NASDAQ OMX

Immunicum AB (publ) Provides Update on Ilixadencel Clinical Development Program

Dela

Press Release

3 April 2018

Immunicum AB (publ) Provides Update on Ilixadencel Clinical Development Program

Immunicum AB (publ; IMMU.ST) provided today an update on planned, ongoing and previously completed clinical trials for its lead program, ilixadencel. Ilixadencel is a cell-based treatment with therapeutic potential as a component of combination regimens for a range of solid tumor cancers. It has been tested in more than 90 cancer patients to date. 

"We proceed according to plan with our ongoing clinical trials for ilixadencel in kidney and gastrointestinal stromal cancer patients. In addition, over the last several months we have achieved important progress in the development of the study protocol for the multi-indication checkpoint inhibitor combination trial. We look forward to start enrolling patients in that trial this year," said Carlos de Sousa, CEO of Immunicum. "Ilixadencel has broad potential as a key component of todays' innovative combination therapies to treat many different forms of solid tumor cancers. Our primary goal is to advance ilixadencel in indications with the greatest medical need and strategic potential."

Trial in preparation

Multi-indication Phase Ib/II Checkpoint Inhibitor Combination Trial
Based on its mode of action and the preclinical proof-of-concept data announced in 2017, Immunicum sees significant potential for ilixadencel as an immune primer in combination with checkpoint inhibitors (CPIs). The Company conducted an in-depth analysis of solid tumor cancers with high unmet medical need and limited sensitivity to CPIs and selected head & neck cancer, gastric adenocarcinoma and non-small cell lung cancer. After meetings with external experts and health authorities, the study protocol is now in its final stages. Immunicum expects to submit the trial documentation first to the US Food and Drug Administration, followed by submission for ethical review, during the second quarter 2018. The Company plans to enroll the first patient during the second half of 2018. The Company will provide updates on the Phase Ib portion of the study. These updates are expected to start during the first half of 2019 and to continue over the course of the year.

"We are very excited about our progress preparing for this important study, which will be conducted primarily at clinics in the US, the most important market for cutting-edge immuno-oncology treatments," added Peter Suenaert, Chief Medical Officer of Immunicum.    

Ongoing clinical trials

MERECA Phase II Trial
As previously reported, patient recruitment has been completed and a total of 88 newly diagnosed mRCC patients have been randomized into the trial conducted at 28 centers in eight European countries and the US. The 18-month follow-up period for the last patient treated will be completed in mid-year 2019, which will allow communication of the main findings of the trial in the 3Q 2019.  To iterate past communications, the study protocol does not permit interim data analysis. It is critical to the success of the trial and the integrity of the data for regulatory and corporate development purposes that Immunicum maintain the protocol and not invalidate the MERECA data. 

Gastrointestinal Stromal Tumors (GIST) Phase I/II Trial
The Company's collaborators at the Karolinska University Hospital have enrolled a total of 5 patients in the clinical Phase I/II study with ilixadencel in patients with Gastrointestinal Stromal Tumors (GIST). GIST is a very rare and complex disease with only 200 cases diagnosed in Sweden every year. It remains a severe cancer indication in desperate need of new therapeutics. Immunicum expects to announce the analysis of primary outcome measures of safety and tolerability, as well as initial secondary outcomes on efficacy, tumor response and progression-free survival in 2019.

Completed clinical trials

Hepatocellular Carcinoma (HCC) Phase I/II Trial
In September 2017, Immunicum announced the most important topline results from the completed Phase I/II safety and tolerability clinical trial of ilixadencel in 18 advanced liver cancer patients. Ilixadencel was shown to be safe and well tolerated in these patients when given both as a single treatment and in combination with the current first line standard treatment, sorafenib. In addition, the results provide evidence of tumor-specific immune activation in the majority of evaluable patients. Based on these positive data, Immunicum will continue to explore the potential of advancing to the next stage of clinical development in this indication based on different strategic and financial opportunities. The Company is preparing a manuscript describing the previously announced data in more detail for submission to a scientific journal for publication.

Renal Cell Carcinoma (mRCC) Phase I/II Trial
The trial initiated in 2012 tested ilixadencel in combination with standard of care in 12 newly diagnosed metastatic renal cell carcinoma (mRCC) patients. The last patient was treated in August 2013. Immunicum has followed the surviving patients over the course of the last 5 years and as of January 18, 2018, which is the final update, three of the 12 patients were still alive. The final median overall survival for the patients is 48 months, which compares favorably with published historical data of 15-16 months overall survival for newly diagnosed mRCC patients treated with sunitinib alone.

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

NASDAQ OMX
NASDAQ OMX



Följ NASDAQ OMX

Abonnera på våra pressmeddelanden.

Senaste pressmeddelandena från NASDAQ OMX

Brookfield Asset Management 2018 Second Quarter Results Conference Call And Webcast13.7.2018 16:04Pressmeddelande

Date: Thursday, August 9, 2018 Time: 11:00 a.m. (Eastern Time) TORONTO, July 13, 2018 (GLOBE NEWSWIRE) -- Second Quarter Conference Call You are invited to participate in Brookfield Asset Management's 2018 Second Quarter Conference Call & Webcast on Thursday, August 9, 2018 at 11:00 a.m. (Eastern Time) to discuss with members of senior management our results and current business initiatives. These results will be released on August 9th before 7:00 a.m. (Eastern Time) and will be available following the release on our website at www.brookfield.com "News - Press Releases." The Conference Call will also be Webcast live on our website, where it will be archived for future reference. To participate in the Conference Call, please dial (877) 255-3077 toll free in North America, or for overseas calls please dial (647) 252-4453 at approximately 10:50 a.m. The Conference Call will also be Webcast live at https://event.on24.com/wcc/r/1795914/64490BD29FBE43FAF176E3AF02943920. For those unable to p

NP3 och Diös gör bytesaffär i Gävle13.7.2018 12:15Pressmeddelande

NP3 och Diös gör en bytesaffär i Gävle. Syftet är att ytterligare stärka närvaron i respektive geografiska fokusområden. Diös köper 5 centrala samhällsfastigheter av NP3 och NP3 köper 13 industri- och bygghandelsfastigheter av Diös. Tillträde sker per den 3 september 2018. De 13 industri- och handelsfastigheter som NP3 förvärvar motsvarar en uthyrningsbar yta om cirka 80 000 kvadratmeter i områdena Näringen och Sörby Urfjäll. De största hyresgästerna är Ahlsells, Trelleborg och Swedol. Fastighetsvärdet uppgår till 345 mkr. De 5 samhällsfastigheterna Diös förvärvar motsvarar en total uthyrningsbar yta om 17 000 kvadratmeter, där den största fastigheten är en projektfastighet i närheten av Alderholmen, vilken kommer inrymma ett nytt kontor för Trafikverket. Tillträdet avseende den fastigheten sker under kvartal 1 2019. Övriga hyresgäster är Migrationsverket och två friskolor. Fastighetsvärdet uppgår till 300 mkr. Transaktionerna sker i bolagsform och kommer att redovisas under tredje kva

Squirrels Research Labs Announces Acorn Cryptocurrency Acceleration Hardware12.7.2018 21:04Pressmeddelande

NORTH CANTON, Ohio, July 12, 2018 (GLOBE NEWSWIRE) -- Squirrels Research Labs today announced Acorn, a new hardware component that improves efficiency and effectiveness of cryptocurrency mining. "We developed a piece of hardware called Acorn that increases the effectiveness of existing GPU mining operations without adding a significant cost," Squirrels president David Stanfill said. "This is a brand new concept that's never been done before." Acorn works in sync with GPUs to offload work that typically creates bottlenecks in mining. It performs the work much faster, resulting in an increase in overall mining efficiency. Initially three models will be available: CLE-101, CLE-215 and CLE-215+. Each model uses high-performance FPGA chips from Xilinx Inc. (NASDAQ:XLNX) in an M.2 slot to perform the least GPU-efficient parts of cryptocurrency mining. All Acorn models work with memory-intensive algorithms like Ethash and CryptoNight V1. The 215 and 215+ models work with both memory-intensive

NRT & Sightline Secure Multi-Year Exclusive Agreement with Ocean Resort Casino12.7.2018 19:30Pressmeddelande

Atlantic City's newest resort casino opens with a seamless customer experience for omni-channel solutions LAS VEGAS, July 12, 2018 (GLOBE NEWSWIRE) -- NRT Technology Corp. and Sightline Payments, LLC (together "NRT Sightline") today announced that Ocean Resort Casino in Atlantic City, N.J. opened its doors with the full suite of NRT Sightline solutions, including Play+, QJ self-serve kiosks, Cash+ ATM, credit and debit advances, VisuaLimits table signs and analytics, and the full suite of NCC credit and compliance solutions. "NRT Sightline has invested in cutting-edge technology that gives us a competitive advantage, and we look forward to our long-term partnership with this world-class technology leader," said Alan Greenstein, Chief Financial Officer of Ocean Resort Casino. "Ocean Resort Casino is Atlantic City's showcase property for a truly omni-channel guest experience. As the lines that separate cash and cashless commerce converge in gaming, our solutions remove friction from the

VeriTransfer(TM) Unveils the First Known Proof-of-Concept for a Blockchain Enabled Firearms Licence Verification and Ownership Transfer12.7.2018 17:43Pressmeddelande

Blockchain Enabled Firearms Solution Ensures Instant Verification of Ownership and Safe Transfer While Maintaining Data Privacy TORONTO, July 12, 2018 (GLOBE NEWSWIRE) -- VeriTransfer(TM) today announced the completion of its Proof-of-Concept ("POC") of the first publicly announced Blockchain enabled solution that decentralizes the process of storing the ownership rights and transfer of firearms. VeriTransfer(TM) is also pleased to announce that it will donate a percentage of all future revenues or the proceeds from any future sale of the company towards foundations whose mission is to end gun violence and build safer communities. The Gun Epidemic & The Economic Impact The United States hosts 4.4% of the world's population, but almost 50% of the 644 million civilian-owned guns globally are located in the U.S. Disturbingly, more American citizens have died as a result of gunshots in the U.S. since 1968 than on the battlefield of all the wars in American history from 1175 to 2015. In add

Nordens första gröna strukturerade placering noteras på Nasdaq Stockholm12.7.2018 13:15Pressmeddelande

STOCKHOLM, Sweden, July 12, 2018 (GLOBE NEWSWIRE) -- Imorgon, den 13 juli, noteras en publikt distribuerad strukturerad placering baserad på en grön obligation på Nasdaq Stockholm. Det är den första i sitt slag i Norden. Placeringen emitteras av den franska banken Crédit Agricole CIB och distribueras av Garantum Fondkommission, en ledande nordisk leverantör av strukturerade placeringar. Garantum har alltid varit en pionjär inom strukturerade placeringar, men det är inte varje dag vi får möjligheten att bryta ny mark på ett så viktigt område som grön finans, säger Mikael Axelsson, VD på Garantum Fondkommission. Vår mission är att skapa rätt placering vid rätt tillfälle och få saker kan vara mer rätt än en investering som ger positiva effekter på samhälle och miljö. Vi ser fram emot att fortsätta utnyttja flexibiliteten i strukturerade placeringar för att erbjuda varierad hållbar exponering på ett effektivt sätt. Och även om det alltid är kul att var först ut med något betydelsefullt, så

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

Besök vårt pressrum