AstraZeneca PLC - AZN STOCK NEWS

AstraZeneca released promising results from the NEURO-TTRansform Phase III trial for eplontersen, which targets hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN). Eplontersen met all primary and secondary endpoints in the study, showcasing its effectiveness at 66 weeks. Key findings include an 82% reduction in transthyretin (TTR) serum concentration and a significant improvement in neuropathy and quality of life compared to a placebo group. Notably, 47% of patients exhibited neuropathy improvements, and 58% reported enhanced quality of life. The drug's safety profile was favorable, with no adverse events leading to discontinuation reported. AstraZeneca and Ionis are pursuing regulatory approvals for the drug in the US and Europe.

Shanghai Cellular Biopharmaceutical Group Ltd. presented promising results for C-CAR031, a novel cell therapy targeting Glypican 3 (GPC3), at the AACR Annual Meeting on April 17, 2023. The Phase I trial indicated that C-CAR031 is well tolerated, showing objective responses in patients with advanced hepatocellular carcinoma (HCC). Out of seven patients, three achieved confirmed partial responses, with substantial tumor shrinkage observed (median -41.4%). The therapy employs a unique safety-enhancing design and aims to provide an effective treatment option for HCC. Ongoing enrollment efforts seek to further confirm these initial findings.

GRAIL’s Methylation Assay demonstrated a remarkable 92% cancer detection rate across six hematologic malignancies with an accuracy of 96% in determining the malignancy subtype. This study, revealed at the AACR Annual Meeting 2023, supports the potential for GRAIL’s methylation platform as a tumor-agnostic, plasma-based test for minimal residual disease (MRD). The technology accurately identified residual cancer in 428 samples, validating its effectiveness post-treatment. The findings suggest a promising avenue for extending patient remission and survival, addressing the challenge of undetected residual cancer that may lead to relapse. GRAIL's collaboration with AstraZeneca also aims at developing companion diagnostic tests for early-stage cancer.

AstraZeneca's IMFINZI® (durvalumab) has demonstrated promising results in the AEGEAN Phase III trial for resectable early-stage non-small cell lung cancer (NSCLC). The trial reported that patients receiving IMFINZI plus neoadjuvant chemotherapy achieved a pathologic complete response (pCR) rate of 17.2%, significantly higher than the 4.3% for chemotherapy alone—a difference of 13% (p=0.000036). Additionally, event-free survival (EFS) showed a 32% risk reduction in recurrence compared to chemotherapy alone. The trial, involving 802 patients across 264 centers globally, aims to provide a new treatment option for lung cancer patients. There were no new safety signals observed. AstraZeneca plans to discuss these data with regulatory authorities in pursuit of approval.

ImaginAb Inc. has announced a poster presentation at AACR 2023 on April 18, 2023, highlighting an independent analysis by AstraZeneca based on the IAB-CD8-201 'iCorrelate' Phase II study. The analysis indicates that CD8 ImmunoPET/CT imaging can differentiate responders from non-responders in patients undergoing immune checkpoint blockade therapy.

The findings suggest a lesion scoring system can provide response evaluations at a median of 35 days, significantly earlier than the 105 days typically required by RECIST. Additionally, it underscores the importance of combining CD8 ImmunoPET and CT measurements for accurate assessments.

ImaginAb’s CD8 ImmunoPET™ aims to enhance drug response evaluations and optimize treatment strategies in immunotherapy trials.

Fusion Pharmaceuticals (FUSN) announced the FDA clearance of IND applications for FPI-2068 and imaging analogue FPI-2107. FPI-2068 is a bispecific targeted alpha therapy (TAT) aimed at delivering actinium-225 to tumors expressing EGFR and cMET, validated targets in cancer treatment. This IND filing marks a critical milestone in the development collaboration with AstraZeneca (AZN), indicating plans for a Phase 1 clinical study. The therapy is intended to enhance tumor specificity and patient screening using corresponding imaging isotopes, potentially increasing therapeutic response rates. The development will be shared equally between Fusion and AstraZeneca through clinical phases, with Fusion managing the initial trial.

AstraZeneca showcased five real-world evidence (RWE) studies from its Cardiovascular, Renal, and Metabolism (CVRM) portfolio at the National Kidney Foundation Spring Clinical Meeting held from April 11-15, 2023. The presented REVOLUTIONIZE I study highlighted the recurrence of hyperkalemia (HK) in chronic kidney disease (CKD) patients following dietary counseling, with rates rising from 37.4% at one month to 56% at six months. Notably, patients with prior HK recurrences experienced shorter intervals between episodes. The study indicates a need for effective treatments like LOKELMA to manage HK in this patient population. AstraZeneca's commitment to developing therapies addressing CKD and HK underscores its strategy to advance patient care.

AstraZeneca announced positive outcomes from the NEURO-TTRansform Phase III trial for eplontersen, targeting hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN). Results at 66 weeks indicated that eplontersen met its co-primary endpoints, showing significant improvement in neuropathic disease progression and quality of life measures compared to a placebo. The third endpoint demonstrated significant TTR concentration reduction. Eplontersen, now seeking regulatory approval in the US and Europe, was also accepted for New Drug Application by the FDA, highlighting its potential as a best-in-class treatment amidst urgent medical needs in the field.