OSLO, Norway--(BUSINESS WIRE)--Nordic Nanovector ASA (OSE: NANO), a biotechnology company focusing on the development of novel targeted therapeutics in haematology and oncology, announces updated results of its ongoing Phase 1/2 study with Betalutin® in relapsed non-Hodgkin lymphoma (NHL) patients. Betalutin® was generally well tolerated and showed a 63.2% Overall Response Rate (ORR) including 31.6% Complete Response (CR) among 21 patients with previously treated CD37+ NHL patients. This data include two additional patients whose efficacy data has become available following submission of the abstract.
This press release was previously issued on Friday 15 April at 11:30pm CEST.
Data and analysis will be presented on Tuesday 19 April in a poster at the American Association for Cancer Research (AACR) annual meeting (16-20 April 2016, New Orleans, LA, USA) by Dr. Jostein Dahle, Nordic Nanovector’s Chief Scientific Officer. A conference call to discuss the results will be held today at 8:30am CEST. Please see conference call details below.
The data being presented in the poster at AACR are from the ongoing Phase 1/2 single dose, open label, dose-finding study investigating three dose levels of Betalutin® in 21 patients with relapsed CD37+ NHL, 19 with Follicular Lymphoma and two with Mantle Cell Lymphoma, previously treated with one to eight treatment regimens. One patient recruited into the study had transformed disease and was excluded from the response rate calculation.
The updated data in the poster confirm the favourable safety profile of Betalutin® and its promising efficacy as a single agent in patients who have failed many prior regimens, characterised by a sustained duration of response. Key conclusions from the update include:
• Betalutin® is well tolerated, with a predictable and manageable safety profile: most adverse events are haematological in nature, and all have been transient and reversible
• Betalutin® delivers a highly favourable response rate (best response) in this heavily pre-treated patient population (Overall Response Rate 63.2% and Complete Response 31.6%)
• The median Duration of Response (DoR) has not yet been reached. Clinical responses observed are sustained, with DoR exceeding 12 months in most responders
Luigi Costa, Nordic Nanovector’s Chief Executive Officer, commented: “These new data continue to confirm Betalutin’s efficacy potential and favourable safety profile. In addition, Duration of Response (DOR) in patients who responded to treatment with Betalutin® has further improved confirming the product’s potential to become a significant treatment of NHL. These encouraging results support the continued clinical development of Betalutin®. We are pleased with the progress that we are making in executing our revised Phase 1/2 study and look forward to confirming the optimal dosing regimen for the pivotal Phase 2 study, PARADIGME, expected in Q1 2017.”
The poster will be presented between 8.00am -12.00pm Central Daylight Time (CDT)/3:00pm – 7:00pm CEST on 19 April and will be available at: http://www.nordicnanovector.com/product-info/scientific-posters at the same time.
The abstract (No. LB-252) was published on Friday 15 April online at AACR abstract (http://www.abstractsonline.com/Plan/ViewAbstract.aspx?mID=4017&sKey=54127483-0c21-40c2-b489-666aab48f2e2&cKey=6ef486c9-3a9d-4e05-92f1-150ed0c9ca6b&mKey=1d10d749-4b6a-4ab3-bcd4-f80fb1922267).
Conference call details
A conference call to discuss the results will take place today at 8.30am CEST.
Please make sure to dial in 5-10 minutes prior to scheduled conference call start time using the number and confirmation code below:
Local - Norway +47 21 00 26 10
Local - UK +44 (0) 203 043 2002
Local – USA and International +1 719 457 1036
Conference ID: 5241435
The presentation for the conference call will be publicly available at www.nordicnanovector.com in the section;
Investor relations/Reports and Presentation/Presentation/2016.
About Nordic Nanovector
Nordic Nanovector is a biotech company focusing on the development and commercialisation of novel targeted therapeutics in haematology and oncology. The Company’s lead clinical-stage product opportunity is Betalutin®, the first in a new class of Antibody-Radionuclide-Conjugates (ARC) designed to improve upon and complement current options for the treatment of non-Hodgkin Lymphoma (NHL). NHL is an indication with substantial unmet medical need and orphan drug opportunities, representing a growing market worth over $12 billion by 2018.
Betalutin® comprises a tumour-seeking anti-CD37 antibody (HH1) conjugated to a low intensity radionuclide (lutetium-177). The preliminary data has shown promising efficacy and safety profile in an ongoing Phase 1/2 study in a difficult-to-treat NHL patient population. The Company is aiming at developing Betalutin® for the treatment of major types of NHL with first regulatory submission anticipated in 1H 2019.
Nordic Nanovector intends to retain marketing rights and to actively participate in the commercialisation of Betalutin® in core markets, while exploring potential distribution agreements in selected geographies. The Company is committed to developing its ARC pipeline to treat multiple selected cancer indications.
Further information about the Company can be found at www.nordicnanovector.com
This announcement may contain certain forward-looking statements and forecasts based on uncertainty, 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”, “will”, “would” or, in each case, their negative, or other variations or comparable terminology are used to identify forward-looking statement. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied in a forward-looking statement or affect the extent to which a particular projection is realised. Factors that could cause these differences include, but are not limited to, implementation of Nordic Nanovector’s strategy and its ability to further grow, risks associated with the development and/or approval of Nordic Nanovector’s products candidates, ongoing clinical trials and expected trial results, the ability to commercialise Betalutin®, technology changes and new products in Nordic Nanovector’s potential market and industry, 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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