–Money runway prolonged late into calendar Q2 2023
–Tumor management achieved following MDNA11 therapy in 3 out of 8 sufferers enrolled in first 3 dose escalation cohorts of the ABILITY Section 1/2 Research.
— Pharmacodynamic information present superior dose-dependent improve in stimulation of anti-cancer immune cells when in comparison with competing IL-2 packages within the clinic
— Administration internet hosting convention name and webcast right this moment at 8:30 AM ET
TORONTO and HOUSTON, June 22, 2022 (GLOBE NEWSWIRE) — Medicenna Therapeutics Corp. (“Medicenna” or “the Firm”) (NASDAQ: MDNA TSX: MDNA), a scientific stage immunotherapy firm, right this moment introduced its monetary outcomes and operational highlights for the fiscal yr ended March 31, 2022. All greenback quantities are expressed in Canadian forex except in any other case famous.
“Over the previous fiscal yr, we made vital progress highlighted by preliminary scientific information in low dose cohorts the place 3 of 8 sufferers confirmed tumor management together with 2 sufferers with uncommon however aggressive types of metastatic sarcomas,” stated Dr. Fahar Service provider, President and CEO of Medicenna. “Dose-dependent and multi-fold will increase within the inhabitants of most cancers combating immune cells have been noticed within the first 3 dose cohorts the place these will increase have been considerably elevated when in comparison with competing IL-2 variants within the clinic at equal doses. We look ahead to sharing further monotherapy information from MDNA11’s ABILITY research all through 2022.”
Dr. Service provider continued, “Now we have additionally demonstrated the flexibility and deep pipeline potential of our Superkine and BiSKITs platform, established world class scientific, improvement and scientific advisory boards, accomplished a complete business bundle for MDNA55 as we proceed to diligently pursue out-licensing efforts whereas sustaining a strong money steadiness on the finish of this fiscal yr.”
Based mostly on Medicenna’s present improvement plans it’s anticipated that the present money readily available shall be adequate to fund operations late into the second calendar quarter of 2023.
Program highlights for the yr ended March 31, 2022, together with latest developments embody:
MDNA11: IL-2 Superkine Program
All through fiscal yr 2022, Medicenna accomplished actions related to GMP compliant manufacturing of MDNA11 the Firm’s selective, long-acting and novel IL-2 super-agonist. for the Section 1/2 ABILITY Research, IND enabling research required for regulatory submissions to start first in human scientific trials with MDNA11 and secured clearance of the varied functions submitted to regulatory companies in Australia, US and Canada. The research is enrolling sufferers at scientific websites in the USA, Canada, and Australia, and is at the moment progressing by its fourth dose escalation cohort.
Though it’s too early to attract significant conclusions on efficacy potential of MDNA11 from the dose escalation portion of the scientific trial, encouraging indicators of selective CD8 T and NK cell activation and proliferation within the periphery have been noticed in most sufferers handled within the first 3 cohorts reaching tumor management in 3 out of the 8 sufferers. MDNA11 has exhibited a suitable security profile within the ABILITY research, with no dose limiting toxicities reported up to now, predicted pharmacokinetic traits with no obvious indicators of immunogenicity.
Following observations from the primary few cohorts within the research in addition to learnings from competitor information and up to date failures, Medicenna is using a step-up dosing technique from Cohort 4 onwards. This technique entails first treating sufferers with two “priming doses” to habituate them to MDNA11 earlier than stepping as much as the upper mounted dose that’s being evaluated. That is anticipated to extend probabilities of figuring out MDNA11’s optimum dose and is in keeping with the FDA’s lately launched “Undertaking Optimus” initiative, which inspires firms to seek out the optimum dose and schedule for oncology medication. Whereas the step-up dosing (SUD) routine is designed to additional enhance affected person outcomes, the remark interval for dose-limiting toxicities (DLTs) will increase from 4 weeks to eight weeks. Accordingly, scientific information from dose Cohort 4 shall be accessible in Q3 of calendar 2022 with a full set of efficacy information for all dose escalation cohorts in This autumn of calendar 2022.
IL-4/IL-13 Tremendous-Antagonists and Bifunctional SuperKine ImmunoTherapies (BiSKITs™) Program
In April 2022 Medicenna introduced outcomes from two of its novel preclinical belongings at American Affiliation for Most cancers Analysis assembly. One poster targeted on Fc-MDNA413, which is derived from Medicenna’s Superkine platform and consists of a long-acting IL-13 super-antagonist for focusing on immunologically chilly tumors and a second poster featured a preclinical candidate from our BiSKITs program consisting of an anti-PD-1 antibody linked to an IL-2 super-agonist thereby reaching twin synergistic actions inside a single molecule. These novel Superkine designs deal with unmet wants and have the potential for changing block-buster checkpoint inhibitors which go off-patent after 2028.
MDNA55: Recurrent Glioblastoma (rGBM) Program
All through fiscal yr 2022, Medicenna’s MDNA55 program was highlighted in each peer-reviewed publications and at medical conferences. In Could 2021, Medicenna introduced a peer-reviewed publication in Scientific Most cancers Analysis and within the third quarter of fiscal 2022, the design of a deliberate open-label hybrid Section 3 trial of MDNA55 in rGBM was highlighted in a peer-reviewed manuscript printed in The Lancet Oncology, and in an oral presentation on the Society for Neuro-Oncology and American Society of Scientific Oncology’s First Annual Convention on CNS Scientific Trials. Moreover, John H. Sampson, M.D., Ph.D., MHSc, MBA, Robert H. and Gloria Wilkins Distinguished Professor of Neurosurgery at Duke College Faculty of Drugs and member of Medicenna’s Board of Administrators, obtained The Summary Award for Excellence in Scientific Trials in reference to an oral presentation on MDNA55 on the 26th Annual Assembly of the Society for Neuro-Oncology. Medicenna continues to hunt a strategic partnership to facilitate MDNA55’s additional improvement and commercialization and stays in lively discussions in pursuit of this objective.
All through fiscal yr 2022, Medicenna formally established essential relationships with specialists and key opinion leaders all through business and academia to realize necessary insights on the event of its pipeline.
In March 2022, the Firm introduced the appointment of Dr. Kapil Dhingra as a Strategic Advisor. Dr. Dhingra is a extremely completed physician-scientist with expertise guiding a number of medication to approval. Concurrently, Medicenna introduced the formation of a Scientific Advisory Board (CAB) comprised of main specialists in immunotherapy and drug improvement. Members of the CAB embody Drs. Paolo Ascierto, Lillian Siu and Hussein Tawbi.
In January 2022, Medicenna introduced the formation of its Scientific Advisory Board (SAB). Members of the SAB are effectively acknowledged leaders within the fields of most cancers immunotherapy and drug improvement and embody Drs. Sergio Quezada, (Chairman), Burkhard Becher, David Mooney, and William Redmond.
In January 2022, Medicenna introduced the appointments of business veterans Dr. Peter Lloyd, Dr. L. Bruce Pearce, and Paul Smith to the Firm’s Growth Advisory Committee and the appointment of Dr. Martin Bexon as interim Chief Medical Officer.
In September 2021, Medicenna introduced the appointment of Dr. John Sampson to its Board of Administrators.
Anticipated Upcoming Milestones
Preliminary PK/PD information from the fourth dose escalation cohort of the Section 1/2 ABILITY research anticipated in July 2022.
Identification of MDNA11’s advisable Section 2 dose (RP2D) within the ABILITY research anticipated within the fourth quarter of calendar 2022.
Graduation of the ABILITY research’s single agent growth part anticipated within the fourth quarter of calendar 2022.
Scientific replace from the ABILITY research anticipated within the fourth quarter of calendar 2022.
Annual Monetary Outcomes
Medicenna had money, money equivalents, and marketable securities of $20.5 million at March 31, 2022. These funds present the Firm with adequate capital to execute its present deliberate expenditures late into the second quarter of calendar 2023 and necessary upcoming catalysts based mostly on its present plans and projections.
Web loss for the yr ended March 31, 2022, was $22.6 million, or $0.42 per share, in comparison with a lack of $17.3 million, or $0.35 per share for the yr ended March 31, 2021. The rise in web loss for the yr ended March 31, 2022, in contrast with the yr ended March 31, 2021, was primarily a results of elevated expenditures associated to the MDNA11 improvement program in addition to greater basic and administrative bills related to the Firm’s Nasdaq itemizing in August 2020.
Analysis and improvement bills of $14.7 million had been incurred throughout the yr ended March 31, 2022, in contrast with $10.9 million incurred within the yr March 31, 2021. The rise in analysis and improvement bills within the present yr is primarily attributable to prices related to the event of MDNA11 together with pre-clinical research, manufacturing of GMP supplies for the scientific trial and scientific and regulatory prices related to initiation of the Section 1/2 ABILITY research.
Basic and administrative bills of $7.8 million had been incurred throughout the yr ended March 31, 2022, in contrast with $6.5 million throughout the yr ended March 31, 2021. The rise in expenditures yr over yr is primarily attributed to a full yr of prices related to Medicenna’s Nasdaq itemizing and corresponding D&O insurance coverage in contrast with solely 9 months of bills within the prior yr interval.
Convention Name and Webcast
Medicenna will host a convention name and webcast right this moment at 8:30 AM ET. To entry the decision, please dial 1-877-407-9716 from the USA or 1-201-493-6779 internationally, and check with convention ID: 13729367. To entry the dwell webcast, go to this hyperlink to the occasion. Following the dwell webcast, an archived model of the decision shall be accessible on Medicenna’s web site.
Medicenna is a scientific stage immunotherapy firm targeted on the event of novel, extremely selective variations of IL-2, IL-4 and IL-13 Superkines and first in school Empowered Superkines. Medicenna’s long-acting IL-2 Superkine, MDNA11, is a next-generation IL-2 with superior CD122 (IL-2 receptor beta) binding with out CD25 (IL-2 receptor alpha) affinity thereby preferentially stimulating most cancers killing effector T cells and NK cells. Medicenna’s early-stage BiSKITs™ program, (Bipractical SuperOkine ImmunoTherapies) is designed to boost the flexibility of Superkines to deal with immunologically “chilly” tumors. Medicenna’s IL-4 Empowered Superkine, MDNA55, has been studied in 5 scientific trials together with a Section 2b trial for recurrent GBM, the commonest and uniformly deadly type of mind most cancers. MDNA55 has obtained Quick-Monitor and Orphan Drug standing from the FDA and FDA/EMA, respectively.
This information launch incorporates forward-looking statements below relevant securities legal guidelines. Ahead-looking statements are sometimes recognized by phrases equivalent to “will”, “could”, “ought to”, “anticipate”, “expects”, “believes”, “seeks” and comparable expressions. All statements apart from statements of historic truth, included on this launch, together with statements associated to money runway, the scientific potential and improvement and security profile of MDNA11 and the Superkine and BISKITs platform, upcoming milestones and the sharing of further information and out-licensing efforts for MDNA55 are forward-looking statements which might be topic to dangers and uncertainties. There could be no assurance that such statements will show to be correct and precise outcomes and future occasions might differ materially from these anticipated in such statements. Vital elements that would trigger precise outcomes to vary materially from the Firm’s expectations embody the dangers detailed within the annual info kind and Type 20-F of the Firm and in different filings made by the Firm with the relevant securities regulators every so often in Canada and the United States.
The reader is cautioned that assumptions used within the preparation of any forward-looking info could show to be incorrect. Occasions or circumstances could trigger precise outcomes to vary materially from these predicted, because of quite a few recognized and unknown dangers, uncertainties, and different elements, a lot of that are past the management of the Firm. The reader is cautioned to not place undue reliance on any forward-looking info. Such info, though thought of cheap by administration, could show to be incorrect and precise outcomes could differ materially from these anticipated. Ahead-looking statements contained on this information launch are expressly certified by this cautionary assertion. The forward-looking statements contained on this information launch are made as of the date hereof and besides as required by regulation, we don’t intend and don’t assume any obligation to replace or revise publicly any of the included forward-looking statements.
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