Immunicum AB (publ) Announces Protocol Approval by the FDA Enabling the Initiation of Expanded Multi-indication Phase Ib/II C...
July 23 2018 - 2:00AM
Press Release
23 July 2018
Immunicum AB (publ) Announces Protocol Approval by the FDA Enabling
the Initiation of Expanded Multi-indication Phase Ib/II Combination
Trial
Immunicum AB
(publ; IMMU.ST) announced today that the U.S. Food and Drug
Administration (FDA) has approved the clinical trial protocol for
its planned Phase Ib/II trial to evaluate the safety and efficacy
of intratumorally-administered ilixadencel in combination with
checkpoint inhibitors (CPI). The regulatory approval allows the
company to start the process of patient enrollment. As previously
communicated, Immunicum expects the trial to enroll the first
patient in the second half of 2018.
The trial, abbreviated ILIAD, is
an Immunicum-sponsored, randomized, open-label, multicenter Phase
Ib/II study to evaluate the safety and efficacy of
intratumorally-administered ilixadencel in combination with CPIs.
It will test the combination in three indications: head and neck
cancer, non-small cell lung cancer and gastric and gastroesophageal
junction adenocarcinoma. The trial will be divided into two parts:
Phase Ib and Phase II. The aim of the Phase Ib part of the study is
to assess safety and define the optimal dose and schedule of
ilixadencel administration in combination with standard doses of
pembrolizumab (Keytruda®) in patients with any of these three types
of cancers.
Importantly, the Phase Ib part of
the study will now include 21 patients as compared to the 9 in the
original draft protocol that was completed in the third quarter
2017. This development in trial design was based on input from
clinical experts and EU regulatory authorities as well as guidance
from the FDA. The expansion will contribute more data on dose
levels and treatment schedules for use in the Phase II and has the
potential to capture initial indications of efficacy. There will be
an impact on the duration of the Phase Ib, which will also depend
on the start and pace of patient enrollment.
The Phase II part of the trial
will include up to 150 subjects randomly assigned in a 2:1 fashion
to ilixadencel combined with a CPI versus a CPI alone. In this
phase, the patients will be grouped by indication into three
studies advancing in parallel. The aim of the Phase II study is to
demonstrate a favorable impact of ilixadencel used in combination
with CPIs. Each indication group will include enough patients
to observe a statistically significant difference in clinical
activity between the different treatment groups.
"It is a great accomplishment for
Immunicum to have achieved the protocol approval and it will allow
us to start the trial as planned. The larger number of patients in
the Phase Ib will provide significant value as well as increase the
potential to observe indications of clinical activity earlier in
the trial," said Carlos de Sousa, CEO of Immunicum. "As previously
communicated, the company remains funded to the end of 2019 and we
will provide updates on the Phase Ib progress during this year and
over the course of 2019."
"We appreciate the contributions
of the clinical experts and investigators to the design of the
protocol and value the positive interactions we have had with the
regulatory authorities," added Peter Suenaert, MD, PhD, Chief
Medical Officer at Immunicum. "We look forward to start enrolling
patients during the second half of 2018."
About
ILIAD
Immunicum has named its planned 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 head and neck cancer, non-small cell lung
cancer and gastric and gastroesophageal junction adenocarcinoma
patients at clinical centers in the United States and across
Europe.
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.
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 23 July 2018 at 8.00 am CET.
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
20180723_Immunicum_Combination
Trial Start_ENG_Final
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
Immunomedics (NASDAQ:IMMU)
Historical Stock Chart
From Aug 2024 to Sep 2024
Immunomedics (NASDAQ:IMMU)
Historical Stock Chart
From Sep 2023 to Sep 2024