GEN1107 / Genmab - LARVOL DELTA

Genmab discards clinical ADC picked up in last year's $1.8B ProfoundBio buy (FierceBiotech) - "The discarded candidate, dubbed GEN1107, is a protein tyrosine K 7 (PTK7)-targeted ADC that was being studied in a phase 1/2 cancer trial....The trial stopped Aug. 18 of this year after launching in January 2024, according to ClinicalTrials.gov."

Discontinued • Trial termination • Endometrial Cancer • Gastroesophageal Cancer • Non Small Cell Lung Cancer • Ovarian Cancer • Triple Negative Breast Cancer • Urothelial Cancer

PRO1107 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=33 | Terminated | Sponsor: Genmab | Trial completion date: Jun 2028 ➔ Aug 2025 | Active, not recruiting ➔ Terminated | Trial primary completion date: Jun 2028 ➔ Aug 2025; Genmab has decided to discontinue the clinical development of GEN1107 as the overall benefit-risk profile no longer supports continuation

Trial completion date • Trial primary completion date • Trial termination • Breast Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer • Urothelial Cancer

PRO1107 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=42 | Active, not recruiting | Sponsor: Genmab | Recruiting ➔ Active, not recruiting | N=280 ➔ 42

Enrollment change • Enrollment closed • Breast Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer • Urothelial Cancer

PRO1107 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=280 | Recruiting | Sponsor: Genmab | N=214 ➔ 280 | Trial completion date: Feb 2027 ➔ Jun 2028 | Trial primary completion date: Feb 2027 ➔ Jun 2028

Enrollment change • Trial completion date • Trial primary completion date • Breast Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer • Urothelial Cancer

PRO1107 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=214 | Recruiting | Sponsor: ProfoundBio US Co. | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer • Urothelial Cancer

ProfoundBio Announces First Patient Dosed in Phase 1/2 Clinical Trial of PRO1107, a Protein Tyrosine Kinase 7 (PTK7)-Targeted Antibody-Drug Conjugate Incorporating a Novel, Proprietary Hydrophilic MMAE-Based Linker-Drug (PRNewswire) - "ProfoundBio...today announced dosing has initiated in the Phase 1/2 first-in-human clinical trial of PRO1107 (NCT06171789)....PRO1107 is being evaluated in a global, open-label, multicenter Phase 1/2 trial. This trial is designed to determine the safety, tolerability, pharmacokinetics, and antitumor activity of PRO1107 in patients with advanced solid tumors, including non-small cell lung, breast, and ovarian cancer."

Trial status • Breast Cancer • Gynecologic Cancers • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

PRO1107 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=214 | Not yet recruiting | Sponsor: ProfoundBio US Co.

New P1/2 trial • Breast Cancer • Endometrial Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer • Urothelial Cancer

A novel PTK7-directed antibody-drug conjugate (ADC) PRO1107 demonstrated broad antitumor activity with a promising safety profile in preclinical models (SITC 2023) - "An in-house synthesized analog of cofetuzumab pelidotin, a clinical-stage PTK7-directed DAR4 ADC, was included as the benchmarking agent in key studies. It may also carry an expanded therapeutic index compared to other antitubulin-based ADCs on conventional linker-drug platforms. PRO1107 is a highly exciting novel agent to bring forward to the clinic for the treatment of various solid tumors."

Preclinical • Bladder Cancer • Genito-urinary Cancer • Oncology • Ovarian Cancer • Solid Tumor • PTK7

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