EnanDIM (DNA-based TLR9 agonist) / Mologen - LARVOL DELTA

EnanDIM - a novel family of L-nucleotide-protected TLR9 agonists for cancer immunotherapy. (PubMed, J Immunother Cancer) - "In summary, EnanDIM® comprise a novel family of TLR9 agonists that facilitate an efficacious activation of both innate and adaptive immunity. Their proven potential in onco-immunotherapy, as shown by cytotoxic activity, beneficial modulation of the tumor microenvironment, inhibition of tumor growth, and induction of long-lasting, tumor-specific memory, supports EnanDIM® molecules for further preclinical and clinical development."

Journal

DGAP-News: MOLOGEN AG: Update on development status of lead product candidates (Mologen Press Release) - P3, N=540; IMPALA (NCT02077868); Sponsor: Mologen AG; "Today, the biopharmaceutical company MOLOGEN AG...published the results of its Phase III IMPALA study at the ESMO 2019 conference...As part of a Proffered Paper Session, an expert was invited to discuss the data and put them into perspective. In light of the IMPALA top-line data, the Company has redirected its future strategic focus on combination approaches both for lefitolimod and the first clinical candidates from the EnanDIM(R) family across all current and planned studies...This data is also educating the development of the first clinical candidates of the EnanDIM(R) platform, which is scheduled to enter clinical development at the start of 2020."

New trial • P3 data

MOLOGEN AG announces implementation of new strategic program including restructuring measures (PharmiWeb) - "The Company's future focus will be on developing a follow-up product candidate from the EnanDIM(R) family in the area of oncology. The plan is to bring this product candidate to the clinical development stage in 2020."

Clinical

DGAP-News: MOLOGEN AG: Funding measures successfully implemented and important operational milestones achieved in H1 2019 (Mologen Press Release) - "An initial candidate from the EnanDIM^(R) platform is currently at an advanced stage of preclinical evaluation, with clinical development in the area of oncology due to begin at the end of 2019."

New trial

MOLOGEN AG: Clinical studies progress as planned and successful funding measures in fiscal year 2018 (Mologen Press Release) - "The preclinical and clinical studies with the lead product candidate lefitolimod in addition to pre-clinical studies with the lefitolimod follow-up molecules EnanDIM(R) were successfully progressed...We are eagerly anticipating the evaluation of the top line data of the phase III IMPALA pivotal study in the indication of metastatic colorectal cancer in particular. The Company expects that this data will be ready sooner than expected, potentially even as early as summer 2019...The TITAN combination study, funded by Gilead Sciences, USA, is set to begin in spring 2019."

P2a data • P3 data: top line • Preclinical

MOLOGEN AG: Impressive extended EnanDIM(R) preclinical data presented at the ITOC6 conference (PharmiWeb) - "The biopharmaceutical company MOLOGEN AG presented data of its EnanDIM(R) molecules, a new generation of potent non chemically-modified TLR9 agonists, at the ITOC6 CONFERENCE 2019, (THE 6TH LEADING INTERNATIONAL CANCER IMMUNOTHERAPY CONFERENCE IN EUROPE) in Vienna, Austria (11 - 13 April 2019). In murine tumor models, monotherapy with one of its EnanDIM(R) candidates induced persistent immune memory which results not only in specific immune responses against the original tumor but also in recognition and killing of tumors of different origin."

Preclinical

Induction of tumor-specific immune responses by the TLR9 agonist EnanDIM in murine syngeneic tumor models (ITOC 2019) - "Treatment of tumors with EnanDIM-C resulted in a reduction of tumor growth up to a complete tumor regression in various syngeneic models. In surviving mice a strong systemic immune response as well as a sustained immune memory against different tu-mors, presumably via shared antigens was induced by EnanDIM-C. These data indicate that EnanDIM-C complies with the essential re-quirements for an immunotherapeutic drug in single-agent mode as well as for an ideal combination partner with other immunotherapeutic agents, like checkpoint inhibitors."

Preclinical

MOLOGEN AG: Next generation TLR9 agonist product family EnanDIM featured in renowned JITC journal (Mologen Press Release) - "The article is featuring the development of the EnanDIM® product family including its innovative design and the identification of potent family members for cancer immunotherapy...Their proven potential in immuno-oncology, as shown by cytotoxic activity, beneficial modulation of the tumor microenvironment, inhibition of tumor growth, and induction of long-lasting, tumor-specific memory, supports EnanDIM® molecules for further preclinical and clinical development."

Preclinical