BioStock publishes updated analysis of Idogen

BioStock has yesterday, the 12th of September 2017, published an updated analysis of Idogen. The analysis is now available on BioStock’s and Idogen’s websites (www.biostock.se, www.idogen.com). On behalf of Idogen, Biostock has analyzed the company’s project portfolio and will continue to follow the company.

 

Extract from BioStock’s analysis:

“Idogens present market cap or around SEK 100 million can be viewed as conservative, given that the company has received 42.5 million SEK in a new issue, the company was the only recipient of the contribution of SEK 27.6 million from Horizon 2020, and that Idogen is also one of the recipients of the 49 MSEK in Vinnova’s funding. All this in addition to the company’s already existing liquid funds.”

 

Read the entire analysis update here in Swedish: https://www.biostock.se/2017/09/analysuppdatering-idogen-avancerar-med-starkta-finanser-och-aggressiv-utvecklingsplan/

 

For additional information about Idogen, please contact:

Lars Hedbys, CEO

Tel: +46 (0)46-275 63 30

E-mail: lars.hedbys@idogen.com

 

Idogen develops tolerogenic immune therapies which re-program the immune system. The term “tolerogenic” refers to that the immune system will tolerate the selected molecule after treatment. It represents a new treatment method for severe diseases with a large medical need currently lacking cure – such as autoimmune diseases, organ rejection after transplantation and patients without treatment after developing antibodies against standard treatment. The treatment method comprises cells from the patient’s blood being reprogrammed to dendritic cells with the capacity to specifically counteract the adverse immune reaction, without affecting the other immune function. The first indication for the therapy will be patients with the bleeding disorder hemophilia A who have developed an immunological reaction against their necessary factor VIII replacement. The company’s next therapeutic area will be a tolerogenic vaccine to counteract organ rejection in transplantation, primarily kidney transplantation. Idogen’s tolerogenic immune therapy is expected to reduce the need for immunosuppressive therapy and increase transplant survival, and thereby reduce the risk of cancer and serious infections. Idogen was founded in 2008 based on a fundamental immunological discovery at Lund University. For more information, visit www.idogen.com

 

Idogen participates in large Vinnova-initiative to make Sweden a leader in biological medicines

Idogen AB (”Idogen”) is a partner in a Vinnova project, awarded in total 48 million SEK in grants to run the cell and gene therapy project CAMP – Centre for Advanced Medical Products. Idogen will collaborate with, among others, AstraZeneca, GE Healthcare, Pfizer, all Swedish universities, several health care regions and research institutions to create an internationally recognized Centre for Advanced Medical Products. The project will have a duration of six years.

 

Vinnova’s investment is part of an eight-year research program for biological drugs totaling 320 million SEK and is part of the government’s strategic cooperation program in life science. The aim is for Sweden to be a leader in the field.

 

Cell- and gene therapy is a future area that provides the opportunity to cure or treat patients who currently lack treatment options, but in the long term also for major public diseases. We have recently seen significant investments internationally in the area, and it is an extremely important signal that Vinnova is now contributing to making Sweden a leader in the field with such an extensive venture. The unique thing in our granted project is that we create a broad collaboration in which academia, healthcare and small as well as large pharmaceutical companies jointly establish an internationally recognized cell and gene therapy center.” Agneta Edberg commented, Chair of the board of Idogen and board member in the CAMP project.

 

”For Idogen, it is very pleasing and satisfying to be participating in the establishment of an internationally recognized center for cell- and gene therapy, together with large and small companies in the area, all Swedish universities and several healthcare providers. The collaboration is expected to contribute positively to the development of our tolerogenic vaccines, as it gives us easier and faster access to cell therapy expertise and becomes an important source of support for clinical development and production, logistics and commercialization”. CEO Lars Hedbys commented.

 

CAMP ‒ Centre for Advanced Medical Products CAMP aims to establish itself as an internationally recognized center focusing on growth in industry and in SMEs, clinical practice, research and education, advanced production technology and a prominent innovation and business environment. In the longer term, the Center can help attract investment from the global life science industry, including pharmaceuticals, biotech, medical technology and service industries.

 

About Vinnova

Vinnova is Sweden’s Innovation Authority. Vinnova’s task is to promote sustainable growth in Sweden through funding of demand-driven research and development of efficient innovation systems. Vinnova is a state agency under the Ministry of Industry and National Contact Authority for the EU Research and Development Framework Program.

 

Read the press release from Vinnova here (Swedish): Stor satsning på forskningscentrum ska göra Sverige ledande inom biologiska läkemedel

 

 

For additional information about Idogen, please contact:

Lars Hedbys, CEO

Tel: +46 (0)46-275 63 30

E-mail: lars.hedbys@idogen.com

 

This is an English version of an original Swedish press release communicated by Idogen AB. In case of interpretation issues or possible differences between the different versions, the Swedish version shall apply. This constitutes information that Idogen AB is required to publish under the EU’s Market Abuse Regulation. The information was submitted for publication through the above contact person on the 21st of June 2017.

 

Idogen develops tolerogenic vaccines which re-program the immune system. The term “tolerogenic” refers to that the immune system will tolerate the selected molecule after treatment. It represents a new treatment method for autoimmune diseases, organ rejection after transplantation and patients without treatment after developing antibodies against standard treatment. The first indication for the therapy will be patients with the bleeding disorder hemophilia A who have developed an immunological reaction against their necessary factor VIII replacement. The treatment method comprises cells from the patient’s blood being reprogrammed to dendritic cells with the capacity to specifically counteract the adverse immune reaction. The company’s technology platform has the potential to develop long-acting treatment of anti-drug antibodies as well as autoimmune diseases that currently cannot be cured. In addition, Idogen has the potential to change the transplantation market by reducing the need for immunosuppressive therapy after transplantation. Idogen was founded in 2008 based on a fundamental immunological discovery at Lund University. For more information, visit www.idogen.com

BioStock publishes analysis of Idogen

Today, June 2 2017, BioStock has published an analysis of Idogen. The analysis is now available on BioStock’s, Idogen’s and Redeye’s respective websites (www.biostock.se, www.idogen.com, http://beta.redeye.se/transaction/idogen). On behalf of Idogen, Biostock has analyzed the company’s project portfolio and will continue to follow the company for one year.

 

Extract from BioStock’s analysis:

“BioStock has analyzed deal values and market caps to see how Idogen compares. Many of the deals have upfront

payments that exceed Idogen’s current market value. Interestingly, another cell therapy company with two preclinical projects is valued at roughly twice as Idogen’s current market cap. Perhaps this could be indicative of a future value when Idogen has established development within renal transplantation. Internationally, cell- and gene-based therapies belong to a space with high investment interest and BioStock believes that it’s just a matter of time until this trend reaches Scandinavian investors.”

 

Read the entire report here: http://www.biostock.se/2017/06/biostock-analys-idogen/

 

For additional information about Idogen, please contact:

Lars Hedbys, CEO

Tel: +46 (0)46-275 63 30

E-mail: lars.hedbys@idogen.com

 

Idogen develops tolerogenic vaccines which re-program the immune system. The term “tolerogenic” refers to that the immune system will tolerate the selected molecule after treatment. It represents a new treatment method for severe diseases with a large medical need currently lacking cure – such as autoimmune diseases, organ rejection after transplantation and patients without treatment after developing antibodies against standard treatment. The treatment method comprises cells from the patient’s blood being reprogrammed to dendritic cells with the capacity to specifically counteract the adverse immune reaction, without affecting the other immune function. The first indication for the therapy will be patients with the bleeding disorder hemophilia A who have developed an immunological reaction against their necessary factor VIII replacement. The company’s next therapeutic area will be a tolerogenic vaccine to counteract organ rejection in transplantation, primarily kidney transplantation. Idogen’s tolerogenic vaccine is expected to reduce the need for immunosuppressive therapy and increase transplant survival, and thereby reduce the risk of cancer and serious infections. Idogen was founded in 2008 based on a fundamental immunological discovery at Lund University. For more information, visit www.idogen.com

 

Idogen has been granted EUR 2.9 million funding from Horizon 2020

Idogen AB (“Idogen”) today announces that the company has been awarded funding of 2.9 million Euro from Horizon 2020, the EU Framework Programme for Research and Innovation, for the development of the company’s tolerogenic vaccine for the treatment of patients with severe hemophilia A and inhibitory antibodies against factor VIII.

 

The EU Horizon 2020 SME Instrument phase II grant runs over 33 months and the overall goal of Idogen’s granted application is to perform preclinical safety studies, establish an in-house production capability for manufacture of the tolerogenic vaccine for clinical studies, and perform the first phase I/IIa study in patients with hemophilia A who have inhibitory factor VIII antibodies. The funding will be paid in tranches during the project’s term.

 

“We are very grateful and proud to be one of the few chosen in the tough competition for funding from the Horizon 2020, SME Instrument. The fact that EU chooses to fund our project is an important confirmation of the potential of our vaccine technology.” CEO Lars Hedbys comments.

 

About Horizon 2020 – The EU Framework Programme for Research and Innovation

Horizon 2020 is the biggest EU Research and Innovation programme ever, with nearly 80 billion Euro of funding available over 7 years (2014 to 2020). It promises more breakthroughs, discoveries and world-firsts by taking great ideas from the lab to the market. The goal of the programme is to ensure that Europe produces world-class science, removes barriers to innovation, and facilitates for the public and private sectors to work together in delivering innovation. The SME Instrument is aimed at small and medium-sized businesses and allows financing of individual companies. For additional information about Horizon 2020, see https://ec.europa.eu/programmes/horizon2020/.

 

 

For additional information about Idogen, please contact:

Lars Hedbys, CEO

Tel: +46 (0)46-275 63 30

E-mail: lars.hedbys@idogen.com

 

This is an English version of an original Swedish press release communicated by Idogen AB. In case of interpretation issues or possible differences between the different versions, the Swedish version shall apply. This constitutes information that Idogen AB is required to publish under the EU’s Market Abuse Regulation. The information was submitted for publication through the above contact person on the 18th of May 2017.

 

Idogen develops tolerogenic vaccines which re-program the immune system. The term “tolerogenic” refers to that the immune system will tolerate the selected molecule after treatment. It represents a new treatment method for autoimmune diseases, organ rejection after transplantation and patients without treatment after developing antibodies against standard treatment. The first indication for the therapy will be patients with the bleeding disorder hemophilia A who have developed an immunological reaction against their necessary factor VIII replacement. The treatment method comprises cells from the patient’s blood being reprogrammed to dendritic cells with the capacity to specifically counteract the adverse immune reaction. The company’s technology platform has the potential to develop long-acting treatment of anti-drug antibodies as well as autoimmune diseases that currently cannot be cured. In addition, Idogen has the potential to change the transplantation market by reducing the need for immunosuppressive therapy after transplantation. Idogen was founded in 2008 based on a fundamental immunological discovery at Lund University. For more information, visit www.idogen.com

Tolerogenic vaccine for kidney transplantation to be next therapeutic area for Idogen

Idogen AB (”Idogen”) today announces that the company has decided that solid organ transplantation will be its next therapeutic area. The company has adopted a progressive development strategy in which a tolerogenic vaccine for kidney transplantation will be developed in parallel with the first tolerogenic vaccine for the treatment of inhibiting anti-factor VIII antibodies in hemophilia A. The development work with a tolerogenic vaccine for kidney transplantation has now commenced with the intention to initiate the first clinical study in 2019.

Currently, following transplantation, patients are given lifelong treatment with drugs that heavily suppress the immune system, which has negative consequences in terms of increased risk of serious infections and cancer. Idogen sees an opportunity with its treatment method to improve graft survival and to reduce the need for immunosuppressive drugs. Idogen’s second therapy area will therefore be a tolerogenic vaccine to prevent transplant rejection, primarily kidney transplantation. The development work is being conducted with the intention of initiating a Phase I/IIa study within kidney transplantation in 2019.

“Based on the three significant advances we have achieved in the past year with successful proof-of-concept in a model of hemophilia, results showing that we can influence parts of the human immune system in test tube experiments and our initiated transfer of the method to a GMP-customed process, we have great confidence in our technology. We have therefore decided on a more progressive development program with parallel development of tolerogenic vaccines within two different important therapeutic areas with need for a novel treatment regimen.”, CEO Lars Hedbys comments.

Idogen is developing a platform technology that can be used to treat a large number of diseases and conditions in the fields of inhibitor antibodies to biological drugs, autoimmune diseases and post-transplant rejection. The same method currently being developed for hemophilia A can be used in additional therapeutic areas with only a minor adjustment of the technology.

Kidney transplantation

Kidney transplantation is the most common type of organ transplant and globally, almost 80,000 kidney transplants are carried out each year, of which about 20,000 takes place in Europe[1]. The largest and most serious complication is if the recipient’s immune system attacks, destroys and rejects the donated organ. To prevent this, the transplanted patients, with few exceptions, are given life-long treatment with a combination of drugs that inhibit the immune system. Although the proportion of patients that are able to keep a functioning transplanted kidney in the first year has increased over the last decades, there has been no improvement in the long-term graft survival[2]. The immunosuppressive treatment also poses a risk of serious infections and cancer. Transplantation is thus a therapeutic area with a large unmet medical need. Idogen’s tolerogenic vaccine can provide the opportunity to improve graft survival and reduce the need for immunosuppressive drugs.

Idogen’s first indication – antibodies in hemophilia A

Idogen’s first tolerogenic vaccine is intended for treating patients with hemophilia A who have developed inhibiting antibodies against their ordinary treatment with factor VIII and thereby are left without efficient treatment alternatives. Hemophilia A is a rare disease, and in January 2017, Idogen received orphan drug designation for the treatment in Europe ‒ an important value-adding step for the company as orphan drug projects has shown to have significantly higher success-rate in clinical trials. Orphan medicinal status from EMA also includes a number of additional benefits, such as smaller clinical trials, support from government agencies during development and ten years of market exclusivity after launch.

 

For additional information about Idogen, please contact:

Lars Hedbys, CEO

Tel: +46 (0)46-275 63 30

E-mail: lars.hedbys@idogen.com

 

This is an English version of an original Swedish press release communicated by Idogen AB. In case of interpretation issues or possible differences between the different versions, the Swedish version shall apply. This constitutes information that Idogen AB is required to publish under the EU’s Market Abuse Regulation. The information was submitted for publication through the above contact person on the 11th of May 2017.

 

Idogen develops tolerogenic vaccines which re-program the immune system. The term “tolerogenic” refers to that the immune system will tolerate the selected molecule after treatment. It represents a new treatment method for autoimmune diseases, organ rejection after transplantation and patients without treatment after developing antibodies against standard treatment. The first indication for the therapy will be patients with the bleeding disorder hemophilia A who have developed an immunological reaction against their necessary factor VIII replacement. The treatment method comprises cells from the patient’s blood being reprogrammed to dendritic cells with the capacity to specifically counteract the adverse immune reaction. The company’s technology platform has the potential to develop long-acting treatment of anti-drug antibodies as well as autoimmune diseases that currently cannot be cured. In addition, Idogen has the potential to change the transplantation market by reducing the need for immunosuppressive therapy after transplantation. Idogen was founded in 2008 based on a fundamental immunological discovery at Lund University. For more information, visit www.idogen.com

 

[1] Global Observatory on Donation & Transplantation in collaboration with WHO.

[2] Afzali B, Taylor AL, Goldsmith DJA. What we CAN do about chronic allograft nephropathy: Role of immunnosuppressive modulations. Kidney International, 2005, 68, 2429-2443.

Wang JH, Skeans MA, Israni AK. Current status of kidney transplant outcomes: dying to survive. Adv Chronic Kidney Dis, 2016, 23, 5, 281-286.

Nomination proposal strengthens Idogen’s Board within cell therapy and drug development

Prior to the Idogen AB (publ) Annual General Meeting of 17 May 2017, the Nomination Committee has presented its proposal for a new Board. Chairman of the Board Agneta Edberg is proposed to be re-elected and re-election is also proposed for Board members Leif G. Salford and Ulf Blom. The Board members Cecilia Hollerup and Mikael Ørum have declined re-election and new Board members, Christina Herder and Karin Hoogendoorn, are proposed.

 

The Nomination committee, representing Idogen’s largest shareholders, proposes that the Board of Directors consist of five ordinary members without alternates until the end of the next Annual General Meeting. The Nomination Committee furthermore proposes remuneration to be issued by SEK 300,000 per year to the Chairman of the Board and with each SEK 150,000 per year to the ordinary Board members.

 

“Idogen now enters a new phase and the Nomination Committee has attached great importance to nominate a Board whose competence is adapted to the next step in the company’s development, which leads to the company being able to create new treatments for vulnerable patient groups. The company’s larger owners have chosen to step aside to strengthen the Board’s competence in the production of cell therapy and later phases of pharmaceutical development.” The Chairman of the Nomination Committee Håkan Hollerup comments.

 

Christina Herder has over 20 years of experience in early phase drug development and business development in the pharmaceutical industry. Her previous assignments include several senior roles in among other Swedish Orphan Biovitrum AB (Sobi) and Biovitrum. The last three years Christina has been CEO of Modus Therapeutics, a Swedish drug development company. Since 2015 she has been a member of the Board of PCI Biotech Holding ASA (listed on Oslo Axess). Christina Herder holds a doctorate from the Royal Institute of Technology in Stockholm and an executive MBA from Stockholm University.

 

Karin Hoogendoorn has significant experience in pharmaceutical product development of cell based medicinal products and the special regulations that apply to these and other advanced therapies (ATMPs). She has previously been appointed as Associate Director of Global Regulatory Affairs-CMC Cell & Gene Therapy Products at Novartis AG, Basel, Switzerland and Associate Director Global Regulatory Affairs-CMC at Janssen Biologics BV, Leiden, the Netherlands, and is currently Head of CMC at Immunicum AB (publ). Karin Hoogendoorn holds a Pharm.D. degree from Utrecht University, the Netherlands.

Of the Board members proposed by the Nomination Committee, Agneta Edberg, Ulf Blom, Christina Herder and Karin Hoogendoorn are independent of the company, the company management and major shareholders in the Company. The Annual General Meeting of Idogen AB will be held on 17th of May 2017 at. 15.00 in “Gamla Gästmatsalen” at Medicon Village, Scheelevägen 2, Lund. The Nomination Committee for the Annual General Meeting consisted of Håkan Hollerup (chairman), representing HCN Group AB, Mikael Ørum, representing Ventac Holdings (Cyprus) Limited, and Leif G. Salford. The Chairman of the Board, Agneta Edberg, has been adjunct to the Nomination Committee.

 

For additional information about Idogen, please contact:

Lars Hedbys, CEO

Tel: +46 (0)46-275 63 30

E-mail: lars.hedbys@idogen.com

 

This is an English version of an original Swedish press release communicated by Idogen AB. In case of interpretation issues or possible differences between the different versions, the Swedish version shall apply.

 

Idogen develops tolerogenic vaccines which re-program the immune system. The term “tolerogenic” refers to that the immune system will tolerate the selected molecule after treatment. It represents a new treatment method for autoimmune diseases, organ rejection after transplantation and patients without treatment after developing antibodies against standard treatment. The first indication for the therapy will be patients with the bleeding disorder hemophilia A who have developed an immunological reaction against their necessary factor VIII replacement. The treatment method comprises cells from the patient’s blood being reprogrammed to dendritic cells with the capacity to specifically counteract the adverse immune reaction. The company’s technology platform has the potential to develop long-acting treatment of anti-drug antibodies as well as autoimmune diseases that currently cannot be cured. In addition, Idogen has the potential to change the transplantation market by reducing the need for immunosuppressive therapy after transplantation. Idogen was founded in 2008 based on a fundamental immunological discovery at Lund University. For more information, visit www.idogen.com

Idogen decides on in-house production of tolerogenic vaccine

Idogen AB (“Idogen”) today announced that it has entered into an agreement with Medicon Village AB for use of custom cleanroom in order to produce the company’s cell therapy products for future clinical studies. The agreement means that Idogen get control over the production of its therapeutic vaccine for the first clinical studies. That the production is kept in-house means that the key skills and knowledge are maintained internally.

 

This is a short English version of an original Swedish press release communicated by Idogen AB. In case of interpretation issues or possible differences between the different versions, the Swedish version shall apply. This constitutes information that Idogen AB is required to publish under the EU’s Market Abuse Regulation. The information was submitted for publication through the above contact person on the 11th of April 2017.

 

Idogen develops tolerogenic vaccines which re-program the immune system. The term “tolerogenic” refers to that the immune system will tolerate the selected molecule after treatment. It represents a new treatment method for autoimmune diseases, organ rejection after transplantation and patients without treatment after developing antibodies against standard treatment. The first indication for the therapy will be patients with the bleeding disorder hemophilia A who have developed an immunological reaction against their necessary factor VIII replacement. The treatment method comprises cells from the patient’s blood being programmed to dendritic cells with the capacity to specifically counteract the adverse immune reaction. The company’s technology platform has the potential to develop long-acting treatment of anti-drug antibodies as well as autoimmune diseases that currently cannot be cured. In addition, Idogen has the potential to change the transplantation market by reducing the need for immunosuppressive therapy after transplantation. Idogen was founded in 2008 based on a fundamental immunological discovery at Lund University. For more information, visit www.idogen.com

 

Idogen recruits Chief Medical Officer

Idogen AB (”Idogen”) announces that it has recruited Dr. Steven Glazer to the position of Chief Medical Officer (CMO) commencing the 1st of April. This appointment means a significant strengthening of the organization for future clinical studies, initially in hemophilia A. Steven Glazer’s most recent role was as CMO at Hansa Medical AB, listed on Nasdaq Stockholm.

 

Steven Glazer has an extensive experience from senior positions in clinical drug development. His previous assignments include Senior Vice President of Development at BioInvent AB, Vice President of Development at Zealand Pharma and Medical Director at Novo Nordisk. He has extensive industrial experience in several therapeutic areas important for Idogen, including hemophilia, hematology, transplantation and diabetes. Steven has a doctorate in medicine from the University of Copenhagen and is trained in internal medicine.

 

“I look forward to working with Idogen and hemophilia again – a patient group I’ve worked a lot with. Idogen has an interesting technology which can change the current treatment modality of medically very vulnerable patients and I think my previous experiences will be useful.” Steven Glazer commented.

 

The recruitment of Steven Glazer as Chief Medical Officer means a considerable strengthening of Idogen’s competence and is very much in line with the aim for the upcoming clinical trials. Steven’s extensive experience in the development of new treatments in hemophilia will be a great asset for us. CEO Lars Hedbys commented.

 

 

For additional information about Idogen, please contact:

Lars Hedbys, CEO

Tel: +46 (0)46-275 63 30

E-mail: lars.hedbys@idogen.com

 

This is an English version of an original Swedish press release communicated by Idogen AB. In case of interpretation issues or possible differences between the different versions, the Swedish version shall apply. This constitutes information that Idogen AB is required to publish under the EU’s Market Abuse Regulation. The information was submitted for publication through the above contact person on the 31st of March 2017.

 

Idogen develops tolerogenic vaccines which re-program the immune system. The term “tolerogenic” refers to that the immune system will tolerate the selected molecule after treatment. It represents a new treatment method for autoimmune diseases, organ rejection after transplantation and patients without treatment after developing antibodies against standard treatment. The first indication for the therapy will be patients with the bleeding disorder hemophilia A who have developed an immunological reaction against their necessary factor VIII replacement. The treatment method comprises cells from the patient’s blood being reprogrammed to dendritic cells with the capacity to specifically counteract the adverse immune reaction. The company’s technology platform has the potential to develop long-acting treatment of anti-drug antibodies as well as autoimmune diseases that currently cannot be cured. In addition, Idogen has the potential to change the transplantation market by reducing the need for immunosuppressive therapy after transplantation. Idogen was founded in 2008 based on a fundamental immunological discovery at Lund University. For more information, visit www.idogen.com