CharlestonPharma

CharlestonPharma, LLC gives the oral presentation "Antibody Targeting of Oncogenic mRNAs" at the virtual 2020 Discovery on Target conference

Daniel J. Fernandes, Ph.D., D.Sc., CSO at CharlestonPharma, presented data which showed that antibody targeting of the multi-functional protein, nucleolin, induces potent cytotoxicity against a panel of more than a dozen tumor cell lines. Nucleolin is known to shuttle between the cell surface and the cytoplasm of human tumor cells. By binding specifically to nucleolin our lead antibody, CP101.2C8, exploits the known shuttling function of nucleolin to gain intracellular access to the cytoplasm of tumor cells, but not normal cells which lack cell surface nucleolin. Nucleolin also has a critical role in stabilizing numerous oncogenic mRNAs by protecting them from degradation. Binding of CP101.2C8 to cytoplasmic nucleolin prevents nucleolin from stabilizing these oncogenic mRNAs and results in tumor cell apoptosis and death. In contrast normal cells, which lack cell surface nucleolin transporter, are not killed by CP101.2C8. Targeting of multiple oncogenic mRNAs explains the broad-spectrum activity of CP101.2C8.

CharlestonPharma, LLC presents poster at 2016 AACR with in vivo proof of concept for its lead antibody clinical candidate

CharlestonPharma today presented its poster, "Development of Anti-Nucleolin Antibodies with Broad Spectrum Anticancer Activity and Negligible Toxicity to Normal Cells", which describes the selective expression of the target on cancer cells versus normal cells, the mechanism of action of the lead antibody in killing cancer cells and in vitro and in vivo proof of concept for this clinical candidate.

The poster describes how in a MV 4-11 Flt-3 human xenograft mouse model, our lead antibody produced an impressive 30% rate of long term survival and a statistically significant overall time to tumor progression.

Nucleolin is an attractive target for drug development and our lead clinical candidate, CP101.2C8, is a promising therapeutic candidate with the potential to treat a broad range of major cancers.

CharlestonPharma, LLC announces selection of abstract for poster presentation at 2016 AACR

CharlestonPharma's abstract, "Selective Targeting and Cytotoxicity of Anti-Nucleolin Antibody CP101.2C8 Results from the Aberrant Expression of Nucleolin in AML and Solid Tumor Cells #1488", has been selected for poster presentation on Monday, April 18 from 8:00am to noon at the Immune Modulating Agents and Therapeutic Antibodies session in the Convention Center, Halls G-J, Poster Section 25 at the American Association for Cancer Research (AACR) conference in New Orleans.

CharlestonPharma, LLC announces issuance of United States patent licensed from Medical University of South Carolina

The United States Patent and Trademark Office today issued a patent to the Medical University of South Carolina (MUSC) that covers the composition of fully human anti-nucleolin antibodies and their use in diagnosing and treating malignant disease. CharlestonPharma is the exclusive licensee of this patent.

This is the second patent to issue from the licensed MUSC patent portfolio. Together with our University of Louisville-license patents, the company believes it has substantial intellectual property covering its proprietary fully human anti-nucleolin antibody program.

CharlestonPharma, LLC sponsors team in the Leukemia & Lymphoma Society's "Light the Night Walk", for fifth consecutive year

Underscoring its commitment to research for the cure of blood cancers, CharlestonPharma announced their fifth consecutive year of sponsorship of the CharlestonPharma's team that will participate in the Leukemia & Lymphoma Society's "Light the Night Walk" taking place today in Mt. Pleasant, SC.

The Leukemia & Lymphoma Society hosts walks across South Carolina each fall to commemorate and celebrate lives touched by cancer. Funds raised support research for cures and patient support services.

CharlestonPharma, LLC discloses the passing of one of its founders, Robert L. Capizzi, M.D.

Robert L. Capizzi, M.D., co-founder, President and Chief Medical Officer of CharlestonPharma, passed away earlier this week. Bob was an outstanding academic and industry leader in cancer research, drug development and patient care; he was also a close friend. Our thoughts are with his family, friends and colleagues. He will be dearly missed.

Dr. Capizzi was a board certified medical oncologist whose career spanned more than 38 years in clinical oncology and oncology drug development in academia and industry. He achieved international recognition for his work in clinical pharmacology, cancer drug development, and clinical trials. His academic laboratory and clinical research resulted in the development of three novel regimens for various malignancies, including a curative therapy for acute myeloid leukemia. He led the clinical development and regulatory teams within industry that obtained four marketing approvals and he made significant individual contributions to the approval of two others. Dr. Capizzi's leadership included service on the Boards of Directors of the American Society of Clinical Oncology (ASCO) and the American Association for Cancer Research (AACR), as a member and chair of the Food and Drug Administration's oncology drug advisory committee (ODAC) and various advisory boards for the National Institutes of Health (NIH), the American Cancer Society and international agencies. Dr. Capizzi served as Executive Vice President and Chief Medical Officer of Xanthus Life Sciences, Vice President-Medical Affairs at Novacea Inc. and Executive Vice President for Worldwide Research and Development at U.S. Bioscience, Inc. He was the former Magee Professor and Chairman of the Department of Medicine at Thomas Jefferson Medical College in Philadelphia.

CharlestonPharma, LLC receives third capital contribution from SC Launch!

CharlestonPharma announced today the receipt of a third $200,000 capital contribution from SC Launch!, as a result of the substantial research progress on its fully human anti-nucleolin antibodies. Under the terms of the financing agreement, SC Launch provides low cost capital for South Carolina based technology companies spun out of one of the state's prestigious research institutions.

CharlestonPharma, LLC announces closing of second financing lead by Sears Capital Management

CharlestonPharma LLC today announced the closing of its second institutional financing lead by Sears Capital Management. Proceeds from the financing will be used to obtain in vivo proof of concept for the company's fully human monoclonal antibodies (mAb) to cell surface nucleolin and complete a license agreement with a pharmaceutical company partner to accelerate development and commercialization of these therapeutic antibodies.

Nucleolin, which is CharlestonPharma's mAb target is a receptor found on the surface of many different types of tumor cells but not on normal cells. Antibodies to cell surface nucleolin may be the first targeted therapy to be clinically relevant in a wide range of human cancers.

CharlestonPharma, LLC sponsors team in the Leukemia & Lymphoma Society's "Light the Night Walk", for fourth consecutive year

Underscoring its commitment to research for the cure of blood cancers, CharlestonPharma's founders announced their fourth consecutive year of sponsorship of the CharlestonPharma's team that will participate in the Leukemia & Lymphoma Society's "Light the Night Walk" taking place today in Mt. Pleasant, SC.

Funds raised by teams walkers allow the Leukemia & Lymphoma Society to invest over $1 billion in research aimed at helping all blood cancer patients live longer, healthier lives.

CharlestonPharma, LLC announces issuance of United States patent licensed from Medical University of South Carolina

The United States Patent and Trademark Office today issued a patent to the Medical University of South Carolina (MUSC) that covers the method of making fully human antibodies used by the company to make its anti-nucleolin antibodies. CharlestonPharma is the exclusive licensee of this patent for the field of making anti-nucleolin antibodies.

This is the first patent to issue from the licensed MUSC patent portfolio. Together with our University of Louisville-licensed patents, the company believes it has substantial intellectual property covering is proprietary fully human anti-nucleolin antibody program.

CharlestonPharma, LLC announces issuance of European patent exclusively licensed from University of Louisville

The European Patent Office today issued a patent to the University of Louisville that covers anti-nucleolin antibodies used to treat a patient with cancer. CharlestonPharma is the exclusive licensee of this patent.

Similar patents have previously issued in the United States, Japan, Canada and Australia and are also subject to the exclusive license to CharlestonPharma.

CharlestonPharma, LLC sponsors team in the Leukemia & Lymphoma Society's "Light the Night Walk", for third consecutive year

Underscoring its commitment to research for the cure of blood cancers, CharlestonPharma's founders announced their third consecutive year of sponsorship of the CharlestonPharma's team that will participate in the Leukemia & Lymphoma Society's "Light the Night Walk" taking place today in Mt. Pleasant, SC.

Funds raised by teams walkers allow the Leukemia & Lymphoma Society to invest over $875 million in research aimed at helping all blood cancer patients live longer, healthier lives.

CharlestonPharma, LLC receives second capital contribution from SC Launch!

CharlestonPharma announced today the receipt of a second $200,000 capital contribution from SC Launch!, in a further show of support by this South Carolina development authority. Under the terms of the financing agreement, SC Launch provides low cost capital for South Carolina based technology companies spun out of one of the state's prestigious research institutions.

CharlestonPharma, LLC announces closing of financing lead by Sears Capital Management

CharlestonPharma LLC today announced the closing of its first institutional financing, lead by Sears Capital Management. Proceeds from the financing will be used to obtain in vivo proof of concept for the company's fully human monoclonal antibodies (mAb) to cell surface nucleolin and complete a license agreement with a pharmaceutical company partner to accelerate development and commercialization of these therapeutic antibodies. Nucleolin, which is CharlestonPharma's mAb target is a receptor found on the surface of many different types of tumor cells but not on normal cells. Antibodies to cell surface nucleolin may be the first targeted therapy to be clinically relevant in a wide range of human cancers.

"CharlestonPharma through its nucleolin targeting antibodies offers a potentially unique, powerful broad spectrum cancer therapy and a compelling investment opportunity", commented Lowell E. Sears, Chairman of Sears Capital Management. "Nucleolin is very unusual as a receptor because it is expressed on the surface of many different tumors, but not on normal tissue. These tumor types represent over half of the incidence of new cancers diagnosed each year in the United States. CharlestonPharma's nucleolin targeting mAbs could be a major advance in cancer therapy."

CharlestonPharma, LLC sponsors team in the Leukemia & Lymphoma Society's "Light the Night Walk", for second consecutive year

Underscoring its commitment to research for the cure of blood cancers, CharlestonPharma's founders announced their second consecutive year of sponsorship of the CharlestonPharma's team that will participate in the Leukemia & Lymphoma Society's "Light the Night Walk" taking place today in Mt. Pleasant, SC.

Funds raised by teams walkers allow the Leukemia & Lymphoma Society to provide lifesaving blood cancer research, free educational materials and events for patients and their families, local programs such as Family Support Groups and First Connection, a peer-to-peer counseling program, and comprehensive, personalized assistance through LLS's Information Resource Center.

CharlestonPharma, LLC presents poster at American Association of Cancer Research on Human Anti-Nucleolin Antibodies with Broad Spectrum Anticancer Activity

CharlestonPharma LLC today presented a poster on the broad spectrum anticancer activities of its fully human anti-nucleolin antibodies at the 2012 AACR Annual Meeting in Chicago, Il. The poster describes the process used to make the first fully human antibodies to nucleolin as well as the results of cell culture experiments in breast, prostate and pancreas cancers as well as acute myeloid lymphomas. Conclusions included: our fully human ant-nucleolin antibodies, CP101 and CP201, bind tightly to human recombinant nucleolin, kill tumor cells independently of CDCC and ADCC (although complement increases the rate of cell killing), and that the broad spectrum activity against multiple tumor types suggest these antibodies have a large market potential.

CharlestonPharma, LLC licenses worldwide rights to a method for the diagnosis and prognosis of malignant disease by detecting the presence of cell surface nucleolin in a patient's tissue biopsy

CharlestonPharma LLC announced today that the company has obtained an exclusive worldwide license of patents, directed to the detection of nucleolin in the cell surface of a patient's tumor tissue biopsy. This license was obtained from the University of Louisville, Louisville, Kentucky and supports the development of diagnostic tests intended to identify patients most likely to benefit from therapy with the anti-nucleolin monoclonal antibodies under preclinical development at the company.

CharlestonPharma, LLC sponsors team in the Leukemia & Lymphoma Society's "Light the Night Walk"

Underscoring its commitment to research for the cure of blood cancers, CharlestonPharma's founders announced their second consecutive year of sponsorship of the CharlestonPharma’s team that will participate in the Leukemia & Lymphoma Society's "Light the Night Walk" taking place today in Mt. Pleasant, SC.

Funds raised by teams walkers allow the Leukemia & Lymphoma Society to provide lifesaving blood cancer research, free educational materials and events for patients and their families, local programs such as Family Support Groups and First Connection, a peer-to-peer counseling program, and comprehensive, personalized assistance through LLS's Information Resource Center.

CharlestonPharma, LLC receives capital contribution from SC Launch!

CharlestonPharma announced today the receipt of a $200,000 capital contribution from SC Launch!, becoming a portfolio company for this South Carolina development authority. Under the terms of the financing agreement, SC Launch provides low cost capital for South Carolina based technology companies spun out of one of the state's prestigious research institutions.

CharlestonPharma, LLC receives economic development grant from South Carolina Research Authority for the development of antibodies to nucleolin

CharlestonPharma announced today the receipt of a $25,000 economic development grant from South Carolina Research Authority (SCRA). The grant will be used to fund development of our first-in-class fully-human monoclonal antibodies to nucelolin and has been provided under SCRA's University Startup Assistance program.

CharlestonPharma, LLC obtains a worldwide license to treat cancer patents with antibodies to nucleolin

CharlestonPharma announced today it has become the exclusive worldwide licensee of patents, including an issued patent in the United States, directed to the use of antibodies to nucleolin to treat cancer patient. This technology was developed at the University of Louisville, Louisville, Kentucky.

CharlestonPharma, LLC licenses the right to fully human antibodies to human nucleolin on an exclusive worldwide basis from the Medical University of South Carolina

CharlestonPharma announced today it has exclusively licensed on a worldwide basis from the Medical University of South Carolina (MUSC) in Charleston, SC the process of making and using fully human antibodies to human nucleolin as well as for eight specific antibodies made from this process.

Laboratory and clinical research at the Medical University of South Carolina (MUSC) have identified a novel therapeutic target in tumor cells. This target, nucleolin, is a receptor protein that is over-expressed on the cell surface of many different types of cancers and leukemias. Importantly, this protein is not, or is only minimally expressed, on the cell surface of corresponding normal tissues of the body. This finding offers the much-sought opportunity for selective, tumor-specific therapies for both solid tumors and leukemias with an excellent safety profile. It also offers the opportunity for "personalized medicine" in identifying those patients likely to benefit from such therapy. MUSC has developed fully human monoclonal antibodies to nucleolin that are ideally suited to fill this opportunity.

CharlestonPharma, LLC establishes its corporate headquarters and laboratories at the Charleston Innovation Center in Charleston, SC

CharlestonPharma announced today it is establishing its corporate headquarters and laboratories at the Charleston Innovation Center in Charleston, SC. Located at 645 Meeting Street, Suite 4 in Charleston, this laboratory and office suite will provide a state of the art facility for the Company's research on fully human anti-nucleolin monoclonal antibodies for the treatment of cancer patients.

The Charleston Innovation Center was developed by the South Carolina Research Authority (SCRA) to provide state of the art laboratory and core services to start up companies spinning out technology from the Medical University of South Carolina in Charleston, SC.

Located a short drive from the Medical University of South Carolina (MUSC), it allows the Company to fully leverage the services of our Chief Scientific Officer, Daniel J. Fernandes, Ph.D., D.Sc., who also serves as a Professor of Biochemistry and Molecular Biology at MUSC and as the Associate Director for Translational Research of the Hollings Cancer Center located at MUSC.

CharlestonPharma's mission is to develop fully human anti-nucleolin monoclonal antibodies as a potential unique new treatment for patients with cancer.

CharlestonPharma, LLC is approved for a Qualifying Therapeutic Discovery Project grant of $183,925

The Internal Revenue Service today notified CharlestonPharma that it has been approved for a grant in the amount of $183,925 for the development of antibodies to nucleolin for the treatment of cancer. This grant is being made under the Qualifying Therapeutic Discovery Project program authorized under the 2010 Affordable Care Act.

CharlestonPharma's mission is to develop fully human anti-nucleolin antibodies as a potential unique new treatment for patients with cancer.

CharlestonPharma, LLC is formed by veteran business and pharmaceutical research and development executives to develop fully human antibodies to nucleolin to treat patients with cancer

Three industry veterans, with a track record of drug development from discovery to commercialization and biotechnology drug partnering, announced today they have created CharlestonPharma, LLC to develop fully human antibodies to the cell surface receptor, nucleolin, as a potential treatment for cancer.

Laboratory and clinical research at the Medical University of South Carolina (MUSC) have identified nucleolin on the cell surface as a novel and unique therapeutic target in cancer cells. This target is a receptor protein that is over-expressed on the cell surface of many different types of cancers and leukemias. Importantly, this protein is not, or is only minimally expressed, on the cell surface of corresponding normal tissues of the body. This finding not only offers the much-sought opportunity for "selective, tumor-specific therapies" and "personalized medicine" for both solid tumors and leukemias, but also is associated with an excellent safety profiles.

One of these MUSC researchers is our co-founder and Chief Scientific Officer, Daniel J. Fernandes, Ph.D., D.Sc., who also serves as a Professor of Biochemistry and Molecular Biology at MUSC and as the Associate Director for Translational Research at the Hollings Cancer Center (HCC) located at MUSC. He is the co-inventor of a fundamental patent that claims the process of making fully human monoclonal antibodies to nucleolin. To date, eight such anti-nucleolin antibodies have been created. His role at MUSC and HCC includes assisting basic scientists in establishing direct links to clinical investigators who can assist in the translation of preclinical research to research in patients, thus bringing discoveries from the laboratory to the clinical setting. He also assists with developing successful relationships with pharmaceutical companies.

Dr. Fernandes' research has been continuously funded by the NCI for 30 years. He is a former Scholar of the Leukemia and Lymphoma Society and served as the principal investigator on a program project grant sponsored by the Society. This is a comprehensive, translational research program that integrates basic and clinical studies aimed at identifying the molecular changes that lead to the development of chronic lymphocytic leukemia (CLL) and acute myeloid leukemia (AML).

His research career has focused on the mechanisms of action and mechanisms by which cancer cells develop resistance to anticancer drugs. The present discovery and development of anti-nucleolin monoclonal anti-nucleolin antibodies provides a new, first in class approach to treating cancers. His prior research assisted in the development of two FDA approved drugs: Fludarabine and Ethyol.

In 1980 Dr. Fernandes was awarded an honorary Doctorate of Science Degree from the University of Massachusetts for his scientific contributions.

The second veteran co-founder is Robert L. Capizzi, M.D., our President and Chief Medical Officer. Dr. Capizzi is a board certified medical oncologist whose career spans more than 38 years in clinical oncology and cancer drug development, both in academia and industry.  He has achieved international recognition for his work in clinical pharmacology, cancer drug development and clinical trials. His academic laboratory and clinical research has resulted in the development of three novel regimens for various malignancies, still in continuous use, including a curative therapy for acute myeloid leukemia. In industry, he has led the clinical development and regulatory teams that obtained marketing approvals for four drugs in six indications. He has made significant individual contributions to the approval of other agents in collaboration with both small and large pharmaceutical companies. Dr. Capizzi's leadership includes service on the Boards of Directors of the American Society of Clinical Oncology (ASCO) and the American Association for Cancer Research (AACR), as a member and chair of the Food and Drug Administration's oncology drug advisory committee (ODAC) and various advisory boards for the National Institutes of Health (NIH), the American Cancer Society, international agencies and pharmaceutical companies. Dr. Capizzi has served as Executive Vice President and Chief Medical Officer of Xanthus Life Sciences, Vice President-Medical Affairs at Novacea Inc. and Executive Vice President for Worldwide Research and Development at U.S. Bioscience, Inc. He was previously a member of the Howard Hughes Medical Institute at Yale University, Chief of Oncology at UNC Chapel Hill, and the Director of the Comprehensive Cancer Center at Wake Forest University. He is the former Magee Professor and Chairman of the Department of Medicine at Thomas Jefferson Medical College in Philadelphia. The Medical College created the Robert L. Capizzi Professorship in Medicine in recognition of his leadership role and service to the University. He was awarded the US Army Meritorious Service Medal for his research while in the Army Chemical Service and as been designated as an ASCO STATESMAN in recognition of his service and contribution to Oncology.

Drs. Fernandes and Capizzi are joined by Bradford S. Goodwin, our Chief Executive Officer, an experienced biotech executive. Mr. Goodwin also serves as a director of two public biotechnology companies: Rigel, Inc. and NeurogesX. Most recently he was Chairman of the Board of Facet Biotech Corp., a monoclonal antibody research and development company, which was sold to Abbott Laboratories for $722 million in April 2010. Previously he was Chairman of the Board of PDL BioPharma, a monoclonal antibody company earning $300 million per year in royalties and Chairman of the Board of CoTherix, Inc. a company commercializing Ventavis for pulmonary arterial hypertension that was sold to Actelion in 2007 for $420 million. From 2001 to 2006, he was Chief Executive Officer and Director of Novacea, Inc., an oncology drug development company that he built from a start up with one employee and one preclinical compound into a public company with three clinical stage products, including one in Phase 3. At Novacea, he led four rounds of financings that raised over $140 million, including its IPO in 2006, and licensed two clinical stage compounds. He led the efforts to obtain a major corporate partnership for the company's lead product, which was consummated shortly after he departed, with a total upfront payment of $72 million plus attractive royalties on product sales. Prior to Novacea, Mr. Goodwin was Vice President of Finance at Genentech, Inc. where he assisted in the commercialization of the first two FDA approved monoclonal antibodies for cancer: Rituxan® and Herceptin®.

CharlestonPharma is a Limited Liability Company incorporated in Delaware and qualified to do business in South Carolina. The company is represented by the law firm of Wilson, Sonsini, Goodrich & Rosati.