IL2RA

NORWOOD, Mass., Feb. 28, 2024 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), a precision oncology company with a diversified portfolio, today announced the appointment of Dr. Dominic Smethurst, MA MRCP, as the Company’s Chief Medical Officer (CMO). In this role, Dr. Smethurst will lead the clinical development of the Company’s investigational oncology drugs: CRB-701, a next generation Nectin-4 targeting antibody drug conjugate (ADC) developed in partnership with CSPC, and CRB-601, a TGFβ blocking monoclonal antibody targeting the integrin αvβ8. Additionally, Dr. Smethurst will help guide strategic development of CRB-913, the Company’s highly peripherally restricted CB1 inverse agonist for the treatment of obesity. “We are pleased to welcome Dominic to the Corbus team and look forward to benefitting from his experience in developing novel oncology therapeutics including ones that specifically target Nectin-4", said Yuval Cohen, Ph.D., Chief Executive Officer of Corbus. “His unique experience will prove invaluable as we are about to initiate the US dose escalation study for CRB-701 this quarter while our partners at CSPC are undertaking the dose expansion study in China. We look forward to sharing the clinical data from these trials at future medical conferences and to Dominic’s leadership in that process.” “The first-in-human data on CRB-701 in Nectin-4 positive tumors presented at ASCO-GU were encouraging, and the emerging clinical data suggests a differentiated PK and favorable safety profile for CRB-701 as compared to enfortumab vedotin,” said Dr. Smethurst. “The potential to deliver higher doses of a Nectin-4 ADC while keeping patients on treatment for longer due to an improved safety and tolerability profile is an attractive and impactful value proposition for both physicians and patients. I look forward to executing the clinical and regulatory strategy for CRB-701 in bladder cancer as well as in other Nectin-4 rich tumors and advancing the other assets in the Corbus pipeline to meaningful clinical and strategic milestones throughout 2024 and beyond.” Dr. Dominic Smethurst has over twenty years of experience working with various pharmaceutical and biotechnology companies, clinical research institutions, and the UK’s National Health Service (NHS). He most recently served as CMO of Bicycle Therapeutics, where he helped advance Nectin-4 investigational drugs through early stage and into late-stage development. Previously, Dr. Smethurst worked as a consultant advising biopharma companies, providing guidance on clinical development strategies and licensing projects. Prior to that, he served as CMO of Tusk Therapeutics, an immuno-oncology company acquired by Roche, where he oversaw development of antibodies targeting CD25 and CD137, among others. Previously, as Vice President Oncology and Global Therapeutic Area Lead at Icon, a global contract research organization, he executed clinical trials involving numerous novel cancer treatments, including CAR-T therapies. Prior to that, Dr. Smethurst held physician leadership roles at AstraZeneca, Amgen and Adaptimmune. Dr. Smethurst is a member of both the Royal College of Physicians and the Faculty of Pharmaceutical Medicine. He earned an MBChB with Distinction from Addenbrooke’s Clinical School Cambridge, as well as an MA from Christ’s College Cambridge. About CorbusCorbus Pharmaceuticals Holdings, Inc. is a precision oncology company with a diversified portfolio and is committed to helping people defeat serious illness by bringing innovative scientific approaches to well understood biological pathways. Corbus’ pipeline includes CRB-701, a next generation antibody drug conjugate that targets the expression of Nectin-4 on cancer cells to release a cytotoxic payload, CRB-601, an anti-integrin monoclonal antibody which blocks the activation of TGFβ expressed on cancer cells, and CRB-913, a highly peripherally restricted CB1 inverse agonist for the treatment of obesity. Corbus is headquartered in Norwood, Massachusetts. For more information on Corbus, visit corbuspharma.com. Connect with us on Twitter, LinkedIn and Facebook. Forward-Looking StatementsThis press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company's trial results, product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statement that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management's current beliefs and assumptions. These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential,” "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors on our operations, clinical development plans and timelines, which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company's filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. All product names, logos, brands and company names are trademarks or registered trademarks of their respective owners. Their use does not imply affiliation or endorsement by these companies. INVESTOR CONTACT: Sean MoranChief Financial OfficerSean.moran@corbuspharma.com Bruce MackleManaging DirectorLifeSci Advisors, LLCbmackle@lifesciadvisors.com

The ABILITY-1 Study is evaluating MDNA11, a highly selective long-acting IL-2 Superkine, in combination with KEYTRUDA® (pembrolizumab) for treatment of patients with advanced solid tumorsMDNA11 continues to demonstrate encouraging single-agent activity from the monotherapy dose escalation portion of the ABILITY-1 StudyCompany expects to report results from both the monotherapy expansion and combination escalation and expansion arms of the Phase 2 study in H1 and H2 2024 TORONTO and HOUSTON, Feb. 13, 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, today announced the first patient dosed in the combination arm of the Phase 1/2 ABILITY (A Beta-only IL-2 ImmunoTherapY) study evaluating MDNA11, a long-acting, “beta-enhanced not-alpha” interleukin-2 (IL-2) super-agonist, with KEYTRUDA® (pembrolizumab). The combination portion of the study is designed to evaluate the potential for a synergistic effect of MDNA11 with KEYTRUDA® in patients with advanced solid tumors. “Dosing the first patient in the combination arm with MDNA11 and KEYTRUDA® is a significant milestone for Medicenna and are excited with the progress of our novel IL-2 superkine," said Fahar Merchant, PhD, President and CEO of Medicenna. “By combining MDNA11 with KEYTRUDA®, we are building upon the promising data generated to date by MDNA11 as a single agent. Targeting the PD1/PD-L1 pathway in addition to MDNA11’s differentiated mechanism of action is expected to further stimulate and restore the patient’s immune system, which should result in improved antitumoral activity and patient outcomes. We are thrilled to enter this new phase of development of MDNA11 and further demonstrate its potential in combination with the world’s best-selling drug.” Solid tumors represent 90% of all cancers and although CPI therapies have shown promising advances in some types of immunosensitive cancers, more than 70% of patients do not respond to or become resistant to such therapies. MDNA11, with its uniquely differentiating ‘beta-enhanced not-alpha’ features, continues to be a potential best-in-class next-generation IL-2 super-agonist for treatment of advanced solid tumors. Pre-clinical data published in JITC in 2022 demonstrated that mice receiving both, MDNA11 and checkpoint inhibitors achieved complete and sustained tumor control even after multiple rechallenges, demonstrating the capacity for MDNA11 to sensitize solid tumors to checkpoint blockade1. The ABILITY-1 Study is actively recruiting patients with different types of recurrent or metastatic solid tumors at multiple sites in the USA, Canada, Australia, and South Korea and is expected to initiate patient enrolment in Europe. Preliminary results from both the monotherapy expansion and combination escalation and expansion arms of ABILITY-1 the study will be available in H1 and H2 2024. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. 1https://pubmed-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/35058325/ About the ABILITY-1 Study The ABILITY-1 study (NCT05086692) is a global, multi-center, open-label study that assesses the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of MDNA11 as monotherapy or in combination with pembrolizumab (Keytruda®). In the combination dose escalation of the Phase 2 study, approximately 6-12 patients are expected to be enrolled and administered ascending doses of MDNA11 intravenously once every two weeks in combination with KEYTRUDA®. This portion of the study includes patients with a wide range of solid tumors with the potential for susceptibility to immune modulating therapeutics. Upon identification of an appropriate dose regimen for combination, the study will proceed to a combination dose expansion cohort. About MDNA11 MDNA11 is an extensively engineered long-acting recombinant IL-2 “Superkine” fused with human albumin. MDNA11 has complete abrogation of IL-2 receptor alpha binding and is the only IL-2 therapy in clinical development with enhanced binding to the intermediate affinity receptor (beta-gamma). These changes enable effective expansion and activation of anti-tumor CD8+ effector and NK cells while avoiding excessive stimulation of immunoinhibitory Treg cells or side effect inducing endothelial cells, as well as ensuring retention in the tumor and tumor draining lymph nodes. These changes vastly increase efficacy and therapeutic index over the predecessor drug aldesleukin. MDNA11 is currently being evaluated in the Phase 1/2 ABILITY-1 study as both a monotherapy and in combination with the PD-1 blocking antibody pembrolizumab (Keytruda®). 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 Twitter and LinkedIn. Forward-Looking Statements This news release contains forward-looking statements within the meaning of applicable securities laws that relate to the future operations of the Company, plans and projections and other statements that are not historical facts, including, without limitation, statements on the clinical development and potential of MDNA11, the ABILITY-1 Study and its enrolment and the timeline for reporting results and additional data. 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 and Annual Report on Form 20-F 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. Contacts Christina CameronInvestor Relations, Medicenna Therapeuticsir@medicenna.com(647) 953-0673

LARKSPUR, Calif.--( BUSINESS WIRE )--Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through the development of best-in-class IL-2 therapeutics, today announced dosing of the first patient in the initial Phase 2 expansion cohorts of its Phase 1/2 clinical trial evaluating AU-007 for treatment of unresectable locally advanced or metastatic cancers. AU-007 is a human IgG1 monoclonal antibody designed to harness the power of interleukin-2 (IL-2) to eradicate solid tumors, and the first AI-designed human monoclonal antibody to be tested in a clinical trial. Phase 1 data demonstrate that AU-007 is currently the only IL-2 agent that can reduce regulatory T cells (Tregs), which suppress the immune system. “ Dosing of the first patient in the Phase 2 portion of our AU-007 Phase 1/2 study marks a significant milestone as we advance development of this promising, novel IL-2 therapeutic for the treatment of solid tumor cancers,” said Aron Knickerbocker, Aulos Bioscience’s chief executive officer . “ AU-007 was created to solve pressing safety and efficacy challenges associated with IL-2 therapeutics, and we are encouraged by ongoing new Phase 1 data that indicate clinical activity in several heavily pre-treated patients whose tumors progressed through checkpoint inhibitors. We are grateful to the participating patients and investigators in this clinical trial, and look forward to enrolling additional patients and presenting clinical data from the Phase 2 expansion cohorts later this year.” Aulos’ Phase 1/2 clinical trial is a two-part, open label, first-in-human study evaluating the safety, tolerability, immunogenicity and clinical activity of AU-007 in patients with unresectable locally advanced or metastatic cancer. The initial Phase 2 expansion cohorts focus on melanoma and renal cell carcinoma (RCC), with AU-007 administered every two weeks in combination with a single loading dose of low-dose, subcutaneous Proleukin ® (aldesleukin; recombinant human IL-2), or with AU-007 and low-dose, subcutaneous Proleukin, both administered every two weeks. Created by Biolojic Design, AU-007’s unique computational design allows it to bind precisely to the portion of IL-2 that binds to CD25, which prevents IL-2 from binding to high-affinity IL-2 receptors on Tregs, vasculature, pulmonary tissue and eosinophils. This redirects IL-2 to medium-affinity receptors on effector T cells (Teffs) and natural killer (NK) cells, which expand and kill tumor cells. Phase 1 dose escalation cohort data presented at two separate medical meetings last fall demonstrate that when AU-007 is administered to patients as monotherapy or in combination with low doses of Proleukin, the number of immunosuppressive Tregs decreases and the numbers of Teffs and NK cells increase. Additionally, data indicate that AU-007 is well tolerated and tumor shrinkage was observed in patients with melanoma, bladder, kidney, head and neck, and lung cancers. To learn more about the AU-007 clinical trial program, please visit ClinicalTrials.gov (identifier: NCT05267626 ). For patients and providers in the U.S., please visit www.solidtumorstudy.com . For patients and health professionals in Australia, please visit www.solidtumourstudy.com . About AU-007 AU-007 is a computationally designed, human IgG1 monoclonal antibody that is highly selective to the CD25-binding portion of IL-2. With a mechanism of action unlike any other IL-2 therapeutic in development, AU-007 leverages IL-2 to reinforce anti-tumor immune effects. This is achieved by preventing IL-2, either exogenous or secreted by effector T cells, from binding to trimeric receptors on regulatory T cells while still allowing IL-2 to bind and expand effector T cells and NK cells. This prevents the negative feedback loop caused by other IL-2-based treatments and biases the immune system toward activation over suppression. AU-007 also prevents IL-2 from binding to CD25-containing receptors on eosinophils, as well as vasculature and pulmonary endothelium, which may significantly reduce the vascular leak syndrome and pulmonary edema associated with high-dose IL-2 therapy. About Aulos Aulos Bioscience is an immuno-oncology company working to revolutionize cancer patient care through best-in-class IL-2 therapeutics that direct patients’ immune systems toward killing tumor cells. Matching world-class machine learning from co-founder Biolojic Design with an in-depth understanding of the immune system, Aulos’ initial clinical candidate, AU-007, is a computationally designed human antibody that harnesses the power of IL-2 to induce tumor killing while limiting the immunosuppression and toxicities typically associated with this validated pathway. The company was founded by Biolojic Design and Apple Tree Partners ( ATP ) and is led by pioneers in the field of artificial intelligence, antibody development and cancer immunotherapies. For more information, visit www.aulosbio.com , X ( @AulosBioscience ) and LinkedIn .