Seagen Inc.
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- Public, Subsidiary
- Established
- 1998-01-01
- Employees
- 3.2K
- Market Cap
- -
- Website
- http://www.seagen.com
Pfizer Enters $6 Billion Licensing Deal with China's 3SBio for Novel Cancer Drug
• Pfizer has secured global rights (excluding China) to 3SBio's experimental cancer drug SSGJ-707 for $1.25 billion upfront, with potential additional payments of up to $4.8 billion based on developmental milestones.
• SSGJ-707 is currently being evaluated for multiple cancer types including non-small cell lung cancer, metastatic colorectal cancer, and gynecological tumors, with Phase III trials in China planned to begin this year.
• The deal includes a $100 million equity investment in 3SBio by Pfizer, with manufacturing planned at Pfizer's facilities in North Carolina and Kansas following FDA clearance of the Investigational New Drug application.
Recludix's STAT6 Inhibitor Shows Promising Efficacy in Preclinical Asthma Model, Matching Biologic Treatments
• Recludix Pharma's novel STAT6 inhibitor demonstrated efficacy comparable to anti-IL-4/IL-13 antibody treatments in preclinical asthma models, with significant dose-dependent reduction of airway inflammation.
• The reversible, non-degrading inhibitor achieved durable target modulation without degrading STAT6 protein, potentially avoiding hematologic safety concerns associated with JAK inhibitors.
• Recludix is collaborating with Sanofi to advance this potential first-in-class oral therapy for type 2 inflammatory diseases including asthma, COPD, and atopic dermatitis into clinical trials.
Merck and Daiichi Sankyo Launch Phase 3 Trial of Novel B7-H3 Targeted ADC for Advanced Esophageal Cancer
• The IDeate-Esophageal01 Phase 3 trial has begun evaluating ifinatamab deruxtecan, a potential first-in-class B7-H3 directed antibody-drug conjugate, against standard chemotherapy in advanced esophageal squamous cell carcinoma.
• Esophageal squamous cell carcinoma accounts for 90% of global esophageal cancers with dismal survival rates of 15-20%, highlighting the urgent need for new treatment approaches after first-line therapy failure.
• The trial follows promising early-phase results and will enroll approximately 510 patients across Asia, Europe, and North America, with overall survival as the primary endpoint.
Phase 3 ECOG-ACRIN EA4151 Trial Evaluates Necessity of Auto-HCT in Modern MCL Treatment
• The phase 3 ECOG-ACRIN EA4151 trial is investigating whether autologous hematopoietic cell transplantation (auto-HCT) still benefits mantle cell lymphoma patients in the era of improved first-line therapies.
• The study enrolled 650 patients across four treatment arms, comparing auto-HCT plus rituximab versus rituximab alone in patients achieving MRD-negative complete remission after frontline therapy.
• This research follows the phase 3 TRIANGLE trial, which previously showed auto-HCT provided no added benefit when combined with rituximab, ibrutinib, and high-dose cytarabine regimens in MCL patients.
Recludix Unveils First-in-Class BTK SH2 Domain Inhibitor with Superior Selectivity for Chronic Spontaneous Urticaria
• Recludix Pharma has developed the first BTK SH2 domain inhibitor showing significant reduction in skin inflammation in preclinical models of chronic spontaneous urticaria.
• The novel inhibitor demonstrates exceptional selectivity compared to traditional BTK tyrosine kinase inhibitors, avoiding off-target effects like platelet dysfunction associated with TEC inhibition.
• This breakthrough approach could potentially address limitations of current BTK inhibitors by providing deeper, more durable pathway inhibition for treating autoimmune and inflammatory diseases.
Akari Therapeutics Appoints Mark F. Kubik to Lead Oncology Business Development for Novel ADC Platform
• 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.
Robust Pipeline of 200+ Therapies Targets Colorectal Cancer Treatment Landscape
• DelveInsight's latest report reveals a robust pipeline with over 195 companies developing 200+ therapies for colorectal cancer, highlighting significant innovation in targeted treatments and immunotherapies.
• Key drug candidates include XL092 (Exelixis), Adagrasib (Mirati Therapeutics), Olaparib (Merck/AstraZeneca), and novel approaches like LYL845, an autologous tumor-infiltrating lymphocyte therapy from Lyell Immunopharma.
• The metastatic colorectal cancer segment shows particular promise with 150+ companies advancing 180+ pipeline therapies, including innovative treatments targeting specific mutations and immune pathways.
Luveltamab Tazevibulin Shows Promising Results in Platinum-Resistant Ovarian Cancer with Low to High FRα Expression
• Luveltamab tazevibulin demonstrated a 32% overall response rate in platinum-resistant ovarian cancer patients with FRα expression ≥25%, showing similar efficacy in both low-medium and high expression subgroups.
• The antibody-drug conjugate achieved a remarkable 96% disease control rate when administered at 5.2 mg/kg with G-CSF prophylaxis for the first two cycles, then 4.3 mg/kg in subsequent cycles.
• Common side effects included arthralgia, nausea, and neutropenia, with researchers selecting the optimized dose regimen for the ongoing phase 3 portion of the REFRΑME-O1 trial.
GSK's Blenrep Secures UK Approval for Multiple Myeloma Treatment in Combination Therapy
• The UK's medicines regulatory body has approved GSK's Blenrep (belantamab mafodotin) in combination with other drugs for multiple myeloma patients whose first treatment failed or caused severe side effects.
• This approval marks a significant comeback for Blenrep, which was withdrawn from markets in 2022 after failing to outperform existing treatments when used as monotherapy.
• Clinical trials demonstrated Blenrep's combination therapy extended progression-free survival and overall survival compared to standard care regimens, including those based on Darzalex (daratumumab).
PADCEV-KEYTRUDA Combination Shows Sustained Survival Benefit in Advanced Urothelial Cancer Trial
• Phase 3 EV-302 trial demonstrates PADCEV plus KEYTRUDA reduces mortality risk by 49% compared to chemotherapy in advanced urothelial cancer patients, with median overall survival of 33.8 months versus 15.9 months.
• The combination therapy showed significant progression-free survival benefit of 12.5 months compared to 6.3 months with chemotherapy, representing a 52% reduction in disease progression risk.
• Extended 12-month follow-up data confirms sustained efficacy across all patient subgroups, including both cisplatin eligible and ineligible patients, with no new safety concerns identified.
Incyte Reports Strong 2024 Growth with $4.2B Revenue, Outlines Ambitious 2025 Pipeline Milestones
• Incyte achieved total revenues of $4.2 billion in 2024, marking a 15% year-over-year growth, driven by strong performance of Jakafi ($2.8B) and Opzelura ($508M).
• The company anticipates four new product launches in 2025, including Niktimvo for chronic GVHD and expanded indications for existing therapies in atopic dermatitis and lymphoma.
• Incyte's R&D pipeline shows significant advancement with plans for four pivotal study readouts, three Phase 3 study initiations, and seven proof-of-concept study results expected in 2025.
Antibody-Drug Conjugates (ADCs) Emerge as Promising Therapeutic Modality in Oncology
• 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.
Clinical Trial Industry Faces Complex Challenges in 2025: Adaptive Designs, Political Shifts, and Diversity Requirements
• Clinical trials are becoming increasingly complex and expensive as they target smaller patient populations and face stricter regulations, driving the need for smarter and more efficient trial designs.
• Political changes, including Trump's presidency, could lead to significant regulatory shifts in the clinical trial landscape, potentially affecting approval pathways and oversight mechanisms.
• New legislation like the Inflation Reduction Act is expected to impact trial initiations and drug development, while diversity guidelines from WHO, FDA, and EMA present both opportunities and challenges for patient recruitment.
Tisotumab Vedotin Demonstrates Survival Benefit in Chinese Cervical Cancer Subpopulation
• Tisotumab vedotin significantly improved overall survival compared to chemotherapy in Chinese patients with previously treated recurrent or metastatic cervical cancer.
• The antibody-drug conjugate reduced the risk of death by 45% in the Chinese subpopulation, consistent with global trial results.
• Zai Lab plans to submit a new drug application to China's National Medical Products Administration based on these findings.
• The results offer hope for addressing the unmet need for effective treatments after relapse, including after anti-PD-(L)1 therapy.
FDA Approves Brentuximab Vedotin Combination for Relapsed/Refractory Large B-Cell Lymphoma
• The FDA has approved brentuximab vedotin in combination with lenalidomide and rituximab for adult patients with relapsed or refractory LBCL.
• The approval is specifically for those ineligible for auto-HSCT or CAR T-cell therapy after two or more lines of systemic therapy.
• Data from the ECHELON-3 trial demonstrated a statistically significant improvement in overall survival with the brentuximab vedotin combination.
• Common adverse events included neutropenia, thrombocytopenia, anemia, and peripheral neuropathy, manageable with dose modifications.
Kailera's HRS9531 Shows Strong Phase II Weight Loss, Pfizer Cautious on Danuglipron
• Kailera Therapeutics' HRS9531, a dual GLP-1/GIP receptor agonist, demonstrated a 21.1% placebo-adjusted weight reduction in Phase II trials over 36 weeks.
• Pfizer CEO Albert Bourla expressed caution regarding their oral obesity candidate, danuglipron, despite plans for late-stage studies of the once-daily formulation.
• Kailera reported that 59% of patients on HRS9531 achieved at least 20% body weight loss, with no plateau observed, suggesting potential for greater efficacy with longer use.
• Pfizer abandoned a twice-daily danuglipron formulation due to toxicities, focusing on a once-daily version, but analysts remain divided on its prospects in the competitive obesity market.
SIL-204 Demonstrates Synergy with Chemotherapy in KRAS-Driven Pancreatic Cancer Models
• Silexion Therapeutics' SIL-204, a next-generation siRNA candidate, shows synergistic effects with first-line chemotherapies in preclinical models of KRAS-mutated pancreatic cancer.
• SIL-204 amplified the efficacy of chemotherapeutic agents like 5-fluorouracil, irinotecan, and gemcitabine, leading to greater reductions in cancer cell confluence.
• Silexion is advancing SIL-204 with toxicology studies underway and Phase 2/3 trials planned for 2026, aiming to address a significant unmet need in KRAS-driven cancers.
• The company recently announced a $5 million public offering to support the clinical development of SIL-204 and other pipeline programs.
Mainz Biomed and Quest Diagnostics Collaborate to Advance Colorectal Cancer Screening
• Mainz Biomed and Quest Diagnostics have partnered to enhance the commercialization of Mainz Biomed's NextGen colorectal cancer screening test.
• Quest Diagnostics will provide laboratory services for Mainz Biomed's ReconAAsense study, involving 15,000 participants across 150 U.S. sites.
• Mainz Biomed has initiated eAArly DETECT 2, a U.S. feasibility study to evaluate its next-generation colorectal cancer test with mRNA biomarkers.
• The ColoAlert test, marketed in Europe and the UAE, utilizes PCR technology on stool samples to detect colorectal cancer tumor DNA.
Novartis' Kisqali Receives EC Approval for Early Breast Cancer Treatment
• The European Commission (EC) has approved Novartis' Kisqali (ribociclib) in combination with an aromatase inhibitor for adjuvant treatment of HR+/HER2- early breast cancer.
• The approval is based on the Phase III NATALEE trial, demonstrating a 25.1% reduction in the risk of disease recurrence compared to endocrine therapy alone.
• Kisqali is now approved for a broader population of early breast cancer patients in Europe, including those with node-negative disease at high risk of recurrence.
• The decision follows positive recommendations and aligns with recent FDA approvals and NCCN guidelines, reinforcing Kisqali's role in early breast cancer treatment.
Niraparib Shows Promise in Extending Progression-Free Survival in Epithelial Ovarian Cancer
• Niraparib monotherapy extends real-world progression-free survival (rwPFS) and time to next treatment (rwTTNT) in patients with epithelial ovarian cancer (EOC).
• Patients with homologous recombination-deficient (HRd) tumors, particularly those with BRCA-mutated tumors, experienced longer rwPFS and rwTTNT.
• Niraparib demonstrates clinical benefit in stage III EOC patients with no visible residual disease (NVRD) after primary cytoreductive surgery (PCS).
• Niraparib stands out among PARP inhibitors for its broad frontline maintenance therapy approval in EOC, regardless of BRCA mutation or HRD status.
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