{"id":36245,"date":"2026-10-06T16:20:37","date_gmt":"2026-10-06T10:50:37","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=36245"},"modified":"2026-10-06T16:20:42","modified_gmt":"2026-10-06T10:50:42","slug":"pharma-news-for-vaxcyte-csl-alentis","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-vaxcyte-csl-alentis","title":{"rendered":"Vaxcyte Announces Positive Phase 3 Topline Data for VAX-31 from OPUS-1 Trial; CSL and Alentis Partner to Advance Lixudebart for Rare Renal and Hepatic Diseases; Pfizer Announces Positive Repigmentation Results for LITFULO in Nonsegmental Vitiligo; AstraZeneca Completes Equity Investment in Summit Therapeutics; Lilly\u2019s Jaypirca Receives FDA Approval Expansion for Certain Patients with Untreated CLL\/SLL; Merck\u2019s Tulisokibart Delivers Positive Phase 2b Results in Moderate-to-Severe Hidradenitis Suppurativa"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_85 counter-hierarchy ez-toc-counter ez-toc-white ez-toc-container-direction\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<label for=\"ez-toc-cssicon-toggle-item-6ac50fc3a3471\" class=\"ez-toc-cssicon-toggle-label\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/label><input type=\"checkbox\"  id=\"ez-toc-cssicon-toggle-item-6ac50fc3a3471\"  aria-label=\"Toggle\" \/><nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-vaxcyte-csl-alentis\/#Vaxcyte_Reports_Successful_Topline_Outcomes_from_Pivotal_Phase_3_OPUS-1_Study_of_VAX-31\" >Vaxcyte Reports Successful Topline Outcomes from Pivotal Phase 3 OPUS-1 Study of VAX-31<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-vaxcyte-csl-alentis\/#CSL_Alentis_Collaborate_Globally_to_Advance_Lixudebart_in_Rare_Kidney_and_Liver_Diseases\" >CSL, Alentis Collaborate Globally to Advance Lixudebart in Rare Kidney and Liver Diseases<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-vaxcyte-csl-alentis\/#Pfizers_LITFULO_Shows_Significant_Repigmentation_Across_the_Face_and_Body_in_Nonsegmental_Vitiligo\" >Pfizer\u2019s LITFULO Shows Significant Repigmentation Across the Face and Body in Nonsegmental Vitiligo<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-vaxcyte-csl-alentis\/#Lilly_Secures_Expanded_FDA_Indication_for_Jaypirca_in_Certain_Treatment-Naive_CLLSLL_Patients\" >Lilly Secures Expanded FDA Indication for Jaypirca in Certain Treatment-Na\u00efve CLL\/SLL Patients<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-vaxcyte-csl-alentis\/#Merck_Reports_Tulisokibart_Met_Key_Efficacy_Endpoints_in_Phase_2b_Hidradenitis_Suppurativa_Trial\" >Merck Reports Tulisokibart Met Key Efficacy Endpoints in Phase 2b Hidradenitis Suppurativa Trial<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\" id=\"h-vaxcyte-reports-successful-topline-outcomes-from-pivotal-phase-3-opus-1-study-of-vax-31\"><span class=\"ez-toc-section\" id=\"Vaxcyte_Reports_Successful_Topline_Outcomes_from_Pivotal_Phase_3_OPUS-1_Study_of_VAX-31\"><\/span>Vaxcyte Reports Successful Topline Outcomes from Pivotal Phase 3 OPUS-1 Study of VAX-31<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Vaxcyte, Inc. <\/strong>reported positive topline findings from <strong>OPUS-1<\/strong>, its pivotal Phase 3 trial in adults evaluating the safety, tolerability, and immunogenicity of <strong>VAX-31<\/strong>, the company\u2019s next-generation 31-valent pneumococcal conjugate vaccine (PCV) candidate being developed to prevent invasive pneumococcal disease (IPD) and <a href=\"https:\/\/www.delveinsight.com\/report-store\/pneumonia-pneumococcal-pipeline-insight\">pneumococcal pneumonia<\/a>. Data from OPUS-1 are expected to form the clinical foundation for Vaxcyte\u2019s planned Biologics License Application (BLA), which will be submitted for review by the U.S. Food and Drug Administration (FDA).<\/p>\n\n\n\n<p>Among adults aged 50 years and older, VAX-31 achieved all prespecified co-primary immunogenicity endpoints in the OPUS-1 study:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>All 28 VAX-31 serotypes that overlap with PCV20 and\/or PCV21 satisfied the prespecified noninferiority criterion, with the lower bound of the 95% confidence interval (LBCI) exceeding 0.667.<\/li>\n\n\n\n<li>For the 11 serotypes common to VAX-31, PCV20, and PCV21, VAX-31 achieved all 11 primary noninferiority assessments based on opsonophagocytic activity (OPA) geometric mean ratios (GMRs). Under the prespecified analysis, each serotype was required to demonstrate noninferiority against one or both comparator vaccines, based on an OPA GMR noninferiority threshold of LBCI >0.667 with multiplicity adjustment.<\/li>\n\n\n\n<li>All nine serotypes shared exclusively between VAX-31 and PCV20 met the prespecified OPA GMR noninferiority threshold of LBCI >0.667.<\/li>\n\n\n\n<li>All eight serotypes shared exclusively between VAX-31 and PCV21 also met the prespecified OPA GMR noninferiority criterion of LBCI >0.667.<\/li>\n\n\n\n<li>The three serotypes unique to VAX-31, along with cross-reactive serotype 20B, achieved the prespecified OPA GMR superiority criterion of LBCI >2.0 following multiplicity adjustment.<\/li>\n\n\n\n<li>For the prespecified primary immunobridging endpoint, VAX-31 demonstrated noninferiority across all 321 serotype OPA GMR comparisons, with an LBCI >0.667, in adults aged 18\u201349 years compared with adults aged 50\u201364 years.<\/li>\n<\/ul>\n\n\n\n<p>VAX-31 was also well tolerated in the study, with a safety profile comparable to those of PCV20 and PCV21 across all evaluated age groups.<\/p>\n\n\n\n<p>In prespecified analyses against individual comparator vaccines, VAX-31 achieved the noninferiority criterion for all 20 of 20 serotypes shared with PCV20 and 17 of 19 serotypes shared with PCV21. Against PCV21, serotypes 3 and 12F did not reach the LBCI &gt;0.667 noninferiority threshold but met the historical threshold of LBCI &gt;0.5.<\/p>\n\n\n\n<p><em>Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte, said the OPUS-1 findings provide clinical support for the company\u2019s site-specific, carrier-sparing platform and its potential to develop broader-spectrum pneumococcal vaccines without compromising the magnitude of immune responses. He noted that VAX-31 achieved all prespecified primary immunogenicity endpoints across the evaluated age groups, establishing the clinical basis for the planned BLA submission. According to Pickering, the vaccine\u2019s broader serotype coverage and robust immune responses, evaluated under a more stringent noninferiority standard, could establish a new benchmark for pneumococcal conjugate vaccines. The company expects to report results from OPUS-2 and OPUS-3 in the first half of 2027, followed by a manufacturing consistency study, as it advances VAX-31 toward potential broad availability for adults at risk of pneumococcal disease.<\/em><\/p>\n\n\n\n<p><em>James Wassil, Chief Scientific Officer and Chief Operating Officer of Vaxcyte, stated that the OPUS-1 results further support VAX-31\u2019s potential to deliver broader protection against IPD and pneumococcal pneumonia. He highlighted the importance of the PCV21 comparison in the context of current U.S. epidemiology, particularly because serotypes unique to PCV21 account for a substantial proportion of adult pneumococcal disease. PCV20 will also remain an important immunogenicity comparator, including for serotypes 4 and 19F, which are not included in PCV21. Wassil also acknowledged the contributions of study participants, investigators, and clinical trial sites to the program.<\/em><\/p>\n\n\n\n<p><em>Luis Jodar, Ph.D., Chief Medical Officer of Vaxcyte, noted that substantial gaps remain in adult pneumococcal disease coverage. He explained that currently available adult PCVs differ in the serotypes they target, creating tradeoffs between covering circulating disease-causing serotypes and retaining protection against historically significant serotypes. VAX-31 is designed to combine these broader coverage requirements into a single 31-valent vaccine. Based on the company\u2019s estimates, the vaccine could potentially provide incremental coverage of 13\u201336% of IPD and 19\u201331% of pneumococcal pneumonia compared with currently available adult PCVs.<\/em><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-csl-alentis-collaborate-globally-to-advance-lixudebart-in-rare-kidney-and-liver-diseases\"><span class=\"ez-toc-section\" id=\"CSL_Alentis_Collaborate_Globally_to_Advance_Lixudebart_in_Rare_Kidney_and_Liver_Diseases\"><\/span>CSL, Alentis Collaborate Globally to Advance Lixudebart in Rare Kidney and Liver Diseases<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>CSL and Alentis Therapeutics<\/strong> have entered into an exclusive global collaboration agreement to jointly develop and commercialize <strong>lixudebart<\/strong>, an investigational therapy with the potential to become a first-in-class treatment targeting claudin-1 across multiple kidney, liver, and other diseases. Lixudebart is currently being investigated in the Phase 2 RENAL trial in patients with <a href=\"https:\/\/www.delveinsight.com\/report-store\/anti-neutrophil-cytoplasmic-antibody-associated-vasculitis-market\">antineutrophil cytoplasmic antibody-associated vasculitis<\/a> with rapidly progressive glomerulonephritis (AAV-RPGN). This rare, potentially life-threatening autoimmune condition can result in irreversible kidney injury and progression to end-stage renal disease.<\/p>\n\n\n\n<p>Lixudebart has a novel mechanism of action and is designed to deliver potent anti-inflammatory and anti-fibrotic effects, with the potential to prevent or reverse organ damage associated with AAV as well as several kidney, liver, and lung diseases. The ongoing Phase 2 program is intended to determine whether these mechanistic effects can translate into meaningful clinical benefits for patients.<\/p>\n\n\n\n<p>The partnership combines Alentis\u2019 scientific expertise as a leading clinical-stage biopharmaceutical company focused on claudin-1 with CSL\u2019s global clinical development and commercialization capabilities in nephrology. Together, the companies aim to advance innovative treatment options for patients with rare kidney and liver diseases. Beyond AAV-RPGN, the partners plan to develop lixudebart for focal segmental glomerulosclerosis (FSGS), a rare and progressive kidney disorder, and primary sclerosing cholangitis (PSC), a chronic autoimmune liver disease.<\/p>\n\n\n\n<p><em>According to Dr. Mark Pruzanski, Chief Executive Officer of Alentis Therapeutics, the collaboration is expected to accelerate the development of lixudebart across multiple indications simultaneously. He highlighted CSL\u2019s clinical development and commercialization expertise in AAV and kidney diseases as key factors supporting the partnership and noted that the agreement further strengthens the validation of claudin-1 as a novel therapeutic target. The collaboration is also expected to support the advancement of Alentis\u2019 other clinical-stage programs and preclinical pipeline.<\/em><\/p>\n\n\n\n<p><em>Dr. Bill Mezzanotte, EVP and Head of R&amp;D at CSL, noted that patients with AAV-RPGN can experience a rapid decline in kidney function and remain at risk of irreversible kidney damage despite existing treatment options. He stated that lixudebart could potentially offer a new treatment approach aimed at improving kidney function and preventing progression to end-stage kidney disease, initially in AAV-RPGN and potentially in FSGS as well. The therapy may also provide similar benefits for liver function in patients with PSC. The partnership supports CSL\u2019s strategy of establishing a leading global nephrology franchise while expanding its portfolio through high-value external collaborations.<\/em><\/p>\n\n\n\n<p>Under the terms of the agreement, CSL and Alentis will jointly develop and co-promote lixudebart globally. CSL will provide Alentis with an upfront payment of <strong>US$355 million<\/strong>, while Alentis is eligible to receive up to an additional <strong>US$1.2 billion<\/strong> in commercial milestone payments. CSL will also fully finance the completion of the ongoing Phase 2 RENAL trial and the planned Phase 3 study in AAV-RPGN, as well as Phase 2 trials in FSGS and PSC and other supporting development activities. Following commercialization, global profits from lixudebart will be shared between the companies, with CSL receiving 55% and Alentis receiving 45%.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-pfizer-s-litfulo-shows-significant-repigmentation-across-the-face-and-body-in-nonsegmental-vitiligo\"><span class=\"ez-toc-section\" id=\"Pfizers_LITFULO_Shows_Significant_Repigmentation_Across_the_Face_and_Body_in_Nonsegmental_Vitiligo\"><\/span>Pfizer\u2019s LITFULO Shows Significant Repigmentation Across the Face and Body in Nonsegmental Vitiligo<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Pfizer Inc. <\/strong>announced results from two Phase 3 trials assessing the efficacy and safety of once-daily oral <strong>LITFULO\u00ae (ritlecitinib)<\/strong> across patients with varying degrees of disease involvement. The <strong>TRANQUILLO 2 and TRANQUILLO studies<\/strong> demonstrated that LITFULO 100 mg and 50 mg, respectively, produced statistically significant improvements in facial and total-body repigmentation compared with placebo. The findings were further supported by patient-reported outcomes showing reductions in perceived disease severity, clinically meaningful improvements in facial and overall <a href=\"https:\/\/www.delveinsight.com\/report-store\/vitiligo-market\">vitiligo<\/a>, and greater disease stabilization versus placebo. The data, generated from the largest Phase 3 program to date evaluating an oral systemic therapy for nonsegmental vitiligo (NSV), were presented in a late-breaking oral session at the 35th European Academy of Dermatology and Venereology (EADV) Annual Congress in Vienna, Austria. Pfizer plans to submit the findings to regulatory agencies worldwide, including the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), for review.<\/p>\n\n\n\n<p><em>\u201cLITFULO has dual selectivity for JAK3 and the TEC family kinases, which are signaling pathways used by immune cells to attack pigment-producing cells in the skin. By targeting these pathways, LITFULO has the potential to address an underlying driver of nonsegmental vitiligo rather than focusing solely on its visible manifestations. Across the largest Phase 3 program to date evaluating an oral systemic treatment for nonsegmental vitiligo, both TRANQUILLO 2 and TRANQUILLO showed robust and progressively increasing improvements in facial and total-body repigmentation over time, while also improving patients\u2019 perceptions of facial and overall disease severity. We look forward to engaging with regulators on these findings with the goal of making this potential treatment option available to patients as quickly as possible.\u201d<\/em><\/p>\n\n\n\n<p><em>\u2014 Michael Vincent, M.D., Ph.D., Chief Inflammation &amp; Immunology Officer, Pfizer<\/em><\/p>\n\n\n\n<p><em>\u201cNonsegmental vitiligo can impose a significant burden on patients\u2019 lives that extends well beyond the visible changes to the skin.\u00b9\u02d2\u00b2\u02d2\u00b3 Although it is a chronic autoimmune condition, patients frequently experience stigma because the disease is often minimized as merely an issue of skin appearance.\u00b2 The disease can progress unpredictably and frequently affects highly visible areas, while people living with vitiligo have historically had relatively limited treatment options.\u00b2\u02d2\u00b3 Research has demonstrated that LITFULO (ritlecitinib) not only significantly improved facial and total-body repigmentation, but also provided greater disease stabilization compared with placebo. These findings reinforce the potential of LITFULO to contribute to a new treatment paradigm centered on systemic therapy that targets underlying disease drivers in people living with nonsegmental vitiligo.\u201d<\/em><\/p>\n\n\n\n<p><em>\u2014 Iltefat Hamzavi, M.D., Senior Staff Physician, Department of Dermatology, Henry Ford Health and Hamzavi Dermatology Specialists<\/em><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-lilly-secures-expanded-fda-indication-for-jaypirca-in-certain-treatment-naive-cll-sll-patients\"><span class=\"ez-toc-section\" id=\"Lilly_Secures_Expanded_FDA_Indication_for_Jaypirca_in_Certain_Treatment-Naive_CLLSLL_Patients\"><\/span>Lilly Secures Expanded FDA Indication for Jaypirca in Certain Treatment-Na\u00efve CLL\/SLL Patients<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Eli Lilly and Company <\/strong>announced that the U.S. Food and Drug Administration (FDA) has expanded the approved indications for <strong>Jaypirca <\/strong>(pirtobrutinib, 100 mg and 50 mg tablets), a non-covalent <a href=\"https:\/\/www.delveinsight.com\/report-store\/btk-inhibitors-market-forecast\">Bruton tyrosine kinase (BTK) inhibitor<\/a>, to include the treatment of adults with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL\/SLL) who do not have a known 17p deletion. The expanded approval enables Jaypirca to be used as a first-line treatment in appropriate patients.<\/p>\n\n\n\n<p>The FDA decision is supported by findings from the BRUIN CLL-313 study, which demonstrated a significant improvement in progression-free survival (PFS) with pirtobrutinib compared with chemoimmunotherapy, while maintaining a safety and tolerability profile consistent with previous clinical experience. Jennifer A. Woyach, M.D., professor and hematologist-oncologist and Director of the Division of Hematology at The Ohio State University Comprehensive Cancer Center \u2013 Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, noted that physicians can now consider pirtobrutinib for appropriate patients at the time of initial treatment rather than reserving it for later lines of therapy. She highlighted that, with the efficacy and tolerability of modern targeted therapies and considerations such as patient age and comorbidities, some individuals diagnosed with CLL\/SLL may require only one or two treatment lines, making the selection of initial therapy particularly important.<\/p>\n\n\n\n<p>The Jaypirca prescribing information includes warnings and precautions related to infections, hemorrhage, cytopenias, cardiac arrhythmias, second primary malignancies, hepatotoxicity, including drug-induced liver injury, and embryo-fetal toxicity. Additional information on these risks, as well as dosing modifications, is provided in the full Prescribing Information.<\/p>\n\n\n\n<p>Jaypirca is the first and only FDA-approved non-covalent BTK inhibitor. The highly selective kinase inhibitor employs a novel non-covalent binding mechanism to target the BTK pathway in patients with CLL\/SLL.<\/p>\n\n\n\n<p>The expanded FDA approval is based on the primary analysis of the Phase 3 BRUIN CLL-313 trial. Results from the study were presented at the American Society of Hematology Annual Meeting and Exposition in December 2025 and subsequently published in The Journal of Clinical Oncology. BRUIN CLL-313 represents the first prospective, randomized Phase 3 trial evaluating the efficacy and safety of a non-covalent BTK inhibitor in patients with previously untreated CLL\/SLL without 17p deletion.<\/p>\n\n\n\n<p>At a median follow-up of 28 months, the study&#8217;s primary endpoint, Independent Review Committee (IRC)-assessed PFS, was significantly improved among patients receiving pirtobrutinib (n=141) compared with those treated with bendamustine plus rituximab (BR) (n=141). The hazard ratio was 0.20 (95% CI, 0.11\u20130.37; p&lt;0.0001). Median PFS had not yet been reached in the pirtobrutinib group, compared with 33.5 months in the BR group.<\/p>\n\n\n\n<p>The IRC-assessed overall response rate (ORR) was 94% (95% CI, 89\u201398) among patients treated with pirtobrutinib, including a complete response (CR) rate of 13% and a partial response (PR) rate of 81%. In the BR arm, the ORR was 81% (95% CI, 73\u201387), comprising a CR rate of 21% and a PR rate of 60%.<\/p>\n\n\n\n<p>Within the BRUIN CLL-313 trial, adverse reactions resulted in dose reductions in 3.6% of patients and permanent discontinuation of Jaypirca in 4.3% of patients. Serious adverse reactions were reported in 28% of patients receiving Jaypirca, with pneumonia occurring as a serious adverse reaction in 5% of patients. The overall safety profile of pirtobrutinib, including the incidence of atrial fibrillation or flutter, remained consistent with findings previously reported across different treatment settings.<\/p>\n\n\n\n<p>Jaypirca is also the first and only non-covalent BTK inhibitor recommended by the National Comprehensive Cancer Network\u00ae (NCCN\u00ae). It carries a Category 2A recommendation for treatment-na\u00efve adults with CLL\/SLL without del(17p), including older patients with cardiac comorbidities who may require only one treatment during their lifetime. In addition, Jaypirca has a Category 1 preferred recommendation for adults with relapsed or refractory CLL\/SLL who have previously received a covalent BTK inhibitor.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-merck-reports-tulisokibart-met-key-efficacy-endpoints-in-phase-2b-hidradenitis-suppurativa-trial\"><span class=\"ez-toc-section\" id=\"Merck_Reports_Tulisokibart_Met_Key_Efficacy_Endpoints_in_Phase_2b_Hidradenitis_Suppurativa_Trial\"><\/span>Merck Reports Tulisokibart Met Key Efficacy Endpoints in Phase 2b Hidradenitis Suppurativa Trial<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Merck <\/strong>announced the initial presentation of results from <strong>MK-7240-012<\/strong>, a Phase 2b, multicenter, randomized, double-blind, placebo-controlled study assessing tulisokibart, an investigational humanized monoclonal antibody directed against tumor necrosis factor-like cytokine 1A (TL1A), in patients with moderate to severe <a href=\"https:\/\/www.delveinsight.com\/report-store\/hidradenitis-suppurativa-market\">hidradenitis suppurativa<\/a>. The findings will be presented during a Late-Breaking News session at the 2026 Congress of the European Academy of Dermatology and Venereology (EADV) (Abstract ID: LB-26).<\/p>\n\n\n\n<p>The trial achieved its primary endpoint, with both the high-dose (480 mg every 2 weeks [Q2W]) and medium-dose (480 mg every 4 weeks [Q4W]) tulisokibart regimens demonstrating superiority over placebo in achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) at week 16. HiSCR50 was achieved by 72% of patients receiving the high-dose regimen (n=42) and 64% of those receiving the medium-dose regimen (n=42), compared with 35% of patients in the placebo group (n=44), corresponding to improvements of 37% and 29%, respectively, over placebo. In an exploratory analysis, 52% of patients in the low-dose cohort (240 mg Q4W; n=21) achieved HiSCR50, representing a 17% improvement over placebo. Safety findings were generally comparable between the tulisokibart and placebo groups.<\/p>\n\n\n\n<p>At week 16, both the high- and medium-dose groups also demonstrated greater numerical improvements versus placebo across the non-ranked key secondary endpoints. HiSCR75 was achieved by 41% of patients in the high-dose group, 40% in the medium-dose group, and 29% in the low-dose group, compared with 15% in the placebo arm. These results represented numerical improvements over placebo of 27%, 24%, and 13%, respectively. Measures of patient quality of life also improved numerically. Mean reductions in Dermatology Life Quality Index (DLQI) scores from baseline were -5.62 in the high-dose cohort and -3.50 in the medium-dose cohort, corresponding to improvements of 3.16 and 1.02 points, respectively, versus the placebo reduction of -2.46. The low-dose cohort did not demonstrate an improvement over placebo in DLQI.<\/p>\n\n\n\n<p><em>According to Alexa B. Kimball, MD, MPH, lead investigator of the study, President and CEO of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center, and Professor of Dermatology at Harvard Medical School, HS is a painful and chronic condition that can significantly affect patients both physically and emotionally. She noted that despite the availability of advanced therapies, many patients continue to experience inadequate long-term disease control, while the MK-7240-012 findings indicate the potential for tulisokibart to provide meaningful improvements in the treatment of this difficult-to-manage disease.<\/em><\/p>\n\n\n\n<p><em>Aileen Pangan, Vice President and Therapeutic Area Head of Immunology Clinical Research at Merck Research Laboratories, stated that the positive Phase 2b findings expand the clinical development experience of tulisokibart beyond inflammatory bowel disease and represent the first dermatology results for the anti-TL1A class. Merck plans to advance tulisokibart into Phase 3 development for patients with HS.<\/em><\/p>\n\n\n\n<p>Adverse events (AEs) were reported in 42.9% of patients receiving high-dose tulisokibart, 47.6% of those receiving the medium dose, and 52.4% of those receiving the low dose, compared with 40.9% of patients receiving placebo. Serious adverse events were uncommon and occurred at comparable frequencies across treatment groups, affecting 2.4% of patients in both the high- and medium-dose groups, 4.8% in the low-dose group, and 2.3% in the placebo group. No serious or opportunistic infections were reported during the study.<\/p>\n\n\n\n<p>The EADV findings are expected to support the Phase 3 development strategy for tulisokibart in HS. The investigational therapy has the broadest development program within the emerging anti-TL1A class and is currently being studied across six disease indications spanning multiple immune-mediated inflammatory conditions. Phase 3 development includes the ATLAS-UC study (NCT06052059) in ulcerative colitis (UC) and the ARES-CD study (NCT06430801) in Crohn\u2019s disease (CD). Phase 2 trials are also evaluating tulisokibart in rheumatoid arthritis (RA) (NCT07176390), psoriatic arthritis (PsA) (NCT07486960), radiographic axial spondyloarthritis (r-axSpA) (NCT07133633), and hidradenitis suppurativa (HS) (NCT06956235).<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Vaxcyte Reports Successful Topline Outcomes from Pivotal Phase 3 OPUS-1 Study of VAX-31 Vaxcyte, Inc. reported positive topline findings from OPUS-1, its pivotal Phase 3 trial in adults evaluating the safety, tolerability, and immunogenicity of VAX-31, the company\u2019s next-generation 31-valent pneumococcal conjugate vaccine (PCV) candidate being developed to prevent invasive pneumococcal disease (IPD) and pneumococcal [&hellip;]<\/p>\n","protected":false},"author":14,"featured_media":36246,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_editorskit_title_hidden":false,"_editorskit_reading_time":0,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":""},"categories":[32],"tags":[20727,132,20025,349,639,23140,911],"industry":[17225],"therapeutic_areas":[17237,17227,17231],"class_list":["post-36245","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-anca-associated-vasculitis","tag-btk-inhibitors","tag-hidradenitis-suppurativa","tag-latest-pharma-news","tag-pharma-news","tag-pneumococcal-pneumonia","tag-vitiligo","industry-pharmaceutical","therapeutic_areas-dermatology","therapeutic_areas-immunological-and-autoimmune-disorders","therapeutic_areas-infectious-diseases"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.9 (Yoast SEO v27.9) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Pharma News | Vaxcyte, CSL, Alentis<\/title>\n<meta name=\"description\" content=\"Vaxcyte\u2019s VAX-31; CSL and Alentis\u2019s Partnership; Pfizer\u2019s LITFULO; Eli Lilly\u2019s Jaypirca; Merck\u2019s Tulisokibart\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-vaxcyte-csl-alentis\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pharma News | Vaxcyte, CSL, Alentis\" \/>\n<meta property=\"og:description\" content=\"Vaxcyte\u2019s VAX-31; CSL and Alentis\u2019s Partnership; Pfizer\u2019s LITFULO; Eli Lilly\u2019s Jaypirca; Merck\u2019s Tulisokibart\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-vaxcyte-csl-alentis\" \/>\n<meta property=\"og:site_name\" content=\"DelveInsight Business Research\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/DelveInsight-1423323754607782\/\" \/>\n<meta property=\"article:published_time\" content=\"2026-10-06T10:50:37+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-10-06T10:50:42+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.delveinsight.com\/blog\/wp-content\/uploads\/2026\/10\/pharma-news-for-vaxcyte-csl-alentis.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"772\" \/>\n\t<meta property=\"og:image:height\" content=\"482\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/webp\" \/>\n<meta name=\"author\" content=\"Sandeep Joshi\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@DelveInsight\" \/>\n<meta name=\"twitter:site\" content=\"@DelveInsight\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Sandeep Joshi\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"13 minutes\" \/>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Pharma News | Vaxcyte, CSL, Alentis","description":"Vaxcyte\u2019s VAX-31; CSL and Alentis\u2019s Partnership; Pfizer\u2019s LITFULO; Eli Lilly\u2019s Jaypirca; Merck\u2019s Tulisokibart","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-vaxcyte-csl-alentis","og_locale":"en_US","og_type":"article","og_title":"Pharma News | Vaxcyte, CSL, Alentis","og_description":"Vaxcyte\u2019s VAX-31; CSL and Alentis\u2019s Partnership; Pfizer\u2019s LITFULO; Eli Lilly\u2019s Jaypirca; Merck\u2019s Tulisokibart","og_url":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-vaxcyte-csl-alentis","og_site_name":"DelveInsight Business Research","article_publisher":"https:\/\/www.facebook.com\/DelveInsight-1423323754607782\/","article_published_time":"2026-10-06T10:50:37+00:00","article_modified_time":"2026-10-06T10:50:42+00:00","og_image":[{"width":772,"height":482,"url":"https:\/\/www.delveinsight.com\/blog\/wp-content\/uploads\/2026\/10\/pharma-news-for-vaxcyte-csl-alentis.webp","type":"image\/webp"}],"author":"Sandeep Joshi","twitter_card":"summary_large_image","twitter_creator":"@DelveInsight","twitter_site":"@DelveInsight","twitter_misc":{"Written by":"Sandeep Joshi","Est. reading time":"13 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-vaxcyte-csl-alentis#article","isPartOf":{"@id":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-vaxcyte-csl-alentis"},"author":{"name":"Sandeep Joshi","@id":"https:\/\/www.delveinsight.com\/blog\/#\/schema\/person\/f1eefd8dd4afdb0617d6166f8b301e0a"},"headline":"Vaxcyte Announces Positive Phase 3 Topline Data for VAX-31 from OPUS-1 Trial; CSL and Alentis Partner to Advance Lixudebart for Rare Renal and Hepatic Diseases; Pfizer Announces Positive Repigmentation Results for LITFULO in Nonsegmental Vitiligo; AstraZeneca Completes Equity Investment in Summit Therapeutics; Lilly\u2019s Jaypirca Receives FDA Approval Expansion for Certain Patients with Untreated CLL\/SLL; Merck\u2019s Tulisokibart Delivers Positive Phase 2b Results in Moderate-to-Severe Hidradenitis Suppurativa","datePublished":"2026-10-06T10:50:37+00:00","dateModified":"2026-10-06T10:50:42+00:00","mainEntityOfPage":{"@id":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-vaxcyte-csl-alentis"},"wordCount":2863,"image":{"@id":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-vaxcyte-csl-alentis#primaryimage"},"thumbnailUrl":"https:\/\/www.delveinsight.com\/blog\/wp-content\/uploads\/2026\/10\/pharma-news-for-vaxcyte-csl-alentis.webp","keywords":["ANCA-associated Vasculitis","BTK Inhibitors","Hidradenitis Suppurativa","Latest pharma news","pharma news","pneumococcal pneumonia","Vitiligo"],"articleSection":["Notizia - Recent Pharma, Healthcare and Biotech Happenings"],"inLanguage":"en-US","copyrightYear":"2026","copyrightHolder":{"@id":"https:\/\/www.delveinsight.com\/blog\/#organization"}},{"@type":"WebPage","@id":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-vaxcyte-csl-alentis","url":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-vaxcyte-csl-alentis","name":"Pharma News | Vaxcyte, CSL, Alentis","isPartOf":{"@id":"https:\/\/www.delveinsight.com\/blog\/#website"},"primaryImageOfPage":{"@id":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-vaxcyte-csl-alentis#primaryimage"},"image":{"@id":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-vaxcyte-csl-alentis#primaryimage"},"thumbnailUrl":"https:\/\/www.delveinsight.com\/blog\/wp-content\/uploads\/2026\/10\/pharma-news-for-vaxcyte-csl-alentis.webp","datePublished":"2026-10-06T10:50:37+00:00","dateModified":"2026-10-06T10:50:42+00:00","author":{"@id":"https:\/\/www.delveinsight.com\/blog\/#\/schema\/person\/f1eefd8dd4afdb0617d6166f8b301e0a"},"description":"Vaxcyte\u2019s VAX-31; CSL and Alentis\u2019s Partnership; Pfizer\u2019s LITFULO; Eli Lilly\u2019s Jaypirca; Merck\u2019s Tulisokibart","inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.delveinsight.com\/blog\/pharma-news-for-vaxcyte-csl-alentis"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-vaxcyte-csl-alentis#primaryimage","url":"https:\/\/www.delveinsight.com\/blog\/wp-content\/uploads\/2026\/10\/pharma-news-for-vaxcyte-csl-alentis.webp","contentUrl":"https:\/\/www.delveinsight.com\/blog\/wp-content\/uploads\/2026\/10\/pharma-news-for-vaxcyte-csl-alentis.webp","width":772,"height":482,"caption":"pharma-news-for-vaxcyte-csl-alentis"},{"@type":"WebSite","@id":"https:\/\/www.delveinsight.com\/blog\/#website","url":"https:\/\/www.delveinsight.com\/blog\/","name":"DelveInsight Business Research","description":"Blog","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.delveinsight.com\/blog\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Person","@id":"https:\/\/www.delveinsight.com\/blog\/#\/schema\/person\/f1eefd8dd4afdb0617d6166f8b301e0a","name":"Sandeep Joshi","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/secure.gravatar.com\/avatar\/7676451175fe155887a18ffb50e674b270d87436a3fc34ca206f86921cddf4cd?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/7676451175fe155887a18ffb50e674b270d87436a3fc34ca206f86921cddf4cd?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/7676451175fe155887a18ffb50e674b270d87436a3fc34ca206f86921cddf4cd?s=96&d=mm&r=g","caption":"Sandeep Joshi"},"sameAs":["http:\/\/Delveinsight.com"]}]}},"author_meta":{"display_name":"Sandeep Joshi","author_link":"https:\/\/www.delveinsight.com\/blog\/author\/sjoshidelveinsight-com"},"featured_img":"https:\/\/www.delveinsight.com\/blog\/wp-content\/uploads\/2026\/10\/pharma-news-for-vaxcyte-csl-alentis-300x187.webp","coauthors":[],"tax_additional":{"categories":{"linked":["<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Notizia - Recent Pharma, Healthcare and Biotech Happenings<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">Notizia - Recent Pharma, Healthcare and Biotech Happenings<\/span>"]},"tags":{"linked":["<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">ANCA-associated Vasculitis<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">BTK Inhibitors<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Hidradenitis Suppurativa<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Latest pharma news<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">pharma news<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">pneumococcal pneumonia<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Vitiligo<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">ANCA-associated Vasculitis<\/span>","<span class=\"advgb-post-tax-term\">BTK Inhibitors<\/span>","<span class=\"advgb-post-tax-term\">Hidradenitis Suppurativa<\/span>","<span class=\"advgb-post-tax-term\">Latest pharma news<\/span>","<span class=\"advgb-post-tax-term\">pharma news<\/span>","<span class=\"advgb-post-tax-term\">pneumococcal pneumonia<\/span>","<span class=\"advgb-post-tax-term\">Vitiligo<\/span>"]}},"comment_count":"0","relative_dates":{"created":"Posted 1 hour ago","modified":"Updated 1 hour ago"},"absolute_dates":{"created":"Posted on Oct 6, 2026","modified":"Updated on Oct 6, 2026"},"absolute_dates_time":{"created":"Posted on Oct 6, 2026 4:20 pm","modified":"Updated on Oct 6, 2026 4:20 pm"},"featured_img_caption":"pharma-news-for-vaxcyte-csl-alentis","series_order":"","_links":{"self":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts\/36245","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/users\/14"}],"replies":[{"embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/comments?post=36245"}],"version-history":[{"count":1,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts\/36245\/revisions"}],"predecessor-version":[{"id":36247,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts\/36245\/revisions\/36247"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/media\/36246"}],"wp:attachment":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/media?parent=36245"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/categories?post=36245"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/tags?post=36245"},{"taxonomy":"industry","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/industry?post=36245"},{"taxonomy":"therapeutic_areas","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/therapeutic_areas?post=36245"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}