On June 12, 2018 Nordic Nanovector ASA (OSE: NANO) reported that the US Food & Drug Administration (FDA) has granted Fast Track designation to Betalutin (177Lu-lilotomab satetraxetan) for the treatment of patients with relapsed or refractory follicular lymphoma (FL) after at least 2 prior systemic therapies (Press release, Nordic Nanovector, JUN 12, 2018, View Source [SID1234553499]).

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Lisa Rojkjaer MD, Nordic Nanovector CMO, commented: "We are pleased to have been granted Fast Track designation for Betalutin. This designation is based on the promising safety and preliminary efficacy data in patients with relapsed/refractory indolent non-Hodgkin’s lymphoma from the first part of the LYMRIT 37-01 study, and highlights the potential of Betalutin to be a new therapeutic option for these patients. We are now focusing the PARADIGME trial on 3L CD20-refractory FL patients, a population in urgent need of new therapies, and look forward to working with the FDA to advance the development of Betalutin".

PARADIGME is a global randomised Phase 2b clinical trial comparing two Betalutin dosing regimens (15MBq/kg Betalutin following 40mg lilotomab pre-dosing; 20MBq/kg Betalutin following 100mg/m2 lilotomab pre-dosing) in 3L FL patients. PARADIGME aims to enrol 130 patients across 80-85 sites in approximately 20 countries.

The primary endpoint for the study is overall response rate (ORR) and secondary endpoints include duration of response (DoR), progression free survival (PFS), overall survival (OS), safety and quality of life. An initial efficacy and safety data read-out for PARADIGME is targeted for the first half of 2020.

About Fast Track designation

Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious diseases and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. The designation provides the opportunity for more frequent meetings with the FDA over the course of drug development. In addition, the Fast Track programme allows for Rolling Review, which enables a company to submit individual sections of its Biologic License Application (BLA) for review as they are ready, rather than waiting until all sections of the BLA are complete, as well as for eligibility for Accelerated Approval and Priority Review if relevant criteria are met.

-End-

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/Isabelle Andrews (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). CD37 is highly expressed in B-cell non-Hodgkin’s lymphoma (NHL), representing a novel therapeutic target. Betalutin is internalised in tumour cells and prolonged exposure of the nucleus to radiation destroys DNA leading to tumour cell death. Betalutin also has a crossfire effect limited to a radius of 40 cells, which destroys surrounding tumour cells. Betalutin has shown promising efficacy and tolerability in the Phase 1/2a LYMRIT 37-01 clinical study in relapsed/refractory follicular lymphoma (R/R FL) and is currently in a pivotal Phase 2b trial, PARADIGME, in third line (3L) FL patients who are refractory to standard-of-care anti-CD20-based therapy (including rituximab).

On June 11, 2018 Nordic Nanovector ASA (OSE: NANO) reported that a poster reporting the ability of Betalutin (177Lu-lilotomab satetraxetan) to reverse resistance to anti-CD20 treatment in non-Hodgkin’s lymphoma (NHL) cell lines will be presented at the inaugural AACR (Free AACR Whitepaper) International Meeting: Advances in Malignant Lymphoma (22-26 June, Boston, MA, USA) (Press release, Nordic Nanovector, JUN 11, 2018, View Source [SID1234553500]).

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The preclinical data, described in an abstract published online (link here), demonstrate that treatment of rituximab-resistant NHL cells with Betalutin significantly elevated the expression of the CD20 receptor on the surface of cells. The increase in CD20 receptors re-sensitizes the cells to the anti-CD20 NHL immunotherapies rituximab (Rituxan) and obinutuzumab (Gazyva/Gazyvaro), causing increased tumour cell death.

These results support previous preclinical studies that highlight the synergistic anti-tumour effects of combining Betalutin with rituximab immunotherapy. Nordic Nanovector is planning to investigate this novel combination therapy in patients with relapsed/refractory follicular lymphoma in the Archer-1 Phase 1b clinical study. This study is targeting dosing of the first patient in the second half of 2018.

Details for the poster presentation are as follows:

Poster Title: 177Lu-lilotomab satetraxetan has the potential to counteract resistance to rituximab and obinutuzumab in non-Hodgkin’s lymphoma Session

Date and Time: Saturday 23 June, 11:45 AM to 1:45 PM (Eastern Daylight Time)

Poster Session A: Basic and Translational Science 1

Location: Salon F, 4th floor, Boston Marriot Copley Plaza Permanent

Abstract Number: A28

The poster will be available on the company’s website at the time of the presentation: www.nordicnanovector.com.

On June 11, 2018 Bristol-Myers Squibb Company (NYSE: BMY) reported that it will take part in Goldman Sachs 39th Annual Global Healthcare Conference on Wednesday, June 13, 2018, in Rancho Palos Verdes, CA (Press release, Bristol-Myers Squibb, JUN 11, 2018, View Source [SID1234527263]). Johanna Mercier, Head of U.S. Commercial, and Fouad Namouni, Head of Oncology Development, will answer questions about the company at 6:20 p.m. ET (3:20 p.m. PT).

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Investors and the general public are invited to listen to a live webcast of the session at View Source An archived edition of the session will be available later that day.

On June 11, 2018 Clovis Oncology, Inc. (Nasdaq: CLVS) reported that Patrick J. Mahaffy, Chief Executive Officer and President, will present at the Goldman Sachs 39th Annual Global Healthcare Conference onTuesday, June 12, 2018 at 4:00 PM Pacific Time (Press release, Clovis Oncology, JUN 11, 2018, View Source [SID1234527264]). The conference will be held at the Terranea Resort in Rancho Palos Verdes, CA.

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A live webcast of the presentation can be accessed through the investor relations section of the Company’s website at www.clovisoncology.com. Following the live presentation, a replay of the webcast will be available on the Company’s website for 30 days.

On JUN 11, 2018 Targovax ASA ("Targovax" or "the Company"; OSE: TRVX), a clinical stage company focused on developing and commercializing immune activating oncology therapies to target, primarily, treatment resistant solid tumors, reported an update to its clinical development strategy (Press release, Targovax, JUN 11, 2018, View Source [SID1234527412]).

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Targovax has previously reported encouraging proof-of-concept data from clinical trials with both of its immune activator platforms technologies; ONCOS, which uses genetically armed oncolytic adenoviruses, and TG, a neo-antigen vaccine that targets mutant RAS cancers. However, based on recent external clinical data and market dynamics, Targovax has decided to prioritize and strengthen the development focus on the ONCOS program.

Over the past 12 months, there has been clinical data released from multiple external studies corroborating the potential of oncolytic viruses as an important class of immune activating agents that can boost the effect of other treatments, such as checkpoint inhibitors. This notion is further strengthened by increased partnering and M&A activity by major global pharmaceutical companies, underscored by the acquisitions earlier this year of Viralytics and Benevir by Merck and Johnson & Johnson, respectively.

Furthermore, data presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting on June 1-5 has fundamentally changed the development preconditions for the TG program. Data from independent trials testing the chemotherapy cocktail Folfirinox in resected pancreas cancer, the lead indication for TG01, has demonstrated an improvement in median overall survival of up to 2 years compared to the current standard of care (gemcitabine and capecitabine). These results are great news for patients suffering from this difficult-to-treat cancer. It is expected that the Folfirinox treatment regimen will be quickly adopted as a new standard of care in resected pancreatic cancer, and it is already clear that that the design of Targovax’s planned randomized phase II trial of TG01 in combination with gemcitabine and capecitabine is inadequate and that the trial will not start. Although we are confident that TG01 will be active in combination with any standard of care therapy, the new Folfirinox median survival benchmark of close to 5 years means that such a combination trial is not practically feasible for Targovax.

Targovax strongly believes in the potential of the TG platform to treat mutant RAS cancers, and is encouraged by the signal of efficacy seen in the recent phase I/II trial in resected pancreas cancer. In addition, the company already has a phase I trial underway in colorectal cancer with TG02, the second-generation product from the TG program, combining with pembrolizumab. This trial is expected to read out in 2019. In light of the new Folfirinox data, the Company will together with its clinical advisors reevaluate and reshape the development plans for TG, and devise a strategy for how to best create value for both patients and shareholders. A revised development strategy for the TG program will be presented during the autumn.

The resources freed up by this decision will be allocated to strengthen and speed up ONCOS development. In particular, Targovax is currently looking into options to expand the ongoing trial in mesothelioma, the target launch indication for ONCOS-102.

Øystein Soug, CEO of Targovax said "It is fortunate for us that the emerging Folfirinox data in resected pancreatic cancer was presented at ASCO (Free ASCO Whitepaper) already this year, as it gave us the opportunity to reassess our trial design before committing to an inadequate combination treatment. We are confident that our TG vaccine has potential to benefit patients with mutant RAS cancers, and will now reassess the TG development plan. ONCOS continues to be our lead program, and we will further sharpen our focus to drive ONCOS-102 forward with full force, and remain in the forefront of oncolytic virus development"