From dogs to bacteria – the history of the first biotechnological drug

The importance and role of biotechnology in our daily lives have evolved rapidly over the past decades. From traditional biotechnology based on producing homemade beverages, cheeses, or fermented foods, we have advanced to molecular biotechnology. This advancement allows us to create genetically modified plants, hormones, vaccines, and biological drugs [1].

The most famous invention of molecular biotechnology is the production of the pancreatic hormone insulin by Escherichia coli bacteria. In the early 20s of the 20th century, insulin was extracted from pig and cattle pancreas. However, in the early 1970s, genes from mammals were successfully introduced into the E. coli genome and expressed, resulting in the production of insulin identical to human insulin. Insulin synthesized by bacteria was approved for use in diabetes treatment by the Food and Drug Administration (FDA) in 1982 as the first of its kind [2].

Sci-Fun Fact:

Initial human trials used insulin extracted from dog pancreas with a 65% ethanol solution. This method was not implemented due to its low profitability in pharmaceutical production.

Biotechnology in Poland in numbers

Now, let’s look at some statistics. In 2021, according to the Central Statistical Office, 173 companies were active in the field of biotechnology in Poland (in 2020 – 177; in 2019 – 181; in 2018 – 208 companies). Internal investments made by these companies in biotechnological activities amounted to PLN 1,380.9 million and increased by 13.2% over the year. Research and development in biotechnology was carried out by 217 entities, which represents a decrease of 4.4% compared to the previous year (in 2020 – 227; in 2019 – 230; in 2018 – 258) [3,4,5,6].

In 2021, 8,202 people were employed in biotechnology for research and development (R&D). This signifies a 5.4% increase in the number of workers compared to 2020. Nearly 75% of employees involved in R&D in biotechnology were researchers.

In 2021, companies allocated PLN 1,380.9 million for biotechnological activities, with 83.0% of these funds coming from the companies’ internal resources. Analyzing the size of companies, it was observed that the largest investments in biotechnology, similar to the previous year, came from medium-sized enterprises (PLN 653.1 million). However, there was a 4.0% decrease in these investments compared to the previous year [3].

Characteristics of Major Polish Biotechnology Companies:

The majority of biotechnology companies are located in Mazovia, Krakow, and Gdansk. Most of these companies are micro-enterprises. The Polish biotechnology sector primarily produces drugs, drug components and carriers, biomaterials, diagnostic tests, probiotics, dietary supplements, biopreparations, and innovative technological solutions used in medicine, pharmacy, and agriculture [12].

1.    Ryvu Therapeutics (formerly Selvita until 2019) – Their history dates back to a small startup founded in 2007, and they have grown into a global organization, one of the largest companies in Central and Eastern Europe. They are involved in the development of small-molecule drugs, biological drugs, and R&D (research and development for new products). Their most important project is RVU120, a CDK8/CDK19 inhibitor, currently in phase Ib clinical trials for patients with acute myeloid leukaemia (AML), myelodysplastic syndrome (MDS), and solid tumour trials. Another project, SEL24 (MEN1703), is a dual PIM/FLT3 kinase inhibitor currently in phase II clinical trials for patients with resistant or relapsed acute myeloid leukaemia (AML). It was developed in collaboration with the Menarini Group under a licensing agreement. The main headquarters are located in Krakow [7].

2.    Captor Therapeutics – The company uses Targeted Protein Degradation (TPD) technology to develop innovative therapies, focusing on diseases such as cancer and autoimmune disorders. TPD revolutionizes drug development and creates new therapeutic possibilities previously unattainable for standard patients. The main headquarters are in Wroclaw [8].

3.    PolTREG – The company’s mission is to develop effective therapies for autoimmune diseases based on regulatory T-cells (TREG) to improve the quality of life for patients and their families. PolTREG has four advanced research projects in the areas of type 1 diabetes and multiple sclerosis. In addition, their portfolio includes projects using the new generation of genetically modified regulatory T-lymphocytes. The company’s headquarters and Research and Development Center are located in Gdansk [9].

4.    Molecure – A biotechnology company that discovers and develops innovative drugs using its expertise in medical chemistry and biology. Their small-molecule drugs can be a therapy for incurable diseases by directly modulating previously unknown protein and RNA targets. The company boasts two candidates for advanced trials: OATD-01, a dual chitinase inhibitor for lung diseases such as sarcoidosis and idiopathic pulmonary fibrosis, and OATD-02, an oral dual arginase inhibitor developed for cancer therapy. Molecure is headquartered in Warsaw and Lodz [10].

5.    Synektik – The company is the exclusive distributor of the da Vinci robot. This advanced robotic system is used for minimally invasive surgeries in urology, gynaecology, and general surgery. The use of this system significantly reduces the risk of postoperative complications. They are also a Polish producer and supplier of radiopharmaceuticals used in positron emission tomography (PET) to diagnose oncological, cardiological, and neurological diseases. The company is headquartered in Warsaw [11].

Why Invest in Polish Biotechnology?

Poland’s significant research potential is increasingly emphasized due to the growing number of graduates and students in the fields of biomedical and biotechnological sciences. These students gain valuable experience through internships and work in renowned scientific institutions, mainly in Western Europe and the United States. Furthermore, the presence of special economic zones that provide tax exemptions makes Poland an attractive investment destination for Western entrepreneurs [12].

The biotechnology market in Poland is worth PLN 15 billion. During the pandemic, the stock prices of biotechnology companies surged, and they are now experiencing a decline. Nevertheless, it is projected to grow to as much as PLN 22 billion by 2027. The National Center provides research funding in collaboration with the industry for Research and Development, but only 20-25% of these funds come from government grants and other public sources. This leaves ample room for investments in stocks and bonds of companies and continuous development through applications for Polish and European grants [12].

References:

1.    David P. Clark, Nanette J. Pazdernik: Biotechnology, Newnes, 2015, ISBN 0123850169, 9780123850164

2.    Arthur D Riggs, Making, Cloning: Expression of Human Insulin Genes in Bacteria: The Path to Humulin, Endocrine Reviews, Volume 42, Issue 3, June 2021, Pages 374–380, https://doi.org/10.1210/endrev/bnaa029

3.    Dane i wykresy Głównego Urzędu Statystycznego z roku 2021: https://stat.gov.pl/obszary-tematyczne/nauka-i-technika-spoleczenstwo-informacyjne/nauka-i-technika/biotechnologia-i-nanotechnologia-w-polsce-w-2021-roku,10,10.html

4.    Dane Głównego Urzędu Statystycznego z roku 2020: https://stat.gov.pl/obszary-tematyczne/nauka-i-technika-spoleczenstwo-informacyjne/nauka-i-technika/biotechnologia-i-nanotechnologia-w-polsce-w-2020-roku,10,9.html

5.    Dane Głównego Urzędu Statystycznego z roku 2019: https://stat.gov.pl/obszary-tematyczne/nauka-i-technika-spoleczenstwo-informacyjne/nauka-i-technika/biotechnologia-i-nanotechnologia-w-polsce-w-2019-roku,10,8.html

6.    Dane Głównego Urzędu Statystycznego z roku 2018: https://stat.gov.pl/obszary-tematyczne/nauka-i-technika-spoleczenstwo-informacyjne/nauka-i-technika/biotechnologia-i-nanotechnologia-w-polsce-w-2018-roku,10,7.html

7.    https://ryvu.com/pl/kontakt/

8.    https://captortherapeutics.pl

9.    https://poltreg.com/pl/o-nas/

10.   https://molecure.com/pl/o-nas/

11.   https://synektik.com.pl/o-firmie/12.   Anna Bogdali: CHARAKTERYSTYKA RYNKU BIOTECHNOLOGICZNEGO W POLSCE, Zeszyty Naukowe Towarzystwa doktorantów UJ, Nauki Ścisłe, nr 6 (1/2023)