On August 26, 2021 Vaccibody reported its interim report for the second quarter of 2021 (Press release, Vaccibody, AUG 26, 2021, View Source [SID1234586903])
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HIGHLIGHTS:
• Vaccibody plans to initiate a Phase 1/2 trial to evaluate two next generation SARS-CoV-2 virus vaccine candidates to address emerging variants of concern
• The VB C-02 clinical trial with the therapeutic HPV cancer vaccine VB10.16 and immune checkpoint inhibitor atezolizumab (Tecentriq) is on track to finalize enrollment during fourth quarter 2021. Per protocol interim safety analysis was conducted with no safety concerns and a recommendation to continue the trial as planned
• Vaccibody appointed Mikkel Wandahl Pedersen as new Chief Scientific Officer and Agnete B. Fredriksen as Chief Innovation & Strategy Officer
• Vaccibody appointed Harald Gurvin as new Chief Financial Officer
• Dr. Birgitte Volck, M.D., Ph.D. appointed as new member of the Board of Directors, providing extensive global drug development and Nasdaq experience Highlights after June 30, 2021:
• Vaccibody entered into worldwide, exclusive license agreement with Adaptive Biotechnologies to access clinically validated SARS-CoV-2 T cell epitopes
• VB10.NEO – approval of the first US site initiation for the VB N-02, Phase 1b trial in collaboration with Genentech
• Vaccibody reached a headcount of more than 80 people Vaccibody AS, Gaustadalléen 21, 0349 Oslo, Norway www.vaccibody.com Org.nr. 990 646 066 3 Michael Engsig, Chief Executive Officer at Vaccibody, comments: "Second quarter 2021 was yet another quarter with great advancement in our activities, in particular with our COVID vaccines.
We will initiate a Phase 1/2 trial with two COVID vaccine candidates and expect the first subject to be dosed in early Q4 2021. The two vaccines are a 2nd generation RBD vaccine and a 3rd generation T cell focused vaccine, respectively." Michael Engsig continues: "The RBD vaccine candidate retains strong neutralization across variants of concern in preclinical tests. The T cell focused vaccine is based on the clinically validated SARS-CoV-2 T cell epitopes that comes out of the exclusive collaboration and licensing agreement with Adaptive Biotechnologies, which was announced mid-July. The partnership is directly in line with our strategic pillar of seeking complimentary partnerships.
It is truly a unique fit of technologies, and we are excited to have used Adaptive’s data to inform the design and development of our T cell-based SARS-CoV-2 vaccine. This 3rd generation T cell focused vaccine candidate elicits T cell responses against conserved and immunogenic regions across a broad set of SARS-CoV-2 antigens and can be used as a universal booster."
R&D UPDATE Please find below an update on Vaccibody’s research and development activities. Oncology VB10.16 VB10.16 is a therapeutic HPV vaccine directed against HPV16+ induced malignancies:
• Clinical trial VB C-02: o Clinical stage: Phase 2 o Indication: HPV16+ advanced, non-resectable cervical cancer o ClinicalTrials.gov Identifier: NCT04405349 Status and highlights Investigational sites in six European countries are screening and enrolling patients. Per protocol interim safety analysis was conducted with no safety concerns and a recommendation to continue the trial as planned. The trial has enrolled more than half of the patients and is on track to have completed enrolment in Q4 2021. The trial plans to report interim clinical data in Q1 2022. VB10.NEO VB10.NEO is an individualized neoantigen cancer vaccine, exclusively licensed to Genentech:
• Clinical trial VB N-01: o Clinical stage: Phase 1/2a o Cancer indications: Melanoma, non-small cell lung cancer, clear renal cell carcinoma, urothelial cancer or squamous cell carcinoma of the head and neck o ClinicalTrials.gov Identifier: NCT03548467
• Clinical trial VB N-02: o Clinical stage: Phase 1b o Cancer indications: Locally advanced and metastatic tumors o ClinicalTrials.gov Identifier: NCT05018273 Status and highlights In collaboration with Genentech, the site initiation for VB N-02 has started in the USA to support enrollment of 40 patients at 10 sites across three countries: USA, Germany and Spain. Approval has been achieved for the first US site and CTA (Clinical Trial Applications) were done for Germany and Spain where approvals are expected in the 2nd half of 2021.
Vaccibody AS, Gaustadalléen 21, 0349 Oslo, Norway www.vaccibody.com Org.nr. 990 646 066 5 Infectious Diseases Vaccibody’s infectious disease initiative continues to generate supportive data and explore and evaluate a diverse set of pathogens as potential next future clinical vaccine targets. VB10.COV2 Vaccibody has chosen a 2-arm strategy for its VB10.COV2 project to fight SARS-CoV2 variants of concern (VoC*). VB10.2129 and VB10.2210 are two vaccines designed using Vaccibody’s modular and Antigen Presenting Cell (APC) targeted technology. :
• Clinical trial VB-D-01, investigating the two vaccine candidates, VB10.2129 and VB10.2210, in both naïve as well as previously vaccinated healthy volunteers o Clinical stage: Phase 1/2 o Pathogen: SARS-CoV-2 o ClinicalTrials.gov Identifier: TBD VB10.2129 – 2nd generation vaccine addressing novel variants of concern* VB10.2129 contains the RBD domain of the Beta (i.e. South African) variant of concern B1.351. Importantly, preclinical data demonstrate induction of rapid, strong and persistent neutralizing antibody responses in animal models by VB10.2129 not only against the South African variant, but also across several other major variants of concern. Vaccibody’s RBD vaccine has the potential to induce rapid and strong levels of neutralizing antibody responses addressing both existing and emerging variants of concern VB10.2210 – 3rd generation universal broadly protective T cell vaccine Increasing evidence highlight the importance of broad T cell responses in providing rapid as well as long-term memory responses against COVID-19 with limited sensitivity to viral mutations. In July, Vaccibody and Adaptive Biotechnologies entered into an exclusive agreement for use of Adaptive’s validated SARS-CoV-2 T cell epitopes. Adaptive is our partner of choice and has applied its immune medicine platform to identify and validate immuno-dominant
T cell epitopes across the viral genome using sequence information from more than 6,500 patients impacted by COVID-19. Further, it has launched T-Detect COVID, which is the first-in-class T cell based clinical test for COVID-19 with FDA Emergency Use Authorization. Vaccibody will use a selected set of these SARS-CoV-2 T cell epitopes in its VB10.2210 vaccine. Vaccibody aims to boost and broaden the most clinically relevant and conserved T cell responses against a broad set of SARS-CoV-2 epitopes identified by Adaptive. Preclinical data confirm induction of strong T cell responses against multiple SARS-CoV-2 antigens in several mouse models.
The aim is to induce long-lasting protective immunity across all population groups and across current and future variants. Vaccibody AS, Gaustadalléen 21, 0349 Oslo, Norway www.vaccibody.com Org.nr. 990 646 066 6 VB-D-01 trial The VB-D-01 trial is a Phase 1/2, open label, dose escalation trial to determine safety and immunogenicity of two SARS-CoV-2 vaccine candidates. The clinical trial application is planned for Q3 2021 and first subject dosed is planned for early Q4 2021. The trial will enroll up to 200 patients in Norway.
*Note: All viruses, including SARS-CoV-2, mutate and change over time. Most changes have limited impact on the virus’ properties. However, some changes may affect the virus’ properties, e.g. as how easily it spreads, the associated disease severity, or the performance of vaccines, diagnostic tools and so forth. The emergence of variants that poses an increased risk to global public health has prompted the characterization of specific variants of concern, in order to prioritize global monitoring and research, and ultimately to inform the ongoing response to the COVID-19 pandemic. Source: Tracking SARS-CoV-2 variants (who.int) Autoimmune disorders Autoimmune disorders are caused by unwanted immunogenicity to autoantigens. Vaccibody has initiated research to take advantage of the platform’s unique APC targeting approach to induce antigen-specific immune tolerance.
Initial focus is screening and identifying the constructs that induce the optimal immune response profile for future product development in the field.
FINANCIAL REVIEW
Income statement The net result for the 2nd quarter of 2021 was a net loss of USD 6.2 million compared to a net loss of USD 6.6 million in the 2nd quarter of 2020. The reduced net loss is mainly due to increased revenue and movement in deferred tax. The operating loss in the 2nd quarter of 2021 was USD 7.7 million compared to a loss of USD 6.4 million in the same period in 2020, driven by increased R&D and operating activities and planned increase in headcount.
The net result for the 1st half of 2021 was a loss of USD 12.8 million compared to a loss of USD 9.4 million in the 1st half of 2020, driven by the increase in R&D and operating activities, planned headcount and finance costs, offset by movement in deferred tax. Revenue and other income Total revenue and other income amounted to USD 1.9 million in the 2nd quarter of 2021 (Q2 2020: USD 0.1 million) and USD 2.7 million for the 1st half of 2021 (1H 2020: USD 0.3 million). Vaccibody AS, Gaustadalléen 21, 0349 Oslo, Norway www.vaccibody.com Org.nr. 990 646 066 7 The Group recognized revenues of USD 1.6 million in the 2nd quarter of 2021 and USD 2.1 million for the 1st half of 2021 according to the development of underlying research activities related to the Genentech agreement announced in October 2020.
The Group also had other income of USD 0.3 million in the 2nd quarter (Q2 2020: USD 0.1 million) and USD 0.6 million in the 1st half (1H 2020: USD 0.3 million), primarily government grants. Operating expenses Total operating expenses amounted to USD 9.6 million in the 2nd quarter of 2021 (Q2 2020: USD 6.5 million) and USD 17.8 million for the 1st half 2021 (1H 2020: USD 10.6 million). Employee benefit expenses were USD 2.7 million in the 2nd quarter (Q2 2020: USD 2.5 million) and USD 6.6 million for the 1st half (1H 2020: USD 3.0 million).
The increase in employee benefit expenses in 2021 is primarily due to the planned increase in headcount, expenses related to the Group’s share option program and recruitment. Employee benefit expenses in the 2nd quarter 2020 were impacted by accrued social security tax on the share option program. Other operating expenses amounted to USD 6.8 million in the 2nd quarter (Q2 2020: USD 3.9 million) and USD 11.1 million for the 1st half (1H 2020: USD 7.5 million). The increase in 2021 was driven by the N-02 Phase 1b study initiation as well as consulting and legal services. Net financial income and expenses Net financial income and expenses were USD 0.1 million in the 2nd quarter of 2021 (Q2 2020: USD 0.2 million loss) and a net loss of USD 0.6 million in the 1st half 2021 (1H 2020: USD 1.0 million gain).
Finance income and finance costs 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 1.3 million in the 2nd quarter of 2021 and USD 3.0 million in the 1st half of 2021, which primarily relates to movement in deferred tax. There was no income tax in the same periods of 2020. Statement of financial position Cash At June 30, 2021, Vaccibody had a cash position of USD 174.4 million compared to USD 183.9 million at December 31, 2020. The decrease in cash is mainly a result from operating activities. Equity At June 30, 2021, total equity amounted to USD 168.5 million, compared to USD 178.9 million at December 31, 2020.
The change mainly reflects the net loss of the period of USD 12.8 million, the exercise of warrants and recognition of share-based payments. Vaccibody AS, Gaustadalléen 21, 0349 Oslo, Norway www.vaccibody.com Org.nr. 990 646 066 8 Trade receivables At June 30, 2021, trade receivables amounted to USD 3.8 million, compared to USD 3.8 million at December 31, 2020. The amount is related to the partial invoiced amount payable under the Genentech agreement. Trade and other payables At June 30, 2021, trade and other payables amounted to USD 5.6 million, compared to USD 9.2 million at December 31, 2020. The decrease is mainly from the outstanding one-off advisory cost related to the Genentech agreement in 2020, offset with increase in accrued expenses related to the N-02 Phase 1b study initiation. Contract assets At June 30, 2021, total contract assets amounted to USD 9.6 million, compared to USD 15.0 million at December 31, 2020.
The contract assets relate to earned revenue not invoiced under the Genentech agreement. The changes in the period are related to fulfilling the performance obligations under the Genentech agreement and transferring to trade receivables. Other current financial assets At June 30, 2021, total other current financial assets amounted to USD 20.8 million compared to USD 24.9 million at December 31, 2020.
The decrease primarily relates to the sales of market based financial instruments and fair value adjustments. Cash flow Net change in cash and cash equivalents was negative USD 5.4 million in the 2nd quarter of 2021 (Q2 2020: USD 2.9 million negative) and negative USD 9.4 million in the 1st half of 2021 (1H 2020: USD 1.7 million negative). Cash and cash equivalents decreased to USD 174.4 million at the end of the period, compared to USD 183.9 million at the end of 2020. Cash flow from operating activities Net cash flow from operating activities was negative USD 9.4 million in the 2nd quarter of 2021 (Q2 2020: USD 5.1 million negative) and negative USD 14.4 million in the 1st half 2021 (1H 2020: USD 7.9 million negative).
This was primarily driven by the increase in research and development expenses and employee benefit expenses due to the planned increase in headcount. Cash flow from investing activities Cash flow from investing activities was USD 3.7 million in the 2nd quarter of 2021 (Q2 2020: USD 2.3 million) and USD 4.3 million for the 1st half 2021 (1H 2020: USD 5.4 million). The amounts mainly relate to the proceeds from sales of market based financial instruments. Vaccibody AS, Gaustadalléen 21, 0349 Oslo, Norway www.vaccibody.com Org.nr. 990 646 066 9 Cash flow from financing activities Cash flow from financing activities was USD 0.3 million in the 2nd quarter of 2021 (Q2 2020: USD 0.06 million negative) and USD 0.7 million for the 1st half 2021 (1H 2020: USD 0.7 million). The amounts primarily relate to the proceeds from equity issuance, offset by payment of lease liabilities.