stabilizer等。据透露，目前该公司共11人，其中研发部9人。两个多月前，便有一项合作展开，DigmBio与Inno Pharma Screen（IPS）签署了一项商业协议，使用分子胶技术开发KRAS抗癌药物，DigmBio将在一个联合开发项目中应用IPS的分子胶技术，以靶向顽固的KRAS G12D突变胰腺癌和结直肠癌。韩国Aston Science公司则是一家专门从事治疗性癌症疫苗临床开发的临床阶段生物制药公司，其主要产品AST-301 (HER2-hICD疫苗)的2期临床试验已获得FDA的新药临床试验批准。除此之外，路演项目中还涉及基于VLP平台技术研制9价HPV疫苗、COPD以及抗衰老细胞外基质疗法、小核酸药物、DMD等多项前沿疗法。而今，韩国生物制药产业仍将其羽翼不断延伸向外，逐渐在国际上打出一片天地。同时，中韩生物医药合作也日益频繁。尤其在当前一级市场投资情绪不高、节奏明显放缓的情况下，合作共赢或成破局之道。

Ely Reeves Callaway (1947-2023). Photo Credit, all images: Callaway Cars American automotive company Callaway Cars (Old Lyme, Conn., U.S.) announces with deepest sadness the passing of its founder and CEO, Ely Reeves Callaway III, on July 11, 2023, at his home in Newport Beach, Calif., U.S. from injuries sustained after a fall. Reeves was a notable figure in the world of high-performance automobiles. Entirely self-taught, Reeves founded the company in 1977 from his garage in Old Lyme, Conn., U.S. His first product success was an aftermarket turbo kit for BMW, which automotive journalist Don Sherman reviewed favorably that year in Car and Driver. The rest was history as Reeves, a Formula Vee champion driver prior to becoming a constructor, moved with his customary speed to open Callaway Cars’ first headquarters. Over the four decades since, Reeves and Callaway Cars have continued to earn top accolades from media, the automotive industry and the global motorsports world. His performance and design innovations have delivered track and road-going successes for global marques, including BMW, Alfa Romeo, Aston Martin, Land Rover, Mazda and General Motors (GM), who looked to Callaway’s innovation, creativity, agility and performance to help accomplish their goals. Reeves is perhaps best known for his work with Corvette, a deep and high-level relationship with the American sports car manufacturer that began in 1987 and culminated with two industry firsts: The Callaway Twin Turbo Corvette “B2K” designation, and a Twin Turbo Corvette, dubbed “The Sledgehammer,” which, in 1989, set a production car top speed record of 254.76 miles per hour. In 1994, Reeves launched a Germany-based racing unit, Callaway Competition, with partners Ernst Wöhr and Giovanni Ciccone. International recognition was achieved by their successes at the 24 Hours of Le Mans, and later a European GT racing team which ultimately led to authorization by GM to construct and homologate C6- and C7-generation GT3 race cars for international competition. Reeves is said to be one of the last and most successful one-man, single-vision practitioners of hyper-performing internal combustion automobiles. It’s a rare-air field that includes the likes of Ettore Bugatti, Ferry Porsche and Enzo Ferrari, to name a few. His vision, creativity and innovation encompassed not only automotive engineering, but aviation and aerospace as well with Callaway Carbon Inc. (Temecula, Calif., U.S.) which performs custom car upgrades with carbon fiber conversion kits. A longtime helicopter pilot and board director for Kaman Corp. (Bloomfield, Conn., U.S.), Reeves was, in recent years, a founding adviser to a hydrogen-powered and composite-intensive, blended-wing aircraft startup with funding from NASA and the Air Force. “Thanks to Reeves’ visionary entrepreneurial spirit, Callaway Cars will continue to innovate and grow in the 21st century, inspired by his unique, extraordinary vision, and by his personal example of integrity, resourcefulness and leadership as our founder,” says his son, Peter Reeves Callaway, the company’s president. “Dad’s passion for making beautifully designed and crafted machines can be seen in each and every project, and we remain devoted to executing to the highest standards, in true Callaway fashion. He was rarely found doing anything other than working towards the next milestone for the company. He was a charismatic leader with a sense of humor that we will all remember through various ‘Reeves-isms.’ I feel fortunate to have grown up working with him and the company.” The first son of Ely Reeves Callaway, Jr., the founder of Callaway Golf, and brother of publisher Nicholas Callaway, Reeves proudly epitomized the entrepreneurial Callaway family tradition of making the finest goods that enhance an individual’s enjoyment, performance and lifestyle. A true gentleman, he was the devoted father of four and grandfather of two. His large circle of friends, colleagues and admirers around the world will mourn his passing and miss him deeply.