BerGenBio ASA
BerGenBio ASA
11/09/2021 | Press release | Distributed by Public on 11/09/2021 07:05
BERGENBIO RECEIVES FDA FAST TRACK DESIGNATION FOR BEMCENTINIB IN STK11-MUTATED ADVANCED/METASTATIC NON-SMALL LUNG CANCER (NSCLC)
Bergen, Norway, 9 November 2021?-BerGenBioASA (OSE: BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL inhibitors for severe
unmet medical needs, today announces that the U.S. Food and Drug Administration
(FDA) has granted Fast Track designation for bemcentinib in combination with an
anti-PD-(L)1 agent as treatment for patients with STK11 altered
advanced/metastatic NSCLC patients without actionable mutations.
Fast Track designation is intended to facilitate the development and review of
drugs used to treat serious conditions and to fill an unmet medical need. It
will enable BerGenBio to have more frequent interactions with the FDA throughout
the drug development process so that an approved product can potentially reach
the market faster.
In a separate release today 9 November 2021, BerGenBio announced that in pre
-clinical NSCLC mouse models harboring STK11 mutations, sensitivity to PD-1
blockade was evaluated in the absence and presence of bemcentinib. Systemic
inhibition of AXL with bemcentinib resulted in the expansion of tumor-associated
T cells and restored therapeutic response to anti-PD-1 check point inhibition.
Further, data from BerGenBio's Phase II bemcentinib and pembrolizumab
combination study (BGBC008) in advanced NSCLC showed that 3 of 3 evaluable
patients with identified STK11/LKB1 mutations demonstrated objective clinical
response / clinical benefit to the combination of AXL inhibitor bemcentinib and
pembrolizumab.
Martin Olin, Chief Executive Officer of BerGenBio, commented: "We are very
pleased to receive Fast Track designation from the FDA for the second time this
year and look forward to continuing to explore bemcentinib's potential as a
treatment option for NSCLC patients. It has been reported that patients
habouring STK11 mutations represents up to 20% of the total NSCLC patient
population, representing a large, identifiable subgroup of patients who may
benefit from treatment with an AXL inhibitor such as bemcentinib."
-Ends-
AboutBerGenBioASA
BerGenBio is a clinical-stage biopharmaceutical company focused on developing
transformative drugs targeting AXL as a potential cornerstone of therapy for
aggressive diseases, including immune-evasive, therapy resistant cancers. The
company's proprietary lead candidate, bemcentinib, is a potentially first-in
-class selective AXL inhibitor in a broad phase II clinical development
programme focused on combination and single agent therapy in cancer and COVID
-19. A first-in-class functional blocking anti-AXL antibody, tilvestamab, is
undergoing phase I clinical testing. In parallel, BerGenBio is developing a
potential companion diagnostic test to identify patient populations most likely
to benefit from AXL inhibition: this is expected to facilitate more efficient
registration trials supporting a precision medicine-based commercialisation
strategy.
BerGenBio is based in Bergen, Norway with a subsidiary in Oxford, UK. The
company is listed on the Oslo Stock Exchange (ticker: BGBIO). For more
information, visit?www.bergenbio.com
About FDA Fast Track
Fast Track designation is intended to facilitate the development and review of
drugs used to treat serious conditions and to fill an unmet medical need. The
designation provides Eligibility forAccelerated Approval, enabling approval
based on a surrogate clinical endpoint;Priority Review, which allows New Drug
Application (NDA) review in six months instead of 10,and eligibility for Rolling
Review, whereby the Company will be able to submit completed sections of its NDA
for review by the FDA before the complete application is submitted.
Contacts
Martin Olin, CEO,BerGenBioASA
[email protected]
RuneSkeie, CFO,BerGenBioASA
[email protected]
International Media Relations
Mary-Jane Elliott, Chris Welsh, Lucy Featherstone
ConsiliumStrategic Communications
[email protected]
+44 20 3709 5700
Forward looking statements
This announcement may contain forward-looking statements, which as such are not
historical facts, but are based upon various assumptions, many of which are
based, in turn, upon further assumptions. These assumptions are inherently
subject to significant known and unknown risks, uncertainties, and other
important factors. Such risks, uncertainties, contingencies and other important
factors could cause actual events to differ materially from the expectations
expressed or implied in this announcement by such forward-looking statements.
This information is considered to be inside information pursuant to the EU
Market Abuse Regulation and is subject to the disclosure requirements pursuant
to section 5-12 of the Norwegian Securities Trading Act.
biopharmaceutical company developing novel, selective AXL inhibitors for severe
unmet medical needs, today announces that the U.S. Food and Drug Administration
(FDA) has granted Fast Track designation for bemcentinib in combination with an
anti-PD-(L)1 agent as treatment for patients with STK11 altered
advanced/metastatic NSCLC patients without actionable mutations.
Fast Track designation is intended to facilitate the development and review of
drugs used to treat serious conditions and to fill an unmet medical need. It
will enable BerGenBio to have more frequent interactions with the FDA throughout
the drug development process so that an approved product can potentially reach
the market faster.
In a separate release today 9 November 2021, BerGenBio announced that in pre
-clinical NSCLC mouse models harboring STK11 mutations, sensitivity to PD-1
blockade was evaluated in the absence and presence of bemcentinib. Systemic
inhibition of AXL with bemcentinib resulted in the expansion of tumor-associated
T cells and restored therapeutic response to anti-PD-1 check point inhibition.
Further, data from BerGenBio's Phase II bemcentinib and pembrolizumab
combination study (BGBC008) in advanced NSCLC showed that 3 of 3 evaluable
patients with identified STK11/LKB1 mutations demonstrated objective clinical
response / clinical benefit to the combination of AXL inhibitor bemcentinib and
pembrolizumab.
Martin Olin, Chief Executive Officer of BerGenBio, commented: "We are very
pleased to receive Fast Track designation from the FDA for the second time this
year and look forward to continuing to explore bemcentinib's potential as a
treatment option for NSCLC patients. It has been reported that patients
habouring STK11 mutations represents up to 20% of the total NSCLC patient
population, representing a large, identifiable subgroup of patients who may
benefit from treatment with an AXL inhibitor such as bemcentinib."
-Ends-
AboutBerGenBioASA
BerGenBio is a clinical-stage biopharmaceutical company focused on developing
transformative drugs targeting AXL as a potential cornerstone of therapy for
aggressive diseases, including immune-evasive, therapy resistant cancers. The
company's proprietary lead candidate, bemcentinib, is a potentially first-in
-class selective AXL inhibitor in a broad phase II clinical development
programme focused on combination and single agent therapy in cancer and COVID
-19. A first-in-class functional blocking anti-AXL antibody, tilvestamab, is
undergoing phase I clinical testing. In parallel, BerGenBio is developing a
potential companion diagnostic test to identify patient populations most likely
to benefit from AXL inhibition: this is expected to facilitate more efficient
registration trials supporting a precision medicine-based commercialisation
strategy.
BerGenBio is based in Bergen, Norway with a subsidiary in Oxford, UK. The
company is listed on the Oslo Stock Exchange (ticker: BGBIO). For more
information, visit?www.bergenbio.com
About FDA Fast Track
Fast Track designation is intended to facilitate the development and review of
drugs used to treat serious conditions and to fill an unmet medical need. The
designation provides Eligibility forAccelerated Approval, enabling approval
based on a surrogate clinical endpoint;Priority Review, which allows New Drug
Application (NDA) review in six months instead of 10,and eligibility for Rolling
Review, whereby the Company will be able to submit completed sections of its NDA
for review by the FDA before the complete application is submitted.
Contacts
Martin Olin, CEO,BerGenBioASA
[email protected]
RuneSkeie, CFO,BerGenBioASA
[email protected]
International Media Relations
Mary-Jane Elliott, Chris Welsh, Lucy Featherstone
ConsiliumStrategic Communications
[email protected]
+44 20 3709 5700
Forward looking statements
This announcement may contain forward-looking statements, which as such are not
historical facts, but are based upon various assumptions, many of which are
based, in turn, upon further assumptions. These assumptions are inherently
subject to significant known and unknown risks, uncertainties, and other
important factors. Such risks, uncertainties, contingencies and other important
factors could cause actual events to differ materially from the expectations
expressed or implied in this announcement by such forward-looking statements.
This information is considered to be inside information pursuant to the EU
Market Abuse Regulation and is subject to the disclosure requirements pursuant
to section 5-12 of the Norwegian Securities Trading Act.