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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
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STOCKHOLM, April 5, 2024 /PRNewswire/ — EQT AB’s Q1 Announcement 2024 will be published on Thursday 18 April 2024 at approximately 07:30 CEST. EQT will host a conference call at 08:30 CEST to present the report, followed by a Q&A session.
The presentation and a video link for the webcast will be available here from the time of the publication of the Q1 Announcement.
To participate by phone and ask questions during the Q&A, please register here in advance. Upon registration, you will receive your personal dial-in details.
The webcast can be followed live here and a recording will be available afterwards.
Information on EQT AB’s financial reporting
The EQT AB Group has a long-term business model founded on a promise to its fund investors to invest capital, drive value creation and create consistent attractive returns over a 5 to 10-year horizon. The Group’s financial model is primarily affected by the size of its fee-generating assets under management, the performance of the EQT funds and its ability to recruit and retain top talent.
The Group operates in a market driven by long-term trends and thus believes quarterly financial statements are less relevant for investors. However, in order to provide the market with relevant and suitable information about the Group’s development, EQT publishes quarterly announcements with key operating numbers that are relevant for the business performance (taking Nasdaq’s guidance note for preparing interim management statements into consideration). In addition, a half-year report and a year-end report including financial statements and further information relevant for investors is published. Finally, EQT also publishes an annual report including sustainability reporting.
Contact
Olof Svensson, Head of Shareholder Relations, +46 72 989 09 15
EQT Shareholder Relations, [email protected]
Rickard Buch, Head of Corporate Communications, +46 72 989 09 11
EQT Press Office, [email protected], +46 8 506 55 334
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- Kia drives forward transformation into ‘Sustainable Mobility Solutions Provider’
- Roadmap enables Kia to proactively respond to uncertainties in mobility industry landscape, including changes in EV market
- Company to expand EV line-up with more models; enhance HEV line-up to manage fluctuation in EV demand
- Goal to sell 1.6 million EVs annually in 2030, introducing 15 models
- PBV to play a key role in Kia’s growth, targeting 250,000 PBV sales annually by 2030 with PV5 and PV7 models
- Kia to invest KRW 38 trillion by 2028, including KRW 15 trillion for future business
- 2024 business guidance : KRW 101 tln in revenue with KRW 12 tln in operating profit; operating profit margin of 11.9% on sales of 3.2 million units globally
- CEO reaffirms Kia’s commitment to ESG management
SEOUL, South Korea, April 5, 2024 /PRNewswire/ — Kia Corporation (Kia) today shared an update on its future strategies and financial targets at its CEO Investor Day in Seoul, Korea.
Based on its innovative achievements in the years since the announcement of mid-to-long-term business initiatives, Kia is focusing on updating its 2030 strategy announced last year and further strengthening its business strategy in response to uncertainties across the global mobility industry landscape.
During the event, Kia updated its mid-to-long-term business strategy with a focus on electrification, and its PBV business. Kia reiterated its 2030 annual sales target of 4.3 million units, including 1.6 million units of electric vehicles (EVs). The 2030 4.3 million annual sales target is 34.4 percent higher than the brand’s 2024 annual goal of 3.2 million units.
The company also plans to become a leading EV brand by selling a higher percentage of electrified models among its total sales, including hybrid electric vehicles (HEV), plug-in hybrid (PHEV), and battery EVs, projecting electrified model sales of 2.48 million units annually or 58 percent of Kia’s total sales in 2030.
“Following our successful brand relaunch in 2021, Kia is enhancing its global business strategy to further the establishment of an innovative EV line-up and accelerate the company’s transition to a sustainable mobility solutions provider,” said Ho Sung Song, President and CEO of Kia. “By responding effectively to changes in the mobility market and efficiently implementing mid-to-long-term strategies, Kia is strengthening its brand commitment to the wellbeing of customers, communities, the global society, and the environment.”
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VANCOUVER, BC, April 4, 2024 /PRNewswire/ — BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF) (the “Company“) is providing this bi-weekly update on the status of the management cease trade order granted on February 29, 2024 (the “MCTO“), by its principal regulator, the Ontario Securities Commission (the “OSC“), under National Policy 12-203 – Management Cease Trade Orders (“NP 12-203“), following the Company’s announcement on February 21, 2024 (the “Default Announcement“), that it was unable to file its audited annual financial statements for the year ended October 31, 2023, its management’s discussion and analysis of financial statements for the year ended October 31, 2023, its annual information form for the year ended October 31, 2023, and related filings (collectively, the “Required Annual Filings“). Under National Instrument 51-102, the Required Annual Filings were required to be made no later than February 28, 2024.
As a result of the delay in filing the Required Annual Filings, the Company was unable to file its interim financial statements for the three months ended January 31, 2024, its management’s discussion and analysis of financial statements for the three months ended January 31, 2024, and related filings (collectively, the “Required Interim Filings“). Under National Instrument 51-102, the Required Interim Filings were required to be made no later than April 1, 2024.
The Company anticipates filing the Required Annual Filings by April 30, 2024. The auditor of the Company requires additional time to complete its audit of the Company, including the Company’s recent acquisition of all intellectual property, immunotherapeutics platform technologies, and clinical stage assets of the former IMV Inc. that closed on February 16, 2024. In addition, the Company anticipates filing the Required Interim Filings immediately after the filing of the Required Annual Filings.
Except as herein disclosed, there are no material changes to the information contained in the Default Announcement. In addition, (i) the Company is satisfying and confirms that it intends to continue to satisfy the provisions of the alternative information guidelines under NP 12-203 and issue bi-weekly default status reports for so long as the delay in filing the Required Annual Filings and/or Required Interim Filings is continuing, each of which will be issued in the form of a press release; (ii) the Company does not have any information at this time regarding any anticipated specified default subsequent to the default in filing the Required Annual Filings and Required Interim Filings; (iii) the Company is not subject to any insolvency proceedings; and (iv) there is no material information concerning the affairs of the Company that has not been generally disclosed.
About BioVaxys Technology Corp.
BioVaxys Technology Corp. (www.biovaxys.com), a biopharmaceuticals company registered in British Columbia, Canada, is a clinical-stage biopharmaceutical company dedicated to improving patient lives with novel immunotherapies based on the DPX™ immune-educating technology platform and it’s HapTenix© ‘neoantigen’ tumor cell construct platform, for treating cancers, infectious disease, antigen desensitization, and other immunological fields. The Company’s clinical stage pipeline includes maveropepimut-S which is in Phase II clinical development for advanced Relapsed-Refractory Diffuse Large B Cell Lymphoma (DLBCL) and platinum resistant ovarian cancer, and BVX-0918, a personalized immunotherapeutic vaccine using it proprietary HapTenix© ‘neoantigen’ tumor cell construct platform which is soon to enter Phase I in Spain for treating refractive late-stage ovarian cancer. The Company is also capitalizing on its tumor immunology know-how and creation of a unique library of T-lymphocytes & other datasets post-vaccination with its personalized immunotherapeutic vaccines to utilize predictive algorithms and other technologies to identify new targetable tumor antigens. BioVaxys common shares are listed on the CSE under the stock symbol “BIOV” and trade on the Frankfurt Bourse (FRA: 5LB) and in the US (OTCQB: BVAXF). For more information, visit www.biovaxys.com and connect with us on X and LinkedIn.
ON BEHALF OF THE BOARD
Signed “James Passin“
James Passin, Chief Executive Officer
Phone: +1 646 452 7054
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