6-Pyruvoyl-Tetrahydropterin Synthase Deficiency

在即将举办的2023年ESMO上，阿斯利康将口头报告其抗PD-1/TIM-3的双特异性抗体AZD7789用的一项早期临床数据。从目前披露的摘要文件看来，该管线的临床前景并不乐观，AZD7789在既往接受过抗PD-(L)1治疗的IIIB-IV期非小细胞肺癌（NSCLC）患者（pts）中不仅只有10%的未经确认部分缓解率，并且突发不良事件（TEAE）还高达82％。想要带领PD-1/TIM-3双抗走向成功，希望可能十分渺茫。10%的未经确认部分缓解AZD7789是一款抗PD-1/TIM-3双特异性抗体，通过对PD-1与TIM-3的双重阻断，AZD7789可以克服或者延缓对PD-（L）1的耐药。2021年在美国获批开展临床，目前AZD7789正在海外开展针对晚期或转移性实体瘤的Ⅰ/Ⅱ期临床研究。2022年5月，AZD7789在国内首次获批临床，适应症为非小细胞肺癌。结果显示：对19例患者中，仅有2例实现了未经确认的部分缓解（PR），11例患者出现疾病进展，8例患者靶病变缩小。在安全性方面，有高达82％的患者出现治疗突发不良事件（TEAE），23％出现≥3级的AE。最常见的TEAE是血肌酐升高，未出现因TEAE导致的停药。41％患者出现治疗相关AE（TRAE），最常见的TRAE是乏力，未出现剂量限制毒性（DLT）和≥3级的TRAE。已被冷落的搭档与LAG3、TIGIT一样，TIM-3曾经是PD-（L）1的热门搭档之一。与CTLA-4/PD-1相同，TIM-3也是一种免疫检查点，在T细胞、Treg细胞以及其他先天免疫细胞表面均有表达，其能够引起癌症与慢性病毒感染过程中T细胞的衰竭。除了TIM-3本身表现出的免疫抑制外，相关研究发现，共表达TIM-3/PD-1的Ｔ细胞表现出更严重的衰竭，并且对抗PD⁃1治疗无反应的患者往往与TIM-3的表达高度相关，而对PD⁃1治疗产生耐药的患者也是由于TIM-3被选择性的高表达，以致肿瘤免疫逃逸。当前已在多种肿瘤中发现，TIM-3水平与肿瘤预后不良有关。鉴于TIM-3与PD-1的协同性，多数TIM-3项目都选择了与PD-1联用或者同时靶向这两个靶点的双抗开发。不过，近几年少有TIM-3管线方面的临床进展，罗氏、礼来等此前也已经终止了TIM-3管线的研发工作。罗氏的RG7769曾是最早进入临床也是进展最快的一款管线，已进入Ⅱ期临床试验。不过，在目前罗氏官网披露的在研管线中已不再见RG7769的身影。而在2019年，礼来就砍掉了LY3415244项目，理由是其I期临床试验结果未达到预期。在这项I期临床研究中，所有（n=12）患者都发生了与可溶性TIM-3靶接合丧失相关的TE-ADAs。两名ADA滴度高的患者表现出与过敏反应一致的过敏反应，最终导致试验终止。目前被验证与PD-1/L-1有协同价值只有LAG-3和CTLA-4，TIM-3能否走到肿瘤领域免疫的舞台中央，需要克服不少挑战。参考出处：https://www.astrazeneca.com/media-centre/press-releases/2023/astrazeneca-advances-scientific-leadership-across-multiple-cancers-with-first-data-from-four-pivotal-phase-iii-trials-at-esmo.htmlhttps://jitc.bmj.com/content/10/Suppl_2/A481阿斯利康AZD7789新适应症获批临床，能否带领PD-1/TIM-3双抗走向成功？本周好文推荐如需转载请联系佰傲谷并在醒目位置注明出处﹀‍‍ ········

VANCOUVER, British Columbia, July 05, 2023 (GLOBE NEWSWIRE) -- Mydecine Innovations Group Inc. ("Mydecine" or the "Company") (NEO:MYCO) (OTC:MYCOF) (FSE:0NFA), a biotechnology company engineering the next wave of innovative medications and treatment protocols to directly address mental health with a particular emphasis on addiction and PTSD, is pleased to announce the results of voting at its special meeting of shareholders which was held on Tuesday, July 4, 2023, by conference call (the “Meeting”). There were 15 shareholders represented in person or by proxy at the Meeting, holding 3,670,377 common shares, representing 14.72% of the Company’s total issued and outstanding common shares as of the record date for the Meeting. The voting results for the Meeting are set out below: Approval of the Re-Pricing of Debenture and Debenture Warrants The resolution to authorize and approve the re-pricing of the debenture and the debenture warrants was approved by a majority of votes cast by the disinterested shareholders who voted for the resolution present or represented by proxy at the Meeting. The re-pricing of the debenture and debenture warrants will be implemented at the discretion of the Board of Directors, should the Board of Directors believe that the adoption of the re-pricing of the debenture and debenture warrants is in the best interest of the Company. Voting results are set out below: Votes ForVotes Against#%#%3,644,28499.29%26,0930.71% Approval of Other Matters The resolution to transact such other business that may be brought properly before the Meeting and any adjournment or postponement of the Meeting. Voting results are set out below: Votes ForVotes Against#%#%3,646,22199.34%24,1560.66% About Mydecine Innovations Group, Inc. Mydecine Innovations Group is a publicly traded, pre-revenue biopharmaceutical company that began operations in North America and Europe in early 2020. Mydecine was founded to increase physicians' access to serotonin-modulating medicine. Recent research has demonstrated the therapeutic potential of psychedelic substances such as psilocybin and MDMA for treating intractable conditions such as pain, anxiety, depression, addiction, and PTSD, along with neurodegenerative disorders. Mydecine believes these compounds can be safer, more effective, and more accessible for patients and medical professionals through modern drug chemistry paired with artificial intelligence (AI). Mydecine is developing innovative medications for target indications with high mortality rates that have lacked innovation for decades and are controlled by dominant corporations. Mydecine developed several prodrug families, beginning with a psilocybin-derived smoking cessation drug undergoing a NIDA-funded trial at Johns Hopkins University. Mydecine is also developing MYCO-006—short-acting chemical analogs derived from MDMA for treating various conditions, including anxiety and pain. Mydecine utilizes cutting-edge artificial intelligence (AI) and pharma research infrastructure at the University of Alberta to develop and manufacture new medications to make them affordable and accessible to the general public upon Health Canada and FDA approval. The Mydecine team is enthusiastic about its mission and is dedicated to creating a positive difference in the lives of others. Learn more at https://www.mydecine.com. For more information, please contact: Media Contact:pr@mydecineinc.com Investor Relations:investorrelations@mydecineinc.com On behalf of the Board of Directors: Joshua Bartch, Chief Executive Officer contact@mydecineinc.com For further information about Mydecine Innovations Group, Inc., please visit the Company’s profile on SEDAR at www.sedar.com or the Company’s website at www.mydecine.com. This news release contains forward-looking information about Canadian securities laws regarding the Company and its business. It relates to future events or performance and reflects management’s expectations and assumptions. Often but not always, forward-looking information can be identified by the use of words such as “expect,” “intends,” “anticipated,” “believes,” or variations (including negative variations) of such words and phrases or by stating that specific actions, events, or results “may,” "could," "would,” or “will” be taken, occur, or be achieved. This news release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the common shares in any jurisdiction in which such an offer, solicitation, or sale would be unlawful before the registration or qualification under the securities laws of any such jurisdiction. Such forward-looking statements reflect management’s beliefs and are based on assumptions and information currently available to the Company. Readers are cautioned that these forward-looking statements are neither promises nor guarantees and are subject to risks and uncertainties that may cause future results to differ materially from those expected, including, without limitation, risks regarding the COVID-19 pandemic, the availability and continuity of financing, the ability of the Company to protect and enforce its intellectual property adequately, the Company's ability to bring its products to commercial production, the continued growth of the global adaptive pathway medicine, natural health products, and digital health industries, and the risks presented by the highly regulated and competitive market concerning the development, production, sale, and use of the Company's products. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, other factors may cause effects not to be as anticipated, estimated, or intended. There can be no assurance that such information will be accurate, as actual results and future events could differ materially from those anticipated. These forward-looking statements are made as of the date hereof. The Company is not obligated to update or revise them to reflect new events or circumstances as required under applicable securities legislation.

CVN Launches Measurement-Based Care Training Toolkit Available to the Field at No-Cost STAMFORD, Conn., June 28, 2023 /PRNewswire/ -- Routine outcomes monitoring (ROM) and measurement-based care (MBC) have been shown to improve mental health outcomes. Yet, despite repeated calls for widespread adoption their use in clinical practice remains the exception within the U.S. mental health care system. Now, in Establishing Benchmarks for Outpatient Mental Health Care: A Call to Action with Consensus Recommendations, a new white paper released today, Cohen Veterans Network (CVN), a national not-for-profit network of mental health clinics for post-9/11 veterans, service members and their families, provides recommendations on how to best advance the use of standardized benchmarks and MBC throughout the field of mental health. "CVN is committed to advancing the field for all Americans as our nation faces unprecedented mental health challenges," says Cohen Veterans Network President & CEO Dr. Anthony Hassan. "We hope this white paper serves as a call to action for our colleagues across the field to mobilize around the use of standardized benchmarks. In doing so, we have an opportunity to improve treatment efficacy, support mental health parity and further transform the lives of the individuals we treat." The white paper captures key findings and recommendations from CVN's National Leadership Summit on Outpatient Mental Health Benchmarks held in October 2022 in Washington, D.C., during which a broad cross-section of leaders from across the mental health landscape convened to identify barriers and implementation challenges as well as actionable solutions related to the advancement of ROM and MBC. Findings from the summit and highlights from the white paper will be presented today in a webinar, Advancing the Field Through Behavioral Health Benchmarks: A Call to Action with Consensus Recommendations, at 12pm EDT hosted by Behavioral Health Business. Participants will learn about a range of recommendations from experts across the field in the areas of policy, practice, research, and training. "The consensus recommendations detailed in the white paper have been developed in collaboration with some of the best minds in the behavioral health field," says CVN-IQ Director Dr. David Linkh. "We are so thankful to all of our partners who joined us in this effort, and we are thrilled to be sharing our findings, which can significantly impact how we deliver mental health care in America." In conjunction with the release of the white paper, the network has launched the CVN Measurement-Based Care Training Toolkit, a comprehensive set of training materials designed to help mental health professionals incorporate measures to enhance the quality of care. It is available at no-cost. "Our MBC Training Toolkit has been thoughtfully designed to help clinicians within CVN and across the field of behavioral health incorporate measures into routine clinical care," says CVN Sr. Director of Clinical Practice and Training Dr. Stephanie Renno. "With the use of these assets, mental health professionals have an opportunity to enhance their clinical practice and further develop client-focused, customized care." Since its inception in 2016, CVN has treated more than 53,000 clients. The network provides evidence-based therapies to post-9/11 veterans, active duty service members and military family members through its 24 Steven A. Cohen Military Family Clinics across the country. Treatment is available for a wide variety of mental health challenges including depression, anxiety, adjustment issues, anger, PTSD, grief and loss, family issues, transition challenges, relationship concerns, and children's behavioral problems. Care is available in person or via CVN Telehealth, face-to-face video therapy. The white paper and executive summary can be found here. ABOUT COHEN VETERANS NETWORK Cohen Veterans Network (CVN) is a 501(c)(3) national not-for-profit philanthropic organization for post-9/11 veterans, active duty service members and their families. CVN focuses on improving mental health outcomes, operating a network of outpatient mental health clinics in high-need communities, in which trained clinicians deliver holistic evidence-based care to treat mental health conditions. It was established in 2016 by philanthropist Steven A. Cohen with a commitment of $275 million to build the network. Learn more about CVN at cohenveteransnetwork.org. SOURCE Cohen Veterans Network