ASTELLAS PHARMA UNSP/ADR - ALPMY STOCK NEWS

Astellas Pharma and Seagen reported initial results from Cohort H of the EV-103 trial on PADCEV® (enfortumab vedotin-ejfv) for muscle-invasive bladder cancer (MIBC) patients ineligible for cisplatin chemotherapy. Of 22 patients analyzed, 36.4% achieved a pathologic complete response, with 50% showing tumor size reduction. All patients proceeded to surgery without delays. Adverse events included fatigue (45.5%) and alopecia (36.4%). The results will be presented at the ASCO Genitourinary Cancers Symposium on February 18, 2022.

Astellas Pharma announced positive interim safety data from the FORTIS trial for AT845, a gene replacement therapy for Late-Onset Pompe Disease (LOPD). This Phase I/II trial aims to assess the safety and efficacy of AT845 in adults. As of December 3, 2021, four participants were enrolled, with no serious adverse events reported. One participant had elevated transaminases, a known immune response. The therapy could address the unmet needs of LOPD patients where enzyme replacement therapy is currently the only approved treatment.

Astellas Pharma and Seagen announced that the European Medicines Agency (EMA) has positively evaluated PADCEV (enfortumab vedotin) for advanced urothelial cancer patients who have undergone platinum-based chemotherapy and PD-1/L1 inhibitors. This marks a significant step as it could be the first antibody-drug conjugate approved in the EU for this condition. The recommendation is based on the Phase 3 EV-301 trial data, highlighting overall survival improvements. The final decision by the European Commission is awaited. Bladder cancer, the most common type of bladder cancer, sees high incidence and mortality rates in Europe.

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.