On August 24, 2022 Nykode Therapeutics reported 1H 2022 Financial result (Press release, Nykode Therapeutics, AUG 24, 2022, View Source [SID1234618594])
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Highlights for 2Q 2022:
• Nykode Therapeutics announced positive interim results from its Phase II trial with VB10.16 in combination
with atezolizumab in advanced cervical cancer
• Anti-tumor activity of VB10.16 in combination with atezolizumab was observed in a heavily pre-treated
population of patients with HPV16-positive advanced cervical cancer. Strong overall response rate
(ORR) was observed in both PD-L1 positive patients (ORR of 27%, including two complete responses)
and in PD-L1 negative patients (ORR of 17%)
• VB10.16 in combination with atezolizumab demonstrated a high disease control rate (DCR, which
includes patients who have achieved complete response, partial response and stable disease) of 77%
in PD-L1 positive patients and 58% in PD-L1 negative patients
• The anti-tumor activity seen in the PD-L1 negative population may potentially open up for treatment of
a new subset of patients
• In addition, a DCR of 71% was observed in patients with non-inflamed tumors, including both immune
desert and T cell excluded tumors
• Nykode will initiate a study in head and neck squamous cell carcinoma (HNSCC) and update the
VB10.16 development plan
• At the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, Nykode presented exciting
preclinical data from its second generation Vaccibody vaccine technology demonstrating a potential to
further increase and control immune responses
• Nykode presented preclinical data from its tolerizing vaccine research for use in autoimmune disorders at its
Capital Markets Day demonstrating the ability to increase antigen specific T regulatory cells and to shift the
cytokine balance towards an immune suppressive profile in mice models
• Nykode Therapeutics AS converted to Nykode Therapeutics ASA, a public limited liability company, and listed
its shares on the main list of the Oslo Stock Exchange
• Elaine Sullivan and Anne Whitaker were elected to join the Board of Directors at the Company’s AGM
• Nykode appointed Klaus Edvardsen as Chief Development Officer
Highlights after June 30, 2022:
• Nykode appointed Louise Stubbe as Chief Legal Officer
Michael Engsig, Chief Executive Officer at Nykode, comments:
"The highlight of the second quarter was the positive interim results from the VB C-02 phase II study with our
Vaccibody construct VB10.16 in combination with atezolizumab in HPV-16 positive cervical cancer. I’m personally
excited about the impressive and high disease control rates observed in hard-to-treat patients and the fact that we
observed this in both PD-L1 positive as well as PD-L1 negative patients. It is still early days, but these data and
other important findings from the study so far strengthens our belief in the program and we are committed to
further developing VB10.16 in cervical cancer and expand the use to other HPV16-positive indications including
head and neck cancer."
Michael Engsig continues: "I am pleased to note that the collaborations with our external partners aiming at
identifying clinical candidates for further development in man progress. We were also thrilled to announce the up
listing to the main list of the Oslo Stock Exchange and the continued internationalization of the executive
management group and the Board of Directors. We are financially well positioned, which combined with the
positive read-outs from the VB C-02 trial and the exciting advancements and prospects coming from our
preclinical pipeline gives us a strong outset to continue our journey of successful business growth."
R&D update
Nykode’s modular technology platform is versatile and may be adapted to generate immunotherapies inducing
specific and controlled immune responses adapted to each disease. Hence, Nykode’s platform may be applied
across a broad range of immunotherapy areas as innovative solutions to an unmet medical need.
Please find below an update on Nykode’s current research and development activities.
Oncology
VB10.16
VB10.16 is a therapeutic HPV vaccine directed against HPV16+ induced malignancies and wholly-owned by
Nykode:
• Clinical trial VB C-02:
• VB10.16 in combination with atezolizumab
• Cancer indication: HPV16+ advanced, non-resectable cervical cancer
• Clinical stage: Phase II
• Fully enrolled
• ClinicalTrials.gov Identifier: NCT04405349
Status and highlights
The trial is fully enrolled and reported positive interim efficacy and safety data on May 9, 2022. Interim results
from 39 patients with a median follow up of 6 months show durable responses with a very high disease control
rate (DCR) of 64% in heavily pre-treated advanced cervical cancer patients. Anti-tumor efficacy was observed in
both PD-L1 positive and negative patients, with 27% overall response rate (ORR) and 77% DCR in PD-L1
positive patients and 17% ORR and 58% DCR in PD-L1 negative patients, respectively. DCR of 71% was
observed in patients with non-inflamed tumors, including both immune desert and T cell excluded tumors.
The anti-tumor activity seen in the PD-L1 negative population may potentially open up for treatment of a new
subset of patients. HPV16-specific IFN-γ T cell responses were associated with clinical efficacy and complete
clearance of HPV16 ctDNA was significantly correlated with clinical outcomes.
VB10.16 in combination with atezolizumab is well-tolerated and has a safety profile comparable to atezolizumab
monotherapy. Nykode expects to report updated key efficacy data read-outs from the VB C-02 trial covering all
patients during the first half of 2023.
The encouraging clinical efficacy and favorable safety profile which was observed with VB10.16 has led Nykode
to focus on updating the development strategy for VB10.16 which is expected during second half of 2022. This
includes expansion into additional HPV16+ indications and a dose escalation trial of VB10.16 in combination with
CPI in patients with HPV16-positive HNSCC where safety, efficacy, and immunogenicity of multiple VB10.16 dose
levels will be assessed.
VB10.NEO
VB10.NEO is an individualized neoantigen cancer vaccine, exclusively licensed to Genentech:
• Clinical trial VB N-01:
• VB10.NEO in combination with immune checkpoint inhibitor
• Cancer indications: Melanoma, non-small cell lung cancer (NSCLC), clear renal cell carcinoma,
urothelial cancer or squamous cell carcinoma of the head and neck (HNSCC)
• Clinical stage: Phase I/IIa
• Fully enrolled
• ClinicalTrials.gov Identifier: NCT03548467
• Clinical trial VB N-02:
• VB10.NEO in combination with atezolizumab
• Cancer indications: Locally advanced and metastatic tumors
• Clinical stage: Phase Ib
• ClinicalTrials.gov Identifier: NCT05018273
Infectious Diseases
Nykode’s infectious disease initiative continues to generate data supporting the potential of the platform to control
immune responses in addition to explore and evaluate a diverse set of pathogens as potential next future clinical
vaccine targets.
VB10.COV2
Nykode has chosen a 2-arm strategy for its VB10.COV2 project to fight SARS-CoV-2 variants of concern (VoC).
VB10.2129 (RBD candidate) and VB10.2210 (T cell candidate) are two vaccine candidates designed using
Nykode’s modular and Antigen Presenting Cell (APC) targeted technology.
• Clinical trial VB-D-01, investigating the two vaccine candidates, VB10.2129 and VB10.2210
• Pathogen: SARS-CoV-2
• Clinical stage: Phase I/II
• ClinicalTrials.gov Identifier: NCT05069623
VB10.2129 – 2nd generation vaccine addressing multiple variants of concern
VB10.2129 contains the RBD domain of the Beta variant of concern B1.351. Nykode’s RBD vaccine candidate
has shown in preclinical studies a potential to induce rapid and strong levels of neutralizing antibody responses
addressing several variants of concern supported by strong Th1 and CD8 T cell responses.
VB10.2210 – 3rd generation universal broadly protective T cell vaccine
Based on efficacy studies with approved Spike based vaccines, T cells appear central in maintaining the
protection against severe disease and death across current VoCs. Vaccines inducing a broader T cell immunity
against additional SARS-CoV-2 antigens less prone to mutations may therefore be a promising way to prevent
severe disease across future VoCs. Nykode aims to broaden the T cell responses against a broad set of epitopes
from multiple SARS-CoV-2 antigens based on a collaboration with Adaptive Biotechnologies. Preclinical data
confirm induction of strong T cell responses against the broad set of SARS-CoV-2 antigens in several animal
models. Nykode’s CCL3L1 targeted technology has shown induction of clinically relevant T cell responses in
multiple preclinical and clinical studies. The aim is to induce long-lasting protective immunity across all population
groups and across current and future variants.
VB-D-01 trial
The VB-D-01 trial is a Phase I/II, open label, dose escalation trial to determine safety and immunogenicity of two
SARS-CoV-2 vaccine candidates VB10.2129 and VB10.2210.
Status and highlights
• VB10.2129 (RBD candidate): First subject dosed November 3, 2021. The trial is fully enrolled at two out
of three dose levels in the dose-escalation cohort. Recruitment is on-going
• VB10.2210 (T cell candidate): First subject dosed December 27, 2021. The trial is fully enrolled at all
three dose levels in the dose-escalation cohort
• Nykode plans to report key results from the trial and guide on the future development strategy during the
second half of 2022
Autoimmune disorders
Autoimmune disorders are caused by unwanted immunogenicity to self-antigens. Antigen-specific tolerization for
the treatment of autoimmune diseases has the potential to suppress autoimmunity without compromising normal
immune function.
Nykode’s platform is uniquely positioned to induce tolerogenic T cell responses through specific targeting of
tolerizing antigen specific cells. Initial preclinical proof-of-concept studies with tolerizing vaccine constructs are
encouraging. Nykode has demonstrated the ability to increase antigen specific T regulatory cells and to shift the
cytokine balance towards an immune suppressive profile in mice models. Patent applications have been filed to
Nykode Therapeutics ASA | Gaustadalléen 21, N-0349 Oslo, Norway | W: nykode.com | Org.no. N-990 646 066 MVA
protect the overall concepts.The Company plans to provide further preclinical data from the tolerization project
within the next 12 months.
4th Module, novel vaccine formats
The 4th module platform allows Nykode to introduce additional new coding regions to the vaccine with the
purpose of further boosting or directing the immune responses.
Nykode presented a poster on the 4th module concept at the American Association for Cancer Research (AACR) (Free AACR Whitepaper)
Annual Meeting in April 2022. Here it was demonstrated how the Vaccibody molecule can be co-expressed with
immune-stimulatory proteins from one plasmid using a multicistronic design. Compared to the Vaccibody
molecule alone, the simultaneous expression of selected immune stimulatory cytokines was shown to boost the
overall immune response and to stimulate an enhanced anti-tumor immune response in preclinical models. At
Nykode’s Capital Markets Day, data on 4th module cytokines boosting T cell and antibodies responses induced by
a SARS-COV-2 subunit vaccine was presented.
An additional 5th and 6th module may be added to further boost and/or direct the immune responses. Nykode will
continue to explore the potential of additional immune modulatory polypeptides and combinations of these.
Other
Due to the growth ambitions and the creation of an international biotech company, Nykode has strived to further
strengthen the Board of Directors. Elaine Sullivan and Anne Whitaker were elected to join the Board of Directors
at the AGM on May 12, 2022, both bringing significant international executive, drug development and commercial
experience from biotech and big pharma.
Klaus Edvardsen was appointed Chief Development Officer, effective July 1, 2022. He brings international
leadership experience in directing successful drug development programs at major biopharmaceutical companies.
Further, Louise Stubbe was appointed Chief Legal Officer. She brings over a decade of life sciences industry
experience from both private and listed companies and has experience from building and managing global legal
departments.
Nykode converted to a public limited liability company and listed its shares on the main list of the Oslo Stock
Exchange (OSE) with first day of trading on June 16, 2022.Financial review
(Numbers in brackets are for the corresponding period the previous year unless otherwise specified)
Income statement
The net result for the six months ended June 30, 2022 was a net loss of USD 15.6 million compared to a net loss
of USD 12.8 million for the same period in 2021. The change in net loss was mainly due to increased activities
and operations in Nykode, leading to increased operating expenses. This was partially offset by an increase in
total revenue as well as a decrease in the social security cost accrual related to share-based payments included
under employee benefit expenses.
Revenue and other income
Total revenue and other income amounted to USD 4.4 million in the six months ended June 30, 2022 (USD 2.7
million). The increase was mainly due to increased R&D service activities under the agreements with Genentech
and Regeneron.
Operating expenses
Total operating expenses amounted to USD 23.3 million in the six months ended June 30, 2022, compared to
USD 17.8 million for the same period in 2021. Other operating expenses increased from USD 11.1 million in the
first six months of 2021 to USD 17.7 million six months ended June 30, 2022, driven by increased operating
activity. Employee benefit expenses were USD 4.7 million in the six months ended June 30, 2022 (USD 6.6
million). The decrease in employee benefit expenses in 2022 is primarily due to the reduction of the social
security cost accrual related to share-based payments. This accrual is dependent on the share price as Nykode is
required to accrue for the social security cost for all warrants and options that are in-the-money at the balance
sheet date. This relates to both the current and the non-current portion. As the share price decreased during the
period the accrual is also reduced. The corresponding reduction is USD 6.6 million (USD 1,5 million increase).
The decrease is offset by the planned increase in headcount.
Net financial income and expenses
Net financial income and expenses was negative USD 0.6 million in the six months ended June 30, 2022 (USD
0.6 million negative). Finance income and finance expenses mainly relate to movements in foreign currency
exchange rates and fair value adjustments of financial instruments.
Income tax expenses
The Group recognized tax income of USD 3.8 million in the six months ended June 30, 2022 and USD 3.0 million
in the same period of 2021. The income tax expense is primarily related to movement in deferred tax. Statement of financial position
Cash and cash equivalents
At June 30, 2022, the Group had a cash position of USD 213.3 million compared to USD 216.2 million at
December 31, 2021. The decrease in cash is mainly a result from operating and investing activities.
Other current financial assets
At June 30, 2022, total other current financial assets amounted to USD 10.0 million compared to USD 12.2 million
at December 31, 2021. Other current financial assets comprise of liquid money marked funds.
Equity
At June 30, 2022, total equity amounted to USD 181.1 million, compared to USD 194.1 million at December 31,
2021. The change mainly reflects the net loss of the period of USD 15.6 million, the exercise of warrants and
options and recognition of share-based payments.
Trade receivables
At June 30, 2022, trade receivables amounted to USD 2.7 million, compared to USD 23.8 million at December 31,
2021. The decrease is mainly due to the receipt of the USD 20 million milestone payment from Genentech in the
first quarter of 2022.
Trade and other payables
At June 30, 2022, trade and other payables amounted to USD 5.4 million, compared to USD 8.5 million at
December 31, 2021.