ADCendo ApS

The Dutch biotech Synaffix has long been one of the top partners for biopharma companies working in antibody-drug conjugates. Now the company is spinning out a pipeline of drugs into a new company. Kivu Bioscience launched Monday with $92 million and a pipeline of three of Synaffix’s ADCs. In the race to create next-gen ADCs, Kivu said it hopes to make Topo1i-based medicines that are more durable, can be dosed higher and have less toxic impact on healthy parts of the body. The startup said it anticipates entering human trials with its first solid tumor ADC, codenamed KIVU-107, next year. A major investor is Novo Holdings. Daniel O’Connell, a Novo Holdings venture partner and Kivu board member, said the pitch was originally about manufacturing drugs, not carrying a pipeline. “The original pitch on hearing it was ‘OK, that’s a pretty interesting manufacturing play,'” O’Connell told Endpoints News . But as it investigated, Novo came to believe that the manufacturing benefit “really probably translates to a clinical benefit,” O’Connell said. “You have a cleaner, more stable product that’s going to ultimately deliver target payload right to the tumor without the indiscriminate loss of payload, which in other words is just naked chemo,” he said. Kivu’s president and operating chief Mohit Trikha is quite familiar with the busy ADC field. Trikha recalls first working on ADCs while at Centocor around the turn of the century. He worked on them again and again at later stops at Triphase Accelerator, Genentech and then AbbVie, where he led early development in the pharma’s oncology unit. The first generation of ADCs were potent but too toxic, Trikha said. Kivu hopes to overcome that by attaching the payload to the right spot on the antibody. It’s all about “location, location, location,” Trikha said. “This site-specific conjugation gives you very good stability,” the Kivu president said. Some of the previous conjugation technologies, he said, can be unstable and fall apart. It believes its linker technology will help the antibody hit fewer non-tumor cells than other ADCs. Trikha, who can speak somewhat philosophically, said that years ago he read Siddhartha Mukherjee ‘s book “The Emperor of All Maladies,” which chronicles the broad history of cancer. “You need guts to get in and you need guts to get out,” Trikha said. “This is a tough disease and most of our approaches have not panned out. We’ve had huge transformative gains in some cancers, but other cancers still remain a big unmet medical need.” The biotech — named after a Synaffix executive’s favorite lake on the border of the Democratic Republic of the Congo and Rwanda — has two additional preclinical ADCs for solid tumors. And oncology might not be the only malady that Kivu tackles. The biotech’s pipeline might eventually expand into autoimmune diseases, O’Connell said, though that is likely far in the future. “Within oncology, we’re going after targets that people have heard of,” O’Connell said. “We’re not going after targets with huge numbers of competitors, but we’re not interested in exploring novel biology.” He said the company could take a similar approach in autoimmune, “in a way that would deliver payloads that might have broader systemic issues if delivered as naked molecules.” Novo has been bullish on the ADC field, investing in other startups like Adcendo and Myricx Bio . Joining Novo in Kivu’s Series A were Gimv, Red Tree Venture Capital, HealthCap, BioGeneration Ventures, Merck KGaA’s M Ventures and Brabantse Ontwikkelings Maatschappij.

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