Microbion Corp.

TORONTO and HOUSTON, Aug. 15, 2024 (GLOBE NEWSWIRE) -- Medicenna Therapeutics Corp. (“Medicenna” or the “Company”) (TSX: MDNA, OTCQB: MDNAF), a clinical-stage immunotherapy company focused on the development of Superkines, announced today the appointment of Mr. Karim Lalji as a new addition to its Board of Directors effective as of August 14, 2024. “We are thrilled to announce the appointment of Mr. Karim Lalji as a new member to our Board of Directors,” said Dr. Fahar Merchant, President and CEO of Medicenna. “With a distinguished career spanning the life sciences sector, Mr. Lalji brings to our Board of Directors his exceptional transactional expertise, strategic vision and a solid track record of big-pharma partnerships that will be invaluable to Medicenna as it builds its Superkine platform and pipeline of promising best and first-in-class clinical assets.” Mr. Lalji added, “I'm honoured and excited to join Medicenna's Board of Directors. The recent data from the Phase 1/2 ABILITY-1 Study highlights the best-in-class potential of MDNA11 in treating advanced solid tumors. Combined with the compelling Phase 2b results for bizaxofusp in brain cancer, a versatile Superkine platform, and a highly capable management team, Medicenna is well-positioned for continued success in advancing its immune-based therapies for cancer and other diseases by ingeniously modulating the immune system.” Mr. Lalji began his career with Merck & Company at their world headquarters in New Jersey. During his 10-year tenure at Merck, he held several positions of increasing responsibilities, eventually driving global strategies for several of the company’s therapeutic franchises including the global executive leading the osteoporosis franchise and growing annual sales of its lead program to over $1 billion. Subsequent to Merck, Mr. Lalji was Vice President of Business Strategy and New Product Commercialization at Sepracor, Inc., significantly contributing to the company’s growth from $50 million to over $1 billion in annual sales. In 2006, Mr. Lalji joined Cardiome Pharma Corp. as Chief Commercial Officer, facilitating a $1 billion licensing transaction with Merck, the largest licensing deal completed by a Canadian biopharma company at that time. Mr. Lalji joins Medicenna’s Board of Directors with broad governance experience, having served as Chairman of the Board for the oncology-focused Sitka Biopharma, and as Board Member of AccelRX and the Centre for Drug Research and Development (now known as adMare BioInnovations). Additionally, he served on the Board of Overseers of Harvard University’s Beth Israel Deaconess Medical Center, a leading academic teaching hospital, where he continues as a Board Member Emeritus and is a member of its Research Oversight Committee. Currently, Mr. Lalji is the CEO of Microbion Pharma Corp., a privately held clinical-stage pharmaceutical company. Karim holds a BBA from Simon Fraser University and a Science Master’s Degree in Health Policy and Management from Harvard University, where he was awarded the Wilinsky Award for Academic Excellence. About Medicenna Therapeutics 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 5 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 FastTrack and Orphan Drug status from the FDA and FDA/EMA, 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” tumors. For more information, please visit www.medicenna.com, and follow us on X and LinkedIn. Forward-Looking Statements This news release contains forward-looking statements within the meaning of applicable securities laws. Forward-looking statements include, but are not limited to, express or implied statements regarding the future operations of the Company, estimates, plans, strategic ambitions, partnership activities and opportunities, objectives, expectations, opinions, forecasts, projections, guidance, outlook or other statements that are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expect”, “believe”, “seek”, “potentially” and similar expressions. and are subject to risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the risks detailed in the latest annual information form of the Company and in other filings made by the Company with the applicable securities regulators from time to time in Canada. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date hereof and except as required by law, we do not intend and do not assume any obligation to update or revise publicly any of the included forward-looking statements. This news releases contains hyperlinks to information that is not deemed to be incorporated by reference in this new release. Investor/Media Contact: Christina CameronInvestor Relations, Medicenna Therapeutics(647) 953-0673ir@medicenna.com

Microbion is one of 6 finalists selected to present at the Advanced Wound Care Summit's Innovation Showcase session on April 17 BOZEMAN, MT and VANCOUVER, BC, April 15, 2024 /PRNewswire/ - Microbion Corporation today announced that the company has been selected to present topical pravibismane for the treatment of diabetic foot infection (DFI) at the Advanced Wound Care Summit USA held at the Boston Marriot Long Wharf from April 16th to 17th. Karim Lalji, Microbion's CEO, will be presenting during the Innovation Showcase portion of the summit on April 17 at 9:30am in the Grand Ballroom. The presentation will focus on topical pravibismane's clinical safety and efficacy for the treatment of moderate to severe DFI and future development plans. In a Phase 1b study in patients with moderate to severe DFI, pravibismane was well-tolerated and pravibismane treated subjects showed an approximately 3-fold reduction in ulcer size compared to the placebo group (85% versus 30%). Furthermore, the incidence of diabetic ulcer-related lower limb amputations was approximately 6-fold lower in the pooled pravibismane group compared to the placebo group (2.6% versus 15.4%). Topically applied pravibismane has the potential to address several unmet medical needs for the successful treatment of DFI by simultaneously treating bacterial biofilm-related infections and accelerating ulcer size reduction, potentially leading to complete re-epithelialization and wound closure along with reduction of reinfection and amputation risks. The company has recently completed a Phase 2 study assessing the safety, tolerability, and wound closure efficacy of a higher concentration and longer, 12-week dosing duration of topical pravibismane in patients with moderately infected chronic diabetic foot ulcers. About Microbion Microbion is a clinical-stage pharmaceutical company developing a new class of therapeutic compounds to improve the lives of patients with rare and serious diseases. Microbion's lead drug candidate, pravibismane, is the first product in this new class and has multiple novel modes of action, including potent broad spectrum anti-infective, antibiofilm, and immuno-modulatory activity, offering unique potential to address the unmet needs of chronic and severe health conditions. Topical pravibismane is completing Phase 2 development for the treatment of chronic wounds. Local pravibismane is in Phase 2 clinical development for orthopedic infections and inhaled pravibismane is advancing into Phase 1 clinical development for the treatment of chronic lung diseases, including non-tuberculous mycobacteria (NTM) and cystic fibrosis-related lung infections. Pravibismane has received backing from the Cystic Fibrosis Foundation, NIH, US DoD, and CARB-X with over $20 million in non-dilutive grants. The FDA has granted pravibismane Orphan Drug, Fast Track, and Qualified Infectious Disease Product (QIDP) designations. For more information visit: . Safe Harbor Statement Certain of the statements made in this press release are forward-looking, such as those, among others, relating to the success of clinical development of pravibismane and preparation for potential commercialization. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: our ability to enroll patients in our clinical trials at the pace that we project; the size and growth of the potential markets for pravibismane or any future product candidates and our ability to serve those markets; our ability to obtain and maintain regulatory approval of pravibismane or any future product candidates; and our expectations regarding the potential safety, efficacy or clinical utility of pravibismane or any future product candidates. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Microbion Corporation disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Second orphan drug designation granted for pravibismane, in addition to the treatment of pulmonary infections in patients with cystic fibrosis Pravibismane demonstrated statistically significant in vivo efficacy against NTM in chronic and acute infection models BOZEMAN, MT and VANCOUVER, BC, Jan. 30, 2024 /PRNewswire/ - Microbion Corporation today announced that the company has been granted a second orphan drug designation for its lead drug candidate, pravibismane, for the treatment of non-tuberculous mycobacterial (NTM) infections. NTM infections are most commonly found in the lungs; however, skin and soft tissue, indwelling medical devices, lymph nodes, and blood can also harbor NTM infections. "We are pleased that the FDA has granted pravibismane this second orphan drug designation for the treatment of NTM infections," said Dr. Jeff Millard, Microbion's Chief Scientific Officer. "Our in vitro and in vivo data for the activity of pravibismane against pulmonary NTM infections and related biofilms, demonstrate unique and highly differentiated, potent activity compared to other agents currently used to treat NTM, while being well tolerated. We look forward to working closely with all our stakeholders and patients to advance the development of pravibismane for the treatment of NTM infections." "This designation comes at an opportune time as Microbion plans to initiate a Phase 3 program for topical pravibismane treatment of chronic wounds and a Phase 1 program with inhaled pravibismane for treatment of NTM lung infections," said Karim Lalji, Chief Executive Officer. "In an in vivo study using a chronic NTM lung infection model, inhaled pravibismane demonstrated an over 18-fold reduction of M. abscessus, the most pathogenic and rapidly growing species, for which no approved therapy exists. We are encouraged by the potential of pravibismane to address the critical unmet need of NTM infections." The FDA has the authority to grant orphan drug designation to a drug or biological product to prevent, diagnose, or treat a rare disease or condition, defined as any disease or condition that affects fewer than 200,000 persons in the United States. Orphan drug designation qualifies Microbion for various development incentives of the Orphan Drug Act, including seven years of market exclusivity. About Microbion Microbion is a clinical-stage pharmaceutical company developing a new class of therapeutic compounds to improve the lives of patients with rare and serious diseases. Microbion's lead drug candidate, pravibismane, is the first product in this new class and has multiple novel modes of action, including potent broad spectrum anti-infective, antibiofilm, and anti-inflammatory activity, offering unique potential to address the unmet needs of chronic and severe health conditions. Topical pravibismane is completing Phase 2 development for the treatment of chronic wounds. Local pravibismane is in Phase 2 clinical development for orthopedic infections and inhaled pravibismane is advancing into Phase 1 clinical development for the treatment of chronic lung diseases, including non-tuberculous mycobacteria (NTM) and cystic fibrosis-related lung infections. Pravibismane has received backing from the Cystic Fibrosis Foundation, NIH, US DoD, and CARB-X with over $20 million in grants. The FDA has granted pravibismane Orphan Drug, Fast Track, and Qualified Infectious Disease Product (QIDP) designations. For more information visit: . Safe Harbor Statement Certain of the statements made in this press release are forward-looking, such as those, among others, relating to the success of clinical development of pravibismane and preparation for potential commercialization. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: our ability to enroll patients in our clinical trials at the pace that we project; the size and growth of the potential markets for pravibismane or any future product candidates and our ability to serve those markets; our ability to obtain and maintain regulatory approval of pravibismane or any future product candidates; and our expectations regarding the potential safety, efficacy or clinical utility of pravibismane or any future product candidates. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Microbion Corporation disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.