David Kalergis (born December 9, 1948) is an American life sciences entrepreneur and the co-founder and chair of Atelerix Life Sciences Inc., a Charlottesville, Virginia, U.S.-based biotechnology and pharmaceutical company developing novel treatments for the reversal of opioid induced respiratory depression. [1] He co-founded the company in 2020 with Stephen Lewis, PhD, James Bates, MD/PhD, and Ben Gaston, MD.
Previously, he co-founded Diffusion Pharmaceuticals in 2001 with American chemical engineer John L. Gainer. Kalergis became Diffusion's CEO in 2004, retaining that position until 2020, when he left to create Atelerix Life Sciences. During this time, he drew extensively on his career in law, business, and clinical trials implementation to advance the company to Phase 3 clinical trials status and into a NASDAQ publicly traded entity. [2] Under Kalergis' leadership, Diffusion Pharmaceuticals has been cited for advancing improved cancer treatments, conducting multicenter clinical trials of a novel therapeutic for brain cancers, including glioblastoma multiforme. [3] [4] [5] [6] Diffusion Pharmaceuticals has also conducted clinical trials for the treatment of oxygen deficiencies associated with COVID-19 and acute stroke. [7]
Kalergis received a B.A. degree in psychology in 1970 and J.D. and M.B.A. Degrees in 1982 from the University of Virginia. He subsequently worked with the New York-based law firm Dewey, Ballantine, Bushby, Palmer & Wood, maintaining that association until 1986, when he became president and General Counsel of Designs Import/Export, Ltd. From 1991 to 1997, he was Consultant, Director of Business Development, and General Counsel to the contract research organization Pharmaceutical Research Associates (PRA), Inc. [1] [8] While with PRA, he was involved in numerous pharmaceutical development projects through the pre-clinical, clinical, and post-marketing stages.
In 1998 Kalergis was appointed Director of University of Virginia Gateway, a program to establish stronger ties between industry and academia, particularly in the area of life sciences. [1] His efforts have been cited in advancing relationships between the high-technology business and academic sectors, both regionally [9] and internationally. [10] It was through his association with the University of Virginia that Kalergis met Gainer, who was at that time a professor of Chemical Engineering, leading to their collaboration in the founding of Diffusion Pharmaceuticals.
Kalergis also attended the Harvard Business School's Leadership and Strategy in Biotechnology and Pharmaceuticals program. [8]
Kalergis was a founding director of publicly traded Virginia National Bank where he was Chairman of the Assets and Liabilities Committee and a member of the Audit Committee. He is a former member of the Boards of Directors of the Virginia Biotechnology Association, the Virginia Piedmont Technology Council, and the Computers4Kids Program in Charlottesville, Virginia. He is a former member of the New York and Virginia State Bar Associations. [1] [8]
Kalergis received the Virginia Piedmont Technology Council's Navigator award in 2002. [8] His and Gainer's work at Diffusion Pharmaceuticals was acknowledged in 2012, when the company received the Virginia Healthcare Innovators "Medical Product or Device" award. [11]
Kalergis is the author of The Role of the university in the Commercialization of Biotechnology (1981). [2]
Kalergis lives in Charlottesville, Virginia, with his wife, noted documentary photographer Mary Kalergis. [12]
Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted.
Tumor hypoxia is the situation where tumor cells have been deprived of oxygen. As a tumor grows, it rapidly outgrows its blood supply, leaving portions of the tumor with regions where the oxygen concentration is significantly lower than in healthy tissues. Hypoxic microenvironments in solid tumors are a result of available oxygen being consumed within 70 to 150 μm of tumor vasculature by rapidly proliferating tumor cells thus limiting the amount of oxygen available to diffuse further into the tumor tissue. In order to support continuous growth and proliferation in challenging hypoxic environments, cancer cells are found to alter their metabolism. Furthermore, hypoxia is known to change cell behavior and is associated with extracellular matrix remodeling and increased migratory and metastatic behavior.
Glioblastoma, previously known as glioblastoma multiforme (GBM), is the most aggressive and most common type of cancer that originates in the brain, and has very poor prognosis for survival. Initial signs and symptoms of glioblastoma are nonspecific. They may include headaches, personality changes, nausea, and symptoms similar to those of a stroke. Symptoms often worsen rapidly and may progress to unconsciousness.
An academic clinical trial is a clinical trial not funded by pharmaceutical or biotechnology company for commercial ends but by public-good agencies to advance medicine. These trials are a valuable component of the health care system; they benefit patients and help determine the safety and efficacy of drugs and devices, and play an important role in the checks and balances that regular commercially oriented clinical trials.
Crocetin is a natural apocarotenoid dicarboxylic acid that is found in the crocus flower together with its glycoside, crocin, and Gardenia jasminoides fruits. It is also known as crocetic acid. It forms brick red crystals with a melting point of 285 °C.
BioMarin Pharmaceutical Inc. is an American biotechnology company headquartered in San Rafael, California. It has offices and facilities in the United States, South America, Asia, and Europe. BioMarin's core business and research is in enzyme replacement therapies (ERTs). BioMarin was the first company to provide therapeutics for mucopolysaccharidosis type I, by manufacturing laronidase. BioMarin was also the first company to provide therapeutics for phenylketonuria (PKU).
Lomustine is an alkylating nitrosourea compound used in chemotherapy. It is closely related to semustine and is in the same family as streptozotocin. It is a highly lipid-soluble drug, thus it crosses the blood–brain barrier. This property makes it ideal for treating brain tumors, which is its primary use, although it is also used to treat Hodgkin lymphoma as a second-line option. It has also been used in veterinary practice as a treatment for cancers in cats and dogs.
Nereus Pharmaceuticals was a pharmaceutical company focused on the development of natural products from marine microbial and other natural sources into small molecule human therapeutics. The major disease area addressed by Nereus is cancer. Nereus was purchased by Triphase Research and Development in 2012.
Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for adults and children with rare and difficult-to-treat cancers. The company is headquartered in Austin, Texas, United States.
Temozolomide, sold under the brand name Temodar among others, is an anticancer medication used to treat brain tumors such as glioblastoma and anaplastic astrocytoma. It is taken by mouth or via intravenous infusion.
An oxygen diffusion-enhancing compound is any substance that increases the availability of oxygen in body tissues by influencing the molecular structure of water in blood plasma and thereby promoting the movement (diffusion) of oxygen through plasma. Oxygen diffusion-enhancing compounds have shown promise in the treatment of conditions associated with hypoxia and ischemia. Such conditions include hemorrhagic shock, myocardial infarction, and stroke.
Diffusion Pharmaceuticals Inc (NASDAQ:DFFN) is a publicly traded biotechnology and drug development company based in Charlottesville, Virginia, U.S. It was co-founded in 2001 by American life sciences entrepreneur David Kalergis and University of Virginia Chemical Engineering Professor John L. Gainer. Gainer is the inventor of the company's platform technology of oxygen diffusion-enhancing compounds and its lead drug, trans sodium crocetinate (TSC). TSC acts to increase the rate at which oxygen moves through blood plasma by the process of diffusion, a phenomenon that forms the basis for the company's name. On January 8, 2016, the formerly privately held company merged with Restorgenex Cororation to become a publicly traded NASDAQ-listed company with the trading symbol DFFN. TSC and other oxygen diffusion-enhancing compounds, including bipolar trans carotenoid salts, have been investigated by Diffusion Pharmaceuticals for treatment of conditions associated with reduced oxygen availability in tissues (hypoxia). Most recently, Diffusion has begun the initiation of clinical trials in the U.S. and Eastern Europe for the use of trans sodium crocetinate in the treatment of COVID-19 patients with respiratory distress-related oxygen deficiency and the risk of multiple organ failure.
Kadmon Corporation is a biopharmaceutical company based in New York City. It also has operations in Warrendale, PA and Brighton, MA. The company was founded in 2009 by Samuel D. Waksal, founder and former CEO of ImClone Systems, now fully merged into Eli Lilly and Company. Waksal had served a federal prison sentence stemming from his fiduciary role as CEO in the 2001 ImClone stock trading case. When released in 2009 he was barred from serving as an officer for any publicly traded company but Kadmon was privately financed.
John L. Gainer is an American chemical engineer and co-founder and former chief scientific officer of Diffusion Pharmaceuticals, a biotechnology and pharmaceutical company based in Charlottesville, Virginia, U.S. Professor Gainer retired from his position as Chief Science Officer of Diffusion Pharmaceuticals in March, 2020. Gainer pioneered investigation into the mechanism of action underlying oxygen diffusion-enhancing compounds (ODECs) and invented the subclass of ODECs known as bipolar trans carotenoid salts. The lead compound of this class is trans sodium crocetinate (TSC) which Gainer invented while a professor of chemical engineering at the University of Virginia.
Two River Group Holdings is a New York-based venture capital firm and merchant bank focused on the life science sector. It specializes in investments in life science, biotechnology, and in firms focused on developing preventive and therapeutic technologies for a broad spectrum of disease areas including oncology, cardiovascular disease, neurological disorders, and companion animal health care.
Seagen Inc. is an American biotechnology company focused on developing and commercializing innovative, empowered monoclonal antibody-based therapies for the treatment of cancer. The company, headquartered in Bothell, Washington, is the industry leader in antibody-drug conjugates or ADCs, a technology designed to harness the targeting ability of monoclonal antibodies to deliver cell-killing agents directly to cancer cells. Antibody-drug conjugates are intended to spare non-targeted cells and thus reduce many of the toxic effects of traditional chemotherapy, while potentially enhancing antitumor activity.
Aldoxorubicin (INNO-206) is a tumor-targeted doxorubicin conjugate in development by CytRx. Specifically, it is the (6-maleimidocaproyl) hydrazone of doxorubicin. Essentially, this chemical name describes doxorubicin attached to an acid-sensitive linker.
Depatuxizumab mafodotin is an antibody-drug conjugate designed for the treatment of cancer. It is composed of an EGFR IGg1 monoclonal antibody (depatuxizumab) conjugated to the tubulin inhibitor monomethyl auristatin F via a stable maleimidocaproyl link.
University of Virginia Cancer Center is a National Cancer Institute-designated Comprehensive Cancer Center affiliated with the University of Virginia School of Medicine and the UVA Health System.
Mary Motley Kalergis, is an author, photographer and interviewer.