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Russian and Korean biotech companies Infectex, Ltd. and Qurient, Ltd. have announced a license agreement granting Infectex exclusive rights to develop and commercialize Qurient’s Tuberculosis-fighting drug Q203 in the Russian Federation, Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Moldova, Tajikistan, Turkmenistan, Uzbekistan  and Ukraine.
Infectex is a portfolio company of Maxwell Biotech Venture Fund, created with the participation of RVC capital.
Russian and Korean biotech companies Infectex, Ltd. and Qurient, Ltd. have announced a license agreement granting Infectex exclusive rights to develop and commercialize Qurient’s Tuberculosis-fighting drug Q203 in the Russian Federation, Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Moldova, Tajikistan, Turkmenistan, Uzbekistan  and Ukraine.
Infectex is a portfolio company of Maxwell Biotech Venture Fund, created with the participation of RVC capital.
Q203 is a highly innovative drug for multidrug-resistant (MDR) and extensively drug-resistant (XDR) tuberculosis and the first drug in its class with an original mechanism of action. The drug inhibits the growth of MDR clinical isolates of M.tuberculosis and demonstrates the efficacy in animal models of TB at very low doses. Preclinical results have recently been published in Nature Medicine (2013, vol. 19, pp. 1157–1160). Infectex will conduct additional preclinical studies and is planning to begin clinical trials by early 2015.
 

Dmitry Popov, Managing Partner at Maxwell Biotech Venture Fund: “We are delighted that Infectex has added a new anti-tuberculosis drug to its portfolio. In spite of the effort of the Russian government, the incidence of multi-drug resistant tuberculosis remains high in Russia. This situation creates serious social risks and has a negative economic impact. One can envision that the global strategy of tuberculosis treatment will involve the use of new and highly effective drug combinations. The drug candidates SQ109 and Q203 developed by Infectex have a great potential to become the basis for such combinations”.

 
According to the World Health Organization Russia has become one of the three nations with the highest incidence of MDR TB in the world including 226,000 cases of MDR TB and 34,800 cases of XDR TB reported in 2013. The Russian market for anti-tubercular drugs is well over $300 million per year, with total TB control costs estimated to be well over $1 billion. The Qurient-Infectex licensing deal could be valued at over $100 million to the parties contingent upon successful development and commercialization of the drug.
 

Ruslan Akhmetov, Investment Department Director at RVC: “This deal is a promising sign for us because it demonstrates that the projects where we are investing jointly with the Maxwell Biotech Venture Fund are attractive to foreign partners and have good prospects in Russia and abroad. For us as investors, we understand that in the long term we will see a good return on our investments”.

 

Kiyean Nam, Chief Executive Officer at Qurient: “It is an excellent opportunity for Qurient to bring Q203 to clinic in Russia and neighboring countries with a competent partner. There are huge unmet medical needs for TB, particularly for MDR/XDR TB, in many parts of the world including Russia. Qurient is ready to work closely with Infectex to provide a life-saving solution to MDR and XDR patients in the territory.”

 

 

Infectex, a Russian biotech company in Maxwell Biotech Venture Fund’s portfolio announced today enrollment of the first patients in its Phase IIb-III clinical trial of SQ109 for MDR-TB. Infectex was founded in 2011 to develop and commercialize innovative products for the treatment of TB. The study, which will be conducted at specialized clinical centers in Russia, is expected to continue for 2 years and will be the pivotal efficacy study in support of Russian and CIS regulatory approval.

Infectex, a Russian biotech company in Maxwell Biotech Venture Fund’s portfolio announced today enrollment of the first patients in its Phase IIb-III clinical trial of SQ109 for MDR-TB. Infectex was founded in 2011 to develop and commercialize innovative products for the treatment of TB. The study, which will be conducted at specialized clinical centers in Russia, is expected to continue for 2 years and will be the pivotal efficacy study in support of Russian and CIS regulatory approval. The trial will compare the effects of an optimized background drug regimen alone with an optimized background regimen plus SQ109 in MDR-TB patients. Study will be conducted in accordance with Russian and international treatment guidelines and in close partnership with U.S. biotech company Sequella, the original developer of the drug.

According to the World Health Organization, Russia is among the 22 countries with the highest level of TB disease, with approximately 120,000 new cases of TB and 18,000–24,000 new MDR-TB cases per year. With MDR patients, standard chemotherapy is no longer effective. In some parts of Russia and neighboring countries, TB infection rates are over 3 times that which the WHO considers epidemic, prompting the Russian government to make TB control a top priority. The Russian market for anti-tuberculosis drugs is well over $300 million per year, with total TB control costs estimated to be over $1 billion.

Oksana Markova, CEO of Infectex, said, "We are happy to announce the first Russian MDR-TB patients dosed with drug in this important clinical trial. SQ109 has already proved to be effective in TB animal models and shows a good safety profile in a number of clinical studies in healthy humans and TB patients. We hope that the new data will also confirm efficacy of this drug, and that it will be an important part of new, more efficient treatment regimens, reducing duration and cost of therapy and incidence of drug resistance."

Dr. Carol Nacy, CEO of Sequella, added, “We are delighted that this pivotal SQ109 trial for Russian and CIS submission has started. This represents the first MDR-TB patients worldwide to receive SQ109. We look forward to combining data from this study with our international MDR-TB study to support an SQ109 global submission for the treatment of MDR-TB.”

 

About SQ109

SQ109, identified as the lead drug candidate from among 63,000 diamine compounds synthesized in a combinatorial chemistry program, was co-discovered by scientists at Sequella and the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health (NIH), under a Cooperative Research and Development Agreement. SQ109 is currently under US IND and completed three Phase 1 studies in the U.S., one Phase 2 study in TB patients in Africa. With a mechanism of action distinct from all other antibiotics used in TB therapy, SQ109 has excellent activity against both drug susceptible and MDR-TB bacteria, including XDR-TB strains. SQ109 also enhances activity of anti-tubercular drugs isoniazid rifampicin, and bedaquiline and shortens by >30% the time required to cure mice of experimental TB.

SQ109 could replace one or more of the current antitubercular drugs, simplify therapy, and shorten the current TB treatment regimens. According to a November 2012 Cowen and Company report, a newly approved drug to treat MDR-TB has a peak sales market of approximately $400-$500 million.

Sequella filed a second IND for SQ109 for treatment of Helicobacter pylori infections in 2011 and is conducting a phase 2a trial in Texas, U.S.A. SQ109 has excellent activity against H. Pylori, killing 99.99% of these bacteria with concentrations easily achievable in stomach contents and tissues.

TV Center

A Skolkovo resident Infectex, a portfolio company of Maxwell Biotech Venture Fund, established with the participation of RVC develops an innovative drug SQ109 for the multidrug-resistant tuberculosis (MDR-TB) treatment together with an American biotech company Sequella. 

TV Center

A Skolkovo resident Infectex, a portfolio company of Maxwell Biotech Venture Fund, established with the participation of RVC develops an innovative drug SQ109 for the multidrug-resistant tuberculosis (MDR-TB) treatment together with an American biotech company Sequella. 

Prof. Sergey Borisov, chief study coordinator, deputy director for science and clinical work at Moscow Research Center for TB control of the Moscow Department of Health tells TV “Center” about the drug development progress.

 

SQ109 will be evaluated for efficacy on multi-drug resistant patients

Infectex has recently received notification from the Russian Ministry of Health for approval to begin the pivotal clinical trial associated with a drug registration submission, and can now proceed with the clinical development of SQ109 for treatment of tuberculosis (TB) in the Russian Federation.

SQ109 will be evaluated for efficacy on multi-drug resistant patients

Infectex has recently received notification from the Russian Ministry of Health for approval to begin the pivotal clinical trial associated with a drug registration submission, and can now proceed with the clinical development of SQ109 for treatment of tuberculosis (TB) in the Russian Federation.

A resident of Skolkovo Biomedical Cluster  Infectex invested by Maxwell Biotech Venture Fund, created with the participation of RVC, is engaged in the development of drug SQ109 with U.S. biotech company Sequella. This drug candidate is a is a low-molecular ethylene diamine compound, that inhibits the enzymes involved in the synthesis of mycobacterial cell wall - unique among anti-TB drugs mechanism of action.

The pivotal clinical trial financed by Maxwell Biotech Venture Fund will be conducted in multi-drug resistant (MDR)-TB patients at TB centers in three major Russian cities (Moscow, Saint-Petersburg and  Ekaterinburg) and will be managed by Infectex.

“We are extremely pleased that our corporate partner has achieved regulatory clearance to allow further study and potential commercialization of SQ109 in patients desperate for new therapeutic options,” said Dr. Carol Nacy, CEO of Sequella. “We congratulate Infectex on this success, and we look forward to the future availability of SQ109 to improve the lives of patients suffering from MDR-TB.”

According to the World Health Organization (WHO), Russia is one of the world’s “high burden” TB countries, with over 150,000 cases of active TB reported each year and over 43,000 cases of MDR-TB. In parts of Russia and the CIS, TB infection rates are over 3 times that which the WHO considers epidemic, prompting the Russian government to make TB control a top priority. The Russian market for anti-tubercular drugs is well over $150 million per year, with total TB control costs estimated to be well over $1 billion.

“We are very glad to participate in this international project in close cooperation with our partners from Maxwell Biotech Venture Fund and Sequella and hope that a new drug candidate will strengthen the efficiency of the existing treatment regimens and will be able to improve Russian and global standards of care in the future”, said Prof. Sergey Borisov, chief study coordinator, deputy director for science and clinical work at Moscow Research Center for TB control of the Moscow Department of Health.

A biotech company Infectex is the second portfolio company of Maxwell Biotech Venture Fund to receive the resident status in the Innovation Center of the Skolkovo Foundation.

Infectex, Ltd. is a Russian innovative company, a member of the biotech holding Maxwell Biotech Group. The main activity of Infectex is aimed at development and market promotion of an innovative drug for treatment of multi-drug resistant tuberculosis.

A biotech company Infectex is the second portfolio company of Maxwell Biotech Venture Fund to receive the resident status in the Innovation Center of the Skolkovo Foundation.

Infectex, Ltd. is a Russian innovative company, a member of the biotech holding Maxwell Biotech Group. The main activity of Infectex is aimed at development and market promotion of an innovative drug for treatment of multi-drug resistant tuberculosis.

“We are very happy that our cooperation with Skolkovo is developing so actively, - says Dmitry Popov, Managing Partner of Maxwell Biotech Venture Fund. – The drug, that is developed by Infectex, seem to be of a great importance for the Russian healthcare, since it is aimed at the solution of a complicated medical and social problem and suggests serious economic effect”.

The basis for the new drug is the development of an American biotech company Sequella, acting as the project partner. The drug candidate represents a low-molecular compound of ethylendiamine class; some of the family members are actively used in the tuberculosis front-line therapy. So, for example, ethambutol – a compound of the same class – is recommended for tuberculosis therapy by the World Healthcare Organization.

In the opinion of Russian and international experts, introduction of a new antitubercular agent, designed by Infectex, to the Russian market will expand the possibilities for treatment of patients with multi-drug resistant form of tuberculosis, by ensuring efficiency upgrade, reduction of therapy timeframes and decrease in causal treatment adverse effects rate.

The investment committee of Maxwell Biotech Venture Fund created with the participation of RVC has approved essential conditions of the deal and the amount of investments into Infectex. This is the fifth project that has received the fund’s investments for the past year. Infectex will concentrate on development and introduction to the market of the innovative drug for treatment of tuberculosis caused by multi-drug resistant mycobacteria. The approved financing round envisages allocation of 60 million rubles for the second phase of clinical trials.

The investment committee of Maxwell Biotech Venture Fund created with the participation of RVC has approved essential conditions of the deal and the amount of investments into Infectex. This is the fifth project that has received the fund’s investments for the past year. Infectex will concentrate on development and introduction to the market of the innovative drug for treatment of tuberculosis caused by multi-drug resistant mycobacteria. The approved financing round envisages allocation of 60 million rubles for the second phase of clinical trials.

The designed drug which basis has been formed by an American biotech company Sequella (www.sequella.com) represents a low- molecular compound of ethylendiamine class. The results of preclinical and first-phase clinical trials performed suggest that the characteristics of the drug candidate will enable it to become a new efficient antitubercular agent. In case of successful completion of the clinical trials and introduction of the drug to the market, the possibilities for causal treatment of tuberculosis with multi-drug resistance will be expanded significantly.

In the opinion of Dmitry Popov, Managing Partner of Maxwell Biotech Group, “the development and introduction of this drug to the Russian market is well-timed. In spite of the efforts of the Russian Government, the incidence of multi-drug resistant tuberculosis remains high in Russia. This situation creates serious social risks and has negative economic effects. By investing into such project, Maxwell Biotech Venture Fund fulfills one of its strategic tasks – providing Russian patients with an access to the world’s best innovative developments in the sphere of drug therapy”.

The American partners of Infectex also assess the deal positively. “We are happy to work with Maxwell Biotech Venture Fund as a reliable partner with an established international reputation, – noted doctor Carol Nacy, CEO of Sequella. – Considering the fearful rates of tuberculosis dissemination in general, and its multi-drug resistant form, in particular, the success of the new drug may be measured not only financially but in human lives as well. It’s a landmark date for TB patients in the territory of the former USSR and all those who, one way or another, are involved in the treatment of this dangerous disease”.

In the opinion of professor Vitaly Litvinov, RAMS Academician, chief specialist in tuberculosis of the Healthcare Department of the City of Moscow, Director of the Moscow Municipal Scientific and Practical Center for Tuberculosis Control, “the introduction of a new antitubercular agent  developed by Infectex into the Russian market will expand the possibilities for treatment of patients with multi-drug resistant tuberculosis, by ensuring efficiency upgrade, reduction of therapy timeframes and decrease in causal treatment adverse effects rate”.

“The top-priority task for Infectex is to organize and hold phases 2 and 3 of the clinical trials, and then, in case they are successful, introduce the drug to Russia and the CIS, – noted Yan Ryazantsev, Director of the Department for investments and expert examination of RVC. – This project requires the highest level of professionalism both from research scientists and from business units of the portfolio company, as well as active assistance on the part of the management team of Maxwell Biotech and RVC employees. The promising drug is very important for the medicine of our country and the medicine of the neighboring countries which have been struggling with tuberculosis for many years now”.

About

Infectex is a private biotechnology company founded with the goal to develop and bring to the Russian market innovative drugs for the treatment of serious infectious diseases. According to the deliberate strategy of commercialization and international partnerships Infectex plans to form a portfolio of innovative drugs that have high social value and significant market potential. To date the Company develops two pharmaceuticals for tuberculosis.