IL-2Rβ

Company will also present new preclinical data for its orthoIL-2 technology for cytokine-inducible cell therapies MENLO PARK, Calif.--(BUSINESS WIRE)-- Synthekine Inc., an engineered cytokine therapeutics company, today announced that data from a Phase 1a/1b clinical trial of its α/β biased IL-2 partial agonist, STK-012, will be presented at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2024 taking place in San Diego, from April 5-10, 2024. The company will also present new preclinical data for its orthogonal IL-2 (orthoIL-2) technology for cytokine-inducible cell therapies, currently being investigated in a Phase 1 study with the STK-009 + SYNCAR-001 combination therapy. “AACR marks the first time Synthekine will present clinical data from the ongoing trial of STK-012, our lead program and a novel approach to biasing IL-2,” said Debanjan Ray, chief executive officer of Synthekine. “We are also excited to share new preclinical data with our orthoIL-2 technology comparing it head-to-head with other armoring approaches for CAR T-cell therapies. We look forward to sharing these results with the scientific community, while continuing our rapid progress to advance our broad pipeline of cytokine programs, including cytokine-inducible cell therapies, for the treatment of cancer, inflammatory and autoimmune diseases.” Details are as follows and available on the AACR online itinerary planner: Title: Initial results from a Phase 1a/1b study of STK-012, a first-in-class α/β IL-2 receptor biased partial agonist in advanced solid tumors (NCT05098132) Session Title: First-in-Human Phase I Clinical Trials 2 Session Date & Time: Tuesday, Apr 9, 2024, 9:00 AM – 12:30 PM PT Location: Poster Section 48 Poster Board Number: 11 Abstract Number: CT183 Title: Orthogonal IL-2/IL-2Rβ signaling selectively enhances and sustains a synthetic effector state via a novel mechanism and outperforms constitutive armoring approaches Session Title: Adoptive Cellular Therapy 2 Session Date & Time: Tuesday, Apr 9, 2024, 1:30 PM – 5:00 PM PT Location: Poster Section 40 Poster Board Number: 3 Abstract Number: 6312 Copies of the posters will be available on Synthekine’s website following presentation at the meeting. About Synthekine Synthekine is harnessing the potential of cytokine therapeutics to develop selective immunotherapies designed to improve the treatment paradigm of cancer and inflammatory disease. Using insights on cytokine structure and function, the company engineers therapeutics designed to unlock the full efficacy potential of cytokines while avoiding their associated toxicities. Synthekine is applying principles of cytokine partial agonism and immunological specificity across multiple protein engineering platforms to create a broad and deep pipeline of product candidates. These novel immunotherapies include modified cytokines, cytokine-enhanced cell therapies and surrogate cytokine agonists. For more information, visit , and follow us on X @synthekine and LinkedIn.

The ABILITY-1 Study will evaluate MDNA11, a highly selective long-acting IL-2 Superkine, in combination with KEYTRUDA® (pembrolizumab) for treatment of patients with advanced solid tumors MDNA11 continues to demonstrate encouraging single-agent activity from the dose escalation portion of the ABILITY-1 Study MDNA11 is generally well tolerated with no dose-limiting toxicities or vascular leak syndrome reported in any of the dose escalation cohorts Company expects to report initial results from both the monotherapy expansion and combination escalation arms of the Phase 2 study in H1 2024 TORONTO and HOUSTON, Jan. 09, 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 initiation of enrollment in the combination arm of the Phase 1/2 ABILITY (ABeta-only IL-2 ImmunoTherapY) study evaluating MDNA11, a long-acting, “beta-enhanced not-alpha” interleukin-2 (IL-2) super-agonist, with Merck’s pembrolizumab (KEYTRUDA®). The combination portion of the study is being conducted as part of the previously announced Clinical Trial Supply and Collaboration Agreement1 between Medicenna and Merck (known as MSD outside the United States and Canada) and is designed to evaluate the potential for a synergistic effect of MDNA11 with KEYTRUDA® in patients with advanced solid tumors. “We are very pleased to announce initiation of the combination study of MDNA11 and the PD-1 inhibitor, pembrolizumab, the leading checkpoint inhibitor therapy,” said Fahar Merchant, Ph.D., President and CEO of Medicenna. “Having established an appropriate dose for monotherapy as well as demonstrating its early clinical validation we believe MDNA11 may further enhance anti-tumor activity when combined with pembrolizumab in patients that do not respond or develop resistance to checkpoint therapy. We look forward to reporting preliminary results from both the monotherapy expansion and combination escalation arms of the Phase 2 study in the first half of 2024.” In the Phase 1 monotherapy dose escalation and dose evaluation portions of the study, MDNA11 was well tolerated with promising single-agent activity. As of the data cutoff date of October 26, 2023, responses included: one confirmed durable (> 1.5 years) and deep (100% resolution of target lesions) partial response in a heavily pretreated patient with metastatic pancreatic cancer and primary resistance to checkpoint inhibitor (CPI) therapy, one deep (70% resolution of target lesion) unconfirmed partial response in a patient with cutaneous melanoma with secondary resistance to CPI, both of whom continue on therapy and, multiple patients with extended stable disease and/or target lesion reductions. 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 2023 demonstrated that mice receiving both, MDNA11 and checkpoint inhibitors achieved complete tumor control even after multiple rechallenges when compared to either treatment alone, demonstrating the capacity for MDNA11 to sensitize solid tumors to checkpoint blockade2. The ABILITY-1 Study is actively recruiting patients with different types of recurrent or metastatic solid tumors at multiple sites in the USA and Australia and is expected to initiate patient enrolment in Canada and South Korea. 1 2 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 pembrolizumab 400mg every six weeks. 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” with complete abrogation of IL-2 receptor alpha binding, enhanced IL-2 receptor beta binding, and fusion to recombinant human albumin. 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 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 and the United States. 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. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Contacts Christina Cameron Investor Relations, Medicenna Therapeutics ir@medicenna.com Investors & Media Argot Partners Phone: 212-600-1902 medicenna@argotpartners.com

Anaptys licenses exclusive global development and commercialization rights to a potential best-in-class BDCA2 modulator portfolio IND filing to support clinical development of ANB101 in autoimmune and inflammatory diseases expected in H2 2024 Reiterating year-end 2023 cash and investments of $400 to $410 million and cash runway through year-end 2026 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, today announced an exclusive license agreement for Centessa Pharmaceuticals’ (NASDAQ: CNTA) blood dendritic cell antigen 2 (BDCA2) modulator antibody portfolio, including lead asset CBS004 and related family of backup antibodies, for the treatment of autoimmune and inflammatory diseases. Anaptys anticipates filing an IND application for CBS004, which will be renamed ANB101, in H2 2024. “Acquiring the rights to this BDCA2 modulator portfolio, which specifically targets plasmacytoid dendritic cells, known to be key drivers of interferon secretion and antigen presentation, complements our portfolio of best-in-class immune cell modulators to drive differentiated clinical outcomes in systemic, heterogeneous autoimmune and inflammatory diseases,” said Daniel Faga, president and chief executive officer of Anaptys. “We now plan to file two INDs in 2024: ANB101 in H2 2024 and ANB033, our CD122 antagonist, in H1 2024.” “We are pleased to enter into this agreement with Anaptys, which enables the continued advancement of Centessa’s BDCA2 modulators,” said Saurabh Saha, M.D., Ph.D., chief executive officer of Centessa. “With their focus on developing immune cell modulators, Anaptys is well positioned to further the research and development of this program in autoimmune and inflammatory diseases.” Plasmacytoid dendritic cells (pDCs) are a key upstream node in the inflammatory cascade that serve as a bridge between innate and adaptive immunity. They have been shown to be prolific secretors of type I interferons, which drive activation of a variety of downstream cell types including T cells and monocytes. Together with their ability to present antigens to the adaptive immune system, this creates a pro-inflammatory environment for the establishment and perpetuation of autoimmune pathology. BDCA2 is a molecule specifically expressed on pDCs, a class of immune cells which, while found in relatively small numbers in healthy patients, are enriched in patients with a variety of inflammatory diseases, that is critical to the regulation of toll-like receptor signaling and interferon secretion. BDCA2 has been implicated in the pathophysiology of systemic lupus erythematosus (SLE), where there exists mechanistic clinical proof of concept for pDC modulation. ANB101 is a potentially best-in-class BDCA2 modulator antibody that targets pDCs and potently inhibits interferon secretion and modulates antigen presentation for the treatment of autoimmune and inflammatory diseases. Under the terms of the agreement, Anaptys will receive from Centessa Pharmaceuticals an exclusive, global license for ANB101. Anaptys will also receive the same rights to ANB102, an extended half-life BDCA2 modulator with the potential to enable quarterly or less frequent dosing. ANB101 has successfully completed IND-enabling studies and manufacturing scale-up. Anaptys will assume responsibility for all future clinical development. In exchange, Anaptys will pay Centessa a one-time upfront cash payment of $7 million, inclusive of a one-time cash payment of $3 million for manufactured and released GMP supply of ANB101. Centessa is eligible to receive an additional development milestone payment and low single-digit royalties on global net sales. Anaptys is a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics. It is developing immune cell modulators, including two checkpoint agonists for autoimmune and inflammatory disease: rosnilimab, its PD-1 agonist, in a Phase 2b trial for the treatment of rheumatoid arthritis and in a Phase 2 trial for the treatment of ulcerative colitis; and ANB032, its BTLA agonist, in a Phase 2b trial for the treatment of atopic dermatitis. Its preclinical immune cell modulator portfolio includes ANB033, an anti-CD122 antagonist antibody, and ANB101, a BDCA2 modulator antibody, for the treatment of autoimmune and inflammatory diseases. In addition, Anaptys has developed two cytokine antagonists available for out-licensing: imsidolimab, an anti-IL-36R antagonist, in Phase 3 for the treatment of generalized pustular psoriasis, or GPP, and etokimab, an anti-IL-33 antagonist for the treatment of respiratory disorders that is Phase 2/3 ready. Anaptys has also discovered multiple therapeutic antibodies licensed to GSK in a financial collaboration for immuno-oncology, including an anti-PD-1 antagonist antibody (Jemperli (dostarlimab-gxly)) and an anti-TIM-3 antagonist antibody (cobolimab, GSK4069889). To learn more, visit www.AnaptysBio.com or follow us on LinkedIn and X. The content above comes from the network. if any infringement, please contact us to modify.