MultiCell Immunotherapeutics, Inc. (MCIT), a majority owned subsidiary of MultiCell Technologies, Inc. has signed a research & development and product license agreement with Oxis Biotech, Inc. (OXIS) to create three novel antibody-drug conjugates (ADCs) containing OXIS' lead drug candidates using MCIT's proprietary ADC platform technology. These ADC product candidates are to be used by OXIS for the treatment of triple-negative breast cancer, and multiple myeloma and associated osteolytic lesions which are significant unmet medical needs.
Under the terms of the agreement, OXIS paid MCIT a license fee of $500,000, and will reimburse MCIT up to $1.125 million in development costs for the three ADC product candidates. Oxis will also pay up to $12.75 million in clinical development milestones, and was granted an option to purchase manufacturing rights to the three ADCs upon payment of an additional $10 million. OXIS was also granted a worldwide exclusive license to sell the three ADC product candidates, and will pay a royalty of 3% of net yearly sales. MCIT retained all rights to its ADC platform for all therapeutic indications, and is free to pursue its own drug development programs and to partner with other interested pharmaceutical and biotechnology companies.
Sales of breast cancer drugs are projected to increase in nine major world markets from $9.8 billion in 2013 to $18.2 billion by 2023, according to new forecasts from IMS Health. Analysts at Visiongain, Ltd. predict the world market for multiple myeloma therapies will reach $11.5 billion in 2017.
According to FiercePharma, Celgene's cancer drug Revlimid for the treatment of multiple myeloma generated nearly $5 billion in revenue for the company in 2014. Analysts believe sales of Revlimid could double within 5 years as a result of FDA's recent approval of expanded labeling concerning the use of Revlimid in combination with dexamethasone for patients newly diagnosed with multiple myeloma. About 93,600 patients are living with multiple myeloma in Europe and about 88,499 patients are living with it in the United States, Celgene said.
PDL BioPharma, Inc. stated its licensee Genentech, Inc. reported sales of Herceptin which is used to treat HER2 breast cancer totaled $7.3 billion in 2014. Of the 280,000 patients in the USA diagnosed annually with breast cancer, about 20% are diagnosed with triple-negative breast cancer. Treatment options for triple-negative breast cancer patients are limited because the three most common types of receptors known to fuel most breast cancer growth – estrogen, progesterone, and the HER-2/neu gene – are not present in the triple-negative breast cancer cells, hence patients are ineligible for treatment with either hormonal or HER2-targeted agents such as Herceptin. Treatment typically involves non-targeted cytotoxic chemotherapies.
The Emmes Group, a strategy consulting firm with offices in Boston and San Francisco, believes if OXIS achieves all of its clinical development milestones, purchases manufacturing rights to the ADCs, and meets worldwide sales and sublicensing expectations following receipt of marketing approval for the three ADCs for the treatment of breast cancer and multiple myeloma, MCIT could expect to receive in excess of $540 million during the term of the agreement.
MCIT's ADC platform technology is based on unique multivalent, cleavable linkers that allow tethered drugs to be released intracellularly or extracellularly upon binding of the antibody to the target cell. Additionally, the MCIT linkers are designed to attach multiple drugs per targeting antibody, and to release the drugs in their original form without modification of the drug.
"We are very excited about our novel, enabling antibody-drug conjugate technology, and are pleased to partner with Oxis Biotech to develop targeted delivery versions of their drug candidates", said W. Gerald Newmin, chairman and chief executive officer of MultiCell Immunotherapeutics. "We continue to explore therapeutic indications and drug combinations of interest to us, and will continue to aggressively seek partnerships with larger pharmaceutical and biotechnology companies who are interested in using our ADC technology to help facilitate the targeted delivery of their drugs," stated Newmin.