Immunotherapy of HIV-infected Patients An Open, Dose-escalating Assessment of Vacc-C5 With Either GM-CSF or Alhydrogel as Adjuvant in HIV-1-infected Subjects on Antiretroviral Therapy (ART)

Background:
Despite the introduction of highly effective antiretroviral therapy (ART) regimes, which control the HIV infection and results in increases in CD4 cell counts and an undetectable viral load, many patients suffer from increased morbidity. There is evidence that presence of antibodies against the C5 region of gp120 strongly correlates with slower disease progression, and that loss of antibody responses to this region are associated with progression.
Investigational product:
Vacc-C5 is a single heterodimeric peptide-based HIV therapeutic vaccine corresponding to the C5 region on gp120 and the external domain of gp41. The vaccine is intended to create a non-neutralizing antibody against C5 region.
Study objectives:
To evaluate safety of the vaccination regimens
To evaluate C5-specific humoral immune responses (antibodies), T cell responses, T cell activation markers and other immune markers.

Start Date01 Sep 2012

Sponsor / Collaborator

Bionor Immuno AS

100 Clinical Results associated with Vacc-C5

100 Translational Medicine associated with Vacc-C5

100 Patents (Medical) associated with Vacc-C5

Literatures (Medical) associated with Vacc-C5

01 Feb 2024·Arthroscopy: The Journal of Arthroscopic & Related Surgery

Eighth Cervical Nerve Root Block During Interscalene Brachial Plexus Block Decreases Pain Caused by Posterior Portal Placement but Increases Horner Syndrome in Patients Undergoing Arthroscopic Shoulder Surgery: A Randomized Controlled Trial

Article

Author: Kim, Jonghae ; Kim, Eugene ; Choi, Chang Hyuk ; Lee, So Young ; Choi, Eunjoo ; Lim, Jung A

PURPOSETo compare the intensity of pain on posterior portal placement between a C5-C7 root block (conventional interscalene brachial plexus block [ISBPB]) and a C5-C8 root block in patients undergoing arthroscopic shoulder surgery.METHODSIn this prospective, single-blinded, parallel-group randomized controlled trial, patients were randomized to receive either a C5-C7 root block (C5-C7 group, n = 37) or a C5-C8 root block (C5-C8 group, n = 36) with 25 mL of 0.75% ropivacaine. The primary outcome was the pain intensity on posterior portal placement, which was graded as 0 (no pain), 1 (mild pain), or 2 (severe pain). The secondary outcomes were the bilateral pupil diameters measured 30 minutes after ISBPB placement; the incidence of Horner syndrome, defined as a difference in pupil diameter (ipsilateral - contralateral) of less than -0.5 mm; the onset of postoperative pain; and the postoperative numerical rating pain score, where 0 and 10 represent no pain and the worst pain imaginable, respectively.RESULTSFewer patients reported mild or severe pain on posterior portal placement in the C5-C8 group than in the C5-C7 group (9 of 36 [25.0%] vs 24 of 37 [64.9%], P = .003). Less pain on posterior portal placement was reported in the C5-C8 group than in the C5-C7 group (median [interquartile range], 0 [0-0.75] vs 1 [0-1]; median difference [95% confidence interval], 1 [0-1]; P = .001). The incidence of Horner syndrome was higher in the C5-C8 group than in the C5-C7 group (33 of 36 [91.7%] vs 22 of 37 [59.5%], P = .001). No significant differences in postoperative numerical rating pain scores and onset of postoperative pain were found between the 2 groups.CONCLUSIONSA C5-C8 root block during an ISBPB reduces the pain intensity on posterior portal placement. However, it increases the incidence of Horner syndrome with no improvement in postoperative pain compared with the conventional ISBPB (C5-C7 root block).LEVEL OF EVIDENCELevel I, randomized controlled trial.

01 Dec 2017·BMC Infectious DiseasesQ3 · MEDICINE

The therapeutic HIV Env C5/gp41 vaccine candidate Vacc-C5 induces specific T cell regulation in a phase I/II clinical study

Q3 · MEDICINE

ArticleOA

Author: Brekke, Kristin ; Kvale, Dag ; Ökvist, Mats ; Sommerfelt, Maja ; Dyrhol-Riise, Anne Margarita

BACKGROUNDLevels of non-neutralising antibodies (AB) to the C5 domain of HIV Env gp120 are inversely related to progression of HIV infection. In this phase I/II clinical study we investigated safety of Vacc-C5, a peptide-based therapeutic vaccine candidate corresponding to C5/gp41^732-744 as well as the effects on pre-existing AB levels to C5/gp41^732-744, immune activation and T cell responses including exploratory assessments of Vacc-C5-induced T cell regulation. Our hypothesis was that exposure of the C5 peptide motif may have detrimental effects due to several of its HLA-like features and that enhancement of non-neutralising anti-C5 AB by vaccination could reduce C5 exposure and thereby chronic immune activation.METHODSThirty-six HIV patients on effective antiretroviral therapy were randomised to one of three dose levels of Vacc-C5 administered intramuscularly with Alhydrogel or intradermally with GM-CSF as adjuvant through initial immunisation and two booster periods over 26 weeks. Vacc-C5-specific AB were measured by ELISA and T cell responses by both IFN-γ ELISPOT and proliferative assays analysed by flow cytometry. Immune regulation was assessed by functional blockade of the two inhibitory cytokines IL-10 and TGF-β in parallel cultures. Non-parametric statistical tests were applied.RESULTSVacc-C5 was found safe and well tolerated in all patients. Only marginal changes in humoral and cellular responses were induced, without any effect on immune activation. Overall, anti-Vacc-C5 AB levels seemed to decrease compared to pre-existing levels. Whereas Vacc-C5-specific CD8⁺ T cell proliferative responses increased after the first booster period (p = 0.020; CD4⁺, p = 0.057), they were reduced after the second. In contrast, Vacc-C5-induced T cell regulation increased after completed vaccination (p ≤ 0.027) and was lower at baseline in the few AB responders identified (p = 0.027).CONCLUSIONSThe therapeutic HIV vaccine candidate Vacc-C5 safely induced only marginal immune responses, whereas Vacc-C5-induced T cell regulation markedly increased. Our data support further attention on immune regulation during therapeutic HIV vaccination studies.TRIAL REGISTRATIONNCT01627678 .

01 Jan 1983·Cancer detection and prevention

Surface antigens defined by monoclonal antibodies as tumor markers in human leukemia.

Article

Author: Lutz, D ; Majdic, O ; Liszka, K ; Knapp, W ; Bettelheim, P

The detection of surface-linked antigenic determinants by heteroantisera has greatly contributed to a better understanding of the heterogeneity of benign and malignant hematopoietic cells. The difficulties encountered in rendering these heteroantisera specific for a unique cell surface component have been a major drawback to a more rapid development of immunologic cell typing. With the introduction of hybridoma technology, it became possible to obtain monoclonal antibodies and markedly improve immunologic cell typing. We have, therefore, used this new technology for the production of monoclonal antibodies against human leukocyte surface antigens. This paper describes four cell type-specific monoclonal antibodies, which turned out to be very useful reagents in leukemia diagnosis. One of these antibodies, VIM-D5, is directed against a myeloid cell surface antigen. VIL-A1 is specific for the common acute leukemia associated antigen. VIB-C5 recognizes B-cell differentiation antigen and VIE-G4 is specific for glycophorin A, and thus detects erythroid precursor cells.

News (Medical) associated with Vacc-C5

02 May 2023

·www.prnewswire.com

REGENXBIO Announces Presentations at the American Society of Gene & Cell Therapy 26th Annual Meeting

ROCKVILLE, Md., May 2, 2023 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced presentations at the American Society of Gene & Cell Therapy (ASGCT) 26th Annual Meeting, taking place in Los Angeles, California from May 16 through 20, 2023. The presentations highlight the Company's end-to-end capabilities across clinical development and research and early development. The presentations will be presented as follows: Oral Presentations: Abstract Title: AUF1 Gene Therapy for Duchenne Muscular Dystrophy Increases Durable Endogenous Utrophin Expression, Muscle Regeneration and Muscle Function Performance in Pre-clinical Animal Studies (abstract #135) Presenter: Dounia Abbadi, Postdoctoral Fellow, NYU Langone Medical Center Session: Gene Tx Approaches for Muscle & Skeletal Diseases Date/Time: Thursday, May 18, 2023, 2:38-2:55 p.m. PST Abstract Title: Mechanistic Evaluation of Liver-specific Transgene Repression from AAV Vectors in Non-Human Primates and Minipigs (abstract #249) Presenter: Zhuo Wang, Ph.D., Scientist II, Research & Early Development at REGENXBIO Session: AAV Vector Genome Biology & Engineering II Date/Time: Friday, May 19 3:45-4:00 p.m. PST Poster Presentations: Abstract Title: RGX-121 gene therapy for the treatment of neuronopathic mucopolysaccharidosis type II (MPS II): Interim analysis of data from the first in human study (abstract #807) Presenter: Paul Harmatz, M.D., Professor in Residence at University of California, San Francisco Session: Wednesday Poster Session Date/Time: Wednesday, May 17, 2023 12:00-2:00 p.m. PST & 5:30-7:00 p.m. PST Abstract Title: In Silico Prediction and In Vivo Testing of Promoters Targeting GABAergic Inhibitory Neurons (abstract #385) Presenter: Robert Duba-Kiss, Ph.D. Candidate, Pharmacology/Neuroscience at University of Toronto University of Toronto Session: Wednesday Poster Session Date/Time: Wednesday, May 17, 2023 12:00-2:00 p.m. PST & 5:30-7:00 p.m. PST Abstract Title: Development of AAV-Expressed C5 Inhibitor to Locally Suppress Complement Pathway Activation in the Eye as a Potential Treatment for Dry Age-related Macular Degeneration (abstract #364) Presenter: Wei-Hua Lee, Ph.D., Senior Scientist, Research & Early Development at REGENXBIO Session: Wednesday Poster Session Date/Time: Wednesday, May 17, 2023 12:00-2:00 p.m. PST & 5:30-7:00 p.m. PST Abstract Title: Addition of a Protein Domain from the Dystrophin C-Terminus Improves Functional and Biochemical Properties of AAV-Encoded Microdystrophin (abstract #668) Presenter: Steven Foltz, Ph.D., Senior Scientist, Research & Early Development at REGENXBIO Session: Wednesday Poster Session Date/Time: Wednesday, May 17, 2023 12:00-2:00 p.m. PST & 5:30-7:00 p.m. PST Abstract Title: Optimization of AAV-DARPin Fusions to Redirect Capsid Tropism (abstract #447) Presenter: Elad Firnberg, Ph.D., Senior Scientist, Research & Early Development at REGENXBIO Session: Wednesday Poster Session Date/Time: Wednesday, May 17, 2023 12:00-2:00 p.m. PST & 5:30-7:00 p.m. PST Abstract Title: RGX-111 gene therapy for the treatment of severe mucopolysaccharidosis type I (MPS I): Interim analysis of data from the first in human study (abstract #932) Presenter: Laura Pisani-Betancourt, MD, MBA, FACMG, Senior Medical Director, Clinical Development Lead at REGENXBIO Session: Thursday Poster Session Date/Time: Thursday May 18, 2023 12:00-2:00 p.m. PST & 5:30-7:00 p.m. PST Abstract Title: Local Delivery of Vectorized Therapeutics Targeting a Pro-inflammatory Cytokine Effectively Reduces Disease Severity in a Mouse Model of Non-Infectious Uveitis (abstract #860) Presenter: Jessica Gumerson, Ph.D., Scientist II, Research & Early Development at REGENXBIO Session: Thursday Poster Session Date/Time: Thursday May 18, 2023 12:00-2:00 p.m. PST & 5:30-7:00 p.m. PST Abstract Title: High Resolution Biodistribution Analysis Following Suprachoroidal Administration of a Pool of AAV3B, AAV8, and AAV9 Vectors to Non-Human Primates Reveals Spatial and Cell-Based Tropism Differences (abstract #876) Presenter: April R. Giles, Ph.D., Senior Scientist, Research & Early Development at REGENXBIO Session: Thursday Poster Session Date/Time: Thursday, May 18, 2023 12:00-2:00 p.m. PST & 5:30-7:00 p.m. PST Abstract Title: Utility of Cryofluorescence Tomography (CFT) as an Unbiased Method to Describe AAV Biodistribution (abstract #1278) Presenter: Samantha A. Yost, Ph.D., Senior Scientist, Research & Early Development at REGENXBIO Session: Friday Poster Session Date/Time: Friday, May 19, 2023 12:00-2:00 p.m. PST & 5:30-7:00 p.m. PST Abstract Title: Development of a Self-Complementary AAV.U7snRNA Vector for Efficient Dystrophin Exon 53 Skipping (abstract #1565) Presenter: Randolph Qian, Ph.D., Scientist II, Research & Early Development at REGENXBIO Session: Friday Poster Session Date/Time: Friday, May 19, 2023 12:00-2:00 p.m. PST & 5:30-7:00 p.m. PST Abstract Title: Kinetic Analyses Reveal Very Early CpG-specific Antagonism to AAV-Mediated Transgene Expression: Implications for TLR9 Stimulatory Effects Prior to Effector T Cell Activation Following Gene Transfer (abstract #1487) Presenter: Justin D. Glenn, Ph.D., Senior Scientist, Research & Early Development at REGENXBIO Session: Friday Poster Session Date/Time: Friday, May 19, 2023 12:00-2:00 p.m. PST & 5:30-7:00 p.m. PST NAV® Technology Licensees: Abstract Title: AAV Vector DNA Carrying Two Concatenated miRNA Stem-Loops is Highly Homogenous and Stable in GLP-Grade AAV Product Presenter: Chenxia HE, Ph.D., Director of Gene Therapy at uniQure, in collaboration with REGENXBIO Session: AAV Vectors – Product Development Manufacturing: Analytics & Stability Studies Date/Time: Thursday, May 18, 2023, 1:45-2:00 p.m. PST Abstract Title: Preclinical Proof-of-Concept of AMT-260, a Novel AAV9-Dual microRNA-Based Vector Targeting GRIK2 for the Treatment of Temporal Lobe Epilepsy (abstract #1159) Presenter: Nick Pearson, Head of Toxicology & Translational Safety at uniQure, in collaboration with REGENXBIO Session: Thursday Poster Session Date/Time: Thursday, May 18, 2023 12:00-2:00 p.m. PST & 5:30-7:00 p.m. PST About REGENXBIO Inc. REGENXBIO is a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy. REGENXBIO's NAV Technology Platform, a proprietary adeno-associated virus (AAV) gene delivery platform, consists of exclusive rights to more than 100 novel AAV vectors, including AAV7, AAV8 and AAV9. REGENXBIO and its third-party NAV Technology Platform Licensees are applying the NAV Technology Platform in the development of a broad pipeline of candidates, including late-stage and commercial programs, in multiple therapeutic areas. REGENXBIO is committed to a "5x'25" strategy to progress five AAV Therapeutics from our internal pipeline and licensed programs into pivotal-stage or commercial products by 2025. Contacts: Dana Cormack Corporate Communications [email protected] Investors: Chris Brinzey ICR Westwicke 339-970-2843 [email protected] SOURCE REGENXBIO Inc.

Gene TherapyClinical Study

25 Aug 2022

·www.biospace.com

AstraZeneca Scores Japanese Approvals in NSCLC, gMG and Breast Cancer

Courtesy of Bodo Marks/Picture Alliance via Getty Images AstraZeneca announced a series of wins in Japan with regulatory approvals for Tagrisso, Ultomiris and Lynparza, based on positive results from three global trials for non-small cell lung cancer, myasthenia gravis and early breast cancer, respectively. The nods came from the Japanese Ministry of Health, Labor and Welfare (MHLW). Tagrisso Obtains Approval for EGFRm NSCLC after Surgery The global ADAURA Phase III trial evaluated Tagrisso (osimertinib) for the adjuvant treatment of patients with epidermal growth factor receptor-mutated (EGFRm) NSCLC post-surgery. The drug demonstrated significant improvement in disease-free survival among patients with Stage II and IIIA EGFRm NSCLC and in the overall population of participants with Stage IB-IIIA disease. Further study will investigate overall survival as well, the researchers stated. Details are published in The New England Journal of Medicine. Lung cancer is the leading cause of cancer death among patients with NSCLC in Japan, with over 35 percent developing tumors with an EGFR mutation. "Patients diagnosed with lung cancer in Japan are more likely than patients anywhere else in the world to be alive five years after their diagnosis. Yet lung cancer remains the country’s leading cause of cancer death," Dave Fredrickson, executive vice president of the oncology business unit at AstraZeneca, said in a statement. Tagrisso is already approved for early-stage lung cancer in over 85 countries. This marks its third approved indication in Japan, following approvals for second-line T790M in 2016 and first-line EGFRm NSCLC in 2018. The latest approval makes targeted treatment options available for patients after undergoing surgery. Ultomiris Scores Approval for Generalized Myasthenia Gravis The MHLW approved Ultomiris (ravulizumab), making it the first and only approved long-acting C5 complement inhibitor to reduce the treatment burden for adults with generalized myasthenia gravis (gMG). Eligible patients are those whose disease is anti-acetylcholine antibody-positive and suffer from symptoms that even high-dose IV immunoglobulin therapy or plasmapheresis cannot manage. Ultomiris is also approved for patients who are not eligible for high-dose IVIg or plasmapheresis due to complications, adverse reactions and other factors. Generalized myasthenia gravis is a rare autoimmune neuromuscular disorder that affects around 22,000 people in Japan. It is characterized by severe muscle weakness and loss of muscle function. The regulator's decision is based on the successful CHAMPION-MG Phase III trial, which demonstrated Ultomiris' ability to significantly improve conditions for people with gMG. Participants were evaluated using the Myasthenia Gravis-Activities of Daily Living Pro week 26, while prolonged follow-up results were taken from an extension study that lasted 60 weeks. Full results are published in NEJM Evidence. In the United States, Ultomiris is approved for adults with anti-AChR antibody-positive gMG. Regulatory evaluations are ongoing in other countries as well. Lynparza Approved for Early Breast Cancer Lynparza (olaparib), the first-in-class PARP inhibitor that AstraZeneca developed with MSD, garnered the Japanese government's nod to be the first and only approved medicine for patients with BRCA-mutated, HER2-negative early breast cancer. The decision was based on positive outcomes from the OlympiA Phase III trial, which tested the drug's performance in terms of invasive disease-free survival, overall survival, safety and tolerability versus a placebo. Complete results are published in NEJM. There are around 95,000 people expected to be diagnosed with breast cancer in Japan in this year alone, and more than 15,000 are likely to die from the illness. Of the 80 percent of patients with HER2-negative breast cancer, 11 percent have BRCA mutations. "Today’s approval marks a significant leap forward for breast cancer patients in Japan, where it is the most commonly diagnosed cancer among women," Frederickson said in a statement. "Patients with BRCA mutations have high rates of disease recurrence and lower survival, and Lynparza has been shown to significantly reduce both the risk of recurrence and death." Lynparza was approved in the U.S. in March for germline BRCAm, HER2-negative high-risk early breast cancer. It was approved in the E.U. in August for the same indication.

AntibodyFirst in Class

24 Aug 2022

·www.prnewswire.com

Argenx's Vyvgart and Alexion's Ultomiris Go Toe-to-Toe in Generalized Myasthenia Gravis, According to Spherix Global Insights

Positive perceptions for both brands will drive expansion of patient share and prescriber base EXTON, Pa., Aug. 24, 2022 /PRNewswire/ -- Competition in the generalized myasthenia gravis (gMG) market is heating up with the launches of argenx's Vyvgart and Alexion's Ultomiris earlier this year. Both brands have the same approved indication but differ on mechanism of action, dosing profiles, and safety (among other factors). Spherix recently carried out a deep dive into neurologists' use and perceptions of the disease modifying therapies as part of the ongoing Launch Dynamix™: Vyvgart (argenx) and Ultomiris (Alexion) in gMG (US) service. Six months into the launch of Vyvgart, neurologists identified (unaided) the brand's efficacy and safety as its greatest advantages for the treatment of gMG. For Ultomiris, efficacy is also as a top advantage of the drug, in addition to its convenient dosing schedule. One interviewed neurologist reported, "I definitely like the every-eight-week dosing interval. It takes the guesswork out of it." Indeed, neurologists report a slight edge for Ultomiris over Vyvgart on favorable dosing, and at this early stage of Vyvgart's launch, some have questions on the drug's treatment schedule. As noted by one respondent, "The bad thing is it's kind of like an as-needed medication. After you give the first cycle, then you have to wait and see if there's deterioration. Sometimes patients get nervous. I can get nervous, especially in a patient who when they do deteriorate, they immediately go into crisis. That's why I choose my patients as to who I should give it to." Conversely, argenx's neonatal fragment crystallizable receptor (FcRn) blocker well outperforms Ultomiris on overall safety, with Alexion's C5 complement inhibitor having a black box warning for serious meningococcal infections – a feature not shared by Vyvgart. Interestingly, some interviewed neurologists did not perceive Ultomiris' black box warning or its REMS program to be a major deterrent to use of the brand – in part because of their previous experience with Alexion's Soliris. However, other neurologists did acknowledge that patients' comfort level with Ultomiris' safety risks does influence their prescribing decisions and not all patients are willing to accept those risks. With some neurologists' expectation that Vyvgart dosing in clinical practice will be more frequent than in the ADAPT Phase III clinical, one respondent noted that Vyvgart's safety in the real world might not mirror trial safety data: "The biggest concern I have is about the safety: we are absolutely, 100% going to be giving the drug [Vyvgart] more often than what was given in the clinical trial because I think they didn't conduct their studies the way they should have. The re-treatment criteria were way too strict…Therefore the safety data is not valid for the way it's going to be used." Despite these concerns, neurologists have overall welcomed the addition of Vyvgart as a new treatment option for gMG and view the brand's unique mechanism of action as fulfilling an unmet need for patients. Indeed, Vyvgart's patient share is expected to increase significantly in the next six months, coupled by expansion in its prescriber base. The launch of a subcutaneous version, expected in 2023, will likely further drive argenx's gMG franchise. About Launch Dynamix™ Launch Dynamix™ is an independent service providing monthly benchmarking of newly launched products for the first eighteen months of commercial availability, augmented by a quarterly deep dive into promotional activity, barriers to uptake, and patient types gravitating to the launch brand. About Spherix Global Insights Spherix Global Insights is a hyper-focused market intelligence firm that leverages our own independent data and expertise to provide strategic guidance, so biopharma stakeholders make decisions with confidence. We specialize in select immunology, nephrology, and neurology markets. All company, brand or product names in this document are trademarks of their respective holders. For more information contact: Emma McFadden, Senior Insights Director, Neurology Email: [email protected] SOURCE Spherix Global Insights

100 Deals associated with Vacc-C5

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Indication	Highest Phase	Country/Location	Organization	Date
HIV Infections	Phase 2	-	Bionor Pharma ASA	-

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