Astellas Pharma - ALPMY STOCK NEWS

Astellas Pharma and Seagen announced a positive opinion from the European Medicines Agency's CHMP, recommending approval for PADCEV™ (enfortumab vedotin) as a treatment for adult patients with advanced urothelial cancer previously treated with chemotherapy and a PD-1/L1 inhibitor. This marks a significant step toward making PADCEV the first authorized ADC for advanced urothelial cancer in the EU, addressing a crucial treatment gap. The CHMP's recommendation is based on data from the phase 3 EV-301 trial, which showed improved overall survival compared to chemotherapy.

Astellas Venture Management and MBC BioLabs announced Vcreate and Weatherwax Biotechnologies as winners of the Future Innovator Prize, granting them one year of access to MBC BioLabs' facilities and Astellas' R&D capabilities. Vcreate focuses on T-cell therapies for untreatable cancers, utilizing advanced screening assays. Weatherwax aims to develop novel bifunctional drugs for previously 'undruggable' oncology targets. Astellas emphasizes its commitment to innovative science for patient benefits. Both companies will receive support from Astellas throughout their residency.

Astellas Pharma and Dyno Therapeutics have entered a partnership aimed at developing next-generation adeno-associated virus (AAV) vectors for gene therapy, focusing on skeletal and cardiac muscle. Signed on November 23, the agreement allows Dyno to leverage its CapsidMap platform to design improved AAV capsids. Astellas will handle preclinical, clinical, and commercialization efforts. Dyno will receive an $18 million upfront payment and potential earnings exceeding $1.6 billion, including milestone payments and royalties.

Astellas Pharma announced its participation in the 63rd American Society of Hematology (ASH) Annual Meeting, taking place from December 11-14 in Atlanta, GA. The company will present 11 abstracts on acute myeloid leukemia (AML), including key data on gilteritinib from Phase 3 trials LACEWING and COMMODORE. The research will cover various patient stages from newly diagnosed to relapsed and refractory cases. Additionally, Astellas will introduce preclinical data on ASP8731, a novel treatment for sickle cell disease that may alleviate related symptoms.

Astellas Venture Management has announced the winners of the Future Innovator Prize, awarding Thymmune Therapeutics and M13 Therapeutics. These emerging biotech companies gain a year of access to LabCentral's state-of-the-art lab and Astellas’ research capabilities. Thymmune focuses on cell therapies for immunologic disorders, while M13 develops non-viral gene therapies for genetic diseases. This initiative underscores Astellas' commitment to supporting innovative science and addressing unmet medical needs.

Seagen and Astellas have completed patient enrollment in Cohort K of the EV-103 clinical trial, evaluating PADCEV in combination with KEYTRUDA for patients with advanced urothelial cancer unable to receive cisplatin chemotherapy. The FDA previously granted Breakthrough Therapy designation for this combination. If the trial yields positive results, the companies may pursue accelerated approval from the FDA. The trial aims to assess the safety and efficacy of this treatment approach, which could significantly impact the treatment landscape for urothelial cancer.

Astellas Pharma and Seagen have completed patient enrollment in Cohort K of the EV-103 clinical trial, testing PADCEV in combination with KEYTRUDA against metastatic urothelial cancer. This phase 1b/2 trial focuses on patients unable to receive cisplatin-based chemotherapy. The FDA granted Breakthrough Therapy designation for this combination in February 2020. Positive trial results may lead to an accelerated approval application to the FDA. Urothelial cancer comprises a significant portion of bladder cancer cases, with an estimated 83,730 diagnoses in the U.S. in 2021.

Enfortumab vedotin has received approval in Japan for patients with advanced urothelial carcinoma that cannot be surgically removed. The approval by Japan's MHLW follows a priority review and is mainly based on the global Phase 3 EV-301 clinical trial. In the trial, patients treated with enfortumab vedotin showed a median overall survival of 12.9 months, compared to 9.0 months for those receiving chemotherapy, indicating improved outcomes. This ADC targets Nectin-4, a protein commonly found in bladder cancer cells, addressing a significant unmet medical need in the region.

Astellas Pharma and Seagen announced on Sept. 27, 2021 that Japan's Ministry of Health, Labour and Welfare has approved PADCEV (enfortumab vedotin) for treatment of radically unresectable urothelial carcinoma post-chemotherapy. The approval followed a six-month priority review based on the Phase 3 EV-301 trial, which showed a median overall survival of 12.9 months for PADCEV versus 9.0 months for chemotherapy. This treatment addresses a significant need, as over 24,300 bladder cancer cases are diagnosed annually in Japan, with about 9,500 deaths.