FDA Approves Valneva’s First-Ever Chikungunya Vaccine
Today’s life science stories include the first-ever Chikungunya virus vaccine, the launch of clinical trials for Stargardt disease, a pneumococcal vaccine, a pancreatic cancer trial, and more.
FDA Approves 1st Vaccine to Prevent Chikungunya Virus
The FDA approved Valneva’s (Saint-Herblain, France) Ixchiq, a single-dose, live-attenuated vaccine for prevention of disease caused by chikungunya virus in people 18 years or older at increased risk of exposure to the virus. This is the first licensed chikungunya vaccine. Chikungunya is a mosquito-borne viral disease, which causes symptoms in up to 97% of humans after four to seven days after the mosquito bite. Symptoms include acute onset of fever, debilitating joint and muscle pain, headache, nausea, rash and chronic arthralgia (joint stiffness). High-risk areas for travelers include the Americas, parts of Africa, and Southeast Asia. Between 2013 and 2023, more than 3.7 million cases were reported in the Americas.
Ocugen Doses 1st Patient in Stargardt Disease Trial
Ocugen (Malvern, Pa.) dosed the first patient in its Phase I/II GARDian trial of OCU410ST for Stargardt disease. Stargardt is a rare, genetically inherited disease of the retina, which often causes slow progressive vision loss in children and adults. OCU410ST is an AAV gene therapy based on the company’s Nuclear Hormone Receptor (NHR) RAR Related Orphan Receptor A (RORA) gene approach. The trial will evaluate the safety of unilateral subretinal administration of the therapy in patients with Stargardt disease.
Vaxcyte Dosed 1st Patients in Phase I/II Trial of Pneumococcal Vaccine
Vaxcite (San Carlos, Calif.) dosed the first participants in a Phase I/II trial for VAX-31, a 31-valent pneumococcal conjugate vaccine candidate to prevent invasive pneumococcal disease (IPD) in adults. The trial will enroll about 1,000 adults 50 years of age and older. Topline data is expected in the second half of 2024.
“Leveraging the foundation established by our lead PCV candidate, VAX-24, we believe we have an opportunity to deliver a best-in-class PCV franchise that provides the broadest spectrum of coverage and improves immune responses compared to the standard of care in adults today,” stated Grant Pickering, CEO and Co-Founder of Vaxcyte.
Pharma Two B Published Positive Phase III Parkinson’s Disease Data
Pharma Two B (Rehovot, Israel) published data from a Phase III trial of P2B001 in early Parkinson’s disease patients. The drug is a fixed, low-dose extended-release combination of pramipexole 0.6mg and rasagiline 0.75mg. The study compared the safety and efficacy of the drug in early Parkinson’s patients compared to its components and to commercial doses of the dopamine agonist pramipexole (PramiER) (mean 3.2mg per day). It included 544 untreated patients with Parkinson’s disease who were randomized 2:2:2:1 to treatment with P2B001, its individual components, or marketed PramiER individually titrated to optimal dose. The drug offered benefits comparable with commercially used doses of PramiER while minimizing associated daytime sleep-related and dopaminergic side effects and superior efficacy on motor symptoms and activities of daily living compared to the individual components.
Trishula Launches Phase II Pancreatic Cancer Trial
Trishula Therapeutics (South San Francisco) initiated a Phase II trial of TTZX-030, a potential first-in-class, anti-CD39 antibody. It will be evaluated in combination with chemotherapy, with or without budigalimab (an investigational anti-PD-1 checkpoint inhibitor) compared to chemotherapy alone as first-line treatment of metastatic pancreatic ductal adenocarcinoma patients. The trial will enroll about 180 patients worldwide. The company will continue to develop the drug in collaboration with AbbVie. Per a previous deal, once this Phase II trial is wrapped up, AbbVie has an option to license the drug for continued development.