Clinical Trial News

Vaxart discussed its 2023 achievements, including progress in oral vaccine development for norovirus and COVID-19, highlighted by a $9.27M BARDA contract for a Phase IIb COVID-19 trial. The company emphasized the potential of its oral pill vaccines to offer advantages over injectables, such as ease of administration and mucosal immunity. Vaxart also announced the appointment of a new CEO, Steve Lo, and shared updates on financial results and future clinical trial plans.

A phase 1 clinical trial evaluating a new CAR-T therapy approach for glioblastoma has shown dramatic tumor regression in patients, with one achieving near-complete regression. Despite eventual tumor progression, the results are promising for treating this deadly brain cancer.

Vir Biotechnology's tobevibart and elebsiran received FDA Breakthrough Therapy and EMA PRIME designations for chronic hepatitis delta treatment, based on Phase 2 SOLSTICE trial data showing rapid virus suppression. The Phase 3 ECLIPSE program starts in 2025, aiming to expedite development for this serious condition with unmet medical needs.

Phase 2b trial of izokibep for hidradenitis suppurativa showed significant clinical improvements, with a third of patients achieving HiSCR100 by week 16. Patients switching from placebo to izokibep at week 16 matched the response speed and magnitude of those starting treatment earlier. Izokibep demonstrated a favorable safety profile and potential for differentiation with higher clinical responses. Long-term data indicated no increased safety risks and further clinical improvements over time.

Early detection of ovarian cancer is challenging, with 80% diagnosed at late stages. AOA Diagnostics, a Denver-based startup, is developing a blood test for early detection, aiming to transform women's healthcare. The company, founded during the COVID-19 pandemic, is at the forefront of innovation in Colorado, conducting a clinical study for their groundbreaking technology.

ACELYRIN's Phase 2b/3 trial of izokibep for psoriatic arthritis met the primary ACR50 endpoint at 16 weeks with high statistical significance, showing robust clinical responses and a favorable safety profile. Izokibep demonstrated potential for differentiation in enthesitis resolution and achieved meaningful benefits in severe cases.

Recursion's REC-1245, a novel RBM39 degrader for treating biomarker-enriched solid tumours and lymphoma, received FDA IND clearance for Phase 1/2 trials. Targeting over 100,000 patients in the US and EU5, it aims to address treatment-resistant tumours, with trials expected to start in late 2024.

The phase III DREAMM-7 study showed belantamab mafodotin-blmf combined with bortezomib and dexamethasone (BVd) significantly improved progression-free survival in relapsed/refractory multiple myeloma, with a median of 36.6 months vs 13.4 months for DVd. BVd also showed a trend towards better overall survival and higher response rates, despite more serious adverse events, including ocular effects.

A clinical trial reveals that subcutaneous nivolumab, an injectable form of immunotherapy, is as effective as the intravenous version for treating advanced kidney cancer, with the added benefits of reduced treatment time and increased convenience for patients.

Doxycycline post-exposure prophylaxis (doxyPEP) significantly reduced STIs among gay and bisexual men and transgender women in San Francisco, with notable decreases in chlamydia and syphilis but less impact on gonorrhoea. Real-world data and clinical trials align, showing doxyPEP's effectiveness, despite concerns over antimicrobial resistance.