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Prostrate Cancer Drug Moves into Human Clinical Trials

Published: Monday, May 19, 2014
Last Updated: Monday, May 19, 2014
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ADC Therapeutics announced that it has selected its first IND candidate under its joint development agreement with MedImmune.

This follows the October 2013 announcement in which MedImmune entered into a collaboration agreement with ADC Therapeutics to jointly develop two of ADCT’s antibody-drug conjugate programs in preclinical development.

ADCT-401 targets Prostate-Specific Membrane Antigen (PSMA) a cell-surface antigen specifically expressed by prostate cancer cells. ADCT-401 comprises an anti-PSMA monoclonal antibody coupled with a pyrrolobenzodiazepine (PBD) warhead using a proprietary linker licensed from London-based Spirogen, a wholly owned subsidiary of MedImmune.  Initial clinical studies will focus on hormone-refractory prostate cancer and an IND filing is anticipated in 2015.

“We are excited by the preclinical efficacy data we have seen with ADCT-401 in a number of in vivo models of prostate cancer.  These data have encouraged us to continue development of this unique ADC for the treatment of refractory prostate cancer.  ADCT-401 was constructed and tested by the joint ADCT and Spirogen teams, and we are very pleased with the outcome,” said Dr. Peter B. Corr, Chairman of ADCT and Co-Founder and Managing General Partner of Auven Therapeutics, the private equity firm behind the formation of ADCT and its majority shareholder.

The PSMA-specific J591 antibody in ADCT-401 was developed by Dr. Neil H. Bander, the Bernard & Josephine Chaus Professor of Urologic Oncology and Director of Urological Oncology Research at the Weill-Cornell Medical College, New York.  Dr. Bander is also Chairman of ADCT’s Scientific Advisory Board. PSMA is a cell-surface antigen expressed by virtually all prostate cancer cells, including metastases, and also in the blood vessels that feed many other tumor types, but is rarely expressed in normal cells.

“PSMA is an ideal target for an ADC therapeutic strategy because it is unparalleled in its prostate cancer specificity, its high density of expression and its very efficient internalization,” said Dr. Neil Bander. “If the preclinical efficacy and safety studies translate into the clinic, ADCT-401 has the potential to be a breakthrough therapy in the treatment of advanced, refractory prostate cancers. I am delighted that the ADCT and MedImmune teams have combined their efforts to advance it into patients as quickly as possible,” he added.

This will be ADCT’s second ADC program into the clinic from its pipeline of eleven programs with an IND filing expected in the first of these programs by the end of this year.  

“We are optimistic that continued investigations of ADCT-401 in patients with prostate cancer will deliver the results we expect. The program is a testament to the close teamwork, commitment to scientific excellence and sense of urgency shared between the MedImmune and ADC Therapeutics teams on this project,” said Stephen Evans-Freke, Co-founder and Managing General Partner of Auven Therapeutics.

The pre-clinical development of ADCT-401 is being managed by a team of scientists based in laboratories at the Queen Mary Bioenterprises Innovation Centre, London which, being co-located with Spirogen, enables close co-operation between the two groups.

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