Pure Biologics: Biological medicine for targeted cancer therapy

Pure biologics in 30s: is a biotechnology company whose research aims to develop new biological medicine and medical products based on antibodies and aptamers. Antibodies aims at serving for targeted therapy of cancer, while aptamers could be used as biological filters for rare disease. Company conducts 6 projects in these areas with one project in preclinical phase. Taking into account the market cap of the stock and possible commercialization of products we find a Pure Bilogice an interesting stock.

Pure biologics is biotechnology company which conducts a research on antibodies (biological medicine) and aptamers (medical product). The company started in 2010, it debuted at Warsaw Stock Exchange in 2020, right now pure biologics has about 80 employees while 40% has PhD.

 

Main company project

Company has main six project called pure body. First three programs: PB001 MULTIBODY, PB003 (PureActivator) and PB004 (PureBIKE)  are focused on antibodies and are aimed at disease like colorectal cancer (CRC), epithelial lung cancer (NSCLC), triple negative breast cancer TNBC consecutively. Antibodies, serving as  biological medicine has a better chance to go through all clinical phase then standard medicine, this medicine is also efficient and has good ability of detection of the target cell. The patent expiration make the cooperation more easy then for chemical substances.

Second three projects: project PB002 (AptaPheresis), PB005 (AptaMG)  and PB006 (AptaMLN) are focused on aptamers, aptamers are particles acting as antigen made from the cut of DNA. Here we have two projects of biomolecular filters based on active particles  for rare diseases PB002 (Neuromyelitis optica spectrum disorders (NMOSD)), PB005 (Myasthenia gravis) and the last project is the proof of concept  in the field of melanoma. Aptamers  used as active particles have many advantages:  the quality is easier to maintain, scaling of production, less contamination, less immunogenic, the size is smaller, and they are easier to modify genetically.

The financing of these projects is done via NCBR (national research grant)  of 70%  while the rest  30% is done via stock emission. This financing is supported till first clinical trials.

Howe drugs are discovered

Medicine discovery is the multilevel process taking even 10 years, however we can divided it into fours stages: conceptual phase, discovery phase, preclinical trials on animals and clinical trials. As the reference in USA 50% of the projects has a partnering at preclinical level  and 80% at clinical phase; As to give you the ideas the referential  transaction at beginning of preclinical phase ranges from 15 mlnusd till 120mln and up-front + 0,6 do 1,7 mld Milestones + Royalties per antibodies particles.
According to Bosa the upfront payment for each project 131 mln US$ – 195 mln US$ for each antibody project and 5  mln  US$ – 7  mln  US$ for PB002 and 6  mln  US$ – 8 mln US$ for aptamers project PB005

It has to also be mentioned that company has created its own platform for selection of antibodies PureSelect and aptamers Pure Apta. These platforms used for internal extremal projects (not contributing much to overall company income). Since it beginning it realize 160 contracts external contracts The main company clients  are Grupa Adamed, Polpharma or Celon Pharma.

Antibody projects

Pure biologic develops therapeutic antibodies which reaper the flaws in the killing of tumor cells of immune system. Evaluate Pharma estimated that market for immunosupresantów is 15% CAGRA, this is already 50% of the whole oncological market. The whole immune oncological market  according to PRNewswire will be 152mld usd in 2027 with 10% CAGR.

 

PB001 MULTIBODY. The aim of this projects is to develop a new medicine based on biospecific antibodies serving for waking up the T lymphocyte by releasing the breaks in cell communication,. This is first in class medicine. This medicine is aimed for cancer patient which are not responding to therapy for colorectal cancer (CRC),. The purpose is to go till second clinical trial.  Results so far are successful, we are right now at first phase of preclinical trials in 3q 2021. The NCBR finance this project since February 2018 till 2023 December, this 24 mln pln plus own 8.4 mln pln (via stock emission)

The mechanism of working of PB001, source Pure biologics

PB003 (PureActivator) Proteins The aim of this project is to develop a new biomedicine  which boost the response of immune system against hostile cells in a precise manner. The aim is produce triple acetic bispecific IgG fusion protein that block immunosuppressive releases Treg cell, the immune system of cancer cell and provoke in this case the activation of natural killer cell against epithelial lung cancer (NSCLC).  The stage of the project: together with twist medicine platform companies have chosen  scope of possible sequence binding molecular goals, they will be produced in IgG format and verified in functional tests. NCBR financing is guaranteed of 30 mln pln plus its own 9.8mln pl(via stock emission) . The project is at in vitro stage

The mechanism of working of PB003, source Pure biologics

PB004 (PureBIKE) The aim of this project is to develop BIspecific Killer Engager (BIKE) for triple negative brest cancer TNBC cancer, this cancer cell is really prolific. BIKE will activate by bonding natural killer cells to TNBC cells, creating the immunise response. Project status: tested 48 format, selected for optimal one the chosen one in vitro, planned preclinical for 2022. Project has NCBR subvention of 30mlnpln plus its own 10mln pln. Project ranges from 06/2019 till end on 2023. 

The mechanism of working of PB004, source Pure biologics

Aptamers, therapeutical projects

The main goal of these projects is to remove the antibodies from organisms which provoke too severe immune response. The first two project are used in apheresis which is the process of separating the cellular and soluble components of blood using a machine, similar process to dialysis. The third project is the proof of concept for developing aptamers-medicine konjugat serves in cancer therapy.

PB002 (AptaPheresis) This project aims at developing biomolecular filters based on aptamers which captures the hostile molecules while keeping necessary blood ingredients intact during apheresis for diseases of (Neuromyelitis optica spectrum disorders (NMOSD). So far it does not exist such a high quality product on the market. Subcontractor produced the first antibodies  (the hostile cell) which will be used ex vivo and in vivo. First preclinical studies done animals are performed by third parties with these antibodies. The whole project costs 14 mln, NCBR financing is  10.5 mln pln and 3.75 mln pln, the financing is provided for the period June 2018 till may 2023 .

PB005 (AptaMG) As for PB002  the aim is to develop biomolecular product for apheresis here for the breathing disease Myasthenia gravis. So far in Q3 2021 they found the base for aptamer, they showed to capture the C5 protein, artificially produced hostile cell. Next dynamic test will be done as to remove this C5 protein. In 2022 preclinical studies on animals are planned. Here the financing is at 14.7mln level which is 10.78mln pln at 3.9mln pln -, the project has a subvention from 2019 till 2023.

PB006 (AptaMLN) This project aims to develop the proof of concept for aptamers – cytotoxical medicine konjugate, serving for targeted cancer treatment for cutaneous melanoma. Here we use company platform for generating of modified aptamers. This work would be done till preclinical studies on animals. The whole values of projects is 2.35 mln pln Project started at January 2020, due to epidemy and some failures , the second stage  which suppose to finish at 02:2021 is postponed till 02/2022; Company improve sits selection and validation process of aptamers

 

Each phase of the projects, taken from 3Q 2021 company report

The pharmaceutical market

Pharmaceutical market is still growing thanks to many tailwind like to population growth, eldering of the society and the conscious of his own help. While on disadvantage we have regulation in USA, pressure on costs, and patents on certain biological cures. IQVIA expect  the pharmaceutical market to have 3% CAGR and  attain 1.5 trillion in 2023.  The biggest part of this market is the oncology which in 2023  should attain 203mld usd according to GlobeNewswire.  While for Oncological market Allied Market Research estimates 7,6% CAGR in 2017-2025. While immuno oncological market according to PRNewswire will attain 153mld usd in 2027 with 10% CAGR.

According to Statista, biological  medicine was about 32% of the pharmaceutical market in 2018 and its share should grow till 52% in 2022. CAGR of 7.4% of this market  is expected, the market should attain 337mld usd in 2050 according to Transparency Market Research.

The market of antibodies

 Antibodies are the most famous biological medicine, according to GlobeNewswire this market will grow till 350 mld usd  til 2027 with CAGR of 14%. In USA was 8 antibodies registered  and 16 waiting for registration. The market if bispecific antibodies was 10mld usd in 2019, and the growth is about 120%, currently we examine more than 300 of such a antibodies HEMILBRA meidice sales was 1.4mld usd in 2019.

The market of aptamers for rare disease

Orphan disease market is 12-15% CAGR and be 574mld by 2030 according to GLOBE NEWSWIRE bigger then whole Rx market, there are 7k of rare diseases, orphan diseases which is 30mln people in usa and 400mln around the world. According to Globe Newswire the apheresis market was worth 1,8mld usd in 2017 and it has 11% CAGR in 2017-2023; PR Newswire state that the apheresis equipment market was worth 1mld usd in 2018 and filters was 55% of this market.

While for 95% rare diseases we do not medicine, and the existing medicine are expansive.

Main head winds

  • Diversified portfolio of six projects
  • Increasing market of biological medicine
  • Big upside potential in case of project commercialization

Main tail winds

  • Risk of project failure, many of medicine projects are not being commercialized
  • Risk of next stock emission due to project prolongation
  • The subvention policy from NCBR may change

Pure biologics main company information

Market Cap: 137 mln PLN(13-03-2021)
 Share Price: 59.8PLN (13-032021)
 Business area:  biological medicine, antibodies, aptamers