Multitude Therapeutics, Inc. (China)

NEW YORK, Aug. 15, 2023 /PRNewswire/ -- OnCusp Therapeutics, a biopharmaceutical company dedicated to transforming cutting-edge preclinical innovation into clinically validated treatments for cancer patients worldwide, announced today the clearance of its Investigational New Drug (IND) Application for CUSP06 by the U.S. Food and Drug Administration (FDA). CUSP06 is a highly differentiated, global second-in-class cadherin-6 (CDH6)-directed antibody-drug conjugate (ADC) designed for the treatment of multiple solid tumors. "We are delighted to announce the IND approval for our flagship program, CUSP06, which has demonstrated excellent anti-tumor efficacy across diverse in vivo cancer models with both high and low CDH6 expression," stated Dr. Bing Yuan, Chairman and CEO of OnCusp Therapeutics. "This achievement is a testament to the dedication and expertise of our exceptional team. As our first asset to receive FDA approval for clinical trials, this marks a transformative milestone for OnCusp and reaffirms our commitment to developing game-changing treatments for cancer patients." CDH6 is overexpressed in a myriad of cancers such as ovarian, renal, uterine, thyroid, lung, and cholangiocarcinoma. CUSP06 is a highly differentiated CDH6 ADC that is thoughtfully engineered to enhance potency, amplify the "bystander effect," improve linker stability, and potentially overcome drug resistance. It has exhibited a robust safety profile and developability in IND enabling studies. The Phase 1 clinical trial will assess the safety and tolerability of escalating doses of CUSP06 to determine the maximum tolerated dose and/or recommended dose for expansion in patients with platinum-refractory/resistant ovarian cancer and other advanced solid tumors. About CUSP06 CUSP06, a CDH6-targeting ADC, is composed of a proprietary antibody with high CDH6 binding affinity, a protease-cleavable linker, and an exatecan payload (a potent and clinically validated topoisomerase-1 inhibitor). The linker is specially designed to complement the exatecan payload, enabling a highly stable and homogenous ADC. The payload is a weak substrate for BCRP/P-gp, which are drug efflux pumps that drive chemoresistance to many therapies. In preclinical data, this linker/payload has been shown to have a stronger "bystander effect" than competitor ADCs. CUSP06 has a drug-to-antibody ratio of 8. OnCusp obtained the exclusive global rights (ex-China) to lead the development and commercialization of CUSP06 from Multitude Therapeutics. WuXi XDC, a global CRDMO company dedicated to end-to-end bioconjugates services, is the CMC partner for CUSP06. About OnCusp Therapeutics OnCusp Therapeutics is a biopharmaceutical company dedicated to transforming cutting-edge preclinical innovation into clinically validated treatments for cancer patients worldwide. OnCusp was founded by a team of accomplished veterans with a proven track record in building a startup biotech to the commercialization stage, leading successful global clinical programs, and creating value in mutually beneficial partnerships. The company is committed to accelerating the advancement of globally competitive oncology assets by leveraging its deep translational and clinical development expertise. OnCusp is headquartered in New York City, with a branch office in Shanghai.  SOURCE OnCusp

DUBLIN, June 16, 2023 /PRNewswire/ -- The "Global Cancer Antibody Drug Conjugates Market Size, Drug Sales, Drug Dosage, Price, & Clinical Trials Outlook 2029" report has been added to ResearchAndMarkets.com's offering. Global Cancer Antibody Drug Conjugates Market Size, Drug Sales, Drug Dosage, Price, & Clinical Trials Outlook 2029 Report Highlights: Global Antibody Drug Conjugates Market Opportunity: > 40 Billion By 2029 Global & Regional Antibody Drug Conjugate Market Insight Approved Drugs Sales Insight Global & Regional, Yearly & Quarterly, 2019 -2023 Approved Antibody Drug Conjugates - Availability, Dosage & Price Insight Insight On Antibody Drug Conjugates In Clinical Trials: > 550 Drugs Insight On Commercially Approved Antibody Drug Conjugates: > 15 Drugs Cancer Antibody Drug Conjugates Clinical Pipeline By Company, Indication & Phase Global Cancer Antibody Drug Conjugate Market Trends by Indication The realm of cancer treatment is experiencing a surge of innovation that may greatly change how we currently diagnose as well as treat cancer. Clinical researchers and pharmaceutical companies continue to seek innovative solutions that offer enhanced efficacy and reduced side effects. Among the ongoing significant advancements, antibody drug conjugates (ADCs) have emerged as a groundbreaker in cancer therapeutics. This rapidly expanding market is transforming the treatment landscape, offering a new therapeutic option for patients globally. Antibody drug conjugates harness the synergistic potential of monoclonal antibodies and potent cytotoxic drugs, delivering a strong strike against cancer cells. By exploiting the specificity of monoclonal antibodies, antibody drug conjugates can selectively bind to cancer antigens, increasing drug delivery directly to tumor sites. This targeted approach enables higher drug concentrations at the desired location while minimizing harm to healthy, normal tissues. The antibody drug conjugate market is experiencing remarkable growth, driven by several key factors including the increasing cancer incidence rates, rowing demand for effective and personalized treatment options and advancements in antibody engineering and drug delivery technologies are propelling the market forward. Moreover, regulatory approvals have opened the way for the commercial success of antibody drug conjugates which has further encouraged investments in the field. For instance, Adcetris and Kadcyla have been in the market for a long time and their commercial sales hold a significant share of the current antibody drug conjugate market. The growth of these antibody drug conjugates represents the significant need for this therapeutic modality. Enhertu, another antibody drug conjugate which is relatively new to the market compared to Kadcyla and Adcetris, has shown immense success commercially. With its recent approval for breast cancer indication, the sales for Enhertu have escalated rapidly. Antibody drug conjugates have welcomed a new age of targeted cancer therapy and this novel class of cancer treatment can be evaluated to have an exponential increase in terms of both commercial success as well as expansion of the global portfolio. However, the development of antibody drug conjugates has been associated with significant challenges with difficulties in manufacturing, bioconjugation and their overall development. Nevertheless, collaboration between pharmaceutical companies and academic institutions has been an important factor that has helped in overcoming these limitations, resulting in such success of antibody drug conjugates. For instance, Lantern Pharma collaborating with Germany's Bielefeld University will leverage its proprietary Artificial Intelligence platform RADR for the rapid development of novel cryptophycin antibody drug conjugates, representing an exciting new class of strong and highly directed drug candidates. It is expected that outcomes from this collaborative arrangement will pave the way for next generation antibody drug conjugated designed using AI with high efficacy, swift development with sibilant cost reduction. The future of antibody drug conjugates is expected to be closely tangled with technological innovations. Novel conjugation strategies such as site specific conjugation are also being explored to enhance stability of antibody drug conjugates, resulting in improved therapeutic outcomes. Additionally, advancements in bioconjugation techniques, payload release mechanism and drug delivery systems offer opportunities to optimize the pharmacokinetics and bio distribution of antibody drug conjugates potentially increasing their effectiveness. Antibody drug conjugates have targeted a new level of efficacy, surpassing the capabilities of traditional monoclonal antibodies and opening opportunities for market expansion. While monoclonal antibodies are highly specific in their binding to cancer cell antigens, their therapeutic impact often relies on the activation of immune responses or blocking signaling pathways. In contrast, antibody drug conjugates offer a multifaceted approach by directly delivering a potent cytotoxic payload to cancer cells, exerting a direct cell killing effect. Overall, the antibody drug conjugates market represents a groundbreaking approach to cancer treatment. As market continues to expand, patients and healthcare professionals are witnessing significant advancements. With ongoing research, technological innovations and strategic collaborations, the future of antibody drug conjugates is set to transform the global cancer therapy market. This report provides a comprehensive analysis about the currently approved antibody drug conjugates in terms of their patent, price, dosage as well as their sales and treatment cost. Furthermore, the report also provides information about the regional impact of approved antibody drug conjugates while also providing information about the possible future opportunities in the global antibody drug conjugates market. Key Topics Covered: 1. Introduction to Antibody Drug Conjugates 1.1 Overview 1.2 Historical Development of ADCs 1.3 Evolution of Antibody Drug Conjugates 2. Need of Antibody Drug Conjugates 3. Global Antibody Drug Conjugate Market Insight 3.1 Current Market Scenario (2019 -2023) 3.2 Future Market Opportunity Assessment 2029 4. Antibody Drug Conjugate Market Regional Analysis 4.1 US 4.2 China 4.3 South Korea 4.4 India 4.5 Australia 4.6 Europe 4.7 Canada 4.8 Japan 4.9 Taiwan 5. Global Cancer Antibody Drug Conjugate Market Trends by Indication 5.1 Breast Cancer 5.2 Lung Cancer 5.3 Lymphoma 5.4 Leukemia 5.5 Cervical Cancer 5.6 Urothelial Cancer 5.7 Gastric Cancer 5.8 Other Cancers 6. Approved Antibody Drug Conjugates - Availability, Dosage & Price Insight 2023 6.1 Mylotarg 6.2 Adcetris 6.3 Kadcyla 6.4 Besponsa 6.5 Lumoxiti 6.6 Polivy 6.7 Padcev 6.8 Enhertu 6.9 Trodelvy 6.10 Blenrep 6.11 Zynlonta 6.12 Tivdak 6.13 Elahere 6.14 Aidixi 6.15 Ujvira 6.16 Akalux 7. Approved Antibody Drug Conjugate Sales Insights (Global & Regional, Yearly & Quarterly, 2019 -2023) 7.1 Adcetris 7.2 Padcev 7.3 Tivdak 7.4 Polivy 7.5 Kadcyla 7.6 Besponsa 7.7 Enhertu 7.8 Trodelvy 7.9 Zynlonta 7.10 Elahere 7.11 Blenrep 8. Global Antibody Drug Conjugates Clinical Trials Insight 2023 8.1 By Phase 8.2 By Indication 8.3 By Company 8.4 By Patient Segment 8.5 By Country 9. Global Cancer Antibody Drug Conjugates Clinical Pipeline By Company, Indication & Phase 9.1 Research 9.2 Preclinical 9.3 Phase-I 9.4 Phase-I/II 9.5 Phase-II 9.6 Phase-II/III 9.7 Phase-III 9.8 Preregistration 10. Marketed Cancer Antibody Drug Conjugates Clinical Insight 11. Global Cancer an Antibody Drug Conjugates Market Dynamics 11.1 Favorable Parameters 11.2 Challenges for Antibody Drug conjugates Market 12. Competitive Landscape 12.1 AbbVie 12.2 ADC Therapeutics 12.3 AstraZeneca 12.4 Bayer 12.5 BiOneCure Therapeutics 12.6 Biosion 12.7 Bio-Thera Solutions 12.8 Boehringer Ingelheim 12.9 Daiichi Sankyo Company 12.10 Duality Biologics 12.11 Exelixis 12.12 Genmab 12.13 Hangzhou DAC Biotech 12.14 Heidelberg Pharma AG 12.15 Iksuda Therapeutics 12.16 ImmunoGen 12.17 LaNova Medicines Limited 12.18 LegoChem Biosciences 12.19 Lepu Biopharma 12.20 Mersana Therapeutics 12.21 Molecular Templates 12.22 Multitude Therapeutics 12.23 NanoValent Pharmaceuticals 12.24 NewBio Therapeutics 12.25 Orum Therapeutics 12.26 ProfoundBio 12.27 Radiopharm Theranostics 12.28 Seagen 12.29 Sorrento Therapeutics 12.30 Sutro Biopharma For more information about this report visit 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. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1904 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

SHENZHEN, China I April 11, 2023 I OnCusp Therapeutics, a global biopharmaceutical company dedicated to transforming cutting-edge preclinical innovation into clinically validated treatments for cancer patients worldwide, today announced that the preclinical data on its lead program CUSP06 will be presented during the American Association for Cancer Research (AACR) Annual Meeting 2023, taking place April 14-19, 2023, in Orlando, Florida. The poster presentation will showcase data demonstrating that CUSP06, a high affinity anti-CDH6 Antibody Drug-Conjugate (ADC) with an exatecan payload (DAR8), shows potent anti-tumor activity in multiple preclinical models, demonstrates significant differentiation from a DXd-payload competitor, and is well tolerated in mice, rats and cynomolgus monkeys. POSTER PRESENTATION DETAILS Title: CUSP06/AMT-707, a new CDH6-targeting antibody-drug conjugate, demonstrates potent antitumor activity in preclinical models Session Category: Experimental and Molecular Therapeutics Session Date and Time: Wednesday Apr 19, 2023, 9:00 AM - 12:30 PM Location: Poster Section 21 Poster Board Number: 27 Published Abstract Number: 6320 The abstract is available here and the Poster will be available on the OnCusp website shortly after the presentation. "We are very excited to present data highlighting the exciting preclinical profile of CUSP06, a differentiated, potential global second-in-class CDH6 ADC, as we pivot to become a clinical stage company this year" stated Eric Slosberg, PhD, Chief Development Officer and co-founder of OnCusp Therapeutics. About CUSP06: CUSP06, a preclinical-stage CDH6 ADC, is composed of a proprietary antibody with high CDH6 binding affinity, a protease cleavable linker, and an exatecan payload (a potent and clinically validated topoisomerase-1 inhibitor). The linker is specially designed to complement the exatecan payload, generating a highly stable and homogenous ADC. The payload is a weak substrate for BCRP/Pgp. In preclinical data, this linker/payload has been shown to enable a stronger "bystander effect" than competitor ADCs. CUSP06 has a drug-to-antibody ratio of 8. OnCusp obtained the exclusive global rights (ex-China) to lead the development and commercialization of CUSP06, from Multitude Therapeutics. About OnCusp Therapeutics OnCusp Therapeutics is a global biopharmaceutical company dedicated to transforming cutting-edge preclinical innovation into clinically validated treatments for cancer patients worldwide. OnCusp was founded by a team of accomplished veterans with a proven track record in building a startup biotech to the commercialization stage, leading successful global clinical programs, and creating value in mutually beneficial partnerships. We are committed to accelerating the advancement of globally competitive oncology assets by leveraging our deep translational and clinical development expertise. OnCusp is headquartered in New York City, with a branch office in Shanghai. For more information, please visit www.oncusptx.com , or contact Andy Fu ( This email address is being protected from spambots. You need JavaScript enabled to view it. // ) SOURCE: OnCusp