Notizia - Recent Pharma, Healthcare and Biotech Happenings
Mar 25, 2025
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Clover Biopharmaceuticals, Ltd. has received FDA clearance for its Investigational New Drug (IND) application and has initiated a Phase I revaccination clinical trial for SCB-1019, its non-adjuvanted bivalent RSV prefusion-stabilized F (PreF)-Trimer subunit vaccine. The trial, now enrolling participants, aims to assess the safety, reactogenicity, and immunogenicity of SCB-1019, which is based on Clover’s proprietary Trimer-Tag vaccine technology platform.
The study includes up to 160 older adults (ages 60-85) who were previously vaccinated with GSK’s RSV vaccine (AREXVY) at least two seasons ago. Participants will be randomized to receive either SCB-1019 as a heterologous revaccination dose, a homologous revaccination dose of AREXVY, or a saline placebo. This follows earlier Phase I data from October 2024, where SCB-1019 demonstrated a promising immunogenicity and tolerability profile in RSV vaccine-naïve individuals when compared head-to-head with AREXVY. Clover also plans to advance SCB-1019 into a respiratory combination vaccine (RSV + hMPV ± PIV3) Phase I trial in 2025.
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“We are pleased to announce the U.S. IND clearance and the initiation of our revaccination clinical trial, which highlights the differentiated global potential of Clover’s RSV PreF vaccine (SCB-1019) utilizing our validated Trimer-Tag platform,” said Joshua Liang, CEO and Board Director of Clover. He emphasized the need for improved RSV revaccination strategies, stating, “While currently approved protein-based RSV vaccines are safe and effective for initial doses, critical gaps remain globally, including suboptimal boostability for revaccination and the inability to protect against related respiratory viruses such as hMPV and PIV3.”
Looking ahead, Liang expressed optimism about SCB-1019’s broader potential in respiratory protection. “We look forward to the trial results in an RSV revaccination setting and as part of a future respiratory combination vaccine,” he said. With its ongoing trials, Clover aims to provide a next-generation RSV vaccine capable of addressing these global challenges while leveraging its Trimer-Tag technology for broader respiratory disease prevention.
Alnylam Pharmaceutical has received FDA approval for a supplemental New Drug Application (sNDA) expanding the use of AMVUTTRA (vutrisiran) to include the treatment of cardiomyopathy in wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults. This approval makes AMVUTTRA the first and only FDA-approved treatment for both ATTR-CM and hereditary transthyretin-mediated amyloidosis with polyneuropathy (hATTR-PN). ATTR-CM is a progressive and fatal disease affecting an estimated 150K individuals in the U.S. and over 300K worldwide, with many patients remaining undiagnosed or experiencing disease progression despite existing treatments.
The FDA’s decision is based on results from the HELIOS-B Phase 3 trial, which demonstrated significant reductions in cardiovascular mortality and hospitalizations compared to placebo. The study showed a 28% reduction in all-cause mortality (ACM) and recurrent cardiovascular (CV) events over 36 months, with mortality reduction reaching 36% through 42 months in a secondary analysis. Patients treated with AMVUTTRA also maintained functional capacity and quality of life while showing early improvements in key biomarkers predictive of cardiovascular outcomes. These findings support AMVUTTRA’s unique ability to target the root cause of ATTR-CM by reducing transthyretin (TTR) production through RNA interference (RNAi) therapy.
“The FDA approval of AMVUTTRA for ATTR-CM marks a pivotal advancement for patients, providing a new and clinically differentiated treatment option that has been shown to improve outcomes, including cardiovascular mortality, and reduce disease progression,” said Yvonne Greenstreet, CEO of Alnylam. “This milestone reflects nearly two decades of collaboration with the ATTR amyloidosis community, and we remain committed to advancing treatment options so patients can live longer, healthier lives.”
Ronald Witteles, M.D., a HELIOS-B investigator and Co-Director of the Stanford Amyloid Center, highlighted the significance of this approval. “The HELIOS-B trial enrolled a real-world patient population and demonstrated meaningful clinical benefits across cardiovascular outcomes and disease progression,” he said. “This approval provides an opportunity to transform ATTR-CM treatment with a new mechanism of action that helps patients live longer and experience fewer hospitalizations.” Muriel Finkel, President of the Amyloidosis Support Groups, also welcomed the approval, calling it “a beacon of hope” for patients and their families affected by this devastating disease.
The FDA has granted traditional approval to pembrolizumab (KEYTRUDA) in combination with trastuzumab and fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1). This approval follows the drug’s accelerated approval in May 2021 and is based on results from the KEYNOTE-811 trial, which demonstrated a significant improvement in overall survival (OS) and progression-free survival (PFS) with pembrolizumab compared to placebo.
The pivotal KEYNOTE-811 study was a multicenter, randomized, double-blind, placebo-controlled trial involving 698 patients, of whom 85% had PD-L1 CPS ≥1 tumors. Patients receiving pembrolizumab in combination with trastuzumab and chemotherapy experienced a median OS of 20.1 months compared to 15.7 months in the placebo arm (HR = 0.79). Median PFS was also significantly longer at 10.9 months versus 7.3 months (HR = 0.72). The combination therapy achieved a higher overall response rate (73% vs. 58%) and a longer median duration of response (11.3 months vs. 9.6 months). The safety profile of pembrolizumab in this setting was consistent with its known adverse reaction profile.
This approval aligns with the FDA’s Project FrontRunner initiative, which aims to bring effective cancer therapies into earlier treatment settings. The agency also granted orphan drug designation to pembrolizumab for this indication. The recommended dosing is 200 mg every three weeks or 400 mg every six weeks in combination with trastuzumab and chemotherapy.
The FDA has approved TREMFYA (guselkumab) as the first and only IL-23 inhibitor offering both subcutaneous and intravenous induction options for adults with moderately to severely active Crohn’s disease. This approval expands TREMFYA’s indications, building on its previous approval for ulcerative colitis and reinforcing Johnson & Johnson’s commitment to addressing inflammatory bowel disease.
TREMFYA is a fully-human, dual-acting monoclonal antibody that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23, a key driver of immune-mediated diseases such as CD. The approval is supported by robust Phase 3 clinical data, including the GRAVITI and GALAXI studies, which demonstrated the drug’s superior efficacy compared to STELARA® in pooled endoscopic endpoints. The studies involved over 1,300 patients with moderately to severely active CD who had failed or were intolerant to conventional therapies or biologics. TREMFYA’s ability to achieve endoscopic remission and sustained clinical response highlights its potential to transform CD treatment.
TREMFYA offers a flexible dosing regimen:
With its first fully subcutaneous treatment regimen for CD, TREMFYA provides enhanced flexibility for both patients and providers. Additionally, Johnson & Johnson offers the TREMFYA withMe patient support program, enabling eligible commercially insured patients to receive their first induction treatment within 24 hours.
This approval marks TREMFYA’s fourth U.S. indication since its initial approval for plaque psoriasis in 2017, followed by psoriatic arthritis in 2020 and UC in 2024. Johnson & Johnson is also pursuing an sBLA for a SC induction regimen in UC, reinforcing its leadership in immune-mediated disease innovation.
The FDA has approved GOZELLIX (TLX007-CDx), a next-generation PSMA-PET imaging agent developed by Telix Pharmaceuticals for prostate cancer. This newly approved diagnostic tool, which uses gallium-68 (68Ga) gozetotide injection, is indicated for PSMA-positive lesions in men with suspected metastasis or recurrence based on elevated PSA levels. GOZELLIX builds upon Telix’s ILLUCCIX, enhancing availability and efficiency in prostate cancer imaging.
GOZELLIX offers extended shelf life (up to six hours) and a broader distribution radius, addressing access challenges in PSMA-PET imaging. Its formulation allows for more scalable production, increasing efficiency and flexibility for scanning centers. This advancement ensures more American men—especially in underserved regions—gain access to high-accuracy PSMA imaging, improving diagnostic precision and treatment planning.
Kevin Richardson, CEO of Telix Precision Medicine, emphasized the significance of this approval, stating, “Securing FDA approval for GOZELLIX is a major win for prostate cancer patients, who gain enhanced access to state-of-the-art 68Ga PSMA-PET imaging.” He highlighted Telix’s dedication to continuous improvement, noting, “With the launch of GOZELLIX, our team is excited to be bringing the new generation of prostate cancer scanning to more American men.”
Additionally, GOZELLIX’s approval is expected to ease financial barriers, as it is eligible for full reimbursement, potentially eliminating or reducing patient co-insurance. The company believes this will drive greater adoption of precision medicine imaging in prostate cancer care. Richardson reaffirmed Telix’s commitment to innovation, saying, “Telix continues to invest in innovation across our portfolio, and GOZELLIX is a testament to this continuous improvement approach.”
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