A Phase 2b Multicenter, Randomized, Open-Label Study Comparing the Efficacy, Safety, PK, and Tolerability of VH3810109, Administered Either Intravenously Or As A Subcutaneous Infusion With rHuPH20, in Combination With CAB LA to Standard of Care in Virologically Suppressed Adults Living With HIV

The study aims at evaluating the efficacy of VH3810109, dosed in accordance with the dosing schedule as either intravenous (IV) infusion or subcutaneous (SC) infusion with recombinant hyaluronidase (rHuPH20), in combination with cabotegravir (CAB) intramuscular (IM) dosed in accordance with the dosing schedule in virologically suppressed, Antiretroviral therapy (ART)-experienced adult participants living with HIV. VH3810109 plus rHuPH20 plus Cabotegravir arm of the study has been discontinued based on preliminary results. The study will be conducted in 3 parts followed by a Long-Term Follow-up phase (LTFU).

开始日期2023-08-17

申办/合作机构

ViiV Healthcare Ltd.

NCT05291520

/ Completed临床1期

A Phase 1, Open-Label, Single-Dose Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, GSK3810109, Administered Either Subcutaneously or Intravenously With Recombinant Human Hyaluronidase PH20 (rHuPH20) to Healthy Adults

An open-label, two part study to assess the safety, tolerability, and PK of VH3810109 in healthy adult participants. Participants will receive a single SC or IV dose of VH3810109 co-administered with rHuPH20 and will be followed up for 24 weeks.

开始日期2022-02-23

申办/合作机构

ViiV Healthcare Ltd.

NCT04871113

/ Completed临床2期

A Phase 2a Multicentre, Randomized, Open-Label, Two-Part Adaptive Design Study to Evaluate the Antiviral Effect, Safety and Tolerability of GSK3810109A, an HIV-1 Specific Broadly Neutralizing Human Monoclonal Antibody in Antiretroviral-naïve HIV-1-Infected Adults

This study is to evaluate antiviral activity, efficacy, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of GSK3810109A in HIV-1 infected treatment naive adults. Participants will receive a single dose of GSK3810109A administered either intravenously (IV) or subcutaneously (SC). The study includes a screening phase, a randomized monotherapy phase and a standard of care follow-up phase.

开始日期2021-06-22

申办/合作机构

ViiV Healthcare Ltd.

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2025-07-01·Lancet HIV

Safety and pharmacokinetics of N6LS, a broadly neutralising monoclonal antibody for HIV: a phase 1, open-label, dose-escalation study in healthy adults

Article

BACKGROUND:

Broadly neutralising antibodies (bNAbs) have shown promise as both prevention and treatment strategies against HIV-1. The clinical effectiveness of bNAbs depends on enhancing their neutralisation breadth and extending their serum half-lives. In this study, we aimed to assess the safety, tolerability, pharmacokinetic profile, and neutralisation activity in serum of N6LS, a HIV-1 bNAb.

METHODS:

In this first-in-human, dose-escalation, open-label, phase 1 trial, healthy adult participants (aged 18-50 years) who were HIV-1 negative were recruited to the National Institutes of Health Clinical Center (Bethesda, MD, USA). Three groups received one intravenous administration of N6LS at 5 mg/kg (n=3), 20 mg/kg (n=3), or 40 mg/kg (n=3); one group received one subcutaneous administration of 5 mg/kg N6LS (n=3); two groups received three administrations of either 5 mg/kg subcutaneous (n=5) or 20 mg/kg intravenous (n=5) N6LS every 12 weeks; and two groups received one subcutaneous administration of either 5 mg/kg (n=5) or 20 mg/kg (n=5) N6LS with ENHANZE drug product (EDP), recombinant human hyaluronidase PH20. The primary objectives were the safety and tolerability of N6LS with and without EDP. All participants who received N6LS were included in the primary safety analyses. This trial is registered at ClinicalTrials.gov, NCT03538626, and is complete.

FINDINGS:

Between June 18, 2018, and April 11, 2022, we enrolled 33 healthy adults (19 female individuals and 14 male individuals). One participant did not receive N6LS and one participant was lost to follow-up after 8 weeks. N6LS had an encouraging safety profile similar to other HIV-1 bNAbs, with no serious adverse events. Local reactogenicity was observed after administration of N6LS, with the most common symptom being mild to moderate injection site pain or tenderness in subcutaneous groups, reported in six of eight participants. All ten participants who received N6LS with EDP had mild to severe injection site erythema, which, despite being graded as severe in size, was generally not noticed by participants or deemed bothersome, and resolved without intervention. Systemic reactogenicity was mild in all groups. N6LS had an overall mean serum half-life of 48·6 days and retained its broad and potent neutralisation characteristics in serum. EDP administration increased N6LS bioavailability. No functional anti-drug antibodies to N6LS were detected following administration.

INTERPRETATION:

N6LS showed a promising safety and pharmacokinetics profile while retaining its potent neutralisation characteristics in serum, making it a promising candidate for inclusion in HIV-1 prevention and therapeutic combination strategies. The addition of EDP can enable safe subcutaneous administration of higher doses and larger volumes of N6LS, supporting additional methods for prophylactic and therapeutic bNAb administration.

FUNDING:

US National Institute of Allergy and Infectious Diseases Intramural Research Program, National Institutes of Health.

2023-12-31·mAbs

Improved pharmacokinetics of HIV-neutralizing VRC01-class antibodies achieved by reduction of net positive charge on variable domain

Article

作者: Zhang, Baoshan ; Yang, Eun Sung ; Kwong, Peter D. ; Lin, Bob C. ; Lusso, Paolo ; Pegu, Amarendra ; McKee, Krisha ; Louder, Mark K. ; Mascola, John R. ; Bender, Michael F. ; Liu, Qingbo ; Asokan, Mangaiarkarasi ; Rawi, Reda ; Shen, Chen-Hsiang ; Liu, Tracy ; Doria-Rose, Nicole A. ; Reveiz, Mateo ; Schaub, Andrew J. ; Kwon, Young D.

The amino-acid composition of the immunoglobulin variable region has been observed to impact antibody pharmacokinetics (PK). Here, we sought to improve the PK of the broad HIV-1-neutralizing VRC01-class antibodies, VRC07-523LS and N6LS, by reducing the net positive charge in their variable domains. We used a structure-guided approach to generate a panel of antibody variants incorporating select Arg or Lys substituted to Asp, Gln, Glu, or Ser. The engineered variants exhibited reduced affinity to heparin, reduced polyreactivity, and improved PK in human FcRn-transgenic mice. One variant, VRC07-523LS.v34, with three charge substitutions, had an observed in vivo half-life and an estimated human half-life of 10.8 and 60 days, respectively (versus 5.4 and 38 days for VRC07-523LS) and retained functionality, neutralizing 92% of a 208-strain panel at a geometric mean IC₈₀ <1 µg/mL. Another variant, N6LS.C49, with two charge substitutions, had an observed in vivo half-life and an estimated human half-life of 14.5 and 80 days (versus 9.0 and 44 days for N6LS) and neutralized ~80% of 208 strains at a geometric mean IC₈₀ <1 µg/mL. Since Arg and Lys residues are prevalent in human antibodies, we propose substitution of select Arg or Lys with Asp, Gln, Glu, or Ser in the framework region as a general means to improve PK of therapeutic antibodies.

2017-08-15·Journal of virology2区 · 医学

Virological Control by the CD4-Binding Site Antibody N6 in Simian-Human Immunodeficiency Virus-Infected Rhesus Monkeys

2区 · 医学

Article

作者: Molloy, Katherine ; Callow, Katherine ; Schmidt, Stephen D. ; Chandrashekar, Abishek ; Pegu, Amarendra ; Keele, Brandon F. ; Chen, Xuejun ; Julg, Boris ; Huang, Jinghe ; Connors, Mark ; Mascola, John R. ; Barouch, Dan H. ; Seaman, Michael S. ; Abbink, Peter ; Liu, Jinyan ; Mojta, Shanell ; Brinkman, Amanda ; Wang, Keyun ; Koup, Richard A.

ABSTRACT:

Passive immunotherapy against HIV-1 will most likely require broadly neutralizing antibodies (bnAbs) with maximum breadth and potency to ensure therapeutic efficacy. Recently, the novel CD4 binding site antibody N6 demonstrated extraordinary neutralization breadth and potency against large panels of cross-clade pseudoviruses. We evaluated the in vivo antiviral activity of N6-LS, alone or in combination with the established V3-glycan antibody PGT121, in chronically simian-human immunodeficiency virus (SHIV)-SF162P3-infected macaques. A single dose of N6-LS suppressed plasma viral loads in 4 out of 5 animals at day 7, while the combination of both antibodies suppressed all animals. The combination of both antibodies had no additive antiviral effect compared to a single dose of PGT121, potentially reflecting the nearly 10-fold-higher potency of PGT121 against this SHIV. Viral rebound occurred in the majority of suppressed animals and was linked to declining plasma bnAb levels over time. In addition to the effect on plasma viremia, bnAb administration resulted in significantly reduced proviral DNA levels in PBMCs after 2 weeks and in lymph nodes after 10 weeks. Autologous neutralizing antibody (nAb) responses and CD8 + T-cell responses were not significantly enhanced in the bnAb-treated animals compared to control animals, arguing against their contribution to the viral effects observed. These results confirm the robust antiviral activity of N6-LS in vivo , supporting the further clinical development of this antibody. IMPORTANCE Monocloncal antibodies (MAbs) are being considered for passive immunotherapy of HIV-1 infection. A critical requirement for such strategies is the identification of MAbs that recognize the diversity of variants within circulating but also reservoir viruses, and MAb combinations might be needed to achieve this goal. This study evaluates the novel bnAb N6-LS alone or in combination with the bnAb PGT121, in rhesus macaques that were chronically infected with SHIV. The results demonstrate that N6-LS potently suppressed plasma viral loads in the majority of animals but that the combination with PGT121 was not superior to PGT121 alone in delaying time to viral rebound or reducing peripheral blood mononuclear cell (PBMC) or lymph node proviral DNA levels. The occurrence of viral escape variants in an N6-LS-monotreated animal, however, argues for the need to maximize breadth and antiviral efficacy by combining bnAbs for therapeutic indications.

项与 Iotivibart 相关的新闻（医药）

2025-05-23

·医学新视点

《柳叶刀》子刊：新药有望安全、长效防治艾滋病，半衰期近49天

艾滋病，即获得性免疫缺陷综合征（AIDS），其病原体为人类免疫缺陷病毒（HIV）。现行抗逆转录病毒治疗药物的联合应用可有效抑制艾滋病进程并显著延长患者寿命，但由于HIV-1潜伏库的存在，艾滋病迄今尚无法治愈。近年发现，抗HIV广谱中和抗体（bNAb）可有效降低HIV-1病毒载量并减缓疾病进展，可能是控制HIV/AIDS的有效策略，为研发艾滋病疫苗和治愈策略带来了曙光。在《柳叶刀》子刊The Lancet HIV发表的一项1期临床试验中，来自美国国立卫生研究院（NIH）临床中心等团队评估了N6LS（新型bNAb）在健康成人中的安全性、耐受性及药代动力学特征。研究结果显示，N6LS单次或多次静脉及皮下给药后均表现出良好的安全性，血清半衰期长达48.6天，且保留了对HIV-1的广谱中和活性，是未来预防或治疗HIV的具有前景的潜在后续药物。截图来源：The Lancet HIV这是N6LS的首次人体、剂量递增、开放标签的1期试验，纳入18~50岁、HIV-1阴性的健康成人33例（1例未接受N6LS治疗、1例治疗8周后失访），探索不同给药途径（静脉或皮下）、不同剂量N6LS（5~40 mg/kg）及联合重组人透明质酸酶PH20（ENHANZE，EDP）对人体的影响，具体治疗如下：单次静脉注射，N6LS 5 mg/kg（3例）、N6LS 20 mg/kg（3例）或N6LS 40 mg/kg（3例）；单次皮下给药，N6LS 5 mg/kg（3例）；多次皮下给药，N6LS 5 mg/kg（5例），或静脉注射，N6LS 20 mg/kg（5例），每12周给药3次；单次皮下给药，N6LS 5 mg/kg（5例）或N6LS 20 mg/kg（5例），联合重组人透明质酸酶PH20；研究结果显示，与其他抗HIV-1的bNAb相似，N6LS展示出了良好的安全性特征，无一例患者发生严重安全性事件。N6LS用药后常见的局部不良反应为皮下注射部位轻中度疼痛或压痛；接受N6LS联合重组人透明质酸酶PH20的参与者均出现注射部位红斑（轻度至重度），但无需干预即可自行缓解。药代动力学分析表明，N6LS平均血清半衰期为48.6天。此外，联合重组人透明质酸酶PH20用药，可提高N6LS的生物利用度。给药后未检测到针对N6LS的功能性抗药抗体。该研究验证了N6LS在人体内的安全性和药代动力学特征，表明N6LS是预防和治疗HIV的具有前景的候选药物。N6LS与重组人透明质酸酶PH20联合用药，有望实现N6LS更高剂量的皮下安全给药，为未来HIV预防或治疗方案提供了新思路。点击文末“阅读原文/Read more”，即可访问The Lancet HIV官网阅读完整论文。推荐阅读欢迎投稿：学术成果、前沿进展、临床干货等主题均可，点此了解投稿详情。参考资料[1] Richard L Wu, Katherine V Houser, Martin R Gaudinski, et al. Safety and pharmacokinetics of N6LS, a broadly neutralising monoclonal antibody for HIV: a phase 1, open-label, dose-escalation study in healthy adults. Published May 20, 2025. The Lancet·HIV. DOI: 10.1016/S2352-3018(25)00041-4.免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「医学新视点」微信公众号留言联系。如有其他合作需求，请联系wuxi_media@wuxiapptec.com分享，点赞，在看，传递医学新知

临床1期临床结果疫苗

2025-05-06

·PRNewswire

HALOZYME RAISES 2025 FINANCIAL GUIDANCE RANGES AND REPORTS STRONG FIRST QUARTER 2025 RESULTS

Announcing New $250M Share Repurchase Total Revenue Increased 35% YOY to $265 million and Royalty Revenue Increased 39% YOY to $168 million Net Income Increased 54% YOY to $118 million; Adjusted EBITDA Increased 40% YOY to $162 million; GAAP Diluted EPS Increased 55% YOY to $0.93; non-GAAP Diluted EPS Increased 41% YOY to $1.111 Raising 2025 Financial Guidance Ranges for Total Revenue to $1,200 - $1,280 million, Representing YOY Growth of 18% - 26%, Adjusted EBITDA to $790 - $840 million, Representing YOY Growth of 25% - 33% and non-GAAP Diluted EPS to $5.30 - $5.70, Representing YOY Growth of 25% - 35%1 SAN DIEGO, May 6, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme" or the "Company") today reported its financial and operating results for the first quarter ended March 31, 2025, provided an update on its recent corporate activities and raised its 2025 financial guidance. "2025 is off to a strong start with our current three blockbuster brands, Darzalex SC, Phesgo and VYVGART Hytrulo, continuing to demonstrate strong growth in their currently approved indications. Our four recently launched products, Ocrevus Zunovo in U.S. and Europe, Tecentriq Hybreza in U.S. and Europe, Opdivo Qvantig in U.S. and Rybrevant SC in Europe are just beginning their contributions as our partners focus on gaining and expanding coverage and reimbursement. This broadened portfolio is resulting in an unprecedented set of 11 additional growth catalysts that have happened recently or are expected to happen in the coming months. These opportunities include multiple new European and U.S. product approvals, multiple new indication approvals and multiple key reimbursement milestones supporting access for an even greater number of patients, all creating new near and longer-term growth opportunity. As a result of this momentum, I am pleased to announce we are increasing our full year 2025 financial guidance ranges and a new $250 million share buyback," said Dr. Helen Torley, president and chief executive officer, of Halozyme. "In addition, our long-term growth prospects have never been better with additional growth opportunities projected to result from our pipeline, where two products, BMS' nivolumab plus relatlimab SC and Takeda's 20% immune globulin SC, continue in Phase 3 and where ViiV and Acumen announced development progress and data in the quarter. I am also pleased to announce that we have signed our first HVAI development agreement with a current ENHANZE partner and that a different ENHANZE partner is now moving our SVAI into clinical testing," concluded Dr. Torley. First Quarter and Recent Corporate Highlights: On May 6, Halozyme announced a second $250 million share repurchase under the $750 million approved program from February 2024. In April 2025, Halozyme filed a patent infringement lawsuit against Merck Sharp & Dohme Corp. ("Merck") in the U.S. District Court in New Jersey alleging that Merck is using Halozyme's patented MDASE™ subcutaneous drug delivery technology to develop Subcutaneous ("SC") Keytruda. Halozyme is seeking damages and injunctive relief to stop Merck's infringement of Halozyme's MDASE™ intellectual property. In March 2025, Halozyme completed the first $250 million Accelerated Share Repurchase of its common stock under the $750 million approved program from February 2024. First Quarter and Recent Partner Highlights: In April 2025, Roche received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use ("CHMP") recommending an update to the European Union ("EU") label for Phesgo® for human epidermal growth factor receptor 2 ("HER2")-positive breast cancer. Administration of Phesgo® outside of a clinical setting (such as in a person's home) by a healthcare professional will be possible, once safely established in a clinical setting. In April 2025, argenx received a positive opinion from the CHMP recommending European Commission approval of VYVGART® 1000mg (efgartigimod alfa) developed with ENHANZE® for SC injection as a monotherapy for the treatment of adult patients with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy ("CIDP") after prior treatment with corticosteroids or immunoglobulins. In April 2025, argenx received U.S. Food and Drug Administration ("FDA") approval of VYVGART® Hytrulo prefilled syringe for self-injection for the treatment of adult patients with generalized myasthenia gravis who are anti-acetylcholine receptor antibody positive and adult patients with CIDP. In April 2025, Janssen received European Commission marketing authorization of the SC formulation of RYBREVANT® (amivantamab) with ENHANZE®, in combination with LAZCLUZE® (lazertinib), for the first-line treatment of adult patients with advanced non-small cell lung cancer ("NSCLC") with epidermal growth factor receptor ("EGFR") exon 19 deletions or exon 21 L858R substitution mutations. Additionally, RYBREVANT® (amivantamab) is approved as a monotherapy for adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after the failure of platinum-based therapy. This represents the 10th partner product with ENHANZE® to be commercialized. In April 2025, Janssen received European Commission approval for an indication extension of DARZALEX® SC in combination with bortezomib, lenalidomide, and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma regardless of transplant eligibility. In March 2025, Bristol Myers Squibb received a positive CHMP opinion recommending approval of Opdivo® (nivolumab) with ENHANZE® across multiple solid tumor indications. In March 2025, Acumen announced top-line results from a Phase 1 study of sabirnetug (ACU193) with ENHANZE® comparing the pharmacokinetics between SC and intravenous administrations in healthy volunteers that demonstrated weekly SC administration of sabirnetug was well-tolerated with systematic exposure supporting further clinical development. In March 2025, ViiV announced results from a Phase 2b study demonstrated N6LS administered every four months SC with ENHANZE® in combination with cabotegravir successfully maintained viral suppression in adults living with HIV who were already stable on treatment. In March 2025, Takeda announced Health Canada expanded the marketing authorization for HYQVIA® to include CIDP as a maintenance therapy after stabilization with intravenous immunoglobulin to prevent relapse of neuromuscular disability and impairment in adults. First Quarter 2025 Financial Highlights: Revenue was $264.9 million, compared to $195.9 million in the first quarter of 2024. The 35% year-over-year increase was primarily driven by royalty revenue growth and an increase in sales of bulk rHuPH20. Revenue for the quarter included $168.2 million in royalties, an increase of 39% compared to $120.6 million in the first quarter of 2024, primarily attributable to increases in revenue of VYVGART® Hytrulo, DARZALEX® SC, and Phesgo®. Cost of sales was $48.4 million, compared to $28.3 million in the first quarter of 2024. The increase in cost of sales was primarily due to an increase in product sales. Amortization of intangibles expense remained flat at $17.8 million, compared to the first quarter of 2024. Research and development expense was $14.8 million, compared to $19.1 million in the first quarter of 2024. The decrease in research and development expense was primarily due to lower compensation expense driven by resource optimization and labor allocation initiatives, and timing of planned investments in ENHANZE® related to the development of our new high-yield rHuPH20 manufacturing process. Selling, general and administrative expense was $42.4 million, compared to $35.1 million in the first quarter of 2024. The increase was primarily due to an increase in consulting and professional service fees and compensation expense. Operating income was $141.5 million, compared to $95.5 million in the first quarter of 2024. Net income was $118.1 million, compared to $76.8 million in the first quarter of 2024. EBITDA and Adjusted EBITDA were $162.0 million, compared to $115.7 million in the first quarter of 2024.1 GAAP diluted earnings per share was $0.93, compared to $0.60 in the first quarter of 2024. Non-GAAP diluted earnings per share was $1.11, compared to $0.79 in the first quarter of 2024.1 Cash, cash equivalents and marketable securities were $747.9 million on March 31, 2025, compared to $596.1 million on December 31, 2024. The increase was primarily a result of cash generated from operations. Financial Outlook for 2025 The Company is raising its financial guidance for 2025. Note that the guidance reflects tariffs that are currently implemented. For the full year 2025, the Company expects: Total revenue of $1,200 million to $1,280 million, representing growth of 18% to 26% over 2024 total revenue, primarily driven by increases in royalty revenue. Revenue from royalties of $750 million to $785 million, representing growth of 31% to 37% over 2024. Adjusted EBITDA of $790 million to $840 million, representing growth of 25% to 33% over 2024. Non-GAAP diluted earnings per share of $5.30 to $5.70, representing growth of 25% to 35% over 2024. The Company's earnings per share guidance does not consider the impact of potential future share repurchases. Webcast and Conference Call Halozyme will host its Quarterly Update Conference Call for the first quarter ended March 31, 2025 today, Tuesday, May 6, 2025, at 1:30 p.m. PT/4:30 p.m. ET. The conference call may be accessed live with pre-registration via link: . The call will also be webcast live through the "Investors" section of Halozyme's corporate website and a recording will be made available following the close of the call. To access the webcast and additional documents related to the call, please visit Halozyme.com. About Halozyme Halozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. As the innovators of ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used to facilitate the subcutaneous delivery of injected drugs and fluids, with the goal of improving the patient experience with rapid subcutaneous delivery and reduced treatment burden. Having touched one million patient lives in post-marketing use in ten commercialized products in at least one major region and across more than 100 global markets, Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical and Acumen Pharmaceuticals. Halozyme also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technologies that are designed to provide commercial or functional advantages such as improved convenience, reliability and tolerability, and enhanced patient comfort and adherence. The Company has two commercial proprietary products, Hylenex® and XYOSTED®, partnered commercial products and ongoing product development programs with Teva Pharmaceuticals and McDermott Laboratories Limited, an affiliate of Viatris Inc. Halozyme is headquartered in San Diego, CA and has offices in Ewing, NJ and Minnetonka, MN. Minnetonka is also the site of its operations facility. For more information visit and connect with us on LinkedIn and Twitter. Note Regarding Use of Non-GAAP Financial Measures In addition to disclosing financial measures prepared in accordance with U.S. generally accepted accounting principles ("GAAP"), this press release and the accompanying tables contain certain non-GAAP financial measures. The Company reports earnings before interest, taxes, depreciation, and amortization ("EBITDA"), adjusted EBITDA, Non-GAAP diluted earnings per share, Non-GAAP diluted shares, and guidance with respect to those measures, in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The Company calculates non-GAAP diluted earnings per share excluding share-based compensation expense, amortization of debt discounts, intangible asset amortization, one-time changes, if any, such as changes in contingent liabilities, inventory adjustments, impairment charges, and certain adjustments to income tax expense. The Company calculates non-GAAP diluted shares excluding the dilutive impact of convertible notes which is used in calculating non-GAAP diluted earnings. The Company calculates EBITDA excluding interest, taxes, depreciation and amortization. The Company calculates adjusted EBITDA excluding one-time items, if any, such as changes in contingent liabilities, inventory adjustments, impairment charges and transaction costs for business combinations. Reconciliations between GAAP and Non-GAAP financial measures are included at the end of this press release. The Company does not provide reconciliations of forward-looking adjusted measures to GAAP due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation, including adjustments that could be made for changes in share-based compensation expense and the effects of any discrete income tax items. For the same reasons, the Company is unable to address the probable significance of the unavailable information. The Company provides non-GAAP financial measures that it believes will be achieved; however, it cannot accurately predict all of the components of the adjusted calculations and the U.S. GAAP measures may be materially different than the non-GAAP measures. The Company evaluates other items of income and expense on an individual basis for potential inclusion in the calculation of Non-GAAP financial measures and considers both the quantitative and qualitative aspects of the item, including (i) its size and nature, (ii) whether or not it relates to the Company's ongoing business operations and (iii) whether or not the Company expects it to occur as part of the Company's normal business on a regular basis. Non-GAAP financial measures do not have any standardized meaning and are therefore unlikely to be comparable to similarly titled measures presented by other companies. These non-GAAP financial measures are not meant to be considered in isolation and should be read in conjunction with the Company's consolidated financial statements prepared in accordance with GAAP, and are not prepared under any comprehensive set of accounting rules or principles. In addition, from time to time in the future there may be other items that the Company may exclude for purposes of its non-GAAP financial measures, and the Company may in the future cease to exclude items that it has historically excluded for purposes of its non-GAAP financial measures. The Company considers these non-GAAP financial measures to be important because they provide useful measures of the operating performance of the Company, exclusive of factors that do not directly affect what the Company considers to be its core operating performance, as well as unusual events. The non-GAAP measures also allow investors and analysts to make additional comparisons of the operating activities of the Company's core business over time and with respect to other companies, as well as assessing trends and future expectations. The Company uses non-GAAP financial information in assessing what it believes is a meaningful and comparable set of financial performance measures to evaluate operating trends, as well as in establishing portions of our performance-based incentive compensation programs. Safe Harbor Statement In addition to historical information, the statements set forth in this press release include forward-looking statements including, without limitation, statements concerning the Company's financial performance (including the Company's expected financial outlook for 2025) and expectations for future growth, profitability, total revenue, royalty revenue, EBITDA, Adjusted EBITDA, and non-GAAP diluted earnings-per-share and potential share repurchases under its share repurchase program. Forward-looking statements regarding the Company's ENHANZE® drug delivery technology may include the possible benefits and attributes of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs and facilitating more rapid delivery and administration of higher volumes of injectable medications through subcutaneous delivery and the expected expiration date of our ENHANZE® patent in Europe. Forward-looking statements regarding the Company's business may include potential growth and receipt of royalty and milestone payments driven by our partners' development and commercialization efforts, potential new clinical trial study starts and clinical data, regulatory submissions and product launches, the size and growth prospects of our partners' drug franchises, potential new or expanded collaborations (including potential HVAI and SVAI collaborations) and collaborative targets and regulatory review, and potential approvals of new partnered or proprietary products, and the potential timing of these events. These forward-looking statements are typically, but not always, identified through use of the words "expect," "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning and involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Actual results could differ materially from the expectations contained in these forward-looking statements as a result of several factors, including unexpected levels of revenues, expenditures and costs, unexpected delays in the execution of the Company's share repurchase program, unexpected results or delays in the growth of the Company's business, or in the development, regulatory review or commercialization of the Company's partnered or proprietary products, regulatory approval requirements, uncertainties in tariffs and trade policies, unexpected adverse events or patient outcomes and competitive conditions. In addition, there can be no assurance as to developments related to the litigation referred to in this press release, the outcome of the litigation or any remedies that could be awarded in connection with the litigation. These and other factors that may result in differences are discussed in greater detail in the Company's most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission. Except as required by law, the Company undertakes no duty to update forward-looking statements to reflect events after the date of this release. Contacts: Tram Bui VP, Investor Relations and Corporate Communications 609-333-7668 [email protected] Samantha Gaspar Teneo 212-886-9356 [email protected] Footnotes: 1. Reconciliations between GAAP reported and non-GAAP financial information for actual results are provided at the end. SOURCE Halozyme Therapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床结果上市批准临床2期临床1期财报

2025-03-12

·药明康德

一年只需一针的长效HIV疗法；罗氏合作开发潜在“best-in-class”减肥疗法……

▎药明康德内容团队编辑只需每年一针，长效HIV预防疗法挺进3期临床吉利德科学（Gilead Sciences）公司日前公布了两种每年一次的lenacapavir配方，作为暴露前预防（PrEP）疗法，在1期临床试验中的积极结果。数据支持每年一次lenacapavir用于PrEP的未来开发。该结果已发表于医学期刊《柳叶刀》。吉利德科学公司计划于2025年下半年启动3期临床试验。 1期临床试验数据显示，每年一次、肌肉注射的两种lenacapavir配方达到并维持了超出在3期临床试验PURPOSE 1和PURPOSE 2试验中观察到的与HIV预防疗效相关的血浆浓度。此前报道的PURPOSE 1和PURPOSE 2数据显示，每年两次皮下注射lenacapavir在降低HIV感染方面显示出优于背景HIV发病率和每日一次口服Truvada。两种配方的受试者血浆中lenacapavir浓度在至少56周内均高于95%有效浓度。此外，两种每年一次lenacapavir配方在第52周的中位谷浓度（分别为57.0 ng/mL和65.6 ng/mL）均高于PURPOSE 1和PURPOSE 2试验中每年两次lenacapavir在第26周观察到的23.4 ng/mL。 Lenacapavir是一种“first-in-class”长效HIV病毒衣壳抑制剂，可以干扰HIV病毒衣壳蛋白的组装和拆卸，在病毒生命周期的多个阶段发挥作用。它已经获得美国FDA授予的突破性疗法认定，用于HIV病毒感染暴露前预防。2024年，《科学》期刊也将lenacapavir评为年度科学突破，表示这一“first-in-class”药物为艾滋病的长效治疗与预防带来了新的曙光。维持HIV病毒抑制48周，默沙东双药疗法达两项3期临床主要终点默沙东（MSD）公司今日宣布，在研每日一次口服双药方案doravirine/islatravir（DOR/ISL）在两项关键性3期试验中获得积极结果。在两项试验中，DOR/ISL与活性对照组相比达到非劣效性标准。基于这些积极结果，默沙东计划在2025年中期启动向监管机构提交上市申请。在双盲试验MK-8591A-052中，主要终点（HIV-1 RNA≥50拷贝/毫升）结果显示，在接受克替拉韦/恩曲他滨/替诺福韦艾拉酚胺（BIC/FTC/TAF）治疗下已实现病毒抑制的成人患者中，第48周切换至DOR/ISL的受试者中有1.5%病毒载量达到或超过50拷贝/毫升，而BIC/FTC/TAF组为0.6%（治疗差异0.9%，95% CI：-1.9，2.9）。第48周切换至DOR/ISL的受试者中有91.5%维持了病毒抑制，而继续接受BIC/FTC/TAF治疗的受试者中这一比例为94.2%（治疗差异-2.6%，95% CI：-7.1，2.6）。在开放标签试验MK-8591A-051中，在接受基线抗病毒治疗（bART）并获得病毒抑制的成人患者中，第48周切换接受DOR/ISL治疗的受试者中有1.4%病毒载量达到或超过50拷贝/毫升，而继续接受bART治疗的患者这一数值为4.9%（治疗差异-3.6%，95% CI：-7.8，-0.8）。第48周切换至DOR/ISL的受试者中有95.6%维持了病毒抑制，而继续接受bART的受试者中这一比例为91.9%（治疗差异3.7%，95% CI：-0.3，8.9）。 4个月一次，长效HIV抗体疗法组合3期临床结果积极 ViiV Healthcare今日宣布，其长效HIV抗体疗法N6LS，在2b期临床试验EMBRACE中取得积极结果。数据显示，每四个月一次给药的N6LS，与每月一次长效cabotegravir（CAB LA）联用，可成功使已稳定接受治疗的HIV成年患者保持病毒抑制，并且耐受性良好。 EMBRACE研究在六个月主要终点时的结果显示，静脉注射60 mg/kg的N6LS组中96%的受试者，以及皮下注射3000 mg的N6LS组中88%的受试者维持了HIV-1 RNA水平低于50拷贝/毫升，而标准治疗组为96%。基于试验中观察到的积极结果，ViiV Healthcare将在EMBRACE的第二部分试验中，进一步评估六个月一次静脉注射N6LS与CAB LA联用的效果。罗氏合作开发潜在“best-in-class”胰淀素类似物 Zealand Pharma今日宣布，与罗氏（Roche）达成全球合作及许可协议，共同开发Zealand Pharma的胰淀素类似物petrelintide，作为体重管理的基石性疗法，同时迅速扩展至相关适应症。新闻稿指出，petrelintide具有成为“best-in-class”疗法的潜力。根据协议，双方将共同开发和商业化petrelintide及其组合产品，包括petrelintide与罗氏的潜在“best-in-class”胰高血糖素样肽-1（GLP-1）、葡萄糖依赖性促胰岛素多肽（GIP）受体双重激动剂CT-388构成的固定剂量组合产品。双方将在美国和欧洲共同商业化petrelintide及本次合作产生的其他产品，而罗氏获得全球其他地区的独家商业化权益。Zealand Pharma可在美国和欧洲参与最多50%的商业化活动。 Zealand Pharma将获得16.5亿美元的前期付款。Zealand Pharma还将有资格获得12亿美元的研发里程碑付款（主要与petrelintide单药治疗3期临床试验启动相关）及24亿美元的销售里程碑付款。 Petrelintide为一种长效胰淀素类似物，适合每周一次皮下注射。该药物在设计时注重化学和物理稳定性，在中性pH值下无纤维化现象，从而可与其他肽类药物实现联合配方及联合给药。超9亿美元助力反义寡核苷酸疗法开发 Ono Pharmaceutical（ONO）宣布已与Ionis Pharmaceuticals签订许可协议，获得反义寡核苷酸（ASO）疗法sapablursen的开发及商业化权益。Sapablursen是一种用于治疗真性红细胞增多症（PV）的在研ASO药物，目前正在2期临床试验IMPRSSION中针对成人PV患者进行评估。Sapablursen已于2024年1月获得美国FDA授予的快速通道资格，并于2024年8月获得孤儿药资格。根据协议，ONO将获得全球范围内开发和商业化sapablursen的独家许可。Ionis将继续负责完成正在进行的2期临床试验IMPRSSION，而ONO将全权负责后续开发、监管申报及商业化工作。ONO将支付2.8亿美元前期付款，并根据达到研发、监管及销售里程碑，支付高达6.6亿美元的额外里程碑付款。 Sapablursen的设计旨在降低TMPRSS6基因编码的跨膜蛋白酶丝氨酸6的产生，从而增加铁稳态关键调控因子铁调素（hepcidin）的表达。通过提高铁调素的产生，sapablursen有望对真性红细胞增多症等血液疾病产生积极影响。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料： [1] First Clinical Data for Gilead’s Investigational Once-Yearly Lenacapavir for HIV Prevention Presented at CROI 2025 and Published in The Lancet. Retrieved March 12, 2025, from https://www.gilead.com/news/news-details/2025/first-clinical-data-for-gileads-investigational-once-yearly-lenacapavir-for-hiv-prevention-presented-at-croi-2025-and-published-in-the-lancet [2] Merck Announces Positive Data from Phase 3 Trials that Show the Investigational, Once-Daily, Oral, Two-Drug Regimen of Doravirine/Islatravir (DOR/ISL) Maintained HIV-1 Viral Suppression at Week 48. Retrieved March 12, 2025, from https://www-merck-com.libproxy1.nus.edu.sg/news/merck-announces-positive-data-from-phase-3-trials-that-show-the-investigational-once-daily-oral-two-drug-regimen-of-doravirine-islatravir-dor-isl-maintained-hiv-1-viral-suppression-at-week-48/ [3] ViiV HEALTHCARE’S INVESTIGATIONAL BROADLY NEUTRALISING ANTIBODY - N6LS - SUCCESSFULLY MAINTAINS VIRAL SUPPRESSION IN LONG-ACTING TREATMENT OF HIV. Retrieved March 12, 2025, from https://viivhealthcare.com/hiv-news-and-media/news/press-releases/2025/march/investigational-broadly-neutralising-antibody/ [4] Zealand Pharma and Roche enter collaboration and license agreement to co-develop and co-commercialize petrelintide as a future foundational therapy for people with overweight and obesity. Retrieved March 12, 2025, from https://www.globenewswire.com/news-release/2025/03/12/3041113/0/en/Zealand-Pharma-and-Roche-enter-collaboration-and-license-agreement-to-co-develop-and-co-commercialize-petrelintide-as-a-future-foundational-therapy-for-people-with-overweight-and-o.html [5] Ono Enters into License Agreement with Ionis Pharmaceuticals for Sapablursen for the Treatment of Polycythemia Vera. Retrieved March 12, 2025, from https://www.businesswire.com/news/home/20250311080840/en 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床结果临床3期突破性疗法临床2期

100 项与 Iotivibart 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
HIV感染	临床2期	美国	National Institute of Allergy & Infectious Diseases	2021-06-22
HIV感染	临床2期	美国	Halozyme Therapeutics, Inc.	2021-06-22
HIV感染	临床2期	美国	ViiV Healthcare Ltd.	2021-06-22
HIV感染	临床2期	阿根廷	ViiV Healthcare Ltd.	2021-06-22
HIV感染	临床2期	巴西	ViiV Healthcare Ltd.	2021-06-22
HIV感染	临床2期	加拿大	ViiV Healthcare Ltd.	2021-06-22
HIV感染	临床2期	墨西哥	ViiV Healthcare Ltd.	2021-06-22
HIV感染	临床2期	秘鲁	ViiV Healthcare Ltd.	2021-06-22

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05291520 (SPAN, CTgov)	临床1期	HIV感染	24	VH3810109+rHuPH20 (Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC])	簾簾憲鹽遞醖鑰鬱憲餘 = 遞繭鏇夢蓋艱積遞餘鑰積遞遞願淵觸遞衊夢醖 (鹽網窪憲築範鏇鹹蓋製, 顧餘壓獵夢艱艱淵窪餘 ~ 夢醖餘鑰構餘醖夢鏇顧) 更多	-	2024-09-19
				VH3810109+rHuPH20 (Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC])	簾簾憲鹽遞醖鑰鬱憲餘 = 鑰積鏇網顧廠築壓壓願積遞遞願淵觸遞衊夢醖 (鹽網窪憲築範鏇鹹蓋製, 襯糧遞鹹鹹遞餘構衊醖 ~ 鑰築顧範衊製壓醖製壓) 更多
NCT04871113 (CTgov)	临床2期	HIV感染	62	GSK3810109A (Part 1:GSK3810109A 40milligram(mg)/Kilogram Intravenously (IV))	選網構範憲糧簾簾鏇憲(齋築壓鏇鹹鏇製蓋鹽衊) = 壓醖築夢齋鬱遞醖齋廠遞壓鬱襯構製醖鬱醖構 (獵繭觸觸淵願構廠構網, 衊簾憲鏇築蓋壓鹹積積 ~ 範範網餘鹽範窪繭鹽網) 更多	-	2023-11-18
				GSK3810109A (Part 1: GSK3810109A 280 mg IV)	選網構範憲糧簾簾鏇憲(齋築壓鏇鹹鏇製蓋鹽衊) = 顧窪鹹簾獵鹽衊網簾壓遞壓鬱襯構製醖鬱醖構 (獵繭觸觸淵願構廠構網, 糧淵醖願觸醖淵選網顧 ~ 餘餘醖顧鹽襯鑰積艱壓) 更多
NCT03538626 (VRC 609, CTgov)	临床1期	HIV感染	33	VRC-HIVMAB091-00-AB (Group 1: N6LS (5 mg/kg IV) Single Dose)	蓋積範廠襯淵鹽廠鏇獵 = 膚衊網鑰簾醖廠壓窪餘餘繭衊蓋齋鏇鹹構窪鹽 (餘糧醖觸製顧繭醖鑰淵, 壓顧鏇獵壓醖壓餘積觸 ~ 繭獵醖獵簾構鏇鹽獵糧) 更多	-	2023-09-21
				VRC-HIVMAB091-00-AB (Group 2: N6LS (5 mg/kg SC) Single Dose)	蓋積範廠襯淵鹽廠鏇獵 = 鏇網選襯繭鬱艱鏇築壓餘繭衊蓋齋鏇鹹構窪鹽 (餘糧醖觸製顧繭醖鑰淵, 顧繭構製衊顧繭艱選齋 ~ 憲網醖簾鹹簾壓襯簾襯) 更多