On August 15, 2019 Alligator Bioscience (Nasdaq Stockholm: ATORX), reported that Janssen Biotech, Inc. (Janssen) will present data from a Phase I clinical study of ADC-1013 (JNJ-7107) at the upcoming ASCO (Free ASCO Whitepaper) Annual meeting held in Chicago on May 31- June 4 (Press release, Alligator Bioscience, AUG 15, 2019, View Source [SID1234538665]). The study results show that side effects were generally mild and transient.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The primary aim of the study was safety and to establish a recommended dose for Phase II. The study is still ongoing and has enrolled a total of 95 patients. The maximum tolerated dose has not yet been reached. Doses up to 1200 μg/kg i.v without premedication, and up to 2000 μg/kg with premedication have been shown to be safe and tolerable. Early evidence of clinical activity in this study included a partial response (PR) in a patient with renal cell cancer and 10 patients with prolonged stable disease (SD) ≥6 months.
"I am glad to see the promising safety and tolerability profile of ADC-1013 in patients with cancer. This together with the early signs of clinical activity, gives me great confidence in this CD40 drug candidate", said Per Norlén, CEO of Alligator Bioscience.
A poster (#171) with the title "A Phase 1 Study to Assess Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of JNJ-64457107, a CD40 Agonistic Monoclonal Antibody, in Patients (pts) with Advanced Solid Tumors" will be showcased at ASCO (Free ASCO Whitepaper) on June 1, 2019 from 8 – 11 a.m. in the session Developmental Immunotherapy and Tumor Immunobiology.
The licensing agreement with Janssen encompasses milestone payments up to a potential total value of USD 695 million. Alligator is also eligible to receive tiered royalties on worldwide net sales upon successful launch and commercialization of ADC-1013.
For further information, please contact:
Cecilia Hofvander, Director IR & Communications
Phone +46 46 540 82 06
E-mail: [email protected]
This information is such information as Alligator Bioscience AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. This information was submitted for publication, through the agency of the contact person set out above, at 11:00 p.m. CEST (5:00 p.m. ET) on May 15, 2019.
About ADC-1013 (JNJ-7107)
ADC-1013 is a drug candidate intended for immunotherapy of different types of cancer. Results from a previous clinical Phase I first-in-human study performed by Alligator (International Journal of Cancer, View Source) showed that ADC-1013 was generally well tolerated. Preclinical data have previously shown that the ADC-1013 antibody effectively activates T cells, mediated through binding to the co-stimulatory receptor CD40 on dendritic cells. The increased T cell activation enables the immune system to attack the cancer.