MRC2

COPENHAGEN, Denmark I October 8, 2024 I Adcendo, a biotech company focused on the development of first-in-class ADCs for the treatment of cancers with a high unmet medical need, today announced that the US Food & Drug Administration (FDA) has provided clearance of the IND application for the Phase I/II study of ADCE-D01 in patients with metastatic and/or unresectable STS (the ADCElerate-01 Trial). ADCElerate-01 is a first-in-human Phase I/II multicenter, open-label, dose escalation and expansion study of ADCE-D01 as a monotherapy in patients with metastatic and/or unresectable STS. The primary objective of the study is to evaluate the safety and tolerability of ADCE-D01, to determine the maximum tolerated dose, as well as the recommended Phase II dose and schedule of ADCE-D01 monotherapy. The secondary objectives are to characterize the pharmacokinetics and to evaluate the preliminary efficacy of ADCE-D01. The study will recruit in the US and Europe, with a CTIS submission planned in the EU during the coming months. Dr. Lone Ottesen, Chief Medical Officer of Adcendo, said: “uPARAP is a highly attractive target for the development of an ADC in mesenchymal cancers including soft tissue sarcoma, as it is highly overexpressed in multiple STS subtypes, has unique internalization properties and shows only very low expression in healthy tissues. The IND clearance of ADCE-D01 is an important milestone for our program and our company, and we look forward to initiating patient enrolment for this study and working with our investigators to evaluate the therapeutic utility of this drug in STS patients as soon as possible.” Prof. Patrick Schöffski, Head of the Department of General Medical Oncology at the University Hospitals and the Laboratory of Experimental Oncology at the Catholic University in Leuven (KU Leuven), and Principal investigator of the ADCElerate-01 trial, commented: “Patients with metastatic soft tissue sarcoma have very limited treatment options and an extremely poor prognosis. We are intrigued by the biology and expression profile of uPARAP, as well as the extensive pre-clinical data package generated for ADCE-D01. ADCs have already significantly altered the therapeutic landscape for many solid tumor indications, and we are excited to be working with Adcendo to develop a potential pan-sarcoma ADC for our STS patients.” About ADCE-D01: ADCE-D01 is an antibody-drug conjugate targeting the uPARAP receptor. uPARAP is a recycling endocytic receptor involved in collagen homeostasis and turnover. uPARAP exhibits a limited expression profile in healthy tissues but is highly upregulated in multiple mesenchymal cancers, including soft tissue sarcoma, bone sarcoma, GIST as well as mesothelioma and glioblastoma, making it a highly attractive target for ADC development. About Adcendo ApS: Adcendo ApS is developing breakthrough antibody-drug conjugates for the treatment of underserved cancers. In 2024, the company completed a Series A extension financing round, increasing the total funds raised to 98M EUR to advance, broaden, and accelerate the development of its first-in-class ADC pipeline assets. Investors include Novo Holdings, Ysios Capital, Pontifax Venture Capital, RA Capital Management, HealthCap, Gilde Healthcare and Dawn Biopharma, a platform controlled by KKR. For further information, please visit www.adcendo.com . SOURCE: Adcendo

ADCE-D01 is a first-in-class antibody-drug conjugate (ADC) targeting uPARAP, an endocytic receptor which is highly overexpressed in mesenchymal cancers including multiple STS subtypes The Phase I/II ADCElerate-01 trial is designed to evaluate the safety, pharmacokinetics, and preliminary efficacy of ADCE-D01 as a monotherapy in patients with metastatic and/or unresectable STS COPENHAGEN, Denmark, Oct. 8, 2024 /PRNewswire/ -- Adcendo, a biotech company focused on the development of first-in-class ADCs for the treatment of cancers with a high unmet medical need, today announced that the US Food & Drug Administration (FDA) has provided clearance of the IND application for the Phase I/II study of ADCE-D01 in patients with metastatic and/or unresectable STS (the ADCElerate-01 Trial). ADCElerate-01 is a first-in-human Phase I/II multicenter, open-label, dose escalation and expansion study of ADCE-D01 as a monotherapy in patients with metastatic and/or unresectable STS. The primary objective of the study is to evaluate the safety and tolerability of ADCE-D01, to determine the maximum tolerated dose, as well as the recommended Phase II dose and schedule of ADCE-D01 monotherapy. The secondary objectives are to characterize the pharmacokinetics and to evaluate the preliminary efficacy of ADCE-D01. The study will recruit in the US and Europe, with a CTIS submission planned in the EU during the coming months. Dr. Lone Ottesen, Chief Medical Officer of Adcendo, said: "uPARAP is a highly attractive target for the development of an ADC in mesenchymal cancers including soft tissue sarcoma, as it is highly overexpressed in multiple STS subtypes, has unique internalization properties and shows only very low expression in healthy tissues. The IND clearance of ADCE-D01 is an important milestone for our program and our company, and we look forward to initiating patient enrolment for this study and working with our investigators to evaluate the therapeutic utility of this drug in STS patients as soon as possible." Prof. Patrick Schöffski, Head of the Department of General Medical Oncology at the University Hospitals and the Laboratory of Experimental Oncology at the Catholic University in Leuven (KU Leuven), and Principal investigator of the ADCElerate-01 trial, commented: "Patients with metastatic soft tissue sarcoma have very limited treatment options and an extremely poor prognosis. We are intrigued by the biology and expression profile of uPARAP, as well as the extensive pre-clinical data package generated for ADCE-D01. ADCs have already significantly altered the therapeutic landscape for many solid tumor indications, and we are excited to be working with Adcendo to develop a potential pan-sarcoma ADC for our STS patients." About ADCE-D01: ADCE-D01 is an antibody-drug conjugate targeting the uPARAP receptor. uPARAP is a recycling endocytic receptor involved in collagen homeostasis and turnover. uPARAP exhibits a limited expression profile in healthy tissues but is highly upregulated in multiple mesenchymal cancers, including soft tissue sarcoma, bone sarcoma, GIST as well as mesothelioma and glioblastoma, making it a highly attractive target for ADC development. About Adcendo ApS: Adcendo ApS is developing breakthrough antibody-drug conjugates for the treatment of underserved cancers. In 2024, the company completed a Series A extension financing round, increasing the total funds raised to 98M EUR to advance, broaden, and accelerate the development of its first-in-class ADC pipeline assets. Investors include Novo Holdings, Ysios Capital, Pontifax Venture Capital, RA Capital Management, HealthCap, Gilde Healthcare and Dawn Biopharma, a platform controlled by KKR. For further information, please visit . SOURCE Adcendo WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Adcendo is expanding its antibody-drug conjugate (ADC) pipeline with the addition of a tissue factor (TF)-targeting asset from Multitude Therapeutics under a deal potentially worth north of $1 billion. The licensing agreement, announced Tuesday, moves Adcendo closer to becoming a clinical-stage biotech, with a Phase I study of the ADC, dubbed ADCE-T02, expected to start this year.“TF is an excellent ADC target with ample opportunity in high unmet need indications,” remarked Adcendo CEO Michael Pehl, adding that ADCE-T02 “perfectly complements our existing unique first-in-class ADC pipeline,” led by its preclinical uPARAP programme in soft-tissue sarcoma and other mesenchymal cancers.Adcendo noted that TF, which has been clinically validated as a target, is highly expressed in indications such as non-small-cell lung, colorectal, cervical, oesophageal, head-and-neck, bladder and certain gastrointestinal cancers, but its expression is limited in normal tissues. Meanwhile, ADCE-T02 features a topoisomerase I inhibitor-based linker/payload, with Adcendo suggesting that its design minimises the impact on the coagulation pathway.Additionally, the T1000-exatecan linker-payload technology platform has been shown to amplify the bystander effect, improve linker stability and could potentially overcome resistance mechanisms, according to the company. An early-stage trial is set to start in Australia next quarter, with a request to begin studies in the US expected in the near future.As part of the deal, Adcendo will obtain exclusive development and commercialisation rights for ADCE-T02 globally, except for the Greater China region, where Multitude will retain rights. Multitude will receive an undisclosed upfront payment, along with milestones and single-digit to low-double-digit tiered sales royalties.Earlier this year, Adcendo added €16 million to its series A financing, bringing the total of the round to €98 million. An initial €51 million was raised in 2021, with €31 million tacked on last year.