Beskrivning
Land | Norge |
---|---|
Lista | OB Match |
Sektor | Hälsovård |
Industri | Läkemedel & Handel |
2021-06-22 07:00:08
Oslo, Norway, 22 June 2021
Nordic Nanovector ASA (OSE: NANOV) announces encouraging initial results from
the LYMRIT 37-05 Phase 1 trial investigating Betalutin® ([177]Lu lilotomab
satetraxetan) in patients with relapsed/refractory diffuse large B-cell lymphoma
(R/R DLBCL) not eligible for stem cell transplantation.
The initial results from the completed Phase I study (n=16 treated with
Betalutin®) show that Betalutin® was well tolerated, with a good safety profile
consistent with all previous studies with Betalutin®. As reported previously, a
single, reversible dose-limiting toxicity (DLT) was seen in the last cohort
investigating the highest dosing regimen (20 MBq/kg Betalutin® and 100 mg/m[2]
lilotomab), which on review by the Independent Review Committee (IRC) resulted
in three additional patients being enrolled. No further DLTs were seen. Clinical
activity of Betalutin® was seen in 6 evaluable patients receiving the highest
dosing regimen including one complete response and one partial response.The IRC
commented that the safety and anti-tumour activity of the highest dosing regimen
could be considered for investigation in combination with other therapies used
in R/R DLBCL which the Company is now evaluating, with an emphasis on
combination partners that would not compromise the current safety profile of
Betalutin®.
Peter Braun, Nordic Nanovector CEO, commented: "We continue to be very
encouraged by the overall safety profile that Betalutin® exhibits in even the
most fragile and highly pre-treated NHL patients. We have also seen clinical
activity in DLBCL patients from a single administration of Betalutin® and we
will now consider the next steps for its development in this large patient
population potentially in combination with other therapies, as part of our
overall strategy to develop Betalutin® for difficult to treat haematological
tumours. Our near-term focus remains very much on completing PARADIGME in 3[rd]
-line follicular lymphoma and delivering top line 3-month data by the end of
2021."
About LYMRIT 37-05
The LYMRIT 37-05 study is a Phase 1 open-label, single-arm, dose-escalation
study designed to assess the safety and preliminary anti-tumour activity of a
single administration of Betalutin®. Patients were enrolled at clinical trial
sites in the US and Europe. More information on this study can be found at
www.clinicaltrials.gov (NCT02658968).
The starting doses of Betalutin® and lilotomab were 10MBq/kg and 60mg (Cohort 1,
n=3), respectively, and then Betalutin® 10MBq/kg and lilotomab 100mg (Cohort 2,
n=3 treated with Betalutin®). Cohort 3 received 15MBq/kg and lilotomab 100mg
(n=3) and Cohort 4 received 20MBq/kg and lilotomab 100mg (n=7 treated, 6
evaluable).
About DLBCL
DLBCL is an aggressive form of non-Hodgkin's Lymphoma (NHL) that accounts for up
to 43% of all NHL cases, making it the most common form of the disease.
Approximately 40% of DLBCL patients relapse after first-line combination
treatment with rituximab and chemotherapy and only 30-40% of relapsed patients
respond with subsequent high-dose chemotherapy followed by Stem Cell
Transplantation (ref. 1). There are currently very few therapeutic options for
patients not eligible for SCT, which makes relapsed DLBCL a serious unmet
medical need. The number of diagnosed incident cases of DLBCL in the 7 major
markets (U.S., and key 5 European markets and Japan) was 64,172 in 2018 and is
expected to be 74,927 in 2028 (ref. 2). The value of the 3L DLBCL market
segment in the key 7 pharma markets is expected to increase from USD 0.6B in
2019 to USD 1.3B in 2028, the value of the 2L DLBCL market segment is expected
to increase from USD 0.4B in 2019 to USD 2.0B in 2028. (ref. 2).
1. L.S. Raut and P. P. Chakrabarti: Management of relapsed-refractory diffuse
large B cell lymphoma (2014) South Asian J. Cancer 3(1): 66-70
2. NHL and CLL Report, CRG, 2000, Disease Landscape and Forecast
For further information, please contact:
IR enquiries
Malene Brondberg, CFO
Cell: +44 7561 431 762
Email: ir@nordicnanovector.com
Media Enquiries
Mark Swallow/Frazer Hall/David Dible (MEDiSTRAVA Consulting)
Tel: +44 207 638 9571
Email: nordicnanovector@medistrava.com
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 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 26 billion by 2028. Nordic Nanovector retains global marketing
rights to Betalutin® and intends to actively participate in the
commercialisation of Betalutin® in the US and other major markets.
Further information can be found at www.nordicnanovector.com.
Forward-looking statements
This press release contains certain forward-looking statements. These statements
are based on management's current expectations and are subject to uncertainty
and changes in circumstances, since they relate to events and depend on
circumstances that will occur in the future and which, by their nature, will
have an impact on Nordic Nanovector's business, financial condition and results
of operations. The terms "anticipates", "assumes", "believes", "can", "could",
"estimates", "expects", "forecasts", "intends", "may", "might", "plans",
"should", "projects", "targets", "will", "would" or, in each case, their
negative, or other variations or comparable terminology are used to identify
forward-looking statements. These forward-looking statements are not historic
facts. There are a number of factors that could cause actual results and
developments to differ materially from those expressed or implied in the forward
-looking statements. Factors that could cause these differences include, but are
not limited to, risks associated with implementation of Nordic Nanovector's
strategy, risks and uncertainties associated with the development and/or
approval of Nordic Nanovector's product candidates, ongoing and future clinical
trials and expected trial results, the ability to commercialise Betalutin®,
technology changes and new products in Nordic Nanovector's potential market and
industry, Nordic Nanovector's freedom to operate (competitors patents) in
respect of the products it develops, the ability to develop new products and
enhance existing products, the impact of competition, changes in general economy
and industry conditions, and legislative, regulatory and political factors. No
assurance can be given that such expectations will prove to have been correct.
Nordic Nanovector disclaims any obligation to update or revise any forward
-looking statements, whether as a result of new information, future events or
otherwise.
This information is subject to a duty of disclosure pursuant to Sections 4-2 and
5-12 of the Securities Trading Act.