GlobeNewswire

Immunicum AB: Immunicum AB (publ) Announces ATMP Certificate Granted by EMA to Ilixadencel for Manufacturing Quality and Non-clinical Data

Dela

Press Release

20 March 2018

Immunicum AB (publ) Announces ATMP Certificate Granted by EMA to Ilixadencel for Manufacturing Quality and Non-clinical Data

Immunicum AB (publ; IMMU.ST) a biopharmaceutical company advancing a novel, immune-priming cancer treatment against a variety of solid tumors, announced today that its lead product candidate, ilixadencel, has been granted an Advanced Therapy Medicinal Product (ATMP) certificate following a review of manufacturing quality and non-clinical data by the European Medicines Agency (EMA).

"The EMA ATMP certificate is an important development milestone for ilixadencel because it validates our manufacturing quality and preclinical data and gives us a firm foundation for the later stages of clinical development. Cell-based therapies must meet very high requirements and we are pleased to have this recognition from the EMA of our work to date," said Carlos de Sousa, CEO of Immunicum.

"Immunicum is one of very few companies that have successfully used this opportunity to submit documentation during the development phase for review and evaluation by the EMA and CAT," said Margareth Jorvid, Head of Regulatory Affairs and Quality Assurance at Immunicum. "This regulatory process is unique to small companies that develop ATMPs and to receive this certificate confirms that we are on the right path for ilixadencel."

The purpose of the ATMP certification is to provide a structured assessment and guidance to small and medium-sized enterprises (SMEs) developing advanced therapies, which include cell and gene therapies and tissue-engineered products. At the conclusion of the evaluation, a certificate may be issued by the EMA upon the recommendation of the Committee for Advanced Therapies (CAT), confirming the quality of the manufacturing process and preclinical data submitted for ATMP review. Although this certification is not a requirement for a future application for marketing authorization, it affirms that manufacturing quality and non-clinical development has been performed in accordance with regulatory  guidelines, taking into consideration the stage of product development.

About ilixadencel
Ilixadencel, a cell therapy product, is an off-the-shelf cancer immune primer, developed for the treatment of solid tumors. Its active ingredient is activated allogeneic dendritic cells, derived from healthy blood donors. Intratumoral injection of these cells generates an inflammatory response which in turn leads to tumor-specific activation of the patient's cytotoxic T-cells.

For more information, please contact:

Carlos de Sousa, CEO, Immunicum
Telephone: +46 (0) 31 41 50 52
E-mail: info@immunicum.com

Michaela Gertz, CFO, Immunicum
Telephone: +46 70 926 17 75
E-mail: ir@immunicum.com  

Media Relations

Gretchen Schweitzer and Joanne Tudorica
Trophic Communications
Telephone: +49 172 861 8540
E-mail: ir@immunicum.com  

About Immunicum AB (publ)

Immunicum is establishing a unique immuno-oncology approach through the development of allogeneic, off-the-shelf cell-based therapies. Our goal is to improve survival outcomes and quality of life by priming the patient's own immune system to fight cancer. The company's lead product ilixadencel, consisting of pro-inflammatory allogeneic dendritic cells, has the potential to become a backbone component of modern cancer combination treatments in a variety of solid tumor indications. Founded and based in Sweden, Immunicum is publicly traded on the Nasdaq Stockholm.  www.immunicum.com




This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Immunicum AB via Globenewswire

Om

GlobeNewswire



Följ GlobeNewswire

Abonnera på våra pressmeddelanden.

Senaste pressmeddelandena från GlobeNewswire

Karolinska Development's portfolio company Modus Therapeutics completes enrollment in Phase II study with sevuparin7.1.2019 12:00Pressmeddelande

STOCKHOLM, January 7, 2019. Karolinska Development's portfolio company Modus Therapeutics announces that the patient enrollment has been completed in the Phase II study with sevuparin in patients with sickle cell disease (SCD). The results from the study is expected in mid 2019. Modus Therapeutic's randomized, double blind study contains 140 SCD-patients with Acute Vaso Occlusive Crisis (VOC). It compares intravenously administered sevuparin with placebo. The primary endpoint of the study is the demonstration of a reduced time to resolution of patient's VOC. Clincal sites across Europe and the Middle East took part in the study that was conducted in conjunction with Modus Therapeutics' co development partner Ergomed. SCD has a high unmet medical need as there are currently no approved therapies for VOCs. It is an inherited blood disorder that affects between 90,000 to 100,000 patients in the U.S. and is characterized by severely painful VOCs that lead to organ damage due to a lack of o

Karolinska Development's portfolio company Modus Therapeutics completes enrollment in Phase II study with sevuparin7.1.2019 12:00Pressmeddelande

STOCKHOLM, January 7, 2019. Karolinska Development's portfolio company Modus Therapeutics announces that the patient enrollment has been completed in the Phase II study with sevuparin in patients with sickle cell disease (SCD). The results from the study is expected in mid 2019. Modus Therapeutic's randomized, double blind study contains 140 SCD-patients with Acute Vaso Occlusive Crisis (VOC). It compares intravenously administered sevuparin with placebo. The primary endpoint of the study is the demonstration of a reduced time to resolution of patient's VOC. Clincal sites across Europe and the Middle East took part in the study that was conducted in conjunction with Modus Therapeutics' co development partner Ergomed. SCD has a high unmet medical need as there are currently no approved therapies for VOCs. It is an inherited blood disorder that affects between 90,000 to 100,000 patients in the U.S. and is characterized by severely painful VOCs that lead to organ damage due to a lack of o

Stillfront Group rekryterar ansvarig för M&A19.12.2018 12:07Pressmeddelande

PRESSMEDDELANDE 19 december, 2018 Stillfront Group rekryterar ansvarig för M&A Stillfront Group, en marknadsledare inom 'free to play' online strategispel, annonserar idag att Marina Andersson har utsetts till ansvarig för M&A och kommer att ingå i koncernledningen. Marina har närmare tjugo års erfarenhet från investment banking och M&A. Hon har omfattande erfarenhet inom strategisk och finansiell rådgivning, affärsgenerering, projektledning inom förvärv och försäljningar av företag, finansiell analys, due diligence, samt företagsvärdering. Tidigare positioner inkluderar: Director, Deloitte's Corporate Finance Advisory team, Director, ICECAPITAL Securities, Associate Partner och Investment Manager, Deseven, samt M&A Analytiker på Carnegie. Marina har två magister-examen från Stockholms universitet och Russian Herzen State Pedagogical University. "Förvärv är en viktig del av Stillfronts affärsstrategi och vi är mycket glada att rekrytera Marina Andersson. Marinas breda erfarenhet och pr

Stillfront Group announces Head of M&A19.12.2018 12:07Pressmeddelande

PRESS RELEASE December 19, 2018 Stillfront Group announces Head of M&A Stillfront Group, a market leader in 'free to play' online strategy games, today announces that Marina Andersson has been appointed as Head of M&A and will be part of the Group's management team. Marina has close to 20 years track record of investment banking and M&A. She has extensive competence within strategic and financial advisory, deal generation, buy and sell side M&A project management, financial analysis, due diligence and company valuation. Former positions include: Director at Deloitte's Corporate Finance Advisory team, Director at ICECAPITAL Securities, Associate Partner and Investment Manager at Deseven, M&A Analyst at Carnegie. She holds two Master degrees from Stockholm University and Russian Herzen State Pedagogical University. "Acquisitions are a crucial part of Stillfront's business strategy and we are very pleased with the appointment of Marina Andersson. Marina's breadth of experience and profess

Oboya tecknar ett samarbetsavtal med Gaia avseende biomaterial13.12.2018 11:41Pressmeddelande

Oboya Horticulture Industries AB (publ) ("Oboya") har tecknat ett viktigt och långsiktigt samarbetsavtal avseende miljövänligt biomaterial med Gaia Biomaterials AB ("Gaia") i Helsingborg, Sverige. Avtalet innebär att Oboya använder Gaias biomaterial för tillverkning och utveckling av miljövänliga odlingsprodukter till odlingsindustrin. Oboya har under de senaste åren arbetat aktivt med innovation, miljö- och hållbarhetsfrågor och vårt mål är att främja miljö och hållbarhet inom odlingsindustrin genom att erbjuda miljövänliga odlingsprodukter till våra kunder. Oboya anser att användningen av biomaterial kommer att vara viktigt för framgång i omställningen till en fossilfri odlingsindustri världen över. Samarbetsavtalet innebär att Oboya använder Gaias biomaterial i sin produktion och att vi genom Gaias kompetens kan utveckla nya miljövänliga odlingsprodukter. Gaias biomaterial är biologiskt nedbrytbart, komposterbart samt ger upp till 80 % lägre koldioxidutsläpp vid förbränning jämfört

Oboya signs a cooperation agreement with Gaia regarding biomaterials13.12.2018 11:41Pressmeddelande

Oboya Horticulture Industries AB (publ) ("Oboya") has signed an important and long-term cooperation agreement on environmentally friendly biomaterials with Gaia Biomaterials AB ("Gaia") in Helsingborg, Sweden. The agreement means that Oboya uses Gaias biomaterials for the production and development of environmentally friendly cultivation products for the cultivation industry. Oboya has been actively involved in innovation, environmental and sustainability issues in recent years, and our goal is to encourage environmental and sustainability in the cultivation industry by offering environmentally friendly cultivation products to our customers. Oboya believes that the use of biomaterials will be important for success in the conversion to a fossil-free cultivation industry worldwide. The cooperation agreement means that Oboya uses Gaias biomaterials in its production and that through Gaias expertise we can develop new environmentally friendly cultivation products. Gaias biomaterials are bi

I vårt pressrum kan du läsa de senaste pressmeddelandena, få tillgång till pressmaterial och hitta kontaktinformation.

Besök vårt pressrum