IO Biotech

IO Biotech, Inc. received a Nasdaq notice on December 26, 2024, for non-compliance with the minimum bid price requirement, risking delisting. The company has until June 24, 2025, to regain compliance, with a possible 180-day extension by transferring to the Nasdaq Capital Market. IO Biotech is developing cancer vaccines, including IO102-IO103, targeting IDO and PD-L1 in phase 3 trials for melanoma.

Morgan Stanley analyst Michael Ulz maintained a Buy rating on Akero Therapeutics (AKRO) on Nov 15, setting a $46.00 price target, citing promising Phase 2b HARMONY study results showing efruxifermin's anti-fibrotic effect in F2/3 MASH patients. Ulz anticipates upcoming SYMMETRY study results in F4 MASH as a key catalyst. Evercore ISI also assigned a Buy rating with a $38.00 price target on Nov 11.

DelveInsight's 'Melanoma Pipeline Insight 2024' covers 150+ companies and 170+ pipeline drugs, including IO Biotech, Moderna Inc., Merck Sharp & Dohme LLC, and BioNTech SE. Key therapies like Amtagvi (Iovance Biotherapeutics) received FDA fast-track approval in 2024 for metastatic melanoma. Neoadjuvant immunotherapy became standard care for stage III melanoma after ESMO 2024 updates. The report assesses therapies by product type, stage, route of administration, and molecule type, highlighting active and inactive pipeline products.

IO Biotech announced promising Phase 2 data for IO102-IO103 in combination with KEYTRUDA® in SCCHN patients at ESMO 2024, showing a 44.4% ORR and 6.6-month median PFS, with no new safety concerns.

Pembrolizumab (Keytruda) showed sustained survival benefits over ipilimumab (Yervoy) in unresectable stage III or IV melanoma patients, with 10-year follow-up data from the KEYNOTE-006 study presented at the 2024 ESMO Congress. Pembrolizumab had a median overall survival (OS) of 32.7 months vs 15.9 months for ipilimumab, with 8- and 10-year OS rates of 36.9% and 34.0% vs 24.8% and 23.6%, respectively. The study also highlighted the safety profile and long-term efficacy of pembrolizumab, supporting its standard of care status in advanced melanoma.

Pembrolizumab (Keytruda) showed improved survival over ipilimumab (Yervoy) in stage III/IV melanoma patients, with 10-year OS rates of 34% vs 23.6% and MSS rates of 45.2% vs 31.3%. Pembrolizumab's median OS was 32.7 months vs 15.9 months for ipilimumab, and median modified PFS was 9.4 months vs 3.8 months. Patients who responded well to initial pembrolizumab treatment had significant long-term benefits, with 80% OS rate after 94 weeks of treatment. These results support pembrolizumab as a standard care for advanced melanoma.

IO Biotech's Phase III trial of IO102-IO103 vaccine with pembrolizumab for advanced melanoma received IDMC recommendation to continue after interim analysis. The open-label, randomized trial compares the combination to pembrolizumab alone, enrolling 407 patients across multiple countries. No new safety signals were observed, and the primary endpoint of progression-free survival is expected in H1 2025.

IDMC recommended continuation of IO Biotech's Phase 3 trial of IO102-IO103 without modifications after a safety and efficacy interim analysis. No new safety signals were observed, and the primary endpoint of progression-free survival is projected to be reached in the first half of 2025.

The Global Immuno-oncology Clinical Trials Market is projected to grow from USD 6.13 billion in 2023 to USD 12.87 billion by 2030, at a CAGR of 11.17%. The report analyzes market dynamics, competitive landscape, and profiles key vendors like AstraZeneca and BioNTech. It covers market segmentation by design, phase, indication, and regional prospects including North America, Asia-Pacific, and EMEA.