Cusatuzumab

- OncoVerity licenses Cusatuzumab, a first-in-class anti-CD70 antibody, from argenx - Max Colao, MBA appointed as Chief Executive Officer and Dr. Clay Smith as Chief Medical Officer - OncoVerity closes $30M Series A financing AURORA, CO, USA I March 27, 2023 I OncoVerity, a pioneer in applying advanced multiomic, data driven patient stratification to the development of human therapeutics in oncology, has secured worldwide licensing rights to cusatuzumab from argenx and received $30M in funding from argenx and a joint venture of UCHealth and University License Equity Holdings, Inc. on the University of Colorado Anschutz Medical Campus for its continued development. Cusatuzumab is a first-in-class anti-CD70 antibody that has generated promising results in early acute myeloid leukemia (AML) human studies. OncoVerity will optimize cusatuzumab’s continued development in AML and explore its application in other cancers. OncoVerity is also announcing the appointment of Max Colao, MBA as Chief Executive Officer, and Dr. Clay Smith as Chief Medical Officer. "We are thrilled to welcome Max and Clay to the OncoVerity leadership team. Together with Max’s extensive commercial leadership experience and Clay’s proven track record in research and development, we are confident that will drive growth and expansion as we enter the next phase of development,” said Arjen Lemmen, Vice President, Corporate Development and Strategy at argenx, and OncoVerity Board Member. Mr. Colao has over 30 years of biotechnology leadership experience. In his most recent position, he served as the Chief Commercial Officer of Aurinia, where he built out the commercial team through launch. Prior to that, Mr. Colao held senior roles of increasing responsibility at Alexion, where he led the US commercial operations and built out the new business units in launching several rare disease therapies. He also spent over 20 years at Amgen, where he launched multiple therapies in the areas of hematology, oncology, and autoimmune disorders supporting Amgen’s growth from small to large biotech. Dr. Smith joins OncoVerity with more than 30 years of experience in oncology research, clinical care and clinical trials. He was previously Professor and Associate Chief of the Hematology Division at the University of Colorado. He was also the Director at UCHealth Blood Disorders and Cell Therapies Center. With the support of the University of Colorado Anschutz Medical Campus and UCHealth, Dr. Smith and his team pioneered the clinical and single cell multiomics infrastructure necessary to support, de-risk, and accelerate the development of this innovative therapy. Throughout his career, Dr. Smith has published over 150 scientific articles. “I am excited to lead OncoVerity to its next phase of development and believe that the licensing of cusatuzumab and new funding demonstrate our commitment to advance novel cancer therapies in areas of high unmet need,” said Max Colao. “OncoVerity’s differentiated approach and talented team put us in a strong position to answer unresolved disease and therapeutic questions in oncology. I’m grateful for the contributions of the University of Colorado and argenx in establishing OncoVerity and look forward to making significant progress on behalf of cancer patients around the world.” “OncoVerity is an example of a unique partnership that bridges the best in research, healthcare delivery, and the use of advanced multiomic data science-driven drug development to bring cutting edge treatments to patients in the areas of greatest unmet medical need,” said Kimberly Muller, Executive Director, CU Innovations, Anschutz Medical Campus, General Partner, CU Healthcare Innovation Fund, and Board Member of OncoVerity. "This is a very exciting time to be joining OncoVerity as we start this journey to advance cancer research and develop targeted therapies that can make a real difference in the lives of patients," said Dr. Clay Smith. "I am particularly enthusiastic about the potential for our work on cusatuzumab for the treatment of AML, a disease where despite many advances in the treatment paradigm there remains a significant opportunity to develop effective therapies that meaningfully prolong survival.” About Cusatuzumab Cusatuzumab is a monoclonal antibody targeting CD70, an immune checkpoint target involved in hematological malignancies, several solid tumors and severe autoimmune diseases. Cusatuzumab is designed to: block CD70, kill cancer cells expressing CD70 through complement dependent cytotoxicity, enhanced antibody-dependent cell-mediated phagocytosis and enhanced antibody-dependent cell-mediated cytotoxicity, and restore immune surveillance against solid tumors (Silence K. et al. mAbs 2014; 6 (2):523-532) . Cusatuzumab is currently being evaluated in patients with hematologic malignancies, including a Phase 2 trial in combination with azacitidine and a Phase 1b trial in combination with azacitidine and venetoclax in patients with newly diagnosed AML. About Acute Myeloid Leukemia Despite the advancements in medical research, there is still a significant lack of effective therapies to treat Acute Myeloid Leukemia (AML). The five-year survival rate for AML patients remains the lowest of all blood malignancies (5-20%), and relapse is common. AML is a heterogeneous disease, which means that it can differ in its genetic and molecular characteristics from one patient to another. This makes it difficult to develop effective treatments that can target all types of AML. Innovative therapies and targeted treatment approaches that can improve the survival rates, reduce toxicity, and target specific subtypes of AML are urgently needed to address this unmet need. About OncoVerity OncoVerity is pioneering the use of a unique clinical and single cell multiomics database to better the lives of patients battling cancer. OncoVerity’s approach leverages the University of Colorado Anschutz Medical Campus and UCHealth infrastructure of single cell analysis capabilities for multiple types of -omic technologies including genomics, transcriptomics, and proteomics, alongside one of the most comprehensive and highly curated AML patient databases to gain insights to tumor characteristics and therapeutic response Cusatuzumab is expected to be the first of many novel therapeutics that will benefit from the OncoVerity platform and differentiated approach to oncology drug development. In collaboration with world-renowned hematologists specializing in acute myeloid leukemia (AML), OncoVerity aims to develop cusatuzumab by truly understanding and acting upon the heterogeneous characteristics of AML. SOURCE: OncoVerity

PRO1184 first-in human study initiated and first patients dosed PRO1160 first-in-human study cleared for initiation in the US Both PRO1184 and PRO1160 are based on a novel, proprietary, and internally developed linker-drug technology platform SUZHOU, China and WOODINVILLE, Wash., Jan. 3, 2023 /PRNewswire/ -- ProfoundBio, a clinical-stage biotechnology company focused on the development of novel antibody-based therapeutics, announced that 1) dosing has initiated in the Phase 1 first-in-human clinical trial of PRO1184 (NCT05579366), and 2) the company received clearance from the U.S. Food and Drug Administration (FDA) to initiate the Phase 1 clinical trial evaluating PRO1160. PRO1184 PRO1184 is an ADC comprising a folate receptor alpha-directed antibody conjugated to the exatecan payload with ProfoundBio's novel, proprietary hydrophilic linker. The Phase 1 study will evaluate the safety, activity, and pharmacokinetics of PRO1184 in patients with ovarian, endometrial, breast, non-small cell lung cancers and mesothelioma. This first-in-human study is actively enrolling with multiple clinical trial sites across the United States. PRO1160 PRO1160 is an antibody-drug conjugate (ADC) comprising a CD70-directed antibody conjugated to the exatecan payload with ProfoundBio's novel, proprietary hydrophilic linker. The Phase 1 study will evaluate the safety, activity, and pharmacokinetics of PRO1160 in patients with metastatic renal cell carcinoma, metastatic or relapsed nasopharyngeal carcinoma, or advanced non-Hodgkin lymphoma. In preclinical studies, PRO1160 demonstrated the potential to be a best-in-class ADC therapeutic with a wide therapeutic window. "We are taking a major step forward with our next generation ADCs." said Naomi Hunder, MD, CMO of ProfoundBio. "Our preclinical data support the potential for improved safety and activity over prior programs targeting folate receptor alpha and CD70, based on our novel hydrophilic linker and exatecan payload. We are excited to bring these advancements to the clinic, where we hope to help a broader patient population due to a potentially wider therapeutic window and ability to target antigens with low-moderate or heterogeneous tumor expression." "With two clinical-stage programs, ProfoundBio is poised to validate our novel, proprietary, and internally developed ADC technology platform in the clinic and to bring a series of ADCs with best- and/or first-in-class potential to patients with unmet medical need." said Baiteng Zhao, PhD, Co-founder, Chief Executive Officer, and Chair of the Board of ProfoundBio. "We conclude 2022 with several significant accomplishments including the FDA clearance of two INDs and a Series A+ funding round. I am very excited about the momentum and look forward to continued progress of our lead programs in the clinic as well as advancing more pipeline assets through preclinical development and making further breakthroughs in ADC technologies in 2023." About ProfoundBio ProfoundBio is a clinical-stage biotechnology company focused on the development of novel antibody-based therapeutics with curative potential for patients with cancer. Built on internally developed, innovative, and proprietary technology platforms, ProfoundBio has developed a pipeline consisting of multiple drug candidates targeting solid tumors and hematological malignancies that are in discovery, preclinical, and clinical development stages. ProfoundBio has operations in both the greater Seattle area, WA, USA and Suzhou, China. For more information, please visit .