Astrazeneca Plc Stock Price, News & Analysis

Fusion Pharmaceuticals (FUSN) announced the nomination of its first targeted alpha therapy (TAT) candidate in collaboration with AstraZeneca (AZN). This candidate utilizes Fusion's Fast-Clear™ linker technology and involves an actinium-225 radiolabeled bispecific antibody. The Phase 1 study is set to proceed following IND-enabling studies, with both companies sharing development costs. Fusion is also advancing its lead program, FPI-1434, targeting IGF-1R in Phase 1 trials, and has a pipeline that includes FPI-1966 and FPI-2059. The collaboration aims to explore up to three TATs and five combination therapies.

Daiichi Sankyo, in partnership with AstraZeneca, announced the validation of their Type II Variation application for trastuzumab deruxtecan by the EMA, aimed at treating unresectable or metastatic HER2 positive breast cancer. The application is based on the DESTINY-Breast03 trial, which demonstrated a 72% reduction in disease progression or death compared to T-DM1. The trial involved 524 patients globally, showing promising results with a median progression-free survival not reached for trastuzumab deruxtecan versus 6.8 months for T-DM1.

Daiichi Sankyo announces the initiation of the DESTINY-Lung04 phase 3 trial, dosing its first patient to evaluate ENHERTU® (trastuzumab deruxtecan) for treating HER2 mutant unresectable, locally advanced, or metastatic non-squamous non-small cell lung cancer (NSCLC).

This head-to-head trial compares ENHERTU to standard care (platinum-pemetrexed doublet chemotherapy with pembrolizumab), targeting a patient group with limited current treatment options. Lung cancer remains a top cancer mortality cause, with HER2 mutations observed in 2% to 4% of NSCLC cases.

AstraZeneca's EVUSHELD, a long-acting antibody therapy for COVID-19 prevention, shows retained neutralization efficacy against the Omicron variant, as reported by studies from University College Oxford and Washington University. With an IC50 of 273 ng/ml and 147 ng/ml, the data indicate promising neutralizing activity, ensuring its role in protecting vulnerable populations. EVUSHELD is the only antibody authorized in the US for pre-exposure prophylaxis against COVID-19, and its Emergency Use Authorization was granted in December 2021. Future publications will detail these findings further.

AstraZeneca's EVUSHELD, a long-acting antibody combination, has shown effectiveness against the Omicron variant of SARS-CoV-2 according to new preclinical data. The Inhibitory Concentration 50 (IC50) values were 171 ng/ml and 277 ng/ml, indicating significant neutralizing activity. EVUSHELD received Emergency Use Authorization (EUA) in December 2021 for pre-exposure prophylaxis in at-risk individuals. It demonstrated a 50% reduction in severe COVID-19 risk in non-hospitalized patients in the TACKLE Phase III trial. Further studies on its efficacy against Omicron are ongoing.

Transgene announced that AstraZeneca has exercised its first license option for an Invir.IO™ oncolytic virus, resulting in an upfront payment of $8 million. This collaboration, ongoing since 2019, allows AstraZeneca to choose transgenes for integration while Transgene contributes its expertise in viral design. The agreement includes potential development and sales milestones, as well as royalties on future commercial sales. Transgene's pilot manufacturing capability enables it to produce drug candidates for clinical development, enhancing its market prospects in oncological treatments.

Samsung Biologics and AstraZeneca have expanded their strategic collaboration, increasing the agreement's value to approximately $380 million from $331 million. The partnership focuses on manufacturing AstraZeneca's COVID-19 long-acting antibody combination, AZD7442, authorized for COVID-19 prevention. Additionally, starting next year, Samsung will produce a cancer immunotherapy product. This collaboration aims to enhance patient safety and expedite crucial therapies during the pandemic and beyond.

AstraZeneca presented updated results from the ASCEND Phase III trial at the ASH Annual Meeting, highlighting CALQUENCE's significant efficacy for relapsed chronic lymphocytic leukemia. After three years, CALQUENCE demonstrated a 71% lower risk of disease progression or death compared to investigator's choice therapies. Moreover, safety data from the ELEVATE-RR trial revealed CALQUENCE had fewer adverse events than ibrutinib, particularly in terms of atrial fibrillation incidence. CALQUENCE is approved for CLL and small lymphocytic lymphoma, with ongoing studies for its use in various hematologic malignancies.

New data from the DESTINY-Breast03 trial presented at SABCS 2021 show that AstraZeneca and Daiichi Sankyo’s ENHERTU demonstrated superior progression-free survival (PFS) and objective response rate (ORR) in HER2-positive breast cancer patients compared to T-DM1. In a subgroup with stable brain metastases, ENHERTU achieved a median PFS of 15 months versus 3 months for T-DM1. Overall, the confirmed ORR was 67.4% for ENHERTU against 20.5% for T-DM1. ENHERTU is gaining recognition for its potential to improve treatment options for patients with previously treated HER2-positive metastatic breast cancer.