GEN1160 / Genmab - LARVOL DELTA

PRO1160 for Advanced Solid and Liquid Tumors (PRO1160-001) (clinicaltrials.gov) - P1/2 | N=134 | Recruiting | Sponsor: ProfoundBio US Co. | Trial completion date: Apr 2025 ➔ Mar 2027 | Trial primary completion date: Apr 2024 ➔ Nov 2026

Metastases • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Head and Neck Cancer • Hematological Malignancies • Lymphoma • Nasopharyngeal Carcinoma • Non-Hodgkin’s Lymphoma • Oncology • Renal Cell Carcinoma • Solid Tumor

Phase 1/2 study of PRO1160, a CD70-directed antibody-drug conjugate, in patients with advanced solid tumors and hematologic malignancies (SITC 2023) - P1/2 | "PK, immunogenicity, and antitumor activity will also be evaluated. The study is currently enrolling at sites in the US, with future enrollment in China planned."

Clinical • Metastases • P1/2 data • Genito-urinary Cancer • Hematological Malignancies • Lymphoma • Nasopharyngeal Carcinoma • Non-Hodgkin’s Lymphoma • Oncology • Renal Cell Carcinoma • Solid Tumor • CD70

ProfoundBio Presents Promising Data on ADC Programs, Including Early Clinical Results of Rinatabart Sesutecan in Ovarian and Endometrial Cancers, at SITC 2023 (Businesswire) - "ProfoundBio...announced multiple data presentations at the Society for Immunotherapy of Cancer’s 38th Annual Meeting (SITC 2023)....LD343 ADCs demonstrated antitumor activity in multiple tumor types, with higher in vivo potency than vedotin even at double the amount of dosed payload. LD343 enabled enhanced delivery of payload to tumor tissue and reduced exposure of payload in circulation....Enhanced preclinical antitumor activity and tolerability are believed to be attributed to PRO1107’s increased hydrophilicity and improved physicochemical properties, augmented delivery of payload to the tumor, less systemic exposure of free payload, and a robust bystander antitumor effect....The trial-in-progress poster presentation for the anti-CD70 sesutecan ADC, PRO1160, describes the currently recruiting PRO1160-001 Phase 1/2 study (NCT05721222) in patients with solid and liquid tumors."

Preclinical • Trial status • Solid Tumor

PRO1160 for Advanced Solid and Liquid Tumors (PRO1160-001) (clinicaltrials.gov) - P1/2 | N=134 | Recruiting | Sponsor: ProfoundBio US Co. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Genito-urinary Cancer • Hematological Malignancies • Lymphoma • Nasopharyngeal Carcinoma • Non-Hodgkin’s Lymphoma • Oncology • Renal Cell Carcinoma • Solid Tumor

ProfoundBio Announces Upcoming Scientific Presentations at SITC 2023 (PRNewswire) - "ProfoundBio...announced four upcoming poster presentations on its ADC platform and lead clinical assets, rinatabart sesutecan (Rina-S) and PRO1160, at the Society for Immunotherapy of Cancer 38th Annual Meeting (SITC 2023), to be held at the San Diego Convention Center and virtually November 1-5, 2023."

Clinical data • P1/2 data • Preclinical • Hematological Malignancies • Oncology • Solid Tumor

"Also by @EJonasch : Phae 1/2 study of PRO1160 a CD70-directed ADC which we will be opening @ClevelandClinic" (@MosheOrnsteinMD)

CD70

Phase 1/2 study of PRO1160, a CD70-directed antibody-drug conjugate, in patients with advanced solid tumors and hematologic malignancies (KCRS 2023) - "This study consists of 2 parts, Part A: dose-escalation and dose-level expansion, and Part B: 3 tumor-specific expansion cohorts (metastatic RCC, metastatic or relapsed NPC, or advanced relapsed/refractory NHL) treated at the RP2D. PK, immunogenicity, and antitumor activity will also be evaluated."

Clinical • Metastases • P1/2 data • Hematological Disorders • Hematological Malignancies • Oncology • Solid Tumor • CD70

ProfoundBio Announces Further Advancement of Lead Programs - PRO1184 (Rinatabart Sesutecan) and PRO1160 in the Clinic (PRNewswire) - "ProfoundBio, a clinical-stage biotechnology company focused on the development of novel antibody-based therapeutics, announced that dosing in the Phase 1/2 first-in-human trial of PRO1160 (NCT05721222) has initiated in the US, and the company received approval from National Medical Products Administration (NMPA) to initiate the PRO1160 trial in China. The company also received NMPA approval to initiate the Rina-S Phase 1/2 first-in-human trial in China."

Trial status • Breast Cancer • Endometrial Cancer • Fallopian Tube Cancer • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Hematological Malignancies • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Kidney Cancer • Lung Cancer • Lymphoma • Mesothelioma • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Ovarian Cancer • Peritoneal Cancer • Renal Cell Carcinoma • Solid Tumor • Triple Negative Breast Cancer

PRO1160 for Advance Solid and Liquid Tumors (PRO1160-001) (clinicaltrials.gov) - P1/2 | N=134 | Not yet recruiting | Sponsor: ProfoundBio US Co.

New P1/2 trial • Genito-urinary Cancer • Hematological Malignancies • Lymphoma • Nasopharyngeal Carcinoma • Non-Hodgkin’s Lymphoma • Oncology • Renal Cell Carcinoma • Solid Tumor

ProfoundBio Announces Initiation of First-in-Human Trial for PRO1184, a Folate Receptor Alpha-Directed ADC with a Topoisomerase 1 Inhibitor Payload, and Receives FDA “Study May Proceed“ Letter for PRO1160, a CD70-Directed ADC (PRNewswire) - "ProfoundBio...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....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....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....'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.'"

FDA event • Trial status • Breast Cancer • Endometrial Cancer • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Hematological Malignancies • Kidney Cancer • Lung Cancer • Lymphoma • Mesothelioma • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Uterine Cancer

"PRO1160https://www.adcreview.com/drugmap/pro1160-an-adc-directed-to-cd70/" (@OncoZine)

Review • CD70

ProfoundBio Announces Completion of $70 Million Series A+ Financing to Advance Antibody-Drug Conjugate (ADC) Programs into the Clinic (PRNewswire-Asia) - "ProfoundBio...announced the closing of a $70 million Series A+ financing round led by Sequoia China. Current investors Lilly Asia Venture, Oriza, Chang'an Capital, LYFE Capital, and K2VC also participated in this round of financing. ProfoundBio has raised a total of more than $138 million in the past two years....ProfoundBio will use the proceeds to advance PRO1184 and PRO1160 into Phase 1 clinical trials. PRO1184 is a folate receptor alpha (FRα)-directed ADC for potential treatment of multiple solid tumors and PRO1160 is a CD70-directed ADC for both hematological and solid tumor indications."

Financing • Hematological Malignancies • Oncology • Solid Tumor

PRO1160, a novel CD70-directed antibody-drug conjugate, demonstrates robust anti-tumor activity in mouse models of renal cell carcinoma and non-Hodgkin lymphoma (AACR 2022) - "PRO1160 has the potential for an expanded therapeutic index. PRO1160 is being developed for the potential treatment of patients with CD70-expressing hematologic and solid tumor cancers."

Preclinical • Genito-urinary Cancer • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Renal Cell Carcinoma • Solid Tumor • CD70

ProfoundBio to Highlight Programs and Technology at AACR 2022 Annual Meeting; Welcomes Zhu Chen, PhD, as Chief Scientific Officer (PRNewswire) - "ProfoundBio announced that preclinical data from its pipeline of novel, proprietary antibody-drug conjugates (ADCs) and technology will be presented at the American Association for Cancer Research (AACR) Annual Meeting being held April 8 - 13, 2022. The presentations will highlight three late-stage preclinical programs utilizing ProfoundBio's leading ADC technology as well as advances in linker-drug development."

Preclinical • Genito-urinary Cancer • Hematological Malignancies • Kidney Cancer • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Renal Cell Carcinoma • Solid Tumor • Urothelial Cancer