BioNTech

Summit Therapeutics' ivonescimab outperformed Merck's Keytruda in NSCLC treatment, with data from China trials showing significant PFS benefits. Analysts caution on data generalizability, and FDA approval may require U.S. data. Ivonescimab also showed promise in other cancers, but overall survival data is pending. Summit plans multi-regional trials in 2025.

PD-1 inhibition with pembrolizumab before and after surgery significantly improves 5-year overall survival (86.6% vs 81.7%) in high-risk early triple-negative breast cancer, according to KEYNOTE-522 trial results.

August 2024 saw significant data updates in CAR-T, mRNA, and GDT therapies for cancer, including a study recommending shorter monitoring after CAR T-cell therapy, BioNTech's mRNA therapy meeting primary endpoint in melanoma, long-term axi-cel data showing durable outcomes in lymphoma, Kiromic BioPharma's Deltacel generating favorable PFS data in NSCLC, and Orgenesis' CAR-T ORG-101 demonstrating efficacy and safety in ALL.

The HIMALAYA study's 5-year survival analysis shows 19.6% survival with STRIDE (durvalumab plus tremelimumab) vs 9.4% with sorafenib in unresectable hepatocellular carcinoma, with no new safety concerns.

At ESMO's annual meeting, Pfizer's ponsegromab showed promise in treating cancer cachexia, helping patients regain weight and improve symptoms. Johnson & Johnson's TAR-200, a chemotherapy-releasing device, demonstrated efficacy in bladder cancer, with 42% of patients showing no cancer evidence. BioNTech and Instil Bio presented early data on drugs targeting PD1 and VEGF, similar to Summit Therapeutics' successful trial. Long-term studies revealed Keytruda's superior survival rates over Yervoy in melanoma patients. Scorpion Therapeutics' STX-478 showed potential as a PI3Ka inhibitor with manageable side effects.

BioNTech to present clinical trial data on mRNA-based cancer vaccines, next-gen immunomodulators, and targeted therapies at ESMO Congress 2024 in Barcelona.

COVID-19 accelerated mRNA vaccine development, leading to record profits and FDA approval of mRNA vaccines. Moderna and Pfizer/BioNTech are expanding their mRNA pipelines into other diseases, with Moderna's RSV vaccine recently approved. The mRNA therapeutics market is projected to reach $68 billion by 2030. mRNA technology is favored for its rapid development potential compared to traditional vaccines. Five mRNA vaccine candidates, including Pfizer/BioNTech's influenza vaccine and Moderna's combination COVID-19/influenza vaccine, are highlighted as near-future prospects.

La Trobe University's Australian Centre for Artificial Intelligence in Medical Innovation (ACAMI) aims to revolutionize personalized medicine, leveraging AI for faster, cheaper, and more effective drug development and testing on digital twins. ACAMI, launched on September 13, partners with mRNA Victoria and BioNTech, focusing on mRNA therapy, immunotherapies, and cancer vaccines. Initial projects include digital twins for breast cancer, a cancer-detecting biosensor, and colour cell mapping to track cancer spread. The centre aims to enhance Victoria's medical innovation and create AI-enabled medical jobs.

Early switch to atezolizumab after vemurafenib plus cobimetinib in BRAF V600-positive melanoma showed improved OS at 4 and 5 years in the ImmunoCobiVem trial, but not statistically significant. Rapid progression after switch to immune checkpoint inhibition was observed in some patients.

Enhertu demonstrated superior efficacy in treating HER2+ breast cancer brain metastases at ESMO 2024, outperforming Kadcyla. Enhertu's 12-month PFS was 61.6% with an ORR of 79% for CNS metastases, maintaining 90.3% OS in active BCBM patients. Analysts predict Enhertu will dominate the ADC market, reaching $11.2bn by 2030, while Kadcyla and Tukysa are projected to achieve $838m and $1.2bn respectively.