PIVOTAL BIOSCIENCES ANNOUNCES $1.4 MILLION SERIES A FINANCING

LOS ANGELES, CA - February 23, 2004 - Pivotal BioSciences, Inc., a privately-held Los Angeles-based biotechnology company developing innovative low toxicity therapies for cancer, today announced it had closed on a private placement of $1,437,000 of Series A Voting Preferred Stock with a limited number of accredited investors. The proceeds of the private placement will be used to fund the development of Pivotal's lead compounds which have been licensed from the University of Southern California. The placement was arranged by Casimir Capital, L.P. of New York, N.Y.

Pivotal products in development include PB1, a low toxicity version of intereukin-2, a drug already approved for the treatment of renal cancer and metastatic melanoma but which has serious side effects for patients including a 5% mortality rate; PB2, a novel anti-angiogenic and anti-metastatic compound derived from the venom of the Southern Copperhead snake; and PB3, a fusion protein consisting of the liver-expressed chemokine (LEC) and a cancer-targeting monoclonal antibody.

Pivotal BioSciences was founded by Alan Epstein, M.D., Ph.D., Professor of Pathology at the University of Southern California Keck School of Medicine; Francis S. Markland, Jr., Ph.D., Professor of Biochemistry and Molecular Biology at the University of Southern California Keck School of Medicine; and Dimitri Villard, a former director of SG Cowen, an investment banking firm. In addition to the founders, Pivotal's Board of Directors includes Krisztina Zsebo, Ph.D., a former executive at Amgen, Cell Genesis, ALZA and other biotechnology companies who is also a consultant to Pivotal; Richard Anthony, Ph.D., President of Catalyst Pharmaceutical Research, LLC, a clinical research organization and product development consultancy in Pasadena, CA; and Alexander Arrow, M.D., C.F.A., senior medical technology analyst at Lazard, a global institutional equity research and investment banking firm.

"Breakthroughs in the basic understanding of the immune system, combined with powerful new biotechnological tools, have provided the foundation for new, rational, and technologically sophisticated approaches to immunotherapy and anti-angiogenesis, and have created an environment where these classes of drugs are now poised for success," said Mr. Villard, Pivotal's Chairman. "Casimir Capital has provided us with the critical early-stage round that will help develop our products so as to move them forward into the clinic."

"We are excited about the opportunity to become involved in the growth of Pivotal," said Richard Sands, President and CEO of Casimir Capital. "We believe they have an outstanding team of scientists and products with large market potential together with excellent proprietary technology."

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MORPHOTEK®, INC. AND PIVOTAL BIOSCIENCES ANNOUNCE AGREEMENT

FOR THE DEVELOPMENT OF THERAPEUTIC MONOCLONAL ANTIBODIES


Exton, PA, September 25, 2008 Morphotek®, Inc., a subsidiary of Eisai Corporation of North America, and Pivotal BioSciences, Inc., a privately held Los Angeles-based biotechnology company developing oncology products, today announced they have entered into an agreement in which Morphotek will access Pivotal BioSciences’ LEC platform technology, developed by Dr. Alan Epstein, M.D., Ph.D, for the development of therapeutic monoclonal antibodies. The technology enhances the human immune system’s ability to produce an effective anti-tumor response.


The agreement with Pivotal BioSciences provides that Morphotek will evaluate the LEC technology in-house and have the right to exercise an option for a license. Should Morphotek choose to exercise its option, Morphotek would obtain a worldwide license under Pivotal’s LEC technology to develop new therapeutic products, and would retain the responsibility for the commercialization of such products derived using the technology.


“We are delighted to be working with Pivotal BioSciences in this effort,” said Nicholas Nicolaides, Ph.D, President and CEO of Morphotek. “This collaboration further illustrates our commitment to discover, develop and commercialize efficacious monoclonal antibodies to address unmet diseases. We are extremely honored to be Pivotal BioSciences’ first partner for the research and development of therapeutic antibodies.”


“We are very pleased that Morphotek views the LEC platform as a potentially robust technology,” said Dimitri Villard, President and CEO of Pivotal BioSciences. “We believe this agreement will provide yet another validation of our proprietary approach. We anticipate a highly productive collaboration with Morphotek, one that will help Morphotek to significantly broaden its antibody pipeline.”


About Pivotal BioSciences

Pivotal BioSciences, Inc. is a privately-held spin-out of the University of Southern California Keck School of Medicine that is focused on developing novel therapeutics for cancer. In addition to its LEC platform technology, Pivotal BioSciences has developed its own fusion protein utilizing the technology. For more information, please visit www.pivotalbiosciences.com.

About Morphotek

Morphotek®, Inc., a subsidiary of Eisai Corporation of North America, is a biopharmaceutical company specializing in the development of protein and antibody products through the use of a novel and proprietary gene evolution technology. The technology has been successfully applied to a broad variety of cell lines and organisms to yield genetically diverse offspring that are suitable for pharmaceutical product development in the areas of antibody therapeutics, protein therapeutics, product manufacturing, drug target discovery, and improved output traits for commercial applications. The company is currently focusing its platform on the development and manufacturing of therapeutic antibodies for the treatment of cancer, inflammation and infectious disease. For more information, please visit www.morphotek.com.


About Eisai Corporation of North America

Eisai Corporation of North America is a wholly-owned subsidiary of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai focuses its efforts in three therapeutic areas: neurology, gastrointestinal disorders and oncology/critical care. Eisai Corporation of North America supports the activities of its operating companies in North America, which include: Eisai Research Institute of Boston, Inc., a discovery operation with strong organic chemistry capabilities; Morphotek, Inc., a biopharmaceutical company specializing in the development of therapeutic monoclonal antibodies; Eisai Medical Research Inc., a clinical development group; Eisai Inc., a commercial operation with manufacturing and marketing/sales functions; and Eisai Machinery U.S.A., which markets and maintains pharmaceutical manufacturing machinery. For more information about Eisai, please visit www.eisai.com.

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USC Keck School of Medicine’s Dr. Alan Epstein
Receives Prestigious National Cancer Institute RAID Award

For Breakthrough IL-2 Molecule Therapeutic

 

$3.5 Million Award Will Advance Clinical "Proof of Principle"
for Expanded Clinical Evaluation

 

Second RAID Award for Dr. Epstein

 

LOS ANGELES (July 7, 2009) – The University of Southern California today announced that Alan Epstein, M.D., Ph.D., Professor, Department of Pathology at the USC Keck School of Medicine of USC, has received approval for a $3.5 million drug development project through the Rapid Access to Intervention Development (RAID) program of the National Cancer Institute (NCI) for his breakthrough Interleukin-2 (IL-2) cytokine immunotherapy analog.   This is the second RAID award Dr. Epstein has received from the National Cancer Institute.

 

The NCI RAID program is a peer-reviewed competitive award program designed to assist translation of novel anticancer therapeutics to the clinic.  The goal of the program is to show proof of principle that a new molecule is a viable candidate for expanded clinical evaluation. As a RAID award recipient, Dr. Epstein will receive access to drug development resources of the Developmental Therapeutics Program. These resources will be used to further the preclinical development of his IL-2 analog therapy for the treatment of certain cancers that appears to retain the benefits of existing IL-2 therapies without the major side effects that currently limit their application.

 

IL-2 cytokine immunotherapy is used to treat metastatic melanoma and metastatic renal cell carcinoma, diseases that afflict over 60,000 and 50,000 people in the United States each year, respectively.  An increase in melanoma incidence has elevated the disease to the sixth most common cancer in the United States.   Approximately 60,000 Americans developed invasive cutaneous melanoma in 2007, with an estimated additional 48,000 or more cases of melanoma in situ. The current lifetime risk for developing invasive melanoma is 1 case per 60 Americans.  Currently, IL-2 is the only FDA approved immunotherapeutic agent.

 

But while the current therapy provides unparalleled recovery for certain cancer patients, the application of IL-2 is severely limited by its significant toxicity and resulting side effects, especially that of capillary leak syndrome where leakage of fluid from the blood results in dangerously low blood pressure (hypotension), edema and multiple organ failure. Capillary leak syndrome affects as many as 65% of patients and can lead to the cessation of therapy.

 

Dr. Epstein has developed an IL-2 analog that eliminates the side effect of capillary leak syndrome while retaining the cytokine and therapeutic activity of IL-2.  His extensive pre-clinical data indicates that this IL-2 analog will allow more clinically effective doses to be administered, resulting in significantly improved disease control with fewer complications. 

 

 

“We believe the full potential of IL-2 has yet to be realized because of its limiting toxicity.

This discovery could mean an exponentially improved success rate for cancer therapies,” said Dr. Epstein.  I am thrilled NCI saw the priority value of this therapeutic and awarded RAID assistance to help propel the manufacturing of this novel molecule toward Phase 1 clinical trials.”

 

“We are in the midst of a biomedical revolution. New technologies promise to reshape medicine – with novel applications in new therapies, drug delivery, and patient care,” said Dr. Richard Hull , Senior Director of Innovation Advancement and Business Development for the USC Stevens Institute for Innovation. “The work and success of Dr. Epstein is a great example of how USC is focused on translating top-notch laboratory research into breakthrough clinical applications that save lives and improve healthcare.”

 

Pivotal BioSciences, Inc., a privately-held Los Angeles-based biotechnology company developing innovative low toxicity therapies for cancer, has licensed the molecule from USC.  The technology is covered under U.S. Patent #7371371 issued on May 13, 2008 titled, “Interleukin-2 Mutants with Reduced Toxicity.” 

 

Dimitri Villard, CEO of Pivotal BioSciences, Inc. added, “We are delighted that the National Cancer Institute’s RAID Program will undertake the critical next steps of process development, manufacturing and toxicology studies that will enable us to apply to the FDA for a Phase I clinical trial. This fortuitous award enables us to bridge the funding gap that so many pre-clinical stage biotechnology companies have experienced lately; we are looking forward to working with Dr. Epstein and USC Stevens to see this important project through to fruition.”

 

# # #

 

About the Keck School of Medicine of USC

The Keck School of Medicine of the University of Southern California trains tomorrow’s leaders in patient care and biomedical research and provides advanced health care to the people of Southern California. Increasingly, the Keck School of Medicine of USC is expanding its biomedical research enterprise and, in so doing, raising its profile as a premier medical school. At present, the Keck School of Medicine of USC ranks among the nation’s top 25 percent of medical schools in federally sponsored research (Association of American Medical Colleges, 2003). Research programs in genetics, cancer, neurogenetics, transplantation medicine, and other key areas have attracted national recognition. The School’s dual commitments to collaborative interdisciplinary research and rapidly translating scientific findings from the lab bench to the patient’s bedside have proved pivotal in its continuing success in research.

 

About the USC Stevens Institute for Innovation

The USC Stevens Institute for Innovation (http://stevens.usc.edu) is a university-wide institute in the office of the Provost designed to harness the creative thinking and innovative work at all of USC’s 17 professional schools, the USC College, and research centers across campus to build a multidisciplinary approach to innovation. To empower USC innovators to make maximum societal impact with their ideas, the USC Stevens Institute identifies, nurtures, protects, and transfers to the market the most exciting innovations from USC, and in turn, provides a central connection for industry seeking cutting edge innovations in which to invest. Furthermore, the USC Stevens Institute develops the innovator as well as innovations, through educational programs, community-building events, and showcase opportunities.

 

 

 

 

About Pivotal BioSciences, Inc.

Pivotal BioSciences, Inc. is an angel-backed spin-out of the University of Southern California Keck School of Medicine that has been developing several promising discoveries in the field of oncology licensed from USC. For more information, visit www.pivotalbiosciences.com.

 

Media Inquiries:     

Elisa Wiefel Schreiber

USC Stevens Institute for Innovation

University of Southern California

p: 213-821-6063  f: 213-821-5001

wiefel@usc.edu

 

Dimitri Villard

Pivotal BioSciences, Inc.

(310) 734-4551

villard@pivotalbiosciences.com

 

 

 

Leslie Ridgeway

Keck School of Medicine of USC

323-442-2823

213-200-8015

leslie.ridgeway@usc.edu

 

 

 

 

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