Aankondiging • Apr 14
Genmab A/S Presents Safety And Tolerability Data Of Rinatabart Sesutecan (Rina-S) In Combination With Bevacizumab In Advanced Ovarian Cancer Genmab A/S announced new data demonstrating that rinatabart sesutecan (Rina-S), an investigational folate receptor alpha (FRa)-targeted, topoisomerase I (TOPO1)-inhibitor antibody-drug conjugate (ADC), evaluated in combination with bevacizumab in patients with advanced ovarian cancer, showed a safety profile consistent with the known safety profiles of Rina-S and bevacizumab. These data are from the combination therapy cohort D2 of the multi-part Phase 1/2 RAINFOL-01 study and were presented during an oral session at the 2026 Society of Gynecologic Oncology Annual Meeting on Women’s Cancer (SGO) in San Juan, Puerto Rico. As of data cutoff, 40 patients with recurrent ovarian cancer had received Rina-S (120 mg/m2) plus bevacizumab every three weeks until disease progression or unacceptable toxicity. The primary endpoint was safety and tolerability. The combination of Rina-S and bevacizumab was tolerable, with manageable adverse events (AEs). The safety profile of the combination was consistent with the known safety profiles of the individual agents, with no new or unexpected safety signals. The most common (=25%) treatment-emergent AEs (TEAEs) included nausea (80%), fatigue (67.5%), anemia (55%), and neutropenia (45%). No safety signals of ocular toxicities, peripheral neuropathy or interstitial lung disease were reported, and no clinically significant bleeding was observed. Serious TEAEs occurred in six patients (15.0%), and TEAEs leading to Rina-S dose reductions occurred in 11 patients (27.5%). Rina-S and bevacizumab discontinuation occurred in two patients (5%). No fatal TEAEs were reported. Rina-S is advancing through late-stage development supported by a growing portfolio of clinical trials, including the ongoing Phase 1/2 RAINFOL-01 trial (NCT05579366), the Phase 3 RAINFOL-02 trial (NCT06619236) in patients with platinum-resistant ovarian cancer (PROC), the Phase 3 RAINFOL-03 trial (NCT07166094) in patients with recurrent or progressive endometrial cancer (EC) who have disease progression on or following prior treatment with a platinum-containing regimen and a PD-(L)1 therapy, and the Phase 3 RAINFOL-04 trial (NCT07225270) in patients with recurrent platinum-sensitive ovarian cancer (PSOC) as maintenance therapy. Rina-S is also being evaluated in the Phase 2 RAINFOL-05 study (NCT07288177) in patients with non-small cell lung cancer (NSCLC). Rina-S (GEN1184) is an investigational ADC. It is composed of a novel human monoclonal antibody directed at FRa, a hydrophilic protease-cleavable linker, and exatecan, a TOPO1 inhibitor payload. The clinical trial program for Rina-S continues to expand, including ovarian, endometrial and other cancers with unmet need. The safety and efficacy of Rina-S has not been established. Aankondiging • Mar 16
H Lundbeck A S Presents New Phase 1b Data for Lu Af28996 and Advances Pipeline in Movement Disorders H. Lundbeck A/S (Lundbeck) announced that new data from a Phase 1b proof-of-mechanism trial of Lu AF28996, a novel compound invented by Lundbeck with dopamine D1/D2 receptor agonist activity, will be presented at the 2026 Alzheimer's and Parkinson's Disease (AD/PD(TM)) conference in Copenhagen, Denmark (17-21 March). The Phase 1b trial evaluated the safety, tolerability, pharmacokinetics and exploratory clinical activity of orally administered Lu AF28996 in people with advanced Parkinson's disease. Results indicate that Lu AF28996 was generally well tolerated and demonstrated early signals consistent with its proposed mechanism of action, supporting continued clinical development. People with advanced Parkinson's disease frequently experience motor fluctuations, including periods of persistent reduced mobility known as "OFF" time, despite available treatments.1,2 Current pharmacological options may also be associated with treatment-related motor complications such as dyskinesia,1 whereas device-aided delivery methods present several practical limitations.3 These challenges reinforce the importance of developing innovative therapies with acceptable tolerability and ease of use for patients with advanced Parkinson's disease. In addition, Lundbeck will present insights into multiple system atrophy (MSA), a rapidly progressing and fatal neurodegenerative disease for which no approved treatments currently exist.4 The data will highlight advances in the understanding of MSA disease progression and the advantages of using Bayesian progression modeling to assess clinical trial outcomes in MSA. Presentations will also underscore the importance of integrating patient perspectives into MSA trial design, and progress in biomarker development to enable earlier diagnosis. These learnings have directly informed Lundbeck's amlenetug pivotal program in MSA. With multiple poster and oral presentations accepted at AD/PD(TM) 2026, Lundbeck demonstrates the breadth of its Research and Development (R&D) program in movement disorders and continued dedication to advancing innovative therapies for patients with severe neurological conditions. Lu AF28996 and amlenetug are investigational compounds which have not been approved for use by any regulatory authority. The efficacy and safety of both compounds have not been established. Oral D1/D2-agonist Lu AF28996: Efficacy and tolerability Oral presentation:Alberto Cucca Weds 18 Mar 16:00 - 16:15 CET in people with Parkinson's disease with motor fluctuations and with/without dyskinesia - Open-label phase 1b results Interpretation of Clinical Progression in Multiple System Atrophy Using Percentage-Wise Slowing in the Unified Multiple System Atrophy Rating Scale Score Mass spectrometry assay for measuring truncated --Synuclein protein levels in CSF from Multiple System Atrophy vs Parkinson's disease Assessing disease progression in MSA: Development of a Bayesian Progression Model Incorporating the patient voice on a protocol for a clinical trial assessing progression in MSA Scientific symposium: --synuclein in MSA: Bridging pathophysiology, biomarker discovery and targeted therapies Forum talk: Targets to Therapies "Translational R&D for --synuclein, LRRK2, and GBA pathologies in PD, LBD and MSA About Lu AF28996 Lu AF28996 is a novel, orally administered D1-like/D2-like receptor agonist discovered by Lundbeck. It is designed to provide continuous dopaminergic stimulation and is being investigated for its potential to improve motor fluctuations and levodopa induced dyskinesia in people with Parkinson's disease. Lu AF28996 is currently in early clinical development. The Phase 1 study evaluated the safety, tolerability and pharmacodynamics of Lu AF28996 in healthy volunteers and Parkinson's disease patients. Based on these results Lundbeck is initiating a Phase 2 study in 2026 in people with advanced Parkinson's Disease. About amlenetug Amlenetug is a human monoclonal antibody (mAb) that recognizes and binds to all major forms of extracellular --synuclein and thereby intended to prevent uptake and inhibit seeding of aggregation. Amlenetug is being developed by Lundbeck under a joint research and licensing agreement between Lundbeck and Genmab A/S. Aankondiging • Feb 19
Genmab A/S, Annual General Meeting, Mar 19, 2026 Genmab A/S, Annual General Meeting, Mar 19, 2026, at 14:00 Romance Standard Time. Location: copenhagen marriott hotel, kalvebod brygge 5, dk-1560 copenhagen v, Denmark Aankondiging • Feb 18
Genmab Provides Earnings Guidance for the Full Year 2026 Genmab provided earnings guidance for the full year 2026. For the year, the company expects revenue to be in the range of $4.1 billion – $4.4 billion, compared to $3.7 billion in 2025. Genmab’s projected revenue growth for 2026 is driven by higher royalties, net product sales and collaboration revenue. Royalty growth relates mainly to DARZALEX and Kesimpta net sales growth. Genmab expects its 2026 operating profit to be in the range of $0.9 billion – $1.4 billion, compared to $1.3 billion in 2025. Aankondiging • Jan 17
Genmab A/S Announces Topline Results for Epcoritamab (DuoBody CD3xCD20) from Phase 3 EPCORE DLBCL-1 Trial in Patients with Relapsed Refractory Diffuse Large B-Cell Lymphoma Genmab A/S announced topline results from the Phase 3 EPCORE DLBCL-1 trial evaluating epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, which demonstrated an improvement in progression-free survival (PFS) (HR 0.74 95% CI 0.60 to 0.92)1 in patients treated with epcoritamab monotherapy. Additionally, improvements were observed in the complete response rate, duration of response, and time to next treatment among patients treated with epcoritAMab monotherapy. EPCORE DL BCL-1 is the first Phase 3 study to demonstrate an improvement in PFS in patients with relapsed or refractory (R R) diffuse large B-cell lymphoma (DLBCL) who were treated with a CD3xCD20 T-cell engaging bispespecific monotherapy. The study demonstrated an overall survival (OS) of HR 0.96 95% CI 0.77 to 1.20, which did not reach statistical significance. The global study enrolled 483 patients with R R DLBCL with at least one prior line of therapy (73% had received two or more prior lines) who were ineligible for high-dose chemotherapy and autologous stem cell transplant (HDT-ASCT). The study evaluated the safety and efficacy of epcoritamab Monotherapy compared to investigator's choice of either rituximab plus gemcitabine and oxaliplatin (R-GemOx), or bendamustine plus rituximab (BR). The adverse events observed in this study appear consistent with the known safety profile of epcoritamab. Further analysis of the results is ongoing, including the potential impact of various factors, such as the COVID-19 pandemic and increasing availability of novel anti-lymphoma therapies. The full trial results will be submitted for presentation at a future medical meeting. Genmab and AbbVie will engage with global regulatory authorities to discuss next steps. Data is anticipated in 2026 from two Phase 3 trials evaluating fixed duration epcoritamab in patients with relapsed or Refractory DLBCL, including EPCORE DLBCL, including E PCORE DLBCL-2, a front-line study evaluating epcoritamab in combination with standard-of-care rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP), and EPCORE DLBCL -4, evaluating epcoritamab In combination with lenalidomide versus chemo-immunotherapy in patients with relapsed orrefractory DLBCL. The EPCORE DLBCL1 trial is the first Phase 3 study evaluating a bispecific antibody monotherapy to demonstrate improvements in progression-free survival in patients with relapsed orRefractory DLBCL. Aankondiging • Dec 12
Genmab A/S (CPSE:GMAB) completed the acquisition of Merus N.V. (NasdaqGM:MRUS) in a tender offer transaction. Genmab A/S (CPSE:GMAB) entered into a transaction agreement to acquire Merus N.V. (NasdaqGM:MRUS) for $7.3 billion on September 29, 2025. A cash consideration valued at $97 per share will be paid by Genmab. The transaction is not subject to a financing condition and the consideration is expected to be funded through a combination of cash on hand and approximately $5.5 billion of non-convertible debt financing. Genmab has obtained a funding commitment from Morgan Stanley Senior Funding, Inc. for this amount.
The closing of the tender offer is subject to the satisfaction of customary closing conditions for similar transactions, including a minimum acceptance condition of at least 80% of Merus’ common shares (which threshold may be reduced to 75% unilaterally by Genmab if all other closing conditions are satisfied), approval by Merus’ shareholders of resolutions relating to Merus’ postclosing governance and the back end transactions at Merus’ extraordinary shareholders meeting to be held for that purpose, and completion of the relevant works councils consultation processes. The transaction has been unanimously approved by the Boards of Directors of both companies. A wholly owned subsidiary of Genmab will commence a tender offer for 100% of Merus’ common shares, which is anticipated to close by early in the first quarter of 2026. Following the closing of the transaction, Genmab will have four proprietary programs expected to drive multiple new drug launches by 2027. Based on Genmab’s experience in late stage development and excellence in commercial execution, Genmab anticipates the potential for the initial launch of petosemtamab in 2027, subject to clinical results and regulatory approvals. Genmab also intends to broaden and accelerate petosemtamab’s development with potential expansion into earlier lines of therapy. Following its initial anticipated approval, Genmab believes that petosemtamab will be accretive to EBITDA with at least one-billion-dollar annual sales potential by 2029, with multi-billion-dollar annual revenue potential thereafter. Tender offer commenced on October 21 and is expected to close on December 11, 2025. As of October 28, 2025, each of Purchaser and Merus filed Premerger Notification and Report Forms under the HSR Act with the FTC and the Antitrust Division in connection with Purchaser’s proposed acquisition of Common Shares pursuant to the Offer. As a result, the required fifteen (15) calendar-day waiting period under the HSR Act with respect to the Offer will expire on November 12, 2025.
Morgan Stanley & Co. International plc acted as financial advisor for Genmab A/S. PJT Partners Inc. acted as financial advisor for Genmab A/S. Allen Overy Shearman Sterling LLP acted as legal advisor for Genmab A/S. Kromann Reumert acted as legal advisor for Genmab A/S. Jefferies LLC acted as financial advisor for Merus N.V. NautaDutilh N.V. acted as legal advisor for Merus N.V. Latham & Watkins B.V. acted as legal advisor for Merus N.V.
Genmab A/S (CPSE:GMAB) completed the acquisition of Merus N.V. (NasdaqGM:MRUS) in a tender offer transaction on December 12, 2025. The depositary for the Offer has advised Genmab and Purchaser that, as of the Expiration Time, a total of 71,463,077 of Merus’ issued and outstanding common shares, constituting 94.2% of its issued and outstanding common shares, had been validly tendered pursuant to the Offer. Aankondiging • Nov 19
Genmab A/S Announces EPKINLY (epcoritamab-bysp) in Combination with Rituximab and Lenalidomide Approved by the U.S. Food and Drug Administration for the Treatment of Relapsed or Refractory Follicular Lymphoma Genmab A/S announced that EPKINLY (epcoritamab-bysp) in combination with rituximab and lenalidomide (EPKINLY + R2) was approved by the U.S. Food and Drug Administration (FDA) for adult patients with relapsed or refractory (R R) follicular lymphoma (FL). Genmab Announces EPKINLY (epCoritamab-bysp), in combination with Rituximab and Lenalidomide Approved by the U.S. food and Drug Administration for the Treatment of Relapsed or Refractory Follicular Lymphoma. Today's milestone marks meaningful progress for people living with follicular lymphoma. In June 2024, EPKINLY monotherapy was granted accelerated approval by the FDA for the treatment of R R FL following two or more lines of systemic therapy. With the results from the confirmatory Phase 3 EPCORE FL-1 study, the FDA has also converted the accelerated approval into a full approval. Genmab Announces EP KINLY (epcoritAMab-bysp) in Combination with Rituximab & Lenalidomide Approval by the U.S.Food and Drug Administration for the treatment of Relapsed or Refractories Follicular Lymphoma Cytokine release syndrome (CRS), which is common during treatment with EPKINLY and can be serious or lead to death. Genmab announced EPKINLY (ep Corituximab-bysp) inCombination with Rituximib and Lenalidomide approved by the U.S., Food and Drug Administration for the Treatment the Treatment of Relapsed or refractory Follicular L lymphoma for 4 months after the last dose of EPKINLY. The most common severe abnormal laboratory test results with EPKINLY when used alone include decreased white blood cells, decreased red blood cells, and decreased platelets. Aankondiging • Nov 08
Genmab Provides Earnings Guidance for the Full Year 2025 Genmab provided earnings guidance for the full year 2025. The company remains on track to achieve existing financial guidance with projected double-digit revenue and double-digit profit growth. The company expects revenue to be in the range of $3.5 billion - $3.7 billion, guidance mid-point $3,600 billion. Genmab’s projected revenue growth for 2025 is driven by higher royalties, net product sales and collaboration revenue. Operating profit to be in the range of $1.1 billion- $1.4 billion, guidance mid-point $1,230 billion. Aankondiging • Oct 19
Genmab A/S Announces New Data Demonstrating Investigational Rinatabart Sesutecan (Rina-S®?) Achieved Anti-Tumor Activity in Heavily Pretreated Patients with Advanced Endometrial Cancer Genmab A/S announced updated data from cohort B2 of the Phase 1/2 RAINFOL™?-01 trial evaluating rinatabart sesutecan (Rina-S®?), an investigational folate receptor alpha (FRa) -targeted, TOPO1-inhibitor antibody-drug conjugate (ADC). The B2 cohort of the Phase 1/2RAINFOL-01 study (NCT05579366) is a dose expansion cohort evaluating the efficacy and safety of Rina-S in patients with advanced or recurrent endometrial cancer. In the study, 64 patients with heavily pretreated advanced or recurrent endometrial Cancer whose disease had progressed on or after an. anti-PD-(L)1 and platinum-based chemotherapy were enrolled and treated with Rina-S. Patients were administered either 100 mg/m2 (n=22) (selected dose for Phase 3 clinical trial) or 120 mg/m2 (n<42) of Rina-S. In the 100 mg/m2 cohort, the confirmed ORR was 50.0%, including two CRs. Common treatment emergent adverse events (TEAEs; all grades) consisted primarily of cytopenias and low-grade gastrointestinal (GI) events. To date, there have been no signals of ocular toxicities, neuropathy, or interstitial lung disease (ILD) observed in Rina-S clinical trials consistent with prior reports. Serious TEAEs (Grade 3 or higher), occurred in 36.4% and 52.4% of patients treated with Rina-S 100 mg/m2 and 120 mg/m2, respectively. Rina-S is advancing through late-stage development supported by a growing portfolio of clinical trials, including the ongoing Phase 1/2 RAIN FOL-01 trial (NCT05579366), the Phase 3 RAINFOL-03 trial (NCT07166094) in patients with endometrial cancer now underway and the Phase 3 RAINFol-02 trial (NCT06619236) in patients with platinum resistant ovarian cancer (PROC). The U.S. Food and Drug Administration (FDA) recently granted Breakthrough Therapy Designation (BTD) to Rina-S for the treatment of adult patients with recurrent or progressive EC who have disease progression on or following prior treatment with a platinum-containing regimen and a PD-(L)1 therapy. About the RAINFOLTM -01 Trial. It is composed of a novel human monoclonal antibody directed at folate receptor a (FRa), a novel hydrophilic protease-cleavable linker, and exatecan, a topoisomerase I inhibitor payload. The clinical trial program for Rina-S continues to expand including ovarian, endometrial and other cancers of unmet need. The safety and efficacy of Rina-S has not been established. Genmab is an international biotechnology company with a core purpose of guiding its unstoppable team to strive toward improving the lives of patients with innovative and differentiated antibody therapeutics. For more than 25 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with knock-your-socks-off (KYSO) antibody medicines®?. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause the actual results or performance to differ materially include, among others, risks associated with preclinical and clinical development of preclinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product products, uncertainties related to product and conduct of product and conduct of product development of product development of Rina-based chemotherapy. Aankondiging • Sep 03
Genmab A/S Announces Updated Results from Phase 2 Epcore®? Nhl-6 Study Evaluating Epcoritamab Monotherapy in the Outpatient Setting in Patients with Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (Dlbcl) Genmab A/S announced updated results from the Phase 2 EPCORE®? NHL-6 trial (NCT05451810) evaluating the safety and efficacy of investigational epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, as a monotherapy administered in the outpatient setting in adult patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have received at least one prior line of systemic therapy, including at least one anti-CD20 monoclonal antibody-containing therapy. The study demonstrated the feasibility of treating and monitoring patients in an outpatient setting following the first dose of epcoritamab and showed that the incidence and severity of adverse events associated with epcoritamab were consistent with previous epcoritamab studies in patients with R/R DLBCL. EPCORE NHL-6 is a Phase 2 open-label clinical trial evaluating the safety of outpatient administration of subcutaneous epcoritamab monotherapy in adult patients with relapsed or refractory diffuse large B-cell lymphom (R/R DLBCL). The most common severe abnormal laboratory test results include decreased white blood cells, decreased red blood cells, and decreased platelets. The most common severe abnormal laboratory testing results include decreased white blood cells and decreased red blood cells. Aankondiging • Jul 02
Genmab Announces Changes to Its Executive Committee Genmab A/S announced that Birgitte Stephensen, Executive Vice President and Chief Legal Officer, will retire from Genmab after a successful tenure that spanned 23 years with the company. Greg Mueller joins Genmab A/S as Executive Vice President, General Counsel and Chief Legal Officer effective July 1, 2025. He will report directly to Genmab’s President and CEO Dr. Jan van de Winkel and be based in Copenhagen, Denmark. Greg will join Jan and the rest of the Executive Committee, including Chief Medical Officer Dr. Tahi Ahmadi, Chief Commercial Officer Brad Bailey, Chief People Officer Chris Cozic, Chief Development Officer Dr. Judith Klimovsky, Chief Financial Officer Anthony Pagano, Chief Strategy Officer Dr. Martine van Vugt, and Chief TechOps Officer Rayne Waller. Greg joins Genmab from AstraZeneca (AZ), where he spent more than 20 years working in North America, Europe and Asia. For the last 12 years, he was part of the Legal Senior Management Team, holding roles as the Deputy General Counsel, International and then as the Deputy General Counsel, Corporate. Prior to his tenure at AZ, he worked as a corporate transactions lawyer at a large national Canadian law firm. Greg holds a Bachelor of Commerce specialist degree from the University of Toronto and a Law Degree (LLB) from Queen’s University. Aankondiging • Jun 03
Genmab A/S Announces Investigational Rinatabart Sesutecan (Rina-S) Demonstrates Encouraging Anti-Tumor Activity Heavily Pretreated Patients with Advanced Endometrial Cancer in Phase 1/2 RAINFOL-01 Trial Genmab A/S announced new data from cohort B2 of the Phase 1/2 RAINFOL™?-01 trial evaluating rinatabart sesutecan (Rina-S®?), an investigational folate receptor alpha (FRa)-targeted, TOPO1-inhibitor antibody-drug conjugate (ADC). The study showed that with a median on-study follow-up of 7.7 months, treatment with Rina-S 100 mg/m2 every 3 weeks (Q3W) resulted in a 50.0% confirmed objective response rate (ORR), including two complete responses (CR), in heavily pre-treated advanced endometrial cancer (EC) patients who experienced disease progression on or after treatment with platinum-based chemotherapy and an immune checkpoint inhibitor. The median duration of response (mDOR) was not reached. These data are from the endometrial cancer monotherapy dose expansion B2 cohort of the multi-part RAINFOL-01 trial evaluating the safety and efficacy of Rina-S in solid tumors and were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois. Aankondiging • May 15
Genmab A/S to Present New and Updated Results from Its Robust Epcoritamab (Epkinly®) Development Program At the 2025 European Hematology Association (Eha) Congress Genmab A/S announced that it will present 14 abstracts evaluating epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, as a monotherapy and in combination across disease settings in patients with diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) at the 30thEuropean Hematology Association (EHA) Congress, being held in Milan, Italy, and virtually, June 12-15, 2025. Two oral presentations will feature data from the Phase 1/2 EPCORE®? NHL-2 trial evaluating epcoritamab plus rituximab and ifosfamide-carboplatin-etoposide (R-ICE) in patients with relapsed/refractory (R/R) DLBCL eligible for autologous stem cell transplantation, and the Phase 1/2 EPCORE NHL-5 trial evaluating epcoritam ab plus rituximab, cyclophosphamide, doxorubicin, and prednisone (pola-R-CHP) in previously-untreated patients with DLBCL. Additionally, results from the Phase 1/2EPCORE NHL-1 and NHL-3 trials, including three years of follow-up in patients with R/R DLBCL and FL treated with epcoritamab monotherapy, will be presented as a poster. All abstracts accepted for presentation have been published and may be accessed online via the EHA Open Access Library. Epcoritamab is an IgG1-bispecific antibody created using Genmab's proprietary DuoBody®? technology and administered subcutaneously. Genmab's DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab are designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells. Epcoritamab (approved under the brand name EPKINLY®? in the U.S. and Japan, and TEPKINLY®? in The EU) has received regulatory approval in certain lymphoma indications in several territories. Epcoritamab has received regulatory approval in certain leukemia indications in several territories. EpCoritamab is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration. The companies will share commercial responsibilities in the U.S. & Japan, with AbbVie responsible for further global commercialization. Both companies will pursue additional international regulatory approvals for the investigational R/R FL indication and additional approvals for the R/R DLBCL indication. Genmab and Abb Vie continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes five ongoing Phase 3, open-label, randomized trials including a trial evaluating epcoritamib as a monotherapy in patients with R/RDLBCL compared to investigators choice chemotherapy (NCT04628494), a trial evaluating epcoritAMab in combination with rituximab and lenalidomide (R2) compared to chemoimmunotherapy in patients with R/R/R FL (NCT05409066), a trial evaluating epcor it in combination with rituxIMab and lenalidomide in patients with R/R FL (N CT05409066), a study evaluating epcoritamab in combination with ritiumimab and lenalidomab and lenalidomide(R2) compared to chemOimmunotherapy in patients with DLBCL. Aankondiging • May 02
Genmab A/S to Submit Supplemental Biologics License Application (sBLA) to U.S. Food and Drug Administration for Epcoritamab Plus Rituximab and Lenalidomide (R2) in Patients with Relapsed Refractory Follicular Lymphoma Genmab A/S announced its intention to submit in the first half of 2025 a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for subcutaneous epcoritamab, a bispecific antibody being investigated in combination with rituximab and Lenalidomide (R2) for the treatment of adult patients with relapsed or refractory (R R) follicular lymphoma (FL), following at least one prior systemic therapy. Epcoritamab is currently approved by the FDA under Accelerated Approval as a monotherapy for the treatment of adults with R R FL after two or more lines of systemic therapy. EpcoritAMab to Submit Supplemental Biologics License Application (SBLA) to U.S. Food and drug Administration for Epcoritamab Plus Rituximab and Lenalomide (R2) in Patients with Relapsed Refractory Follicular Lymphoma (FL) manufacturing, the lack of market acceptance of products, inability to manage growth, the competitive environment in relation to business area and markets, inability to attract and retainably qualified personnel, the unenforceability or lack of protection of patents and proprietary rights. Aankondiging • Mar 28
Genmab A/S Announces Japan Ministry of Health, Labour and Welfare Approves TIVDAK for the Treatment of Advanced or Recurrent Cervical Cancer Genmab A/S announced that the Japan Ministry of Health, Labour and Welfare has approved TIVDAK (tisotumab vedotin) for the treatment of advanced or recurrent cervical cancer that has progressed on or after cancer chemotherapy. TIVDAK is the first and only ADC to be approved for people living with cervical cancer in Japan. The approval is based on data from the randomized, open-label, global Phase 3 innovaTV 301 clinical trial that evaluated the efficacy and safety of TIVDAK compared to chemotherapy in patients with advanced or recurrent cervical cancer who were previously treated with chemotherapy. The trial included 502 patients, 101 of which were Japanese. The trial met its primary endpoint of overall survival, demonstrating a 30% reduction in risk of death (HR: 0.70 [95% CI: 0.54-0.89], two-sided p=0.0038) compared to chemotherapy. Median OS was 11.5 months [95% CI: 9.8-14.9] among patients treated with TIVDAK compared to 9.5 months [95% CI: 7.9-10.7] for patients who received chemotherapy. Secondary endpoints of progression-free survival and confirmed objective response rate were also met. Adverse drug reactions occurred in 219 (87.6%) of 250 patients (including 50 Japanese patients) treated with TIVDAK. The most common (20%) adverse reactions included conjunctivitis (n=76; 30.4%), nausea (n=73; 29.2%), peripheral sensory neuropathy (n=67; 26.8%), alopecia (n=61; 24.4%), and epistaxis (n=57; 22.8%), at the data cutoff date of July 24, 2023. The innovaTV 301 trial is a global, 1:1 randomized, open-label Phase 3 trial evaluating tisotumab vedotin versus investigator's choice of single agent chemotherapy (topotecan, vinorelbine, gemcitabine, irinotecan or pemetrexed) in 502 patients with recurrent or metastatic cervical cancer who received one or two prior systemic regimens in the recurrent or metastatic setting. Patients with recurrent or metastatic cervical cancer with squamous cell, adenocarcinoma or adenosquamous histology, and disease progression during or after treatment with chemotherapy doublet +/- bevacizumab and an anti-PD-(L)1 agent (if eligible) are included. The primary endpoint was overall survival. The main secondary outcomes were progression-free survival and objective response rate. Tisotumab vedotin (approved under the brand name TIVDAK® in the U.S. and Japan) is an antibody-drug conjugate (ADC) composed of Genmab's human monoclonal antibody directed to tissue factor (TF) and Pfizer's ADC technology that utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody. Nonclinical data suggest that the anticancer activity of tisotumab vedotin is due to the binding of the ADC to TF-expressing cancer cells, followed by internalization of the ADC-TF complex and release of MMAE via proteolytic cleavage. MMAE disrupts the microtubule network of actively dividing cells, leading to cell cycle arrest and apoptotic cell death. In vitro, tisotumab vedotin also mediates antibody-dependent cellular phagocytosis and antibody- dependent cellular cytotoxicity. Aankondiging • Mar 19
Genmab A/S Updates Data from Cohort B1 of the Phase 1/2 RAINFOL-01 Study of Rina-S Genmab A/S announced updated data from cohort B1 of the Phase 1/2 RAINFOL-01 study of Rinatabart sesutecan (Rina-S®?), an investigational folate receptor-alpha (FRa)-targeted, TOPO1 antibody-drug conjugates (ADC) that showed Rina-S 120 mg/m2 every 3 weeks (Q3W) resulted in a confirmed objective response rate (ORR) of 55.6% (95% CI: 30.8-78.5) in heavily pre-treated ovarian cancer (OC) patients regardless of FRa expression levels. With a median on-study follow-up of 48 weeks, 1 out of 10 patients experienced disease progression and the median duration of response (mDOR) was not reached (95% CI: 40.14-NR). Rina-S®?; GEN1184) is a FRa-targeted, TOPO1 ADC, currently being evaluated for the potential treatment of ovarian cancer and other FRa-expressing cancers. A Phase 3 trial (RAINFOL-02, NCT06619236) evaluating Rina-S in patients with platinum resistant ovarian cancer compared to treatment of investigator's choice is ongoing. In January 2024, the U.S. Food and Drug Administration granted Fast Track designation to Rina-S for the treatment of patients with FRa-expressing high-grade serous or endometrioid platinum-resistant ovarian cancer. Aankondiging • Feb 14
Genmab A/S, Annual General Meeting, Mar 12, 2025 Genmab A/S, Annual General Meeting, Mar 12, 2025, at 14:00 Romance Standard Time. Location: copenhagen marriott hotel, kalvebod brygge 5, dk-1560 copenhagen v, Denmark Aankondiging • Dec 08
Genmab A/S Announces New Results from the Phase 1b/2 EPCORE NHL-2 Trial Genmab A/S announced new results from the Phase 1b/2 EPCORE® NHL-2 trial evaluating fixed-duration epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, plus lenalidomide + rituximab (R2) in adult patients with relapsed or refractory (R/R) follicular lymphoma (FL). The results demonstrated an overall response rate (ORR) of 96% and a complete response (CR) rate of 87% among 111 patients after a median follow-up of two years. Additionally, the study showed an estimated 21-month progression-free survival (PFS) rate of 80% and a two-year overall survival (OS) rate of 90%. The data (Abstract #342) were shared during an oral presentation at the 66th Annual Meeting and Exposition of the American Society of Hematology (ASH). Additional data from the study showed an estimated 89% of complete responders to the combination therapy remained in CR at 18 months (duration of CR; DoCR). With the majority of patients being enrolled and treated during the global COVID-19 pandemic, COVID-19 was reported in 57% of patients and led to epcoritamab discontinuation in 13% of patients. Five cases of COVID-19 led to fatal treatment-emergent adverse events (TEAEs; COVID-19, n=3; COVID-19 pneumonia, n=2). The other most common TEAEs were neutropenia (62%) and cytokine release syndrome (CRS; 51%). CRS events with the 2-step step-up dose regimen were mostly low grade (38% Grade 1, 12% Grade 2, 2% Grade 3) and primarily occurred following the first full dose. All CRS cases resolved. One case of immune effector cell-associated neurotoxicity syndrome (ICANS) was reported (Grade 1). The CRS and ICANS cases did not lead to treatment discontinuation. The U.S. Food and Drug Administration (FDA) recently granted breakthrough therapy designation (BTD) for epcoritamab plus R2 for the treatment of adult patients with R/R FL who have received at least one prior line of therapy. Epcoritamab in combination with R2 is being studied further in the ongoing, randomized, Phase 3 EPCORE FL-1 trial (NCT05409066). Use of epcoritamab + R2 in R/R FL is not approved in the U.S. or in the EU or in any other territory. The safety and efficacy of epcoritamab for use as a combination therapy in FL have not been established. FL is typically an indolent (or slow-growing) form of non-Hodgkin's lymphoma (NHL) that arises from B-lymphocytes and is the second most common form of NHL accounting for 20% -30% of all cases. About 15,000 people develop FL each year in the U.S.iii and it is considered incurable with current standard of care therapies.iv Patients often relapse and, with each relapse the remission and time to next treatment is shorter.v Over time, transformation to diffuse large B-cell lymphoma (DLBCL), an aggressive form of NHL associated with poor survival outcomes, can occur in more than 25% of FL patients. NHL-2 Trial EPCORE® NHL-2 is a Phase 1b/2 open-label interventional trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics/biomarkers, immunogenicity, and preliminary efficacy of epcoritamab as a monotherapy and in combination with other standard of care agents in patients with B-cell non-Hodgkin’s lymphoma (B-NHL). The trial consists of two parts: Part 1 (Dose Escalation) and Part 2 (Dose Expansion). The primary objective of Part 1 is safety, and the primary goal of Part 2 is preliminary efficacy. Arm 2 of the trial is epcoritamab + rituximab and lenalidomide (R2) in participants with relapsed/refractory (R/R) follicular lymphoma (FL). Epcoritamab is an IgG1-bispecific antibody created using Genmab's proprietary DuoBody® technology and administered subcutaneously. Genmab's DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells. Epcoritamab (approved under the brand name EPKINLY® in the U.S. and Japan, and TEPKINLY® in the EU) has received regulatory approval in certain lymphoma indications in several territories. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. Both companies will pursue additional international regulatory approvals for the investigational R/R FL indication and additional approvals for the R/R DLBCL indication. Aankondiging • May 22
Genmab A/S (CPSE:GMAB) completed the acquisition of ProfoundBio, Inc. Genmab A/S (CPSE:GMAB) entered into a definitive agreement to acquire ProfoundBio, Inc. for $1.8 billion on April 3, 2024. Genmab will acquire ProfoundBio for $1.8 billion on cash and debt free basis. The transaction is funded through existing cash on hand, Genmab maintains significant balance sheet flexibility. The proposed transaction, which has been unanimously approved by the Boards of Directors of both companies, is expected to close in the first half of 2024. The closing of the proposed transaction is subject to the satisfaction of customary closing conditions.
Goldman Sachs International is acting as sole financial advisor to Genmab in this transaction. Clare O’Brien, Derrick Lott, JB Betker, Ben Gris, Mike Walsh, Larry Crouch, Jason “Jake” Pratt, Jeff Hoschander, Jonathan Cheng, and Matthew Behrens of Shearman & Sterling LLP, Jingyuan Shi, Ruina Liu, Jenny Liu, Yanyu Lai, Yuchen Lai, Donia Chu, Cecilia Tsang and Rachel Tang of Simmons & Simmons LLP and Kromann Reumert are legal advisors for Genmab. BofA Securities, Inc. and Morgan Stanley & Co. LLC are acting as financial advisors to ProfoundBio in this transaction and Rama Padmanabhan, Patrick Loofbourrow, Rowook Park, Ruomu Li and Jenny Ge of Cooley LLP, Travers Thorp Alberga and Jun He Law Offices, Julia L. Minitti of Wilson Sonsini Goodrich & Rosati, P.C. are its legal advisors for ProfoundBio.
Genmab A/S (CPSE:GMAB) completed the acquisition of ProfoundBio, Inc. on May 21, 2024. Aankondiging • Apr 05
Genmab A/S (CPSE:GMAB) entered into a definitive agreement to acquire ProfoundBio for $1.8 billion. Genmab A/S (CPSE:GMAB) entered into a definitive agreement to acquire ProfoundBio for $1.8 billion on April 3, 2024. Genmab will acquire ProfoundBio for $1.8 billion on cash and debt free basis. The transaction is funded through existing cash on hand, Genmab maintains significant balance sheet flexibility. The proposed transaction, which has been unanimously approved by the Boards of Directors of both companies, is expected to close in the first half of 2024. The closing of the proposed transaction is subject to the satisfaction of customary closing conditions.Goldman Sachs International is acting as sole financial advisor to Genmab in this transaction and Clare O’Brien, Derrick Lott, JB Betker, Ben Gris, Mike Walsh, Larry Crouch, Jason “Jake” Pratt, Jeff Hoschander, Jonathan Cheng, and Matthew Behrens of Shearman & Sterling LLP, Simmons & Simmons LLP and Kromann Reumert are its legal advisors. BofA Securities, Inc. and Morgan Stanley & Co. LLC are acting as financial advisors to ProfoundBio in this transaction and Cooley LLP, Travers Thorp Alberga and Jun He Law Offices, Julia L. Minitti of Wilson Sonsini Goodrich & Rosati, P.C. are its legal advisors. 
