Immunicum Presents Phase II Data Demonstrating Reduced MRD and Improved Survival with DCP-001 Treatment in AML Patients at ASH 2021

Press Release

Stockholm, Sweden, December 11, 2021

Immunicum Presents Phase II Data Demonstrating Reduced MRD and Improved Survival with DCP-001 Treatment in AML Patients at ASH 2021

Immunicum AB (“Immunicum”, publ; IMMU.ST), a biopharmaceutical company focused on hard-to-treat established tumors and the prevention of cancer recurrence, today will present positive data from its ADVANCE II Phase II study at the 63^rd American Society of Hematology (ASH) Annual Meeting being held in Atlanta, Georgia from December 11-14, 2021. The Phase II data demonstrate the ability of DCP-001 to convert or significantly reduce detectable minimal residual disease (MRD) in acute myeloid leukemia (AML) patients, with fully converted patients demonstrating greater overall survival. The results of the trial also reinforced data from a preceding Phase I trial demonstrating intradermal injection of DCP-001 to be generally well-tolerated.

The Phase II study enrolled twenty-six AML patients in complete remission (CR) following chemotherapy induction, but who remained MRD positive and were therefore deemed to be at elevated risk of relapse. Of twenty patients with evaluable MRD levels post-vaccination, six demonstrated a measurable improvement in MRD status with four of those patients converting from MRD positive to MRD negative, and two patients achieving a substantial reduction in MRD throughout the course of the trial. Patients who converted from MRD positive to MRD negative over the course of the trial were observed to have improved survival over those not having fully converted. An additional seven patients remained in CR with stable MRD levels and only six patients encountered relapse. Intradermal injections of DCP-001 were well tolerated, with only limited drug related side effects. No serious adverse events were reported in conjunction with DCP-001.

“We are pleased with the results from the ADVANCE II study demonstrating DCP-001’s ability to significantly reduce, and in several instances fully convert, MRD in AML patients,” said Jeroen Rovers, M.D, Ph.D., Chief Medical Officer at Immunicum. “Perhaps even more important is how that consequential conversion from MRD positive to MRD negative appears to translate into a higher likelihood of survival. Combined with the data from the preceding Phase I trial, the efficacy and safety data now assembled provide compelling justification to continue advancing of DCP-001 as a potential key tool in maintenance therapy for AML patients.”

“The data presented at ASH underscore the potential relevance of DCP-001 in AML maintenance therapy,” said Erik Manting, Ph.D., Chief Executive Officer at Immunicum. “The product combines off-the-shelf convenience with relative ease of administration via intradermal vaccination and an excellent safety profile. The current monotherapy data indicate competitive efficacy and provide a basis for future combination studies with other drugs used in the treatment of AML, such as hypomethylating agents.”

Patients in the ADVANCE II trial were divided into two cohorts, with each administered a different dose level of DCP-001 biweekly for four times, followed by additional booster administrations at weeks 14 and 18. MRD responses were recorded at 14, 20, and 32 weeks and patients were followed for up to 70 weeks after first administration. Median follow up of patients was 389 and 224 days for the two dose cohorts respectively. The primary endpoint of the study is MRD response, and the projected secondary endpoints of relapse free survival (RFS) and overall survival (OS) are still to be evaluated. The trial is continuing follow-up on patients to assess MRD responses over time and to assess relapse free (RFS) and overall (OS) survival.

About DCP-001
DCP-001 is an allogeneic, off-the shelf cell therapy product candidate that leverages dendritic cell biology to transform a proprietary, enhanced leukemic cell, DCOne^® into an effective cancer vaccine. With positive tolerability and efficacy data from recent Phase I and Phase II AML trials, DCP-001 is being developed as an effective tool in cancer maintenance therapy in order to reduce the incidence of relapse and increase survival. Published data demonstrates DCP-001’s therapeutic mechanism of effectively transferring tumor-associated antigens to patients’ own antigen-presenting cells prompting targeted immune activation and resulting in a durable anti-tumor response. Immunicum received Advanced Therapy Medicinal Product Classification from the EMA for DCP-001 in June 2021. DCP-001 is also presently being investigated in a Phase I clinical trial in patients with High-Grade Serous Ovarian Cancer (HGSOC).

The information is such information that Immunicum is obliged to make public pursuant to EU Market Abuse Regulation. The information was released for public disclosure through the contact persons detailed below on December 11^th, 2021, at 3:00 pm CET.

FOR MORE INFORMATION, PLEASE CONTACT:

Erik Manting
Chief Executive Officer
E-mail: ir@immunicum.com

INVESTOR RELATIONS

Brendan Payne
Stern Investor Relations
Telephone: +1 212-698-8695
E-mail: brendan.payne@sternir.com

For Sweden:

Kristina Windrup Olander
Spikinc AB
Telephone: +46 8 732 8400
E-mail: ir@immunicum.com

MEDIA RELATIONS

Eva Mulder and Sophia Hergenhan
Trophic Communications
Telephone: +49 89 2388 7731
E-mail: immu@trophic.eu

ABOUT IMMUNICUM AB (PUBL)

Immunicum is a biopharmaceutical company focused on hard-to-treat established tumors and the prevention of cancer recurrence, two key challenges in oncology. We are leveraging our unparalleled expertise in allogeneic dendritic cell biology to develop an advanced clinical pipeline of novel, off-the-shelf, cell-based therapies for solid and blood-borne tumors. Based in Sweden and the Netherlands, Immunicum is publicly traded on the Nasdaq Stockholm.
www.immunicum.com

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• 20211211_Immunicum_ASH Press Release_ENG_FINAL