A Randomized, Phase 3, Open-label Study to Investigate Pharmacokinetics, Safety, and Efficacy of Subcutaneous Compared to Intravenous Frexalimab in Adult Participants With Multiple Sclerosis

This is a randomized, open-label, parallel, Phase 3 study with 2-arms for treatment.
The purpose of this study is to evaluate SC administration of frexalimab every 4 weeks (q4w) compared to IV administration of frexalimab q4w in male and female participants with RMS and nrSPMS (aged 18 to 60 years at the time of enrollment). People diagnosed with MS are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria.
Study details include:
The study intervention duration will be 48 weeks (12 months) for Parts A and B combined. Optional Part C will last until the initiation of a long term safety study for Frexalimab.The follow up duration after the end of study intervention (in case of discontinuation) will be 6 months.
The number of scheduled visits (Parts A and B) will be 17 or 11 for participants receiving frexalimab SC or IV, respectively, with an on-site visit frequency of every month between Week 4 and Week 24 in Part A, then every 1 to 3 months in Part B, then every 6 months in Part C. Participants discontinuing treatment before the End of Study will have an additional 3 follow-up visits.

Start Date14 Jan 2026

Sponsor / Collaborator

Sanofi

NCT06500702

/ RecruitingPhase 2

A Parallel-group Treatment, Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Umbrella Study to Evaluate the Efficacy and Safety of Frexalimab, Brivekimig, and Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis (FSGS) or Minimal Change Disease (MCD)

This is a parallel, Phase 2a, double-blind, 6-arm study for the treatment of primary focal segmental glomerulosclerosis (FSGS) or primary minimal change disease (MCD).
The purpose of this study is to measure the change in proteinuria and its impact on the rates of remission of nephrotic syndrome with frexalimab, brivekimig, or rilzabrutinib compared with placebo in participants with primary FSGS or primary MCD aged 16 to 75 years.
Study details for each participant include:
The study duration will be up to 76 weeks. The treatment duration will be 24 weeks. There will be up to 18 visits.

Start Date19 Dec 2024

Sponsor / Collaborator

Sanofi

NCT06141486

/ RecruitingPhase 3

A Randomized, Double-blind, Phase 3 Study Comparing Efficacy and Safety of Frexalimab (SAR441344) to Placebo in Adult Participants With Nonrelapsing Secondary Progressive Multiple Sclerosis

The purpose of this randomized, double-blind, placebo-controlled, parallel group study is to determine the efficacy of frexalimab in delaying the disability progression and the safety up to 36 months double-blind administration of study intervention compared to placebo in male and female participants with nrSPMS (aged 18 to 60 years at the time of enrollment). People diagnosed with nrSPMS are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria. Study details include:
* This event-driven study will end when the target number of 6-month cCDP events is achieved, and the study is expected to last 43 months from randomization of the first participant to the common study end.
* The number of scheduled visits will be up to 25 (including 3 follow-up visits) with a visit frequency of every month for the first 6 months and then every 3 months.
* If the prespecified number of events for 6-month cCDP is not reached by V21/W180, scheduled visits will continue every 3 months.

Start Date27 Dec 2023

Sponsor / Collaborator

Sanofi

100 Clinical Results associated with Frexalimab

100 Translational Medicine associated with Frexalimab

100 Patents (Medical) associated with Frexalimab

Literatures (Medical) associated with Frexalimab

15 Feb 2024·The New England journal of medicineQ1 · MEDICINE

Inhibition of CD40L with Frexalimab in Multiple Sclerosis

Q1 · MEDICINE

Article

Author: Truffinet, Philippe ; Dufek, Michal ; Giovannoni, Gavin ; Staikov, Ivan ; Wallstroem, Erik ; Cutter, Gary ; Vermersch, Patrick ; Granziera, Cristina ; Kalbus, Oleksandr ; Bejuit, Raphael ; Saubadu, Stephane ; Mao-Draayer, Yang ; Djukic, Biljana

BACKGROUND:

The CD40-CD40L costimulatory pathway regulates adaptive and innate immune responses and has been implicated in the pathogenesis of multiple sclerosis. Frexalimab is a second-generation anti-CD40L monoclonal antibody being evaluated for the treatment of multiple sclerosis.

METHODS:

In this phase 2, double-blind, randomized trial, we assigned, in a 4:4:1:1 ratio, participants with relapsing multiple sclerosis to receive 1200 mg of frexalimab administered intravenously every 4 weeks (with an 1800-mg loading dose), 300 mg of frexalimab administered subcutaneously every 2 weeks (with a 600-mg loading dose), or the matching placebos for each active treatment. The primary end point was the number of new gadolinium-enhancing T1-weighted lesions seen on magnetic resonance imaging at week 12 relative to week 8. Secondary end points included the number of new or enlarging T2-weighted lesions at week 12 relative to week 8, the total number of gadolinium-enhancing T1-weighted lesions at week 12, and safety. After 12 weeks, all the participants could receive open-label frexalimab.

RESULTS:

Of 166 participants screened, 129 were assigned to a trial group; 125 participants (97%) completed the 12-week double-blind period. The mean age of the participants was 36.6 years, 66% were women, and 30% had gadolinium-enhancing lesions at baseline. At week 12, the adjusted mean number of new gadolinium-enhancing T1-weighted lesions was 0.2 (95% confidence interval [CI], 0.1 to 0.4) in the group that received 1200 mg of frexalimab intravenously and 0.3 (95% CI, 0.1 to 0.6) in the group that received 300 mg of frexalimab subcutaneously, as compared with 1.4 (95% CI, 0.6 to 3.0) in the pooled placebo group. The rate ratios as compared with placebo were 0.11 (95% CI, 0.03 to 0.38) in the 1200-mg group and 0.21 (95% CI, 0.08 to 0.56) in the 300-mg group. Results for the secondary imaging end points were generally in the same direction as those for the primary analysis. The most common adverse events were coronavirus disease 2019 and headaches.

CONCLUSIONS:

In a phase 2 trial involving participants with multiple sclerosis, inhibition of CD40L with frexalimab had an effect that generally favored a greater reduction in the number of new gadolinium-enhancing T1-weighted lesions at week 12 as compared with placebo. Larger and longer trials are needed to determine the long-term efficacy and safety of frexalimab in persons with multiple sclerosis. (Funded by Sanofi; ClinicalTrials.gov number, NCT04879628.).

INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES

Monoclonal Antibodies as Therapeutic Agents in Autoimmune and Neurodegenerative Diseases of the Central Nervous System: Current Evidence on Molecular Mechanisms and Future Directions

Review

Author: Rentzos, Michail ; Angelopoulou, Efthalia ; Papageorgiou, Sokratis G. ; Anagnostouli, Maria ; Skarlis, Charalampos

Monoclonal antibodies (mAbs) have revolutionized the treatment landscape for neurological diseases, providing targeted, mechanism-based therapies for conditions ranging from autoimmune demyelinating disorders to neurodegenerative diseases. In multiple sclerosis (MS), mAbs against CD20, CD52, and α4-integrins offer disease-modifying efficacy by altering immune responses, depleting B cells, or blocking leukocyte migration into the central nervous system (CNS). Similarly, novel agents under investigation, such as frexalimab and foralumab, modulate T and B cell interactions and regulatory immunity. In neuromyelitis optica spectrum disorder (NMOSD), mAbs targeting IL-6, the complement cascade, and B cell lineage have demonstrated significant clinical benefit in preventing relapses and disability. In Alzheimer’s disease (AD), several anti-amyloid mAbs have gained regulatory approval. Anti-tau and anti-α-synuclein antibodies, though promising, have shown limited efficacy to date in AD and parkinson’s disease (PD), respectively. The evolving armamentarium of mAbs reflects a paradigm shift toward personalized neuroimmunology and neurodegeneration-targeted treatments, based on ongoing clarification of molecular and neuroinflammatory mechanisms. In this context, the present review summarizes current evidence on mAbs used in CNS disorders, with an emphasis on their pathophysiological targets, molecular mechanisms, clinical efficacy, and safety.

Hormone Research in Paediatrics

Moving from Insulin Substitution to the Treatment of the Underlying Autoimmune Disease in Type 1 Diabetes

Review

Author: Weiskorn, Jantje ; Danne, Thomas

Currently, a paradigm change occurs in type 1 diabetes from insulin substitution to the treatment of the underlying autoimmune disease. Teplizumab, a humanized monoclonal anti-CD3 antibody, is the first FDA-approved disease-modifying treatment of preclinical stage 2 diabetes. Research of drugs like golimumab, a monoclonal antibody specific for TNF alpha, baricitinib, a tyrosine kinase inhibitor, or frexalimab, a monoclonal antibody against the CD40 ligand, is still ongoing. Repurposing drugs that have been used in other indications like the calcium channel blocker verapamil, antithymocyte globulin (ATG), an antibody preparation used in solid organ transplantation, glucagon-like peptide-1 agonists utilized in type 2 diabetes and obesity, or the antiviral drugs pleconaril and ribavirin have shown positive effects in preserving beta-cell function. While new therapies to halt autoimmunity and restore beta cells in stages one to three are being developed, replacing beta-cell function via inducible pluripotent stem cells have shown glucose control and insulin independence in long-standing type 1 diabetes, albeit with concomitant immunosuppression. Multicenter multinational initiatives developing a clinical trial network like INNODIA or a research platform with the goal of stopping type 1 diabetes in its early stages like EDENT1FI will be instrumental to study these new strategies.

News (Medical) associated with Frexalimab

29 Aug 2025

·endpoints.news

FDA approves BTK inhibitor that’s key to Sanofi’s immunology strategy

The FDA approved Sanofi’s BTK inhibitor that the French drugmaker acquired in its $3.7 billion buyout of Principia Biopharma. The company said Friday that the regulators cleared rilzabrutinib in a rare disease called immune thrombocytopenia, or ITP. The drug is branded as Wayrilz. The wholesale acquisition cost for Wayrilz will be $17,500 a month, which is before discounts, rebates or patient assistance programs, a Sanofi spokesperson said. Wayrilz is part of a larger effort at Sanofi to become the leading immunology pharma company. Sanofi has unveiled or acquired a handful of programs targeting immunological conditions in recent years, and the company expects Wayrilz to produce between €2 billion and €5 billion in annual peak sales. So far, Sanofi’s strategy hasn’t always led to success. The company was forced to shelve studies of another drug from Principia called tolebrutinib in 2023 after trials were put on hold . The drug continued to be dogged by safety concerns despite positive efficacy results in a multiple sclerosis trial that read out last year. Tolebrutinib had been Principia’s lead drug at the time Sanofi acquired the company in 2020. Another program called itepekimab underwhelmed in a COPD study earlier this year. And even the path for Wayrilz has been bumpy. The drug failed an atopic dermatitis study in 2023. Sanofi’s immunology pipeline also includes amlitelimab, an OX40L drug from Kymab that’s currently in Phase 3 studies for atopic dermatitis; lunsekimig, an anti-IL-13/TSLP program with a Phase 2 readout in asthma expected next year; and frexalimab, a CD40L-targeting therapy that’s expecting Phase 2 lupus data in the second half of 2026. “Our current and evolving portfolio within immunology and immunoscience more broadly really explores the multifaceted nature of key neurologic nodes within the immune system,” Sanofi CSO Mike Quigley told Endpoints News in an interview ahead of the decision. As for Wayrilz, ITP is a rare autoimmune disorder that leads to low platelet counts and an increased risk of bleeding and bruising. Quigley estimates there are about 100,000 ITP patients in the US. In addition to ITP, Sanofi is continuing to study Wayrilz in asthma, chronic hives, IgG4-related disease and other rare diseases, though these studies are early and no readouts are expected until 2027. Editor’s note: This story was updated to add the drug’s wholesale acquisition cost.

ImmunotherapyAcquisitionPhase 3Drug ApprovalPhase 2

11 Aug 2025

·www.fiercebiotech.com

Novartis scores double phase 3 win in Sjögren\'s syndrome, succeeding where rivals failed

Novartis hailed the win as the “first ever global phase 3 trials to demonstrate statistically significant reduction in disease activity for Sjögren\'s disease.”\n Novartis may have abandoned one Sjögren\'s syndrome asset this year, but it looks like the drugmaker has a winner on its hands with another candidate.The Swiss pharma had been evaluating ianalumab, a dual-mechanism, B-cell-depleting antibody that targets the protein BAFF-R, in a pair of phase 3 studies dubbed Neptunus 1 and 2, which in total enrolled 779 patients with the systemic autoimmune disease.Both studies hit their primary endpoint of demonstrating an improvement in disease activity as measured on the EULAR Sjögren\'s syndrome disease activity index at 52 weeks compared to placebo, Novartis announced in an Aug. 11 release. The drug was also well tolerated and demonstrated a favorable safety profile, according to the pharma.The company hailed the win as the “first ever global phase 3 trials to demonstrate statistically significant reduction in disease activity for Sjögren\'s disease.” For now, Novartis is holding back the data for a future medical conference, while referencing plans to take the results to global regulators with the aim of bringing the first targeted treatment for the autoimmune disease to market.“Sjögren\'s disease is a serious, progressive, systemic autoimmune disease, often unrecognized or misdiagnosed with a significant detrimental impact to quality of life, with very limited treatment options and an established unmet need,” Novartis Chief Medical Officer Shreeram Aradhye, M.D., said in the release.“Both phase 3 trials demonstrate that ianalumab improves disease activity in patients with Sjögren\'s disease,” Aradhye added. “These phase 3 studies mark a significant milestone. We look forward to engaging with health authorities to discuss these findings in the near future.”It’s a big win for Novartis, which started the year dropping its anti-CD40 antibody iscalimab after becoming doubtful of its competitive profile. That left ianalumab as Novartis’ last and best hope for the disease.Ianalumab had already shown \"meaningful differences in patients with this very difficult-to-treat disease” in phase 2, Novartis executives pointed out at the time.Iscalimab was only the latest Big Pharma prospect to fail to make the grade in Sjögren\'s. Last year, Sanofi crossed off Sjögren’s from the list of targeted indications for its CD40L monoclonal antibody frexalimab after seeing phase 2 efficacy data, while, more recently, Kiniksa Pharmaceuticals ended work on its own Sjögren\'s prospect abiprubart. While Novartis had always sounded positive about the potential of ianalumab in the automimmune disease, the therapy has faced its own clinical setbacks. Only last month, the company reported that the B-cell-depleting antibody had failed to hit the efficacy threshold in a phase 2 study for a painful skin condition called hidradenitis suppurativa.Ianalumab\'s story begins with Novartis’ collaboration with MorphoSys, before the Big Pharma went on to buy the biotech last year. The therapy is also being investigated for other B cell-driven autoimmune diseases like immune thrombocytopenia, systemic lupus erythematosus, lupus nephritis, warm autoimmune hemolytic anemia and diffuse cutaneous systemic sclerosis.

$Novartis scores double phase 3 win in Sjögren\'s syndrome, succeeding where rivals failed$

Phase 3Phase 2Clinical ResultClinical Trial Failure

22 May 2025

·www.biopharmadive.com

Sanofi gains experimental Alzheimer’s drug through Vigil buyout

Sanofi has agreed to spend $470 million to take control of a young biotechnology company and its experimental drug for Alzheimers disease.The newly announced acquisition has Sanofi paying $8 for each share of Vigil Neuroscience it doesnt already own, reflecting a premium of nearly 250% to the price Vigil shares traded at Wednesday afternoon. The French pharmaceutical giant invested $40 million into Vigil last June, and in exchange got an exclusive right to be first in line for deal talks if Vigil chose to license out its platform of small molecule drugs that amplify a protein called TREM2.The most advanced of those drugs, code-named VG-3927, several months ago completed an early-stage study that enrolled both healthy volunteers and patients with Alzheimers disease. Vigils president and CEO, Ivana Magovevi-Liebisch, said in a statement that the acquisition should help fully unlock and accelerate the development of VG-3927.A second molecule from the platform, VGL101, is not being acquired by Sanofi.Instead, rights to that molecule will be returned to the original licensor, Amgen.Neuroscience is one of Sanofis core strategic research focuses, alongside cancer, rare diseases and the immune system. Yet, in terms of product sales, it pales in comparison to those other three areas. Sanofis portfolio lists just one neurology drug, the multiple sclerosis therapy Aubagio, which last year accounted for less than 1% of the 41 billion euros in net sales recorded by the companys biopharma unit.Sanofi is trying to grow this pool with a few experimental medicines that have progressed to the later stages of development. One, frexalimab, is what Sanofi touts as a pipeline-in-a-product asset, since the company believes it has the potential to treat a range of illnesses, from MS to lupus to diabetes. Another, riliprubart, is being evaluated against CIPD, a rare disorder that harms the peripheral nerves, leading to arm and leg weakness.A third, tolebrutinib, has been tested across different types of MS and is currently being considered for approval by Food and Drug Administration, with a decision deadline set for late September. Sanofi got ahold of tolebrutinib through its $3.7 billion purchase of Principia Biopharma in 2020.Notably, all of these medicines work by regulating the immune system, which is characteristic of Sanofis approach to neurology.The Vigil deal follows this approach, too, as TREM2 alerts the brains resident immune cells to threats like the toxic abeta plaques that are a hallmark of Alzheimers. When this protein is impaired or loses its function, it can increase the risk of nerve cell injury, inflammation and death.TREM2 represents a compelling target at the intersection of immune dysregulation and neurodegeneration, said Houman Ashrafian, Sanofis head of R&D, in that Wednesday statement.The acquisition also supports Sanofis strategy of leveraging our expertise in immunology to solve health problems with critical unmet need, Ashrafian added.The companies expect their deal to close sometime between July and the end of September, provided investors holding a majority of the outstanding shares of Vigil common stock approve it. Sanofi said Magovevi-Liebisch as well as Vigil backers Atlas Venture and Bruce Booth, a partner at the firm have signed voting and support agreements in favor of the deal.Together, they represent roughly 16.2% of Vigils total common shares outstanding.In addition to the upfront payment, Vigils shareholders will receive a so-called contingent value right that would entitle them to receive a deferred cash payment of $2 for each share they own once VG-3927 has its first commercial sale.“We believe this is a good outcome for shareholders in the current funding environment,“ wrote Myles Minter, an analyst at William Blair who covers Vigil, in a note to clients.Vigil debuted at $14 per share when it went public in January 2022, but has lost most of its market value since.In his own note, Stifel analyst Paul Matteis argued the timing of the deal is “interesting,“ given a TREM2-targeting drug from Alector and AbbVie recently failed in a mid-stage study. That setback “significantly diminished enthusiasm for the target,“ according to Matteis, so while there were reasons to think Vigil's drug could fare better, “it was going to be hard to have conviction in this until we saw [Phase 2] data.“ '

AcquisitionImmunotherapyClinical ResultPhase 2

100 Deals associated with Frexalimab

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Multiple Sclerosis, Secondary Progressive	Phase 3	United States	Sanofi	27 Dec 2023
Multiple Sclerosis, Secondary Progressive	Phase 3	China	Sanofi	27 Dec 2023
Multiple Sclerosis, Secondary Progressive	Phase 3	Japan	Sanofi	27 Dec 2023
Multiple Sclerosis, Secondary Progressive	Phase 3	Argentina	Sanofi	27 Dec 2023
Multiple Sclerosis, Secondary Progressive	Phase 3	Australia	Sanofi	27 Dec 2023
Multiple Sclerosis, Secondary Progressive	Phase 3	Belgium	Sanofi	27 Dec 2023
Multiple Sclerosis, Secondary Progressive	Phase 3	Brazil	Sanofi	27 Dec 2023
Multiple Sclerosis, Secondary Progressive	Phase 3	Bulgaria	Sanofi	27 Dec 2023
Multiple Sclerosis, Secondary Progressive	Phase 3	Canada	Sanofi	27 Dec 2023
Multiple Sclerosis, Secondary Progressive	Phase 3	Chile	Sanofi	27 Dec 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04572841 (phaethuSA, CTgov)	Phase 2	Primary Sjögren's syndrome	84	Placebo (Placebo)	kemyfpkmsy(hfsuzzuaox) = poekbmfxfq sczyqrnvpc (zlijxmjkxx, 0.60) View more	-	09 Oct 2025
				SAR441344 (SAR441344)	kemyfpkmsy(hfsuzzuaox) = biqyztdrtv sczyqrnvpc (zlijxmjkxx, 0.59) View more
NCT04879628 (Phase 2 trial, CTgov)	Phase 2	Multiple sclerosis relapse	129	MRI contrast-enhancing preparations (SC Placebo)	vpdnmajinz = dspjsaicsh qwiemoheww (znavmyqcjf, dmwtjydrzv - zorevtkauw) View more	-	30 Sep 2025
				MRI contrast-enhancing preparations (IV Placebo)	vpdnmajinz = gzbuakgsie qwiemoheww (znavmyqcjf, dgwbrzibox - ibdvqwzzvh) View more
NCT04879628 (NEWS) Manual	Phase 2	Multiple sclerosis relapse	129	Frexalimab high dose	wtdruqvrmh(zedtovoqll) = xebgaypkgc uqbpvtqosi (kiimwcxbrk )	Positive	05 Jul 2024
				Frexalimab low dose	wtdruqvrmh(zedtovoqll) = befehroido uqbpvtqosi (kiimwcxbrk )
NCT04879628 (Phase 2 trial, EAN2024)	Phase 2	-	129	Frexalimab-high dose	wlnvnetmji(pegkccbxvy) = quuyfhffue cdjlwnuggd (wylobswgxa )	Positive	28 Jun 2024
				Frexalimab-low dose	wlnvnetmji(pegkccbxvy) = knzmmmyulj cdjlwnuggd (wylobswgxa )
NCT04879628 (phase 2 trial, EAN2024)	Phase 2	Multiple sclerosis relapse plasma neurofilament light chain	129	Frexalimab high dose	ispckzxfua(zpwzohlpgu) = asyzkhlhuu hzjommwxuw (yuqtyevfki, 2.0)	Positive	28 Jun 2024
				Frexalimab low dose	ispckzxfua(zpwzohlpgu) = pigjrudeap hzjommwxuw (yuqtyevfki, 1.7)
NCT04879628 (Corporate Publications) Manual	Phase 2	Multiple Sclerosis	125	frexalimabfrexalimab 1200 mg	dsggoxzbhn(glpxhxholj) = iwvqxkbarm zcqcecccmi (melndryyyi ) View more	Positive	17 Apr 2024
				frexalimab 300 mgfrexalimab 300 mg	dsggoxzbhn(glpxhxholj) = dvcbrmvdqy zcqcecccmi (melndryyyi ) View more
AAN2024	Not Applicable	Multiple sclerosis relapse	-	Frexalimab high-dose	-	-	09 Apr 2024
				Frexalimab low-dose	jnlohjdktq(pzppytbfhu) = svgjjevvdx zgfbasmphk (mjpopuwygr, 1.95)
AAN2024	Not Applicable	Multiple sclerosis relapse	-	Frexalimab high dose	bjoukcbeqi(bjbrxyuplt) = qcsrzykvdz xheoliocdo (esvpwjdtrb )	-	09 Apr 2024
				Frexalimab low dose	bjoukcbeqi(bjbrxyuplt) = oojstxqfmw xheoliocdo (esvpwjdtrb )
NCT04879628 (Literature \| Pubmed \| N Engl J Med) Manual	Phase 2	Multiple Sclerosis	129	frexalimab 300 mg	ebjqmmpqzx(tnykmbymzm) = uiibzplmdu fpxlwmdnlg (jymuuokzak, 0.1 - 0.6)	Positive	15 Feb 2024
				frexalimab 1200 mg	ebjqmmpqzx(tnykmbymzm) = nsjnuaymby fpxlwmdnlg (jymuuokzak, 0.1 - 0.4)
NCT04879628 (GlobeNewswire) Manual	Phase 2	Multiple sclerosis relapse	129	frexalimab (high-dose)	yfjeizzvcc(bfyfsjosje) = nanpwhdgeu goatdaqmmy (bbefcbwmcb, -62 to -97) Met View more	Positive	31 May 2023
				placebo (high-dose)	-

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