Genmab Stock Price, News & Analysis

Genmab A/S (Nasdaq: GMAB) announced promising results from a Phase 1/2 study of rinatabart sesutecan (Rina-S), an investigational folate receptor-alpha (FRα)-targeted antibody-drug conjugate for ovarian cancer. The study showed a 50% confirmed objective response rate in patients treated with Rina-S 120 mg/m2 every 3 weeks, regardless of FRα expression levels. Key findings include:

- 95% of patients in the 120 mg/m2 group had platinum-resistant ovarian cancer
- 50% ORR for 120 mg/m2 vs 18.2% for 100 mg/m2
- 88.9% disease control rate for 120 mg/m2
- All confirmed responses ongoing at data cutoff

Based on these results, Rina-S 120 mg/m2 will be evaluated in a Phase 3 trial for advanced ovarian cancer, expected to start in 2024. Common side effects included anemia, neutropenia, and nausea, with infrequent dose reductions or discontinuations.

Genmab A/S (Nasdaq: GMAB) announced that the European Commission has granted conditional marketing authorization for TEPKINLY® (epcoritamab) as a monotherapy for treating adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. TEPKINLY is the first and only subcutaneous T-cell engaging bispecific antibody approved for this patient population in the EU, EEA countries, and Northern Ireland.

The approval is based on data from the Phase 1/2 EPCORE® NHL-1 clinical trial, which showed an overall response rate of 83% and a complete response rate of 63% in patients treated with TEPKINLY. The median duration of response was 21.4 months. The most common adverse reactions included cytokine release syndrome, injection site reactions, fatigue, and viral infection.

Genmab A/S (Nasdaq: GMAB) announced changes to its Executive Committee to support its growth as a fully integrated biotech innovation powerhouse. Rayne Waller joins as Executive Vice President and Chief Technology Officer, while Brad Bailey is promoted to Executive Vice President and Chief Commercial Officer. Anthony Mancini, the current Executive Vice President and Chief Operating Officer, will leave Genmab.

Waller, with over 30 years of biopharmaceutical experience, will lead Genmab's technical operations, manufacturing, and supply chain capabilities. Bailey, previously Senior Vice President and US General Manager, will oversee global commercial strategies. Both will report directly to CEO Dr. Jan van de Winkel and join the existing Executive Committee members.

These changes aim to strengthen Genmab's commitment to its diverse mid- to late-stage clinical programs and pipeline, aligning with its 2030 vision to transform lives with innovative antibody medicines.

Genmab (Nasdaq: GMAB) has announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on epcoritamab (TEPKINLY®) for conditional marketing authorization. This T-cell engaging bispecific antibody targets relapsed or refractory (R/R) follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) after two or more lines of therapy. The recommendation is based on the Phase 1/2 EPCORE® NHL-1 study, which demonstrated significant response rates. If approved, epcoritamab will be the first bispecific antibody monotherapy for these conditions in the EU. The CHMP opinion is supported by clinical trial data showing a 49% incidence of cytokine release syndrome (CRS) with optimized dosing. Final approval from the European Commission is expected later this year.

The U.S. FDA has approved EPKINLY® (epcoritamab-bysp) for adults with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. This makes EPKINLY the first and only T-cell engaging bispecific antibody administered subcutaneously approved in the U.S. for this patient group. Approval is based on data from the Phase 1/2 EPCORE® NHL-1 study, which showed an overall response rate of 82% and a complete response rate of 60%. EPKINLY is also approved for treating R/R diffuse large B-cell lymphoma (DLBCL). Common adverse events include injection site reactions, cytokine release syndrome (CRS), fatigue, and upper respiratory tract infections. The National Comprehensive Cancer Network (NCCN) has included EPKINLY in their guidelines as a preferred option for third-line and subsequent therapies for FL.

Genmab announced Phase 2 results from the innovaTV 207 trial, showing that tisotumab vedotin demonstrated encouraging antitumor activity in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The study, presented at the 2024 ASCO Annual Meeting, revealed a 32.5% confirmed objective response rate (cORR) with one complete response and 12 partial responses. Median duration of response was 5.6 months, and median time-to-response was 1.4 months. The study highlighted treatment options for these patients, emphasizing the need for further clinical development. Safety findings were consistent with previous trials, with the most common Grade ≥3 treatment-emergent adverse events being peripheral neuropathy (40%).

Genmab announced new data from Phase 1/2 trials evaluating epcoritamab, a T-cell engaging bispecific antibody for follicular lymphoma (FL).

The EPCORE™ NHL-2 study showed a 95% overall response rate (ORR) and 85% complete response rate (CRR) in patients with untreated FL.

The EPCORE™ NHL-1 study demonstrated a reduction in cytokine release syndrome (CRS) and no high-grade CRS or immune effector cell-associated neurotoxicity syndrome (ICANS) in relapsed/refractory (R/R) FL patients.

These results were presented at the 2024 ASCO Annual Meeting. Epcoritamab is not yet approved for FL in the U.S. or EU.

Genmab will present multiple abstracts at the 2024 ASCO Annual Meeting. These include studies on epcoritamab, tisotumab vedotin, and acasunlimab, showcasing their efficacy and safety across different cancers.

The presentations will cover six oral and poster sessions, including the first Phase 2 study of acasunlimab in metastatic non-small cell lung cancer (mNSCLC).

Genmab’s Chief Development Officer, Dr. Judith Klimovsky, highlighted the significant progress in developing antibody therapies.

The meeting will be held from May 31 to June 2, 2024, in Chicago, IL, and virtually.

Genmab (Nasdaq: GMAB) has completed the acquisition of ProfoundBio, a clinical-stage biotech firm, for USD 1.8 billion in cash. This acquisition grants Genmab global rights to three clinical candidates, including rinatabart sesutecan (Rina-S), and ProfoundBio's novel antibody-drug conjugate (ADC) technology platforms.

Rina-S is a potential best-in-class ADC currently in part 2 of a Phase 1/2 trial for ovarian cancer and other FRα-expressing tumors. The U.S. FDA has granted Fast Track designation for Rina-S in treating high-grade serous or endometrioid platinum-resistant ovarian cancer.

Genmab expects increased operating expenses due to this acquisition but maintains its revenue guidance. The combination of both companies' ADC technology platforms aims to enhance the development of innovative cancer treatments.