On June 21, 2018 PharmaEngine Inc. (TWO: 4162) and its corporate partner, Nanobiotix S.A. (Euronext: NANO) reported that PEP503 (NBTXR3) in combination with radiotherapy met the primary endpoint of pathological Complete Response Rate (pCRR) as compared to radiotherapy alone in a global pivotal phase II/III trial in patients with locally advanced soft tissue sarcoma (STS) of the extremity and trunk wall (Press release, PharmaEngine, JUN 21, 2018, View Source [SID1234527423]). The pCRR on the combination arm was 16.1% as compared to 7.9% for the control arm of radiotherapy alone (p = 0.0448). Also PEP503 activated by radiation demonstrated a significant increase of R0 resection rate as compared to radiation alone (p = 0.042). PEP503 demonstrated a good local tolerance among this patient population. The findings showed a very similar radiation-related safety profile in both arms.

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This prospectively randomized, multi-national, open-label and active controlled two-arm (1:1 ratio) pivotal phase II/III trial, referred to as Study 301 (act.in.sarc study) has been conducted in partnership with Nanobiotix. PharmaEngine is the co-sponsor of this study in Asia-Pacific Region. The antitumor activity and safety of PEP503 combined with radiotherapy in Study 301 was compared with that of radiotherapy alone, as preoperative treatment. The primary objective of Study 301 is to enhance pCRR by dosing PEP503 through intra-tumor injection and then activated by standard dose (25 x 2 Gy) of external beam radiation therapy (EBRT). The secondary endpoints are the objective response rate (ORR) by imaging (MRI); the tumor volume changes; the resection margins (R0 rate) and the limb amputation rate, as well as the evaluation of the safety profile in term of clinical and laboratory adverse events. The detailed data analysis, with the exception of long-term follow up will be reported in an international medical conference in the next few months.

"We are very pleased to take part in the global study alongside with Nanobiotix, and are excited that PEP503 has achieved the primary and secondary endpoints of this pivotal study in STS patients," said C. Grace Yeh, Ph.D., President and Chief Executive Officer of PharmaEngine. "The promising results from this study validated its fundamental mechanism of action as a radio-enhancer, which is expected to be generally applicable in other cancers treated with radiotherapy. In addition, previously reported preliminary data from a small set of tumor samples in this study demonstrated that PEP503 activated by radiotherapy induces a specific adaptive immune pattern as an immune-enhancer, while radiotherapy alone did not show any impact on triggering adaptive immune response."

About Study 301 (act.in.sarc study)

The Study 301 recruited a total of 180 patients in Europe (36 sites in 10 countries) by Nanobiotix, and in Asia-Pacific region (7 sites in Australia, Hong Kong, and Philippines) by PharmaEngine. The Global Principal Investigator is Dr. Sylvie Bonvalot, MD, PhD (Head of Sarcoma and Complex Tumor Surgery Unit, Institut Curie, Paris, France). The primary endpoint of pCRR is defined as the rate of patients showing less than 5% of residual viable cancer cells in the tumor post treatment. A centralized evaluation of the pathological response was performed. For additional information, please visit www.clinicaltrials.gov. (Identifier: NCT02379845).

About PEP503 (NBTXR3)

PEP503, the lead project of the NanoXray pipeline of Nanobiotix, is a nanoparticle formulation of hafnium oxide crystals. It is a first-in-class product designed to destroy, when activated by radiotherapy, tumors through physical cell death and metastasis via immunogenic cell death leading to specific activation of the immune system. In August 2012, PharmaEngine licensed the development and commercialization rights of NBTXR3 in the Asia-Pacific region from Nanobiotix. In addition to STS, Nanobiotix and PharmaEngine are performing clinical trials in head & neck cancers, liver cancers (liver metastasis and hepatocellular carcinoma), rectal cancer, prostate cancer, as well as in combination with anti-PD1 antibodies in head & neck cancers and non-small cell lung cancer. PEP503 has been classified as a class III medical device in many European and certain Asian countries.

About Soft Tissue Sarcoma (STS)

STS are rare malignant tumors that arise from extraskeletal connective tissues, accounting for 0.7% of all cancers. They can occur anywhere in the body, but most originate in an extremity and the trunk (78%). The conventional treatment for STS is wide margin surgery whenever possible with the addition of radiotherapy. In locally advanced STS, however, clear margins are not often achievable, which could lead to higher local failure rates, and negatively affect overall survival. Scientific reports have demonstrated how preoperative radiotherapy can offset the negative prognostic impact of marginal resection on local outcome and survival for patients with STS, extending the limit of limb and function preservation.

Although improvements in surgical techniques and preoperative radiotherapy have been made, local tumor recurrence and distant metastases have been frequently noted to develop. PEP503 (NBTXR3), a radio-enhancer designed to maximize x-ray absorption within the tumor, aims to improve the efficacy of radiotherapy and increase the feasibility of surgical tumor removal.

On June 21, 2018 Alligator Bioscience (Nasdaq Stockholm: ATORX), a biotechnology company developing antibody-based pharmaceuticals for tumor-directed immunotherapy, reported that it will present additional preclinical data for the drug candidate ATOR-1017 at the 3rd Annual World Preclinical Congress in Boston, US (Press release, Alligator Bioscience, JUN 21, 2018, View Source [SID1234527422]). ATOR-1017 is a monoclonal antibody being developed for the treatment of metastasizing cancer. ATOR-1017 activates the costimulatory receptor 4-1BB which is highly expressed on both T cells and NK cells in the tumor environment.

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These new data show that ATOR-1017 activates NK cells as well as T cells, both contributing to an effective immune-mediated killing of tumor cells. NK cells are immune cells that directly target tumor cells which attempt to evade the immune system. NK cells also enhance the cytotoxic response induced by tumor specific T cells. Agonistic antibodies recognizing 4-1BB will therefore strengthen the tumor killing capacity of both NK cells and cytotoxic T cells.

The data further support a best-in-class profile for ATOR-1017, with demonstrated high efficacy and potential for tumor-directed immune activation.

"These preclinical data provide further evidence of ATOR-1017’s unique positioning as a best-in-class 4-1BB antibody. ATOR-1017 has the properties and potential to minimize side-effects and to induce a powerful, long lasting immune response," said Christina Furebring, SVP Research, at Alligator Bioscience.

Dr Karin Enell Smith, Senior Scientist Preclinical Development at Alligator, will give an oral presentation with the title: "ATOR-1017 – A tumor directed Fcγ-receptor cross-linking dependent 4-1BB agonistic antibody" today at 3:30 p.m. EDT (9:30 p.m. CEST)

For further information, please contact:
Cecilia Hofvander, Director Investor Relations & Communications
Phone +46 46 286 44 95
E-mail: [email protected]

The information was submitted for publication, through the agency of the contact person set out above, at 8:00 a.m. CEST on June 21, 2018.

About ATOR-1017
ATOR-1017 is an immunostimulatory antibody (IgG4) that binds to the costimulatory receptor 4-1BB (also known as CD137) expressed on tumor-specific T cells and NK cells. 4-1BB has the capacity to support the immune cells involved in tumor control, making 4-1BB a particularly attractive target for cancer immunotherapy.

ATOR-1017 is differentiated from other 4-1BB antibodies, partly because of its unique binding profile, but also because its immunostimulatory function is dependent on cross-linking to Fc-gamma receptors on immune cells. The aim is to achieve effective tumor-targeted immune stimulation with minimum side effects.

On June 21, 2018 Taiho Oncology, Inc. and Servier reported clinical data from the pivotal Phase III trial (TAGS) evaluating LONSURF (trifluridine and tipiracil, TAS-102) plus best supportive care (BSC) versus placebo plus BSC in patients with previously treated metastatic gastric cancer refractory to standard therapies (Press release, Taiho, JUN 21, 2018, View Source [SID1234527421]). This trial met its primary endpoint of overall survival (OS) and secondary endpoint measures of progression-free survival (PFS), and safety and tolerability, as well as quality of life. The data were presented as oral and poster presentations at the ESMO (Free ESMO Whitepaper) 20th World Congress on Gastrointestinal Cancer 2018 (ESMO-GI) in Barcelona, Spain, June 20 to 23.

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In the TAGS trial, patients treated with LONSURF had a 31% risk reduction of death and a prolongation of their median survival by 2.1 months when compared with placebo (OS of 5.7 months compared to 3.6 months in the placebo group (hazard ratio [HR]: 0.69; 95% confidence interval [CI] 0.56, 0.85; one-sided p=0.0003); at 12-months, OS rates were 21.2% in the LONSURF group and 13.0% in the placebo group. In addition, the risk for disease progression as measured by PFS, a key secondary endpoint, was reduced by 43% (HR: 0.57).

Any Grade 3 or higher adverse events (AEs) occurred in 80% of treated patients who received LONSURF and in 58% of treated patients who received placebo. Grade 3/4 hematological AEs in patients treated with trifluridine and tipiracil included neutropenia (38%), leucopenia (21%), anemia (19%) and lymphocytopenia (19%). Of the 38% of patients who experienced grade 3/4 neutropenia when treated with LONSURF, six (2%) experienced febrile neutropenia. No new safety signals were observed for LONSURF in the TAGS study.

"We are excited to be able to share these important data with the medical oncology community and to continue to add to the growing body of research supporting the efficacy and safety of LONSURF," said Martin J. Birkhofer, MD, senior vice president and Chief Medical Officer, Taiho Oncology, Inc. "We intend to include these data in an sNDA submission to the U.S. Food and Drug Administration (FDA) for consideration as a third-line treatment option for appropriate patients with metastatic gastric cancer."

LONSURF is currently indicated in the United States for the treatment of patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy and, if RAS wild-type, an anti-EGFR therapy.1

"These results provide a potential new treatment option to patients with advanced gastric cancer," said Professor Josep Tabernero, MD, PhD, MSc, head of the Medical Oncology Department at the Vall d’Hebron Barcelona Hospital Campus, director of the Vall d’Hebron Institute of Oncology (VHIO), and primary investigator on the TAGS trial. "We are grateful to the patients, caregivers and physician investigators for their participation in this important clinical study."

The abstract for this presentation is available on the ESMO (Free ESMO Whitepaper)-GI website at View Source

About TAGS
The TAGS (TAS-102 Gastric Study) trial is a Taiho-sponsored pivotal Phase III multinational, randomized, double-blind study evaluating LONSURF (trifluridine and tipiracil), also known as TAS-102, plus best supportive care (BSC) versus placebo plus BSC in patients with metastatic gastric cancer refractory to standard treatments. The primary endpoint in the TAGS trial is overall survival (OS), and secondary endpoint measures include progression-free survival (PFS), and safety and tolerability, as well as quality of life.

The TAGS trial aimed to enroll 500 adults 18 years and older with metastatic gastric cancer who had previously received at least two prior regimens for advanced disease. The trial enrolled 507 subjects and was conducted in Japan, North America, Europe, Russia and Turkey, among other locations.

For more information on the TAGS trial, please visit www.ClinicalTrials.gov (View Source). The ClinicalTrials.gov Identifier is NCT02500043.

About Metastatic Colorectal Cancer
Colorectal cancer is the third most common type of cancer, excluding skin cancers, in the United States, with an estimated 135,430 new patients diagnosed in 2017.2 It is the second and third leading cause of cancer-related deaths among men and women, respectively.2

Colorectal cancers that have spread to other parts of the body are often harder to treat and tend to have a poorer outlook.3 Metastatic, or stage IV colon and rectal cancers, have a five-year relative survival rate of about 11% and 12%, respectively.3 Still, there are often many treatment options available for people with this stage of cancer.3 Further, treatments have improved over the last few decades.3 As a result, there are now more than one million survivors of colorectal cancer in the United States.3

About Metastatic Gastric Cancer
Gastric cancer, also known as stomach cancer, is a disease in which malignant cells form in the lining of the stomach. It is the fifth most common cancer worldwide and the third most common cause of cancer-related death (after lung and liver cancer), with an estimated 723,000 deaths annually.4 Approximately 50% of patients with gastric cancer have advanced disease at the time of diagnosis.5

Standard chemotherapy regimens for advanced gastric cancer include fluoropyrimidines, platinum derivatives, and taxanes (with Ramucirumab), or irinotecan. The addition of trastuzumab to chemotherapy is standard of care for patients with HER2-neu-positive advanced gastric cancer. However, after failure of first- and second-line therapies, standard third-line treatments are limited.

About LONSURF (TAS-102)
LONSURF is an oral combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor, anticancer drug indicated in United States for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy and, if RAS wild-type, an anti-EGFR therapy.1 LONSURF is also available in EU,6 Japan, and other countries.

In June 2015, Taiho Pharmaceutical Co., Ltd. entered into an exclusive license agreement with Servier for the co-development and commercialization of LONSURF. Under the terms of the agreement, Taiho Pharmaceutical Co., Ltd. granted Servier the right to co-develop and commercialize LONSURF in Europe and other countries outside of the United States, Canada, Mexico and Asia. Taiho Pharmaceutical Co., Ltd. retains the right to develop and commercialize LONSURF in the United States, Canada, Mexico, and Asia and to manufacture and supply the product.

Important Safety Information1

WARNINGS AND PRECAUTIONS

Severe Myelosuppression: In RECOURSE Study, LONSURF caused severe and life-threatening myelosuppression (Grade 3-4) consisting of anemia (18%), neutropenia (38%), thrombocytopenia (5%), and febrile neutropenia (3.8%). One patient (0.2%) died due to neutropenic infection. In Study 1, 9.4% of LONSURF-treated patients received granulocyte-colony stimulating factors.

Obtain complete blood counts prior to and on day 15 of each cycle of LONSURF and more frequently as clinically indicated. Withhold LONSURF for febrile neutropenia, Grade 4 neutropenia, or platelets less than 50,000/mm3. Upon recovery, resume LONSURF at a reduced dose as clinically indicated.

Embryo-Fetal Toxicity: LONSURF can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with LONSURF.

USE IN SPECIFIC POPULATIONS

Lactation: It is not known whether LONSURF or its metabolites are present in human milk. There are no data to assess the effects of LONSURF or its metabolites on the breast-fed infant or the effects on milk production. Because of the potential for serious adverse reactions in breast-fed infants, advise women not to breastfeed during treatment with LONSURF and for 1 day following the final dose.

Male Contraception: Because of the potential for genotoxicity, advise males with female partners of reproductive potential to use condoms during treatment with LONSURF and for at least 3 months after the final dose.

Geriatric Use: Patients 65 years of age or over who received LONSURF had a higher incidence of the following compared to patients younger than 65 years: Grade 3 or 4 neutropenia (48% vs 30%), Grade 3 anemia (26% vs 12%), and Grade 3 or 4 thrombocytopenia (9% vs 2%).

Hepatic Impairment: Patients with severe hepatic impairment (total bilirubin greater than 3 times ULN and any AST) were not studied. No adjustment to the starting dose of LONSURF is recommended for patients with mild hepatic impairment. Do not initiate LONSURF in patients with baseline moderate or severe (total bilirubin greater than 1.5 times ULN and any AST) hepatic impairment.

Renal Impairment: In RECOURSE Study, patients with moderate renal impairment (CLcr=30 to 59 mL/min, n=47) had a higher incidence (difference of at least 5%) of ≥Grade 3 adverse events, serious adverse events, and dose delays and reductions compared to patients with normal renal function (CLcr ≥90 mL/min, n=306) or patients with mild renal impairment (CLcr=60 to 89 mL/min, n=178).

Patients with moderate renal impairment may require dose modifications for increased toxicity. Patients with severe renal impairment were not studied.

ADVERSE REACTIONS

Most Common Adverse Drug Reactions in Patients Treated With LONSURF

(≥5%): The most common adverse drug reactions in LONSURF-treated patients vs placebo-treated patients with refractory mCRC, respectively, were asthenia/fatigue (52% vs 35%), nausea (48% vs 24%), decreased appetite (39% vs 29%), diarrhea (32% vs 12%), vomiting (28% vs 14%), abdominal pain (21% vs 18%), pyrexia (19% vs 14%), stomatitis (8% vs 6%), dysgeusia (7% vs 2%), and alopecia (7% vs 1%).

Additional Important Adverse Drug Reactions: The following occurred more frequently in LONSURF-treated patients compared to placebo: infections (27% vs 15%) and pulmonary emboli (2% vs 0%).

The most commonly reported infections which occurred more frequently in LONSURF-treated patients were nasopharyngitis (4% vs 2%) and urinary tract infections (4% vs 2%).

Interstitial lung disease (0.2%), including fatalities, has been reported in clinical studies and clinical practice settings in Asia.

Laboratory Test Abnormalities in Patients Treated With LONSURF: Laboratory test abnormalities in LONSURF-treated patients vs placebo-treated patients with refractory mCRC, respectively, were anemia (77% vs 33%), neutropenia (67% vs 1%), and thrombocytopenia (42% vs 8%).

On June 21, 2018 Trovagene, Inc. (NASDAQ: TROV), a clinical-stage oncology therapeutics company, developing targeted therapeutics for the treatment of hematologic and solid tumor cancers, reported they have received Institutional Review Board (IRB) approval from Dana-Farber/Harvard Cancer Center and its Phase 2 clinical trial of PCM-075 in combination with Zytiga (abiraterone acetate) and prednisone in metastatic Castration-Resistant Prostate Cancer (mCRPC) is officially activated and recruiting patients (Press release, Trovagene, JUN 21, 2018, View Source [SID1234527420]). The trial is being conducted by Beth Israel Deaconess Medical Center (BIDMC), Dana-Farber Cancer Institute (Dana-Farber), and Massachusetts General Hospital Cancer Center (MGH). David Einstein, MD, Genitourinary Oncology Program at BIDMC, is the principal investigator for the trial.

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In this multi-center, open-label, Phase 2 trial, PCM-075 in combination with the standard dose of Zytiga (abiraterone acetate) and prednisone, all administered orally, will be evaluated for safety and efficacy. The Phase 2 clinical trial will enroll up to 45 patients, with mCRPC, showing signs of disease progression demonstrated by two rising PSA values separated by at least one week, while on abiraterone acetate and prednisone therapy. The primary efficacy endpoint is the proportion of patients achieving disease control after 12 weeks of study treatment, as defined by lack of prostate specific antigen (PSA) progression in patients who are showing signs of early progressive disease (rise in PSA but minimally symptomatic or asymptomatic) while currently receiving abiraterone acetate and prednisone.

"Prostate cancer will kill an estimated 29,430 men in the United States this year. It is clear that resistance to standard therapies continues to be an urgent problem for our patients. Pre-clinical work has identified polo-like kinase 1 as a drug target meriting study in combination with abiraterone," said Dr. Einstein.

"We are excited to be working with the Dana-Farber/Harvard Cancer Center and look forward to evaluating the impact of PCM-075 in combination with abiraterone acetate in patients with mCRPC," said Bill Welch, Chief Executive Officer of Trovagene.

About Castration-Resistant Prostate Cancer (CRPC)

Castration-Resistant Prostate Cancer (CRPC) is defined by disease progression despite androgen-deprivation therapy (ADT) and may present as one or any combination of a continuous rise in serum levels of prostate-specific antigen (PSA), progression of pre-existing disease, or appearance of new metastases. Prognosis is associated with several factors, including performance status, presence of bone pain, extent of disease on bone scan, and serum levels of alkaline phosphatase. Bone metastases occur in 90% of men with CPRC and can produce significant morbidity, including pain, pathologic fractures, spinal cord compression, and bone marrow failure. Paraneoplastic effects are also common, including anemia, weight loss, fatigue, hypercoagulability, and increased susceptibility to infection. Institution of treatment and the choice of systemic or local therapy depend on a number of factors.

About PCM-075

PCM-075 is a highly-selective adenosine triphosphate (ATP) competitive inhibitor of the serine/threonine polo-like-kinase 1 (PLK 1) enzyme, which is over-expressed in multiple hematologic and solid tumor cancers. PCM-075 only targets PLK1 isoform (not PLK2 or PLK3), is oral, has a 24-hour drug half-life with reversible on-target hematologic toxicities. A Phase 1 open-label, dose escalation safety study of PCM-075 has been completed in patients with advanced metastatic solid tumor cancers and published in 2017 in Investigational New Drugs. The maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) in this trial was 24 mg/m2.

PCM-075 has demonstrated synergy in preclinical studies with over 10 chemotherapeutic and target agents used in hematologic and solid tumor cancers, including abiraterone acetate (Zytiga), FLT3 and HDAC inhibitors, taxanes, and cytotoxins. Trovagene believes the combination of its targeted PLK1 inhibitor, PCM-075, with other compounds has the potential for improved clinical efficacy in Acute Myeloid Leukemia (AML), metastatic Castration-Resistant Prostate Cancer (mCRPC), Non-Hodgkin Lymphoma (NHL), Triple Negative Breast Cancer (TNBC), as well as other hematologic and solid tumor cancers.

Trovagene has a Phase 2 trial of PCM-075 in combination with abiraterone acetate (Zytiga) in metastatic Castration-Resistant Prostate Cancer currently recruiting and enrolling patients that was accepted by the National Library of Medicine (NLM) and is now publicly viewable on www.clinicaltrials.gov. The NCT number assigned by clinicaltrials.gov for this study is NCT03414034.

On June 21, 2018 Nordic Nanovector ASA (OSE: NANO) reported that the first patient has been dosed in its pivotal PARADIGME Phase 2b trial with Betalutin (177Lu-satetraxetan-lilotomab) in third-line (3L) follicular lymphoma (FL) patients who are refractory to anti-CD20 immunotherapy (including rituximab), a population with high unmet medical need (Press release, Nordic Nanovector, JUN 21, 2018, View Source [SID1234527419]).

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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 objective of PARADIGME is to determine the best dosing regimen for Betalutin as a new treatment option for 3L FL patients. The data from this study are expected to support market authorisation applications for Betalutin as a new treatment option for 3L FL patients.

The primary endpoint for the trial 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. Initial efficacy and safety data read-out for PARADIGME is target for the first half 2020.

Lisa Rojkjaer MD, Nordic Nanovector CMO, commented: "Dosing of the first patient in PARADIGME marks important progress for Nordic Nanovector in the development of Betalutin for the treatment of FL patients. We remain convinced of the drug’s potential in this indication following promising clinical data to-date and look forward to advancing this clinical trial to a successful conclusion."

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 (lilotumab) 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).