GlobeNewswire

Immunicum AB (publ) Announces Next Safety and Enrollment Update for Phase Ib/II ILIAD Combination Trial

Share

Press Release

6 October 2020

Immunicum AB (publ) Announces Next Safety and Enrollment Update for Phase Ib/II ILIAD Combination Trial

Immunicum AB (publ; IMMU.ST) announced today that a total of 15 patients have now been enrolled in the ongoing Phase Ib/II ILIAD combination trial.In addition, ilixadencel has maintained a consistent safety profile in the study to-date and the Dose Escalation Committee (DEC) confirmed there were no dose limiting toxicities.The Phase Ib portion of the ILIAD trial will be evaluating the safety and tolerability of Immunicum’s lead cell-based candidate, ilixadencel, in combination with the checkpoint inhibitor (CPI) Keytruda® (pembrolizumab) in a total of 21 patients.

In June 2020, the Company announced that the non-staggered phase of the trial had started which enabled the recruitment and enrollment of patients to proceed more rapidly as the safety waiting period between patient enrollment was no longer necessary. Now, the DEC evaluated the safety profile for patients treated to date and recommended to continue treatment and open the last cohort to fully enroll the Phase Ib portion of the study.

“The patient enrollment progress we have achieved since the non-staggered phase opened is a positive development in this study and is ahead of the communicated timeline at the last safety update. Nonetheless, we maintain guidance that we expect the completion of patient enrollment for the Phase Ib portion of the trial in the first half of 2021,” commented Sven Rohmann, CEO of Immunicum. “The ILIAD trial is an important and exciting part of our core clinical development strategy in which we aim to evaluate ilixadencel in multiple solid tumor indications combined with a modern, standard of care treatment.”

The ILIAD trial includes patients who are candidates for pembrolizumab therapy in its approved label by the FDA, which includes, among others, the tumor types head and neck squamous cell carcinoma, non-small cell lung cancer and gastric and gastroesophageal junction adenocarcinoma. In terms of dosing, three patients were planned to receive two intratumoral doses of 3 million cells, six patients two doses of 10 million cells, six patients three doses of 10 million cells and the last six patients will receive one dose of 20 million cells followed by two doses of 10 million cells. The Phase II part of the ILIAD trial will then continue with the selected dose regimen from the Phase Ib. Completion of the Phase Ib trial with longer duration of follow-up of patients for signs of efficacy is expected towards the second half of 2021.

About ilixadencel
Ilixadencel is an off-the-shelf cell-based cancer immunotherapy developed for the treatment of solid tumors. Its active ingredient is activated allogeneic dendritic cells, derived from healthy blood donors. Injection of these cells in the patient’s tumor generates an inflammatory response which in turns leads to tumor-specific activation of the patient’s cytotoxic T cells. To-date ilixadencel has been tested in a range of clinical trials in various solid tumor indications including metastatic Renal Cell Carcinoma (mRCC), hepatocellular carcinoma (HCC) and gastrointestinal stromal tumors (GIST) and in combination with several standard-of-care cancer therapies such as the tyrosine kinase inhibitors Sutent® (sunitinib) and Stivarga® (regorafenib), and the checkpoint inhibitor Keytruda® (pembrolizumab). Ilixadencel has consistently maintained a positive safety and tolerability profile and demonstrated initial signs of efficacy as seen in the randomized Phase II MERECA trial. Ilixadencel is currently moving towards late-stage clinical development.

About ILIAD
Immunicum has named its multi-indication Phase Ib/II CPI combination trial ILIAD. The name represents ILIxadencel in combination with checkpoint inhibitors in ADvanced cancer patients. The trial will enroll patients with different cancer indications, including head and neck squamous cell carcinoma, non-small cell lung cancer and gastric and gastroesophageal junction adenocarcinoma.

For more information, please contact:

Sijme Zeilemaker, COO, Immunicum
Telephone: +46 8 732 8400
E-mail: info@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. Immunicum has evaluated ilixadencel in several clinical trials including the recently completed exploratory Phase II MERECA study in kidney cancer and the Company is moving towards late-stage clinical development. Founded and based in Sweden, Immunicum is publicly traded on the Nasdaq Stockholm. www.immunicum.com

Attachment

To view this piece of content from www.globenewswire.com, please give your consent at the top of this page.

About GlobeNewswire

GlobeNewswire
GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://globenewswire.com

GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Subscribe to releases from GlobeNewswire

Subscribe to all the latest releases from GlobeNewswire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from GlobeNewswire

New Zolgensma data demonstrate age-appropriate development when used presymptomatically and rapid, clinically meaningful efficacy in symptomatic children, even those with severe SMA at baseline18.6.2021 18:30:00 CEST | Press release

All children (100%) treated presymptomatically in the SPR1NT two-copy cohort survived without respiratory or nutritional support, and sat independently for ≥30 seconds, most (11/14) within the WHO window of expected normal development The majority of children (82%) treated in STR1VE-EU achieved developmental motor milestones not observed in the natural history of SMA Type 1, including patients with more severe disease More than 1,200 patients have now been treated with Zolgensma globally across clinical trials, managed access programs, and in the commercial setting1 Basel, June 18, 2021– Novartis today announced data that reinforce the transformational benefit of Zolgensma® (onasemnogene abeparvovec), an essential, one-time treatment and the only gene therapy for spinal muscular atrophy (SMA). New late-breaker data from the completed two-copy cohort of the Phase 3 SPR1NT clinical trial demonstrate age-appropriate milestone development in presymptomatic children with SMA without respira

The results of the private placement of Subordinated Convertible Notes and private placement of Secured Notes of AS PRFoods / transactions with persons connected with the issuer18.6.2021 16:22:48 CEST | Press release

THIS NOTICE IS NOT INTENDED FOR PUBLICATION, ALLOCATION OR TRANSMISSION, IN PART OR WHOLLY, DIRECTLY OR INDIRECTLY, IN THE UNITED STATES, AUSTRALIA, CANADA, HONG KONG, JAPAN, NEW ZEALAND, SINGAPORE, SOUTH AFRICA, OR ELSEWHERE THE DISCLOSURE OR TRANSMISSION OF THIS INFORMATION IS NOT ALLOWED. By a company announcement dated 04.06.2021, AS PRFoods (hereinafter "PRFoods") informed investors that it was conducting an issue of subordinated convertible notes, whereunder PRFoods is to issue up to 350 subordinated convertible notes, with the maximum aggregate nominal value of up to EUR 3,500,000, nominal value of EUR 10,000 per subordinated convertible note, interest rate of 7% per annum and maturity date on 01.10.2025 (hereinafter the “ConvertibleNotes”). The subscription period for the Convertible Notes ended on 14.06.2021. In course of the private placement, investors subscribed for 237 Convertible Notes, with the aggregate nominal value of EUR 2,370,000, i.e. for approximately 67% of the m

CONDITIONS FOR PURCHASES OF CORPORATE BONDS18.6.2021 16:20:00 CEST | Press release

Bid procedure, 2021-06-23BondsBonds issued in SEK by Swedish non-financial undertakings. The following bonds are eligible for delivery: RIKSHEM AB: SE0011452507, 2023-07-18 RIKSHEM AB: SE0011869981, 2023-05-08 EPIROC AB: XS1918042364, 2023-12-06 EPIROC AB: XS2258568778, 2026-05-18 SCANIA CV AB: XS2042641121, 2022-08-22 SCANIA CV AB: XS2332891089, 2023-04-19 AB INDUSTRIVARDEN: SE0011869668, 2022-02-28 AB INDUSTRIVARDEN: SE0012676724, 2023-02-20 SVENSK FASTIGHETS FIN: SE0012194058, 2022-02-28 SVENSK FASTIGHETS FIN: SE0012676872, 2022-09-07 Delivery of a Bond may not occur if the Counterparty has purchased the Bond from the issuer more recently than one month prior to the date of announcement of the Special terms, that is, the purchase may not have taken place after: 2021-05-23Bid date2021-06-23Bid times10.00-11.00 (CET/CEST) on the Bid dateRequested volume (corresponding nominal amount)SE0011452507: 30 mln SEK +/-30 mln SEK SE0011869981: 30 mln SEK +/-30 mln SEK XS1918042364: 30 mln SEK

CONDITIONS FOR RIKSBANK BID PROCEDURE KOMMUNINVEST BONDS18.6.2021 16:20:00 CEST | Press release

Bid procedure, 2021-06-22BondsKOMMUNINVEST I SVERIGE: 2311. SE0010948240. 2023-11-13 KOMMUNINVEST I SVERIGE: 2505, SE0011414010, 2025-05-12 KOMMUNINVEST I SVERIGE: 2805, SE0015660139, 2028-05-12 BidsBids on interest and volume are entered via Bloomberg Bond Auction SystemBid date2021-06-22Bid times10.00-11.00 (CET/CEST) on the Bid dateRequested volume (corresponding nominal amount)2311: 500 mln SEK +/-250 mln SEK 2505: 1000 mln SEK +/-500 mln SEK 2805: 750 mln SEK +/-350 mln SEK Highest permitted bid volume (corresponding nominal amount)2311: 500 mln SEK per bid 2505: 1000 mln SEK per bid 2805: 750 mln SEK per bid Lowest permitted bid volume (corresponding nominal amount)SEK 50 million per bidExpected allocation timeNot later than 11.15 (CET/CEST) on the Bid dateDelivery and payment date2021-06-24Delivery of bondsTo the Riksbank's account in Euroclear Sweden AB's securities settlement system 1 4948 6383General Terms and ConditionsGeneral Terms and Conditions General Terms and Condition

CONDITIONS FOR THE RIKSBANK´S PURCHASES OF COMMERCIAL PAPER18.6.2021 16:20:00 CEST | Press release

Bid procedure, 2021-06-23CertificateCommercial paper issued in SEK by non-financial companies with their registered office in Sweden and with a remaining maturity of up to six months on the Bid date. i.e. with the latest maturity date as of 2021-12-23 Delivery may not be made in commercial paper purchased by the Counterparty from the issuer less than one week prior to the date for announcing the Special terms, i.e. the purchase may not have been made after 2021-06-11 BidsCounterparties may make one bid per Credit rating class and maturity class. Bids are made to tel 08-696 69 70 and confirmed by e-mail to EOL@riksbank.se.Bid date2021-06-23Bid times09.00-09.30 (CET/CEST) on the Bid dateRequested volume (corresponding nominal amount)SEK 4 billionHighest permitted bid volume (corresponding nominal amount)The total bid volume from one Counterparty for the two Credit rating classes may not exceed SEK 4 billion. No bid may contain Commercial paper in excess of SEK 250 million issued by the s

Eolus förvärvar två fullt tillståndsgivna svenska vindkraftsprojekt18.6.2021 16:15:00 CEST | Pressemelding

Hässleholm den 18 juni 2021 Eolus har tecknat avtal med RWE om att förvärva två fullt tillståndsgivna svenska vindkraftsprojekt. Projekten som omfattar 99 MW är lokaliserade i SE3 och Eolus kommer under sommaren att påbörja försäljningsprocessen med ambitionen att teckna avtal med en investerare under hösten 2021. Projekten är belägna i Avesta kommun (Skallberget/Utterberget) och Hedemora kommun (Tjärnäs) och omfattar totalt vardera 74,4 MW och 24,8 MW. Projekten är fullt tillståndsgivna. Eolus kommer under sommaren att påbörja försäljningsprocessen med ambitionen att teckna ett avtal med en investerare under hösten 2021. Planerad driftsättning är under 2023. För ytterligare information kontakta: Per Witalisson, VD, telefon +46 (0)70-265 16 15 Johan Hammarqvist, kommunikationschef, telefon +46 (0)720-50 59 11 Kort om Eolus Eolus Vind är en av Nordens ledande projektörer av vindkraftsanläggningar. Eolus skapar värden i alla led inom ramen för projektutveckling och drift av vindkraftsanl