Genmab A/S ADS - GMAB STOCK NEWS

Genmab (NASDAQ: GMAB) announced the acceptance of 19 abstracts for the 64th Annual Meeting of the American Society of Hematology (ASH) taking place December 10-13, showcasing investigational therapies including epcoritamab. The data will feature four oral presentations on epcoritamab's efficacy in treating various B-cell malignancies. The company will present early data on GEN3014 and GEN3017. A 2022 R&D Update and ASH Data Review meeting is scheduled for December 12.

Genmab has submitted a Biologics License Application (BLA) to the U.S. FDA for epcoritamab, a bispecific antibody targeting relapsed/refractory large B-cell lymphoma. AbbVie has also validated a Marketing Authorization Application (MAA) for epcoritamab with the European Medicines Agency (EMA). These submissions stem from the EPCORE NHL-1 phase 2 trial, showing the drug's safety and efficacy in treating CD20+ mature B-cell non-Hodgkin lymphoma, a significant medical need exists for these patients. The joint development with AbbVie aims to bring new therapeutic options to market.

Zai Lab has secured exclusive rights to develop and commercialize TIVDAK, an FDA-approved antibody-drug conjugate, in Mainland China, Hong Kong, Macau, and Taiwan. The collaboration with Seagen involves a $30 million upfront payment, milestone payments, and shared royalties. TIVDAK addresses a significant unmet need in treating recurrent or metastatic cervical cancer, with 110,000 new cases annually in China. Ongoing clinical trials underpin the therapeutic potential of TIVDAK in various cancer treatments.

Genmab (NASDAQ: GMAB) and BioNTech (NASDAQ: BNTX) have expanded their collaboration to develop novel monospecific antibody candidates aimed at treating malignant solid tumors. The partnership will leverage Genmab's proprietary HexaBody technology, with the first candidate, GEN1053/BNT313, expected to enter clinical trials by the end of 2022. Both companies will share development costs and potential profits equally. This collaboration enhances their oncology pipeline, targeting high unmet medical needs in cancer immunotherapy.

Genmab A/S (Nasdaq: GMAB) announced that AbbVie (NYSE: ABBV) will submit a conditional marketing authorization application (MAA) to the European Medicines Agency for epcoritamab to treat relapsed/refractory diffuse large B-cell lymphoma (DLBCL) in H2 2022. This follows Genmab's intention to submit a biologics license application (BLA) to the FDA for the same drug. The MAA is supported by preliminary efficacy results from the EPCORE™ NHL-1 trial, emphasizing the significant medical need for new treatment options for patients with DLBCL.

Genmab A/S (NASDAQ: GMAB) announced promising results from the EPCORE™ NHL-1 phase 2 trial of epcoritamab for relapsed/refractory large B-cell lymphoma (LBCL). With a total patient population of 157, the study reported an overall response rate (ORR) of 63% and a complete response (CR) of 39%. Notably, CAR T-naïve patients exhibited a 69% ORR, while those previously treated with CAR T had a 54% ORR. Epcoritamab demonstrated a manageable safety profile, with treatment-emergent adverse events primarily occurring in the initial treatment weeks. Results were showcased at the EHA Annual Congress.

Genmab and Seagen presented interim results from the Phase 1b/2 innovaTV 205 trial on June 6, 2022, indicating a 41% objective response rate (ORR) in patients with recurrent or metastatic cervical cancer treated with tisotumab vedotin and pembrolizumab. This study highlights a median progression-free survival of 5.3 months and notable durability of response. Common treatment-related adverse events included alopecia and diarrhea. A new web-based tool was introduced to identify areas needing cervical cancer intervention, reflecting the companies' commitment to addressing healthcare disparities.

Seagen and Genmab have announced interim results from the innovaTV 205 trial, revealing a 41% objective response rate (ORR) for tisotumab vedotin in combination with pembrolizumab among patients with recurrent or metastatic cervical cancer (r/mCC). The data, presented at ASCO 2022, also shows a median progression-free survival of 5.3 months. The trial included 33 patients, with 25% achieving partial responses. Adverse events were primarily manageable, with common occurrences including alopecia and diarrhea. The companies will continue to explore tisotumab vedotin in combination therapies to address unmet needs.

Genmab (Nasdaq: GMAB) announced the acceptance of multiple abstracts for presentation at the 2022 ASCO Annual Meeting, showcasing investigational medicines from its pipeline. Key highlights include data from the phase 1b/2 EPCORE™ NHL-2 trial evaluating epcoritamab (DuoBody-CD3xCD20) in B-cell non-Hodgkin lymphoma and an oral presentation of tisotumab vedotin in recurrent or metastatic cervical cancer. The findings reinforce Genmab's commitment to delivering innovative therapies, with partnerships alongside AbbVie (ABBV) and Seagen (SGEN).