CUSP06 / OnCusp, Multitude Therap - LARVOL DELTA

Sarah Cannon Research Institute to Showcase Cancer Insights at 2025 ASCO Annual Meeting (Businesswire) - "Today, Sarah Cannon Research Institute (SCRI), one of the world’s leading oncology research organizations conducting community-based clinical trials, announced that it will showcase its latest research highlights through more than 155 accepted abstracts and presentations at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, held in Chicago from May 30-June 3, 2025. Over 75 investigators from more than 20 research sites in SCRI’s network are first authors and co-authors on the clinical trial updates featured at the Annual Meeting, including findings from 55 early-phase clinical trials."

Clinical data • Platinum resistant • Biliary Tract Cancer • Colorectal Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Negative Breast Cancer • Non Small Cell Lung Cancer • Ovarian Cancer • Solid Tumor

First-in-human (FIH) phase 1 study of CUSP06, a cadherin-6 (CDH6)-directed antibody-drug conjugate (ADC), in patients with platinum-refractory/resistant ovarian cancer and other advanced solid tumors. (ASCO 2025) - P1 | "Of the 18 pts with OC, all pts received prior platinum and taxane, 67% received bevacizumab, and 22% received mirvetuximab (MIRV)... The preliminary data from the Phase 1a dose escalation portion of this study showed acceptable tolerability and encouraging efficacy in pts with OC, which support further evaluation of CUSP06 in the Phase 1b expansion cohorts. NCT06234423"

Clinical • IO biomarker • Metastases • P1 data • Anemia • Biliary Cancer • Cholangiocarcinoma • Fatigue • Genito-urinary Cancer • Neutropenia • Oncology • Ovarian Cancer • Refractory Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • Thrombocytopenia • Uterine Cancer • CDH6 • MUC16

OnCusp Therapeutics Announces Encouraging Initial Phase 1a Results from Ongoing First-in-Human Study Evaluating its CDH6-Directed Antibody-Drug Conjugate, CUSP06, in Platinum-Refractory/Resistant Ovarian Cancer and Other Advanced Solid Tumors at the 2025 ASCO Annual Meeting (The Manila Times) - P1 | N=180 | NCT06234423 | Sponsor: OnCusp Therapeutics, Inc. | "As of May 13, 2025, data are available for 37 patients who have received CUSP06 once every three weeks (Q3W) at doses ranging from 1.6 to 5.6 mg/kg. These patients were heavily pretreated, with a median of 4 prior lines of therapy. Promising efficacy was observed in patients with heavily pretreated platinum-resistant HGSOC without CDH6 pre-selection. The overall response rate (ORR) was 36% in HGSOC (9/25; 5 confirmed (including 2 responders who had previously received mirvetuximab treatment) and 4 unconfirmed partial responses (PRs)). All patients with unconfirmed PRs remain on treatment. The ORR reached 50% at both 4.0 mg/kg + prophylactic granulocyte colony-stimulating factor (G-CSF) and 4.4 mg/kg + G-CSF cohorts (3/6 and 1/2 patients, respectively); all responders remain on treatment. The clinical benefit rate (CBR) was 92% (23/25)."

P1 data • Platinum resistant • Ovarian Cancer

OnCusp Therapeutics Receives FDA Fast Track Designation for CUSP06 for the Treatment of Platinum-Resistant Ovarian Cancer (PRNewswire) - "OnCusp Therapeutics, Inc...today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to CUSP06...for the treatment of patients with platinum-resistant ovarian cancer (PROC)....The early results from our Phase 1 trial have been encouraging, and this designation will expedite our efforts to bring this potentially transformative therapy to patients."

Fast track • Ovarian Cancer

A phase 1, first-in-human study of CUSP06, a cadherin-6 (CDH6) -directed antibody-drug conjugate, in patients with platinum-refractory/resistant ovarian cancer and other advanced solid tumors. (ASCO 2024) - P1 | "Mandatory pre- and on-study biopsies in dose expansion cohorts will support a robust exploratory biomarker plan that may include correlation of CDH6 levels with response, and other RNA and protein markers of sensitivity and resistance. The study is currently enrolling in Phase 1a dose-escalation."

Clinical • Metastases • P1 data • Biliary Cancer • Brain Cancer • Cholangiocarcinoma • CNS Tumor • Endocrine Cancer • Endometrial Serous Adenocarcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Glioma • Hepatocellular Cancer • Hepatology • Liver Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Refractory Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • Thyroid Gland Carcinoma • Thyroid Gland Papillary Carcinoma • Uterine Cancer • CDH6

OnCusp Therapeutics Announces First Patient Dosed in Phase 1 Trial of CUSP06 in Patients with Platinum-Refractory/Resistant Ovarian Cancer and Other Advanced Solid Tumors (PRNewswire) - "'Ovarian cancer is the third most common and the most lethal gynecologic cancer worldwide,' said Alexander Spira...'There is significant unmet medical need in the treatment landscape, especially in the platinum-resistant setting. We are excited to participate in this clinical trial and evaluate the potential of CUSP06 in treating ovarian cancer and other advanced solid tumors.'"

Media quote

OnCusp Therapeutics Announces First Patient Dosed in Phase 1 Trial of CUSP06 in Patients with Platinum-Refractory/Resistant Ovarian Cancer and Other Advanced Solid Tumors (PRNewswire) - "OnCusp Therapeutics, Inc...today announced that the first patient has been dosed in the Phase 1 study evaluating CUSP06 for the treatment of platinum-refractory/resistant ovarian cancer and other advanced solid tumors....The Phase 1 multicenter study will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of CUSP06 in adults with platinum-refractory/resistant ovarian cancer and other advanced solid tumors."

Trial status • Oncology • Ovarian Cancer • Solid Tumor

A Study of CUSP06 in Patients With Platinum-Refractory/Resistant Ovarian Cancer and Other Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=180 | Recruiting | Sponsor: OnCusp Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Ovarian Cancer • Refractory Ovarian Cancer • Solid Tumor

A Study of CUSP06 in Patients With Platinum-Refractory/Resistant Ovarian Cancer and Other Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=180 | Not yet recruiting | Sponsor: OnCusp Therapeutics, Inc.

New P1 trial • Oncology • Ovarian Cancer • Refractory Ovarian Cancer • Solid Tumor

OnCusp Therapeutics Raises Oversubscribed $100 Million Series A Financing to Advance Portfolio of Assets for Cancer Patients (PRNewswire) - "The proceeds from this financing will be used to advance CUSP06, an ADC targeting CDH6, toward clinical proof-of-concept."

Financing • Oncology

OnCusp Therapeutics Receives FDA Clearance for the Phase 1 Clinical Trial of CUSP06, Targeting Ovarian Cancer and Other Advanced Solid Tumors (PRNewswire) - "OnCusp Therapeutics... 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....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."

IND • New P1 trial • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor

CUSP06/AMT-707, a new CDH6-targeting antibody-drug conjugate, demonstrates potent antitumor activity in preclinical models (AACR 2023) - "CUSP06 showed an expected toxicity profile consistent with it's exatecan payload in the ongoing pilot toxicology studies. We plan to initiate a Phase 1 first-in-human clinical trial in the 2nd half of 2023."

Preclinical • Biliary Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Kidney Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • Thyroid Gland Carcinoma

OnCusp Therapeutics Showcases Potent Anti-Tumor Activity of its CDH6 ADC at AACR Annual Meeting 2023 (PRNewswire) - "OnCusp Therapeutics...announced that the preclinical data on its lead program CUSP06 will be presented during the American Association for Cancer Research (AACR) Annual Meeting 2023....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."

Preclinical • Oncology

OnCusp Therapeutics and Multitude Therapeutics Enter into an Ex-China Licensing Agreement for a Potentially Highly Differentiated CDH6-Targeting Antibody Drug Conjugate (PRNewswire) - "OnCusp Therapeutics announced today a licensing agreement with Multitude Therapeutics for the development and commercialization of AMT-707 (now referred to as CUSP06), a potentially highly differentiated second-in-class CDH6 antibody drug conjugate ('ADC'). Under the agreement, OnCusp obtains the exclusive global rights to lead development and commercialization of CUSP06 worldwide outside of Greater China. Multitude will receive an upfront payment as well as development, regulatory and sales milestone payments, and tiered royalties....CUSP06 is currently in Investigational New Drug ('IND') enabling studies. OnCusp and Multitude have engaged WuXi XDC, a global CRDMO company dedicated to end-to-end bioconjugates services, as the CMC partner for CUSP06."

Licensing / partnership • Oncology