AstraZeneca PLC - AZN STOCK NEWS

AstraZeneca announced positive interim results from the AEGEAN Phase III trial, demonstrating that IMFINZI (durvalumab) combined with neoadjuvant chemotherapy significantly improves event-free survival (EFS) for patients with early-stage non-small cell lung cancer (NSCLC). In the study, IMFINZI was given before and after surgery, showing a clinically meaningful benefit over chemotherapy alone. The results align with previous findings regarding pathologic response rates. The trial continues to evaluate key secondary endpoints such as disease-free survival and overall survival. IMFINZI was well tolerated, and no new safety concerns were reported.

Personalis, Inc. (Nasdaq: PSNL) announced an ongoing collaboration with AstraZeneca (LSE/STO/Nasdaq: AZN) to explore ultra-sensitive molecular residual disease (MRD) measurement using Personalis' NeXT Personal® assay. This partnership aims to enhance the detection of circulating tumor DNA (ctDNA) and clinically relevant mutations to guide cancer therapy. The CALLA trial will focus on locally advanced cervical cancer, assessing the roles of ctDNA and HPV detection in plasma. Personalis emphasizes the assay's high sensitivity and specificity, crucial for early and personalized patient interventions.

Genomic Vision has launched FiberSmart®, an AI-based technology that enhances the analysis of fluorescent signals in DNA. This platform offers up to three times more precision and ten times faster analysis compared to previous software solutions. Successfully tested by AstraZeneca and the Fritz Lipmann Institute, FiberSmart® is compatible with Genomic Vision’s scanners and aims to improve genomic analysis in cell and gene therapy. However, the company has initiated convertible note financing, which could cause dilution and downward pressure on share value, risking shareholder capital.

AstraZeneca and Daiichi Sankyo reported promising results from the DESTINY-PanTumor02 Phase II trial of ENHERTU (fam-trastuzumab deruxtecan-nxki). The therapy met the prespecified criteria for objective response rate (ORR) and showed durable response in patients with HER2-expressing advanced tumors not eligible for curative treatment. The trial focuses on various cancers including biliary tract and pancreatic cancers. Safety data confirmed no new safety signals. The findings will be shared at an upcoming medical meeting and with regulatory authorities, highlighting ENHERTU's expanding role in addressing significant unmet medical needs.

Alexion, a part of AstraZeneca Rare Disease, will present vital findings at the American Academy of Neurology Annual Meeting from April 22-27, 2023. The company will showcase 19 abstracts focused on C5 inhibition therapies for rare neurological diseases, including generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). Key data will highlight the efficacy and safety of ULTOMIRIS® and SOLIRIS®. Notably, new Phase I data for gefurulimab, an investigational C5 inhibitor, reinforces its future Phase III trials in gMG. CEO Marc Dunoyer emphasized the company’s commitment to innovative treatments for rare disease communities.

Keymed Biosciences Inc. and Lepu Biopharma Co., Ltd have entered into a global exclusive license agreement with AstraZeneca (AZN) for CMG901, a potential first-in-class antibody drug conjugate targeting Claudin 18.2. AstraZeneca will oversee research, development, manufacturing, and commercialization of CMG901, which is currently in Phase I trials for Claudin 18.2-positive solid tumors. The agreement provides Keymed with an upfront payment of $63 million and potential milestone payments up to $1.1 billion, along with low double-digit tiered royalties. Closing is anticipated in the first half of 2023, pending regulatory approvals.

Results from the PROpel Phase III trial for metastatic castration-resistant prostate cancer (mCRPC) indicate that the combination of LYNPARZA® (olaparib) and abiraterone offers a median overall survival (OS) of 42.1 months, compared to 34.7 months for abiraterone alone. This 7.4-month increase, though not statistically significant (HR 0.81), underscores the potential of the combination therapy. The safety profile remains consistent with previous studies, showing no new long-term safety issues. LYNPARZA was approved in the EU in December 2022 for mCRPC patients, highlighting its importance in addressing a critical treatment gap in prostate cancer.

SOPHiA GENETICS (Nasdaq: SOPH) is partnering with AstraZeneca (Nasdaq: AZN) to enhance precision oncology through its SOPHiA DDM™ platform and multimodal technology. This collaboration aims to improve early patient identification, optimize clinical development, and accelerate the use of innovative treatments. The partnership will integrate various data modalities, including radiomics, molecular data, and clinical information, to provide better insights for treatment decisions. Additionally, SOPHiA is conducting its own DEEP-Lung-IV clinical study to identify predictive signatures for lung cancer immunotherapy response.

AstraZeneca and Amgen's TEZSPIRE® (tezepelumab-ekko) has received FDA approval for self-administration via a pre-filled pen for patients aged 12 and older with severe asthma. This makes TEZSPIRE the first biologic treatment for severe asthma with no phenotype or biomarker limitations. The approval comes from extensive clinical trials, showing high success rates in administering the drug at home or in clinics. TEZSPIRE is also approved in the EU and Japan, with ongoing reviews in other regions. The collaboration aims to enhance treatment options for patients suffering from this complex condition, addressing significant unmet needs.