jankistomig (OTP-01) / Ottimo Pharma - LARVOL DELTA

Lotte Biologics has won additional manufacturing work from U.K. biotech Ottimo Pharma for an antibody drug now in phase 1/2a testing. (Korea Biomedical Review) - "The Korean contract development and manufacturing organization (CDMO) said Monday it will produce more drug substance for Ottimo’s OTP-01, also known as Jankistomig, at its Syracuse Bio Campus in New York."

Commercial • Oncology

A Study of OTP-01, a Dual Paratopic PD-1/VEGFR2 Antibody, in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=41 | Recruiting | Sponsor: Ottimo Pharma Limited

New P1/2 trial • Breast Cancer • Oncology • Ovarian Cancer • Solid Tumor

A Study of OTP-01, a Dual Paratopic PD-1/VEGFR2 Antibody, in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=170 | Recruiting | Sponsor: Ottimo Pharma Limited | N=41 ➔ 170

Enrollment change • Trial initiation date • Breast Cancer • Oncology • Ovarian Cancer • Solid Tumor

A Study of OTP-01, a Dual Paratopic PD-1/VEGFR2 Antibody, in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=18 | Recruiting | Sponsor: Ottimo Pharma Limited

New P1/2 trial • Breast Cancer • Oncology • Ovarian Cancer • Solid Tumor

Phase 1/2A Study of OTP-01, a Dual Paratopic PD-1/VEGFR2 Antibody, in Patients with Advanced Solid Tumors (clinicaltrialsregister.eu) - P1/2 | N=9 | Not yet recruiting | Sponsor: Ottimo Pharma Limited

New P1/2 trial • Breast Cancer • Oncology • Ovarian Cancer • Solid Tumor

A Study of OTP-01, a Dual Paratopic PD-1/VEGFR2 Antibody, in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=170 | Recruiting | Sponsor: Ottimo Pharma Limited | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Ovarian Cancer • Solid Tumor

Ottimo Pharma Announces FDA Clearance of Investigational New Drug (IND) Application for OTP-01, a First-in-Class, Dual-Paratopic, Single-Agent, Anti-PD-1/VEGFR2 Antibody (The Manila Times) - "The first patient has been dosed and recruitment is well underway...The broad Phase I/IIA, open-label, multicenter study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and early anti-tumor activity of OTP-01. The study is enrolling patients in the US and Australia and will expand to approximately 20 centers globally."

IND • Trial status • Solid Tumor

A Study of OTP-01, a Dual Paratopic PD-1/VEGFR2 Antibody, in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=170 | Not yet recruiting | Sponsor: Ottimo Pharma Limited

New P1/2 trial • Solid Tumor

Lotte Biologics wins UK contract for antibody drug manufacturing, aims for more orders (Chosun Biz) - "Lotte Biologics has won a contract for contract manufacturing organization (CMO) for a dual antibody new drug candidate being developed by OTTIMO Pharma in the United Kingdom. This is the second contract win in about two months, following the agreement in April with an Asia-based corporation for the production of a candidate for clinical trials of an antibody-drug conjugate (ADC)....Jankistomig is a dual antibody that targets the protein PD-L1, which cancer cells use to disguise themselves as normal cells, and the vascular endothelial growth factor (VEGF) that promotes tumor growth. Under this contract, Lotte Biologics will produce the active pharmaceutical ingredient for jankistomig at its Syracuse plant in New York, USA."

Licensing / partnership • Oncology