Immunogenesis, Inc.

导读“我们只关注癌症，并见过各种疑难杂症。我们的医生一天内治疗的罕见癌症比大多数医生一生看到的还要多”。 MD安德森癌症中心在官网介绍自己时有这样一段话。  如果是别的研究所这么说多少有点说大话的嫌疑，但如果是MD安德森，那似乎就很合理了。        在今年新鲜出炉的“美国最佳医院”排名中，MD安德森再一次在肿瘤医院排名中位列第一，而在近十年里，它几乎年年第一。          MD安德森logo也非常有趣，那就是它将“cancer”一词用斜线划掉，可见MD安德森对战癌症的勃勃雄心。          2016年奥巴马政府发起了癌症登月计划，而MD安德森早在2012年就启动了这项计划。为何MD安德森总能在癌症研究方面快人一步？    01癌症疫苗IMGS-001开启临床试验           2023年10月底，德克萨斯大学MD安德森正式开展了IMGS-001对局部晚期或转移性实体肿瘤患者的1a/1b期试验。                          IMGS-001是由美国生物技术公司ImmunoGenesis研发的抗癌新药，是一种双特异性PD-L1/PD-L2抗体药物，旨在针对现有免疫疗法具有抵抗力、难以治愈、排斥免疫的肿瘤。           为何IMGS-001的药物试验会选择在MD安德森进行？这或许与MD安德森在癌症领域的绝对权威有关。在《美国新闻与世界报道》的肿瘤排名名单中，MD安德森常年霸榜第一。           2022年，MD安德森开启了1680项临床试验，22种药物获得了FDA批准。02MD安德森雄心勃勃的创建史MD安德森位于休斯顿的德克萨斯医疗中心，而德克萨斯医疗中心是世界上最大的医疗中心。MD安德森的创建与一个人密切相关，那就是梦露·邓纳威·安德森（Monroe Dunaway Anderson）。                          安德森出生于1873年，他的父亲是一位银行行长。长大后，安德森和家族成员共同从事棉花生意，并很快积攒了一大笔财富。1936年，安德森创建了以他的名字命名的慈善基金会，并为基金会提供了约30万美元的启动资金。           1939年，安德森去世，基金会分得了一笔1900万美元的巨款。事实上，对于这笔巨额基金该如何处理，MD安德森基金会没有明确的章程。不过这笔基金的受托人有一个强烈的愿景，希望用于医疗保健。           1941年，德克萨斯州政府批准了德克萨斯大学在该州某地建立一家癌症研究和治疗医院的请求，并为这项计划拨款了50万美元，但没有具体说明建设地点。           得克萨斯大学与安德森基金会协商后达成一致：如果这所医院建在休斯顿，并以基金会的捐助者名字来命名，那么安德森基金会可以再提供50万美元的资金。之后，德克萨斯大学在德克萨斯州立癌症医院和癌症研究部的基础上，成立了MD安德森癌症研究医院。           在那之后，MD安德森癌症研究医院经历了多次名字的变迁：    1941年：由德克萨斯州立法机构成立，前身为德克萨斯州立癌症医院和癌症研究部。1942年：更名为德克萨斯大学MD安德森癌症研究医院，以表彰MD安德森基金会的支持。1955年：更名为德克萨斯大学MD安德森医院和休斯顿肿瘤研究所。1972年：德克萨斯大学系统重组导致德克萨斯大学系统癌症中心的成立，包括休斯顿的医院和研究机构以及史密斯维尔的科学园。       1946年，研究医院迎来第一位全职校长——伦道夫·李·克拉克（Randolph Lee Clark）。           乔纳森·罗兹与李·克拉克（右）           彼时，MD安德森癌症研究医院在当时才刚刚起步，正值战乱年代，美国研究所的费用和各类用品都极为短缺，因此研究医院的发展一度受限，举步维艰。克拉克上任后立志用有限的资源，将研究医院发展为“美国大学系统内的第一家癌症医院”。他当时给好友伦道夫·菲尔兹（Randolph Fields）写信时提到建设癌症医院的思路：           “有三个主要目标：与癌症疾病相关的教育、治疗和研究活动。这些目标是整个企业的主题，也是每个部门职能的基调”。              可以说，克拉克一生都在兢兢业业为实现这三个目标而奋斗，他在这里工作了32年，直到1978年退休；之后由查尔斯·A·莱梅斯特（Charles A. LeMaistre）和约翰·门德尔森（John Mendelsohn）陆续接任。           直到2011年，第四任校长罗纳德·德皮尼奥（Ronald DePinho）的上任又将MD安德森的癌症研究带向了全新的方向，在他的带领下，MD安德森启动了一项雄心勃勃的癌症“登月”（Moon Shots）计划。03MD安德森何以成为全球癌症研究的先行者？目前，MD安德森如今有23040名员工，包括1870名教职员工。MD安德森现任领导，即第五任总裁彼得·W·T·皮斯特斯（Peter WT Pisters），他以癌症外科医生、研究员、教授和医院管理人员而闻名。              MD安德森的财政来源也很丰富，最主要的一个来源是德克萨斯州癌症预防研究所（CPRIT）。2022财年，MD安德森从CPRIT获得了超过3200万美元的资金支持，用于研究、招聘和培训等事务。           此外，MD安德森获得了国家癌症研究所卓越研究专业计划（SPORE）资助，用于子宫内膜癌、前列腺癌、黑色素瘤、胃肠道癌、脑癌、白血病癌、肺癌、卵巢癌和肝细胞癌等9个方面的研究。           “对抗癌症”是MD安德森一个非常显著的标签，可以说，MD安德森是个不折不扣的癌症研究和治疗的先行者，甚至在Logo设计上，MD安德森特意将“癌症”一词划掉了。           1971，美国颁布《国家癌症法》，指定的美国最早的三个综合癌症中心，MD安德森是其中之一；目前，美国国家癌症研究所指定了53个综合癌症中心，MD安德森亦是其中之一。           另外，在《美国新闻与世界报道》“2023年-2024年最佳医院”评选中，MD安德森在癌症护理方面排名第一。自1990年有这项排名以来，该机构每年都被评为全国癌症护理排名前两位，近十多年来，几乎年年第一。                          之所以能够在癌症领域获得如此高的声誉，离不开MD安德森在癌症方面的开拓精神。           2016年，奥巴马政府启动癌症登月计划，主张将1亿9500万美元用于癌症研究，2022年，拜登政府紧随其后，承诺在未来25年将癌症死亡率降低50%。           而早在2012年的时候，有着先见之明的MD安德森第四任校长罗纳德·德皮尼奥（Ronald DePinho）带领MD安德森开启了“登月”（Moon Shots）计划。               2016年12月，德皮尼奥（中）在华盛顿特区签署的《21世纪治愈法案》           这项计划旨在降低癌症的死亡率和发病率。在最开始的时候，MD安德森计划为该项目投入30亿美元，并提出口号：“癌症在此终结”（Cancer ends here）。让癌症可预防、可看见、可治疗，甚至被遗忘。           事实上，这项计划也取得了不错的成果：2014年10月，研究人员提出新算法将卵巢肿瘤切除成功率提高到80%；2016年8月，早期治疗活检预测黑色素瘤免疫治疗的反应；2016年10月，首个由IACS开发的饥饿癌细胞药物进入临床试验；2020年2月，CD19 CAR NK细胞在血液系统癌症中取得高反应。           在医疗试验之外，MD安德森还实现了从法律、提案等角度提升公众健康指数：2019年5月，德克萨斯州将烟草销售年龄提高至21岁，这同样是MD安德森癌症登月计划的一项重要成果。              尽管30亿美元的资金投入不足以让MD安德森未实现“消除癌症”的终极目标，但这项计划无疑推动了癌症领域的研究，更在社会范围内促成了对癌症的关注。后续拜登政府再次提出癌症登月计划，或许多少受到MD安德森该计划的指引。           在临床试验方面，2022年这年，MD安德森进行了1680项临床试验，临床试验共有10074名患者参与，获得了116项专利，研究的经费高达11亿美元，在该中心测试的22种药物获得了FDA批准。           可以说，“癌症登月计划”是MD安德森癌症研究和治疗的一个缩影，正是这种开拓精神以及对人类健康和安全的关切，才会铸就MD安德森在癌症领域的高峰。           参考资料     1、Best Hospitals | U.S. News Hospital Rankings and Ratings.U.S. News & World Report.2、Dosing Begins in Phase 1a/1b Study of IMGS in R/R Solid Tumors..targeted Oncology.3、Randolph Lee Clark.wikipedia.4、MD Anderson Cancer Center.wikipedia.识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

[28-September-2023] IMGS-001 is the first dual-specific PD-L1/PD-L2 antibody with cytotoxic function designed to treat immune-excluded cancers that are resistant to existing immunotherapies HOUSTON, Sept. 28, 2023 /PRNewswire/ -- ImmunoGenesis, a clinical-stage biotechnology company developing science-driven immunotherapies, today announced the first patient has been dosed in the company's Phase 1a/1b clinical trial of its lead candidate, IMGS-001, at The University of Texas MD Anderson Cancer Center in Houston, Texas. IMGS-001 is a dual-specific programmed cell death 1 ligand 1 (PD-L1)/programmed cell death 1 ligand 2 (PD-L2) antibody engineered with cytotoxic function designed to treat cold, immune-excluded tumors, which are resistant to existing immunotherapy. The Phase 1a/1b first-in-human, open-label, multicenter study (NCT06014502) consists of a dose escalation and expansion portion to evaluate the safety, pharmacokinetics and preliminary anti-tumor activity of IMGS-001 in adult patients with locally advanced or metastatic solid tumors refractory to standard-of-care treatment. Anticipated tumor types in the dose escalation portion of the study include ovarian, colorectal and triple-negative breast cancer. "Many tumors are not responsive to the current immunotherapies, representing a significant unmet need," said ImmunoGenesis President and CEO James Barlow. "Our vision is to unlock the potential of immunotherapy for a broader group of patients by targeting key mechanisms of immune resistance. We believe that this study will deliver initial proof of concept for our groundbreaking multitasking approach of using a single molecule to address immunosuppression and PD-1 pathway blockade." "PD-L1 and PD-L2 are widely expressed not only on various tumors but also on immunosuppressive cells in the tumor microenvironment," said ImmunoGenesis Acting Chief Medical Officer Dr. Jeremy Barton. "IMGS-001 is designed to remove these immunosuppressive cells and potentially improve PD-1 pathway blockade. This Phase 1a/1b clinical trial is an important first step towards validating this approach as potentially effective in treating cold, immune-excluded cancers." About IMGS-001, a PD-L1/PD-L2 Dual-Specific Inhibitor IMGS-001, the lead program at ImmunoGenesis, is a PD-L1/PD-L2 dual-specific monoclonal antibody with engineered cytotoxic effector function. IMGS-001 is the first molecule in clinical testing to target PD-L2 in addition to PD-L1, potentially improving blockade of the PD-1 pathway. The engineered effector function may enable IMGS-001 to eliminate immunosuppressive PD-L1- and/or PD-L2-expressing cells present in the tumor microenvironment, providing the potential to overcome immune resistance in immune-excluded tumors. Preclinical data showed that IMGS-001 drove higher response rates in head-to-head studies compared to currently available immunotherapies. IMGS-001 may provide a new foundational therapy with its innovative multitasking mechanism of superior blockade and cytotoxic effector function. This work was conducted with support from the Cancer Prevention and Research Institute of Texas (CPRIT) DP200094 as well as an investment from the Cancer Focus Fund, LP. About ImmunoGenesis ImmunoGenesis is a clinical-stage immuno-oncology biopharmaceutical company re-envisioning the treatment of cold tumors, particularly of immune-excluded tumors. Immune-excluded tumors, which account for more than half of all cancers, are characterized by having mechanisms of resistance that suppress the immune response. ImmunoGenesis is creating therapies based on the pathology of these tumors that are rationally designed to overcome immune exclusion and thereby drive an effective immune response. For more information, visit Contacts ImmunoGenesis Investors: James Barlow President and CEO James.barlow@immunogenesis.com Media: Jennifer Guinan Sage Strategic Marketing jennifer@sagestrat.com

First dual-specific PD-L1/PD-L2 antibody with killing function designed to treat the many "immune-excluded" cancers that are resistant to existing immunotherapies Phase 1b will focus on tumors that are resistant to existing immunotherapy, which may include ovarian, colorectal, and triple negative breast cancers HOUSTON, June 27, 2023 /PRNewswire/ -- ImmunoGenesis, a clinical-stage biotechnology company developing science-driven immune therapies, and Cancer Focus Fund, LP, a unique investment fund established in collaboration with The University of Texas MD Anderson Cancer Center to provide funding and clinical expertise to advance promising cancer therapies, today announced that Cancer Focus Fund plans to invest $4.5 million to support the Phase 1a/1b clinical trial of ImmunoGenesis' lead candidate, IMGS-001. IMGS-001 is a dual-specific PD-L1/PD-L2 antibody designed to treat immune-excluded tumors, which are resistant to existing immunotherapy. The investment will support the portion of the IMGS-001 Phase 1a/1b multi-site clinical trial being conducted at MD Anderson. It coincides with ImmunoGenesis' Series A financing, which is expected to close in the third quarter. "Overcoming the widespread resistance to immunotherapy in immune-excluded tumors requires re-envisioning the starting point for treatment," said Dr. Michael A. Curran, Founder of ImmunoGenesis. "We are addressing this challenge by developing a novel, dual–specific PD–L1/PD–L2 inhibitor engineered to include tumor-killing effector function – essentially addressing tumor pathology at the roots. Based on the results of preclinical studies, we believe that IMGS–001 has the potential to significantly improve clinical response over currently approved checkpoint inhibitors for patients with immune-excluded tumors." IMGS-001 is based on discoveries made by the laboratory of Dr. Curran, Associate Professor of Immunology at MD Anderson, and by the Oncology Research for Biologics & Immunotherapy Translation (ORBIT) platform, part of MD Anderson's Therapeutics Discovery division. The technology was licensed to ImmunoGenesis in 2019. "The Cancer Focus Fund Scientific Advisory Board is made up of expert scientists and clinicians and to be recommended for an investment by this group is an honor that we believe provides validation of the clinical potential for IMGS-001," said James Barlow, ImmunoGenesis President and CEO. "We believe that IMGS-001 has the potential to become the foundational treatment for immune-excluded tumors where there is both significant unmet need and tremendous market opportunity. This funding, combined with our upcoming Series A financing, will provide the opportunity to establish the initial proof of concept for this groundbreaking approach and bring hope, and potentially life-saving treatments, to the patients battling these difficult tumors." "Cancer Focus Fund was founded with the goal of assuring that innovative early-stage cancer therapies had the opportunity to undergo the rigorous clinical testing needed for advancement," said Ross Barrett, a founder and Managing Partner of Cancer Focus Fund. "We are thrilled at the opportunity to invest in the exciting new approach to cancer immunotherapy pioneered by Dr. Curran – our first investment in a discovery made at MD Anderson and developed by a biotechnology company located here in Houston. Immune-excluded tumors are thought to represent more than half of all cancers and contribute to the high failure rates that limit the potential of cancer immunotherapy for too many patients. We welcome the opportunity to support ImmunoGenesis by investing in this promising candidate and look forward to the results of this important clinical trial." About the IMGS-001 Phase 1a/1b Clinical Trial This funding will support a Phase 1a/1b, first-in-human, open-label, dose-escalation and dose–expansion study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary anti-tumor activity of IMGS-001. Phase 1a is a dose-escalation study that aims to determine the safety, tolerability, and maximum tolerated dose (MTD) of IMGS-001 in adult patients with locally advanced or metastatic solid tumors refractory to appropriate standard of care treatments. Phase 1b is an open-label, dose-expansion cohort study of patients with prespecified tumors intended to further assess the safety and preliminary antitumor activity of IMGS-001. Dr. David S. Hong, Professor of Investigational Cancer Therapeutics at MD Anderson, will serve as Principal Investigator of the trial. About IMGS-001, a PD-L1/PD-L2 Dual-Specific Inhibitor IMGS-001, the lead program at ImmunoGenesis, is a PD-L1/PD-L2 dual-specific inhibitor with engineered cytotoxic effector function. IMGS-001 is the first molecule to target PD-L2 in addition to PD-L1. This means that IMGS-001 has the potential to shut down the entire PD-1 pathway and provide a superior blockade compared to other PD-1 or PD-L1 inhibitors. The engineered effector function enables IMGS-001 to kill immunosuppressive PD-L1- and/or PD-L2-expressing cells present in the tumor microenvironment, which may enable it to overcome immune resistance in immune-excluded tumors. Preclinical data showed that IMGS-001 drove substantially higher response rates in head-to-head studies vs. currently available immunotherapies. With its innovative multi-tasking mechanism of superior blockade and killing function, IMGS-001 may provide a new foundation for combination therapies. About ImmunoGenesis ImmunoGenesis is a clinical-stage immuno-oncology biopharmaceutical company re-envisioning the treatment of immune-excluded tumors. Immune-excluded tumors, which account for more than half of all cancers, are characterized by having mechanisms of resistance that suppress the immune response. ImmunoGenesis is creating therapies based on the pathology of these immune-excluded tumors that are rationally designed to overcome immune exclusion and thereby drive an effective immune response. For more information, visit . About Cancer Focus Fund The Cancer Focus Fund LP is a unique investment fund established in collaboration with The University of Texas MD Anderson Cancer Center. The fund provides investment support to advance promising cancer therapies that are close to being tested in humans or are in early clinical development, along with the clinical trial expertise and infrastructure of MD Anderson and strategic partners Ochsner Health System Precision Cancer Therapies Program New Orleans and the LSU Feist Weiller Cancer Center Shreveport. The Fund's objective is to leverage this unique combination to provide investors with superior risk-adjusted returns by supporting significant advances in cancer treatments. In collaboration with partner MD Anderson, the Cancer Focus Fund provides both capital and translational research expertise with the goal of accelerating the development of novel cancer therapies that result in better outcomes for patients while generating returns for investors. Disclosures Dr. Curran's financial relationship with ImmunoGenesis is managed and monitored by the MD Anderson Conflict of Interest Committee. The University of Texas MD Anderson Cancer Center's relationships with Cancer Focus Fund and ImmunoGenesis, and all research conducted at MD Anderson related to Cancer Focus Fund or ImmunoGenesis, have been identified as institutional financial conflicts of interest by MD Anderson's Institutional Conflict of Interest Committee and therefore are managed under Institutional Conflict of Interest Management and Monitoring Plans. SOURCE Cancer Focus Fund and ImmunoGenesis