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Business Update
Awaiting Scan Results to Confirm Partial Response in ABILITY Trial
On August 15, 2022, Medicenna Therapeutics Corp. 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). As of this time, four out of 10 evaluable patients have achieved tumor control with MDNA11. The four patients to achieve tumor control are:
1. Metastatic Leiomyosarcoma Stage IV (Dose level 2 @ 10 μg/kg); stable disease
2. Metastatic Melanoma Grade 4C (initial dose level 1 @ 10 μg/kg; escalated to dose level 3 @ 30 mg/kg and dose level 4 @ 60 μg/kg); stable disease
3. Metastatic Sarcoma Stage IV (Dose level 3 @ 30 μg/kg); stable disease
4. Pancreatic Ductal Adenocarcinoma (PDAC) Stage IV (Dose Level 4 @ 60 μg/kg following two divided doses of 30 μg/kg); unconfirmed partial response
The following image shows the responses for the 10 evaluable patients:
The pancreatic cancer patient with the unconfirmed partial response had previously had the Whipple procedure and multiple systemic therapies, including FOLFIRINOX, Abraxane/gemcitabine, and Keytruda (the patient was unable to tolerate either Abraxane/gemcitabine or Keytruda). The patient received a loading dose of 2x30 μg/kg MDNA11 at Day 0 and Day 15 then a 60 μg/kg dose at week 4 onwards. The patient has two liver tumors, both of which had decreased in size at week 12, however it was not enough to be considered a partial response. A second scan at week 16 showed that both tumors had further decreased in size with the sum of diameters of the tumors decreasing by > 30%. According to the protocol and RECIST 1.1 criteria, a second scan ≥ 28 days after the most recent scan is required to confirm a partial response. We expect the patient will have the second scan in the coming weeks.
A melanoma patient that achieved tumor control began the trial in the 10 mg/kg dose cohort and has since been escalated to the 30 μg/kg and 60 μg/kg dose levels. This patient is also expected to receive the first scan next month after administration of the 60 μg/kg dose.
Lastly, there are four additional patients from the 60 μg/kg dose cohort that have yet to receive their first scan at 12 weeks. We anticipate those occurring over the next few weeks and the company should be able to provide an update on all those patients by the end of September 2022.
Taken together, the data presented thus far by Medicenna provide an early sign of MDNA11's single agent activity, which is especially encouraging given the tumor types in which the company is seeing the responses. Sarcoma and pancreatic ductal adenocarcinoma are two cancer types that are very difficult to treat and are also highly resistant to immunotherapies. In addition, all 14 patients enrolled in the trial to-date have each failed between one and four lines of prior systemic therapies. Lastly, the lymphocyte counts seen thus far in patients in the ABILITY trial have been much lower than those seen in prior studies of Proleukin, indicating that this population of patients is highly immunosuppressed. Based on this, Medicenna has amended the trial protocol to ensure that patients enrolled from here on out will have baseline lymphocyte counts that are more in line with what will likely be seen in the dose expansion portion of the ABILITY trial. The amendment will apply to the fifth dosing cohort, in which patients receive two 30 μg/kg priming doses of MDNA11 followed by a step-up to a fixed 90 μg/kg dose.
Financial Update
On August 15, 2022, Medicenna announced financial results for the first quarter of fiscal year 2023 that ended June 30, 2023. The company reported a net loss for the first quarter of fiscal year 2023 of CAD$4.2 million, or CAD$0.07 per share, compared to a net loss of CAD$6.4 million, or CAD$0.12 per share, for the three months ending June 30, 2021. R&D expenses for the first quarter of fiscal year 2023 were CAD$2.4 million compared to CAD$4.3 million for the first quarter of fiscal year 2022. The decrease in expenses was primarily due costs associated with the development of MDNA11 incurred in the prior year including IND enabling studies and manufacturing of GMP material for the ABILITY trial. G&A expenses for the first quarters of fiscal year 2022 and 2023 were CAD$1.9 million.
As of June 30, 2022, Medicenna had approximately CAD$19.3 million in cash, cash equivalents, and marketable securities. On August 9, 2022, Medicenna announced the pricing of a US$20 million public offering of approximately 13.3 million units for US$1.50 per unit. Each unit consists of one common share and one common share purchase warrant, with an exercise price of US$1.85 and an expiration date 60 months following the closing of the offering. Following this financing, we estimate that Medicenna now has sufficient capital to fund operations into early 2024, and importantly is sufficiently financed to complete both the monotherapy and combination therapy trials of MDNA11 as well as to perform IND-enabling studies and clinical manufacturing for at least one BiSKIT compound. As of August 15, 2022, Medicenna had approximately 69.6 million common shares outstanding and, when factoring in stock options and warrants, a fully diluted share count of approximately 91.5 million.
Conclusion
The unconfirmed PR in a patient with pancreatic cancer is very encouraging news, particularly since pancreatic cancer has not previously been shown to respond to IL-2 therapy. If additional tumor responses can be shown in patients with pancreatic or other gastrointestinal cancers, the company may be justified in evaluating the potential for MDNA11 in those patient populations. Interestingly, an independent research group previously published on the use of an IL-2 variant (same amino acid modifications as MDNA109 but without albumin fusion) in an oncolytic virus that showed anti-tumor effects in a hamster model of pancreatic cancer (Quixabeira et al., 2021), thus demonstrating that IL-2 variants can show activity against pancreatic cancer in vivo.
We are eagerly awaiting the results of the next scan for the patient with the unconfirmed PR to determine if it is confirmed, along with the scans for the other four patients from dosing level 4. The recently announced financing will help ensure that the company has sufficient capital to finish the Phase 1/2 monotherapy and combination trials for MDNA11, and should allow them to advance at least one BiSKIT compound to be IND ready. Our valuation currently stands at $7 per share and we would view any pullback in the share price as a buying opportunity ahead of the expected data in September 2022.
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