The partnership builds on a previous agreement that awarded Valneva $24.6 million to develop and market the single-shot vaccine in certain LMICs. Valneva has partnered with Brazil’s Instituto Butantan to support vaccine licensure in Brazil and potentially extend the vaccine’s use in the U.S. and other territories. The Brazilian Health Regulatory Agency (ANVISA) is expected to review the marketing authorization application for IXCHIQ® in 2024.
CEPI funding will also support technology transfer to an additional manufacturer to expand vaccine access in Asian LMICs vulnerable to chikungunya outbreaks.
CEPI CEO Dr. Richard Hatchett emphasized the importance of making the vaccine affordable in areas with the highest disease burden. Valneva CEO Thomas Lingelbach highlighted the vaccine’s potential to protect people in chikungunya-affected regions, especially with the increasing spread of mosquito vectors due to climate change. Instituto Butantan’s Director Esper Kallás noted the global importance of addressing arboviruses amid changing climates.
The European Commission representatives Laurent Muschel and Irene Norstedt underscored the EU’s commitment to supporting research and improving global health preparedness.
Innovent Achieves Phase III Success for Mazdutide in Chinese Type 2 Diabetes Patients, Preparing for NMPA NDA Submission
Innovent Biologics announced that the Phase III clinical trial (DREAMS-1) of mazdutide (IBI362), a GLP-1R and GCGR dual agonist, in Chinese adults with type 2 diabetes met both primary and all key secondary endpoints. This follows the successful DREAMS-2 trial, which showed mazdutide’s superiority over dulaglutide in glycemic control, weight loss, and multiple cardiometabolic benefits.
DREAMS-1, a randomized, double-blind, placebo-controlled trial, evaluated mazdutide in 320 Chinese adults with T2D. Results showed that mazdutide significantly reduced glycated hemoglobin (HbA1c) and body weight compared to placebo. At week 24, HbA1c reduction was 1.57% for the 4 mg dose and 2.15% for the 6 mg dose, versus 0.14% for placebo. Weight loss was also significant, with the 6 mg dose group losing 9.6% of body weight by week 48.
Mazdutide also improved cardiovascular metabolic indicators, such as postprandial blood glucose, waist circumference, blood pressure, blood lipids, liver enzymes, and the urinary albumin-to-creatinine ratio. Safety and tolerability were favorable, with gastrointestinal issues being the most common adverse events, mostly mild to moderate, and no new safety signals detected.
Innovent plans to submit a new drug application for mazdutide to the Center for Drug Evaluation of China’s National Medical Products Administration for T2D treatment, following the acceptance of its first NDA for chronic weight management in February 2024.
According to Professors Dalong Zhu and Jiajun Zhao, the principal investigators, mazdutide’s multifaceted benefits are promising for T2D patients who often have multiple chronic conditions. They highlighted the need for innovative medications in China, where diabetes prevalence is the highest globally.
Dr. Lei Qian, Vice President of Clinical Development at Innovent, emphasized mazdutide’s rapid development as a GLP-1R/GCGR dual agonist and its potential for comprehensive T2D management. Innovent looks forward to publishing detailed data and further evaluating mazdutide in the ongoing DREAMS-3 study, a head-to-head trial with semaglutide.
This news highlights mazdutide’s potential to become a superior therapeutic option for T2D, offering significant improvements in glycemic control and overall metabolic health, positioning Innovent as a key player in diabetes treatment.
European Medicines Agency Accepts Review Application for BLENREP (belantamab mafodotin) Combination Therapies in Multiple Myeloma
GSK is aiming to relaunch BLENREP (belantamab mafodotin) after its 2022 market withdrawal, targeting a second-line treatment niche for relapsed or refractory multiple myeloma. GSK recently announced that the European Medicines Agency (EMA) has accepted its marketing authorization application for BLENREP, as part of a combination regimen. GSK proposes using BLENREP with either bortezomib plus dexamethasone (BorDex) or pomalidomide plus dexamethasone (PomDex). The EMA’s Committee for Medicinal Products for Human Use will now review the application before making a final recommendation to the European Commission.
Hesham Abdullah, GSK’s global head of oncology R&D, called the EMA’s acceptance a “milestone” that highlights BLENREP’s potential to improve outcomes for multiple myeloma patients at or after first relapse.
GSK supports BLENREP’s EMA bid with data from the Phase III DREAMM-7 and DREAMM-8 studies, which showed that BLENREP-based combinations led to significant improvements in progression-free survival and positive interim trends for overall survival. Both studies also met secondary endpoints, showing deep and durable responses. Patient follow-up for overall survival continues.
BLENREP, an antibody-drug conjugate, targets the B-cell maturation antigen overexpressed in multiple myeloma. It delivers a cytotoxic auristatin F agent that induces cancer cell death.
The FDA granted BLENREP accelerated approval in August 2020 as a monotherapy for relapsed or refractory multiple myeloma, contingent on confirmatory Phase III trial results. However, BLENREP failed to significantly improve PFS versus pomalidomide in the Phase III DREAMM-3 trial, leading to its U.S. market withdrawal in November 2022.
GSK now plans to relaunch BLENREP based on newer data from DREAMM-7 and DREAMM-8, which showed superior performance compared to Johnson & Johnson’s DARZALEX (daratumumab) and Takeda’s VELCADE (bortezomib), respectively.
GSK’s Chief Commercial Officer, Luke Miels, stated that these data could help BLENREP achieve peak sales of $3 billion and potentially replace Darzalex as the second-line standard of care for multiple myeloma.
GSK’s relaunch of BLENREP offers renewed hope for multiple myeloma patients and could significantly improve treatment outcomes, enhancing competition and innovation in the pharmaceutical industry.
Darolutamide Achieves Primary Endpoint in Phase III ARANOTE Trial for Metastatic Hormone-Sensitive Prostate Cancer in Men
Orion and Bayer’s Phase III ARANOTE trial of darolutamide, combined with androgen deprivation therapy, has met its primary endpoint in metastatic hormone-sensitive prostate cancer (mHSPC), showing a significant increase in radiological progression-free survival (rPFS) compared to placebo plus ADT. The trial demonstrated that darolutamide significantly outperformed placebo in delaying disease progression, both with and without docetaxel.
The safety profile of darolutamide was comparable to placebo plus ADT, confirming the established tolerability seen in earlier studies such as ARAMIS and ARASENS. Darolutamide is already approved as Nubeqa® for non-metastatic castration-resistant prostate cancer (nmCRPC) and, in combination with ADT and docetaxel, for metastatic hormone-sensitive prostate cancer.
Bayer plans to present the full results at an upcoming scientific congress and will submit the data to global health authorities to expand darolutamide’s indications. This trial is part of a broader clinical program evaluating darolutamide across various prostate cancer stages, including ongoing studies like ARASTEP and DASL-HiCaP.
Professor Outi Vaarala, Senior Vice President of Innovative Medicines and Research & Development at Orion, stated, “The results of the ARANOTE trial reconfirm that darolutamide, a compound discovered by Orion scientists, is a viable treatment option for patients with metastatic hormone-sensitive prostate cancer. In these patients, darolutamide has now shown efficacy with and without docetaxel, and thus, pending regulatory approval, can provide choices for the personalized treatment regime.”
The ARANOTE trial’s positive results reinforce darolutamide’s potential as a superior treatment for metastatic hormone-sensitive prostate cancer, offering significant improvements in disease progression while maintaining a strong safety profile, and supporting its broader application in advanced prostate cancer therapy.
Roche’s SUSVIMO Shows Long-Term Efficacy in Treating Two Severe Diabetic Eye Conditions
Roche has announced promising two-year results from the Phase III Pagoda and Pavilion studies for SUSVIMO® (Port Delivery System with ranibizumab), targeting diabetic macular edema (DME) and diabetic retinopathy—the leading causes of vision loss in adults with diabetes. SUSVIMO is the first refillable eye implant providing continuous delivery of ranibizumab.
The updated results demonstrate sustained efficacy and safety over two years. In the Pagoda study, SUSVIMO showed consistent visual acuity gains and maintenance of retinal structure, with 95% of patients not needing additional injections. Similarly, the Pavilion study revealed significant improvements in the Diabetic Retinopathy Severity Scale (DRSS), with 98% of participants avoiding extra treatments.
Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer, remarked, “These results show SUSVIMO’s potential to deliver robust vision outcomes for diabetic eye diseases. If approved, it could offer a new treatment paradigm for DME and Diabetic Retinopathy.”
The FDA has accepted Roche’s supplemental Biologics License Application (sBLA) for SUSVIMO, based on the studies’ data. SUSVIMO is already approved in the U.S. for wet age-related macular degeneration (nAMD). Roche plans to present detailed data at an upcoming congress and aims for expanded approval for DME and Diabetic Retinopathy.
Roche’s SUSVIMO is showing strong long-term efficacy and safety in treating diabetic eye diseases, potentially offering a significant advancement in managing DME and Diabetic Retinopathy.
