MorphoSys AG and US-based biopharmaceutical company Xencor, Inc., announced the signing of a worldwide exclusive license and collaboration agreement for an antibody in phase 1 clinical development. The agreement provides MorphoSys with an exclusive worldwide license to XmAb5574, a high potency monoclonal antibody developed by Xencor for the treatment of B-cell malignancies.

As part of the agreement, the companies will collaborate on the phase 1 trial in patients with chronic lymphocytic leukaemia (CLL) in the USA., for which Xencor will continue to carry the costs under its development plan. MorphoSys will be solely responsible for further clinical development. Xencor will receive an upfront payment of US$ 13 million (approx. EUR 10.5 million), and will be eligible to receive development-, regulatory- and commercialization-related milestone payments and tiered royalties based on product sales. Further financial terms were not disclosed.

XmAb5574, which will be renamed MOR208, is a humanized anti-CD19 monoclonal antibody for the treatment of B-cell malignancies. It has been engineered to possess significantly enhanced antibody-dependent cell-mediated cytotoxicity (ADCC), thus improving a key mechanism for tumour cell killing and offering potential for enhanced efficacy compared to traditional antibodies for the treatment of cancer. In preclinical studies, XmAb5574 was well tolerated at various dose levels, elicited immediate and sustained B-cell depletion, and showed strong anti-tumour potency, anti-proliferative and apoptotic activity. B-cell malignancies, such as non-Hodgkin's lymphoma, chronic lymphocytic leukaemia (CLL) and acute lymphoblastic leukaemia afflict more than one hundred and fifty thousand patients in the seven major markets each year. The target is expressed more broadly and earlier in B-cell development than CD20, the target of the marketed cancer drug Rituxan, therefore potentially allowing for an even broader use of XmAb5574 as compared to Rituxan.

"We are delighted to add this clinical program to our growing portfolio of innovative development candidates," commented Dr Simon Moroney, chief executive officer of MorphoSys AG. "Our first in-licensing deal of a clinical compound is a further step in the execution of our plan to build a strong portfolio of proprietary therapeutic antibodies to complement those being developed by our partners. The strong cash-flow from our partnered discovery business gives us the means of supporting an attractive proprietary development programme, to which XmAb5574/MOR208 is an important addition."

"Our interest in XmAb5574 is based on a comprehensive survey of antibodies in late preclinical or early clinical development in the areas of cancer and inflammation," commented Dr. Arndt Schottelius, chief development officer of MorphoSys AG. "B-cell depletion is a well-validated strategy to treat lymphomas and CLL, exemplified by the success of Rituxan. We are convinced by the sound scientific data Xencor has built around its anti-CD19 cancer programme and we believe it to be a valuable addition to our proprietary pipeline. By further developing the Xencor program, we will broaden our drug portfolio and also realize synergies with our cancer program MOR202, since both drugs target haematological malignancies."

"As we look ahead to the potential of XmAb5574 to treat B-cell cancers, a development collaboration with a leading global antibody company like MorphoSys is an important step forward for us by allowing us to bring significant additional resources to the programme," said Dr Bassil Dahiyat, chief executive officer of Xencor. "Progressing the development of XmAb5574 through this collaboration further underscores the success of our XmAb platform technology in creating a pipeline of innovative and potent next-generation antibody product candidates. We are excited by the progress of both our internal and partnered programmes."

MorphoSys is an independent biotechnology company that develops novel antibodies for therapeutic, diagnostic and research applications. The company's HuCAL technology is one of the most powerful methods available for generating fully human antibodies.

Xencor, Inc. engineers superior biotherapeutics using its proprietary Protein Design Automation technology platform, and is a leader in the field of antibody engineering to significantly improve antibody half-life, immune-regulatory function and potency.