Genmab A/S ADS - GMAB STOCK NEWS

Genmab announced promising results from the Phase 1b/2 EPCORE® CLL-1 trial evaluating epcoritamab in treating relapsed/refractory chronic lymphocytic leukemia (CLL). The trial demonstrated an overall response rate of 61% and a complete response rate of 39% in difficult-to-treat patients. Among evaluable responders, 75% achieved undetectable minimal residual disease.

The study showed median progression-free survival of 12.8 months, with 65% of patients alive at 15 months. The most common side effect was cytokine release syndrome (96%). The trial included heavily pretreated patients with at least four previous therapy lines, showing particularly encouraging results in patients with high-risk factors, including those with TP53 aberrations (67% ORR) and IGHV-unmutated disease (63% ORR).

Genmab A/S (GMAB) announced promising results from the Phase 1b/2 EPCORE® NHL-2 trial evaluating epcoritamab combination therapy in relapsed/refractory follicular lymphoma patients. The study demonstrated remarkable efficacy with a 96% overall response rate and 87% complete response rate among 111 patients after two years median follow-up.

Key outcomes include 80% progression-free survival at 21 months and 90% overall survival rate at two years. The treatment showed durable responses with 89% of complete responders maintaining their response at 18 months. The FDA recently granted breakthrough therapy designation for this combination therapy.

Notable adverse events included neutropenia (62%) and cytokine release syndrome (51%, mostly low-grade). COVID-19 affected 57% of patients, leading to treatment discontinuation in 13% of cases, with five fatal outcomes.

Genmab A/S (GMAB) announced the presentation of over 20 abstracts evaluating epcoritamab-bysp at the 2024 ASH Annual Meeting. The presentations include four oral sessions highlighting data on fixed-duration subcutaneous epcoritamab in various B-cell malignancies. Key presentations will feature data from previously untreated DLBCL, LBCL, relapsed/refractory follicular lymphoma, and chronic lymphocytic leukemia patients. The event will also showcase three-year efficacy and safety data from the EPCORE NHL-1 trial in R/R DLBCL patients. Genmab will host a virtual R&D Update and ASH Data Review on December 11.

Life Science Washington Institute (LSWI) has awarded the 2024 Entrepreneurial Achievement Award to Dr. Baiteng Zhao and Dr. Tae H. Han, co-founders of ProfoundBio. The award recognizes their significant contributions to life science innovations and economic development in Washington state. ProfoundBio, founded in 2020, focused on developing antibody-drug conjugates (ADCs) for cancer treatment. In just four years, the company advanced multiple ADC candidates into clinical trials and secured $250 million in funding, including a $112 million Series B round in February 2024.

ProfoundBio was recently acquired by Genmab A/S (Nasdaq: GMAB) for approximately $1.8 billion in cash, marking one of the top life science deals in 2024. Dr. Zhao and Dr. Han are graduates of LSWI's Washington Innovation Network (WIN) mentoring program, which has supported 102 ventures that have collectively raised over $3.2 billion. The award highlights the success of Washington's life sciences ecosystem in fostering homegrown talent and innovation.

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.