OSLO, Norway, Nov. 2, 2018 /PRNewswire/ -- Nordic Nanovector ASA (OSE: NANO) announces that the first patient has been dosed in the Archer-1 trial investigating Betalutin® (177Lu-satetraxetan-lilotomab) in combination with rituximab (RTX) in second-line follicular lymphoma (2L FL).
Rituximab is a CD20-targeting monoclonal antibody that is administered to patients with newly-diagnosed or relapsed FL as a single agent or in combination with chemotherapy. Over time, patients may develop resistance to RTX, thus alternative targets are important. In addition, developing novel "chemo-free" regimens for patients as an alternative to chemotherapy is desirable.
Archer-1 is a Phase 1b open-label, single-arm, multi-centre dose-escalation trial to assess the safety and preliminary activity of combining CD37-targeted Betalutin® with CD20-targeted RTX in 20-25 patients with relapsed/refractory FL who have received one or more prior therapies. Starting doses of Betalutin® and lilotomab are 10MBq/kg and 40mg, respectively, with the option for dose escalation. Following Betalutin® dosing, patients will receive four weekly doses of RTX (375mg/m2). The primary endpoint is safety, and secondary endpoints include overall response rate, duration of response, progression free survival and overall survival.
The rationale for Archer-1 was provided by preclinical data recently published in the European Journal of Haematology in July 2018 (reference below). These data demonstrate that treatment with the combination of Betalutin® and RTX significantly prolonged overall survival in a murine model of NHL compared to treatment with either agent alone, possibly by reverting downregulation of CD20 and resistance to RTX.
Eduardo Bravo, Nordic Nanovector CEO, commented: "Archer-1 presents an opportunity to investigate the potential of a novel dual CD37/CD20-targeting combination approach in 2L FL patients. If the preclinical results translate to patients, this may indicate a new way to administer biologic therapy in FL."
Reference
Repetto-Llamazares, A.H.V. et al. Combination of 177Lu-lilotomab with rituximab significantly improves the therapeutic outcome in preclinical models of non-Hodgkin's lymphoma. Eur J Haematol. 2018 https://doi.org/10.1111/ejh.13139
For further information, please contact:
IR enquiries
Malene Brondberg, VP Investor Relations and Corporate Communications
Cell: +44-7561-431-762
Email: [email protected]
International Media Enquiries
Mark Swallow/David Dible (Citigate Dewe Rogerson)
Tel: +44-207-638-9571
Email: [email protected]
About Betalutin®
Betalutin® is a tumour-seeking anti-CD37 antibody (lilotomab) conjugated to a low-intensity radionuclide (lutetium-177). It has shown promising efficacy and safety in the first part of the Phase 1/2 LYMRIT 37-01 clinical study in relapsed/refractory follicular lymphoma (R/R FL). A global, randomised Phase 2b trial, PARADIGME, in third line (3L) FL patients who are refractory to anti-CD20 immunotherapy (including rituximab, RTX) is currently on-going. Betalutin® is also being investigated in the Phase 1b Archer-1 study in combination with RTX in second-line FL patients, and in the Phase 1 LYMRIT 37-05 study in patients with R/R diffuse large B-cell lymphoma (DLBCL), the most common form of non-Hodgkin's lymphoma (NHL). Betalutin® has been granted Fast Track designation in the US and Promising Innovative Medicine (PIM) Designation in the UK for the treatment of patients with R/R FL. Betalutin® also received Orphan Drug designations for FL in both the USA and Europe in 2014. Betalutin® is selective for CD37, which is highly expressed on the surface of B-cell non-Hodgkin's lymphoma (NHL) cells. When bound to CD37 on tumour cells, Betalutin® is internalised, causing DNA damage and cell death.
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 20 billion by 2024. Nordic Nanovector intends to retain marketing rights and to actively participate in the commercialisation of Betalutin® in core markets. Further information about the Company 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 Section 5-12 of the Securities Trading Act.
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Rituximab is a CD20-targeting monoclonal antibody that is administered to patients with newly-diagnosed or relapsed FL as a single agent or in combination with chemotherapy. Over time, patients may develop resistance to RTX, thus alternative targets are important. In addition, developing novel "chemo-free" regimens for patients as an alternative to chemotherapy is desirable.
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Archer-1 is a Phase 1b open-label, single-arm, multi-centre dose-escalation trial to assess the safety and preliminary activity of combining CD37-targeted Betalutin® with CD20-targeted RTX in 20-25 patients with relapsed/refractory FL who have received one or more prior therapies. Starting doses of Betalutin® and lilotomab are 10MBq/kg and 40mg, respectively, with the option for dose escalation. Following Betalutin® dosing, patients will receive four weekly doses of RTX (375mg/m2). The primary endpoint is safety, and secondary endpoints include overall response rate, duration of response, progression free survival and overall survival.
The rationale for Archer-1 was provided by preclinical data recently published in the European Journal of Haematology in July 2018 (reference below). These data demonstrate that treatment with the combination of Betalutin® and RTX significantly prolonged overall survival in a murine model of NHL compared to treatment with either agent alone, possibly by reverting downregulation of CD20 and resistance to RTX.
Eduardo Bravo, Nordic Nanovector CEO, commented: "Archer-1 presents an opportunity to investigate the potential of a novel dual CD37/CD20-targeting combination approach in 2L FL patients. If the preclinical results translate to patients, this may indicate a new way to administer biologic therapy in FL."
Reference
Repetto-Llamazares, A.H.V. et al. Combination of 177Lu-lilotomab with rituximab significantly improves the therapeutic outcome in preclinical models of non-Hodgkin's lymphoma. Eur J Haematol. 2018 https://doi.org/10.1111/ejh.13139
For further information, please contact:
IR enquiries
Malene Brondberg, VP Investor Relations and Corporate Communications
Cell: +44-7561-431-762
Email: [email protected]
International Media Enquiries
Mark Swallow/David Dible (Citigate Dewe Rogerson)
Tel: +44-207-638-9571
Email: [email protected]
About Betalutin®
Betalutin® is a tumour-seeking anti-CD37 antibody (lilotomab) conjugated to a low-intensity radionuclide (lutetium-177). It has shown promising efficacy and safety in the first part of the Phase 1/2 LYMRIT 37-01 clinical study in relapsed/refractory follicular lymphoma (R/R FL). A global, randomised Phase 2b trial, PARADIGME, in third line (3L) FL patients who are refractory to anti-CD20 immunotherapy (including rituximab, RTX) is currently on-going. Betalutin® is also being investigated in the Phase 1b Archer-1 study in combination with RTX in second-line FL patients, and in the Phase 1 LYMRIT 37-05 study in patients with R/R diffuse large B-cell lymphoma (DLBCL), the most common form of non-Hodgkin's lymphoma (NHL). Betalutin® has been granted Fast Track designation in the US and Promising Innovative Medicine (PIM) Designation in the UK for the treatment of patients with R/R FL. Betalutin® also received Orphan Drug designations for FL in both the USA and Europe in 2014. Betalutin® is selective for CD37, which is highly expressed on the surface of B-cell non-Hodgkin's lymphoma (NHL) cells. When bound to CD37 on tumour cells, Betalutin® is internalised, causing DNA damage and cell death.
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 20 billion by 2024. Nordic Nanovector intends to retain marketing rights and to actively participate in the commercialisation of Betalutin® in core markets. Further information about the Company 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 Section 5-12 of the Securities Trading Act.
This information was brought to you by Cision http://news.cision.com
http://news.cision.com/nordic-nanovector/r/nordic-nanovector-announces-first-patient-dosed-in-archer-1-trial-of-betalutin--plus-rituximab-in-fo,c2662480
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