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
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Fintech PR
Enabling Regenerative Agriculture for Independent Smallholders in Indonesia: The BIPOSC Project, in Collaboration with Musim Mas, L3F, SNV Indonesia, and ICRAF
JAKARTA, Indonesia, Oct. 18, 2024 /PRNewswire/ — Musim Mas Group, the Livelihoods Fund for Family Farming (L3F), SNV Indonesia, and World Agroforestry (ICRAF) are collaborating to improve the knowledge and capacity of independent oil palm smallholders through the Biodiverse & Inclusive Palm Oil Supply Chain (BIPOSC) project.
The project began in 2021 and takes a long-term approach to sustain a deforestation-free supply chain, regenerate degraded land, restore local biodiversity, and improve the livelihoods of independent smallholder farmers in Labuhanbatu, North Sumatra. BIPOSC will achieve this through implementing regenerative agriculture, locally adapted agroforestry models, capacity-building for sustainable businesses, and others.
The independent palm smallholders taking part previously received complementary training from Musim Mas. Following the training, these smallholders formed a smallholder’s association, Labuhanbatu Independent Oil Palm Smallholders Association (APSKS LB), North Sumatra. Musim Mas encourages smallholders to form associations to get better access to resources and obtain certification by the Roundtable on Sustainable Palm Oil (RSPO) and Indonesian Sustainable Palm Oil (ISPO).
“Musim Mas has long saw that smallholders are key to achieving palm oil sustainability, and that’s why we lead Indonesia’s most extensive smallholder program. We believe that the way forward is to collaborate with more partners to achieve a wider impact. With our BIPOSC partners, we hope to advance the skills and knowledge of smallholders through regenerative agriculture and related techniques. Regenerative agriculture and agroforestry have the potential to help smallholders be part of a sustainable palm oil supply chain. It could help them develop alternative sources of income, especially during the replanting period where their palm oil crops are unproductive, typically for three years,” said Rob Nicholls, General Manager, Projects & Programs, Musim Mas Group.
In the face of climate change and threatened biodiversity, regenerative agriculture can play a role for small farms because it maintains soil health, prevents erosion and water runoff, and can potentially reduce greenhouse gas emissions and nitrogen leakage.
“As a global development partner organization, SNV aims to support Indonesia in achieving its Sustainable Development Goals (SDGs). To achieve this, we need to implement effective and impactful programs to transform agricultural and food systems, energy, and water. In the BIPOSC program, we promote a comprehensive regenerative agriculture and agroforestry model to maintain soil fertility and biodiversity, providing maximum benefits for farmers’ livelihoods and economy,” said Rizki Pandu Permana, Country Director of SNV Indonesia.
The key regenerative agriculture techniques taught include the application of bio-input, mulching to protect topsoil, planting cover crops, integrated pest management that reduces the need for chemical pesticides, and application of compost that reduces the amount of chemical fertilizers needed. To date, 1,032 independent smallholders received training and implement these techniques on their farms, representing a total land with a total area of 1,063.68 hectares. The project trained 25 village facilitators to provide hands-on assistance to smallholders, and seven demo plots established as pilot areas and learning facilities for regenerative agriculture.
“When I visited palm oil smallholders a few years ago in the area, their biggest concern was access to more fertilizers. While fertilizers play a key role in boosting yields, there was a noticeable gap in understanding how to protect the soil from long-term degradation. Smallholders needed more knowledge about maintaining soil health, preserving soil structure, and other critical factors. This is exactly what the BIPOSC project aimed to address, and we’re pleased to see that the farmers involved are now reporting not only higher yields but also healthier soils on their plots,” said Bernard Giraud, President & Co-Founder, Livelihoods.
The projectalso looks into capacity-building. In addition to home composting, the project enabled the local farmer association, APSKS LB, to develop and manage a composting unit with a capacity of 100-150 tons/month. Producing compost at scale with inputs from nearby mills and farmer plots, the unit offers compost to member farmers at half of typical market prices. In 2023, its first year of operation, the unit produced 588 tons of compost, and generated a profit of IDR 421 million. The project partners believe it is a model that can be replicated elsewhere.
“One of the most impactful outcomes of this project for smallholders is the Composting Unit as the business model around it. It enables smallholders to obtain compost affordably, and the profits are shared among member farmers. This is a practical solution to promote the adoption of composting, and all ASPKS-LB smallholders are now using compost in their plots,” said Syahrianto, Chairman of the Labuanbatu Independent Oil Palm Smallholders Association.
As of 2023, independent smallholders manage about 41% of oil palm planted areas in Indonesia, representing 6.94 million hectares. This figure is expected to increase to 60% by 2030, making projects like BIPOSC critical in shaping the future of sustainable palm oil production.
Devane Sharma
[email protected]
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JAKARTA, Indonesia, Oct. 18, 2024 /PRNewswire/ — Nium, the leading global infrastructure for real-time cross-border payments, is thrilled to announce a partnership with Bank Rakyat Indonesia (BRI) to provide Indonesian customers with real-time international money transfer capabilities. This collaboration aims to enhance the cross-border offerings for BRI’s individual and corporate customers, delivering more accessible and cost-effective financial services across Indonesia.
This partnership empowers more than 150 million BRI account holders, including those in remote regions of Indonesia, to access modern, real-time cross-border payment services. The offering includes a variety of real-time payment mechanisms, supporting bank account destinations, a global electronic card network, and digital wallets. These innovations are closely aligned with BRI’s ongoing mission to provide affordable and customer-focused financial products, particularly for traditionally underserved communities.
BRI’s Corporate Secretary, Agustya Hendy Bernadi, emphasized BRI’s dedication to constantly improving customer convenience through innovations in its global network and cross-border transaction services. “This collaboration reflects BRI’s continuous efforts to enhance productivity and efficiency by expanding its digital payment channel network to meet the growing demand for global transactions,” he said. Agustya added that the partnership with Nium aligns perfectly with BRI’s vision to be Southeast Asia’s most valuable banking group and a champion of financial inclusion by 2025. “With Nium’s global transaction network, BRI strengthens the digitalization of its business processes and enhances retail banking capabilities in line with our 2025 strategic vision.”
Anupam Pahuja, General Manager and Executive Vice President for Asia Pacific, Middle East, and Africa at Nium, shared his excitement about the partnership, highlighting BRI’s extensive presence across Indonesia’s 17,000 islands. “By integrating Nium’s advanced technology into BRI’s platform, we are dedicated to providing BRI’s customers, no matter where they are, with access to exceptional financial services. This partnership will remove the risks associated with cash handling and provide faster, more cost-effective transactions—whether individuals are sending money to family members abroad or businesses are making international payments.”
Cross-border payments are projected to grow significantly in Indonesia, with a forecasted year-on-year increase of 15% through 2025, driven largely by the digital transformation in financial services (Statista, 2024).
This partnership between BRI and Nium is expected to transform the way Indonesians engage with global financial services, meeting the rising demand for modern payment infrastructure and enhancing the overall experience for BRI’s customers in their international transactions.
About Nium
Nium, the leading global infrastructure for real-time cross-border payments, was founded on the mission to deliver the global payments infrastructure of tomorrow, today. With the onset of the global economy, its payments infrastructure is shaping how banks, fintechs, and businesses everywhere collect, convert, and disburse funds instantly across borders. Its payout network supports 100 currencies and spans 220+ markets, 100 of which in real-time. Funds can be disbursed to accounts, wallets, and cards and collected locally in 40 markets. Nium’s growing card issuance business is already available in 34 countries. Nium holds regulatory licenses and authorizations in more than 40 countries, enabling seamless onboarding, rapid integration, and compliance – independent of geography. The company is co-headquartered in San Francisco and Singapore.
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Fintech PR
Grexie Signchain Launches on November 1st, 2024: Enabling Smart Contract Developers to Bring Off-Chain Data On-Chain with Seamless Gas-Paid Signing
Grexie Signchain enables developers to sign off-chain data into smart contracts, with self-hosted or secure vault signer wallet management.
MANCHESTER, England, Oct. 17, 2024 /PRNewswire/ — Grexie Limited proudly announces the launch of its innovative smart contract solution, Signchain, on November 1st, 2024. Designed specifically for developers, Signchain introduces a powerful way to bring off-chain data on-chain through user-paid gas fees and secure signing of data into smart contract methods using its extendable smart contract, Signable.
In the growing landscape of blockchain technology, securely managing off-chain data and integrating it into on-chain smart contracts has posed significant challenges for developers. Signchain eliminates these hurdles by offering a robust, gas-efficient system for signing and authenticating data in real-time.
Key Features of Signchain:
1. Seamless Off-Chain to On-Chain Data Integration
Signchain enables developers to securely bring off-chain data on-chain by signing it directly into smart contract methods through user-paid gas fees. This integration ensures that data authenticity is preserved, and its entry into the blockchain remains tamper-proof, streamlining processes for industries relying on real-world data verification. Signchain also supports integration with Google Sheets, AWS, and Firebase, making it easy to pull data from popular off-chain data sources.
2. Extendable Smart Contract – Signable
The core of Signchain’s technology is its extendable smart contract, Signable, which allows developers to customize and build upon existing smart contracts. With Signable, developers can easily implement contract signatures for any data type, offering flexibility across industries from finance to logistics and beyond.
3. Signer Wallet Management
Signchain offers comprehensive signer wallet management as part of its service, empowering developers to manage and authenticate signers effectively. Wallets can either be self-hosted using Signchain’s Docker container for those who prefer their own infrastructure, or they can leverage Signchain’s network of secure vaults for maximum security.
4. Self-Hosted or Managed Service
For developers who want full control of their infrastructure, Signchain provides a self-hosted option via Docker containers, allowing them to deploy the platform on their own servers. Alternatively, developers can opt to use Signchain’s secure vault network, offering a hassle-free solution with enterprise-grade security and wallet management.
5. User-Paid Gas Fees
By integrating a user-paid gas fee model, Signchain allows users to cover the costs of signing and authenticating their data, ensuring the signing process is efficient and doesn’t overburden developers with additional expenses. This makes Signchain an ideal solution for dApps and platforms handling high transaction volumes.
6. Google Sheets, AWS, Firebase Integration with Serverless Model
Signchain supports integration with Google Sheets, AWS, and Firebase in a serverless model, powered by a hosted Sign In With Ethereum (SIWE) implementation provided by Signchain’s API. Developers can simply connect their Google Sheets and configure the contract parameters associated with each column. Signchain will automatically look up the user’s wallet address in the spreadsheet, sign the transaction data, and execute it in the blockchain along with any user-supplied parameters. This creates an easy, efficient way to manage data inputs from off-chain sources without heavy infrastructure setup.
Revolutionizing Smart Contract Workflows
With Signchain, developers now have the tools to handle the complexities of integrating off-chain data into smart contracts. The extendable nature of Signable offers flexibility, allowing developers to cater to various use cases, whether it’s automating financial transactions, supply chain data, or verifying legal agreements.
Tim Behrsin, CEO of Grexie Limited, said, “Signchain is more than just a signing solution—it’s a platform that empowers developers to securely integrate off-chain data into their smart contracts with minimal effort. The flexibility of Signable and our focus on signer wallet management offers developers control and security at every stage of the process.”
Why Signchain Matters
Signchain addresses critical challenges faced by developers, particularly those dealing with off-chain data. By signing data into smart contracts and enabling user-paid gas fees, the platform significantly reduces friction in managing secure, scalable smart contracts. Whether developers need to manage high volumes of data transactions or create bespoke smart contracts, Signchain offers a scalable and secure solution.
In industries like DeFi, real estate, and supply chain management, data integrity and security are paramount. Signchain’s secure vault network and customizable signing workflows allow businesses to handle sensitive information with confidence.
Launch Event and Future Developments
The official launch of Signchain will take place on November 1st, 2024, alongside a virtual event. The event will showcase live demonstrations of Signable, with detailed walkthroughs of the Docker-based self-hosted solution and signer wallet management features. Attendees will also get an exclusive preview of future enhancements, including multi-signature workflows and advanced blockchain network integrations.
About Signchain
Signchain is a cutting-edge platform developed by Grexie Limited, based in Manchester, Cheshire, United Kingdom. Signchain simplifies smart contract development by offering a secure, scalable, and customizable solution for signing and authenticating off-chain data on-chain. Developers can either self-host the solution using Signchain’s Docker container or rely on the network’s secure vault infrastructure. With an emphasis on security, flexibility, and developer experience, Signchain is set to transform how smart contracts handle off-chain data.
For more information, visit signchain.net.
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