Four of 13. That is how many patients whose gastrointestinal tumors had already outlasted checkpoint immunotherapy responded to Medicenna’s MDNA11, in data presented at a cancer immunotherapy meeting on November 7. The published benchmarks the company cites for comparable patients sit at roughly 11% to 13%. Thirteen patients, though, is a group small enough that a single response moves the rate by nearly eight points.
Medicenna Reports 40% ORR for MDNA11 in MSI-H and TMB-H GI Cancers
Medicenna Therapeutics Corp. (TSX: MDNA) (OTCQB: MDNAF) announced on November 9 new clinical data from its Phase 1/2 ABILITY-1 study of MDNA11, presented two days earlier in an oral session at the Society for Immunotherapy of Cancer (SITC) 2026 Annual Meeting by Professor Paolo Ascierto of Italy’s National Cancer Institute IRCCS Fondazione G. Pascale. The headline figure comes from 20 efficacy-evaluable patients whose gastrointestinal cancers were either MSI-H (microsatellite instability-high, a DNA repair defect that tends to make tumors more visible to the immune system) or MSS TMB-H (microsatellite-stable, but carrying a high tumor mutational burden).
In that group, MDNA11 given alone or with the checkpoint inhibitor pembrolizumab (sold as Keytruda) produced a 40% objective response rate, or 8 of 20 patients. Objective response rate (ORR) is the share of patients whose tumors shrank by a protocol-defined amount. The disease control rate, which also counts patients whose tumors stopped growing, was 80%.
Not every one of those eight responses is settled. Five were confirmed on a follow-up scan; the other three are unconfirmed or ongoing, and the company includes them in the 40% figure. Median duration of response has not been reached, with responses still ongoing, according to the release.
By arm, monotherapy produced a 36% ORR (4 of 11) and the combination with pembrolizumab 44% (4 of 9). Responses appeared in colorectal cancer, pancreatic ductal adenocarcinoma, cholangiocarcinoma and anal squamous cell carcinoma.
Liver metastases are associated with weaker checkpoint responses in these cancers. All four evaluable MSI-H GI patients with measurable liver target lesions who received MDNA11 alone saw those lesions shrink, eight of eight lesions in total.
ABILITY-1 Trial Design and the MDNA11 Patient Population
ABILITY-1 is an open-label, multicenter Phase 1/2 study: patients and investigators know what is being given, and there is no concurrent control arm. It tests MDNA11 alone and with pembrolizumab across dose-escalation and expansion cohorts in advanced solid tumors. Medicenna completed enrollment at 152 patients across Canada, the US, Australia, Europe and South Korea, as announced November 4. The GI result is a 20-patient slice of that total.
MDNA11 itself is an engineered version of interleukin-2 (IL-2), a signaling protein that drives immune cell growth. Medicenna describes it as long-acting and designed to preferentially activate cancer-fighting CD8+ T cells and natural killer cells while minimally stimulating regulatory T cells, which can dampen an immune attack. It is investigational and has not been approved by any regulator for any indication.
These were sick patients. The GI cohort had a median of three prior systemic treatment lines (range 1 to 10), and 45% had been through at least four. Nearly two-thirds, 65%, had already received checkpoint therapy. Active liver metastases were present in 35% at baseline.
The four-of-13 figure in the opening is a subset of that cohort: patients whose disease was refractory to checkpoint inhibitors (ICIs, the drug class that includes pembrolizumab). Their ORR was 31%, split as 3 of 9 on monotherapy and 1 of 4 on the combination. The release does not describe this subset as pre-specified.
The benchmarks are Medicenna’s own selection. The company cites published post-checkpoint datasets in MSI-H GI cancers showing ORRs of about 11% for checkpoint rechallenge and 12% to 13% for chemotherapy with or without targeted therapy. Emerging salvage programs have reported roughly 7% to 22%. Those numbers come from different trials with different patients. None were tested against MDNA11 in the same study.
MDNA11 Melanoma, Endometrial and Safety Results From ABILITY-1
Melanoma results were lower than the GI figure. In the protocol-defined melanoma expansion cohorts (18 patients, all Stage IV, 90% previously treated with both PD-1 and CTLA-4 checkpoint drugs), monotherapy in patients with secondary checkpoint resistance produced a 30% ORR and 60% disease control (n=10). Patients with primary resistance on the combination posted a 38% ORR and 38% disease control (n=8).
In microsatellite-stable endometrial cancer, the combination produced a confirmed ORR of 28.6%, or 2 of 7 patients with secondary checkpoint resistance, including several who had progressed after pembrolizumab plus lenvatinib. Seven patients.
Safety data cover 69 monotherapy and 73 combination patients. More than 90% of treatment-related adverse events (TRAEs, side effects investigators attribute to the drug) were Grade 1 or 2, the two mildest tiers, and most lasted one to two days. No dose-limiting toxicities were observed through 120 micrograms per kilogram. About 65% of Grade 3 or higher TRAEs were laboratory abnormalities, mostly without symptoms.
One patient with low baseline blood pressure had a transient Grade 4 cytokine release syndrome, an inflammatory reaction to immune activation, that resolved within four days. Medicenna reported no treatment-related deaths. Treatment-related permanent discontinuations were 0% on monotherapy and 4% on the combination.
Medicenna Cash Position, Dilution and the Pending Sorbie Financing
The SITC release contains no update on cash or financing. The most recent figures are from the August 14 first-quarter fiscal 2027 report, where Medicenna disclosed cash and cash equivalents of $5.7 million at June 30, 2026, down from $6.3 million at March 31, with a quarterly net loss of $5.1 million.
That quarter included the May public offering. Medicenna issued 8,880,000 units at C$0.50 for gross proceeds of about C$4.44 million; each unit carries one share and half a warrant, with each whole warrant exercisable at $0.65 for three years. Warrant exercises would add further dilution.
The runway guidance depends on a second deal. In May, Medicenna signed a term sheet with Sorbie Bornholm LP and Sorbie Investments LLP under which Sorbie would buy 16,000,000 units at $0.50 for $8.0 million, paired with an equity swap (the Sharing Agreement) on an $8.0 million notional amount settled over 18 monthly tranches against the company’s TSX share price. Medicenna has said it may ultimately receive more or materially less than $8.0 million, and completion is subject to closing conditions including regulatory and stock exchange approvals. If those financings complete as contemplated, the company expects to fund planned expenditures into the second quarter of calendar 2027. No announcement that the Sorbie transaction has closed was identified in the sources reviewed.
Shareholders separately approved a share consolidation at the October 1 annual meeting, at a board-chosen ratio between 2-for-1 and 20-for-1. The board retains authority not to proceed.
Medicenna’s Next MDNA11 Steps: FDA Meeting Plan and NEO-CYT Data
Medicenna said in its August 14 release that it plans an FDA end-of-Phase 1 meeting to explore an expedited registrational path for MDNA11; no meeting date has been disclosed. The same release guided preliminary data from the Phase 1b NEO-CYT melanoma study to the fourth quarter of 2026. The November 9 release’s forward-looking statements reference advancing MDNA11 toward a Phase 2 registrational trial in checkpoint-resistant MSI-H and TMB-H GI cancers, with no timeline attached. Results for the quarter ended September 30, 2026 had not been published as of this writing; the equivalent report last year was released November 13, 2025.
Sources
- GlobeNewswire: Medicenna Presents ABILITY-1 Data at SITC 2026 Showing 40% ORR in Gastrointestinal Cancer Patients with Biomarker Enriched Tumors Resistant to Approved Therapies, November 9, 2026
- GlobeNewswire: Medicenna Completes Phase 1/2 ABILITY-1 Enrollment and Announces Webinar to Discuss Updated MDNA11 Results with Key Opinion Leaders, November 4, 2026
- GlobeNewswire: Medicenna Announces Results of Annual General and Special Meeting of Shareholders, October 1, 2026
- GlobeNewswire: Medicenna Therapeutics Reports First Quarter Fiscal 2027 Financial Results and Announces Oral Presentations at Upcoming Conferences, August 14, 2026
- Medicenna Investor Relations: Medicenna Announces Closing of Public Offering of Units Raising CDN$4.44 Million to Support Lead Programs, May 28, 2026
- Medicenna Investor Relations: Medicenna Announces the Filing of its Prospectus Supplement and Investment Term Sheet, May 22, 2026
- GlobeNewswire: Medicenna Therapeutics Reports Second Quarter Fiscal 2026 Financial Results and Provides a Corporate Update, November 13, 2025
Editorial Disclosure
This article is based entirely on publicly available information, including company press releases distributed via GlobeNewswire and published on Medicenna’s investor relations site. The security discussed is Medicenna Therapeutics Corp. (TSX: MDNA) (OTCQB: MDNAF). Medicenna’s 2026 releases have listed its US line as OTCQX through mid-year and OTCQB from October onward; readers should confirm the current OTC tier with their broker. aktiego.com has not received any compensation from Medicenna Therapeutics, its management, investor relations representatives, or any third party. No staff member or principal of aktiego.com holds a position in this security at the time of publication.
MDNA11 is investigational and has not been approved by the FDA, Health Canada, or any other regulatory authority for any indication. ABILITY-1 is an open-label, non-randomized Phase 1/2 study with no concurrent control arm; 152 patients were enrolled in total, and the gastrointestinal efficacy figures cited here come from a 20-patient cohort. The 40% response rate includes three unconfirmed or ongoing responses; five of eight were confirmed. The checkpoint-refractory subset (13 patients) is not described in the release as pre-specified and should be treated as exploratory. Comparisons with published response rates for other treatments are cross-trial comparisons selected by the company, not head-to-head results, and are descriptive only.
The chief executive’s statement that the data position MDNA11 for potential registrational studies is the company’s own characterization; no regulatory agreement on a registrational path has been disclosed, and the planned FDA end-of-Phase 1 meeting has no disclosed date.
Medicenna reported cash and cash equivalents of $5.7 million at June 30, 2026 and a quarterly net loss of $5.1 million. Its guidance for funding planned expenditures into the second quarter of calendar 2027 assumes completion of the Sorbie structured financing, which remains subject to closing conditions including regulatory and stock exchange approvals; no closing announcement was identified in the sources reviewed, and proceeds under the Sharing Agreement may be materially less than $8.0 million. The May 2026 offering issued 8,880,000 units with attached warrants exercisable at $0.65, and the Sorbie term sheet contemplates a further 16,000,000 units with warrants; both are dilutive. The quarterly release reviewed contained no going-concern language; the full interim financial statements on SEDAR+ were not reviewed for this article. The share consolidation approved October 1 is discretionary, and the board may decide not to proceed.
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