MDNA: Commences Monotherapy Dose Expansion in Phase 1/2 ABILITY Trial…
NASDAQ:MDNA
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Business Update
MDNA11 Dose Escalation Complete; Monotherapy Dose Expansion Underway
On August 9, 2023, Medicenna Therapeutics Corp. (NASDAQ:MDNA) provided an update on the ongoing Phase 1/2 ABILITY Study (A Beta-only IL-2 ImmunoTherapY Study) of MDNA11 in patients with advanced solid tumors (NCT05086692). The dose escalation portion of the trial has ended and there have been a number of key findings, including:
A favorable safety profile: MDNA11 has been generally well tolerated across all dosing cohorts. The majority of adverse events (AEs) have been grade 1 or 2 and there have been no grade 4 or 5 AEs.
Promising single-agent activity: Tumor control was observed in 7 or 19 evaluable patients (37%). One particularly encouraging outcome was a confirmed partial response in a patient with metastatic pancreatic ductal adenocarcinoma (PDAC). This patient had failed multiple prior systemic therapies. The most recent scan showed an 80% decrease in total tumor size (sum or tumor diameters of the target lesions) with complete regression in two out of the three lesions, as shown in the following image. The patient is continuing on study treatment with MDNA11.
Pharmacodynamic data continues to support use of MDNA11: MDNA11 induces a robust expansion of activated CD8+ T cells and NK cells while at the same time limiting the expansion of Tregs. For example, the following slide shows the expansion of CD8+ T cells increasing with increasing dose of MDNA11 (lower left). In addition, MDNA11 increases the CD8+/Treg ratio (lower right).
Recommended dose for expansion of 90 µg/kg: Medicenna has selected 90 µg/kg given every other week by IV infusion for the monotherapy expansion phase of the trial.
Targeted tumor types: Following consultation with Medicenna’s Clinical Advisory Board, evaluation of the clinical data from the ABILITY study, and an understanding of the immunobiology of the selected tumor types, the following tumor types will be recruited into the dose expansion phase of the study – melanoma, non-melanoma skin cancers, and microsatellite instability-high (MSI-H) or deficient DNA mismatch repair (dMMR) cancers.
We anticipate initial results from the monotherapy dose expansion portion of the trial to be available in the fourth quarter of 2023. The company is also planning to initiate a combination phase of the trial evaluating MDNA11 with Keytruda. That portion of the trial is expected to begin in the fourth quarter of 2023, with initial results expected in early 2024.
Financial Update
On July 28, 2023, Medicenna announced financial results for the first quarter of fiscal year 2024, which ended June 30, 2023. As expected, the company did not report any revenues for the first quarter of fiscal year 2024. Net loss for the first quarter of fiscal year 2024 was CAD$2.9 million, or $0.04 per share, compared to a net loss of CAD$4.2 million, or $0.07 per share, for the first quarter of fiscal year 2024. R&D expenses for the current quarter were approximately CAD$2.8 million, compared to approximately CAD$2.4 million for the first quarter of fiscal year 2024. The increase was primarily due to increased licensing and patent legal fees along with higher clinical costs for the ABILITY study. G&A expenses in the first quarter of fiscal year 2024 were CAD$1.6 million, compared to CAD$1.9 million for the first quarter of fiscal year 2023. The decrease was primarily due to reduction in directors and officers liability insurance premiums.
As of June 30, 2023, Medicenna had approximately CAD$29.6 million in cash, cash equivalents, and marketable securities. We estimate that the company is funded through key milestones in the ABILITY trial and through calendar 3Q24. As of July 28, 2023, Medicenna had approximately 69.6 million shares of common stock outstanding and, when factoring in warrants and stock options, a fully diluted share count of approximately 91.5 million.
Conclusion
We are pleased to see that Medicenna has finished the dose escalation portion of the ABILITY trial and will be initiating the dose expansion phase of the study. The results seen in the dose escalation phase are very encouraging, particularly the partial response in the patient with pancreatic cancer. We look forward to updates from the dose expansion portion of the study in the fourth quarter of 2023. We will also be interested to see how MDNA11 performs in combination with Keytruda, with initial results from that study expected in the first quarter of 2024. We have made no changes to our model and our valuation remains at $7.00 per share.
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