MDNA109 / Medicenna - LARVOL DELTA

Medicenna’s IL-2 Superkine Platform Featured in Peer-Reviewed Publication Demonstrating its Superiority and Ability to Reprogram the Tumor Microenvironment in Pancreatic Cancer (GlobeNewswire) - "Medicenna Therapeutics Corp...announced the peer-reviewed publication of preclinical data on MDNA109, the Company’s IL-2 Superkine platform that forms the basis for MDNA11....Treatment with MDNA109-virus led to superior tumor growth inhibition by showing a clear tendency towards complete tumor regression and improved survival; MDNA-109-virus weakened tumor-protecting myeloid cells in the tumor microenvironment (TME)."

Preclinical • Gastrointestinal Cancer • Oncology • Pancreatic Cancer

[VIRTUAL] Emergence of novel long-acting mono- and bi-specific IL-2/IL-13 Superkines as potent immune modulators (AACR-NCI-EORTC 2020) - "Background: Use of IL-2 (Proleukin®) remains limited due to a short half-life, toxicity, and preferential activation of Tregs driven by a high affinity for IL2Rα over IL2Rβ. To bypass these limitations, we further engineered MDNA109, an IL-2 superkine, to generate MDNA11 by (1) addition of mutations to abrogate IL2Rα binding and (2) fusion with albumin to extend half-life... MDNA11 is a long-acting IL-2 superkine with superior potency at activation of naïve CD8 T cells and NK cells, and diminished activity on Tregs. MDNA11 potently inhibited growth of tumors and induced durable regression and strong memory response. Novel bispecific constructs also demonstrated efficacy in these in vivo tumor models."

IO Biomarker • Melanoma • Oncology • Solid Tumor • CD8 • IL13 • IL2 • IL4 • STAT5

[VIRTUAL] Emergence of novel long-acting mono- and bi-specific IL-2/IL-13 Superkines as potent immune modulators (AACR-NCI-EORTC 2020) - "Background: Use of IL-2 (Proleukin®) remains limited due to a short half-life, toxicity, and preferential activation of Tregs driven by a high affinity for IL2Rα over IL2Rβ. To bypass these limitations, we further engineered MDNA109, an IL-2 superkine, to generate MDNA11 by (1) addition of mutations to abrogate IL2Rα binding and (2) fusion with albumin to extend half-life... MDNA11 is a long-acting IL-2 superkine with superior potency at activation of naïve CD8 T cells and NK cells, and diminished activity on Tregs. MDNA11 potently inhibited growth of tumors and induced durable regression and strong memory response. Novel bispecific constructs also demonstrated efficacy in these in vivo tumor models."

IO Biomarker • Melanoma • Oncology • Solid Tumor • CD8 • IL13 • IL2 • IL4 • STAT5

Medicenna announces March 31, 2020 year-end results (PRNewswire) - "Upcoming Milestones: Meeting with the US FDA to discuss the development path forward for MDNA55. It is currently anticipated this meeting will be held in Q3 calendar 2020. Initiation of IND enabling studies for MDNA109 Superkine Platform (MDNA19 or MDNA11) in Q4 of calendar 2020. Initiation of Phase 1 clinical study for MDNA109 Superkine Platform (MDNA19 or MDNA11) in mid-2021."

FDA event • New P1 trial • New trial • Glioblastoma • Oncology

Long-acting MDNA109 : Emerging IL-2 Superkines displaying potent anti-tumoral responses. (CRI-CIMT-EATI-AACR 2019) - "Background: Use of cytokines as cancer therapy was initiated with the approval of interleukin-2 (Proleukin®) for treatment of metastatic melanoma and renal cell carcinoma. MDNA109 is the only IL-2 in development that has been engineered for high affinity binding to CD122. Furthermore, three long-acting Superkines, MDNA109-LA, MDNA109-LA1, and MDNA109-LA2 have superior potency over IL-2 at activating NK and naïve CD8 effector T-cells. These 3 molecules potently inhibited CT26 and B16F10 tumor growth in vivo as monotherapies as well as in combination with ICIs on a dosing schedule that is similar to that of antibody based therapies."

Medicenna presented promising preclinical results from its IL-2 superkine platform at the 5th Annual International Cancer Immunotherapy Conference (Canada Newswire) - "The data was presented as a poster entitled "Long-acting MDNA109: Emerging IL-2 Superkines displaying potent anti-tumoral responses" this past weekend on September 27th, 2019 at the International Cancer Immunotherapy Conference held in Paris, France...In preclinical studies, we have combined MDNA109 variants with checkpoint inhibitors and we see very dramatic cure rates in mice..."

Preclinical

Nature Communications publishes studies on Medicenna's IL-2 superkine platform (Canada Newswire) - "Medicenna Therapeutics Corp...announced the publication of a peer-reviewed article in last month's edition of Nature Communications providing independent third-party validation of Medicenna's IL-2 Superkine platform, MDNA109....It has increased half-life and preferentially boosts tumor killing CD8+ T cells instead of tumor protecting regulatory T cells (Tregs); It has reduced CD25 binding, a better safety profile and is not immunogenic."

Preclinical

Medicenna to present MDNA19 pre-clinical update at the 5th Annual International Cancer Immunotherapy Conference (PRNewswire) - “Medicenna Therapeutics Corp….announced that it will present an update on the lead candidate from its IL-2 superkine platform, MDNA19, at the International Cancer Immunotherapy Conference to be held from September 25-28, 2019 in Paris, France.”

Preclinical

Medicenna reports first quarter fiscal 2020 financial results (Canada Newswire) - “Medicenna announced the selection of MDNA19 (formerly, MDNA109-LA1) as its second immuno-oncology clinical candidate for the treatment of cancer….Medicenna expects to begin clinical trials with MDNA19 in 2020.”

New trial

Medicenna selects its lead immuno-oncology clinical candidate, MDNA19, from its IL-2 superkine platform (PRNewswire) - “Medicenna Therapeutics Corp….announced the selection of MDNA19 (formerly, MDNA109-LA1) as its second immuno-oncology clinical candidate for the treatment of cancer. MDNA19 is a best-in-class long-acting IL-2 developed from Medicenna's Superkine platform that has shown unique ability to selectively stimulate cancer killing immune cells without the limitations seen with other long-acting IL-2 programs….With IND-enabling studies expected to be completed next year, Medicenna expects to enter clinical studies with MDNA19 in 2020.”

Trial initiation date

Medicenna presents new preclinical results for its IL-2 superkine platform, MDNA109 (PRNewswire) - “When MDNA109-LA was co-administered with the immune-checkpoint blocker anti-cytotoxic T-Lymphocyte-Associated Protein (CTLA)4 in a colon cancer mouse model, 67% of animals with pre-established tumors remained tumor-free for over 100 days. When these animals received a second and third re-challenge of the tumor without further treatment, 100% and 75% remained tumor free, respectively, demonstrating a strong memory response….Data show that MDNA109-LA1 may not only minimize adverse effects, but could also eliminate immunosuppression caused by Tregs using a dosing schedule that is compatible with immune-checkpoint blockers.”

Preclinical

Medicenna to present preliminary top-line results on MDNA55 at the Immuno-Oncology Pharma Congress (Canada Newswire) - “Medicenna Therapeutics Corp….announced that it will present preliminary top-line results from the recently completed Phase 2b clinical trial of MDNA55 for the treatment of recurrent glioblastoma at the Inaugural Immuno-Oncology Pharma Congress to be held from June 18-20, 2019 during World Pharma Week in Boston, MA….In addition, Medicenna will be presenting new preclinical data on its pipeline compound MDNA109…”

P2 data • Preclinical

MDNA109: Effect of an interleukin-2 superkine on CD8 T-cell properties in the tumor microenvironment. (ASCO 2019) - "Altogether, these data demonstrate that both MDNA109 and MDNA109-Fc are therapeutically superior to Proleukin. Furthermore, use of MDNA109-based strategies will not only ensure complete abrogation of adverse effects, but will in addition eliminate immunosuppression caused by both Tregs and myeloid cells."

Biomarker • Tumor microenvironment

Medicenna announces upcoming presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting (PRNewswire) - “Medicenna Therapeutics Corp…announced that Dr. Dina Randazzo of Duke University, will present updates related to the recently completed Phase 2b clinical trial of MDNA55 for the treatment of recurrent glioblastoma at the 2019 Annual Meeting of the American Society of Clinical Oncology (ASCO) to be held from May 31 to June 4, 2019 in Chicago, Illinois….Medicenna will have two abstracts published in the Conference Proceedings reporting (1) the use of multi-parametric MRI techniques to monitor tumor response in rGBM patients treated with MDNA55 in the recently completed Phase 2b clinical trial, and (2) preclinical data on its immuno-oncology pipeline candidate MDNA109.”

P2b data • Preclinical

Medicenna shows promising pre-clinical results in solid tumor models with its IL-2 Superkine, MDNA109 (PRNewswire) - “Medicenna Therapeutics Corp…announced that new pre-clinical data on its IL-2 Superkine program, MDNA109…demonstrating lack of immunogenicity while achieving potent anti-tumor activity particularly when combined with anti-PD1 and anti-CTLA-4 checkpoint inhibitors...Likewise, significant delay in the growth of pre-established MC38 and CT-26 colon cancer was observed in syngeneic mice receiving MDNA109, whereas its co-administration with anti-PD1 checkpoint inhibitor eliminated tumors in 90% of MC38 tumor-bearing mice.”

Preclinical

Newly added product (PRNewswire) - P1, Oncology

Pipeline update

Preliminary results on MDNA55 and MDNA109 to be presented at the Immuno-Oncology 360° conference (PRNewswire) - “Medicenna Therapeutics Corp…announced two presentations at the Immuno-Oncology 360° Conference….Title: The IL4 Receptor as a Biomarker and Immunotherapeutic Target for Glioblastoma: Preliminary Evidence with MDNA55, a Locally Administered IL-4 Guided Toxin; Title: Putting Pedal to the Metal: Combining IL-2 Superkine (MDNA109) with Checkpoint Inhibitors.”

Clinical data • Preclinical