CD74

On April 1, 2024, Sutro Biopharma, a NASDAQ-listed American company, and the renowned French pharmaceutical company Ipsen, entered into a global exclusive licensing agreement. The agreement covers Sutro's investigational ADC (Antibody-Drug Conjugate) candidate, STRO-003. Under the terms of the deal, Ipsen will make an upfront payment of $90 million to Sutro and potentially pay up to $900 million in milestone payments. This is Ipsen's first major investment in the ADC field. STRO-003 is a next-generation ADC targeting ROR1 (Receptor Tyrosine Kinase-Like Orphan Receptor 1). This ADC uses exatecan (iexabepilone) as the payload, delivered through a β-glucuronidase-cleavable linker. In addition to STRO-003, Sutro has other ADC candidates in clinical development, including FRa ADC and CD74 ADC, as well as TF ADC in preclinical stages. The company is also collaborating with Astellas on immunostimulatory ADCs (iADCs) in preclinical research. In the ROR1 ADC space, other notable candidates include CS5001 from LegoChem/Cornerstone, Zilovertamab Vedotin (MK-2140) from Merck/VelosBio, a bispecific antibody-drug conjugate from Bolt Biotherapeutics, and NBE-002 from BI/NBE Therapeutics. According to recent clinical data from Cornerstone, CS5001 has demonstrated promising anti-tumor activity and a favorable safety profile across various solid tumors and hematological malignancies. This transaction not only highlights the immense potential of ADC technology in targeted cancer therapy, but also reflects the intense competition among domestic and international pharmaceutical companies in this field. A thorough analysis of the current clinical and market landscape of ROR1 ADCs will help us better understand the future development trends of innovative medicines.

LA JOLLA, Calif., June 03, 2024 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ: MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that MediciNova’s collaborator, Gilbert Youssef, M.D. at Harvard Medical School, Attending Physician, Center for Neuro-Oncology at Dana-Farber Cancer Institute and Brigham and Women's Hospital, presented new data and results of a Phase 1b/2a Clinical Trial of MN-166 (ibudilast) in Glioblastoma (GBM) at the American Society of Clinical Oncology (ASCO) Annual meeting 2024 held May 31- June 4th in Chicago, IL. The highlights of presentation entitled “Phase 1b/2a study evaluating the combination of MN-166 (ibudilast) and temozolomide (TMZ) in patients with newly diagnosed and recurrent glioblastoma (GBM) (Abstract # 2016)“ are as follows: The clinical study enrolled a total of 62 patients, including 36 with newly diagnosed GBM patients and 26 with recurrent GBM. The primary endpoints were safety and tolerability of MN-166 and TMZ combination treatment and the efficacy of combination treatment. The recommended Phase 2-dose (R2PD) of MN-166 is 50 mg BID. The combination of Temozolomide (TMZ) and MN-166 was safe and well tolerated. No unexpected adverse effects were observed in both new GBM and recurrent GBM patients. Most reported adverse events were Lymphopenia, Leukopenia, Thrombocytopenia and Neutropenia. Progression Free Survival at 6 months (PFS6) was 44% (new GBM) and 31% (recurrent GBM), respectively. PFS6 in recurrent GBM was higher than historical control. Median PFS was 8.7 months in new GBM and 2.4 months in recurrent GBM. Median Overall Survival (OS) was 21 months in new GBM and 8.6 months in recurrent GBM. Neither were higher than historical data. Immunohistochemistry evaluation was performed for the patients whose pre-treatment tumor tissue samples were available from resected tumors at initial surgery or biopsy to evaluate MIF (macrophage migration inhibitory factor), pERK, Ki67, CD3, CD11b, and CD74 The intra-tumoral CD3 expression was significantly higher in the patients had disease progression within 5 months of treatment initiation compared to patients that had no disease progression over 5 months, whereas the expression of MIF, CD74 (MIF receptor), Ki67 (proliferation index), and CD11b (marker expressed on myeloid-derived suppressor cells and macrophages, among other cell types) were not different between these 2 subgroups of patients. Preclinical data has shown improved survival with the combination of Ibudilast and PD-1 or PD-L1 antibody therapy compared to treatment with ibudilast alone or PD-1/PD-L1 antibody alone, suggesting a potential promising therapeutic benefit of this combination. Kazuko Matsuda, M.D., Ph.D., M.P.H., Chief Medical Officer of MediciNova, Inc., commented, “First, we wish to express our sincere thanks to the study participants, their familys, the investigators, and their staff for their dedication and courage to conduct and volunteer for this trial. We are very pleased to have the opportunity to present our positive safety and efficacy results from the clinical trial of MN-166 in the treatment of GBM at the most prestigious clinical oncology conference. GBM’s rapid progression and resistance to therapy poses a serious challenge to the medical community. Evaluation of MN-166 (ibudilast) as an adjuvant therapy with TMZ in GBM patients was generally safe and well tolerated. For the PFS6 primary efficacy endpoint, recurrent GBM patients showed a higher PFS6 rate compared to most historical studies. Moreover, the preclinical studies data from 2 different research groups presented at this meeting support our postulation that adding MN-166 (ibudilast) to existing immunotherapy, i.e. anti-PD1 or anti-PD-L1, improves survival more than the individual therapies alone. We are eager to evaluate MN-166 (ibudilast) in combination with anti-PD1 and anti-PD-L1 therapies in a future clinical trial.” About MN-166 (ibudilast) MN-166 (ibudilast) is a small molecule compound that inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines, including macrophage migration inhibitory factor (MIF). It is in late-stage clinical development for the treatment of neurodegenerative diseases such as ALS (amyotrophic lateral sclerosis), progressive MS (multiple sclerosis), and DCM (degenerative cervical myelopathy); and is also in development for glioblastoma, Long COVID, CIPN (chemotherapy-induced peripheral neuropathy), and substance use disorder. In addition, MN-166 (ibudilast) was evaluated in patients that are at risk for developing acute respiratory distress syndrome (ARDS). About MediciNova MediciNova, Inc. is a clinical-stage biopharmaceutical company developing a broad late-stage pipeline of novel small molecule therapies for inflammatory, fibrotic, and neurodegenerative diseases. Based on two compounds, MN-166 (ibudilast) and MN-001 (tipelukast), with multiple mechanisms of action and strong safety pro MediciNova has 11 programs in clinical development. MediciNova’s lead asset, MN-166 (ibudilast), is currently in Phase 3 for amyotrophic lateral sclerosis (ALS) and degenerative cervical myelopathy (DCM) and is Phase 3-ready for progressive multiple sclerosis (MS). MN-166 (ibudilast) is also being evaluated in Phase 2 trials in Long COVID and substance dependence. MN-001 (tipelukast) was evaluated in a Phase 2 trial in idiopathic pulmonary fibrosis (IPF) and a second Phase 2 trial in non-alcoholic fatty liver disease (NAFLD) is ongoing. MediciNova also has a strong track record of securing investigator-sponsored clinical trials funded through government grants. Statements in this press release that are not historical in nature constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding the future development and efficacy of MN-166, MN-001, MN-221, and MN-029. These forward-looking statements may be preceded by, followed by, or otherwise include the words "believes," "expects," "anticipates," "intends," "estimates," "projects," "can," "could," "may," "will," "would," “considering,” “planning” or similar expressions. These forward-looking statements involve a number of risks and uncertainties that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by these forward-looking statements include, but are not limited to, risks of obtaining future partner or grant funding for development of MN-166, MN-001, MN-221, and MN-029 and risks of raising sufficient capital when needed to fund MediciNova's operations and contribution to clinical development, risks and uncertainties inherent in clinical trials, including the potential cost, expected timing and risks associated with clinical trials designed to meet FDA guidance and the viability of further development considering these factors, product development and commercialization risks, the uncertainty of whether the results of clinical trials will be predictive of results in later stages of product development, the risk of delays or failure to obtain or maintain regulatory approval, risks associated with the reliance on third parties to sponsor and fund clinical trials, risks regarding intellectual property rights in product candidates and the ability to defend and enforce such intellectual property rights, the risk of failure of the third parties upon whom MediciNova relies to conduct its clinical trials and manufacture its product candidates to perform as expected, the risk of increased cost and delays due to delays in the commencement, enrollment, completion or analysis of clinical trials or significant issues regarding the adequacy of clinical trial designs or the execution of clinical trials, and the timing of expected filings with the regulatory authorities, MediciNova's collaborations with third parties, the availability of funds to complete product development plans and MediciNova's ability to obtain third party funding for programs and raise sufficient capital when needed, and the other risks and uncertainties described in MediciNova's filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2023 and its subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof. MediciNova disclaims any intent or obligation to revise or update these forward-looking statements. INVESTOR CONTACT: David H. Crean, Ph.D. Chief Business Officer MediciNova, Inc info@medicinova.com

VIENNA--(BUSINESS WIRE)-- OncoOne, a biotechnology company focused on discovering precision medicines for cancer and autoimmune diseases, announced today the formation of a clinical advisory board to provide strategic and clinical insights for the company’s lead program in immunology, ON104. ON104 is a monoclonal antibody targeting the oxidized isoform of the macrophage migration inhibitory factor (oxMIF) for the treatment of chronic inflammatory diseases. “The growing amount of preclinical data for ON104 is very promising and illustrates its broad applicability in key indications such as RA, inflammatory bowel disease, asthma, and nephritis,” commented Randolf Kerschbaumer, Ph.D., CEO of OncoOne. “As we continue to validate our technology’s ability to effectively neutralize disease progression in autoimmune diseases, this board of distinguished experts will be invaluable to the clinical strategy for ON104 and will support OncoOne’s vision of supplying a new class of therapeutic solutions to patient populations with a high unmet medical need.” The members of the OncoOne Clinical Advisory Board include: Richard Bucala, M.D., Ph.D. Richard Bucala, is the Chief of Rheumatology, Allergy & Immunology at the Yale Institute for Global Health and the Waldemar Von Zedtwitz Endowed Professor of Medicine, Pathology, Epidemiology, & Public Health at the Yale School of Medicine. Dr. Bucala is renowned in MIF research and is recognized for discovering MIF's receptor CD74, as well as elucidating MIF's critical role in regulating glucocorticoid immunosuppression. He is an attending physician in the Yale New Haven Health System and is the past Editor-in-Chief of Arthritis & Rheumatology. Dr. Bucala was elected to the American Society for Clinical Investigation (ASCI) and the Association of American Physicians (AAP), in addition to having served on an advisory board for the United Nations and various other U.S. federal, academic, and pharmaceutical organizations. Daniel Aletaha, M.D. Daniel Aletaha is Professor and Head of the Clinical Department of Rheumatology at the Medical University of Vienna. Dr. Aletaha is the current president of the European Alliance of Associations for Rheumatology (EULAR). His research focuses on arthritis and other inflammatory rheumatic diseases, precision medicine, and the management of complex diseases. He has experience in the areas of novel therapies and treatment strategies, diagnosis, prognosis, outcomes, and biomarkers. He currently holds over 350 indexed publications. Seamas Donnelly, M.D. Dr. Seamas Donnelly is a Professor of Medicine at Trinity College Dublin. He is a global leader in translational medicine with a research focus on the development of novel compounds as anti-inflammatory/anti-cancer therapies. He has authored many MIF-focused publications in renowned peer-reviewed journals, including Nature Medicine and Molecular Medicine. Dr. Donnelly’s research epitomizes classical bench to bedside on an international scale, and, in recognition of this, has been awarded an Honorary Professorship in Translational Medicine by the University of Edinburgh. He is the current President of the Association of Physicians of Great Britain & Ireland, the leading academic medical association in the UK and Ireland. Dr. Donnelly is also the lead Trinity PI of Health Innovation Hub Ireland and has been a member of OncoOne’s scientific advisory board since 2022. Michael Freissmuth, M.D. Dr. Freissmuth is the Director of the Center of Physiology & Pharmacology as well as the Chairman of the Institute of Pharmacology at the Medical University in Vienna. He was appointed Professor of Pharmacology in 1995 and received many awards, including the Novartis Award for Medicine. Dr. Freissmuth is a member of numerous editorial boards and serves on several review panels and scientific advisory boards. His most recent appointments include positions on international panels such as the Scientific Advisory Board of the Institut Cochin de Génétique Moléculaire in Paris and of the Engelhorn Foundation for Life Sciences. He is also a member of the supervisory board of Boehringer Ingelheim Austria. Dr. Freissmuth is an inaugural member of OncoOne’s scientific advisory board, where he continues to support the development of the company’s pipeline of biotherapeutics. About OncoOne OncoOne seeks to overcome the limitations of targeting macrophage migration inhibitory factor by harnessing the disease-related isoform, oxidized macrophage migration inhibitory factor (oxMIF). The Company is focused on developing multiple proprietary drug modalities to leverage oxMIF’s potential as a target for systemic treatment of cancer, as well as for chronic inflammatory diseases. Equipped with a successful track-record in early-stage drug development, as well as a deep understanding of the target itself, OncoOne’s leadership will advance a pipeline based on oxMIF’s promise in inflammation and other disease areas. View source version on businesswire.com: Contacts For OncoOne: Randolf Kerschbaumer, Ph.D., CEO Website: E-mail: contact@oncoone.com Phone: +43 1 909 2208 - 6000 For Media Inquiries: Trophic Communications Desmond James E-mail: OncoOne@trophic.eu Phone: +49 1516 7859086 Source: OncoOne View this news release online at: