Update on PARADIGME from Nordic Nanovector

Our portfolio company Nordic Nanovector provided an update on its clinical development programme, including updated guidance on expected milestones for the pivotal PARADIGME trial in early April. At the same time CEO Luigi Costa informed that he would resign from his position.

Nordic Nanovector’s lead clinical-stage candidate is Betalutin®, a novel CD37-targeting Antibody-Radionuclide-Conjugates (ARC) designed to advance the treatment of non-Hodgkin’s Lymphoma (NHL). PARADIGME is a global randomised Phase 2b study comparing two Betalutin® dosing regimens in third line follicular lymphoma (3L FL) patients, which have shown a promising clinical profile in the LYMRIT 37-01 Phase 1/2a trial.

The pivotal PARADIGME study was initiated at the end of 2017 in Europe and the first patient is expected to be dosed during the first half of 2018. The trial is aiming to enrol 130 patients in 20 countries
To date, PARADIGME is open for enrolment at 13 sites and in six countries
In Norway, PARADIGME is pending approval and the company is working closely with the Norwegian regulators to address its questions
In the USA, the Food & Drug Administration (FDA) has completed its review of the PARADIGME study and Nordic Nanovector expects US sites to be open for enrolment during mid-2018

Lisa Rojkjaer MD, Nordic Nanovector CMO, said: “While we are encouraged with the progress being made to the start-up of the pivotal PARADIGME study, a re-analysis of the patient enrolment rate and the fact that it has taken longer than expected to enrol the first patient have led us to adjust the timelines we previously communicated. We now expect to deliver data from PARADIGME in the first half of 2020.

“The PARADIGME study reflects our conviction in the significant potential of Betalutin® based on the promising clinical data generated to-date. We therefore remain committed to completing this robust study, which is designed to select the best dosing regimen to support Betalutin® as an important new treatment option for 3L FL patients.”

Highlights from the update:

• A re-assessment of expected recruitment rates has led the company to revise its timelines for the pivotal PARADIGME Phase 2b trial with Betalutin® in third line (3L) follicular lymphoma (FL) patients. Results from PARADIGME are targeted for 1H 2020 (previously 2H 2019) and first regulatory filing in 2020. The first patient is expected to be dosed in 1H 2018.

• The company will focus its resources towards PARADIGME and other Betalutin® clinical programmes, which has led to the decision to postpone the start of the first-in-human clinical trial with Humalutin® for the foreseeable future; this study was being prepared to start in 2H 2018.

• Guidance is unchanged for previously reported milestones for ARCHER-1 (Betalutin® plus rituximab in second line FL; first patient dosed) and LYMRIT 37-05 (Betalutin® in R/R diffuse large B cell lymphoma, DLBCL; preliminary data read-out), both anticipated in 2H 2018.

• Financial resources are expected to be sufficient to reach data read-out from PARADIGME

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-Conjugates (ARC) 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.

The Company is also advancing a pipeline of ARCs and other immunotherapies for multiple cancer indications.

Further information about the Company can be found at www.nordicnanovector.com

Source: Nordic Nanovector