Study to Assess the Safety and Durability of Viral Control Beyond 24 Weeks of Analytical Treatment Interruption After the Administration of Candidate HIV-1 Vaccines DNA.HTI, MVA.HTI and ChAdOx1.HTI or Placebo in Early Treated HIV-1 Positive Individuals (ATI Extension of AELIX-002 Study)

The AELIX-002 trial has been conducted on a cohort of individuals who started cART within the first 6 months after the primary VIH infection, thus increasing the likelihood of observing a certain rate of post-treatment controls (PTC), regardless of treatment efficacy. Although the kinetics of HIV rebound should allow observing differences between placebo and control regarding the post treatment controls rate in case of efficacy of the IMPs, assessing the length and determinants of a post-intervention control (PIC) (i.e., associated with vaccination) beyond 24 weeks is crucial for developing a curative approach to HIV infection. In this regard, an extension of the ATI phase for those individuals with pVL less than 2,000 copies/mL after 24 weeks of ATI in the AELIX-002 offers an unique research opportunity to better understand relevant aspects of the mechanisms involved in the different phenotypes of a PIC and PTC.

Start Date01 Jun 2020

Sponsor / Collaborator

Aelix Therapeutics SLStartup

NCT04364035 / CompletedPhase 2

A Phase IIa Randomised, Double-blind, Placebo-controlled Study of HIV-1 Vaccines MVA.HTI and ChAdOx1.HTI With TLR7 Agonist Vesatolimod (GS-9620) in Early Treated HIV-1 Infection

AELIX-003 study aims to investigate the safety, tolerability, immunogenicity and efficacy of a regimen containing AELIX Therapeutics' HTI T-cell vaccines and Gilead´s Toll-Like Receptor 7 (TLR7) agonist vesatolimod in HIV-infected individuals on antiretroviral therapy. Study that will be conducted in 57 participants who have started antiretroviral therapy during early HIV infection, enrolled at various clinical trial sites in Spain. All participants will be on antiretroviral therapy upon starting the study, with their HIV viral loads <50 copies/mL. Following exposure to the vaccine/vesatolimod, all participants, under careful monitoring, will temporarily stop their antiretroviral drugs to determine if the intervention is effective in keeping their HIV levels under control.

Start Date20 Feb 2020

Sponsor / Collaborator

Aelix Therapeutics SLStartup

[+1]

NCT03204617 / CompletedPhase 1

A Phase I, Randomized, Double-Blind, Placebo-Controlled Safety, Tolerability and Immunogenicity Study of Candidate HIV-1 Vaccines DNA.HTI, MVA.HTI and ChAdOx1.HTI in Early Treated HIV-1 Positive Individuals

The AELIX-002 study aims to evaluate the safety and the immunogenicity of an heterologous prime-boost regimen with DNA.HTI, MVA.HTI and ChAdOx1.HTI in early diagnosed and treated HIV-1 positive individuals, males and females,18-60 years of age.

Start Date07 Jul 2017

Sponsor / Collaborator

Aelix Therapeutics SLStartup

100 Clinical Results associated with HTI immunogen(Aelix Therapeutics SL)

100 Translational Medicine associated with HTI immunogen(Aelix Therapeutics SL)

100 Patents (Medical) associated with HTI immunogen(Aelix Therapeutics SL)

Literatures (Medical) associated with HTI immunogen(Aelix Therapeutics SL)

01 Dec 2022·Nature MedicineQ1 · MEDICINE

Safety, immunogenicity and effect on viral rebound of HTI vaccines in early treated HIV-1 infection: a randomized, placebo-controlled phase 1 trial

Q1 · MEDICINE

Article

Author: Alarcón-Soto, Yovaninna ; Wee, Edmund G ; Hanke, Tomáš ; Mothe, Beatriz ; Oriol-Tordera, Bruna ; Casadellà, Maria ; Parera, Mariona ; Pérez, Francisco ; McGowan, Ian ; Leselbaum, Anne R ; Sengupta, Devi ; Ruiz-Riol, Marta ; Coll, Josep ; Paredes, Roger ; Noguera-Julian, Marc ; Bailón, Lucia ; Escribà, Tuixent ; Molto, Jose ; Llano, Anuska ; Rivero, Àngel ; Perez, Felix ; Lopez, Miriam ; Brander, Christian ; Clotet, Bonaventura ; Cedeño, Samandhy ; Rosás-Umbert, Miriam

HIVACAT T-cell immunogen (HTI) is a novel human immunodeficiency virus (HIV) vaccine immunogen designed to elicit cellular immune responses to HIV targets associated with viral control in humans. The AELIX-002 trial was a randomized, placebo-controlled trial to evaluate as a primary objective the safety of a combination of DNA.HTI (D), MVA.HTI (M) and ChAdOx1.HTI (C) vaccines in 45 early-antiretroviral (ART)-treated individuals (44 men, 1 woman; NCT03204617). Secondary objectives included T-cell immunogenicity, the effect on viral rebound and the safety of an antiretroviral treatment interruption (ATI). Adverse events were mostly mild and transient. No related serious adverse events were observed. We show here that HTI vaccines were able to induce strong, polyfunctional and broad CD4 and CD8 T-cell responses. All participants experienced detectable viral rebound during ATI, and resumed ART when plasma HIV-1 viral load reached either >100,000 copies ml^-1, >10,000 copies ml^-1 for eight consecutive weeks, or after 24 weeks of ATI. In post-hoc analyses, HTI vaccines were associated with a prolonged time off ART in vaccinees without beneficial HLA (human leukocyte antigen) class I alleles. Plasma viral load at the end of ATI and time off ART positively correlated with vaccine-induced HTI-specific T-cell responses at ART cessation. Despite limited efficacy of the vaccines in preventing viral rebound, their ability to elicit robust T-cell responses towards HTI may be beneficial in combination cure strategies, which are currently being tested in clinical trials.

News (Medical) associated with HTI immunogen(Aelix Therapeutics SL)

22 Aug 2023

·www.prnewswire.com

High Temperature Insulation (HTI) Materials Market to grow by USD 2.82 billion from 2022 to 2027 | The expansion of steel production capacity drives the market - Technavio

NEW YORK, Aug. 22, 2023 /PRNewswire/ -- The high temperature insulation (HTI) materials market size is set to grow by USD 2,827.85 million from 2022 to 2027 and register a CAGR of 8.2%, according to Technavio's latest market research report estimates. With a focus on identifying dominant industry influencers, Technavio's reports present a detailed study by the way of synthesis, and summation of data from multiple sources. This report offers an up-to-date analysis of the current market scenario, the latest trends and drivers, and the overall market environment. Technavio offers an up-to-date analysis of the current global market scenario and the overall market environment. View Sample Report Continue Reading Technavio has announced its latest market research report titled Global High Temperature Insulation (HTI) Materials Market 2023-2027 The report also covers the following areas : High Temperature Insulation (HTI) Materials Market size High Temperature Insulation (HTI) Materials Market trends High Temperature Insulation (HTI) Materials Market industry analysis Factors such as the increasing use of ceramic, Increasing demand for aluminium, and expansion of steel production capacity will offer immense growth opportunities. To leverage the current opportunities, market vendors must strengthen their foothold in the fast-growing segments, while maintaining their positions in the slow-growing segments. The high temperature insulation (HTI) materials market is fragmented, and the degree of fragmentation will accelerate during the forecast period. What's New? - Special coverage on the Russia-Ukraine war; global inflation; recovery analysis from COVID-19; supply chain disruptions, global trade tensions; and risk of recession Global competitiveness and key competitor positions Market presence across multiple geographical footprints - Strong/Active/Niche/Trivial - Buy the Report High Temperature Insulation (HTI) Materials Market 2023-2027: Segmentation End-user Petrochemicals Sector Ceramics Sector Aluminum Industry Glass And Others Product Ceramic Fibers Insulating Firebricks Others Geography Europe North America APAC South America Middle East And Africa The petrochemicals sector segment is estimated to witness significant growth during the forecast period. High-temperature insulation (HTI) materials find extensive utilization in diverse sectors such as oil and gas refractories and chemical-processing refractories. These industries necessitate materials capable of withstanding elevated temperatures. Consequently, the expansion of the oil and gas and chemical sectors holds pivotal significance in propelling the demand for HTI materials within the refractories application. The growth of HTI materials within the oil and gas industry is notably driven by their capacity to cater to high-temperature requirements inherent to the sector. Additionally, HTI materials are harnessed in various petrochemical applications, including cracked gas dryers, desulfurization units, and oxidation reactors. The broad spectrum of these applications is poised to underdrive pin the global growth of the high-temperature insulation (HTI) materials market during the forecast period. High Temperature Insulation (HTI) Materials Market 2023-2027: Comany Analysis and Scope Some of the major vendors of the high temperature insulation (HTI) materials market in the l4 industry include 3M Co., Almatis BV, Armacell International SA, Aspen Aerogels Inc., CARCO PRECISION RUBBER PRODUCTS S.P.A, Etex NV, Firwin Corp., Hi Temp Insulation Inc., IPCOM NV, James Walker Group Ltd., Luyang Energy saving Materials Co. Ltd., M.E. SCHUPP INDUSTRIEKERAMIK GMBH, Morgan Advanced Materials Plc, Owens Corning, Pyrotek Inc., Rath Aktiengesellschaft, RHI Magnesita GmbH, Shinagawa Refractories Co. Ltd., Unifrax I LLC, and Mitsubishi Heavy Industries Ltd.. To help businesses improve their market position, Technavio's report provides a detailed analysis of around 15+ vendors operating in the market. Company Offerings 3M Co. - The company offers high temperature insulation HTI materials such as 3M Thinsulate High Temperature Acoustic Absorber HT500P. Almatis BV - The company offers high temperature insulation HTI materials such as Tabular Alumina T60 T64, BSA 96, SLA 92, and CA 14M. Armacell International SA - The company offers high temperature insulation HTI materials such as HT ArmaFlex. Market dynamics Key Driver The expansion of steel production capacity is notably driving market growth. Major Trends The increasing adoption of eco-friendly HTI materials is an emerging market trend. The growth of HTI materials is significantly spurred by the increasing transition from conventional construction methods to drywall construction within the construction industry. Notably, numerous players within the global HTI materials market are progressively embracing the production of environmentally friendly options, like calcium silicate boards, to align with the construction of sustainable buildings. This trend is exemplified by the heightened focus on manufacturing 100% non-asbestos calcium silicate boards aimed at mitigating the production of harmful radiation and toxic gases. These boards offer additional attributes, including termite and insect resistance, high strength, lightweight nature, and anti-corrosive properties. As a result, these elements are anticipated to propel the growth of the global high-temperature insulation (HTI) materials market during the forecast period. Significant Challenges Regulatory measures pertaining to adverse effects of HTI materials exposure are the key challenges hindering market growth. High Temperature Insulation (HTI) Materials Market 2023-2027: Key Highlights CAGR of the market during the forecast period 2023-2027 Detailed information on factors that will assist high temperature insulation (HTI) materials market growth during the next five years Estimation of the high temperature insulation (HTI) materials market size and its contribution to the parent market Predictions on upcoming trends and changes in consumer behaviour The growth of the high temperature insulation (HTI) materials market Analysis of the market's competitive landscape and detailed information on vendors Comprehensive details of factors that will challenge the growth of high temperature insulation (HTI) materials market vendors Register for a trial today and gain instant access to 17,000+ market research reports. Technavio's SUBSCRIPTION platform Related Reports: The high temperature superconducting wires market size is estimated to grow at a CAGR of 9.33% between 2022 and 2027. The market size is forecast to increase by USD 258.64 million. This report extensively covers market segmentation by type (second generation HT superconductors wires, and first generation HT superconductors wires), application (healthcare, electronics, R&D, and others), and geography (APAC, North America, Europe, South America, and Middle East and Africa). Growing demand for power electronics is the key factor driving the growth of the global high temperature superconducting wires market. The high temperature cables market share is expected to increase by USD 923.52 million from 2021 to 2026, and the market's growth momentum will accelerate at a CAGR of 8.9%. This report extensively covers high temperature cables market segmentation by end-user (energy, transport, industrial, and others) and geography (APAC, Europe, North America, Middle East and Africa, and South America). One of the key factors driving the global high temperature cables market growth is the improvements in railway infrastructure. Table of contents Executive Summary Market Landscape Market Sizing Historic Market Size Five Forces Analysis Market Segmentation by End-user Market Segmentation by Product Market Segmentation by Geography Customer Landscape Geographic Landscape Drivers, Challenges, and Trends Vendor Landscape Vendor Analysis Appendix About US Technavio is a leading global technology research and advisory company. Their research and analysis focus on emerging market trends and provides actionable insights to help businesses identify market opportunities and develop effective strategies to optimize their market positions. With over 500 specialized analysts, Technavio's report library consists of more than 17,000 reports and counting, covering 800 technologies, spanning across 50 countries. Their client base consists of enterprises of all sizes, including more than 100 Fortune 500 companies. This growing client base relies on Technavio's comprehensive coverage, extensive research, and actionable market insights to identify opportunities in existing and potential markets and assess their competitive positions within changing market scenarios. Contact Technavio Research Jesse Maida Media & Marketing Executive US: +1 844 364 1100 UK: +44 203 893 3200 Email: [email protected] Website: SOURCE Technavio

16 Jun 2023

·www.prnewswire.com

Healthcare Trust Announces Preferred Stock Dividends

NEW YORK, June 16, 2023 /PRNewswire/ -- Healthcare Trust, Inc. (Nasdaq: HTIA / HTIBP) ("HTI") announced today that it declared quarterly dividends on its outstanding preferred stock. Specifically, HTI declared a dividend of $0.4609375 per share on its 7.375% Series A Cumulative Redeemable Perpetual Preferred Stock (the "Series A Preferred Stock") payable on July 17, 2023, to holders of record at the close of business on July 6, 2023. In addition, HTI declared a dividend of $0.4453125 per share on its 7.125% Series B Cumulative Redeemable Perpetual Preferred Stock (the "Series B Preferred Stock") payable on July 17, 2023, to holders of record at the close of business on July 6, 2023 on a quarterly basis. About Healthcare Trust, Inc. Healthcare Trust, Inc. (Nasdaq: HTIA/HTIBP) is a publicly registered real estate investment trust focused on acquiring a diversified portfolio of healthcare real estate, with an emphasis on seniors housing and medical office buildings, located in the United States. Additional information about HTI can be found on its website at . Important Notice The statements in this Current Report on Form 8-K that are not historical facts may be forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause actual results or events to be materially different. The words "anticipates," "believes," "expects," "estimates," "projects," "plans," "intends," "may," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are subject to a number of risks, uncertainties and other factors, many of which are outside of the Company's control, which could cause actual results to differ materially from the results contemplated by the forward-looking statements. These risks and uncertainties include the potential adverse effects of (i) the global COVID-19 pandemic, including actions taken to contain or treat COVID-19, (ii) the geopolitical instability due to the ongoing military conflict between Russia and Ukraine, including related sanctions and other penalties imposed by the U.S. and European Union, and the related impact on the Company, the Company's tenants, the Company's operators and the global economy and financial markets, and (iii) inflationary conditions and higher interest rate environments, as well as those risks and uncertainties set forth in the Risk Factors section of the Company's Annual Report on Form 10-K for the year ended December 31, 2022 filed on March 17, 2023, and all other filings with the Securities and Exchange Commission after that date, as such risks, uncertainties and other important factors may be updated from time to time in the Company's subsequent reports. Further, forward-looking statements speak only as of the date they are made, and the Company undertakes no obligation to update or revise any forward-looking statement to reflect changed assumptions, the occurrence of unanticipated events or changes to future operating results over time, unless required to do so by law. Contact Investors and Media: Email: [email protected] Phone: (866) 902-0063 SOURCE Healthcare Trust, Inc.

Financial Statement

22 Feb 2023

·pipelinereview.com

AELIX Therapeutics presents positive results from randomized placebo-controlled phase I/IIa therapeutic HIV vaccine clinical trial

BARCELONA, Spain I February 21, 2023 I AELIX Therapeutics S.L. (‘AELIX’), a clinical-stage biotechnology company specialized in the discovery and development of immunotherapies for HIV infection, today announced positive topline results from the AELIX-003 trial. The study evaluated the safety, tolerability, immunogenicity and efficacy of AELIX’s HTI T-cell therapeutic HIV vaccine in combination with Gilead’s investigational Toll-Like Receptor 7 (TLR7) agonist, vesatolimod (VES), in people with HIV on antiretroviral therapy. VES is an immune modulator being evaluated as part of an investigational combination regimen that could potentially lead to viral remission. The results of the trial were presented today at the 2023 Conference on Retroviruses and Opportunistic Infections ( CROI ). The study met its primary and secondary endpoints for safety, tolerability and immunogenicity. The trial also evaluated the efficacy of HTI vaccines in combination with VES to avoid, delay or contain viral rebound compared to a placebo group. For this evaluation, participants underwent an analytical treatment interruption (ATI) in their antiretroviral therapy (ART) for up to 24 weeks. During this time, plasma viral load was monitored weekly. The data show that a higher proportion of HTI+VES-treated participants remained off ART for the full 24 weeks. The combination of the HTI vaccine and VES as part of an HIV cure strategy in early treated people with HIV was safe and well tolerated. Preliminary immune data suggest that HTI vaccines given in combination with VES induce high levels of HTI-specific T-cell responses; VES consistently induced pharmacodynamic response over multiple doses in combination therapy with the HTI vaccine. A lower pre-intervention reservoir was associated with better viral outcomes during the ATI, but only in the placebo group. The magnitude and breadth of vaccine response correlated with better viral outcomes. Importantly, HTI vaccines were highly immunogenic in a simpler regimen than in previous AELIX-002 study, and the vaccine-induced responses were associated with higher time off ART, supporting the contribution of the HTI vaccines to better viral control. “These encouraging efficacy data demonstrate that the HTI vaccine in combination with VES may be able to modulate an individual’s HIV-specific immune response in a way that can potentially contribute to a better HIV control in the absence of ongoing ART. The AELIX-003 data are exciting, and confirm what we have seen in the AELIX-002 study, where the HTI vaccine alone also extended the time off ART for the vaccinated participants,” said Dr. Christian Brander, Chief Scientific Officer of AELIX. “The HTI vaccine is aimed at refocusing the immune response to especially vulnerable sites in HIV. The vaccine contains antigenic regions of HIV that are more commonly targeted by individuals who naturally control the virus. Maintenance of viral remission without ART represents the next frontier in HIV infection treatment and an important step towards HIV eradication.” About the AELIX-003 clinical trial AELIX-003 ( NCT04364035 ) was a randomized, multi-center, placebo-controlled trial to evaluate the safety, immunogenicity, and antiviral efficacy of the MVA.HTI (M)/ChAdOx1.HTI (C) vaccines and VES 6 mg in early-treated PLWH. Participants on ART were randomized 2:1 to active placebo treatment. During a 24-week ATI, plasma viral load (pVL) was monitored weekly, and ART was resumed if pVL >100,000 copies/mL (c/mL), or >10,000 c/mL for eight consecutive weeks, and/or CD4<350 cells/mL. Key results include: “The AELIX-003 data are exciting, and confirm what we have seen in the AELIX-002 study, where the HTI vaccine alone also extended the time off-ART for the vaccinated participants. Both AELIX’s HIV cure studies (AELIX-002 and AELIX-003) have shown that the HTI vaccines have the potential to enhance immune control. It is clear that they should be considered as a backbone for future HIV cure eradication trials,” said Dr. José Ramon Arribas, AELIX-003 Coordinating Investigator, Hospital Universitario La Paz, CIBERINFEC, Madrid, Spain. About the HTI immunogen The HTI immunogen was designed at IrsiCaixa by Dr. Christian Brander, CSO at AELIX and Head of the IrsiCaixa Host Genetics and Cellular Immunity Group, and his colleagues. It is based on the observation that T-cell responses to certain parts of HIV are enriched in individuals with a non-progressor clinical phenotype. The HTI immunogen combines these regions in a vaccine immunogen. The HTI sequence design is driven by functional immune data from close to 1,000 individuals from four different cohorts on three continents (Mothe et al. 2011). It does not rely solely on sequence conservation, density of HLA binding motifs or gene expression levels and kinetics as other vaccine candidates do. The predictive power of HTI directed T-cell responses on in vivo virus control has been validated in unrelated cohorts and through sub-studies in samples from earlier vaccine trials, including the STEP trial. About AELIX Therapeutics AELIX, a clinical-stage biotechnology company based in Barcelona, Spain, is focused on the development of a therapeutic HIV vaccine to be included in cure/eradication strategies. AELIX is a spin-off of HIVACAT, the Catalan public-private consortium conducting cutting-edge research in the HIV vaccine field, and the support of Fundació Glòria Soler. AELIX holds a worldwide, exclusive license for the development and commercialization of the HTI immunogen. The company is backed by a syndicate of experienced Spanish and international investors including Ysios Capital, Caixa Capital Risc, 10K Lakes Capital, and the Centro para el Desarrollo Tecnológico e Industrial (CDTI). www.aelixtherapeutics.com SOURCE: AELIX Therapeutics

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100 Deals associated with HTI immunogen(Aelix Therapeutics SL)

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Indication	Highest Phase	Country/Location	Organization	Date
Acquired Immunodeficiency Syndrome	Phase 2	ES	Aelix Therapeutics SLStartup	20 Feb 2020
HIV Seropositivity	Phase 2	ES	Aelix Therapeutics SLStartup	20 Feb 2020

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03204617 (AELIX-002, Pubmed \| Nat Med) Manual	Phase 1	HIV Infections	45	DNA.HTI+MVA.HTI+ChAdOx1.HTI	(ejbavyqybs) = mostly mild and transient ubwibhdcuz (jjigxyscxj )	Positive	27 Oct 2022
NCT03204617 (AELIX-002, Biospace) Manual	Phase 1/2	HIV Infections	45	DNA.HTI+ChAdOx1.HTI	abnlsbhxdq(sdbotaiqnp) = sgrlgkuufc kdhzfvjknf (gfuhigpznn ) View more	Positive	11 Mar 2021
NCT03204617 (AELIX-002, Biospace) Manual	Phase 1/2	HIV Infections	45	Placebo	abnlsbhxdq(sdbotaiqnp) = ucsvpqyiaj kdhzfvjknf (gfuhigpznn ) View more	Positive	11 Mar 2021

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