Seagen Inc.

Xenon Pharmaceuticals has appointed Darren Cline as Chief Commercial Officer to lead commercial strategy for azetukalner, the company's lead Phase 3 candidate targeting epilepsy, major depressive disorder, and bipolar depression.

The 15th World ADC San Diego conference (November 4-7, 2024) represents the industry's largest and most comprehensive ADC-focused forum, featuring 120+ speakers across six development tracks.

• Akari Therapeutics has appointed Mark F. Kubik as Head of Business Development - Oncology, bringing over 25 years of experience in transformative deal creation across oncology therapeutics. • Kubik will lead business development activities for Akari's novel antibody-drug conjugate (ADC) platform and its lead asset AKTX-101, which utilizes a first-in-class spliceosome inhibitor payload. • The strategic hire aims to position Akari as a key player in the growing ADC market, capitalizing on increasing Big Pharma interest in early-stage ADC technologies with novel mechanisms of action.

• A US jury ruled that Daiichi Sankyo and AstraZeneca's breast cancer drug Enhertu infringes Seagen's patent, resulting in a $42 million damages award for past royalties. • The disputed patent covers antibody-drug conjugate technology using auristatin compounds, with the jury finding willful infringement in Enhertu's design and manufacture. • The verdict could have significant financial implications as Enhertu's sales doubled last year to $426 million, with potential expansion into HER2-low breast cancer representing a $3 billion opportunity.

• Pfizer has named Jeffrey Legos, a veteran Novartis executive with over two decades of oncology drug development experience, as its new chief oncology officer, replacing interim leader Roger Dansey. • Under Legos' leadership at Novartis, the company secured notable approvals for drugs like Pluvicto and Kisqali, contributing to over 40 regulatory approvals throughout his career. • The appointment comes as Pfizer aims to revitalize its oncology division, which generated about 25% of its $64 billion revenue in 2023, amid declining COVID-19 product sales and upcoming patent expirations.

DelveInsight's latest pipeline analysis reveals 40+ pharmaceutical companies actively developing 50+ therapeutic candidates for urothelial carcinoma treatment, indicating robust research activity in this space.

• Seagen has entered a $2.6 billion licensing agreement with Chinese biotech RemeGen for disitamab vedotin, a HER2-targeting antibody-drug conjugate, with $200 million paid upfront. • The drug has already received conditional approval in China for HER2-positive gastric cancer and breakthrough designation from FDA for bladder cancer. • This strategic move positions Seagen to compete with established HER2-targeting ADCs like AstraZeneca/Daiichi Sankyo's Enhertu and Roche's Kadcyla in multiple cancer indications.

• Antibody-drug conjugates (ADCs) combine monoclonal antibody specificity with potent small molecule cytotoxicity, precisely delivering toxins to tumors and sparing normal tissues. • Clinical trial volumes for ADCs have dramatically accelerated, with 2.5 times more Phase 2 and 3 trials initiated in 2022 compared to 2017, indicating growing interest and investment. • ADCs in Phase 3 trials demonstrate a 12% higher probability of success compared to other oncology drugs, including monoclonal antibodies, highlighting their potential impact. • The ADC field is expanding beyond solid tumors, with approximately 15% of ongoing trials exploring their efficacy in hematological malignancies, suggesting broader applicability.

Pfizer is focusing on debt reduction following the acquisition of Seagen, an oncology biotech, to improve its financial flexibility.

• Activist investor Starboard Value's $1 billion stake and campaign to challenge Pfizer CEO Albert Bourla's leadership has lost momentum after failing to demonstrate compelling evidence for management change. • Pfizer's Q3 2024 revenues showed over 30% growth compared to Q3 2023, with $854 million in sales from the Seagen acquisition, strengthening Bourla's position and strategic decisions. • Despite criticism of Pfizer's $70 billion post-pandemic acquisitions, experts argue that Bourla's reinvestment of COVID-19 profits through strategic M&As, including the $43 billion Seagen deal, shows prudent long-term planning.