September 22, 2014 4:22 PM ET

Biotechnology

Company Overview of Kadmon Corporation, LLC

Company Overview

Kadmon Corporation, LLC, a biopharmaceutical company, focuses on the discovery and development of therapeutic drugs based on molecular biology and genomics for the treatment of oncology, immunology, and infectious and neurodegenerative diseases. It also distributes and markets a portfolio of branded and generic drugs for the treatment and management of hepatitis C. Kadmon Corporation, LLC was formerly known as Kadmon Holdings, LLC. The company was incorporated in 2009 and is based in New York, New York with operations in Warrendale, Pennsylvania; and Boston, Massachusetts.

450 East 29th Street

5th Floor

New York, NY 10016

United States

Founded in 2009

Phone:

212-308-6000

Key Executives for Kadmon Corporation, LLC

Founder
Age: 66
Chief Financial Officer
Executive Vice President of Biologics and President of Kadmon China
Chief Administrative
Chief Medical Officer and Executive Vice President
Age: 70
Compensation as of Fiscal Year 2014.

Kadmon Corporation, LLC Key Developments

Kadmon Corporation, LLC Initiates 2a Portion of KD020 Study in Autosomal Dominant Polycystic Kidney Disease

Kadmon Corporation, LLC announced the initiation of the Phase 2a portion of a Phase 1b/2a study of KD020, the company's orally bioavailable small molecule kinase inhibitor of Src, HER2, EGFR and VEGFR2/KDR, in autosomal dominant polycystic kidney disease (ADPKD). Initiation of the Phase 2a portion of the study follows the unanimous recommendation of the study's Data Safety Committee after their review of all Phase 1b safety and pharmacokinetics data. ADPKD is the most prevalent monogenic disease in the US and globally, affecting about 600,000 Americans and about 12.5 million people worldwide, with no disease modifying approved therapies currently available. ADPKD is caused by a mutation in either the polycystin 1 or 2 (PKD1 or PKD2) genes, resulting in the abnormal, uncontrolled growth of renal tubular epithelial cells. The disease is characterized by the formation of cysts in the kidney causing destruction of the kidney parenchyma resulting in loss of renal function. PKD is the fourth highest cause of kidney failure. Clinical symptoms usually develop between the ages of 30 and 40, but they can begin earlier and include persistent flank pain, hypertension, kidney and urinary tract infections and hematuria. In the Phase 1b portion of the study, KD020 was generally well tolerated, with rash (Grade 2) as the most common > Grade 1 adverse event in the highest dose cohort (150 mg daily). The Phase 2a study is designed to evaluate the activity, safety and tolerability of an alternate dosing schedule of 150 mg of KD020 administered three times weekly.

Kadmon Corporation and National Institute of Dental and Craniofacial Research Announce to Evaluate Gene Therapy Program

Kadmon Corporation, LLC announced that it has established a Cooperative Research and Development Agreement (CRADA) with the National Institute of Dental and Craniofacial Research (NIDCR), an institute of the National Institutes of Health, to develop an Adeno-associated virus vector containing the human aquaporin-1 gene (AAV2hAQP1) for the treatment of xerostomia resulting from the use of ionizing radiation (IR) in the treatment of head and neck cancer. Kadmon and NIDCR will also explore the use of the salivary gland as a delivery mechanism for therapeutic proteins into the blood. A significant consequence of IR treatment is the irreversible damage to salivary glands in the IR field resulting in dramatic and permanent reduction in salivary output. Because saliva plays such a critical role in the protection of the tissues of the upper gastrointestinal tract, xerostomia patients suffer considerable morbidity, including oral infections, mucositis, dysphagia, as well as extreme discomfort. There is no adequate therapy currently available to treat this severe condition, which affects approximately 168,000 patients in the US. Under terms of the agreement, Kadmon and NIDCR will conduct a Phase 1 study to test the safety of single escalating doses of AAV2hAQP1. Effectiveness, measured by increase in parotid gland salivary output post-IR, will also be tested for up to three years. As salivary glands are easily and non-invasively accessible, self-contained and able to secrete proteins into the bloodstream, the potential exists to use them to express and secrete specific transgene-encoded proteins into the blood. Based on data previously obtained at NIDCR, and using Kadmon's technology for transgene expression and regulation, the parties will seek to optimize conditions for the delivery of therapeutic proteins in patients via salivary glands.

Kadmon Corporation, LLC Announces the Initiation of Phase 1b/2a Study of KD019 and Trastuzumab in HER2-Positive Metastatic Breast Cancer

Kadmon Corporation, LLC announced the initiation of a Phase 1b/2a study of KD019, the Company's orally bioavailable small molecule kinase inhibitor of Src, HER2, EGFR and VEGFR2/KDR, in combination with trastuzumab (Herceptin(R)) for the treatment HER2+ breast cancer metastasized to the brain. Activation of Src kinase has emerged as a key resistance mechanism in trastuzumab treated HER2-positive breast cancer. Additionally, Src activity has been shown to play a critical role in brain metastases of HER2-positive breast cancers. Subjects with HER2-positive breast cancer frequently develop brain metastases, despite control of systemic disease by trastuzumab or other HER2 inhibitors. These brain metastases are largely unresponsive to pharmaceutical treatment as none of the currently approved HER2 inhibitors effectively cross the blood-brain barrier (BBB) resulting in limited drug exposure in the brain. In preclinical studies, unlike the available HER2/EGFR inhibitor Iapatinib (Tykerb(R)), KD019 demonstrated the ability to cross the BBB in vivo while also inhibiting HER2/EGFR as well as Src. The primary objective of this multicenter, multiple ascending dose, open-label, Phase 1b/2a study is to assess the safety, tolerability and efficacy of KD019 when given in combination with trastuzumab to subjects with HER2-positive metastatic breast cancer who have received prior trastuzumab therapy. The study is expected to enroll up to 38 patients. In the Phase 1b portion of the study, KD019 will be orally administered in successive dose cohorts at 150, 250, and 300 mg doses once daily until the maximum tolerated dose is established for the Phase 2a expansion group. Patients in the Phase 1b portion of the study may be enrolled with or without brain metastases. The Phase 2a portion of the study will be limited to subjects with HER2-postive breast cancer with brain metastases progressing after radiation therapy.

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