Clinical Trial News
Henlius to Present Latest Clinical Data of HLX22 at 2024 ESMO Gastrointestinal Cancers Congress
Henlius is set to share the latest clinical data from its phase 2 study of HLX22, a novel anti-HER2 monoclonal antibody, at the 2024 ESMO Gastrointestinal Cancers Congress. The study, led by Professor Jin Li, explores the combination of HLX22 with HANQUYOU and chemotherapy for treating HER2-positive gastric/gastroesophageal junction cancer, showing promising results in prolonging progression-free survival and enhancing antitumour response.
Atara Biotherapeutics Submits BLA for Tabelecleucel to Treat EBV+ PTLD
- Atara Biotherapeutics has submitted a Biologics License Application (BLA) to the FDA for tabelecleucel, a monotherapy for Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD).
- The BLA submission is supported by data from multiple studies, including the pivotal ALLELE study, which demonstrated a statistically significant 48.8% Objective Response Rate (ORR).
- Tabelecleucel has already been granted Breakthrough Therapy Designation and orphan drug designation by the FDA for rituximab-refractory EBV-associated lymphoproliferative disease.
- If approved, tabelecleucel will be the first FDA-approved therapy for EBV+ PTLD, addressing a critical unmet need for adult and pediatric patients.
Spinogenix Receives FDA Orphan Drug Designation for SPG601 to Treat Fragile X Syndrome
Spinogenix, Inc. has been granted Orphan Drug Designation by the U.S. FDA for SPG601, a novel treatment for Fragile X syndrome (FXS), highlighting the urgent need for new therapies. FXS, a leading cause of inherited intellectual disability and autism, lacks FDA-approved treatments. SPG601 aims to address core symptoms by modulating BK channels to restore synaptic function.
HIV Vaccine Breakthrough: New Candidate Successfully Generates Broadly Neutralizing Antibodies
- NIAID-supported clinical trial demonstrates that an HIV vaccine candidate can elicit broadly neutralizing antibodies (bNAbs) targeting the membrane proximal external region (MPER) of HIV, a crucial step toward developing an effective preventive vaccine.
- The vaccine generated immune responses in 13 out of 20 recipients, with two participants showing antibodies capable of neutralizing multiple HIV strains after receiving three doses, occurring within weeks rather than years.
- Complementary animal studies using nanoparticle-based immunogens successfully stimulated precursor B cells that could develop into cells producing 10E8-class bNAbs, which target a highly conserved region of HIV's surface protein gp41.
Highlighted Clinical Trials:
National Institute of Allergy and Infectious Diseases (NIAID)
Posted 8/26/2019
Anokion Announces Promising Clinical Data for KAN-101 in Celiac Disease Treatment
Anokion SA has revealed new clinical data from its Phase 1b/2 ACeD-it trial, showcasing the safety and efficacy of KAN-101 as a potential disease-modifying treatment for celiac disease. The data, presented at Digestive Disease Week 2024, highlights KAN-101's unique liver-targeting mechanism and its ability to induce immune tolerance to gluten.
Neuralink Receives FDA Approval for Second Human Brain Implant
- Neuralink has secured FDA approval to implant a second patient with its brain-computer interface (BCI) chip, aiming to refine the technology after initial challenges.
- The first recipient, Noland Arbaugh, experienced a malfunction due to detached wires but has regained functionality through software updates and remains supportive.
- Neuralink plans to implant up to 10 additional patients by year-end, embedding wires deeper to improve signal transmission and device performance.
- The PRIME Study aims to evaluate the safety and initial functionality of Neuralink's BCI, with over 100 quadriplegic individuals registered as potential participants.
Bayer's Elinzanetant Shows Strong Phase III Results for Menopause Symptoms
- Bayer's elinzanetant met primary endpoints in Phase III OASIS 1 and 2 trials, significantly reducing the frequency and severity of moderate to severe hot flashes in post-menopausal women.
- The OASIS trials demonstrated statistically significant reductions in hot flash frequency at both four and twelve weeks compared to placebo, along with improvements in sleep and quality of life.
- Elinzanetant, a dual neurokinin-1,3 receptor antagonist, offers a non-hormonal alternative for managing vasomotor symptoms, potentially competing with Astellas' Veozah.
- Bayer plans to submit data from the OASIS 1, 2, and 3 trials to regulatory authorities, seeking approval for elinzanetant as a treatment for menopausal symptoms.
Highlighted Clinical Trials:
Bayer
Posted 11/8/2023
Maternal Vaccine Trials Face Critical Challenges: Only 6% of Late-Stage Studies Include Pregnant Women
- Recent analysis reveals severe underrepresentation of pregnant women in clinical trials, with only 22 out of 400 Phase 3 and 4 studies between 2018-2023 including pregnant participants.
- Pregnant women face significantly higher risks from infectious diseases, demonstrated by historical data showing 45% mortality rate for pregnant women with influenza during the 1918 pandemic.
- Key challenges in maternal vaccine trials include increased vaccine hesitancy, complex consent requirements, and the need for coordinated data collection across multiple healthcare providers.
Iparomlimab/Tuvonralimab Plus Chemo Shows Promise in Recurrent/Metastatic Cervical Cancer
- Combination therapy with iparomlimab and tuvonralimab alongside chemotherapy demonstrates encouraging responses in patients with recurrent or metastatic cervical cancer.
- The addition of bevacizumab to the iparomlimab/tuvonralimab and chemotherapy regimen may further enhance treatment efficacy in this patient population.
- This novel approach offers a potential new treatment option for cervical cancer where effective therapies are urgently needed.
- Further research is warranted to confirm these findings and determine the optimal use of this combination in clinical practice.
Investors Launch $400M Hercules Startup to Develop Novel GLP-1 Therapies for Obesity and Diabetes
- Four major life science investors, led by Bain Capital, have invested $400 million to create Hercules CM NewCo, acquiring rights to three weight loss drug candidates from Jiangsu Hengrui Pharmaceuticals.
- The deal includes $110 million in upfront payments and a 20% equity stake to Hengrui, with potential milestone payments reaching $5.7 billion based on clinical development and sales performance.
- Hercules' lead candidate HRS-7535, an oral GLP-1 agonist, is currently in Phase 2 trials for type 2 diabetes and obesity, competing with established players like Novo Nordisk and Eli Lilly.