AstraZeneca PLC - AZN STOCK NEWS

Pinetree Therapeutics has entered into an exclusive option and global license agreement with AstraZeneca for a preclinical EGFR degrader candidate. The deal includes:

• Up to $45 million in upfront and near-term payments
• Total deal value of over $500 million, including potential milestone payments
• Tiered royalties on net sales worldwide

Pinetree's pan-EGFR degrader, developed from their proprietary AbReptor™ multispecific antibody platform, has shown promising preclinical anti-tumor activity in drug- and TKI-resistant tumors. The agreement allows AstraZeneca to exclusively license the candidate for global development and commercialization.

AstraZeneca's IMFINZI® (durvalumab) combined with chemotherapy shows significant improvement in event-free survival and overall survival for muscle-invasive bladder cancer (MIBC) in the NIAGARA Phase III trial. This trial demonstrated a notable reduction in disease recurrence and progression. Patients were treated with IMFINZI pre- and post-surgery, achieving better outcomes compared to chemotherapy alone. Approximately 117,000 MIBC patients are treated annually with standard care, which often leads to high recurrence rates. The IMFINZI regimen, well-tolerated with no new safety concerns, potentially transforms the standard of care for MIBC. Data will be presented at an upcoming medical meeting.

AstraZeneca’s IMFINZI® (durvalumab), in combination with chemotherapy, has received FDA approval for treating mismatch repair deficient (dMMR) advanced or recurrent endometrial cancer. This approval is based on the DUO-E Phase III trial, showing a 58% reduction in disease progression or death compared to chemotherapy alone. The trial results were published in the Journal of Clinical Oncology. Endometrial cancer is notably prevalent, with over 66,000 diagnoses and nearly 12,000 deaths in the US in 2022. Early-stage diagnosis boasts an 80-90% five-year survival rate, but advanced stages drop below 20%. The combination treatment is seen as a significant advancement in a field that has seen progress. The safety profile of IMFINZI combined with chemotherapy is considered manageable and consistent with previous trials. Further regulatory reviews are ongoing in the EU, Japan, and other countries.

AstraZeneca's ECHO Phase III trial revealed that CALQUENCE® (acalabrutinib) combined with bendamustine and rituximab significantly reduced the risk of disease progression or death by 27% in untreated mantle cell lymphoma (MCL) patients compared to standard chemoimmunotherapy. Median progression-free survival (PFS) was 66.4 months with CALQUENCE vs. 49.6 months with the standard treatment. The study demonstrated a favorable trend in overall survival (OS) but the data remains immature. Safety profiles were consistent with previous findings, and no new safety signals were identified. These results were presented at the European Hematology Association (EHA) 2024 Hybrid Congress in Madrid.

AstraZeneca's FARXIGA® (dapagliflozin) has received FDA approval for glycemic control in pediatric patients aged 10 years and older with type-2 diabetes (T2D). This approval is based on positive results from the T2NOW Phase III trial, which showed significant A1C reductions compared to placebo (-0.62% for FARXIGA vs. +0.41% for placebo). The approval extends the previously approved use of FARXIGA in adults as an adjunct to diet and exercise.

FARXIGA demonstrated a well-characterized safety profile consistent with adult studies and is now approved in 126 countries, including the EU. AstraZeneca emphasizes this approval as a milestone for pediatric T2D patients, addressing the rising incidence of T2D in children and adolescents, who often face earlier and faster disease progression compared to adults.

AstraZeneca's supplemental New Drug Application (sNDA) for TAGRISSO® (osimertinib) has received Priority Review from the FDA for treating adult patients with unresectable, Stage III EGFR-mutated non-small cell lung cancer (NSCLC) post-chemoradiotherapy. The decision is based on the LAURA Phase III trial, which indicated a significant extension in median progression-free survival (PFS) of more than three years. TAGRISSO was also granted Breakthrough Therapy Designation for this setting. The FDA action date is anticipated in Q4 2024. TAGRISSO showed an 84% reduction in the risk of disease progression or death compared to placebo, with a PFS of 39.1 months versus 5.6 months with placebo. Safety profiles were consistent with no new concerns identified. Additionally, TAGRISSO is approved in over 100 countries for various indications in treating EGFR-mutated NSCLC.

I-Mab (NASDAQ: IMAB) has announced the appointment of Dr. Phillip Dennis as Chief Medical Officer, effective June 17, 2024. Dr. Dennis will lead I-Mab's global clinical development and join the Executive Leadership Team. With two decades of oncology drug development experience, including key roles at Sanofi and AstraZeneca, Dr. Dennis brings significant expertise. His appointment aims to advance I-Mab's clinical pipeline, particularly for treatments like uliledlimab, givastomig, and ragistomig. Before his industry roles, Dr. Dennis was a professor at Johns Hopkins University and a senior investigator at the US National Cancer Institute.

Nucleus RadioPharma announced the closing of a Series A extension funding round with AstraZeneca as a new investor. The funding aims to expand Nucleus's development, supply, and commercial manufacturing capabilities for targeted radiotherapies and theranostics, improving global patient access. Dr. Tyrell Rivers, Executive Director of Corporate Ventures at AstraZeneca, joined Nucleus’s Board of Directors. The precision of theranostics, combining diagnostics and therapeutics through radiotracers, offers a promising treatment for metastatic cancers, minimizing side effects compared to traditional methods. Charles S. Conroy, CEO of Nucleus, highlighted the remarkable effectiveness and safety of these drugs. The funding will facilitate large-scale production, addressing the challenges of the perishable nature of radiopharmaceuticals and enhancing their accessibility for cancer treatment worldwide.

AbelZeta Pharma has reported preliminary data from its first human trial of C-CAR031, a GPC3-targeting CAR-T therapy for advanced hepatocellular carcinoma (HCC), presented at the 2024 ASCO Annual Meeting. The study showed a 91.3% disease control rate (DCR) and a 56.5% objective response rate (ORR) across all dose levels, with an ORR of 75.0% at dose level 4. Tumor reductions were observed in 91.3% of patients, with a median reduction of 42.2%. The median overall survival (mOS) was 11.14 months. Safety data indicated manageable side effects, with no dose-limiting toxicity or ICANS observed, and most cytokine release syndrome cases were mild.