OSLO, Norway, June 10, 2022 /PRNewswire/ -- Nordic Nanovector ASA (OSE: NANOV) announces an update from the LYMRIT 37-05 Phase 1 trial investigating Betalutin (177Lu lilotomab satetraxetan) in patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) not eligible for stem cell transplantation.
The latest data to be presented at the European Hematology Association (EHA) Congress in Vienna, Austria on 10 June 2022 shows that Betalutin continues to be well tolerated with no further dose-limiting toxicity (DLT). The data analysis showed that clinical activity of Betalutin was seen with two complete responses out of 16 evaluable patients.
Erik Skullerud, Nordic Nanovector CEO, commented: "This update from the LYMRIT 37-05 trial being presented at EHA shows two complete responses, demonstrating early signs of efficacy for Betalutin in this fragile and heavily pre-treated patient population. Importantly this is combined with a consistently good safety profile. There remains a need for combination therapies that provide high response rates with a curative intent and a low side effect burden for R/R DLBCL patients, and we continue to explore the options for advancing Betalutin in this setting with the right therapeutic combination partner."
Details of the poster presentation on 10 June at EHA are as follows:
Title: BETALUTIN IN PATIENTS WITH RELAPSED/ REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL) NOT ELIGIBLE FOR AUTOLOGOUS STEM CELL TRANSPLANT
Authors: Illidge T, Beasley M, Gomez Codina J, Vavallo F, Pascal V, Wills V
Session Title: Poster session
Session date and time: Friday, June 10 202 - 16:30 - 17:45 CEST
Final Abstract Code: P1165
About LYMRIT 37-05
The LYMRIT 37-05 study is a Phase 1 open-label, single-arm, dose-escalation study designed to assess the safety and preliminary anti-tumour activity of a single administration of Betalutin. Patients were enrolled at clinical trial sites in the US and Europe. More information on this study can be found at www.clinicaltrials.gov (NCT02658968).
The starting doses of Betalutin and lilotomab were 10 MBq/kg and 60 mg (Cohort 1, n=3), respectively, and then Betalutin 10 MBq/kg and lilotomab 100 mg (Cohort 2, n=3 treated with Betalutin). Cohort 3 received 15 MBq/kg and lilotomab 100 mg (n=3) and Cohort 4 received 20 MBq/kg and lilotomab 100 mg (n=7).
About DLBCL
DLBCL is an aggressive form of non-Hodgkin's Lymphoma (NHL) that accounts for up to 43% of all NHL cases, making it the most common form of the disease. Approximately 40% of DLBCL patients relapse after first-line combination treatment with rituximab and chemotherapy and only 30-40% of relapsed patients respond with subsequent high-dose chemotherapy followed by Stem Cell Transplantation (ref. 1). There are currently very few therapeutic options for patients not eligible for SCT, which makes relapsed DLBCL a serious unmet medical need. The number of diagnosed incident cases of DLBCL in the 7 major markets (U.S., and key 5 European markets and Japan) was 64,172 in 2018 and is expected to be 74,927 in 2028 (ref. 2). The value of the 3L DLBCL market segment in the key 7 pharma markets is expected to increase from USD 0.6B in 2019 to USD 1.3B in 2028, the value of the 2L DLBCL market segment is expected to increase from USD 0.4B in 2019 to USD 2.0B in 2028. (ref. 2).
1. L.S. Raut and P. P. Chakrabarti: Management of relapsed-refractory diffuse large B cell lymphoma (2014) South Asian J. Cancer 3(1): 66-70
2. NHL and CLL Report, CRG, 2000, Disease Landscape and Forecast
For further information, please contact:
IR enquiries
Malene Brondberg, CFO
Cell: +44 7561 431 762
Email: ir@nordicnanovector.com
Media Enquiries
Mark Swallow/Frazer Hall (MEDiSTRAVA Consulting)
Tel: +44 203 928 6900
Email: nordicnanovector@medistrava.com
About Nordic Nanovector:
Nordic Nanovector is committed to develop and deliver innovative therapies to patients to address major unmet medical needs and advance cancer care. The Company aspires to become a leader in the development of targeted therapies for haematological cancers. Nordic Nanovector's lead clinical-stage candidate is Betalutin, a novel CD37-targeting antibody-radionuclide-conjugate designed to advance the treatment of non-Hodgkin's lymphoma (NHL). NHL is an indication with substantial unmet medical need, representing a growing market forecast to be worth nearly USD 26 billion by 2028. Nordic Nanovector retains global marketing rights to Betalutin and intends to actively participate in the commercialisation of Betalutin in the US and other major markets.
Further information can be found at www.nordicnanovector.com.
Forward-looking statements
This press release contains certain forward-looking statements. These statements are based on management's current expectations and are subject to uncertainty and changes in circumstances, since they relate to events and depend on circumstances that will occur in the future and which, by their nature, will have an impact on Nordic Nanovector's business, financial condition and results of operations. The terms "anticipates", "assumes", "believes", "can", "could", "estimates", "expects", "forecasts", "intends", "may", "might", "plans", "should", "projects", "targets", "will", "would" or, in each case, their negative, or other variations or comparable terminology are used to identify forward-looking statements. These forward-looking statements are not historic facts. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied in the forward-looking statements. Factors that could cause these differences include, but are not limited to, risks associated with implementation of Nordic Nanovector's strategy, risks and uncertainties associated with the development and/or approval of Nordic Nanovector's product candidates, ongoing and future clinical trials and expected trial results, the ability to commercialise Betalutin, technology changes and new products in Nordic Nanovector's potential market and industry, Nordic Nanovector's freedom to operate (competitors patents) in respect of the products it develops, the ability to develop new products and enhance existing products, the impact of competition, changes in general economy and industry conditions, and legislative, regulatory and political factors. No assurance can be given that such expectations will prove to have been correct. Nordic Nanovector disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
This information is subject to a duty of disclosure pursuant to Sections 4-2 and 5-12 of the Securities Trading Act.
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