Atara Biotherapeutics Secures $16 Million Funding to Advance Tab-cel BLA Approval
• Atara Biotherapeutics has priced a $16 million offering of common stock and pre-funded warrants to institutional investors including Adiumentum Capital Management and EcoR1 Capital.
• The proceeds will primarily fund ongoing activities required to achieve biologics license application (BLA) approval for tab-cel, a T-cell immunotherapy leveraging Atara's allogeneic EBV T-cell platform.
• The offering, expected to close around May 16, 2025, includes 834,237 shares at $6.61 per share and pre-funded warrants for 1,587,108 shares at $6.6099 per warrant.
Aura Biosciences to Present New Phase 1 Data for Bel-sar in Bladder Cancer at EAU 2025
• Aura Biosciences will present additional Phase 1 clinical data for bel-sar in non-muscle invasive bladder cancer at the upcoming European Association of Urology Congress in Madrid.
• The presentation will showcase the latest findings on bel-sar, a novel therapeutic candidate being evaluated for patients with non-muscle invasive bladder cancer.
• The company will also participate in the EAU Research Forum, providing an opportunity to engage with leading urological researchers and clinicians.
Clearside's CLS-AX Phase 2b Trial Data Shows Promise in Treatment-Naïve AMD Patients
• New subgroup analyses from Clearside Biomedical's ODYSSEY Phase 2b trial provide strategic insights for upcoming Phase 3 program in neovascular age-related macular degeneration.
• Data presented at the Angiogenesis 2025 meeting supports focusing on treatment-naïve patients and implementing specific visual acuity criteria for future trials.
• The 36-week ODYSSEY trial employed a robust design, being randomized, double-masked, and active-controlled across multiple centers.
J&J Seeks FDA Approval for TAR-200 in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
• Johnson & Johnson has initiated a New Drug Application (NDA) submission to the FDA for TAR-200.
• TAR-200 is intended for patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC).
• Phase 2b SunRISe-1 study data showed an 83.5% complete response rate with TAR-200 monotherapy.
• The FDA is reviewing the application under the Real-Time Oncology Review (RTOR) program to expedite potential approval.
Pfizer's Sasanlimab Plus BCG Shows Promise in BCG-Naive, High-Risk NMIBC
• Pfizer's Phase 3 CREST trial showed that sasanlimab combined with BCG significantly improved event-free survival in BCG-naive, high-risk NMIBC patients.
• The combination therapy demonstrated a clinically meaningful and statistically significant improvement compared to BCG alone in the study.
• Sasanlimab's safety profile in combination with BCG was consistent with the known profiles of both agents, according to the trial data.
• Pfizer plans to submit the CREST trial results for presentation at an upcoming medical congress and discuss potential regulatory filings.
Mural Oncology Gears Up for Key Data Readouts of Nemvaleukin in Ovarian Cancer and Melanoma in 2025
• Mural Oncology's ARTISTRY-7 trial evaluating nemvaleukin with pembrolizumab in platinum-resistant ovarian cancer has reached 75% of overall survival events.
• Top-line data from ARTISTRY-6, a phase 2 trial of nemvaleukin monotherapy in mucosal melanoma, is expected in Q2 2025, potentially supporting accelerated approval.
• Preliminary data for less-frequent intravenous dosing of nemvaleukin in cutaneous melanoma is anticipated in 1H and 2H 2025 for monotherapy and combination therapy, respectively.
• Mural Oncology plans to submit an IND application for MURA-8518, a novel IL-18 candidate, in Q4 2025, expanding its cytokine-based immunotherapy pipeline.
Aura Biosciences' Bel-sar Shows Promise in Choroidal Melanoma and Bladder Cancer Trials
• Aura Biosciences reports positive Phase 2 data for bel-sar in early-stage choroidal melanoma, demonstrating 80% tumor control and 90% visual acuity preservation.
• Phase 1 trial of bel-sar in NMIBC shows clinical complete response in low-grade disease and immune activation, suggesting potential as a novel immune-ablative treatment.
• The Phase 3 CoMpass trial for choroidal melanoma has received EMA authorization to begin enrolling patients in Europe, expanding the trial's global reach.
• With a strong cash position, Aura Biosciences expects to fund operations into the second half of 2026, supporting ongoing clinical development programs.
Belzupacap Sarotalocan Shows Promise in Early-Stage Bladder Cancer Trial
• Belzupacap sarotalocan (bel-sar) demonstrates encouraging clinical activity and a favorable safety profile in patients with non-muscle-invasive bladder cancer (NMIBC) in an ongoing phase 1 trial.
• In low-grade NMIBC patients treated with light-activated bel-sar, 4 of 5 achieved a complete clinical response, showing no tumor cells detected post-treatment.
• The trial observed immune activation in both treated and untreated tumors, suggesting a bladder urothelial field effect with a single low dose of bel-sar.
• Aura Biosciences plans to expand the phase 1 trial to optimize dosing and treatment regimens, with potential for a phase 2 registration-supporting trial.
Aura Biosciences' Bel-Sar Shows Promise in Phase 2 for Early-Stage Choroidal Melanoma
• Bel-sar (AU-011) demonstrated an 80% tumor control rate in Phase 2 trial participants with early-stage choroidal melanoma.
• The study showed a 90% visual acuity preservation rate among patients treated with bel-sar, offering a vision-sparing alternative to radiation.
• The Phase 2 trial highlighted a favorable safety profile for bel-sar, with no serious adverse events reported during the study.
• Aura Biosciences is advancing bel-sar into a Phase 3 trial, with potential to become a first-line treatment for choroidal melanoma.
Clearside Biomedical's CLS-AX Phase IIb Trial Readout Anticipated in Q3 2024
• Clearside Biomedical anticipates primary data readout from its Phase IIb ODYSSEY trial of CLS-AX for wet AMD in Q3 2024, assessing its potential as a maintenance therapy.
• The company's SCS Microinjector continues to demonstrate benefits in suprachoroidal drug delivery, with multiple partnerships and clinical trials underway for various indications.
• A new collaboration with BioCryst Pharmaceuticals will utilize Clearside's SCS Microinjector to deliver their compound aboard Elestat for treating diabetic macular edema.
• Clearside Biomedical's cash balance, including proceeds from a recent offering, is expected to fund operations into Q3 2025, supporting the CLS-AX Phase III program.
Novel Treatment Landscape Expands for Uveal Melanoma with Multiple Promising Therapies in Development
• Recent FDA approvals of Kimmtrak and Hepzato mark significant breakthroughs in uveal melanoma treatment, offering new options for patients with metastatic disease.
• IDEAYA Biosciences' darovasertib-crizotinib combination enters phase 3 trials, potentially expanding treatment options for both HLA-A2 positive and negative metastatic uveal melanoma patients.
• Multiple innovative approaches are advancing through clinical development, including Roche's T-cell engager RO7293583 and iOnctura's novel PI3Kδ inhibitor IOA-244.
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