Immuneoncia Therapeutics, Inc.

DUBLIN--( BUSINESS WIRE )--The "Global CD47 Inhibitor Drug Clinical Trials Insight & Market Opportunity Outlook 2028" report has been added to ResearchAndMarkets.com's offering. Inhibition of the cell surface protein CD47 has emerged as a novel cancer immunotherapy approach that has piqued the interest of both academia and industry in the recent years. Cancer cells often overexpress CD47, which triggers the "don't eat me" signal pathway, thereby helping malignant cells to escape immune surveillance. CD47 inhibitors seek to uncover cancer cells by inhibiting this protein, leaving them open to immune system attack, specifically through increased macrophage phagocytosis. Although no CD47 inhibitor is currently approved for therapeutic usage, the availability of candidates in phase 3 trials suggests that one may be approved in the coming years. With multiple candidates at varying stages of development, the field of CD47 inhibitor research and development is rapidly evolving. Developed by Forty Seven, which is now a part of Gilead, magrolimab is among the most advanced CD47 inhibitors. In early stage clinical trials for hematological tumors, it has demonstrated encouraging outcomes, especially when combined with other cancer treatments. Furthermore, late stage clinical trials evaluating Magrolimab in solid cancer alongside conventional cancer treatments such as docetaxel, Nivolumab, Pembrolizumab, Azacitidine, and Venetoclax are now under progress. Another significant candidate is Evorpacept (ALX148) from ALX Oncology, a high affinity SIRP? fusion protein that inhibits CD47. Currently, evorpacept is being assessed as a monotherapy and in combination with widely used anticancer drugs in a number of early phase clinical trials for a variety of solid and hematological tumors. Furthermore, a late-phase trial evaluating Evorpacept in combination with Trastuzumab, Ramucirumab, and Paclitaxel for the treatment of HER2+ gastric cancer is also under progress. A number of other CD47 inhibitors, including as TQB 2928 (Chia Tai Tianqing Pharmaceutical), MP 0621 (Molecular Partners), IMC-002 (ImmuneOncia Therapeutics), and CC 90002 (Celgene), are in the early phases of clinical research. The emphasis on combination therapies is undoubtedly one of the key trends in clinical development. Combining CD47 inhibitors with other immunotherapies, targeted treatments, and chemotherapy is being studied in an effort to overcome resistance mechanisms and provide synergistic benefits. Anticipated growth in the global market for CD47 inhibitors is attributed to the rising cancer incidence and increased use of immunotherapies in the upcoming years. The potential of CD47 inhibitors has been acknowledged by a number of prominent pharmaceutical companies, which has resulted in notable partnerships and acquisitions. The commercial interest in this field is demonstrated by Gilead Science's US$ 4.9 billion acquisition of Forty Seven in 2020 and Pfizer's US$ 2.26 billion acquisition of Trillium Therapeutics in 2021. Although Chinese and American companies presently dominate the market, there is increasing participation from South Korea, Australia, Canada, and Japan. Through clinical research, companies such as Shaperon, InnobationBio, Bitterroot Bio, and ImmuneOncia Therapeutics are making strides with their CD47 inhibitors. The market is becoming increasingly competitive, with several firms striving for market share. Therefore, for commercial success, differentiation based on safety profile, efficacy, and possible combination strategies will be essential. The market for CD47 inhibitors has both opportunities and challenges. Strong commercial interest and encouraging clinical evidence point to substantial development potential. However, there are challenges to address, such managing toxicity profiles, coming up with the best combination plans, and demonstrating distinct therapeutic advantages over current treatments. As the field develops, biomarker development for response prediction and patient selection will probably become more crucial for clinical development as well as marketing tactics. In conclusion, the market for CD47 inhibitors globally is an active rapidly expanding area of cancer immunotherapy. In the years to come, CD47 inhibitors could have a big impact on cancer therapy paradigms because there are several candidates in clinical development and a lot of commercial interest. Global CD47 Inhibitor Drug Clinical Trials Insight & Market Opportunity Outlook 2028 Report Highlights Global & Regional Market Opportunity Outlook Insight On More Than 100 CD47 Inhibitor Drugs In Clinical Trials Global CD47 Inhibitors Clinical Trials Insight By Company, Country, Indication & Phase Orphan, Fast Track, Breakthrough Therapy Designation Insight Key Drugs Initiation & Completion Year CD47 Clinical Application & Development Outlook By Indication CD47 Inhibitor Drugs Clinical Developments & Trends By Country Global CD47 Inhibitor Drug Market Dynamics Key Topics Covered: 1. CD 47 As Novel Cancer Immunotherapy Target 2. Global CD47 Inhibitors Drug Clinical Pipeline Overview 2.1 By Country 2.2 By Company 2.3 By Indication 2.4 By Patient Segment 2.5 By Phase 2.6 By Priority Status 3. CD47 Inhibitors Clinical Trials Insight By Company, Country, Indication & Phase 3.1 Research 3.2 Preclinical 3.3 Phase I 3.4 Phase I/II 3.5 Phase II 3.6 Phase II/III 3.7 Phase III 4. Global CD47 Inhibitor Drug Market Opportunity Outlook 4.1 Current Market Overview 4.2 Future Outlook & Opportunities 5. CD47 Clinical Application & Development Outlook by Indication 5.1 Solid Cancers 5.1.1 Breast Cancer 5.1.2 Colorectal Cancer 5.1.3 Lung Cancer 5.1.4 Urogenital Cancer 5.1.5 Gastrointestinal Cancer 5.2 Hematological Malignancies 5.2.1 Lymphoma 5.2.2 Leukemia 5.2.3 Multiple Myeloma 5.2.4 Myelodysplastic Syndrome 5.3 Microbial Infections 6. CD47 Inhibitor Drugs Clinical Developments & Trends By Country 6.1 China 6.2 US 6.3 South Korea 6.4 Australia 6.5 Canada 7. Global CD47 Inhibitors Market Dynamics 7.1 Favorable Parameters 7.2 Market Restraints 8. Competitive Landscape Adagene ALX Oncology ImmuneOncia Therapeutics ImmuneOnco Biopharma Light Chain Bioscience Phanes Therapeutics Virtuoso Therapeutics For more information about this report visit https://www.researchandmarkets.com/r/qs8ua0 About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

SEOUL, South Korea--(BUSINESS WIRE)-- ImmuneOncia (CEO Heung Tae Kim) announced the results of its solid tumour Phase 1a clinical trial of IMC-002, an anti-CD47 mAb, presented at the American Society of Clinical Oncology (ASCO) Annual Meeting held in Chicago, USA on June 1, 2024 (local time). These results include updates on the Phase 1a clinical trial outcomes, along with biomarker findings achieved through collaboration with Lunit (CEO; Brandon Suh), a leading provider of AI-powered solutions for cancer diagnostics and therapeutics. This press release features multimedia. View the full release here: ImmuneOncia Announces Biomarker Results from Phase 1 Clinical Trial of CD47 Antibody at ASCO (Graphic: ImmuneOncia Therapeutics, Inc.) The study, a dose escalation part of Phase 1, enrolled a total of 12 patients across four dose cohorts starting from May 2022. Each patient received IMC-002 at doses of 5, 10, 20, or 30 mg/kg every two weeks. Treatment outcomes revealed stable disease (SD) in 6 out of 12 evaluable patients, demonstrating a disease control rate (DCR) of 50%. Among these, 5 patients had hepatocellular carcinoma, and 1 had breast cancer. Furthermore, 4 patients maintained stable disease for over 6 months, resulting in a clinical benefit rate (CBR) of 33.3%. AI-powered biomarker analysis, utilizing Lunit SCOPE IO, revealed that the density of CD47-positive macrophages was numerically higher in the CBR group compared to the non-CBR group (71.0/mm² vs. 44.3/mm²), while the density of CD47-positive tumour cells was similar between the two groups. These findings suggest a correlation between the density of CD47-positive macrophages and treatment response, underscoring the potential significance of targeting CD47 in future therapeutic strategies. Principal investigator Dr. Ho Yeong Lim of Samsung Medical Center stated, "No dose-limiting toxicities (DLTs) were observed across all cohorts, and common adverse events associated with anti-CD47 therapy such as infusion-related reactions, haemolytic anaemia, thrombocytopenia, and neutropenia were not reported, confirming the high safety pro IMC-002." He added, "Particularly noteworthy is the absence of long-term toxicity in a patient with hepatocellular carcinoma who has been on single-agent IMC-002 treatment for 15 months, demonstrating a favourable prognosis with stable disease and a 20% reduction in tumour size." CEO Heung Tae Kim of ImmuneOncia commented, "We previously disclosed the high safety and tolerability of IMC-002, along with the recommended Phase 2 dose (RP2D) of 20 mg/kg every 3 weeks, based on interim results presented at the European Society for Medical Oncology (ESMO) in October 2023." He further stated, "With the Phase 1b trial for IMC-002 initiated last November, we anticipate additional efficacy confirmation for IMC-002 in specific solid tumours with high unmet needs." About IMC-002 IMC-002 is an immune-checkpoint-inhibitor targeting the CD47 of macrophages, blocking the 'don't eat me' signal of CD47/SIRPα interaction between cancer cells and macrophages to enhance phagocytosis of cancer cells. IMC-002 is a potential first-in-class and second-generation anti-CD47 mAb demonstrating high safety with no commonly associated adverse events (hemagglutination, thrombocytopenia, neutrophilia, etc.) due to minimal binding to normal cells such as red blood cells. About ImmuneOncia Therapeutics, Inc. ImmuneOncia is a South Korean clinical-stage biotech company focused on immuno-oncology, established in 2016. Leveraging expertise in drug development and antibody engineering, ImmuneOncia is dedicated to delivering safe, effective, and novel immunotherapies to oncology patients worldwide. Its portfolio includes a variety of immune checkpoint antibodies such as PD-L1, CD47, LAG3, Bi-specifics, and ADC/AIC.

SEOUL, South Korea--(BUSINESS WIRE)-- ImmuneOncia (CEO Heung Tae Kim) announced the results of its Phase 1a solid tumour clinical trial (IMC-002-K102 Study) of IMC-002, a CD47 monoclonal antibody, at the European Society for Medical Oncology (ESMO 2023) held in Madrid, Spain on October 23rd, 2023. The dose-escalation study aimed to assess the safety and tolerability, and to establish the recommended Phase 2 dose (RP2D) of IMC-002. From May 2022 to October 2023, a total of 12 patients were enrolled in four dose cohorts, each receiving IMC-002 at doses of 5, 10, 20, or 30 mg/kg every 2 weeks (Q2W). The clinical data showed no dose-limiting toxicities (DLT). 92% of treatment-related adverse events (TRAE) were of Grade 1-2, with 94% occurring during the first treatment cycle. Common side effects associated with anti-CD47 therapy, such as infusion-related reactions, thrombocytopenia, and neutropenia, were not reported. The recommended Phase 2 dose of 20 mg/kg every 3 weeks (Q3W) was established. 6 out of 11 evaluable patients with measurable lesions also demonstrated stable disease (SD). 5 of the patients had liver cancer, and 1 had breast cancer. Professor Ho Young Lim of Samsung Medical Center, the Principal Investigator (PI) of IMC-002, commented, "CD47 is a promising immune checkpoint inhibitor for activating the anticancer function of macrophages, but it is also expressed on normal cells, raising concerns about hemolytic anemia and thrombocytopenia. However, most of the side effects of IMC-002 were mild, and 4 out of 6 SD patients received long-term treatment for over 6 months. This clinical trial has confirmed the safety of IMC-002." Heung Tae Kim, CEO of ImmuneOncia, said, "The recommended dose of every 3 weeks (Q3W) enhances patient convenience and opens up combination treatment opportunities with immune checkpoint inhibitors such as PD-(L)1 or other cytotoxic agents. Observing disease control for over 6 months in 4 SD patients, we expect to further confirm efficacy in Phase 1b, which is set to commence in November this year. We hope to further advance towards our goal of providing patients with a best-in-class anti-CD47 therapy." IMC-002 is an anti-CD47 antibody that functions as an immune checkpoint inhibitor against macrophages, allowing them to attack cancer cells by blocking the 'don't eat me' signal between CD47 on cancer cells and SIRPα on macrophages. IMC-002 is expected to have a good safety pro minimising binding to normal cells, including red blood cells. ImmuneOncia is a biotechnology company specialising in immuno-oncology drug development. In addition to the CD47 antibody IMC-002, ImmuneOncia also has a wide range of pipeline that includes the Phase 2 clinical-stage PD-L1 antibody IMC-001, and the preclinical-stage bispecific antibody IMC-201.