Fintech PR
Imlifidase met primary endpoint in 16-HMedIdes-12 phase 2 trial in patients with AMR following kidney transplantation
Statistically significant reduction in donor-specific antibodies (DSAs) observed among imlifidase patients within five days of treatment as compared to standard of care
LUND, Sweden, Dec. 14, 2023 /PRNewswire/ — Hansa Biopharma, “Hansa” (Nasdaq Stockholm: HNSA), today announced full results from the 16-HMedIdeS-12 phase 2 trial in patients with antibody mediated rejection (AMR) episodes following a kidney transplant demonstrating that imlifidase significantly reduced donor-specific antibodies (DSAs) within the first five days of treatment.
In the trial, the primary endpoint was the maximum reduction in DSA level at any time point during the 5 days following the start of treatment. Patients treated with imlifidase demonstrated a statistically significant reduction of DSAs by 94.4% compared to a 35.6% (p-value: <0.001) reduction in patients who received standard of care (plasma exchange, or PE). DSA levels subsequently returned to approximately 70% of the initial level in both treatment arms.
The secondary endpoint investigated overall kidney function following treatment. The imlifidase arm demonstrated a 74% six-month graft survival and eGFR of 30mL/min/1.73m2. A 100% six-month graft survival and eGFR of 33mL/min/1.73m2 was observed in the PE arm. Given the heterogeneity of the patient population, the trial was not designed nor sufficiently powered to be able show a statistically significant difference in the secondary outcome measures. Imlifidase demonstrated a safety profile consistent with previous clinical trials.
Dr. Achim Kaufhold, Chief Medical Officer, Hansa Biopharma said, “This is the first clinical trial with a head-to-head comparison of imlifidase and a frequently used standard of care treatment (plasmapheresis, or plasma exchange). Plasmapheresis can be challenging for both the patient and the physician, often requiring multiple treatment sessions over several weeks with slow reduction in donor specific antibody (DSA) levels. We are very encouraged by these results which underscore imlifidase’s ability to rapidly reduce DSA levels, which is good news for patients who require safe and efficient reduction of DSA levels.”
Prof. Stanley Jordan MD, Principal Investigator, Director of Division of Pediatric and Adult Nephrology at Cedars Sinai Medical Center, Los Angeles said, “AMR is a heterogeneous and complex disease that remains difficult to diagnose and treat. As clinicians we focus on reduction of DSAs levels quickly and effectively to limit the irreversible damage to the organ that can occur. This is an important step in understanding how imlifidase may benefit patients with AMR. The findings of this trial may inform a path forward to potentially address the issues of chronic inflammation and antibody rebound which will allow clinically meaningful results for this very difficult to treat patient population.”
The AMR patient population is heterogeneous, consisting of both chronic patients – those who experience slow rejection after a transplant, and which often results in irreversible damage to the organ – and acute patients who experience AMR early post-transplant. Additionally, AMR can be driven by a combination of antibodies and T-cells-mediated action (CMR – cell mediated rejection), creating additional complexity when it comes to treatment strategy. Treatment guidelines indicate reduction of DSA levels as one of the main goals of any AMR treatment.1 To date, there are no approved therapies for the treatment of AMR, and all current treatments including standard of care are used off-label.1
More information about the trial is available at ClinicalTrials.gov: NCT03897205.
This is information that Hansa Biopharma AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the contact person set out below, at 20:00 CET on 14 December 2023.
Contacts for more information:
Klaus Sindahl, VP Head of Investor Relations
M: +46 (0) 709 298 269
E: [email protected]
Stephanie Kenney, VP Global Corporate Affairs
M: +1 (484) 319 2802
E: [email protected]
Notes to editors
About imlifidase
Imlifidase is a unique antibody-cleaving enzyme originating from Streptococcus pyogenes that specifically targets IgG and inhibits IgG-mediated immune response.2 It has a rapid onset of action, cleaving IgG-antibodies and inhibiting their activity within hours after administration. Imlifidase has conditional marketing approval in Europe and is marketed under the trade name Idefirix® for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor.
About 16-HMedIdes-12
16-HMedIdes-12 is randomized, open-label, multi-center, controlled phase 2 trial designed to evaluate safety, tolerability, and efficacy of imlifidase compared to plasma exchange (PE) in removal of DSAs in patients experiencing active and chronic active AMR episodes. The trial included 30 patients with AMR randomized to receive either imlifidase or PE in a 2:1 ratio.
About imlifidase and autoimmune diseases
Autoimmune diseases occur when the immune system mistakenly recognizes the body’s own proteins, as foreign and mounts an immune response, creating antibodies against the body’s own cells and tissues. Many autoimmune diseases are driven by pathological IgGs.
Hansa is exploring how imlifidase may be able to prevent or slow disease progression including debilitating, life-threatening symptoms. Imlifidase is currently being studied in the following autoimmune diseases: anti-glomerular basement membrane (anti-GBM) disease, Guillain-Barré Syndrome, and ANCA-associated vasculitis.
About Hansa Biopharma
Hansa Biopharma is a commercial-stage biopharmaceutical company and pioneer in immunoglobulin G (IgG)-cleaving enzyme technology on a mission to develop and commercialize innovative, lifesaving and life-altering treatments for patients with rare immunological conditions. Hansa has developed a first-in-class IgG antibody-cleaving enzyme therapy, which has been shown to enable kidney transplantation in highly sensitized patients. Hansa Biopharma is based in Lund, Sweden, and has operations in Europe and the U.S. The Company is listed on Nasdaq Stockholm under the ticker HNSA. Find out more at www.hansabiopharma.com.
References
1. Schinstock CA, et al. Transplantation. 2020 May;104(5):911-922.
2. EDQM. (2020). International figures on donation and Transplantation 2019
The following files are available for download:
https://mb.cision.com/Main/1219/3894073/2496348.pdf 20231214 – HNSA 16-12 AMR trial full data read out – En
View original content:https://www.prnewswire.co.uk/news-releases/imlifidase-met-primary-endpoint-in-16-hmedides-12-phase-2-trial-in-patients-with-amr-following-kidney-transplantation-302016091.html
DUBAI, UAE, Sept. 6, 2024 /PRNewswire/ — Bybit, the world’s second-largest cryptocurrency exchange by trading volume, set out to make the community’s TOKEN2049 journey more rewarding. Gearing up for the most anticipated blockchain and Web3 event in the region, Bybit is thrilled to announce three bonus events to enable both attendees and remote fans to both be part of the experience.
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#Bybit / #TheCryptoArk
About Bybit
Bybit is the world’s second-largest cryptocurrency exchange by trading volume, serving over 40 million users. Established in 2018, Bybit provides a professional platform where crypto investors and traders can find an ultra-fast matching engine, 24/7 customer service, and multilingual community support. Bybit is a proud partner of Formula One’s reigning Constructors’ and Drivers’ champions: the Oracle Red Bull Racing team.
For more details about Bybit, please visit Bybit Press.
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DUBAI, UAE, Sept. 6, 2024 /PRNewswire/ — Bybit, the world’s second-largest cryptocurrency exchange by trading volume, is excited to announce it’s among the first to be granted consent to a full authorization by the Astana Financial Service Authority (AFSA). This milestone brings Bybit closer to becoming a fully regulated Digital Asset Trading Facility (DATF).
As part of a rigorous process, Bybit Kazakhstan has passed a full AML check, business conduct audit, and detailed compliance inspections. This is part of Bybit’s focus on securing new user opportunities in Kazakhstan and the broader Commonwealth of Independent States (CIS) region.
“Kazakhstan has become a key player in the global crypto ecosystem, and we are thrilled to be expanding our services in such a dynamic market,” said Ben Zhou, co-founder and CEO of Bybit. “We are committed to bringing our cutting-edge technology, security, and transparency to crypto traders in Kazakhstan, ensuring they can access the best possible tools and services to thrive in this fast-growing industry.”
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#Bybit / #TheCryptoArk
About Bybit
Bybit is the world’s second-largest cryptocurrency exchange by trading volume, serving over 40 million users. Established in 2018, Bybit provides a professional platform where crypto investors and traders can find an ultra-fast matching engine, 24/7 customer service, and multilingual community support. Bybit is a proud partner of Formula One’s reigning Constructors’ and Drivers’ champions: the Oracle Red Bull Racing team.
For more details about Bybit, please visit Bybit Press.
For media inquiries, please contact: [email protected]
For more information, please visit: https://www.bybit.com
For updates, please follow: Bybit’s Communities and Social Media
Discord | Facebook | Instagram | LinkedIn | Reddit | Telegram | TikTok | X | Youtube
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Fintech PR
Integrum ESG and CSRHub enable fund managers to monitor both long-term trends and short-term movements in ESG ratings for companies, across a 10-year time series
LONDON, Sept. 6, 2024 /PRNewswire/ — Integrum ESG, the leading alternative ESG data provider, has today announced the launch of their Consensus ESG Ratings module.
Just as investors monitor movements in consensus earnings estimates or credit ratings, investors now are aware of the demand for the ability to monitor long-term trends and short-term movements in consensus ESG ratings.
This new feature enables Integrum ESG’s asset manager clients to now see the consensus ESG score for any company, either as an absolute rating or a relative percentile ranking, across a 10-year time series.
These scores will indicate to any investor what the capital markets have ‘priced in’ for a company’s ESG performance, allowing users to quickly understand the market’s view on a company and easily conduct relative ESG analysis on the positions they hold within their Portfolio.
This regularly updated data is provided by CSRHub, the world’s leading provider of consensus ESG ratings. CSRHub has spent years aggregating and normalising a vast range of licensed sources – from large ESG ratings firms such as MSCI, ISS, S&P Global, and Sustainalytics to specialists such as CDP and Better World Companies.
Shai Hill, Founder and CEO of Integrum ESG, commented: “Many investors have told us they want a sense of ‘what is priced in’ in terms of a company’s ESG performance, so they can compare this to what anyone ESG ratings firm is saying. CSRHub is the only firm to have credibly achieved this, thanks to a model refined over years and a vast data lake – so we are delighted to be partnering with them.”
Bahar Gidwani, Co-Founder of CSRHub, added: “Investors need to fine tune their ESG-related investment strategies to improve their returns and better match the preferences of their clients. Combining CSRHub’s expert outside-in, consensus view of ESG with Integrum ESG’s detailed real-time data stream provides a strong solution for these needs.”
About Integrum ESG
Integrum ESG is the leading alternative ESG data and ratings platform for investors, blending human analysis and award-winning artificial intelligence models to capture, verify and display granular and relevant ESG data for analysis and assessment. Their Platform allows clients to dissect ESG scores, real-time sentiment, and more with a variety of unique-to-market features, empowering industry professionals and investors and giving them complete oversight of ESG risk across their portfolio.
For more information, visit www.integrumesg.com
About CSRHub
CSRHub offers the most comprehensive global set of Consensus ESG (Environmental, Social, and Governance) ratings, information, and tools. CSRHub’s business intelligence system measures the ESG business impact that drives corporate and investor sustainability decisions. Founded in 2007, CSRHub covers 56,545 public and private companies, and provides ESG performance scores on over 37,899 companies from 135 industries in 210 countries. Our Big Data platform uses algorithms to aggregate, normalize and weight ESG metrics from 957 sources to produce a strong consensus signal on corporate sustainability performance.
For more information, visit www.csrhub.com
Media Contact
Harish Karunalingam
Integrum ESG
[email protected]
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