Nordic Nanovector R&D Day unveils updates on several programs

Clinical         

• LYMRIT 37-01 (relapsed iNHL) - median duration of response of 13.6 months for all responders and 32.0 months for complete responders versus 9.0 months and 20.7 months respectively reported last December at ASH 

• Archer-1 - 100% ORR (3/3 complete response (CR)) in the first cohort of patients in a phase 1b study of Betalutin® + rituximab in relapsed/refractory follicular lymphoma

Preclinical 

• NOK 6 million in Eurostars funding granted for taking the chimeric alpha-particle emitting anti-CD37 radioimmunoconjugate Alpha37 through the last step towards clinical testing 

• Superior efficacy of Alpha37 with respect to market leading ibrutinib has been shown in an ibrutinib-resistant mouse model of chronic lymphocytic leukemia (CLL)

Oslo, Norway, 17 September 2019

Nordic Nanovector ASA (OSE: NANO) will today host an R&D day in Oslo. The programme will include presentations from three external experts and by Nordic Nanovector’s senior management team. The full programme of the event is available at www.nordicnanovector.com under press releases.

The R&D day presentations will cover

• the progress of the company’s research and pre-clinical projects
• the clear medical need in the patient populations suffering from the diseases targeted by Nordic Nanovector products in development and
• the latest data on some of the clinical trials currently being conducted.

In addition, the company will provide an update on its work and progress on the CMC (Chemistry, Manufacturing and Control) area, which will be a key part of the planned regulatory filing for Betalutin® in the first half of 2021.

The pivotal Phase 2b PARADIGME trial of Betalutin® in advanced recurrent follicular lymphoma (FL) is progressing with 83 sites in 24 countries open for enrolment as of September 16th, 2019.

“The clinical results obtained so far with Betalutin® demonstrate that the rationale behind its design for the treatment of non-Hodgkin’s lymphoma was right”, commented Dr Jostein Dahle, Chief Scientific Officer and Co-founder of Nordic Nanovector. “Over the last ten years we have continued to advance our knowledge of the biology of the disease and the peculiarities of our treatment modality in general and Betalutin® in particular. We are very excited with the data we continue to generate and the opportunities that this information will provide to keep the company at the forefront of this race towards finding new and improved therapies or combinations that will benefit the thousands of patients still at need”.

Dr J.P. Pouget, PhD, Radiobiology and targeted radiotherapy group Montpellier Cancer Research Institute (IRCM), French National Institute of Health and Medical Research (INSERM) will present interesting new pre-clinical results with Betalutin®, including its increased therapeutic activity when combined with cell cycle inhibitors.

Dr Jostein Dahle will summarize the focus and most recent advances of Nordic Nanovector’s research. During his presentation, he will preview data that will be presented at the EANM (European Association of Nuclear Medicine) Congress in Barcelona in October that shows the synergistic effect of Humalutin® with the PARP inhibitor Olaparib in DLBCL (Diffuse Large B Cell Lymphoma) cell lines.

Dr Jostein Dahle will also explain in detail some of the data that the company has generated with Alpha37 (an anti-CD37 mAb linked to alpha-particle generating lead 212). This will include demonstration of the superiority of Alpha37 to ibrutinib in an ibrutinib-resistant mouse model of CLL (chronic lymphocytic leukaemia). Ibrutinib is today the most widely used product in this indication, both first line and second line. These data have been selected for the highlights session of the already mentioned EANM Congress in Barcelona. Alpha37, which is partnered with OranoMed, has recently been awarded a grant of NOK 6 million by the Eurostar programme.

Prof Pier Luigi Zinzani, Professor of Hematology at Bologna University, will analyse the therapeutic landscape in recurrent FL and marginal zone lymphoma (MZL), reviewing the efficacy and safety profile of approved agents and products in development. Despite the availability of new therapies, the unmet medical need in recurrent FL and MZL is still high.  

Dr Arne Kolstad from the Department of Oncology, Oslo University Hospital, and the Principal Investigator of the LYMRIT-37-01 trial, will hold a presentation which provides the latest update from this trial of Betalutin® in patients with relapsed indolent NHL.

With a median follow-up time for responders of 30 months, this latest update confirms a median duration of response (mDoR) of 13.6 months for all 45 responders and an even more durable response of 32.0 months for the 22 patients showing a complete response (compared with 9.0 and 20.7 respectively last December at ASH).

Dr Arne Kolstad will also present data from the first safety cohort of three patients of the Phase 1b Archer-1 study of Betalutin® + rituximab (RTX) in relapsed/refractory follicular lymphoma. This open label, single-arm dose escalation study in 2L FL expects to recruit a total of 20-25 patients to evaluate the safety and tolerability of Betalutin® in combination with RTX and to evaluate the preliminary anti-tumour activity of combination treatment.

In the first safety cohort an overall response rate of 100% was observed with three complete responders and importantly no dose limiting toxicities. Full data read out from this study is expected in the second half of 2020.

With Nordic Nanovector’s strategic priorities focused on efforts to maximize the value of Betalutin® across the major types of NHL (FL and DLBCL) and in earlier treatment lines in combination with standard treatments, we decided together with our partner Heidelberg Pharma to discontinue development of NNV014 (anti-CD37 ADC), an early stage discovery project in leukaemia.

“The data presented during this R&D day highlights our potential to become a leader in radiopharmaceuticals and our commitment to deliver innovative products for the patients suffering from these devastating diseases”, commented Eduardo Bravo, CEO of Nordic Nanovector. “We are very pleased with the latest results from the LYMRIT-37-01 study and with the early indications from the first safety cohort in Archer-1. These encouraging data support our decision to broaden the clinical development of Betalutin® in NHL and to develop the regulatory and commercial strategy for a commercial launch in the US. We are entering an exciting phase in the company’s development with key data due to be reported next year and the prospect of our first regulatory filing for Betalutin® in third line FL in the first half of 2021.”

For further information, please contact:

IR enquiries

Malene Brondberg, VP Investor Relations and Corporate Communications

Cell: +44 7561 431 762

Email: ir@nordicnanovector.com

International Media Enquiries

Mark Swallow/David Dible (Citigate Dewe Rogerson)

Tel: +44 207 638 9571

Email: nordicnanovector@citigatedewerogerson.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 29 billion by 2026. Nordic Nanovector intends to retain marketing rights and to actively participate in the commercialisation of Betalutin® in core 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 Section 5-12 of the Securities Trading Act.

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