Dr. Fahar Merchant reports
MEDICENNA THERAPEUTICS REPORTS FISCAL YEAR 2024 FINANCIAL RESULTS AND OPERATIONAL HIGHLIGHTS
Medicenna Therapeutics Corp. today released its 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, PhD, president and chief executive officer of Medicenna. "We are encouraged by the 29-per-cent response rate observed in the study to date, including durable complete regression of target and non-target lesions in a pancreatic cancer patient who remains in remission and a melanoma patient that continues to show durable complete response of the target lesions. On the back of these data, we are delighted with the recent financial backing by RA Capital Management, which has strengthened our balance sheet by $20-million, extending our cash runway into mid-2026. We are also pleased to see acceptable safety profile of MDNA11 in combination with pembrolizumab, which continues to enroll patients at the higher dose used in the MDNA11 monotherapy expansion arm as well as the recent approval by EMA of our application to expand the Ability-1 study in Europe. We look forward to sharing new clinical data from the monotherapy dose expansion as well as the combination arms of the study at medical conferences during the second half of 2024."
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-tumour activity with single-agent MDNA11
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29-per-cent response rate (N equals four/14) and 50-per-cent clinical benefit rate (four patients with partial responses, three patients with stable disease greater than 24 weeks) in high-dose phase 2 eligible patients who failed checkpoint inhibitor therapy;
- A pancreatic cancer patient with 100-per-cent regression of target and non-target lesions for over 104 weeks and continues to show remission four months after stopping treatment;
- A melanoma patient who is continuing on MDNA11 treatment shows 100-per-cent regression of target lesions with continued regression of non-target lesions;
- Two of two MSI-High patients and two of four 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 tumours. Combination escalation arm of the Ability-1 study is enrolling patients with advanced solid tumours who progressed following earlier lines of treatment.
Monotherapy: acceptable safety profile
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Complete phase 1 monotherapy dose escalation data were 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 per cent) of treatment-related adverse events (TRAEs) were of grade 1 to 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
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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 pretreatment 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
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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 microg/kilogram Q2W and 400 mg pembrolizumab Q6W (priming MDNA11 30and 60 mug/kg) following absence of any DLT at 60 microg/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 fast-track and orphan drug status from the FDA (Food and Drug Administration) 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 1, 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:
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In the phase 2b study, a single treatment with bizaxofusp in unresectable rGBM patients achieved significant survival benefit (mOS of 13.5 versus 7.2 months, p equals 0.009) and reduced risk of death by almost half (hazard ratio: 0.54, 95-per-cent confidence interval: 0.34 to 0.83) versus a propensity score (PS) balanced external control arm (ECA).
- Bizaxofusp significantly increased median overall survival (mOS) by 88 per cent (p equals 0.009) and improved overall survival at one and two years by 180 per cent and 290 per cent, respectively.
- Tumour 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 European Union and United States.
Preclinical pipeline programs
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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 tumours (affecting over two million cancer patients annually) where it is activated by cancer specific enzymes.
These data demonstrated that the T-MASK platform exemplified by MDNA113, facilitates tumour targeting and minimizes systemic toxicity while maximizing therapeutic activity at the tumour site.
Operational highlights
On April 30, 2024, the company closed a $20-million financing through a private placement with RA Capital Management (RA), a multistage investment manager based in Boston, Mass., by way of a non-brokered private placement. Pursuant to the terms of the offering, RA subscribed for 5,141,388 common shares in the capital of the company at a price of $1.95 per share and, in lieu of common shares, prefinanced warrants to purchase 5,141,388 common shares at a purchase price of $1.94 per prefinanced warrant, for total net proceeds to the company of approximately $20-million.
Expected upcoming milestones
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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.
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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 $17.0-million, compared with $33.6-million on March 31, 2023. These funds, in combination with the $20-million in proceeds from the offering, are expected to provide the company with sufficient capital to execute its current planned expenditures to mid-2026 based on its current plans and projections.
For the year ended March 31, 2024, the company reported total operating costs of $18.7-million compared with total operating costs of $16.3-million for the year ended March 31, 2023. The increase is related to an increase in general and administrative expenses ($700,000) and research and development expenses ($1.5-million) as discussed further herein.
Net loss for the year ended March 31, 2024, was $25.5-million or 37 cents per share compared with a loss of $10.0-million or 16 cents per share for the year ended March 31, 2023. The increase in net loss for the year ended March 31, 2024, was primarily a result of an increase in the fair value of the derivative warrant liability of $8.0-million compared with a decrease of $4.3-million in the prior year. The significant increase in fair value of the warrant derivative is due to the 111-per-cent increase in the company's share price year over year, as share price is a key variable in the valuation of the derivative liability.
Research and development expenses of $10.8-million were incurred during the year ended March 31, 2024, compared with $9.3-million incurred in the year ended March 31, 2023. The increase in research and development expenses in the current fiscal year is primarily attributed to increased clinical costs related to the expansion of the MDNA11 Ability-1 with new clinical sites added in South Korea, the commencement of the combination arm with Keytruda, and an increase in salaries and benefits due to the addition of research staff during the period.
General and administrative expenses of $7.8-million were incurred during the year ended March 31, 2024, compared with $7.0-million during the year ended March 31, 2023. The increase in G&A expenses in the current year primarily relates to increased salaries and benefits in fiscal 2024 related to the addition and subsequent restructuring of executive staff in the United States as the company refocused its operations to Canada following its delisting from Nasdaq. This transition is anticipated to result in cost savings in future periods.
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+.
About Medicenna Therapeutics Corp.
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 five 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 fast-track and orphan drug status from the Food and Drug Administration and FDA/European Medicines Agency, 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 tumours.
We seek Safe Harbor.
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