API Based on Thymosin 

beta 4 Peptide

for therapy of vascular and eye diseases

COOPERATION OPTIONS

LICENSE

FROM 100 MILLION RUR

RESEARCH PARTNERSHIP

FROM 20 MILLION RUR

more detail

ABOUT THE PROJECT

API Based on Thymosin beta 4 Peptide

NEW TARGETED DRUG FOR THERAPY OF VASCULAR AND EYE DISEASES.

RegeneRx Biopharmaceuticals (USA) is the main company, which develop Tβ4-based drugs. The company has initiated clinical trials of Tβ4-based drugs:
- RGN-259 - eye drops,
- RGN-137 - ointment,
- RGN-352 - injectable form.

The developing Thymosin Beta 4 API is the similar to the main component of Regenerx Biopharmaceuticals' RGN-259 drug for therapy (as a drops) of dry eye syndrome, neurotrophic keratitis and non-healing corneal ulcers caused mainly by diabetes or Herpes zoster virus.

In addition to the therapy of eye diseases, the cardioprotective properties of Tβ4 have been investigated. It was found, that the drug maintains left ventricular pumping function at an adequate level. In pilot experiments, performed on a model of acute myocardial infarction in rats reproduced by the Selje method, it was shown by echocardiographic studies that recombinant Thymosin β4 (2 mg/kg, w/w, for 3 days) statistically significantly prevents the development of acute left ventricular postinfarction remodeling. 

The candidate substance is expected to have low toxicity (meeting the requirements of Hazard Class 4 "low-hazard substances" (GOST 12.1.007-76 "Harmful substances"), good tolerability and complete absence or mild side effects. 

STAGE OF DEVELOPMENT

API BASED ON THYMOSIN beta 4 PEPTIDE
FOR THERAPY OF VASCULAR AND EYE DISEASES

COOPERATION OPTIONS

LICENSE

FROM 100 MILLION RUR

RESEARCH PARTNERSHIP

FROM 20 MILLION RUR

more detail

ABOUT THE PROJECT

API BASED ON THYMOSIN beta 4 PEPTIDE

NEW TARGETED DRUG FOR THERAPY OF VASCULAR AND EYE DISEASES.

RegeneRx Biopharmaceuticals (USA) is the main company, which develop Tβ4-based drugs. The company has initiated clinical trials of Tβ4-based drugs:
- RGN-259 - eye drops,
- RGN-137 - ointment,
- RGN-352 - injectable form.

The developing Thymosin Beta 4 API is the similar to the main component of Regenerx Biopharmaceuticals' RGN-259 drug for therapy (as a drops) of dry eye syndrome, neurotrophic keratitis and non-healing corneal ulcers caused mainly by diabetes or Herpes zoster virus.

In addition to the therapy of eye diseases, the cardioprotective properties of Tβ4 have been investigated. It was found, that the drug maintains left ventricular pumping function at an adequate level. In pilot experiments, performed on a model of acute myocardial infarction in rats reproduced by the Selje method, it was shown by echocardiographic studies that recombinant Thymosin β4 (2 mg/kg, w/w, for 3 days) statistically significantly prevents the development of acute left ventricular postinfarction remodeling.

The candidate substance is expected to have low toxicity (meeting the requirements of Hazard Class 4 "low-hazard substances" (GOST 12.1.007-76 "Harmful substances"), good tolerability and complete absence or mild side effects. 

STAGE OF DEVELOPMENT

STAGE OF DEVELOPMENT
& RESULTS OF INTELLECTUAL ACTIVITY STATUS


APPLICATION

  • The Thymosin Beta 4 API is applicable for the production of biosimilars of Regenerx Biopharmaceuticals: RGN-259, RGN-352 RGN-137, as well as for the search of new dosage forms and nosologies
  • Obtaining drugs for the therapy of dry keratoconjunctivitis, bullous epidermolysis, peripheral neuropathy and cardiac ischemia
  • Possibility to obtain a dosage form for injection 

BENEFITS

Author's easily scalable technology of obtaining acetylated thymosin beta 4, which combines in vivo N-terminal acetylation and autocatalytic cleavage of interin-containing hybrid protein 
 Lack of thymosin beta 4-based reproduced drugs registered in the Russian Federation 
LOW COST OF THE SUBSTANCE DUE TO THE UNIQUE BIOTECHNOLOGICAL PRODUCTION SCHEME

HIGH DEMAND FOR PREPARATIONS BASED ON THYMOSIN BETA 4 API

COOPERATION OPTIONS

Options for project implementation include Intellectual Property license agreement and/or further product development together with investor.
license agreement 

Conclusion of agreements on disposal of exclusive intellectual property rights (license agreements). 

Approximate investment amount: 

• Granting the right to use results of intellectual activity - starting at RUB 100 million RUR

• Royalty 5%

Small Innovation Enterprise (SIE)

Creation of the project company as a Small Innovation Enterprise (SIE), the founders of which include IBCh RAS and some investor & scientists-developers.

The aim: to bring research to the market launching stage and to organize product manufacturing and sales.

Approximate investment amount: 

Starting at 400 million RUR 

Small Innovation Enterprise (SIE)

Creation of the project company as a Small Innovation Enterprise (SIE), the founders of which include IBCh RAS and some investor & scientists-developers.

The aim: to reach the further research stage(s) and to sale of the scientific product in the form of sublicensing.

Approximate investment amount:

• Preclinical studies
Starting at 20 million RUR

• Clinical trials, phase 1
Starting at 60 million RUR

• Clinical trials, phase 2
Starting at 100 million RUR

• Clinical trials, phase 3
Starting at 150 million RUR

investment partnership agreements

Conclusion of investment partnership agreements for further research stages on the investor basis with the participation of IBCh RAS.

The aim: to obtain a scientific product or "ready to market" product.

Approximate investment amount: 

• Preclinical studies
Starting at 20 million RUR

• Clinical trials, phase 1
Starting at 60 million RUR

• Clinical trials, phase 2
Starting at 100 million RUR

• Clinical trials, phase 3
Starting at 150 million RUR

• Start manufacturing
Starting at 20 million RUR

• Promotion activities
Starting at 50 million RUR

DEVELOPERS

The Shemyakin & Ovchinnikov Institute of bioorganic chemistry (IBCh) of the Russian Academy of Sciences is one of the largest Russian scientific organizations. The Institute is a leader in fundamental and innovative researches on the fields of molecular, structural and cell biology, bioorganic chemistry, biophysics, bioengineering, cell technologies, “in vivo” molecular based bioimaging, genome editing, bioinformatics etc. This multidisciplinary structure allows large-scale research at the interface of sciences, where the most interesting scientific discoveries are born today.

The hallmark of the IBCh RAS is the concentration of efforts and resources on solving the most urgent and complicated problems on the field of life sciences. Talented young people and leading specialists, including Russian and foreign science leaders, Nobel Prize laureates and members of the international advisory council of the Institute are involved in.

HEAD OF THE PROJECT

ROMAN ESIPOV

Dr. of Sc. in Chemistry

Head of the Laboratory of Biopharmaceutical Technologies

 

CONTACT us

get in touch

On cooperation issues please contact the head of NTI Center project department
Sergey Semenov
E-mail consortium@cnti-ibch.ru
address 16/10, Miklukho-Maklaya St, Moscow, Russian Federation, 117997
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