Rubella Syndrome, Congenital

SHANGHAI and NANJING, China and SAN JOSE, Calif., July 2, 2023 /PRNewswire/ -- IASO Biotechnology ("IASO Bio"), a clinical-stage biopharmaceutical company engaged in discovering, developing, manufacturing and marketing innovative cell therapies and antibody products, and Innovent Biologics, Inc. ("Innovent", HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune, ophthalmology and other major diseases, today announced that China National Medical Products Administration (NMPA) has approved the New Drug Application (NDA) for FUCASO (Equecabtagene Autoleucel, co-developed and co-commercialized by IASO Bio and Innovent, IASO Bio R&D code: CT103A, Innovent R&D code: IBI326), the world's first fully-human anti-B cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T-cell therapy for the treatment of relapsed and/or refractory multiple myeloma (R/R MM) who received ≥3 lines of prior therapies containing at least one proteasome inhibitor and an immunomodulatory agent. FUCASO® (Equecabtagene Autoleucel) is an autologous BCMA CAR-T cell injection, transduced by a lentiviral vector containing a CAR structure with a fully human scFv, CD8a hinger and transmembrane, 4-1BB co-stimulatory and CD3ζ activation domains. FUCASO® was given as a one-time treatment with a recommended dose of 1.0×106 CAR-T cells/kg. Based on strict selection and screening of the molecular structures, using a proprietary in-house optimization platform and integrated in-house manufacturing process, FUCASO® is potent and shows prolonged persistency in patients. It will bring new treatment options to R/R MM patients with higher and more profound responses. The NDA approval is based on the data from the pivotal FUMANBA-1 study (CTR20192510, NCT05066646) conducted at multiple sites in China. In June 2023, the updated data from FUMANBA-1 study was presented at the 2023 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Abstract Number: 8025). The study enrolled 103 R/R MM patients with a median follow-up time of 13.8 (0.4, 27.2) months. Among the 101 evaluable patients, the overall response rate (ORR) was 96%, with the stringent complete response/ complete response (sCR/CR) rate of 74.3%. Median time to response (mTTR) was only 16 days, and the 12-month Progression-Free Survival (PFS) rate was 78.8%. 95% of the patients achieved minimal residual disease (MRD) negativity, and all sCR/CR patients achieved MRD negativity. Of the 12 patients with prior CAR-T therapy, 9 achieved response, and 5 achieved sCR (including 4 patients achieved sustained sCR for over 18 months post-infusion). In 89 patients without prior CAR-T therapy, 78.7% reached sCR/CR. Of the 103 safety evaluable patients, only one experienced grade ≥3 cytokine release syndrome (CRS), and 2 experienced grade 1-2 immune effector cell-associated neurotoxicity syndrome (ICANS). All patients with CRS or ICANS recovered after the treatment. FUCASO® was still detectable in 50% and 40% respectively of the patients who completed 12-month and 24-month follow-ups after infusion. Only 19.4% of the patients were anti-drug antibody (ADA)-positive. "There's a significant unmet medical need for the treatment of multiple myeloma in China. As a fully-human BCMA CAR-T therapy, FUCASO® has demonstrated remarkable efficacy, with evidence of deep and durable response. Its approval also offers clinicians more options to treat R/R MM patients after multi-lines of treatment," said Prof. Lugui Qiu, MD, Chinese Academy of Medical Science Hematology Hospital, and Prof. Chunrui Li, MD, PhD, Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, who is the principal investigators of the registration trial of FUCASO®. M s. Jinghua Zhang, Chairman and Chief Executive Officer of IASO Bio, stated, "We are excited that FUCASO® was approved, it is a significant milestone for the Company. FUCASO® is not only IASO Bio's first marketed product but is also the world's first commercially available fully-human CAR-T therapy. Furthermore, FUCASO® is the first self-developed and in-house manufactured CAR-T cell therapy in China as well as China's first approved BCMA CAR-T for the treatment of multiple myeloma. The NMPA NDA approval of FUCASO® will help us in achieving our strategic goal of bringing break through therapy to patients in unmet need, with the hope for a potential cure." Dr. Hui Zhou, Senior Vice President of Innovent Biologics, stated, "Multiple myeloma is a common hematology malignant disease with high incidence rate, and relapse and refractory are inevitable after current treatments. There's an urgent unmet need requesting a treatment with well-tolerated and long persistence for patients. FUCASO®, as an innovative fully-human cell therapy, has demonstrated robust and long-lasting efficacy and outstanding safety in long-term follow-up data from the registrational clinical study, which underscores its potential to be a pioneering treatment option for patients with RRMM. We are very pleased with the successful approval of FUCASO® and hope it could benefit RRMM patients as the first approved BCMA CAR-T therapy in China.." About Multiple Myeloma (MM) Multiple Myeloma (MM) is a deadly blood cancer that often infiltrates the bone marrow causing anemia, kidney failure, immune problems, and bone fractures. For MM patients, common first-line drug treatments include proteasome inhibitors, immunomodulatory drugs, and alkylating agents. While treatment may result in remission, most patients will inevitably enter the relapsed or refractory stage as there's currently no cure. As a result, there is a significant unmet need for patients with relapsed/refractory multiple myeloma. According to Frost & Sullivan, new MM cases in China rose from 20,100 in 2018 to 22,400 in 2022 and are expected to increase to 25,700 by 2027. About IASO Bio IASO Bio is a clinical stage biopharmaceutical company engaged in discovery and development of novel cell therapies and biologics for oncology and autoimmune diseases. Leveraging its proprietary fully human antibody discovery platform (IMARS), high-throughput chimeric antigen receptor T-cell (CAR-T) drug screening platform, and proprietary manufacturing processes, IASO Bio is developing a rich clinical-stage pipeline of multiple autologous and allogeneic CAR-T and biologics product candidates. This pipeline includes a portfolio of over 10 novel products, including FUCASO® (Equecabtagene Autoleucel). Equecabtagene Autoleucel received New Drug Application (NDA) approval from China's National Medical Products Administration (NMPA) and U.S. FDA IND approval for the treatment of R/R MM. IASO also received Breakthrough Therapy Designation (BTD) from the NMPA in February 2021 and Orphan Drug Designation (ODD) from the FDA in February 2022, Regenerative Medicine Advanced Therapy (RMAT) and Fast Track (FT) Designations from the FDA in February 2023. In addition to multiple myeloma, NMPA has approved IND application of FUCASO® for the new expanded indication of Neuromyelitis Optica Spectrum Disorder (NMOSD). Additionally, the company's in-house developed fully human CD19/CD22 dual-targeted CAR-T cell therapy received two IND clearances for treating relapsed/refractory B-cell non-Hodgkin's lymphoma (r/r B-NHL) and relapsed/refractory acute B-lymphoblastic leukemia (r/r B-ALL). It is currently in Phase I clinical trial for r/r B-NHL. It was also granted ODD for treatment of acute lymphoblastic leukemia by the FDA in October 2021. And the fully human monoclonal antibody targeting human CD19, IASO-782 Injection, received both FDA and NMPA IND approvals in June 2023 for use in U.S. and China clinical trials for Autoimmune hematological disorders, including primary immune thrombocytopenia (ITP) and warm autoimmune hemolytic anemia (wAIHA). Leveraging its strong management team, innovative product pipeline, integrated manufactural and clinical capabilities, IASO aims to deliver transformative, curable, and affordable therapies that fulfil unmet medical needs to patients in China as well as around the world. For more information, visit or . About Innovent Biologics Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high-quality innovative medicines for the treatment of cancer, autoimmune disease, metabolic disorder and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK. Since its inception, Innovent has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 35 valuable assets in the fields of cancer, metabolic disorder, autoimmune disease and other major therapeutic areas, with 9 approved products on the market. These include: TYVYT® (sintilimab injection), BYVASDA® (bevacizumab injection), SULINNO® (adalimumab injection), HALPRYZA® (rituximab injection), Pemazyre® (pemigatinib oral inhibitor), olverembatinib(BCR ABL TKI), Cyramza® (ramucirumab), Retsevmo® (selpercatinib) and FUCASO® (Equecabtagene Autoleucel). An additional 2 assets are under NMPA NDA review, 6 assets are in Phase III or pivotal clinical trials, and 18 more molecules are in clinical studies. Innovent has built an international team with advanced talent in high-end biological drug development and commercialization, including many global experts. The company has also entered into strategic collaborations with Eli Lilly, Roche, Sanofi, Adimab, Incyte, MD Anderson Cancer Center and other international partners. Innovent strives to work with many collaborators to help advance China's biopharmaceutical industry, improve drug availability and enhance the quality of the patients' lives. Disclaimer: Innovent does not recommend any off-label usage. Contact: IASO Bio Media: [email protected] Investors: [email protected] Innovent Biologics Media: [email protected]com +86 512-6956 6088 Investors: [email protected]com +86 512-6956 6088 SOURCE IASO Bio

- Based on the topline results of epcoritamab from the EPCORE™ NHL-1 clinical trial, AbbVie and Genmab will engage global regulatory authorities to discuss next steps - Additional data from the clinical trial will be presented at a future medical meeting - Follicular lymphoma is a common form of non-Hodgkin's lymphoma and currently has limited treatment options, particularly in the relapsed/refractory setting NORTH CHICAGO, Ill., June 27, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) and Genmab (Nasdaq: GMAB) today announced topline results from the follicular lymphoma (FL) cohort of the Phase 1/2 EPCORE™ NHL-1 clinical trial evaluating epcoritamab (DuoBody®-CD3xCD20), an investigational T-cell engaging bispecific antibody administered subcutaneously. The study cohort includes 128 adult patients with relapsed or refractory (R/R) FL who received at least two or more lines of systemic therapy. 70.3 percent of patients were double refractory to an anti-CD20 monoclonal antibody and an alkylating agent. Epcoritamab is being co-developed by AbbVie and Genmab as part of the companies' oncology collaboration. "We are encouraged by these topline results, which further support the clinical profile of epcoritamab as a potential therapeutic option for patients with relapsed or refractory follicular lymphoma," said Mariana Cota Stirner, M.D., Ph.D., vice president, therapeutic area head for hematology, AbbVie. "Together with our partner Genmab, these results may bring us one step closer to our goal of advancing a potential core therapy for patients with B-cell malignancies." EPCORE™ NHL-1 is an open-label trial evaluating the safety and preliminary efficacy of epcoritamab and consists of three parts: a Phase 1 first-in-human, dose escalation part; a Phase 2a expansion part; and a Phase 2a optimization part. The topline results from this cohort showed an overall response rate (ORR) of 82 percent as confirmed by an independent review committee (IRC), which exceeded the protocol prespecified threshold for efficacy. The observed median duration of response (DOR) was not reached, and longer follow-up will be required. The median number of lines of prior therapy in this cohort was three (range: two to four lines of therapy). No new safety signals were observed with epcoritamab in this study at the time of this analysis. The most common treatment-emergent adverse event was cytokine release syndrome (CRS) with 66.4 percent (1.6 percent Grade 3 or higher). The optimization part of the trial is continuing to evaluate alternative step-up dosing regimens to help further mitigate the risk of CRS, preliminary data are encouraging. Full results from the study will be submitted for presentation at a future medical meeting. About the Phase 1/2 EPCORE™ NHL-1 trial EPCORE™ NHL-1 is an open-label, multi-center safety and preliminary efficacy trial of epcoritamab that consists of three parts: a Phase 1 first-in-human, dose escalation part; a Phase 2a expansion part; and a Phase 2a dose optimization part. The trial was designed to evaluate subcutaneous epcoritamab in adult patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin's lymphoma (NHL), including follicular lymphoma (FL). In the Phase 2a expansion part, additional patients are being enrolled to further explore the safety and efficacy of epcoritamab in three cohorts of patients with different types of relapsed or refractory (R/R) B-cell NHLs who have limited therapeutic options. The dose optimization part evaluates the potential for alternative step-up dosing regimens to help further minimize Grade 2 CRS and mitigate Grade ≥3 cytokine release syndrome. The primary endpoint of the expansion part was overall response rate as assessed by an independent review committee. Secondary efficacy endpoints included duration of response, complete response rate, duration of complete response, progression-free survival, and time to response as determined by the Lugano criteria. Overall survival, time to next therapy, and rate of minimal residual disease negativity were evaluated as secondary efficacy endpoints. About Follicular Lymphoma Follicular lymphoma (FL) is typically an indolent, or slow growing, form of NHL that arises from B-cell lymphocytes.1 FL is the second most common form of NHL overall, accounting for 20 to 30 percent of all NHL cases, and representing 10 to 20 percent of all lymphomas in the western world.2,3 Although FL is an indolent lymphoma, it is considered incurable with conventional therapy.4,5 About Epcoritamab Epcoritamab is an investigational 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.6 Epcoritamab-bysp (EPKINLY™) was recently approved in the United States (U.S.) and is indicated for the treatment of adult patients with R/R diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma (HGBL) after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication is contingent upon verification and description of clinical benefit in a confirmatory trial(s). Please see U.S. Important Safety Information below. In October 2022, a Marketing Authorization Application was submitted for epcoritamab for the treatment of patients with R/R DLBCL after two or more lines of systemic therapy, which was validated by the European Medicines Agency. Additionally, in December 2022, a Japan new drug application was submitted to the Ministry of Health, Labor and Welfare of Japan for epcoritamab for the treatment of patients with R/R large B-cell lymphoma (LBCL) after two or more lines of systemic therapy. Epcoritamab is not approved in the European Union and Japan. The companies will share commercial responsibilities in the United States and Japan, with AbbVie responsible for further global commercialization. AbbVie will continue to pursue regulatory submissions for epcoritamab across international markets excluding the United States and Japan throughout the year. Genmab and AbbVie are continuing to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes an ongoing Phase 3, open-label, randomized trial evaluating epcoritamab as a monotherapy in patients with R/R DLBCL (NCT: 04628494), an ongoing Phase 3, open-label, randomized trial evaluating epcoritamab in combination in adult participants with newly diagnosed DLBCL (NCT: 05578976), and a Phase 3, open-label clinical trial evaluating epcoritamab in combination in patients with R/R FL (NCT: 05409066). Epcoritamab is not approved to treat newly diagnosed patients with DLBCL or FL. The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit clinicaltrials.gov for more information. EPKINLY™ ( epcoritamab-bysp) U.S. IMPORTANT SAFETY INFORMATION Important Warnings—EPKINLY can cause serious side effects, including: Cytokine Release Syndrome (CRS). CRS is common during treatment with EPKINLY and can be serious or life-threatening. Tell your healthcare provider or get medical help right away if you develop symptoms of CRS, including fever of 100.4°F (38°C) or higher, dizziness or lightheadedness, trouble breathing, chills, fast heartbeat, feeling anxious, headache, confusion, shaking (tremors), or problems with balance and movement, such as trouble walking. Due to the risk of CRS, you will receive EPKINLY on a "step-up" dosing schedule. The step-up dosing schedule is when you receive smaller "step-up" doses of EPKINLY on day 1 and day 8 of your first cycle of treatment (cycle 1). You will receive your first full dose of EPKINLY on day 15 of cycle 1. If your dose of EPKINLY is delayed for any reason, you may need to repeat the step-up dosing schedule. Before each dose in cycle 1, you will receive medicines to help reduce your risk of CRS. Your healthcare provider will decide if you need to receive medicine to help reduce your risk of CRS with future cycles. Neurologic problems. EPKINLY can cause serious neurologic problems that can be life-threatening and lead to death. Neurologic problems may happen days or weeks after you receive EPKINLY. Your healthcare provider may refer you to a healthcare provider who specializes in neurologic problems. Tell your healthcare provider right away if you develop any symptoms of neurologic problems, including trouble speaking or writing, confusion and disorientation, drowsiness, tiredness or lack of energy, muscle weakness, shaking (tremors), seizures, or memory loss. Due to the risk of CRS and neurologic problems, you should be hospitalized for 24 hours after receiving your first full dose of EPKINLY on day 15 of cycle 1. Your healthcare provider will monitor you for symptoms of CRS and neurologic problems during treatment with EPKINLY, as well as other side effects, and treat you if needed. Your healthcare provider may temporarily stop or completely stop your treatment with EPKINLY if you develop CRS, neurologic problems, or any other side effects that are severe. Do not drive or use heavy or potentially dangerous machinery if you develop dizziness, confusion, tremors, drowsiness, or any other symptoms that impair consciousness until your symptoms go away. These may be symptoms of CRS or neurologic problems. EPKINLY can also cause other serious side effects, including: Infections. EPKINLY can cause serious infections that may lead to death. Your healthcare provider will check you for symptoms of infection before and during treatment. Tell your healthcare provider right away if you develop any symptoms of infection during treatment, including fever of 100.4°F (38°C) or higher, cough, chest pain, tiredness, shortness of breath, painful rash, sore throat, pain during urination, or feeling weak or generally unwell. Low blood cell counts. Low blood cell counts are common during treatment with EPKINLY and can be serious or severe. Your healthcare provider will check your blood cell counts during treatment. EPKINLY may cause low blood cell counts, including low white blood cell counts (neutropenia), which can increase your risk for infection; low red blood cell counts (anemia), which can cause tiredness and shortness of breath; and low platelet counts (thrombocytopenia), which can cause bruising or bleeding problems. Your healthcare provider may temporarily stop or completely stop treatment with EPKINLY if you develop certain side effects. Before you receive EPKINLY, tell your healthcare provider about all of your medical conditions, including if you: have an infection. are pregnant or plan to become pregnant. EPKINLY may harm your unborn baby . Females who are able to become pregnant: Your healthcare provider should do a pregnancy test before you start treatment with EPKINLY. You should use effective birth control (contraception) during treatment and for 4 months after your last dose of EPKINLY. Tell your healthcare provider if you become pregnant or think that you may be pregnant during treatment with EPKINLY. are breastfeeding or plan to breastfeed. It is not known if EPKINLY passes into your breast milk. Do not breastfeed during treatment with EPKINLY and for 4 months after your last dose of EPKINLY. Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. The most common side effects of EPKINLY include CRS, tiredness, muscle and bone pain, injection site reactions, fever, stomach-area (abdominal) pain, nausea, and diarrhea. These are not all the possible side effects of EPKINLY. Call your doctor for medical advice about side effects. You are encouraged to report side effects to the FDA at (800) FDA-1088 or or to Genmab US, Inc. at 1-855-4GENMAB (1-855-443-6622). Please see the Full Prescribing Information and Medication Guide, including Important Warnings. About AbbVie in Oncology At AbbVie, we are committed to transforming standards of care for multiple blood cancers while advancing a dynamic pipeline of investigational therapies across a range of cancer types. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines. We are evaluating more than 20 investigational medicines in over 300 clinical trials across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit . About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology and gastroenterology, in addition to products and services across our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2022 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. 1 What is Lymphoma. Lymphoma Research Foundation. . Accessed June 22, 2023. 2 Ma S. Risk factors of follicular lymphoma. Expert Opin Med Diagn. 2012;6:323–33. DOI: 10.1517/17530059.2012.686996. 3 Luminari S, Bellei M, Biasoli I, et al. Follicular lymphoma—treatment and prognostic factors. Rev Bras Hematol Hemoter. 2012;34:54–9. DOI: 10.5581/1516-8484.20120015. 4 Link BK, Day BM, Zhou X, et al. Second-Line and Subsequent Therapy and Outcomes for Follicular Lymphoma in the United States: Data From the Observational National LymphoCare Study. Br J Haematol. 2019;184(4):660-663. DOI: 10.1111/bjh.15149. 5 Ren J, Asche CV, Shou Y, Galaznik A. Economic Burden and Treatment Patterns for Patients With Diffuse Large B-Cell Lymphoma and Follicular Lymphoma in the USA. J Comp Eff Res. 2019;8(6):393-402. DOI: 10.2217/cer-2018-0094. 6 Engelberts PJ, Hiemstra IH, de Jong B, et al. "DuoBody-CD3xCD20 induces potent T-cell-mediated killing of malignant B cells in preclinical models and provides opportunities for subcutaneous dosing." EBioMedicine. 2020;52:102625. DOI: 10.1016/j.ebiom.2019.102625. SOURCE AbbVie

Company Announcement Based on the topline results from the EPCORE™ NHL-1 clinical trial, Genmab and AbbVie will engage with global regulatory authorities to discuss next stepsData from the clinical trial will be presented at a future medical meetingFollicular Lymphoma is a common form of non-Hodgkin’s lymphoma (NHL) and currently has limited treatment options, particularly in the relapsed/refractory setting COPENHAGEN, Denmark; June 28, 2023 – Genmab A/S (Nasdaq: GMAB) and AbbVie (NYSE: ABBV) today announced topline results from the follicular lymphoma (FL) cohort of the phase 1/2 EPCORE™ NHL-1 clinical trial evaluating epcoritamab (DuoBody® CD3xCD20), an investigational T-cell engaging bispecific antibody administered subcutaneously. The study cohort includes 128 adult patients with relapsed/refractory follicular lymphoma (FL) who received at least two prior lines of systemic therapy. 70.3 percent of patients were double refractory to an anti-CD20 monoclonal antibody and an alkylating agent. Based on the topline results, the companies will engage with global regulatory authorities to determine next steps. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies' oncology collaboration. The topline results from this cohort showed an overall response rate (ORR) of 82 percent as confirmed by an independent review committee (IRC), which exceeded the protocol prespecified threshold for efficacy. The observed median duration of response (DOR) was not reached. No new safety signals were observed with epcoritamab in this study at the time of analysis. The most common treatment-emergent adverse event was cytokine release syndrome (CRS) with 66.4 percent (1.6 percent grade >2). Aligned with the U.S. Food and Drug Administration’s (FDA) Project Optimus, the optimization part of the trial is continuing to evaluate alternative step-up dosing regimens to mitigate the risk of CRS; preliminary data on the initial patients enrolled indicate a clinically meaningful improvement in CRS rate. The results from this cohort, along with the results from the optimization part of the trial, will be submitted for presentation at an upcoming medical congress. “These topline results are encouraging for relapsed or refractory follicular lymphoma patients who are in need of new therapeutic options,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “With our partner AbbVie, we are committed to evaluating epcoritamab as a potential core therapy across B-cell malignancies. We look forward to sharing the full results from this study cohort at an upcoming medical congress and discussing the results with global regulatory authorities.” About the Phase 1/2 EPCORE™ NHL-1 trialEPCORE™ NHL-1 an open-label, multi-center safety and preliminary efficacy trial of epcoritamab that consists of three parts: a phase 1 first-in-human, dose escalation part; a phase 2 expansion part; and an optimization part. The trial was designed to evaluate subcutaneous epcoritamab in patients with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin’s lymphoma (B-NHL), including FL. In the phase 2 expansion part, additional patients were enrolled to further explore the safety and efficacy of epcoritamab in three cohorts of patients with different types of relapsed/refractory B-NHLs who have limited therapeutic options. The optimization part evaluates the potential for alternative step-up dosing regimens to further minimize grade 2 CRS and mitigate the risk of grade ≥3 CRS. The primary endpoint of the expansion part was ORR as assessed by an IRC. Secondary efficacy endpoints included DOR, complete response rate, duration of complete response, progression-free survival, and time to response as determined by the Lugano criteria. Overall survival, time to next therapy, and rate of minimal residual disease negativity were evaluated as secondary efficacy endpoints. About Follicular Lymphoma (FL)FL is typically an indolent (or slow growing) form of non-Hodgkin’s lymphoma (NHL) that arises from B-lymphocytes.i FL is the second most common form of NHL overall, accounting for 20-30 percent of all NHL cases, and represents 10-20 percent of all lymphomas in the western world.ii,iii Although FL is an indolent lymphoma, it is considered incurable with conventional therapy.iv,v About Epcoritamab Epcoritamab is an investigational 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 towards 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.vi Epcoritamab-bysp (EPKINLYTM) was recently approved in the United States and is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma (HGBL) after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication is contingent upon verification and description of clinical benefit in a confirmatory trial(s). In October 2022, a Marketing Authorization Application was submitted for epcoritamab for the treatment of patients with R/R DLBCL after two or more lines of systemic therapy, which was validated by the European Medicines Agency. Additionally, in December 2022, a Japan new drug application was submitted to the Ministry of Health, Labor and Welfare of Japan for epcoritamab for the treatment of patients with R/R LBCL after two or more lines of systemic therapy. Epcoritamab is not approved in the European Union and Japan. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. AbbVie will continue to pursue regulatory submissions for epcoritamab across international markets excluding the U.S. and Japan throughout the year. Genmab and AbbVie are continuing to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes an ongoing phase 3, open-label, randomized trial evaluating epcoritamab as a monotherapy in patients with R/R DLBCL (NCT: 04628494), an ongoing phase 3, open-label, randomized trial evaluating epcoritamab in combination in adult participants with newly diagnosed DLBCL (NCT: 05578976), and a phase 3, open-label clinical trial evaluating epcoritamab in combination in patients with R/R follicular lymphoma (FL) (NCT: 05409066). Epcoritamab is not approved to treat newly diagnosed patients with DLBCL or FL. The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit clinicaltrials.gov for more information. EPKINLY™ (epcoritamab-bysp) U.S. IMPORTANT SAFETY INFORMATION Important Warnings—EPKINLY can cause serious side effects, including: Cytokine Release Syndrome (CRS). CRS is common during treatment with EPKINLY and can be serious or life-threatening. Tell your healthcare provider or get medical help right away if you develop symptoms of CRS, including fever of 100.4°F (38°C) or higher, dizziness or lightheadedness, trouble breathing, chills, fast heartbeat, feeling anxious, headache, confusion, shaking (tremors), or problems with balance and movement, such as trouble walking.Due to the risk of CRS, you will receive EPKINLY on a "step-up" dosing schedule. The step-up dosing schedule is when you receive smaller "step-up" doses of EPKINLY on day 1 and day 8 of your first cycle of treatment (cycle 1). You will receive your first full dose of EPKINLY on day 15 of cycle 1. If your dose of EPKINLY is delayed for any reason, you may need to repeat the step-up dosing schedule. Before each dose in cycle 1, you will receive medicines to help reduce your risk of CRS. Your healthcare provider will decide if you need to receive medicine to help reduce your risk of CRS with future cycles. Neurologic problems. EPKINLY can cause serious neurologic problems that can be life-threatening and lead to death. Neurologic problems may happen days or weeks after you receive EPKINLY. Your healthcare provider may refer you to a healthcare provider who specializes in neurologic problems. Tell your healthcare provider right away if you develop any symptoms of neurologic problems, including trouble speaking or writing, confusion and disorientation, drowsiness, tiredness or lack of energy, muscle weakness, shaking (tremors), seizures, or memory loss. Due to the risk of CRS and neurologic problems, you should be hospitalized for 24 hours after receiving your first full dose of EPKINLY on day 15 of cycle 1. Your healthcare provider will monitor you for symptoms of CRS and neurologic problems during treatment with EPKINLY, as well as other side effects, and treat you if needed. Your healthcare provider may temporarily stop or completely stop your treatment with EPKINLY if you develop CRS, neurologic problems, or any other side effects that are severe. Do not drive or use heavy or potentially dangerous machinery if you develop dizziness, confusion, tremors, drowsiness, or any other symptoms that impair consciousness until your symptoms go away. These may be symptoms of CRS or neurologic problems. EPKINLY can also cause other serious side effects, including: Infections. EPKINLY can cause serious infections that may lead to death. Your healthcare provider will check you for symptoms of infection before and during treatment. Tell your healthcare provider right away if you develop any symptoms of infection during treatment, including fever of 100.4°F (38°C) or higher, cough, chest pain, tiredness, shortness of breath, painful rash, sore throat, pain during urination, or feeling weak or generally unwell.Low blood cell counts. Low blood cell counts are common during treatment with EPKINLY and can be serious or severe. Your healthcare provider will check your blood cell counts during treatment. EPKINLY may cause low blood cell counts, including low white blood cell counts (neutropenia), which can increase your risk for infection; low red blood cell counts (anemia), which can cause tiredness and shortness of breath; and low platelet counts (thrombocytopenia), which can cause bruising or bleeding problems. Your healthcare provider may temporarily stop or completely stop treatment with EPKINLY if you develop certain side effects. Before you receive EPKINLY, tell your healthcare provider about all of your medical conditions, including if you: have an infection.are pregnant or plan to become pregnant. EPKINLY may harm your unborn baby. Females who are able to become pregnant: Your healthcare provider should do a pregnancy test before you start treatment with EPKINLY. You should use effective birth control (contraception) during treatment and for 4 months after your last dose of EPKINLY. Tell your healthcare provider if you become pregnant or think that you may be pregnant during treatment with EPKINLY.are breastfeeding or plan to breastfeed. It is not known if EPKINLY passes into your breast milk. Do not breastfeed during treatment with EPKINLY and for 4 months after your last dose of EPKINLY. Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. The most common side effects of EPKINLY include CRS, tiredness, muscle and bone pain, injection site reactions, fever, stomach-area (abdominal) pain, nausea, and diarrhea. These are not all the possible side effects of EPKINLY. Call your doctor for medical advice about side effects. You are encouraged to report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch or to Genmab US, Inc. at 1-855-4GENMAB (1-855-443-6622). Please see the Full Prescribing Information and Medication Guide, including Important Warnings. About Genmab Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. 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. Established in 1999, Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan. For more information, please visit Genmab.com and follow us on Twitter.com/Genmab. Contact: Marisol Peron, Senior Vice President, Communications and Corporate AffairsT: +1 609 524 0065; E: mmp@genmab.com Andrew Carlsen, Vice President, Head of Investor RelationsT: +45 3377 9558; E: acn@genmab.com This Company Announcement contains forward looking statements. The words “believe”, “expect”, “anticipate”, “intend” and “plan” and similar expressions identify forward looking statements. 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 our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law. Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; DuoBody in combination with the DuoBody logo®; HexaBody®; HexaBody in combination with the HexaBody logo®; DuoHexaBody® and HexElect®. EPKINLY™ is owned by AbbVie Biotechnology Ltd. i Lymphoma Research Foundation official website. https://lymphoma.org/aboutlymphoma/nhl/fl/. Accessed June 2023.ii Ma S. Risk factors of follicular lymphoma. Expert Opin Med Diagn. 2012;6:323–33. doi: 10.1517/17530059.2012.686996.iii Luminari S, Bellei M, Biasoli I, Federico M. Follicular lymphoma—treatment and prognostic factors. Rev Bras Hematol Hemoter. 2012;34:54–9. doi: 10.5581/1516-8484.20120015.iv Link BK, et al. Second-Line and Subsequent Therapy and Outcomes for Follicular Lymphoma in the United States: Data From the Observational National LymphoCare Study. Br J Haematol 2019;184(4):660-663.v Ren J, et al. Economic Burden and Treatment Patterns for Patients With Diffuse Large B-Cell Lymphoma and Follicular Lymphoma in the USA. J Comp Eff Res 2019;8(6):393-402.vi Engelberts et al. "DuoBody-CD3xCD20 induces potent T-cell-mediated killing of malignant B cells in preclinical models and provides opportunities for subcutaneous dosing." EBioMedicine. 2020;52:102625. DOI: 10.1016/j.ebiom.2019.102625 Company Announcement no. 33 CVR no. 2102 3884 LEI Code 529900MTJPDPE4MHJ122 Genmab A/S Kalvebod Brygge 43 1560 Copenhagen V Denmark Attachment 280623-ca33-epcoritamab-fl-topline