doctors, patients and scans

Leading CRAC Channel Platform Company Delivering Drug Candidates For Inflammatory Diseases

Learn more about AuxoraTM for severe COVID-19 pneumonia >

About Us

CalciMedica is a leader in the discovery and development of CRAC channel inhibitor drugs. CRAC channels are expressed on many cell types, including lung endothelium cells, pancreatic acinar cells and immune system cells, where aberrant activation of these channels may play a key role in the pathobiology of acute and chronic inflammatory syndromes. The Company has a portfolio of highly selective CRAC channel inhibitor drugs that it is developing to improve outcomes for patients with acute inflammatory indications. CalciMedica’s lead compound AuxoraTM has delivered promising Phase 2 results in two indications, down-regulating cytokines and preventing organ damage in both severe COVID-19 pneumonia and predicted severe acute pancreatitis. Potential registration studies in severe COVID-19 pneumonia, flu pneumonia with respiratory failure/acute respiratory distress syndrome (ARDS) and predicted severe acute pancreatitis are scheduled to start in 2020.

CalciMedica is headquartered in San Diego, CA.

Company History

CalciMedica was founded in 2007 by Ken Stauderman, CalciMedica’s Chief Scientific Officer, along with Anjana Rao and Patrick Hogan (then at Harvard’s CBR Institute of Biomedical Research and currently at the La Jolla Institute of Immunology) and Stefan Feske (then at Harvard’s CBR Institute of Biomedical Research and currently at NYU School of Medicine). Dr. Stauderman’s work includes the discovery of STIM1, a protein that works in concert with Orai1 to form the CRAC channels targeted by CalciMedica’s drugs. At CalciMedica, Dr. Stauderman developed a series of proprietary assays that have allowed for the identification of highly selective CRAC channel inhibitors and has built a leading platform for this work. The Company has advanced two different CRAC channel inhibitors into human clinical testing, including its lead compound AuxoraTM. It has also generated a novel set of CRAC channel inhibitors with different features, and assembled a portfolio of patents and patent applications covering those compounds as well as different aspects of CRAC channel biology, including the STIM and Orai proteins that are key elements of a CRAC channel.
Nurse and Cell Image

CRAC Channel Biology

Calcium release-activated calcium (CRAC) channels are comprised of two key components – STIM and Orai proteins—that work to regulate the flow of Ca2+ into cells. CRAC channels are expressed in many cell types, including lung endothelium cells, pancreatic acinar cells and immune system cells, where they control a variety of normal cell functions. However, when a cell is under attack, for example by a virus or toxin, the CRAC channel can open excessively, leading to an imbalance of calcium and disrupting cell function. Evidence suggests that overactivated CRAC channels play a role in inflammation-induced injury of pulmonary endothelial cells, resulting in loss of alveolar-capillary barrier function and accumulation of fluid into the alveoli. Similarly, hyperactivation of CRAC channels results in excessive calcium influx in pancreatic acinar cells, which plays a pivotal role in cellular injury and the progression of acute pancreatitis. Efforts to block CRAC channels and restore healthy cell function have focused on inhibiting STIM or Orai proteins. CalciMedica’s AuxoraTM targets the Orai1 protein, thereby blocking excessive calcium entry caused by aberrant CRAC channel activity.

Reference: Adapted from Roos,…Stauderman, J. Cell Bio. 2005; Zhang…Stauderman, Cahalan, Nature, 2005; Zhang…Stauderman, Cahalan, PNAS, 2006.

Pipeline

CalciMedica’s lead clinical compound, AuxoraTM, is a potent and selective small molecule inhibitor of Orai1-containing CRAC channels that is being developed for use in patients with diseases that have respiratory dysfunction, including ARDS as a major component. Such diseases include severe COVID-19 pneumonia, acute flu pneumonia with respiratory failure/ARDS, and acute pancreatitis with accompanying systemic inflammatory response syndrome (SIRS). Evidence suggests that CRAC channels play a role in inflammation-induced injury of pulmonary endothelial cells, resulting in loss of alveolar-capillary barrier function and accumulation of fluid in the alveoli. Similarly, hyperactivation of CRAC channels results in excessive calcium influx into pancreatic acinar cells and plays a pivotal role in cellular injury and the progression of acute pancreatitis. In each of these settings, local and systemic inflammation can lead to organ failure and death. Auxora has demonstrated reduced ventilator use and mortality as well as improved time to recovery in patients with severe COVID-19 pneumonia on low-flow supplemental oxygen therapy. In patients with hypoxemia secondary to SIRS from acute pancreatitis, Auxora has been found to accelerate patient recovery, decrease hospital stay and potentially protect lung and kidney function.

CalciMedica is also exploring other acute indications for Auxora such as viral pneumonia, acute lung injury (ALI), acute respiratory distress syndrome (ARDS) and acute kidney injury (AKI).

CalciMedica Product Pipeline

For more details on the clinical trial of Auxora in patients with severe COVID-19 pneumonia, please visit: clinicaltrials.gov.

Team

Management

The CalciMedica team is comprised of scientists, physicians, drug development experts and entrepreneurs dedicated to the development of CRAC channel inhibitors for acute and chronic inflammatory conditions.
Rachel Leheny
A. Rachel Leheny, Ph.D.
Chief Executive Officer and Chairman

A. Rachel Leheny, Ph.D.

Chief Executive Officer

Dr. Leheny has over 25 years of experience in the life sciences industry as a scientist, a research analyst at several investment banks, and as a venture capital investor. Dr. Leheny is a Founding Managing Director for Valence Advantage Life Sciences, a venture firm based in New York. Prior to Valence, she co-founded Caxton Advantage Venture Partners, from which Valence Life Sciences emerged. Before that, she was a Senior Vice President and Head of the biotechnology research team at Lehman Brothers. She also led the biotechnology research team at UBS Warburg. She started her biotechnology research career at Hambrecht and Quist. Dr. Leheny obtained an A.B in Chemistry with honors from Harvard College, and a Ph.D. in chemistry from Columbia University. She did post-doctoral work at the University of California, Berkeley, where she was an NIH fellow and a lecturer.
Michael Dunn
Michael Dunn, MBA
President & Chief Operating Officer

Michael Dunn, MBA

President & Chief Operating Officer

Mr. Dunn has 30 years of experience in the pharmaceutical and biotech industries. Before joining CalciMedica, Mr. Dunn was Senior Vice President, Corporate Development at Biocept, Inc., a company focused on the analysis of circulating tumor cells (CTCs) to better target therapy for cancer patients. Prior to that, he served as Vice President and Chief Business Officer of Monogram Biosciences, a biotech clinical laboratory specializing in infectious disease and cancer testing, which was acquired by LabCorp in 2009. Mr. Dunn served as Vice President and Chief Business Officer of ACLARA Biosciences, a company specializing in microfluidic chips and oncology testing, through its merger with ViroLogic, Inc., as well as Vice President and Chief Business Officer at ActivX Biosciences, a biopharmaceutical company that utilizes proteomics to discover and develop small molecule drugs for major unmet medical needs. Additionally, Mr. Dunn served as Vice President of Business Development at Aurora Biosciences, a company that developed and commercialized proprietary drug discovery systems and services, and in various project management and business development roles at Salk Institute Biotechnology Industrial Associates, Inc. (SIBIA) and its successor SIBIA Neurosciences, culminating as Vice President of Business Development. SIBIA was acquired by Merck in 1999. Mr. Dunn holds a B.A. in Biology from the University of Chicago and an MBA in Finance from the University of San Diego.
Sudarshan Hebbar
Sudarshan Hebbar, M.D.
Chief Medical Officer

Sudarshan Hebbar, M.D.

Chief Medical Officer

Dr. Hebbar has 10+ years of clinical development and product development experience in both the pharmaceutical and diagnostics industries. Before joining CalciMedica, Dr. Hebbar was a consultant for Mallinckrodt Pharmaceuticals, where he served as the clinical development lead for a global multicenter Phase IV trial. Prior to that, he was the Vice President of Nephrology at Thrasos Innovation where he helped implement a global multicenter Phase II trial of a novel therapeutic compound for acute kidney injury. Before working at Thrasos, Dr. Hebbar served as Medical Vice President and a member of the U.S. Board of Directors at Oncimmune, a company that pioneered the development of autoantibody assay technologies for the early detection of lung cancer. Before joining Oncimmune, Dr. Hebbar served as a Medical Director at Reata Pharmaceuticals, where he was a medical monitor for both a Phase III global multicenter trial and multiple Phase I trials, and the clinical development lead for multiple Phase II trials. Dr. Hebbar began his industry career at Abbott, where he initially served as a Senior Medical Director in the Quality and Regulatory division before transferring to the Diagnostics division, where he supervised a team that provided medical input into product development, supported commercial launches of diagnostic products and led the clinical development of novel biomarkers.

 

Prior to joining Abbott, Dr. Hebbar was a Medical Director at Dialysis Clinics Incorporated and a partner at Kidney Associates of Kansas City where for 12 years he practiced nephrology, hypertension, transplant medicine and critical care medicine. Dr. Hebbar received a B.A. in Natural Sciences from The Johns Hopkins University and a M.D. from Tulane University School of Medicine. He completed a residency in Internal Medicine and a fellowship in Critical Care Medicine, both at Hennepin County Medical Center, a fellowship in Nephrology at the University of Chicago and a fellowship in Clinical Medical Ethics at The Maclean Center for Clinical Medical Ethics at the University of Chicago.

Kenneth Stauderman
Kenneth Stauderman, Ph.D.
Co-founder & Chief
Scientific Officer

Kenneth Stauderman, Ph.D.

Chief Scientific Officer

Dr. Stauderman brings more than 30 years of research and management experience in pharmaceuticals and biotechnology, and has an extensive research background in mechanisms controlling intracellular calcium. Prior to co-founding CalciMedica with Dr. Gonul Velicelebi and joining the company in April 2007, Dr. Stauderman was Executive Director of Biology and Lead Discovery at TorreyPines Therapeutics, since its inception as Neurogenetics, Inc. While at TorreyPines, he directed two successful drug discovery programs and one target discovery initiative that led to the discovery of STIM1 as a key regulator of calcium release-activated Ca2+ channels. Prior to TorreyPines Therapeutics, Dr. Stauderman was Director of Molecular and Cell Biology at SIBIA Neurosciences, Inc. (which later became Merck Research Laboratories, San Diego) from 1994-2000, and Senior Scientist at Marion Merrell Dow Pharmaceuticals (now Sanofi-Aventis; 1986-1994). Dr. Stauderman has authored/co-authored over 50 scientific publications and is an inventor on several patents. Dr. Stauderman received a B.A. in Psychology from the University of Virginia and a Ph.D. in Pharmacology from the University of Texas Health Science Center in San Antonio, Texas.
Michael Dixon
Michael Dixon, CPA, CA
Chief Financial Officer

Michael Dixon, CPA, CA

Chief Financial Officer

Michael Dixon, CPA CA has over 18 years of experience working in an executive role for venture-backed companies. As CEO of Therillia Development Company Inc., Mr. Dixon oversees the development of therapeutic assets of interest to Therillia’s shareholders, including dalcetrapib. Prior to his role in Therillia, Mr. Dixon was Chief Financial Officer of Gemin X Pharmaceuticals. At Gemin X he structured and negotiated equity financings leveraged with venture debt and other forms of non-dilutive capital to fund the company’s Canadian and U.S. operations over an 11-year period. Gemin X was successfully sold to Cephalon (now Teva), at the time one of the largest private biotech deals in Canada. Prior to Gemin X, Mr. Dixon was Interim COO and Vice President Finance at Morphometrix Technologies, a medical device company specialized in the automation of cervical cancer screening. Mr. Dixon began his career at Price Waterhouse with a focus on compliance services for entrepreneurial businesses, strategic financial modeling and management information systems. Mr. Dixon received his Bachelor of Commerce degree from the University of Toronto and his Chartered Accountant designation while at Price Waterhouse.

Board of Directors

  • Robert McNeil, Ph.D.
    Co-Chairman of the Board
  • Robert N. Wilson
    Co-Chairman of the Board
  • Eric Roberts
    Vice Chairman of the Board
  • A. Rachel Leheny, Ph.D.
    Chief Executive Officer and Chairman
  • Michael Dunn, MBA
    President & Chief Operating Officer
  • Fred Middleton, MBA
    Managing Director, Sanderling Ventures
  • Lakhmir Chawla, M.D.
    Chief Medical Officer, La Jolla Pharmaceuticals Company

Robert McNeil, Ph.D.

Co-Chairman of the Board

Robert McNeil has over 36 years of experience as an active investor and management participant in seed and early-stage biomedical companies. He founded Sanderling Ventures in 1979 and has served since then as a Managing Director of Sanderling’s seven investment partnerships. Dr. McNeil has been the seed investor for many successful companies including Western Technology Ventures, Advanced Cardiovascular Systems (acquired by Eli Lilly and spun out as Guidant Corp.) and Ventritex (acquired by St. Jude Medical). Dr. McNeil was the Chairman of Ista Pharmaceuticals, GeminX, as well as other entities. Currently he serves as CEO of DalCor Pharmaceuticals, U.K and is active in Sanderling VII portfolio companies. As an active investor, Dr. McNeil has been instrumental in the development many companies. In addition, he has been instrumental in the development and management of Sanderling Ventures six successive partnerships. In each case, close relationships with management and careful understanding of the companies’ technologies have allowed successful development of products at very early stage. Dr. McNeil earned his Ph.D. in the fields of molecular biology, biochemistry and genetics in 1972 from the University of California, Irvine. He is well known for his love of the sea and restoration of important historical vessels.

Robert N. Wilson

Co-Chairman of the Board

Mr. Wilson brings a wealth of expertise in the pharmaceutical, biotech and medical device industries, having held leadership roles on boards and been Chairman of various companies and organizations including Johnson & Johnson, the Pharmaceutical Research and Manufacturers of America (PhRMA), Synta Pharmaceuticals Corporation and Mevion Systems, among others. In addition, Mr. Wilson previously served as a member of the board of directors of Charles Schwab Corporation, Hess Corporation and as Chairman of Caxton Health Holdings, leading efforts in pharmaceutical and health technology investments. Prior to that, Mr. Wilson served in several roles at Johnson & Johnson, notably as Vice Chairman of the Board of Directors for 15 years and on the executive committee for 20 years. During his nearly 40-year tenure at Johnson & Johnson, he played a key role in the expansion of the pharmaceutical, device and diagnostic programs while establishing the company as a leader in the search for new solutions for patients. He holds a Bachelor’s degree from Georgetown College in Kentucky.

Eric Roberts

Vice Chairman of the Board

Mr. Roberts has 30 years of experience in the finance, investment and life sciences industry and has completed hundreds of financings and merger transactions. Mr. Roberts is currently Vice Chairman of the Board of CalciMedica Inc. and serves as the company’s Chief Business Officer and has served on a number of boards of public and private companies. In 2012, Mr. Roberts co-founded investment firm, Valence Life Sciences. Prior to Valence Life Sciences, Mr. Roberts managed the Caxton Advantage Life Sciences Fund which he co-founded in 2005. Prior to Caxton Advantage, he was Managing Director and Co-Head of the Global Healthcare Investment Banking Group at Lehman Brothers. Mr. Roberts was also a Managing Director, Partner and founder of the Life Sciences Department at Dillon, Read & Co. Inc. which was ultimately merged into UBS. At UBS, Mr. Roberts ran the Life Sciences investment banking team. Earlier in his career, Mr. Roberts worked at Citicorp in the Citicorp Venture Capital (CVC) group. Mr. Roberts received a B.S. in Economics from the Wharton School of the University of Pennsylvania. He is also a Director of the Cary Institute for Ecosystem Studies, the Atlantic Salmon Federation and is a past Director of the American Museum of Fly Fishing.

Lakhmir Chawla, M.D.

Chief Medical Officer, La Jolla Pharmaceuticals Company

Dr. Chawla joined La Jolla Pharmaceuticals in 2015, and previously was a Professor of Medicine at the George Washington University, where he had dual appointments in the Department of Anesthesiology and Critical Care Medicine and in the Department of Medicine, Division of Renal Diseases and Hypertension. He was also the Chief of the Division of Intensive Care Medicine at the Washington D.C. Veterans Affairs Medical Center. Dr. Chawla designed and led the ATHOS 3 Phase 3 trial for La Jolla Pharmaceutical’s FDA-approved drug for shock, GiaprezaTM. He is an internationally renowned expert in the field of acute care and especially acute kidney injury, and is the author of over 100 peer-reviewed publications.

Fred Middleton, MBA

Managing Director, Sanderling Ventures

Fred Middleton has over thirty years of experience in the biotechnology and biomedical industries in both corporate operating management and as an institutional venture capital investor. At Sanderling, he has worked as an investor, management team member and director in over 20 new biomedical ventures built in Sanderling’s venture investment portfolios since 1988. Recently, he has played an active role as Chairman, CEO or Director of a number of current Sanderling portfolio companies, including as Chairman of Pacira Pharmaceuticals, Stereotaxis, Viacyte and Altor Biosciences. He also served as an early stage investor and director of Regeneron Pharmaceuticals, CardioNet, Endocyte, LineaGen, Inc. and Actimis. In 1978, Mr. Middleton joined Bob Swanson and Herb Boyer, the founders of biotechnology pioneer Genentech, Inc., as the third member of the original management team, where he served in various capacities, including Vice President of Finance, Administration, Corporate Development, Chief Financial Officer, and as President of Genentech Development Corporation. While at Genentech, Mr. Middleton successfully completed over $200 million in corporate partnering and institutional funding transactions, which included managing the Company’s (and the biotech industry’s first) successful IPO in 1980. In 1984, Mr. Middleton founded Morgan Stanley Ventures, an affiliate of Morgan Stanley, serving as Managing General Partner of an institutional fund making technology investments. Mr. Middleton joined Sanderling in 1987 as a General Partner and Managing Director to invest in and build early stage biomedical companies. Mr. Middleton earned his B.S. in chemistry from the Massachusetts Institute of Technology in 1971 and received an M.B.A with distinction from Harvard Business School in 1973. In 2007, he was elected to serve as a member of the M.I.T. Corporation.

News

CalciMedica Announces Peer-Reviewed Publication of Positive COVID-19 Data and Initiation of Blinded, Placebo-Controlled Trial of Auxora™ in Patients with Severe COVID-19 Pneumonia

August 18, 2020

Study published in Critical Care journal shows patients with severe COVID-19 pneumonia treated with Auxora and standard of care had substantially improved outcomes compared to …

CalciMedica and EpiPharma Enter into Research Collaboration to Discover and Develop CRAC Channel Inhibitor Therapies

July 21, 2020

Under the terms of the research collaboration agreement, CalciMedica will use EpiPharma’s state of the art Pre-clinical Drug Testing and Diagnostics Laboratory Platform to accelerate …

CalciMedica Announces Data Showing Auxora™ Substantially Improved Outcomes in Patients with Severe COVID-19 Pneumonia

July 16, 2020

Median time to recovery was more than two times faster for patients treated with Auxora plus standard of care compared to standard of care alone …

CalciMedica Appoints Robert N. Wilson as Co-Chairman of the Board of Directors and Eric W. Roberts as Vice Chairman

June 2, 2020

Robert N. Wilson was Former Johnson & Johnson Vice Chairman Board Member, Eric W. Roberts, named Vice Chairman and Chairman of the Strategic Transactions and …

CalciMedica Announces Positive Topline Data from Interim Analysis of Trial Evaluating Auxora™ in Patients with Severe COVID-19 Pneumonia

May 28, 2020

Interim results showed Auxora plus standard of care improved time to recovery and reduced ventilator use in patients compared to standard of care alone  LA …

CalciMedica Raises $15 Million in Series C Financing Round Led by Valence Life Sciences

May 22, 2020

Funds to support ongoing clinical trials in patients with COVID-19 pneumonia and commercial manufacturing of Auxora™   LA JOLLA, Calif., May 22, 2020 – CalciMedica Inc. (“CalciMedica” …

CalciMedica Announces that FDA Has Strongly Recommended Moving to a Blinded Placebo-controlled Trial with Auxora™ in Patients with Severe COVID-19 Pneumonia

May 21, 2020

LA JOLLA, Calif., May 21, 2020 – CalciMedica Inc. (“CalciMedica” or the “Company), a clinical-stage biotechnology company targeting calcium release-activated calcium (CRAC) channels for the treatment …

CalciMedica Announces Independent Safety Review Committee Recommendation to Continue Phase 2 Study of CM4620-IE in Patients with Severe COVID-19 Pneumonia on Low-Flow Oxygen Therapy

May 7, 2020

LA JOLLA, Calif., May 7, 2020 – CalciMedica Inc. (“CalciMedica” or the “Company), a clinical-stage biotechnology company targeting calcium release-activated calcium (CRAC) channels for the treatment …

CalciMedica Expands Clinical Study to Assess CM4620-IE in Patients with Critical COVID-19 Pneumonia on High-Flow Oxygen Therapy

April 30, 2020

Phase 2 open-label study expands to additional sites across the U.S. and aims to enroll 120 patients  LA JOLLA, Calif., April 30, 2020 – CalciMedica Inc. …

FDA Grants CalciMedica Permission to Begin Dosing CM4620-IE in Patients with Severe COVID-19 Pneumonia under a Newly Opened IND

April 9, 2020

Regions Hospital in St. Paul, Minnesota has begun a Phase 2 clinical study of CM4620-IE in patients with severe COVID-19 pneumonia this week, and Henry …

CalciMedica to Present Results of PD/PK Study in Acute Pancreatitis Patients for Its CRAC Channel Inhibitor CM4620 at APA Annual Meeting

November 7, 2019

LA JOLLA, CA, November 7, 2019 /PRNewswire/ — Kenneth Stauderman, Ph.D., CalciMedica’s Chief Scientific Officer, is presenting a poster at the American Pancreas Association annual …

Henry Ford Hospital Physician Presents Results from the Initial Patient Study of CalciMedica’s CRAC Channel Inhibitor CM4620 in Acute Pancreatitis at ACEP Meeting

October 30, 2019

LA JOLLA, CA, October 30, 2019 /PRNewswire/ — Joseph Miller, MD, MS, a physician at the Henry Ford Health System in Detroit, MI, and a …

CalciMedica Names Life Science Veteran to Its Board of Directors

March 26, 2019

LA JOLLA, CA, March 26, 2019 /PRNewswire/ — CalciMedica, a clinical-stage biopharmaceutical company developing CM4620, a novel small molecule compound for acute pancreatitis, announced that …

CalciMedica, Inc. to Present Study Population Profile from Its Initial Patient Study of Its CRAC Channel Inhibitor CM4620 in Acute Pancreatitis at International Conference

March 19, 2019

LA JOLLA, CA, March 19, 2019 /PRNewswire/ — Physicians from several study sites involved in CalciMedica’s initial acute pancreatitis clinical study of its CRAC channel …

CalciMedica Names Two Senior Executives to Its Board of Directors

May 1, 2018

LA JOLLA, CA, May 1, 2018 /PRNewswire/ — CalciMedica announced that it named two independent members to its Board of Directors, Lakhmir Chawla, MD, currently …

Contact Us

General:

info@calcimedica.com

Media contact:

Karen O’Shea, Ph.D.
LifeSci Communications
koshea@lifescicomms.com

CalciMedica
505 Coast Boulevard South
Suite 202
La Jolla, CA 92037

858-952-5500
info@calcimedica.com

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