Nykode Therapeutics Archives

Best known for its folklore and tales of the Vikings, Norway’s landscape boasts postcard-like islands and the northern lights. In addition to ranking top as one of the happiest nations in the world, the country relies on sectors like oil and gas, hydropower and aquaculture to strengthen its economic growth. And of late, the biotech industry has been picking up pace in Norway, propelled by the presence of numerous top-tier biotech companies leading the way. Key companies in the Norwegian biotech sector are international giants like the U.S.-based Pfizer and Bristol-Myers Squibb, Japanese pharmaceutical Takeda and Danish multinational company Novo Nordisk, with Swiss-based Sandoz monopolizing the industry’s revenue of more than NOK 2 billion ($18.8 billion), according to statistics from 2021. However, the country is a budding space for clinical-stage companies as well. As Norway celebrates Constitution Day on May 17, let us take a look at some of the country's biotech companies that are making their way to the top. Algipharma Algae’s many bioactive components make them ideal for drug delivery. Algipharma is a Norwegian biotech that aims to harness this potential. Formed in 2006, the company’s OligoG technology uses Laminaria hyperborea (brown algae), from which alginate polysaccharide is extracted to obtain purified oligosaccharides. Alginate can be used in the form of a hydrogel for wound healing, drug delivery and even in tissue engineering. To fight microbial infections, AlgiPharma’s alginate oligosaccharides are capable of releasing mucus in the airway and intestine, improving drug and lipid-based nanoparticle (LNP) delivery across mucus barriers, preventing tissue invasion of fungal cells and destroying the microbial biofilms that form in airways and infected wounds. With a focus on treating cystic fibrosis, OligoG was granted Orphan Drug designation by the Food and Drug Administration (FDA) in the U.S. for the condition, in 2016. Formulated as a dry powder for inhalation, the drug has completed six clinical trials in cystic fibrosis. In 2021, AlgiPharma was awarded NOK 16 million ($1.51 million) for its project ‘Therapeutic Alginates for Resistant and Recurrent Infections: Generating Eradication Therapies‘ (TARRGET), which will be completed in 2025. Arctic Bioscience As the importance of functional foods and dietary supplements gains recognition, the growth rate of the nutraceutical industry has doubled over the past few years, with the current global market estimated to be $117 billion. And on the northwestern coast of Norway, the biotech company Arctic Bioscience contributes to the industry by developing nutraceutical products that are based on natural and cultured marine membrane lipids. The company’s proprietary products branded as Romega, are derived from marine extracts such as herring roe. The proteins and lipids from the eggs are extracted using a specialized technology that enables the protection of the product fractions from exposure to high temperatures and too much oxygen. Excessive heat and oxygen can lead to the deterioration of the compounds that are drawn out from the roe. Hundreds of tons of roe are frozen into blocks during the harvesting season. Rich in omega-3 fatty acids, caviar oil and protein nutraceuticals are altered and sold to a variety of customers. Besides commercializing nutraceutical products, the company is developing an oral drug to treat mild-to-moderate psoriasis, a condition that causes flaky patches of skin that form scales. The phospholipid HRO350 is a complex polar lipid matrix that is also extracted from herring roe. The company will soon begin phase 2b studies for HRO350, to evaluate its efficacy and safety. Set up in 2011, Arctic Bioscience makes annual revenues of around NOK 34.5 million ($3.25 million), as of 2022. BerGenBio Founded in 2007, BerGenBio is a clinical-stage company that has two candidates focused on treating indications including cancer and respiratory diseases. Its lead drug candidate is bemcentinib, which is being investigated as a therapy against acute myeloid leukemia, non-small cell lung cancer (NSCLC) and even COVID-19, in phase 1 and 2 studies. Bemcentinib is an oral drug that inhibits the AXL receptor, which is a tyrosine kinase (cell-surface receptor). The receptor is associated with tumor proliferation and resistance to cancer therapy, thereby making it a key drug target. Additionally, AXL signaling promotes viral infectivity in the body, which is why the company is evaluating its efficacy in COVID-19 patients. For NSCLC patients with a mutation in the STK11 gene - which occurs in around 20% of NSCLC cases - BerGenBio has preclinical data that suggest that when in combination with an anti-PD1 antibody therapy, the drug candidate can generate tumor-killing T cells, improving the treatment response in those with the gene mutation. The biotech has also collaborated with global biopharma Merck in a phase 2 study to examine bemcentinib’s therapeutic potential as a combination treatment along with Keytruda (pembrolizumab) for NSCLC. In its lineup, BerGenBio has also developed tilvestamab, an anti-AXL monoclonal antibody. According to preclinical studies, it could prevent AXL signaling - for which an international phase 1b clinical trial is ongoing. With the latest funding round in 2022, this biotech company based in Norway has raised a total of $160.3 million over nine rounds since 2011. Cytovation Formed in 2001, Cytovation specializes in the development of immunotherapies for the treatment of cancer. The company’s novel technology CyPep-1 is capable of inducing a tumor-specific immune response by vaccination at the site of the tumor. The mechanism behind CyPep-1 is to inject the therapy into the tumor to target the tumor cells. CyPep-1, which is positively charged, binds to the negatively-charged membranes of tumor cells, thus forming pores on the membrane. Rupturing the membrane, the pores release neoantigens after which the tumor cells undergo lysis - where the cells disintegrate. The neoantigens are then released into the microenvironment and, upon being presented to T cells, induce a systemic immune response against cancer cells, while healthy cells remain intact. Cytovation has seven programs in its pipeline, with three indications in early-stage clinical trials, where the candidate is being investigated both as a monotherapy as well as in combination with cancer immunotherapy drug pembrolizumab. In February this year, the company announced that it had dosed the first patient in a phase 2a study that will evaluate CyPep-1’s safety and efficacy against advanced melanoma. Last year, the company raised NOK 180 million ($20 million) in a series A funding round for the continued development of CyPep-1, the lead investor being Norwegian venture capital firm Sandwater. Targovax Established in 2010, Targovax is focused on RNA-based therapies, and has built the circVec platform for the production of circular RNA, which can be tailored to target specific cells. With plans to rebrand as Circio, the company employs its ONCOS-102 technology, which is a genetically engineered AdV5 adenovirus system that can kill cancer cells and give rise to an immune response, for the treatment of PD-1 checkpoint inhibitor (CPI) refractory advanced melanoma. Having obtained positive results from phase 1 trials, where the drug, in combination with a PD-1 checkpoint inhibitor, demonstrated a high response rate in 35% of the study group, Targovax will go ahead with phase 2 soon. Along with ONCOS-102, the company’s KRAS program, which targets the mutation on the KRAS gene - found in 30% of all cancers - includes the lead candidate TG01. As a polyvalent mutant RAS neoantigen vaccine, TG01 has undergone a phase 1/2 study where patients with pancreatic cancer were also given the chemotherapy drug gemcitabine. The results of the trial were encouraging, with 94% of patients depicting mutant RAS-specific immune activation, and the median overall survival (mOS) for all participants in the cohort was 33.3 months. The Norwegian biotech company has raised $33.8 million over five rounds of funding, with the latest financing round completed in March 2023. Nykode Therapeutics Human papillomavirus (HPV) is responsible for around 690,000 cases of cancer globally, every year. Nykode Therapeutics aims to target the disease with its novel individualized vaccine candidate. For this, the patient’s tumor biopsy and blood sample are taken, through which the tumor-specific mutations and immune markers are identified. Then, using Nykode’s neoantigen selection algorithm NeoSELECT, the mutations are selected for the vaccine. The gene construct is cloned into a plasmid and a cell bank is generated. Once the drug is developed using recombinant microbial fermentation, it is filled into vials to be administered to the specific patient. Previously known as Vaccibody, Nykode Therapeutics also specializes in vaccine development for infectious diseases like COVID-19 and autoimmune diseases. These are in different stages of clinical trials currently - preclinical, phase 1 and phase 2 - apart from the six ongoing trials in oncology. The vaccine platform’s mechanism behind its needle-free jet injection is to bind to the APC protein which then absorbs it. Once internalized, the antigen is presented to CD4 and CD8 cells, which kill the cancer cells. Similarly, the vaccine is used to neutralize pathogens. For the further development of its individualized neoantigen cancer vaccines, the company entered into a partnership with American biotech Genentech, a subsidiary of Swiss multinational company Roche, in 2020. Founded in 2007, the company has obtained €31.7 million ($34.53) in funding over four rounds. In April 2023, the Norway-headquartered biotech company announced positive results from phase two trials for VB10.16 in combination with PD-L1 inhibitor atezolizumab for the treatment of advanced cervical cancer, where the median overall survival was greater than 25 months - the median is yet to be reached - and a median progression free survival of 6.3 months was observed in PD-L1 positive patients.

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