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
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.
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
Nordic Nanovector is ready to initiate the pivotal Phase 2b study, PARADIGME, with Betalutin® in patients with relapsed, anti-CD 20 Ab-refractory FL (R/R FL), a high unmet medical need group, pending approval of the proposed trial design from regulatory authorities.
PARADIGME is designed to generate the clinical data needed to support the filing of the best Betalutin® dosage regimen for this patient population. The PARADIGME design is aligned with health authority and clinical expert feedback. The company is also enrolling patients into its Phase 1 study in DLBCL, and making final preparations to start a Phase 2 combination study of Betalutin® and rituximab in iNHL patients (ARCHER-1) in 2017. Preparations to initiate a Phase 1 study of Humalutin® are also progressing.
Luigi Costa, CEO of Nordic Nanovector, comments: “The company has made excellent progress during 2017. Clinical results with Betalutin® and in-depth market research confirm its potential to be an important treatment of patients with iNHL. We are on track to start the pivotal PARADIGME study, which aims to compare the two promising dosing regimens that have emerged from our ongoing clinical trial with Betalutin®. We are confident that the trial design will generate the robust data needed and improve the probability of a successful regulatory filing. We are also pleased with recruitment into our DLBCL study and with the preparations to start the ARCHER-1 study of Betalutin® in combination with rituximab, which is on track to begin soon.”
Operational Highlights Q3’17
• Steady progress towards planned start of the pivotal Phase 2b study PARADIGME in 2H 2017 to investigate Betalutin® in patients with 3rd line R/R FL
o PARADIGME expected to be a global, randomized Phase 2b trial comparing the two most promising dosing regimens identified from the LYMRIT-37-01 Phase 1/2 study in approximately 130 patients with R/R FL
o Objective to generate the clinical data needed to support the filing for market approval of the best Betalutin® dosage regimen
o Design builds on promising clinical results and is aligned with regulatory authority feedback
o Protocol amendment submitted and under review by multiple regulatory authorities with further submissions expected in the coming weeks; other preparations to initiate trial underway
o Patient screening anticipated to begin before end of 2017 (pending approval of the amendment)
• Recruitment of DLBCL patients into Phase 1 dose-escalation study with Betalutin® ongoing
o Patient recruitment on track in the US and Europe
• Preparations advancing for Phase 2 clinical trial to investigate the potential of Betalutin® combined with rituximab in 2nd line FL (ARCHER-1)
o Phase 2 trial planned to begin in 2H 2017
• Appointment of Dr. Reza Safaei as Head of Medical Affairs
o First field-based medical staff being recruited, to support patient enrolment into clinical trials in US and EU and to raise awareness of Nordic Nanovector’s technology
Financial Highlights Q3’17
(Figures in brackets = same period 2016 unless otherwise stated)
• Revenues for the third quarter amounted to NOK 0.1 million (NOK 0.1 million). Revenues for the first nine months of 2017 were NOK 0.3 million (NOK 0.2 million).
• Total operating expenses for the third quarter were NOK 72.7 million (NOK 50.4 million). Total operating expenses for the first nine months of 2017 amounted to NOK 214.9 million (NOK 151.3 million).
• Comprehensive loss for the third quarter amounted to NOK 85.9 million (loss of NOK 61.3 million). Comprehensive loss for the first nine months of 2017 was NOK 207.9 million (NOK 176.5 million).
• Cash and cash equivalents amounted to NOK 803.7 million at the end of September 2017 (NOK 881.4 million at 30 June 2017, NOK 933.3 million at 31 March 2017 and NOK 1 018.2 million at 31 December 2016).
Nordic Nanovector aspires to become a leader in the field of Precision Therapies for haematological cancers by developing, manufacturing and commercialising innovative therapies to address major unmet medical needs and advance cancer care.
Betalutin®, the company’s most advanced product candidate, is developing a well differentiated, competitive, clinical profile for R/R FL, based on the promising preliminary results from the LYMRIT 37-01 Phase 1/2 clinical study. The company anticipates initiating its pivotal Phase 2b PARADIGME trial with Betalutin® in 3rd line R/R FL with the goal to have the data read-out and first submission for marketing approval in the second half of 2019. Management will continue to focus its efforts on the efficient execution of its plans and to meet clinical and pre-commercialisation milestones. The company is confident that Betalutin® could become an attractive and convenient therapeutic option, which, based on detailed market research, has the potential to be commercially successful.
Nordic Nanovector intends to maximize the value of Betalutin® across other stages of FL, NHL and other haematological cancer indications. A further element of the company’s strategy is to selectively extend its pipeline of novel targeted biopharmaceutical candidates to support future growth.
Current cash resources are expected to be sufficient until first regulatory filing of Betalutin® in 3L FL, based on the timely approval of the proposed new trial design, and to advance other key programmes.
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
I følge Dagens Medisin får tre prosjekter innen legemiddelproduksjon og produksjon av medisinsk utstyr 41 millioner kroner av Forskningsrådet. To av prosjektene involverer porteføljebedriftene Oncoinvent og Nordic Nnaovector.
Dette er prosjekter som ifølge Forskningsrådet bygger videre på godt etablerte fagmiljøer og aktører, og som skal bidra til å trekke norsk helsenæring i ønsket retning, mot industrialisering.
De 41 millioner kronene fordeles på følgende prosjekter:
- 16 millioner til Development of new production technologies for biopharmaceuticals – produksjon av biologiske legemidler og radiofarmaka i Norge. Er et konsortium med Diatec Monoclonals i spissen, og Catapult Life Science, IFE, Norsk Medisinsk Syklotronsenter, Nordic Nanovector, Prediktor Instruments og Mektron, samt forsknings- og utviklingspartnerne SINTEF Materialer og kjemi, SINTEF Raufoss Manufacturing og Universitetet i Oslo
- 10,6 millioner til Novel technology for production of alpha-emitters for radionuclide therapy – utvikling av ny produksjonsteknologi for radionuklider som er nyere, billigere og mer miljøvennlig enn dagens. Er et konsortium med Thor Medical, Oncoinvent og Reetec, samt IFE som forsknings- og utviklingspartner
- 14,4 millioner til Advanced manufacturing technologies for high impact medical devices, som skal utvikle fleksible og semi-automatiserte prosesser for produksjon av sensorer. Er et konsortium av Sensocure, GE Vingmed Ultrasound og Medistim, samt forsknings- og utviklingspartnerne SINTEF Raufoss Manufacturing, Norner Research AS og Høgskolen i Sørøst Norge
– Det er interessant at Institutt for energiteknikk på Kjeller (IFE) trekker på erfaringene fra blant annet Algeta/Bayer-produksjonen, og ved disse nye prosjektene posisjonerer seg enda sterkere innenfor legemiddelproduksjon, uttaler divisjonsdirektør for innovasjon i Forskningsrådet, Anne Kjersti Fahlvik i pressemeldingen fra Forskningsrådet i følge Dagens Medisin.
– Vi synes også det er spennende at fagmiljøene innenfor sensorfeltet i Vestfold går sammen med solide selskaper som norske Medistim og GE Vingmed for å dele erfaringer og bygge sterkere medisinsk-teknisk produksjon. Fint er det også at solide industrifagmiljøer som SINTEF Raufoss Manufacturing er inne i prosessen.
En av de viktigste næringene
Helseminister Bent Høie mener prosjektmidlene er viktige:
– Vi er gode innen radiofarmasi, kreftbehandling og sensorteknologi i Norge, men vi er helt i starten på å konvertere denne styrken til industri – derfor er disse prosjektmidlene fra Forskningsrådet meget viktige, uttaler Høie i pressemeldingen.
Næringsminister Monica Mæland påpeker at prosjektene kobler unge helseselskaper og utviklingsmiljøer, som gjennom denne satsingen kan gå tyngre inn i helsenæringen.
– Næringen har betydelig potensial som verdiskaper og for sysselsetting, samtidig som helsenæringen adresserer store utfordringer for pasienter og samfunn, sier Mæland.
Ifølge Forskningsrådet kan helsenæringen kan bli en av de viktigste vekstnæringene i Norge. Forskningsrådet har en helsenæringsportefølje på cirka 400 millioner kroner, samt cirka 500 helseprosjekter i SkatteFUNN.
Our portfolio company Photocure ASA is on the roll in the U.S and reported a revenue growth of 45% for this important market in the third quarter of 2017. Following the new Medicare reimbursement from 2018, Photocure increases the annual revenue ambition for 2020 to a range of USD 20 to 25 million.
“Our third quarter report demonstrates continued significant progress in our US business. The new reimbursement of Blue Light Cystoscopy with Cysview for Medicare patients, as well as the potential to expand Cysview’s label in the US show our commitment to this important market. It also confirms our desire to deliver patients better access to bladder cancer treatment. We expect the new reimbursement to drive significant growth in the future,” says Kjetil Hestdal, President and Chief Executive Officer of Photocure.
Photocure has built considerable experience in the urology sector through its Hexvix/Cysview franchise and sees significant long-term value creation potential in this market segment. The company aims to capitalize on the inclusion in the AUA guidelines, as well as the increased patient awareness and the changes to reimbursement of Cysview in the outpatient setting, to significantly increase penetration in the US market. CMS (United States Centers for Medicare & Medicaid Services) released in November the Final Rule stating that it will reimburse hospital outpatient departments for certain Blue Light Cystoscopy (BLC) with Cysview procedures from January 1, 2018.
Our portfolio company Photocure with more positive news from the the U.S. market. The United States Centers for Medicare & Medicaid Services (CMS) will from January 1, 2018 reimburse hospital outpatient departments for certain Blue Light Cystoscopy (BLC™) with Cysview®.
“The effectiveness and benefits of using Blue Light Cystoscopy (BLC) with Cysview for improved detection and management of bladder cancer are widely recognized. It is very positive that the CMS have created a separate payment code and additional payment for Blue Light Cystoscopy with Cysview procedure as this should result in more patients having access to BLC with Cysview and should increase equality of care in the management of bladder cancer patients,” said Cheryl Lee, M.D., FACS Chair, Department of Urology, Dorothy M. Davis Chair in Cancer Research at The Ohio State University.
To ensure appropriate reimbursement for BLC with Cysview, CMS has created new and unique codes to describe Blue Light Cystoscopy with the fluorescent imaging agent, Cysview. The CMS final rule for Medicare patients is outlined in the New 2018 CMS hospital outpatient prospective payment system (OPPS) final rule.
“We are pleased that CMS has implemented new improved coverage and coding for Blue Light Cystoscopy with Cysview procedures. We, along with many stakeholders, including the American Urological Association (AUA), Society of Urological Oncology (SUO), the patient advocacy group Bladder Cancer Advocacy Network, Hospitals and Urologists, have worked hard to secure a reimbursement path for Cysview, in order to ensure better access for Medicare patients to this leading-edge technology for the management of bladder cancer. We estimate the new rule will positively impact approximately 50% of Medicare bladder cancer resection procedures (TURBTs), so this is an important step forward both for patients and our mission to improve the management of bladder cancer,” commented Kjetil Hestdal, President and CEO of Photocure ASA.
The effectiveness and benefits of Blue Light Cystoscopy (BLC) with Cysview for improved detection and management of bladder cancer have been recognized by the AUA/SUO. In 2016, BLC with Cysview was adopted into the AUA/SUO Non-Muscle Invasive Bladder Cancer NMIBC Guidelines.
About Bladder Cancer
Bladder cancer is the fifth most commonly diagnosed cancer in the US and is the fourth most common cancer found in men in the US.1,2,3 In 2016, it is estimated that 76,960 new cases of bladder cancer will occur along with 16,390 deaths due to bladder cancer.
Bladder cancer is one of the most expensive cancers to manage, accounting for approximately $3.7 billion in direct costs each year.4,5
Bladder cancer is classified into two types, non-muscle invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of invasion in the bladder wall. 2 NMIBC remains in the inner layer of cells lining the bladder. These cancers are the most common (70%) of all BC cases and include the subtypes Ta, carcinoma in situ (CIS) and T1 lesions. MIBC is when the cancer has grown into deeper layers of the bladder wall. These cancers, including subtypes T2, T3 and T4, are more likely to spread and are harder to treat. 2
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.
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).
Our portfolio company Targovax presented third quarter results on November 2nd. Highlights included several patent grants, new collaborations and updated survival rates.
Research & Development
- Targovax presented data from three trials at the annual meeting of the European Society of Molecular Oncology (ESMO) in September in Madrid, highlighting some of the important clinical progress from both of its two platforms
- Targovax announced the initiation of the Phase I/II trial in ovarian and colorectal cancer, where, for the first time, ONCOS-102 will be administered intra-peritoneally. The trial is in combination with IMFINZI(TM) (durvalumab), and is a collaboration between Targovax and the Cancer Research Institute (CRI), and sponsored by Ludwig Cancer Research
- Targovax was granted a US patent for the therapeutic use of the product candidates in its TG mutant-RAS neo-antigen cancer vaccine platform in combination with anti-metabolite chemotherapy
- At the Nordic Life Science Days conference in Malmø in September, Targovax received the 2017 Nordic Stars award for outstanding innovation and entrepreneurial skills
- In July, Targovax completed the private placement of NOK 200m (USD 26m) announced in June, as well as a subsequent offering raising a further NOK 6.5m(USD 0.8m)
- In October, Targovax reported encouraging one-year survival rate, immune activation, and safety data for the modified “second” cohort in the TG01 phase I/II trial in resected pancreatic cancer, in line with the first cohort data published earlier in the year
- In October, Targovax was granted a US patent for its product candidate TG02 and its use to stimulate the immune system of cancer patients, the 2ndgeneration product from the TG platform, which is currently under testing in a phase I trial in colorectal cancer
Øystein Soug, CEO, said he is pleased with progress and results generated:
“The momentum generated in the business this year continued in the third quarter. During the period, we initiated a very interesting collaboration trial in colorectal and ovarian cancer, where we will test intraperitoneal administration of ONCOS-102, and combine it with AstraZeneca’s checkpoint inhibitor IMFINZI. We also got an important patent granted in the US for the therapeutic use of the TG platform in combination with chemotherapy. In October, the patent position of the TG platform was strengthened further by the grant of a US product/composition of matter patent for TG02. In recent weeks, we were also pleased to see the encouraging one-year survival rate, immune activation, and safety data from the second cohort in the TG01 trial in resected pancreatic cancer, which further strengthens the potential of this program. We now look forward to an exciting period in the end of 2017 and through 2018, with several important data read-outs from our ongoing clinical trial programs.”
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.
Our portfolio company Nordic Nanovector will present updated results from the phase I/II trial of Betalutin in non-Hodgkin lymphoma in a poster at the American Society of Hematology (ASH) meeting, 9-12 December 2017 in Atlanta, US.
The dataset includes 55 evaluable patients. Data from patients receiving the two most promising dosing regimens in the phase II expansion cohorts – Arm 1 (15 MBq/kg Betalutin® after 40 mg lilotomab pre-dosing) and Arm 4 (20 MBq/kg Betalutin® after 100 mg/m2 lilotomab) – are described and will be updated at the congress.
The data continue to highlight the encouraging clinical profile of single-agent Betalutin® therapy in iNHL patients, particularly in those with follicular lymphoma (FL), the primary NHL population for which Betalutin® is being developed. These data will continue to mature up until presentation in December.
Key facts are:
Single-agent Betalutin® is highly active and well tolerated in recurrent iNHL:
• 64% Overall Response Rate (ORR) and 24% Complete Responses (CR) in the 55 evaluable iNHL patients
• 81% ORR (CR 28%) in 21 FL patients in Arm 1 (of 32 iNHL patients evaluated); median duration of response (DoR) of 15 months in FL patients
• No unexpected safety findings, the safety profile is both predictable and manageable
Lisa Rojkjaer, Chief Medical Officer of Nordic Nanovector, commented:
“These data are very encouraging for a primarily elderly, heavily pre-treated patient population, especially for those with relapsed FL, where the greatest need exists. The data from Arm 4, while so far evaluable in only six patients (50% ORR, CR 17%) are also very encouraging and we look forward to seeing how these data evolve with a larger patient population. These data from both arms of the study are enabling us to refine the design of the pivotal Phase 2 PARADIGME trial, which we expect to initiate this year.”
Luigi Costa, Chief Executive Officer of Nordic Nanovector, added:
“We are very excited with these results, which support the strategy course we undertook when we decided to explore alternative dosing regimens. These data strengthen our confidence in the potential of Betalutin® to be an attractive therapeutic option with the convenience of being a one-time treatment. We now have two promising dosing options, and as a result we have further strengthened the development path for Betalutin®. We are also very encouraged that Betalutin® treatment consistently demonstrates a highly competitive profile when compared to other therapies in development or recently approved for FL.”
Abstract and poster details
The ASH annual meeting is the premier event for scientific exchange in the field of haematology, attracting more than 20,000 attendees from all over the world. Typically, more than 5,000 scientific abstracts are submitted each year, and more than 3,000 abstracts are accepted for oral and poster presentations through an extensive peer review process.
Abstract 2769 Abstract title: 177Lu-Lilotomab Satetraxetan, a Novel CD37-Targeted Antibody-Radionuclide Conjugate in Relapsed Non-Hodgkin’s Lymphoma (NHL): Updated Results of an Ongoing Phase I/II Study (LYMRIT 37-01) Authors: Kolstad, A et al.
- Session Name: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster II
- Date: Sunday, December 10, 2017
- Presentation Time: 6:00 PM – 8:00 PM
- Location: Georgia World Congress Center, Bldg A, Lvl 1, Hall A2, Atlanta, GA, USA
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 (ARC) designed to advance the treatment of non-Hodgkin 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 1H 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.