Update on PARADIGME from Nordic Nanovector

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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

Vaccibody with informed consent from first patient

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Our portfolio company Vaccibody is ready to start the first clinical trial of their personalized neoantigen cancer vaccines to target solid tumors as the first patient has signed the informed consent.

 

The news hit the front page of the second largest newspaper in Norway, VG

 

Vaccibody AS is a clinical stage immunotherapy company focused on developing personalised neoantigen cancer vaccines to target solid tumors. The company is now ready to start the phase I/II clinical trial of the vaccines and the first patient will be enrolled in, Germany at the National Center for Tumor Diseases by principal investigator, Prof. Dr. med. Jürgen Krauss, Head of Section for Clinical Immunotherapy.

 

Dr. Agnete Fredriksen, President and Chief Scientific Officer in Vaccibody, commented “The first patient marks an important new phase in Vaccibody and we are very excited to start to tailor-make one vaccine per patient using our proprietary vaccination technology. The unique ability to induce strong CD8 T cell responses to multiple neoepitopes that we have observed in preclinical models, in addition to the manufacturing advantages essential for individualized vaccines, are basis for our enthusiasm moving this concept into clinical trials.”

 

This first-in-man trial is planned to enroll up to 40 patients with locally advanced or metastatic non-small cell lung cancer, melanoma, renal, bladder or head and neck cancer. The VB10.NEO vaccine will be given in combination with standard of care checkpoint inhibitors as a new treatment modality to help patients with cancer.

 

Prof. Dr. med. Jürgen Krauss, said, “We are very pleased to have initiated this clinical phase I/IIa for Vaccibody’s neoantigen vaccine. The neoantigen vaccine holds the potential to assist the patient’s immune system to generate specific T-cell responses to its individual cancer neoantigens and in this way may help the patient to more effectively fight the cancer. We hope this clinical trial will help pave the way for a novel class of new efficacious and safe treatment for cancer patients”

 

 

About Vaccibody AS
Vaccibody is a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies. Vaccibody is a leader in the rapidly developing field of individualized cancer neoantigen vaccines and is using the Vaccibody technology to generate best-in-class therapeutics to treat cancers with a high unmet medical need.

Vaccibody’s front runner program (VB10.16) is a therapeutic DNA vaccine against HPV16 induced pre-malignancies and malignancies. The first-in-human study (phase I/IIa), which is now fully enrolled, evaluates the safety and immunogenicity of VB10.16 in women with high grade cervical intraepithelial neoplasia (HSIL; CIN 2/3).

Source: www.vaccibody.com

PCI Biotech: “A transformative year”

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Our portfolio company PCI Biotech published their full year report for 2017 today. 

 

 

Per Walday, CEO of PCI Biotech, comments: “The achievements in 2017 has transformed PCI Biotech to a pivotal phase ready company with two promising assets in clinical development. The regulatory discussions last year provided important information on the requirements to bring fimaCHEM to the market and our focus is now on progression of all activities leading to start of the pivotal development phase.  The clinical translation of the fimaVACC asset has provided promising initial results, suggesting that fimaVACC can provide highly sought-after features for vaccination technologies, such as early responses and high response rates.”

 

Highlights

  • New funds raised enabling further progress in development programmes. Successful rights issue completed in January 2017, enabling PCI Biotech to progress the fimaCHEM programme in bile duct cancer towards pivotal phase.
  • Received important guidance from regulators for development of fimaCHEM in bile duct cancer.Encouraging outcome from regulatory meetings on the development for treatment of bile duct cancer.
  • Granted Orphan Drug Designation (ODD) for fimaporfin in bile duct cancer by the US FDA. ODD is a significant regulatory milestone providing important development and commercialisation benefits.
  • Promising initial clinical results for the fimaVACC programme. The initial clinical results on overall T-cell responses indicate enhanced cellular immune responses, with early and high response rates.
  • Progress in research collaborations with key players for the fimaNAc programme. Collaboration projects with key players within nucleic acid therapeutics were expanded and extended.
  • Executive management team further strengthened with Dr Olivecrona as Chief Medical Officer. Dr Olivecrona leads the execution of all clinical development programmes.

Source: PCI Biotech

Tidligere leder av Utprøvingsenheten, Steinar Aamdal, går til Ultimovacs

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Vår porteføljebedrift Ultimovacs AS har nylig ansatt professor emeritus Steinar Aamdal som Senior Medical Adviser.

 

Steinar Aamdal går nå av ved aldersgrensen for stillingen som overlege ved Avdeling for kreftbehandling ved Oslo universitetssykehus. Han har etablert og ledet Utprøvingsenheten på Radiumhospitalet som utfører tidlig-fase studier av nye kreftmedisiner. De senere år har han vært leder av Seksjon for utprøvende kreftbehandling og forskningsstøtte.

 

 

Bidra med kunnskap, kompetanse og nettverk

I Ultimovacs skal Aamdal bidra med sin kunnskap, kompetanse og sitt nettverk for å utvikle Ultimovacs sin vaksineteknologi til å bli et viktig bidrag i fremtidens kreftbehandling.

Som svar på hvorfor han ønsker å arbeide i Ultimovacs sier Aamdal:

«Immunterapi har revolusjonert kreftbehandlingen. For første gang ser vi mulighetene til å kunne kurere pasienten med alvorlig kreftsykdom. Den utviklingen som skjer i Ultimovacs med sine kreftvaksiner er noe av det mest lovende og spennende som skjer innen immunterapi. Jeg ser fram til å være del av dette miljøet og å kunne bidra til videre utvikling av kreftvaksinene.»

Daglig leder Øyvind Kongstun Arnesen kommenterer:

«For oss er det svært bra å få med en kapasitet som Steinar Aamdal på laget. Vi skal ta mange viktige og komplekse beslutninger i tiden som kommer. Å få med vurderingene til Aamdal har stor betydning og gir oss trygghet. Vi har dessuten behov for å diskutere og samarbeide med eksterne miljøer. Aamdal kjenner disse fra før og vi kan raskere komme i gang med samarbeidsprosjekter.»

 

Om Ultimovacs:

Ultimovacs AS er et norsk selskap som arbeider med å utvikle immunterapi mot kreft i form av en universell kreftvaksine.  I dag har selskapet 12 ansatte som holder til i Oslo Cancer Cluster Innovasjonspark ved Radiumhospitalet.

Selskapet har avsluttet tre fase-I-studier som har dokumentert vaksinens sikkerhet og evne til å aktivere immunsystemet. Selskapet arbeider systematisk mot søknad om registrering av vaksinen som nytt kreftlegemiddel.

Ultimovacs’ største eiere er Gjelsten Holding AS, Inven2 AS, Canica AS, Radiumhospitalets Forskningsstiftelse, Sundt AS, Langøya Invest AS, og Watrium AS.

Les mer: www.ultimovacs.com

Photocure: FDA approval for new indications

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Our portfolio company Photocure ASA with great news form the U.S: FDA has today approved the indication for Blue Light Cystoscopy (BLC™) with Cysview® to include Flexible Cystoscopes. This  means that Photocure´s drug and device for detection of bladder cancer may also be used in the ongoing surveillance of afflicted patients. 

 

The approval of this new indication is based on the results from a large Phase 3 study using KARL STORZ blue light enabled rigid and flexible cystoscopes. This study showed that BLC™ significantly  improves detection of patients with recurrent bladder cancer.

“This approval is an important milestone for Photocure. With 1.2 million surveillance cystoscopies performed annually in the U.S., this represents a significant opportunity for the company and allows us to bring solutions to current clinical challenges,” said Kjetil Hestdal M.D. Ph.D., President & CEO.

“The expanded label now allows repetitive use in the same patient which enables physicians to provide an improved continuum of care to their bladder cancer patients and should lead to reduced cost.”

Bladder cancer is the fifth most commonly diagnosed cancer in the U.S., and also one of the most expensive cancers to manage, accounting for approximately $3.7 billion in direct costs each year.

 

35 % more patients diagnosed 
The expanded indication includes the combination of Cysview with the KARL STORZ PDD Flexible Blue Light Videoscope System. The approval also expands the indication in the current rigid setting (TURBT) by including the detection of carcinoma in situ (CIS) in bladder cancer patients as well as the repeated use of BLC with Cysview.

“Blue light cystoscopy with Cysview, will enable physicians to provide appropriate and more accurate treatment earlier, which in my experience results in improved outcomes for my patients. In this study, an additional 35% of CIS patients were found by using BLC with Cysview alone and missed with white light,” says Gary Steinberg, M.D., The Bruce and Beth White Family Professor, Vice Chairman and Director of Urologic Oncology, University of Chicago Medicine.

In collaboration with KARL STORZ Endoscopy-America, Inc., Photocure plans to launch Cysview in combination with blue light enabled flexible video cystoscopy in mid-2018.

 

For more information on this news – please read the full press release from Photocure.

Facts:

 

About Hexvix®/Cysview®
Hexvix®/Cysview® is a drug that is selectively taken up by cancer cells in the bladder making them glow bright pink during Blue Light Cystoscopy (BLCTM). BLCTM with Hexvix® /Cysview® improves the detection of tumors and leads to more complete resection, less residual tumors and better management decisions.

Cysview® is the tradename in the US and Canada, Hexvix® is the tradename in all other markets. Photocure is commercializing Hexvix®/Cysview® directly in the US and the Nordic region, and has strategic partnerships for the commercialization of Hexvix®/Cysview® in Europe, Canada, Australia and New Zealand. Please refer to https://www.photocure.com/Partnering-with-Photocure/Our-partners for further information on our commercial partners.

About KARL STORZ Endoscopy-America, Inc.
KARL STORZ Endoscopy-America, Inc., is an affiliate of KARL STORZ SE & Co. KG, an international leader for more than 70 years in reusable endoscope technology, encompassing all endoscopic specialties. Based in Tuttlingen, Germany, KARL STORZ SE & Co. KG is a family-owned company that designs, engineers, manufactures, and markets all its products with an emphasis on visionary design, precision craftsmanship and clinical effectiveness. For more information, call (800) 421-0837 or visit the company’s website at www.karlstorz.com.

About Photocure
Photocure, headquartered in Oslo Norway, is a specialty pharmaceutical company focusing on urology. Based on its unique proprietary Photocure Technology® platform, Photocure is committed to developing and commercializing highly selective and minimally invasive solutions to improve health outcomes for patients worldwide. The company is listed on the Oslo Stock Exchange (OSE: PHO).

More information about Photocure is available at www.photocure.com, www.hexvix.com, www.cysview.com

– Productive year for Targovax

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Our portfolio company Targovax ASA presents full year and fourth quarter results for 2017 today. CEO Øystein Soug says they had a productive year where they made progress with product candidates and also raised significant funding.

 

Targovax is a clinical stage company focused on developing immuno-oncology therapies to target solid tumors. 

 

Øystein Soug, CEO: “2017 was a very productive year for Targovax, in which we made significant progress with product candidates from both of our two platforms, and completed a significant fund-raising to deliver on our ongoing clinical program. In particular, the initial clinical data from the TG01 trial in pancreatic cancer were encouraging and we look forward to the complete trial results in this challenging disease in the first half of 2018. Overall, the prospects are great for 2018, where we anticipate delivery of several clinical data readouts from ongoing trials, which we expect to further demonstrate the potential of our two immuno-oncology platforms.”

 

HIGHLIGHTS FOR THE FOURTH QUARTER 2017

Research & Development

  • In October, Targovax reported encouraging one-year survival rate, immune activation, and safety data for the second cohort in the TG01 phase I/II trial in resected pancreatic cancer, in line with data from the first cohort published earlier in the year
  • In October, Targovax was granted a product composition-of-matter patent in the US for TG02
  • In December, Targovax announced that TG02 had passed the initial safety review in the first-in-man clinical trial in colorectal cancer, and also reported immune activation data in the first treated patients
  • In December, Targovax announced that the two first combination trials with ONCOS-102, in melanoma and mesothelioma, both had passed their initial, planned, safety reviews

  

Corporate

  • In November, Patrick Vink was appointed as the new chairman of the Board of Directors
  • In December, Targovax was included in the OSEBX index at the Oslo Stock Exchange

 

POST-PERIOD HIGHLIGHTS

  • In January, Targovax announced that ONCOS-102 generated immune activation in checkpoint inhibitor (CPI) refractory melanoma in four out of the first four patients treated
  • Also in January, Dr. Michael Bogenstätter was appointed Chief Business Officer of Targovax
  • In February, Targovax announced that the safety lead-in part of its ONCOS-102 trial in unresectable, malignant, pleural mesothelioma was completed without any safety concerns, and that ONCOS-102 generates immune activation in treated patients

 

Reporting material

The quarterly report and presentation are also available at the website  www.targovax.com.

 

 

About Targovax: Arming the patient’s immune system to fight cancer

Targovax (OSE:TRVX) is a clinical stage company focused on developing and commercializing novel immuno-oncology therapies to target, primarily, treatment-resistant solid tumors. Immuno-oncology is currently one of the fastest growing therapeutic fields in medicine.

The Company’s development pipeline is based on two novel proprietary platforms:

The first platform, ONCOS, uses oncolytic viruses as potential multi-target, neo-antigen therapeutic cancer vaccines. ONCOS uses an adenovirus that has been engineered to be an immune activator that selectively targets cancer cells. In phase I trials it has demonstrated immune activation at lesional level which was associated with clinical benefit. In an ongoing phase I trial in advanced melanoma we expect important proof of concept data for checkpoint inhibitor refractory patients.

The second platform, TG, are neo-antigen cancer vaccines designed to specifically treat tumors that express mutated forms of RAS. Mutations to the RAS protein are common in many cancers and are known to drive aggressive disease progression and treatment resistance. There is a high unmet medical need for therapies that are effective against tumors that express these mutations. The TG platform’s therapeutic potential stems from its ability to enable the patient’s immune system to identify and destroy tumors bearing any RAS mutations. In early 2017, key proof of concept data for the TG platform from a clinical trial of TG01 in resected pancreatic cancer patients showed encouraging overall survival and will give guidance for the future clinical development of this platform.

Targovax’s development pipeline has three novel therapeutic candidates in clinical development covering six indications.

Both platforms are protected by an extensive portfolio of IP and know-how and have the potential to yield multiple product candidates in a cost-effective manner. Additionally, Targovax has other products in early stages of development.

Source: Targovax. 

Prestigious BIA-funding to OncoImmunity and Oncoinvent

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Our portfolio companies Oncoinvent and OncoImmunity  have both been awarded funding from the prestigious BIA-programme. This is a Norwegian Research Council programme that funds user-driven innovation research across all industries. 

 

Oncoinvent receives funding for the project “Development of an alpha-emitting product for cancer treatment”, whilst OncoImmunity receives funding for the project “A machine-learning platform to predict antibody-stimulating neoantigens from liquid biopsies”.

The BIA programme received 160 applications across all industries for this call. 46 of them were in total granted 483 MNOK.

Both Oncoinvent and OncoImmunty will now enter into contract negotiations with the Research Council to determine the details of the grants, such as the amount of funding granted, timelines and milestones for the project.

 

 

About Oncoinvent
Oncoinvent AS is a privately held Norwegian company based in Oslo, Norway. The company is committed to developing new innovative products to provide better treatment options to cancer patients.

The company’s founders started Oncoinvent in 2010 with a view to designing better cancer treatments by applying known physical and chemical principles of selected novel materials in new ways to maximize their medical benefit while minimizing potential safety concerns. This approach has allowed the company to develop a rich development pipeline and to explore multiple technological avenues before selecting a lead product candidate for preclinical testing.
www.oncoinvent.com

 

About OncoImmunity
OncoImmunity is a bioinformatics company offering proprietary machine-learning based software to address the key knowledge gaps in the prediction of bone fide immunogenic neoantigens for personalized cancer immunotherapy.

OncoImmunity is dedicated to develop software solutions that facilitate effective patient selection for cancer immunotherapy, and identify optimal neoantigen targets for truly personalised cancer vaccines & cell therapies in a clinically actionable time-frame.
www.oncoimmunity.com

 

 

 

Oncoinvent with new production facility at Nydalen

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Our portfolio company Oncoinvent opened brand-new lab and production facilities at Nydalen Oslo. Now they control the whole production line of their lead product candidate Radspherin.

 

2017 has been a good year for Oncoinvent. The company has relocated and built new office and laboratory facilities, grown from four to twelve employees, and raised new capital. CEO at Oncoinvent Jan A. Alfheim believes that this represents a significant milestone for the company and will enable to further develop Radspherin®, a novel alpha-emitting radioactive microparticle designed for treatment of metastatic cancers in body cavities.

Oncoinvent ends the year in fashion by opening brand new laboratory and production facilities. A lot of interested investors came to tour the new facilities, observing an impressive lab with special infrastructure. Treating radioactivity, and circulating air in a facility that treats radioactive materials, calls for an extra advanced ventilation system.

 

Lab With all the Facilities
The idea of the new lab and research facility is to be able to contain the whole production line, from research to drug manufacturing, to one location. All this contained in an area of 581 m2.

Creating a modern lab with the capabilities to treat radioactive materials in an active and well populated part of Oslo demands very strict guidelines. The production suites in the facility are constructed to be qualified for Good Manufacturing Practice (GMP) for production of Medical Product Candidates. Systems for purifying and monitoring of air and water quality as well as the removal of any potential radioactivity have been installed to ensure the safety of the operators, population and the environment.

The Production and Research areas of the laboratory will facilitate both the development of the Radspherin program and other discovery projects of the Company.

 

A Weapon for Precision Medicine
Radspherin® has been shown to cause a significant reduction in tumor growth in preclinical studies  an it is anticipated that the product can potentially treat several forms of metastatic cancer, primarily in peritoneal carcinomatosis originating from ovarian cancer. Oncoinvent is developing Radspherin® as a ready-to-use injectable product that seeks out cancer tumors and destroys them from inside by emitting its radioactive content.

The first clinical indication for Radspherin® will be treatment of peritoneal carcinomatosis, a rare type of cancer that occurs in the peritoneum, the thin layer of tissue that covers abdominal organs and surrounds the abdominal cavity. Additionally, Oncoinvent has lined up a collaboration with European and American clinical research centers for the clinical development Radspherin®.

 

Source: Oslo Cancer Cluster

 

PCI Biotech with pivotal study in 2018

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Our portfolio company PCI Biotech (OSE: PCIB) got an early Christmas present this year. For some time, they have been in dialogue with the regulatory authorities in the US and Europe. On December 20th, they sent out the notice that they in 2018 will start a pivotal, randomized study on the development of fimaporfin in combination with gemcitabine for treatment of inoperable cholangiocarcinoma, bile duct cancer.

 

Dr Per Walday, CEO of PCI Biotech, said:

“With promising efficacy results generated so far, orphan drug designations granted and guidance from regulators and key opinion leaders, we are focused on finalising the preparations for the pivotal randomised adaptive study. Patients with inoperable cholangiocarcinoma have no approved treatment alternatives today and fimaporfin has the potential to play a role in this area of high unmet medical need. We are therefore pleased that the regulators are open to a potential approval based on interim results“.

A common understanding between the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) has been reached on several important factors for a pivotal study with fimaporfin in inoperable cholangiocarcinoma, including the sufficiency of a single randomised two-arm study and importantly, the potential for accelerated/conditional approval based on interim results.

The required randomised study will provide the opportunity to generate robust comparative data of importance for market acceptance of fimaporfin as a first line treatment of inoperable cholangiocarcinoma.

Further information on the study, which is planned for initiation during the first half of 2018, will be announced following completion of discussions with regulators and clinical advisors.

 

 

About PCI Biotech
PCI Biotech is a biopharmaceutical company focusing on development and commercialisation of novel therapies for the treatment of cancer through its innovative photochemical internalisation (PCI) technology platform. PCI is applied to three distinct anticancer paradigms: fimaCHEM (enhancement of chemotherapeutics for localised treatment of cancer), fimaVACC (T-cell induction technology for therapeutic vaccination), and fimaNAc (nucleic acid therapeutics delivery).

Photochemical internalisation induces triggered endosomal release that is used to unlock the true potential of a wide array of therapeutic modalities. The company’s lead fimaCHEM programme consists of a Phase I/II clinical study in bile duct cancer, an orphan indication with a high unmet need and without approved products. fimaVACCapplies a unique mode of action to enhance the essential cytotoxic effect of therapeutic cancer vaccines, which works in synergy with several other state-of-the-art vaccination technologies. fimaNAc utilises the endosomal release to provide intracellular delivery of nucleic acids, such as mRNA and siRNA therapeutics, thereby addressing one of the major bottlenecks facing this emerging and promising field.

 

Nordicna Novector

ASH: Betalutin® shows strong clinical profile

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Our portfolio company Nordic Nanovector ASA  presented updated results from its LYMRIT 37-01 Phase 1/2 clinical study of Betalutin® (177Lu-satetraxetan-lilotomab) in patients with relapsed/refractory (R/R) indolent NHL (iNHL) at the 59th Annual ASH meeting.

 

The updated data continue to highlight Betalutin®’s strong clinical profile as a single agent for treatment of R/R iNHL, and particularly of third-line R/R follicular lymphoma (3L FL), the primary patient population for which Betalutin® is initially being developed.

 

Single-agent Betalutin® is effective and well-tolerated in patients with R/R iNHL:

· 90% of all patients (n=59) had a reduction in tumour size

· Overall response rate (ORR) of 60% and complete response (CR) of 24% for all evaluable iNHL patients

· Highly active in patients with 2 or more prior therapies (3L FL) with 66% ORR and 25% CR

· Encouraging results in FL patients:

o Arm 1 40/15: 68% ORR and 28% CR

o Arm 4 100/20: 50% ORR and 25% CR

 

· Durable responses, especially for patients with a CR

o 13.3 months for all iNHL patients

▪ 20.5 months for patients with CR

o 13.3 months for FL patients treated with 40 mg lilotomab/15 MBq/kg Betalutin®

▪ 22.9 months for patients with CR

 

As reported previously, Betalutin® treatment was well-tolerated with a safety profile characterized by reversible transient neutropenia and thrombocytopenia and a low incidence of infections.

Dr Arne Kolstad, MD, Principal Investigator of the study, commented: “The data presented at ASH are very exciting. The combination of efficacy, tolerability and the convenience of a single administration highlight Betalutin®’s potential in this primarily elderly, heavily pre-treated patient population. Notably, the CRs seen in both Arm 1 and Arm 4 in FL patients and the duration of responses are very promising, and we look forward to treating more patients in the upcoming PARADIGME study.

Dr Lisa Rojkjaer, Chief Medical Officer of Nordic Nanovector, added: “We are very pleased about these data, which continue to demonstrate a strong clinical profile for Betalutin®, particularly in 3L FL patients. The CR rates are especially encouraging. This is a population of high unmet medical need for whom safe effective therapies are needed, and the Phase 2b PARADIGME trial will focus on these patients. The results obtained provide a strong foundation for this trial.”

The poster has been published on Nordic Nanovector’s website (www.nordicnanovector.com) in the section: /what-we-do/scientific-background/scientific-posters.

 

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. The Company aims to rapidly develop Betalutin®, alone and in combination with other therapies, for the treatment of major types of NHL, targeting first regulatory submission in relapsed/refractory follicular lymphoma in 2019. 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