Medicenna Therapeutics Reports Fiscal Year 2024 Financial Results and Operational Highlights
Medicenna Therapeutics announced its fiscal year 2024 results, showcasing a robust financial position with an increased cash balance of $37 million due to a $20 million investment by RA Capital. This investment extends the company's operational runway to mid-2026. Notably, MDNA11, an IL-2 Superkine, demonstrated significant anti-tumor activity with a 29% response rate in patients with checkpoint-resistant tumors, and a favorable safety profile. The European Medicines Agency has approved the expansion of the ABILITY-1 study to the EU. Medicenna also reported net loss for the year ended March 31, 2024, at $25.5 million, compared to $10.0 million the previous year, primarily due to increased operating costs and derivative warrant liability. Current cash reserves and the recent investment are expected to sustain operations until mid-2026.
- Increased cash balance to $37 million after $20 million investment by RA Capital.
- MDNA11 showed a 29% response rate in patients with checkpoint-resistant tumors.
- EMA approved the expansion of the ABILITY-1 study in the EU.
- No dose-limiting toxicity reported in MDNA11 trials.
- Cash reserves and recent funding expected to sustain operations until mid-2026.
- Net loss for the year ended March 31, 2024, was $25.5 million, up from $10.0 million the previous year.
- Increased operating costs, with total expenses rising from $16.3 million to $18.7 million.
- Research and development expenses increased from $9.3 million to $10.8 million.
- General and administrative expenses increased from $7.0 million to $7.8 million.
Increased cash balance to
MDNA11 continues to exhibit compelling deep and durable single agent activity and best-in-class potential relative to other IL-2 therapies in clinical development
Results presented at the Annual Meeting of the AACR showed single agent MDNA11 response rate of
Combination dose escalation with pembrolizumab (KEYTRUDA) continues to enroll patients at the MDNA11 monotherapy expansion dose (90 µg/kg, Q2W) having cleared safety at 60 µg/kg, Q2W
Approval of Clinical Trial Application by the European Medicines Agency expands the ABILITY-1 study of MDNA11 to Cancer Centers in the EU
Updated MDNA11 monotherapy expansion and combination escalation results to be presented at medical conferences in H2 of 2024
TORONTO and HOUSTON, June 27, 2024 (GLOBE NEWSWIRE) -- Medicenna Therapeutics Corp. (“Medicenna” or the “Company”) (TSX: MDNA, OTCQB: MDNAF), a clinical-stage immunotherapy company focused on the development of Superkines, today reported financial results and corporate highlights for the fiscal year ended March 31, 2024, as well as anticipated corporate milestones.
“Over the past year, we have continued to demonstrate best-in-class potential of MDNA11, having shown durable single-agent efficacy in end-stage cancer patients who have failed immunotherapies while maintaining an acceptable safety profile,” said Fahar Merchant, Ph.D., President and CEO of Medicenna. “We are encouraged by the
Program highlights for the fiscal year ended March 31, 2024, along with recent developments, include:
MDNA11: IL-2 Superkine Program
Clinical activity highlights include:
Deep and Durable Anti-tumor Activity with Single-Agent MDNA11
29% response rate (N=4/14) and50% clinical benefit rate (4 patients with partial responses, 3 patients with stable disease > 24 weeks) in high-dose phase 2 eligible patients who failed checkpoint inhibitor therapy- A pancreatic cancer patient with
100% regression of target and non-target lesions for over 104 weeks and continues to show remission 4 months after stopping treatment - A melanoma patient who is continuing on MDNA11 treatment shows
100% regression of target lesions with continued regression of non-target lesions - 2 of 2 MSI-High patients and 2 of 4 evaluable dose expansion patients have had a partial response
- Previously reported patients with partial responses and stable disease continue on the study further supporting the durability of MDNA11
The monotherapy expansion arm is enrolling patients with metastatic melanoma, non-melanoma skin cancers and MSI-H/dMMR tumors. Combination escalation arm of the ABILITY-1 study is enrolling patients with advanced solid tumors who progressed following earlier lines of treatment.
Monotherapy: Acceptable Safety Profile
- Complete Phase 1 monotherapy dose escalation data was presented and affirmed that MDNA11 has an acceptable safety profile.
- No dose limiting toxicity (DLT) was reported with no evidence of vascular leak syndrome (VLS). Vast majority (95 %) of treatment-related adverse events (TRAEs) were of grade 1-2 and resolved within 48 hours; grade 3 TRAEs mainly constituted asymptomatic transient LFT elevations; no grade 4 or 5 events were reported.
- Repeat administration of MDNA11 at the target doses showed further improvement in tolerability.
Monotherapy: Pharmacodynamic Analysis Showed Potent and Durable Systemic Immune Activation
- Significant increases in stemness, central and effector memory and markers of enhanced effector function in circulating CD8+ T and NK cells, all of which are critical for achieving meaningful and durable anti-cancer response.
- Analysis of gene expression signatures from pre-treatment and on-treatment paired biopsies show that cancer promoting pathways were degraded while immune-related pathways against cancer cells were enhanced following MDNA11 treatment.
Combination with KEYTRUDA®: Enrolling in Cohort 2 in the Absence of DLTs in the First Dose Cohort
- In February 2024, the company announced dosing of the first patient in the Phase 1 combination escalation portion of the ABILITY-1 Study
- Dose escalation in combination with KEYTRUDA® is now enrolling at the next higher dose of MDNA11 90 µg/kg Q2W and 400 mg pembrolizumab Q6W (priming MDNA11 30 & 60 μg/kg) following absence of any DLT at 60 µg/kg
The company expects to report additional data from the ongoing monotherapy expansion and combination arms of the ABILITY-1 study at medical conferences in the second half of calendar 2024.
Bizaxofusp (formerly MDNA55): Empowered IL-4 Superkine Program
The Company is currently pursuing partnership opportunities for its phase-3 ready IL-4 Superkine for recurrent glioblastoma (rGBM). Bizaxofusp, which holds both FastTrack and Orphan drug status from the FDA and FDA/EMA, respectively, is Medicenna’s Phase 3-ready asset for rGBM which has been tested in 118 patients with high grade gliomas (including 112 patients with rGBM).
On June 1st, 2024, the Company presented survival follow-up, and updated final Phase 2b study results for bizaxofusp at the 2024 ASCO Annual Meeting in Chicago.
Clinical activity highlights include:
- In the Phase 2b study, a single treatment with bizaxofusp in unresectable rGBM patients achieved significant survival benefit (mOS of 13.5 vs. 7.2 months, p=0.009) and reduced risk of death by almost half (hazard ratio: 0.54,
95% confidence interval: 0.34-0.83) versus a propensity score (PS) balanced external control arm (ECA). - Bizaxofusp significantly increased median overall survival (mOS) by
88% (p = 0.009) and improved overall survival at 1 and 2 years by180% and290% , respectively. - Tumor control was associated with a significant increase in mOS following treatment with bizaxofusp and consequently, may be an early surrogate of survival benefit in future studies.
With the compelling survival benefit with bizaxofusp in rGBM, the most aggressive form of brain cancer which lacks a standard of care, Medicenna is seeking Breakthrough Therapy Designation with the FDA.
The proposed Phase 3 trial design incorporating a hybrid external control arm has been accepted by the FDA. Medicenna is currently working toward securing alignment with the EMA thereby enabling data from a single Phase 3 registrational trial being sufficient to file for approval in the EU and USA.
Pre-clinical Pipeline Programs
- On April 9, 2024, at the 2024 AACR Annual Meeting, the Company presented preclinical data on its first-in-class IL-13R2 targeted candidate, MDNA113, from its T-MASK™ platform, which specifically delivers a masked bispecific anti-PD1-IL2 Superkine to IL-13R2 expressing tumors (affecting over 2 million cancer patients annually) where it is activated by cancer specific enzymes.
These data demonstrated that the T-MASK™ platform exemplified by MDNA113, facilitates tumor targeting and minimizes systemic toxicity while maximizing therapeutic activity at the tumor site.
Operational Highlights
On April 30, 2024, the Company closed a
Expected Upcoming Milestones
- Topline MDNA11 monotherapy expansion data to be presented at medical conferences in H2 of calendar 2024.
- Clinical update and combination escalation data from the ABILITY-1 Study evaluating MDNA11 with KEYTRUDA expected in H2 of calendar 2024.
- Potential for Breakthrough Therapy Designation (BTD) for bizaxofusp. With compelling longer term survival benefit with bizaxofusp in rGBM patients, as presented at the ASCO meeting held in April 2024, Medicenna will seek to apply for BTD with the FDA.
- Seek alignment with the European Medicines Agency (“EMA”) for the Phase 3 registration trial of bizaxofusp.
Annual Financial Results
As of March 31, 2024, cash and cash equivalents were
For the year ended March 31, 2024, the Company reported total operating costs of
Net loss for the year ended March 31, 2024, was
Research and development expenses of
General and administrative expenses of
Medicenna’s financial statements for the year ended March 31, 2024 and the related management’s discussion and analysis (MD&A) will be available on SEDAR at www.sedarplus.ca.
About Medicenna
Medicenna is a clinical-stage immunotherapy company focused on developing novel, highly selective versions of IL-2, IL-4 and IL-13 Superkines and first-in-class Empowered Superkines. Medicenna’s long-acting IL-2 Superkine, MDNA11, is a next-generation IL-2 with superior affinity toward CD122 (IL-2 receptor beta) and no CD25 (IL-2 receptor alpha) binding, thereby preferentially stimulating cancer-killing effector T cells and NK cells. Medicenna’s IL-4 Empowered Superkine, bizaxofusp (formerly MDNA55), has been studied in 5 clinical trials enrolling over 130 patients, including a Phase 2b trial for recurrent GBM, the most common and uniformly fatal form of brain cancer. Bizaxofusp has obtained FastTrack and Orphan Drug status from the FDA and FDA/EMA, respectively. Medicenna’s early-stage BiSKITs™ (Bifunctional SuperKine ImmunoTherapies) and the T-MASK™ (Targeted Metalloprotease Activated SuperKine) programs are designed to enhance the ability of Superkines to treat immunologically “cold” tumors.
For more information, please visit www.medicenna.com, and follow us on Twitter and LinkedIn.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
Forward-Looking Statements
This news release contains forward-looking statements within the meaning of applicable securities laws. Forward-looking statements include, but are not limited to, express or implied statements regarding the future operations of the Company, estimates, plans, strategic ambitions, partnership activities and opportunities, objectives, expectations, opinions, forecasts, projections, guidance, outlook or other statements that are not historical facts, such as statements on the Company’s cash runway, the clinical performance and potential, safety profile of MDNA11 and bizaxofusp (MDNA55), the reporting of additional results, anticipated corporate milestones, partnership efforts and cost savings following the Nasdaq delisting. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical studies may not be indicative of full results or results from later stage or larger scale clinical studies and do not ensure regulatory approval. You should not place undue reliance on these statements or the scientific data presented. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expect”, “believe”, “seek”, “potentially” and similar expressions. Forward-looking statements are based on a number of assumptions believed by the Company to be reasonable at the date of this news release. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, there can be no assurance that such statements will prove to be accurate. These statements are subject to certain risks and uncertainties and may be based on assumptions that could cause actual results and future events to differ materially from those anticipated or implied in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the risks detailed in the latest annual information form of the Company and in other filings made by the Company with the applicable securities regulators from time to time in Canada.
The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management, may prove to be incorrect and actual results may differ materially from those anticipated or implied in forward-looking statements. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date hereof and except as required by law, we do not intend and do not assume any obligation to update or revise publicly any of the included forward-looking statements.
This news release contains hyperlinks to information that is not deemed to be incorporated by reference in this news release.
Investor and Media Contact:
Christina Cameron
Investor Relations, Medicenna Therapeutics
ir@medicenna.com
(647) 953-0673
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