A Phase IIa Efficacy and Safety Trial With Intravenous S95011 in Primary Sjögren's Syndrome Patients: An International, Multicentre, Randomised, Double-blind, Placebo-controlled Study

The purpose of this study is to assess the effect of multiple intravenous infusions of S95011 compared to placebo in reducing disease activity in patients with primary Sjögren's syndrome.

Start Date03 Aug 2021

Sponsor / Collaborator

Institut de Recherches Intern Servier

[+1]

NCT04882007

/ Unknown statusPhase 2

Randomized, Double-blind, Phase 2 Study to Evaluate the Efficacy and the Safety of OSE-127 Versus Placebo in Subjects With Moderate to Severe Active Ulcerative Colitis Who Have Failed or Are Intolerant to Previous Treatment(s)

This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group study in patients with moderate to severe active ulcerative colitis.

Start Date02 Oct 2020

Sponsor / Collaborator

OSE Immunotherapeutics SA

NCT03980080

/ CompletedPhase 1

Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study for the Assessment of Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single and Multiple Ascending Intravenous and Subcutaneous Doses of OSE-127 in Healthy Subjects

This study is a first-in-human phase I randomised, double-blind, placebo-controlled, evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single (IV and SC) and Multiple (IV only) Ascending Doses of OSE-127 in Healthy Subjects.

Start Date19 Dec 2018

Sponsor / Collaborator

OSE Immunotherapeutics SA

[+1]

100 Clinical Results associated with Lusvertikimab

100 Translational Medicine associated with Lusvertikimab

100 Patents (Medical) associated with Lusvertikimab

Literatures (Medical) associated with Lusvertikimab

27 Jun 2024·Blood

The IL-7R antagonist lusvertikimab reduces leukemic burden in xenograft ALL via antibody-dependent cellular phagocytosis

Article

Author: Schewe, Denis M. ; Winterberg, Dorothee ; Poirier, Nicolas ; Alten, Julia ; Neyton, Stéphanie ; Pengam, Sabrina ; Narbeburu, Emma ; Mary, Caroline ; Schüler, Thomas ; Peipp, Matthias ; Lenk, Lennart ; Dietterle, Anna ; Schrappe, Martin ; den Boer, Monique L. ; Boer, Judith M. ; Baccelli, Irène ; Wessels, Wiebke ; Déramé, Mylène ; Taurelle, Julien ; Bourquin, Jean-Pierre ; Bornhauser, Beat ; Cario, Gunnar ; Reimer, Claas ; Escherich, Gabriele ; Raffel, Simon ; Heymann, Julia ; Antić, Željko ; Brüggemann, Monika ; Laqua, Anna ; Dovhan, Vladyslava ; Vogiatzi, Fotini ; Corallo, Frédérique ; Bergmann, Anke K.

AbstractAcute lymphoblastic leukemia (ALL) arises from the uncontrolled proliferation of B-cell precursors (BCP-ALL) or T cells (T-ALL). Current treatment protocols obtain high cure rates in children but are based on toxic polychemotherapy. Novel therapies are urgently needed, especially in relapsed/refractory (R/R) disease, high-risk (HR) leukemias and T-ALL, in which immunotherapy approaches remain scarce. Although the interleukin-7 receptor (IL-7R) plays a pivotal role in ALL development, no IL-7R–targeting immunotherapy has yet reached clinical application in ALL. The IL-7Rα chain (CD127)–targeting IgG4 antibody lusvertikimab (LUSV; formerly OSE-127) is a full antagonist of the IL-7R pathway, showing a good safety profile in healthy volunteers. Here, we show that ∼85% of ALL cases express surface CD127. We demonstrate significant in vivo efficacy of LUSV immunotherapy in a heterogeneous cohort of BCP- and T-ALL patient-derived xenografts (PDX) in minimal residual disease (MRD) and overt leukemia models, including R/R and HR leukemias. Importantly, LUSV was particularly effective when combined with polychemotherapy in a phase 2-like PDX study with CD127high samples leading to MRD-negativity in >50% of mice treated with combination therapy. Mechanistically, LUSV targeted ALL cells via a dual mode of action comprising direct IL-7R antagonistic activity and induction of macrophage-mediated antibody-dependent cellular phagocytosis (ADCP). LUSV–mediated in vitro ADCP levels significantly correlated with CD127 expression levels and the reduction of leukemia burden upon treatment of PDX animals in vivo. Altogether, through its dual mode of action and good safety profile, LUSV may represent a novel immunotherapy option for any CD127+ ALL, particularly in combination with standard-of-care polychemotherapy.

01 Jan 2024·Journal of Otolaryngology - Head & Neck Surgery

Canadian Real-World Study Long-Term Clinical Results Using Dupilumab for Chronic Rhinosinusitis With Polyps

Article

Author: Lasso, Andrea ; Kilty, Shaun J.

Background Dupilumab, an anti-IL4 receptor-α monoclonal antibody, was the first biologic to be approved in Canada for the treatment of Chronic Rhinosinusitis with Nasal Polyps (CRSwNP). In phase III clinical trials, it has demonstrated to be effective in reducing nasal polyp size and the severity of symptoms, improve disease-specific quality of life, and to have an acceptable safety profile. This study aims to present long-term follow-up data on disease-specific sinonasal outcomes of patients with CRSwNP who have been treated with dupilumab for up to 3 years in a real-world setting. Methods Retrospective review of electronic medical records of a single Canadian rhinology center evaluating disease-specific sinonasal outcomes that are routinely collected for clinical care. This study included all patients who received dupilumab for the treatment of CRSwNP and who had completed at least one follow-up visit. The Sino-Nasal Outcome Test (SNOT)-22 was used to evaluate treatment symptom improvement. Results Ninety-nine patients started dupilumab therapy during the study period. The mean SNOT-22 at the start of therapy was 61.1 (±22.91) At the time of the review, 65 patients had completed 1 year of therapy, 40 had completed 2 years of therapy, and 18 had completed 3 years of therapy. The mean SNOT-22 score at these timepoints was 16.75 (±13.86), 15.02 (±14.40), and 10.22 (±11.56), respectively. Conclusion This real-world study shows that in patients with CRSwNP treated with dupilumab, improvement in disease-specific quality of life seen after 1 year continues and can be maintained at 3 years of treatment.

15 Mar 2023·The Journal of Immunology

First-in-Human Study in Healthy Subjects with the Noncytotoxic Monoclonal Antibody OSE-127, a Strict Antagonist of IL-7Rα

Article

Author: Conduzorgues, Jean-Pascal ; Poirier, Nicolas ; Josien, Regis ; Soma, Emilienne ; Pengam, Sabrina ; Girault, Isabelle ; Teppaz, Géraldine ; De Sa, Fanny ; Poli, Sonia ; Belarif, Lyssia ; Costantini, Dominique ; Braudeau, Cécile ; Abès, Riad ; Mary, Caroline ; Corallo, Frédérique ; Volckaert, Bram ; Baccelli, Irène ; Fromond, Claudia

AbstractOSE-127 is a humanized mAb targeting the IL-7Rα-chain (CD127), under development for inflammatory and autoimmune disease treatment. It is a strict antagonist of the IL-7R pathway, is not internalized by target cells, and is noncytotoxic. In this work, a first-in-human, phase I, randomized, double-blind, placebo-controlled, single-center study was carried out to determine the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of OSE-127 administration. Sixty-three healthy subjects were randomly assigned to nine groups: six single ascending dose groups with i.v. administration (0.002–10 mg/kg), a single s.c. treatment group (1 mg/kg), and two double i.v. injection groups (6 or 10 mg/kg). Subjects were followed during <146 d. OSE-127’s pharmacokinetic half-life after a single dose increased from 4.6 (1 mg/kg) to 11.7 d (10 mg/kg) and, after a second dose, from 12.5 (6 mg/kg) to 16.25 d (10 mg/kg). Receptor occupancy was ≥95% at doses ≥0.02 mg/kg, and this saturation level was maintained >100 d after two i.v. infusions at 10 mg/kg. IL-7 consumption was inhibited by OSE-127 administration, as demonstrated by a decreased IL-7 pathway gene signature in peripheral blood cells and by ex vivo T lymphocyte restimulation experiments. OSE-127 was well tolerated, with no evidence of cytokine-release syndrome and no significant alteration of blood lymphocyte counts or subset populations. Altogether, the observed lack of significant lymphopenia or serious adverse events, concomitant with the dose-dependent inhibition of IL-7 consumption by target cells, highlights that OSE-127 may show clinical activity in IL-7R pathway–involved diseases.

News (Medical) associated with Lusvertikimab

18 Dec 2024

·www.globenewswire.com

OSE Immunotherapeutics to Present Anti-IL-7R Lusvertikimab Phase 2 Induction Results in Ulcerative Colitis at 20th Congress of ECCO

A clinical abstract on the induction results from the CoTikiS Phase 2 trial of anti-IL-7 Receptor Lusvertikimab in Ulcerative Colitis accepted for Oral Presentation and selected amongst the Top 10 oral abstracts for 20th Congress of European Crohn’s and Colitis Organization (ECCO) Highlights. Research highlights OSE Immunotherapeutics’ continued commitment to advancing the treatment and management of IBD. NANTES, France, December 18, 2024 – 6:00pm CET - OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), today announced that an abstract related to its first in class anti-IL-7 Receptor (IL-7R) Lusvertikimab, has been accepted for Oral Presentation at the 20th congress of the European Crohn’s and Colitis Organization (ECCO) being held February 19-22, 2025, in Berlin (Germany). Details of the presentation: EC25-1892 - "Lusvertikimab, a first-in-class IL7 receptor antagonist, in moderate to severe Ulcerative Colitis: results of a multicenter, randomized, placebo-controlled phase II study" has been accepted as an Oral Presentation in the Scientific Program and selected amongst the Top 10 oral abstracts for the Congress Highlights of ECCO’25 video. Presentation number: OP36Session name: Sustainability in IBD and beyond - Session 10: Hot topics in IBDSession date: 22/02/25; Session time: 08:30 - 10:50; Presentation time: 10:10 - 10:20Session hall: Plenary Hall / Hall B Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, comments: “We are excited to present for the first time at a congress the clinical efficacy and safety data from the induction study in ulcerative colitis. This prestigious scientific meeting gathers the world’s leading specialists in Inflammatory Bowel Diseases (IBD). Lusvertikimab, a pure interleukin-7 receptor antagonist mAb that exclusively blocks IL-7 boasts a differentiated mechanism of action and a favorable tolerance profile. We believe Lusvertikimab is uniquely positioned in IBD, with potential also for a broader spectrum of chronic inflammatory and autoimmune diseases.” Interleukin-7 (IL-7) produced locally by epithelial cells is a crucial survival factor for pathogenic T lymphocytes residing in tissues, such as colitogenic memory T cells1. Lusvertikimab is a unique antagonist of IL-7R targeting the CD127 receptor, the alpha chain of the IL-7R, with a differentiated mechanism of action allowing a selective inhibition of the IL-7 biology while sparing TSLP (Thymic Stromal LymphoPoietin) cytokine and growth factor. This allows potent inhibition of pathogenic memory and effector T lymphocytes expressing high level of CD127, while promoting regulatory T cells (Tregs) biology expressing low level of CD127. The protective role of TSLP in intestinal immunity has been reproducibly described, in particular to instruct Treg generation against commensal bacteria2 and TSLP inhibition has been reported to exacerbate mucosal inflammation and colitis3. This biology together with the results of the CoTikiS study supports the continued clinical development of a pure IL-7 antagonist in IBD, and other diseases where Tregs and microbiota cross-talks are implicated in tissular healing. Interleukin-7 Receptor (IL-7R) overexpression has been associated with numerous diseases4 and therapeutic areas, with preclinical efficacy already demonstrated in IBD5, rheumatoid arthritis6, neuroinflammation7, airways inflammation8, dermatology9, type 1 diabetes10 and lupus11. ABOUT ULCERATIVE COLITIS (UC)Ulcerative colitis is a chronic disease of the large intestine, in which the lining of the colon becomes inflamed and develops tiny open sores, or ulcers. This condition is the result of the immune system’s overactive response. UC affects 3.3 million patients in the US, Europe and Japan (1). Despite broad therapeutic options, remission rates remain only 25-30% (2) leaving most patients without satisfactory treatments. 15% of patients (3) fail to respond to all therapies and undergo surgery as a last option.(1) EvaluatePharma (2) Drugs Context. 2019; 8: 212572 –doi: 10.7573/dic.212572(3) Scientific Reports volume 10, Article number: 12546 (2020)ABOUT OSE IMMUNOTHERAPEUTICS OSE Immunotherapeutics is a biotech company dedicated to developing first-in-class assets in immuno-oncology (IO) and immuno-inflammation (I&I) that address the unmet patient needs of today and tomorrow. We partner with leading academic institutions and biopharmaceutical companies in our efforts to develop and bring to the market transformative medicines for people with serious diseases. OSE Immunotherapeutics is based between Nantes and Paris and is quoted on Euronext. Additional information about OSE Immunotherapeutics assets is available on the Company’s website: www.ose-immuno.com. Follow us on X and LinkedIn Contacts Fiona Olivierfiona.olivier@ose-immuno.comSylvie Détrysylvie.detry@ose-immuno.comFrench Media Contact FP2COMFlorence Portejoiefportejoie@fp2com.fr+33 6 07 768 283U.S. Media ContactRooney Partners LLCKate Barrettekbarrette@rooneypartners.com+1 212 223 0561 Forward-looking statementsThis press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management considering its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate. These forward-looking statements include statements typically using conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Universal Registration Document filed with the AMF on April 30, 2024, including the annual financial report for the fiscal year 2023, available on the OSE Immunotherapeutics’ website. Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements. 1 Markus F. Neurath, Strategies for targeting cytokines in inflammatory bowel disease, Nat Rev Immunol 20242 I Spadoni et al., Dendritic cells produce TSLP that limits the differentiation of Th17 cells, fosters Treg development, and protects against colitis, Mucosal Immunol, 2012 3 Jonathan L Messerschmidt et al., TSLP/dendritic cell axis promotes CD4+ T cell tolerance to the gut microbiome, JCI Insight, 2023 Betsy C Taylor et al., TSLP regulates intestinal immunity and inflammation in mouse models of helminth infection and colitis, J Exp Med, 20094 Barata, J. T., S. K. Durum, and B. Seddon. 2019. Flip the coin: IL-7 and IL-7R in health and disease. Nat. Immunol. 20: 1584_1593.5 Belarif, L., R. Danger, L. Kermarrec, V. Nerri`ere-Daguin, S. Pengam, T. Durand, C. Mary, E. Kerdreux, V. Gauttier, A. Kucik, et al. 2019. IL-7 receptor influences anti-TNF responsiveness and T cell gut homing in inflammatory bowel disease. J. Clin. Invest., 2019.Willis, C. R. et al., Interleukin-7 receptor blockade suppresses adaptive and innate inflammatory responses in experimental colitis. J. Inflamm., 2012.6 Sarita A Y Hartgring, Blockade of the interleukin-7 receptor inhibits collagen-induced arthritis and is associated with reduction of T cell activity and proinflammatory mediators, Arthritis Rheum, 2010Zhenlong Chen, The novel role of IL-7 ligation to IL-7 receptor in myeloid cells of rheumatoid arthritis and collagen-induced arthritis, J Immunol, 2013 7 Li-Fen Lee et al., IL-7 promotes T(H)1 development and serum IL-7 predicts clinical response to interferon-β in multiple sclerosis 8 Hoa Le Mai et al., Targeting the interleukin-7 receptor alpha by an anti-CD127 monoclonal antibody improves allergic airway inflammation in mice, Clin Exp Allergy, 2020 9 Lyssia Belarif et al., IL-7 receptor blockade blunts antigen-specific memory T cell responses and chronic inflammation in primates, Nat Commun, 2018Zhenpeng Dai et al., Blockade of IL-7 signaling suppresses inflammatory responses and reverses alopecia areata in C3H/HeJ mice, Sci Adv, 2021 10 Li-Fen Lee et al., Anti-IL-7 receptor-α reverses established type 1 diabetes in nonobese diabetic mice by modulating effector T-cell function, Proc Natl Acad Sci U S A, 2012 Cristina Penaranda, IL-7 receptor blockade reverses autoimmune diabetes by promoting inhibition of effector/memory T cells, Proc Natl Acad Sci U S A, 201211 Rosana Gonzalez-Quintial et al., Systemic autoimmunity and lymphoproliferation are associated with excess IL-7 and inhibited by IL-7Rα blockade PLoS One, 2011 Attachment EN_241218_ECCO Lusvertikimab

Phase 2Clinical ResultImmunotherapy

05 Nov 2024

·pipelinereview.com

OSE Immunotherapeutics Announces Statistically Significant and Clinically Meaningful Results from the Phase 2 Study of Anti-IL7R mAb Lusvertikimab for the Treatment of Ulcerative Colitis

NANTES, France I November 4, 2024 I OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), today reported positive results from the induction period of the CoTikiS randomized, double-blind, placebo-controlled, Phase 2 study of Lusvertikimab (OSE-127) demonstrating a strong efficacy and favorable safety profile in moderate to severe active ulcerative colitis (UC). Topline results from the CoTikiS Phase 2 Study The randomized, double-blind Phase 2 clinical trial CoTikiS has evaluated the efficacy and the safety of Lusvertikimab versus placebo in 136 patients with moderate to severe active UC who failed or lost response to previous treatment(s)*. CoTikiS is a 50-week study, with a 10-week induction period evaluating two doses (450mg or 850mg) of Lusvertikimab against placebo, a 24-week additional open label treatment extension period (OLE) during which all subjects received Lusvertikimab 850mg infusions every 4 weeks and a 16-week safety follow-up period free of treatment. Lusvertikimab (Lusv) met the primary efficacy endpoint defined by the improvement of the Modified Mayo Score (MMS)** at week 10 (W10) at the two doses tested and demonstrated statistically significant and clinically meaningful results on key secondary endpoints. A favorable safety profile was observed during both the induction period and during the 6 months of open-label extension period trial. 134 patients were analyzed in the W0-W10 period [group 850mg (50 patients); group 450mg (35 patients); drug group pooled 850mg + 450mg (85 patients); group placebo (49 patients)]. A total of 120 patients treated with Lusvertikimab participated to the additional 24-week OLE treatment period. Final analysis of the primary endpoint at W10*** Improvement of the global Disease Activity Index of UC (MMS) Key secondary endpoint results at W10 Clinical remission**** Endoscopic remission (endoscopic score at 0) Endoscopic improvement (endoscopic score ≤ 1 point) Ulcerative Colitis Endoscopic index of Severity***** (UCEIS score decreases at week 10) Safety Profile Lusvertikimab displayed a good safety profile and was well tolerated, with no difference between both dose groups and placebo in the incidence of drug related serious adverse events (SAEs), adverse events (AEs) leading to discontinuation, severe drug-related AEs, opportunistic infections or infusion reactions during the induction period. In addition, no safety signal was observed in the patient population who received 850mg of Lusvertikimab for an additional 24-week period in the OLE, regardless of the initial randomization groups. Pr. Arnaud Bourreille, Associate professor in Gastroenterology, Institut des Maladies de l’Appareil Digestif, Nantes University Hospital, Principal/ Scientific coordination of the CoTikiS study , said: “We are very excited to share these positive topline efficacy results which could establish Lusvertikimab as a potential new breakthrough therapeutic option for UC patients. We are beyond enthusiastic with the very high endoscopy efficacy and what it could mean for patients suffering from chronic ulcerative colitis. This promising drug-candidate with a differentiated mode of action and very good safety profile needs to be further actively explored in ulcerative colitis and in other indications. We are grateful to all the investigators and patients for their participation in this study and we are eager to present a more complete clinical and biomarkers data set in future medical congresses.” Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics , adds: “These impressive efficacy and safety results represent a major milestone in the clinical development of Lusvertikimab and a strong catalyst for the subsequent steps. Lusvertikimab has clearly demonstrated meaningful clinical proof-of-efficacy in UC and we are now looking forward to further evaluating it in additional studies with the ultimate goal of making this innovative therapy accessible to millions of patients in need of more efficacious and safe treatments. Lusvertikimab is a pure interleukin-7 receptor antagonist mAb and we believe it has a broad first-in-class potential in various chronic inflammatory and autoimmune diseases. We look forward to making progress on this strategy and to go ahead with the most relevant partners.” * Previous corticosteroids, immunosuppressive agents or previous biological treatments. ** Ulcerative Colitis is a chronic inflammatory disease of the rectum and colon characterized by mucosal inflammation, abdominal pain associated with symptoms and frequency of diarrhea and rectal bleeding. The moderate to severe UC is measured by a Modified Mayo Score (MMS) between 4 and 9, inclusive. The primary endpoint is the mean change at Week 10 from baseline in the Modified Mayo Score, a Disease Activity Index for UC defined by the addition of the stool frequency and the rectal bleeding sub-scores (two patient’s clinical elements as Patient Reported Outcomes) and the endoscopic sub-score (mucosal endoscopy activity), assessed by an endoscopist through a central reading platform. *** An interim Futility analysis performed early (about 30% of patients) by the IDMC proposed interruption of the 450 mg group for risk of futility. The 850 mg group was initially considered as primary analysis, in the final analysis the futility of the 450mg was not confirmed. SAP (Statistical Analysis Plan) Addendum: Results of 450mg group reconsidered with all patients already included in this group. In addition, the two groups have been pooled for the drugs cohort to a global treatment effect. **** Clinical remission at Week 10, a modified Mayo score of ≤ 2 points with no individual sub-score of > 1 point and a rectal bleeding at 0, therefore a stool frequency score of 0 or 1 and an endoscopic score of 0 or 1. ***** Ulcerative Colitis Endoscopic Index of Severity, UCEIS, is a validated endoscopic scoring tool with lower interobserver variability, score change at Week 10 from baseline measuring specific subscores: vascular pattern/ presence of bleeding/ erosions and ulcerations (Pabla B S et al Gastroenterol Clin North Am. 2020). About OSE Immunotherapeutics OSE Immunotherapeutics is a biotech company dedicated to developing first-in-class assets in immuno-oncology (IO) and immuno-inflammation (I&I). The Company’s current well-balanced first-in-class clinical pipeline includes: OSE Immunotherapeutics expects to generate further significant value from its three proprietary drug discovery platforms, which are central to its ambitious goal to deliver next-generation first-in-class immunotherapies: Additional information about OSE Immunotherapeutics assets is available on the Company’s website: www.ose-immuno.com . Follow us on X and LinkedIn SOURCE: OSE Immunotherapeutics

Clinical ResultImmunotherapyPhase 2

04 Nov 2024

·endpts.com

Novo, Ascendis to work on monthly GLP-1; KalVista makes a royalty deal

Plus, news about Disc Medicine, OSE Immunotherapeutics, CrossBridge Bio, Lomond Therapeutics, Relief Therapeutics and Renexxion: Novo Nordisk, Ascendis Pharma ink deal: The Danish drugmaker will pay up to $285 million as part of an agreement to develop a once-monthly GLP-1 receptor agonist using Ascendis’ TransCon platform. Ascendis may also receive up to $77.5 million in milestones and royalties for other metabolic or cardiovascular disease product candidates that they develop. — Jaimy Lee KalVista’s new royalty deal and financing: Per the new agreement with DRI Healthcare Trust, the company will receive $100 million upfront, a $22 million payment if sebetralstat gets FDA approval, and up to $57 million in sales milestones. KalVista also disclosed a $55M offering as it gears up for the FDA’s decision in June on its hereditary angioedema drug. Its stock $KALV was up about 12% on Monday morning. — Jaimy Lee Disc Medicine sets sights on accelerated approval: CEO John Quisel said that the company was “thrilled” with the outcome of its end-of-Phase-2 meeting with US regulators regarding its rare blood cell disease treatment, bitopertin. The biotech believes it has coalesced with the agency on surrogate endpoint data for an accelerated approval application in addition to parameters for a confirmatory trial. Disc is expected to meet with the FDA again to “finalize the details” of bitopertin’s confirmatory study. Its stock $IRON gained about 22% on Monday morning. — Max Bayer OSE’s Phase 2 data for ulcerative colitis drug: The trial hit the primary endpoint of improvement in the Modified Mayo Score, which is a test measuring disease in UC patients. The drug, called lusvertikimab, also showed statistically significant and clinically meaningful results in the study’s secondary endpoints. OSE CEO Nicolas Poirier said in a statement that the company believes the drug has promise in “various chronic inflammatory and autoimmune diseases.” Its stock $OSE was up about 5% on Monday morning. — Katherine Lewin ADC biotech closes $10M seed round: CrossBridge Bio said the money will go toward development of CBB-120, its lead candidate, and a TROP-2 dual-payload antibody-drug conjugate for solid tumors. The funding will also “further de-risk” its ADC platform in order to improve the safety and efficacy for current and future candidates. — Katherine Lewin Lomond’s reverse merger: The company, which is developing treatments for hematologic cancers, announced the transaction with Venetian-1 Acquisition in addition to a $44 million placement. Investors included OrbiMed and Deerfield Management Company. — Jaimy Lee Another reverse merger, this time for Relief and Renexxion: The Swiss drugmaker proposed the merger with Renexxion, which is developing gastrointestinal therapies, after undergoing a strategic review. — Jaimy Lee

Phase 2AcquisitionClinical ResultAccelerated Approval

100 Deals associated with Lusvertikimab

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Indication	Highest Phase	Country/Location	Organization	Date
Colitis, Ulcerative	Preclinical	LV	OSE Immunotherapeutics SA	02 Oct 2020
Colitis, Ulcerative	Preclinical	BG	OSE Immunotherapeutics SA	02 Oct 2020
Colitis, Ulcerative	Preclinical	UA	OSE Immunotherapeutics SA	02 Oct 2020
Colitis, Ulcerative	Preclinical	GE	OSE Immunotherapeutics SA	02 Oct 2020
Colitis, Ulcerative	Preclinical	PL	OSE Immunotherapeutics SA	02 Oct 2020
Colitis, Ulcerative	Preclinical	BY	OSE Immunotherapeutics SA	02 Oct 2020
Colitis, Ulcerative	Preclinical	RU	OSE Immunotherapeutics SA	02 Oct 2020
Colitis, Ulcerative	Preclinical	ZA	OSE Immunotherapeutics SA	02 Oct 2020
Colitis, Ulcerative	Preclinical	HR	OSE Immunotherapeutics SA	02 Oct 2020
Colitis, Ulcerative	Preclinical	HU	OSE Immunotherapeutics SA	02 Oct 2020

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04882007 (CoTikiS, GlobeNewswire) Manual	Phase 2	Colitis, Ulcerative	136	Lusvertikimab	-	Positive	04 Nov 2024
				Lusvertikimab (850mg)	(asfguxytja) = iiychliocj dxkgnbcnth (ngafcfooes ) Met View more
NCT04882007 (CoTikiS, PipelineReview) Manual	Phase 2	Ulcerative colitis, active moderate \| Ulcerative colitis, active severe	136	Lusvertikimab	(kcnttborli) = no safety signal was reported by the Data Safety Monitoring Board during the trial. Both doses of lusvertikimab show favorable safety profile in comparison with placebo, with similar rates of adverse events across the 3 treatment groups. gncgkljevi (kbphnxjnrk )	Positive	24 Jul 2024
				Lusvertikimab (850 mg group)
NCT04605978 (CTgov)	Phase 2	Primary Sjögren's syndrome	48	S95011 concentrate for solution for infusion (S95011 Concentrate for Solution for Infusion)	dhstjpcbtj(mowjcwehht) = cypwwwvqva wmioapwmvn (icoouuwdhh, xxdfguvcap - promwwyinl) View more	-	23 Apr 2024
				Placebo concentrate for solution for infusion (S95011 Placebo Concentrate for Solution for Infusion)	dhstjpcbtj(mowjcwehht) = oowmshcwhg wmioapwmvn (icoouuwdhh, zpxfhnlzkw - rxphlgaams) View more

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