Ibalizumab-UIYK

Results show similar levels of virus undetectability in patients on ibalizumab-containing regimens as in controls, despite greater baseline severity of HIV Ibalizumab continues to demonstrate long-term efficacy and safety as part of combination antiretroviral therapy in heavily treatment-experienced people with multidrug resistant HIV MONTREAL, March 12, 2025 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a commercial-stage biopharmaceutical company, today presented data from a real-world, observational, registry study demonstrating the efficacy and safety of ibalizumab in reducing HIV RNA to undetectable levels in heavily treatment-experienced (HTE) patients with multidrug resistant HIV. In a poster session at the 2025 Conference on Retroviruses and Opportunistic Infections (CROI) in San Francisco, Calif., investigators from the Prospective Observational Study of Multidrug-Resistant Patient Outcomes with and without Ibalizumab in a Real-World Setting: United States (PROMISE-US) reported that patients treated with regimens containing ibalizumab achieved undetectable HIV viral load levels at similar rates as those receiving non-ibalizumab-containing regimens, despite displaying characteristics indicative of more severe HIV disease at baseline. “The availability of long-term injectable therapies has not eliminated the phenomenon of multidrug resistance, and heavily treatment-experienced people with HIV deserve fully suppressive antiretroviral regimens that can help them establish and maintain virologic control,” stated presenting author Smitha Gudipati, MD, an infectious disease specialist at Henry Ford Hospital in Detroit, Mich. “We are therefore encouraged to see such impressive reductions in viremia in patients whose regimens include ibalizumab, despite having lower CD4 counts and higher viral loads at baseline than the non-ibalizumab control group.” Theratechnologies previously announced the study design and baseline characteristics of participants in PROMISE-US (ClinicalTrials.gov identifier: NCT05388474), a phase 4, multicenter, retrospective and prospective, observational, non-interventional registry study. The trial is designed to assess risk factors and predictors of virologic and immunologic response in HTE people with HIV (PWH) and specific sub-populations. Its primary objective is to evaluate the long-term efficacy and durability of ibalizumab, a CD4-directed post-attachment inhibitor of HIV, in combination with other antiretroviral therapies by comparing the clinical outcomes of patients receiving ibalizumab (Cohort 2) versus matched patients not receiving ibalizumab (Cohort 1). At CROI, the PROMISE-US investigators presented an interim, unmatched subgroup analysis comprising 112 participants, of whom 70 were enrolled in Cohort 1 and 42 in Cohort 2. At baseline, 27 of participants in Cohort 1 and 25 in Cohort 2 were viremic, defined as viral load above 50 RNA copies/mL (39% and 57%, respectively; p=0.0279). Three-quarters (74%) of participants in Cohort 1 who had baseline viremia had more than 200 CD4 T-cells/mm3 at baseline, compared to only 44% of those in Cohort 2 who were viremic at baseline (p=0.0376). Among those with baseline viremia, 50% of Cohort 1 participants and 47% in Cohort 2 achieved undetectable viral load (≤50 RNA copies/mL) after six months of treatment (p=0.873). At 12 months, viral load was undetectable in 53% of Cohort 1 participants and in 42% of those in Cohort 2 (p=0.0.524). Ibalizumab was well-tolerated with no infusion reactions reported and no discontinuation of treatment by participants in Cohort 2 due to a treatment emergent adverse event. “The PROMISE-US trial is the first registry to capture long-term clinical outcomes for highly treatment-experienced patients with multidrug-resistant HIV in a real-world setting and in the US specifically,” commented Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer of Theratechnologies. “The data presented today suggest that ibalizumab can be a critical component of therapeutic regimens in the modern antiretroviral era. We look forward to validating these interim findings as we continue to enroll and monitor patients in this ongoing study.” About Theratechnologies Theratechnologies (TSX: TH) (NASDAQ: THTX) is a specialty biopharmaceutical company focused on the commercialization of innovative therapies that have the potential to redefine standards of care. Further information about Theratechnologies is available on the Company's website at www.theratech.com, on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov. Follow Theratechnologies on Linkedin and X. Forward-Looking Information This press release contains forward-looking statements and forward-looking information (collectively, the “Forward-Looking Statements”), within the meaning of applicable securities laws, that are based on our management’s beliefs and assumptions and on information currently available to our management. You can identify Forward-Looking Statements by terms such as “may”, “will”, “should”, “could”, “promising”, “would”, “outlook”, “believe”, “plan”, “envisage”, “anticipate”, “expect” and “estimate”, or the negatives of these terms, or variations of them. The Forward-Looking Statements contained in this press release include, but are not limited to, statements regarding the long-term safety and efficacy of ibalizumab, the effect of ibalizumab on the reductions of viremia and the use of ibalizumab as a component of therapeutic regimens in the modern antiretroviral era. Forward-looking statements involve a number of assumptions, risks and uncertainties. Some of these assumptions include, but are not limited to, the fact that patients receiving ibalizumab will achieve undetectable HIV viral load levels. The Company refers current and potential investors to the “Risk Factors” section of its Annual Information Form filed under the Company’s Form 20-F dated February 26, 2025 available on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov under Theratechnologies’ public filings for the risks associated with the business of Theratechnologies. The reader is cautioned to consider these and other risks and uncertainties carefully and not to put undue reliance on forward-looking statements. Forward-Looking Statements reflect current expectations regarding future events and speak only as of the date of this press release and represent the Company’s expectations as of that date. The Company undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise, except as may be required by applicable law. Contacts: Media inquiries:Julie SchneidermanSenior Director, Communications & Corporate Affairscommunications@theratech.com1-514-336-7800 Investor Inquiries:Joanne ChoiSenior Director, Investor Relationsjchoi@theratech.com1-551-261-0401

2025年2月6日，申联生物（688098）正式发布对外投资公告，旗下全资子公司上海本天成生物医药有限公司斥资6000万元，将取得创新药企业扬州世之源生物科技有限责任公司20.48%的股权。这一战略举措标志着申联生物正式进军人用创新药领域，在生物科技行业发展的征程中迈出了重要一步。 世之源是一家专注于创新药开发与生产的高科技企业，搭建了先进的单抗垂直整合平台，目前拥有三款在研新药在中国大陆的商业化权益，包括创新抗过敏 Anti-IgE 单克隆抗体药物 (UB-221)、艾滋病治疗单克隆抗体药物 (UB-421) 以及抗单纯疱疹病毒单克隆抗体药物 (UB-621)。三款新药已在多个国家和地区完成了不同阶段的研究，展现出了良好的市场前景和临床价值。其中，艾滋病治疗单克隆抗体药物（UB-421）从台湾联合生物制药股份有限公司（UBP）获得授权并引进中国大陆，该新药由美国联合生物医学公司（UBI）原研研发。2025年1月3日，UB-421的研究成果在自然-医学期刊(Nature Medicine)刊登。这篇原创论文中的受试患者对多数抗逆转录病毒药物、广谱中和抗体及中裕新药的Trogarzo(抗CD4第2结构域抗体)均具有高度的耐药性，并患有卡波西氏肉瘤。研究团队发现，患者T细胞上CD4的第1结构域在整个研究期间皆被UB-421抗体完全占据，HIV病毒无法进入患者宿主细胞进行病毒基因复制，因此在整个长达48周的研究期间都没有观察到病毒耐药突变发生。研究发现，患者表现出对UB-421输注有良好的耐受性，没有发生任何不良事件，CD4+T细胞数也显著增加而HIV储存库减少。这些成果显示了UB-421能以直接作用或辅助药物的形式，用于治疗携带多重耐药或泛耐药病毒的病患，在艾滋治疗史上具有重大意义，可说是一种划时代的新医疗方案。 艾滋病（AIDS）是由人类免疫缺陷病毒（HIV）引起的全球性公共卫生难题。UB-421作为一种创新的抗HIV单克隆抗体药物，通过靶向宿主CD4受体，提供了一种全新的治疗策略。其具备广谱抗病毒活性、长效性和高安全性的特点，为艾滋病治疗领域带来重要突破。未来，UB-421有望在耐药患者管理、简化治疗方案以及功能性治愈研究中发挥重要作用，为HIV感染者带来新的希望。 申联生物作为全球首家将合成肽技术应用于兽用生物制品并实现大规模商业化推广的企业，在生物大分子医药领域已经建立起了一套完整且领先的技术体系。尤其在长链肽技术合成方面处于全球领先地位，已具备长达100个氨基酸以上的超长链的固相合成技术、高度模拟天然结构的空间构象构建技术、公斤级稳定的规模化量产技术等显著优势。公司也是全球兽用生物制品领域首个环状mRNA技术的应用实践企业，已具备全工艺链自主知识产权体系，突破现有技术壁垒。同时，公司积极利用基因工程技术精准开发宠物治疗性单抗，已具备宠物特有靶点的筛选及抗体设计、制备能力。 此次进军人用创新药领域，是申联生物基于自身技术优势做出的重大战略决策，更是申联生物发展历程中又一个重要里程碑。通过本次与世之源的深度合作，申联生物能够将自身前沿的生物技术及生产优势进一步延伸应用，并与世之源的创新药研发能力相结合，实现技术与资源的高效整合，进一步拓展业务版图，提升综合竞争力，强化市场地位。 未来，公司将凭借在前沿生物技术平台和疫苗制备工艺方面的显著优势，在经济动物生物制品领域持续精耕细作，在伴侣动物领域积极拓展版图，在人用生物制品领域不断开拓创新。通过多领域协同发展，逐步成长为世界一流的高科技集团化生物公司，为增进人类健康福祉、提升动物福利贡献更大力量 。 识别微信二维码，可添加药时空小编 请注明：姓名+研究方向！