• Calimmune Expands Lentiviral Gene Therapy Pipeline Through License of Sickle Cell Disease Therapeutic Candidate

    License of Gamma-Globin from Cincinnati Children’s Hospital Medical Center to be used in combination with Calimmune’s Select+™ Technology

    TUCSON, Ariz.-- December 5, 2016

    -- (BUSINESS WIRE) -- Calimmune, Inc., a clinical-stage gene therapy company, today announced a license agreement with Cincinnati Children’s Hospital Medical Center  (Cincinnati Children’s) to develop and commercialize gene therapies combining Calimmune’s Select+™ technology with Cincinnati Children’s proprietary gene therapy construct for the treatment of patients with sickle cell disease and beta thalassemia. Calimmune’s Select+™ platform aims to improve engraftment of stem cell gene therapies through a post-cellular infusion selection process. 

    “The combination of Cincinnati Children’s proprietary lentiviral construct with Calimmune’s Select+ technology is a powerful innovative step in the fight against debilitating hematologic conditions such as sickle cell disease and beta thalassemia,” said Salim Yazji, M.D., chief medical officer of Calimmune. “We are applying our unique experience in ex vivo lentiviral vector gene therapy to make treatments for hemoglobinopathy more effective, less toxic, and ultimately more accessible to the patients that need them.” 

    “Our current clinical vector has been optimized to efficiently correct hematopoietic stem cells in patients suffering from sickle cell disease, so that the cells are able to produce the hemoglobin our circulatory system requires to function properly,” said Punam Malik, M.D., the Marjory J. Johnson chair of gene and cell therapy and director of the Cincinnati Comprehensive Sickle Cell Program at Cincinnati Children’s. “This collaboration with Calimmune allows us to create long-term or permanent solutions for patients with these diseases who are facing shortened life expectancy and reduced quality of life - even with the benefit of current therapies.” 

    Monogenic diseases such as hemoglobinopathies are prime targets for gene therapy due to their high prevalence, significant morbidity and mortality, and the resulting high cost of medical care that indicate that gene therapy can greatly improve patient outcomes and significantly reduce associated medical costs. Calimmune’s approach for the treatment of sickle cell disease involves introduction of the gamma-globin gene (known to have anti-sickling properties) into the patient’s own hematopoietic stem cells (HSCs) via a self-inactivating lentiviral vector. Following introduction of the gamma-globin gene, Calimmune’s Select+™ technology will be used to positively select for the modified HSCs, thus increasing the population of modified versus unmodified cells in the patient’s system. 

    Sickle cell disease and beta thalassemia are among the most common genetic defects worldwide. In the United States alone it is estimated that at least 2 million people carry one gene encoding for sickle cell anemia. Lentiviral vector delivery of a gamma-globin gene therapy to autologous HSCs holds great promise in creating healthy, long-lived HSCs in patients suffering from these currently incurable genetic diseases.  

    About Select+™
    Calimmune’s proprietary Select+TM technology is a safe tool aimed at driving selection of the genetically modified stem cells once they are given back to patients, to improve potency and lower toxicity.  One of the historical challenges for gene therapy is achieving a high enough engraftment of stem cells in the bone marrow to reach the relevant therapeutic window.  Toxic conditioning regimens used to drive engraftment of gene modified cells cause a list of adverse events that often require hospitalization and have additional long-term risks.  Calimmune has focused on and made significant investments to solve this issue with Select+TM.  By coupling Select+TM with lentiviral therapeutic applications, we aim to reduce the conditioning regimens, increase efficacy, and improve the patient experience, ultimately making stem cell gene therapy an out-patient modality.

    About Calimmune
    Calimmune is accelerating the promise of gene therapy to liberate patients from chronic and currently incurable diseases. To achieve our ambitious goal, we have built a suite of technologies to advance the delivery, manufacturing, and overall efficiency of these life-changing medicines. Calimmune’s lead development programs are novel ex vivo gene therapies for hematologic diseases.

    Contacts
    Cammy Duong
    MacDougall Biomedical Communications
    781-591-3443
    cduong@macbiocom.com

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  • Calimmune Appoints Salim Yazji, M.D. as Executive Vice President and Chief Medical Officer

    Former Vice President and Global Therapeutics Head of Oncology at Baxalta Inc.

    Tucson, Ariz., November 17, 2016

    – Calimmune, Inc., a clinical-stage gene therapy company, has made a key addition to its leadership team with the appointment of Salim Yazji, M.D. as executive vice president and chief medical Officer. Dr. Yazji was most recently the vice president and global therapeutics head of oncology for Baxalta, Inc.

    “Salim’s depth of experience and proven leadership in shepherding innovative products from pre-clinical development through product approval will be vital to Calimmune as we move our next generation hematopoietic stem cell therapies forward in the clinic,” said Louis Breton, chief executive officer of Calimmune. “I believe that his direct global pharmaceutical product development experience will also provide us with important insights as we advance our therapeutic candidates toward commercialization and seek to establish partnerships to further validate our pipeline programs. Therefore, on behalf of the Calimmune team, I welcome Salim and look forward to his contributions as we advance the field of gene therapy.”

    “Calimmune is at the forefront of developing the next generation of gene therapies for the treatment of hematologic diseases, building on its successful early clinical work of applying hematopoietic stem cell gene therapy to the treatment of HIV,” said Dr. Salim Yazji. “I am thrilled to join the Calimmune team at this important juncture in the development of gene therapy with the opportunity to work alongside a highly skilled scientific team, key opinion leaders and management team. Together, we will work to develop products that liberate patients currently facing chronic and currently incurable hematologic diseases.”

    Dr. Yazji will apply over 20 years of experience to the leadership of Calimmune’s clinical development and quality assurance teams. As a vice president and global therapeutic head at Baxalta, Inc., he was responsible for building the oncology medical organizations as well as expanding and advancing the oncology product pipeline into multiple successful global marketing authorizations. Prior to Baxter International’s spinoff of its bioscience business unit to create Baxalta, Dr. Yazji served as a vice president and therapeutic area head of oncology at Baxter.

    Prior to his role at Baxter, Dr. Yazji held leadership positions at Novartis Pharmaceutical, most recently as senior global clinical leader, hematology development. Prior to Novartis Pharmaceutical, Dr. Yazji held senior clinical research physician and medical director roles at Exelixis, Inc., PDL BioPharma, Inc. and Johnson & Johnson. Dr. Yazji obtained his medical degree from the Pavlov School of Medicine, University of St. Petersburg, St. Petersburg, Russia and completed postgraduate training at University of Texas M.D. Anderson Cancer Center, Park Plaza Hospital, Houston and Department of Cardiology, Almozov Hospital, St. Petersburg, Russia.

    About Calimmune
    Calimmune is accelerating the promise of gene therapy to liberate patients from chronic and currently incurable diseases. To achieve our ambitious goal, we have built a suite of technologies to advance the delivery, manufacturing, and overall efficiency of these life-changing medicines. Calimmune’s lead development programs are novel ex-vivo gene therapies for HIV and other hematologic diseases.

    Media Contact:
    MacDougall Biomedical Communications
    Cammy Duong
    781-591-3443
    cduong@macbiocom.com

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  • Calimmune CEO, Louis Breton Named to PharmaVOICE 100 for 2016

    Tucson, Ariz., August 2, 2016

    –Calimmune, Inc., a clinical-stage gene therapy company, is pleased to announce that its Chief Executive Officer, Louis Breton, has been selected by PharmaVOICE magazine as one of the top 100 most inspirational and extraordinary leaders in the life sciences industry for 2016.

    “I am honored and humbled to have been selected by PharmaVOICE,” said Mr. Breton. “It is a privilege to be among other leaders as we give ourselves to a common goal: to alleviate human suffering by advancing disease treatment options.”

    Mr. Breton has become a prominent voice over the past decade for improving access to gene therapies as a means to create a better quality of life for individuals struggling with incurable and chronic diseases.

    Calimmune is focused on developing gene therapies that enhance the body’s own defenses to defeat disease. Under Mr. Breton’s leadership, Calimmune’s lead program for treatment of HIV positive patients for whom traditional treatments are not effective has advanced to Phase I/II clinical trials. Advances in this program will establish Calimmune as a leader in ex-vivo gene therapy (gene modification of the patient’s own cells performed outside the body for reinfusion). Calimmune is building on this platform with next-generation gene therapy programs directed toward new out-patient treatments for hematologic diseases.

    About Calimmune

    Calimmune Inc. is a clinical-stage, international biotechnology company focused on developing novel gene therapies that have the potential to improve and protect the lives of patients by enhancing their immune system. Calimmune’s lead therapeutic candidate, now in Phase I/II clinical studies, is being evaluated as a one-time treatment to prevent HIV progression to AIDS. Calimmune’s development pipeline includes additional out-patient treatments for hematologic diseases. The company’s clinical and laboratory operations are based in Pasadena, California and Sydney, Australia. Calimmune’s corporate office is located in Tucson, Arizona.

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  • Calimmune Appoints Tana Session as Vice President, Human Resources and Promotes Jeffrey Bartlett, Ph.D., to Chief Scientific Officer

    Tucson, Ariz., July 14, 2016

    Calimmune Inc., a clinical-stage gene therapy company, has expanded its leadership team with the appointment of Tana Session as vice president, human resources. In addition, Jeffrey Bartlett, Ph.D., has been promoted to chief scientific officer to lead global research and development programs for Calimmune. Dr. Bartlett joined the company in 2012 as vice president, research and development.

    “Tana and Jeff will each play significant roles in propelling Calimmune into its next phase of growth and clinical development,” said Louis Breton, chief executive officer of Calimmune. “Their contributions to the executive leadership team will provide further momentum for Calimmune as we near completion of our U.S. Phase I/II trial dosing of Cal-1 for the treatment of HIV/AIDS, and as we pursue new hematologic disease indications.”

    Ms. Session leads all recruiting, hiring, onboarding and training of Calimmune employees worldwide. She previously served in several executive positions in human resources for diverse New York- and California-based public and private institutions including Golden State Water Company, Capco, Inc., The Center for Discovery, and Coleman Research Group. Additionally, Ms. Session founded and served as principal consultant for TMS Business Solutions Inc., a human resources consulting and coaching organization. Ms. Session earned her bachelor’s degree in business administration and her MBA with a concentration in organizational psychology and development. She holds certifications as Certified Career and Life Coach, Professional in Human Resources (PHR), Global Professional in Human Resources (GPHR), and SHRM Senior Certified Professional (SHRM-SCP).

    Dr. Bartlett brings more than 20 years of experience in development of viral vectors, novel gene and cell-based therapies, and the transition of scientific innovation and early phase clinical studies into accepted treatments. As chief scientific officer, he oversees external and internal research programs, manufacturing, and clinical laboratory activities. He also provides scientific guidance for ongoing clinical programs and overall corporate strategy. Prior to Calimmune, Dr. Bartlett was an investigator within the Centers for Gene Therapy and Childhood Cancer at The Research Institute at Nationwide Children’s Hospital, and served as a tenured academic faculty member at The Ohio State University and the University of North Carolina at Chapel Hill. He was also the scientific founder of Nexigen Biologics and has served on numerous special emphasis and regular grant review panels for the National Institutes of Health, as well as on FDA and NIH advisory committees, including two terms on the NIH Recombinant DNA Advisory Committee. He is an inventor on numerous patents, patent applications and licensed technologies relating to viral vectors and cell and gene therapy. Dr. Bartlett holds a bachelor’s degree from Middlebury College in Vermont and a doctorate in molecular biology from the University of Pittsburgh School of Medicine.

    About Calimmune

    Calimmune Inc. is a clinical-stage, international biotechnology company focused on developing novel gene therapies that have the potential to improve and protect the lives of patients by enhancing their immune system. The company was founded in 2006 from technology developed in the labs of Nobel Laureate David Baltimore, Ph.D. (California Institute of Technology), Irvin Chen, Ph.D. (University of California, Los Angeles), and Inder M. Verma, Ph.D. (Salk Institute for Biological Studies). Calimmune’s lead product candidate for HIV, now in Phase I/II studies, is being evaluated as a one-time treatment to prevent HIV progression to AIDS. The company is headquartered in Tucson, Arizona with labs and branch offices in Pasadena, California and Sydney, Australia.

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  • Calimmune Appoints Mark Smith as Chief Financial Officer

    Tucson, Ariz., March 23, 2016

    Calimmune Inc., a clinical-stage gene therapy company, has expanded its leadership team with the appointment of Mark Smith as chief financial officer. Mr. Smith brings more than 20 years of operational, financial and transactional experience to the position, in which he will oversee all financial operations and transactional activities for the company worldwide.

    “Mark is an accomplished finance executive who, throughout his career, has successfully navigated a variety of strategic transactions including private and public financings, mergers and acquisitions, corporate partnerships and debt financings,” said Louis Breton, chief executive officer of Calimmune. “His deep business acumen further rounds out Calimmune’s growing leadership team, providing added strength as we continue to expand our gene therapy platform into novel application areas and advance our clinical programs.”

    Mr. Smith has helped guide and grow companies in the life science, medical device and renewable biofuels sectors, most recently serving as CFO at Fluidic Energy. Previously, he held the same role for Gevo, where he played a key role in the company’s $123 million initial public offering. He also held the CFO post for biotech firm Replidyne during its initial public offering through its 2009 sale to Cardiovascular Systems, and has served in various financial executive capacities at healthcare companies including Nabi Biopharmaceuticals, Neuromedical Systems, Genzyme Corp. and Genetrix. He began his career with PricewaterhouseCoopers, holding accounting roles in Australia and the U.S. Mr. Smith holds a bachelor’s degree in accounting from the University of Canberra, Australia.

    About Calimmune

    Calimmune Inc. is a clinical-stage, international biotechnology company focused on developing novel gene therapies that have the potential to improve and protect the lives of patients by enhancing their immune system. The company was founded in 2006 from technology developed in the labs of Nobel Laureate David Baltimore, Ph.D. (California Institute of Technology), Irvin Chen, Ph.D. (University of California, Los Angeles) and Inder M. Verma, Ph.D. (Salk Institute for Biological Studies). Calimmune’s lead product candidate for HIV, now in Phase I/II studies, is being evaluated as a one-time treatment to prevent HIV progression to AIDS. The company is headquartered in Tucson, Arizona with labs and branch offices in Pasadena, California and Sydney, Australia.

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  • Calimmune and St. Jude Expand Partnership to Improve Lentiviral Vector Manufacturing for Novel Gene Therapies

    The licensed technology can increase global access to gene therapy through lower costs and shortened regulatory timelines

    Tucson, Ariz., January 5, 2016

    Calimmune Inc., a clinical-stage gene therapy company, has expanded its intellectual property estate covering Cytegrity™, an innovative lentiviral vector manufacturing technology, through a second licensing agreement with St. Jude Children’s Research Hospital. Financial terms of the deal were not disclosed.

    Calimmune and St. Jude have collaborated on vector manufacturing technology since December 2013.

    Under the expanded agreement, Calimmune is granted an exclusive, worldwide license to develop and commercialize product candidates using a second stable packaging cell line that produces lentiviral vectors. The technology will be part of Calimmune’s proprietary Cytegrity lentiviral vector bioproduction process, which improves scalability and affordability of gene therapy, and could result in as much as a 90 percent decrease in the cost of current methods for vector production.

    In an aligned effort to improve access to gene therapy globally, Calimmune and St. Jude have agreed that no royalties should be due from the sale of licensed products in developing-world countries if those products are sold at minimal or no profit. In addition, Calimmune aims to make this technology broadly available to companies developing lentivector-based gene therapies through commercial license.

    “This partnership is a significant piece of the larger mission that brings us one step closer toward democratizing gene therapy,” said Louis Breton, chief executive officer of Calimmune. “Together with St. Jude, we are developing solutions that will make gene therapy accessible and affordable to all who might benefit.”

    About Cytegrity™

    Cytegrity is a scalable manufacturing technology for the production of lentiviral vectors, which are used as a delivery mechanism for gene therapy. Lentiviral vectors are traditionally manufactured in small batches through a tedious process; Cytegrity introduces a new system that increases consistency and quality, while significantly lowering costs. By streamlining the production of lentiviral vectors, Calimmune seeks to enable clinically successful gene therapies to be more widely accessible.

    St. Jude Children’s Research Hospital

    St. Jude Children’s Research Hospital is leading the way the world understands, treats and defeats childhood cancer and other life-threatening diseases. It is the only National Cancer Institute-designated Comprehensive Cancer Center devoted solely to children. Treatments developed at St. Jude have helped push the overall childhood cancer survival rate from 20 percent to 80 percent since the hospital opened more than 50 years ago. St. Jude freely shares the breakthroughs it makes, and every child saved at St. Jude means doctors and scientists worldwide can use that knowledge to save thousands more children. Families never receive a bill from St. Jude for treatment, travel, housing and food—because all a family should worry about is helping their child live. To learn more, visit stjude.org or follow St. Jude at @stjuderesearch.

    About Calimmune

    Calimmune Inc. is a clinical-stage, international biotechnology company focused on developing novel gene therapies that have the potential to improve and protect the lives of patients by enhancing their immune system. The company was founded in 2006 from technology developed in the labs of Nobel Laureate David Baltimore, Ph.D. (California Institute of Technology), Irvin Chen, Ph.D. (University of California, Los Angeles) and Inder M. Verma, Ph.D. (Salk Institute for Biological Studies). Calimmune’s lead product candidate for HIV, now in Phase I/II studies, is being evaluated as a one-time treatment to prevent HIV progression to AIDS. The company is headquartered in Tucson, Arizona with labs and branch offices in Pasadena, California and Sydney, Australia.

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  • Calimmune Expands Board of Directors, Names R. Scott Greer as Chairman

    Mr. Greer and AbbVie’s James Sullivan, Ph.D., add to Calimmune’s depth of experience in developing and commercializing novel gene therapies

    Tucson, Ariz., November 19, 2015

    Calimmune Inc., a clinical-stage gene therapy company, today announced the appointment of R. Scott Greer as chairman of its board, and AbbVie Vice President of Discovery James Sullivan, Ph.D., as a new director. Mr. Greer will serve as chairman, replacing David Baltimore, Ph.D., who will remain active with Calimmune as a board member.

    “We look forward to benefiting from the complementary leadership and technical skills of Scott and Jim as we continue to expand our gene therapy platform technologies into novel application areas, advance our clinical development programs and pursue broader strategic relationships,” said Louis Breton, chief executive officer of Calimmune. “With Scott taking the helm of our board, we express our sincere gratitude to Dr. Baltimore for his many years of leadership as chairman, and are pleased that we will continue to benefit from his renowned expertise as he remains a director.”

    As Calimmune’s new chairman, Mr. Greer brings a sophisticated knowledge of the business and financial decisions that advance private and public biotech companies. He has served as the managing director of venture capital firm Numenor Ventures LLC since 2002 and was previously the founder and CEO and chairman of Abgenix Inc., a biotechnology company focused on developing and commercializing human antibody based therapeutics (Amgen acquired Abgenix in 2006). Previously, Mr. Greer held the role of chief financial officer and senior vice president of corporate development for Cell Genesys Inc., guiding the company through its initial public offering.

    Mr. Greer currently serves as a director of several biopharmaceutical and medical device companies including: Inogen Inc., Nektar Therapeutics and Versartis Inc. In the past he was chairman of Ablexis LLC and Sirna Therapeutics Inc. (acquired by Merck) and served on the board of several companies including Anaptys BioScience Inc., Auspex Pharmaceuticals Inc. (acquired by Teva Pharmaceuticals), CV Therapeutics Inc. (acquired by Gilead, Inc.) and Illumina Inc. Mr. Greer holds a Bachelor of Arts in economics from Whitman College and an M.B.A. from Harvard University.

    “With first-in-class viral vector manufacturing technology and a truly innovative approach to treating disease, Calimmune has the opportunity to make a substantial mark on the gene therapy market, starting with HIV,” Mr. Greer said. “I’m thrilled to join Calimmune at a time of great momentum for clinical development.”

    New board member Dr. Sullivan serves as vice president of pharmaceutical discovery at AbbVie, where he is responsible for research in a variety of disease areas including cancer, Alzheimer’s, hepatitis C and various autoimmune disorders. He oversees a global network of scientists that includes AbbVie researchers at sites in the United States and Europe, and external research partners around the world. Dr. Sullivan has advanced multiple compounds into clinical development and is an inventor on 11 patents. The prolific researcher is an adjunct faculty member at Northwestern University of Chicago. Dr. Sullivan earned his bachelor’s degree and Ph.D. in biochemistry from Trinity College in Dublin, Ireland, and conducted post-doctoral research in neurobiology at Northwestern University.

    “Calimmune is addressing a significant unmet need for the treatment of currently incurable diseases, including HIV/AIDS,” Dr. Sullivan said. “I’m excited to join Calimmune’s board of leading gene therapy industry experts, clinicians and academics to ultimately bring a long-term solution to patients.”

    The breakthrough gene modification and cell delivery technology developed in the lab of Nobel Laureate Dr. Baltimore at the California Institute of Technology laid the groundwork for Calimmune’s formation in 2006, along with the discoveries of Irvin Chen, Ph.D. and Inder M. Verma, Ph.D., both of whom serve as scientific advisors for Calimmune.

    “It’s been an honor to serve as chairman and to see first-hand the research from my lab come to life under Calimmune’s leadership,” said Dr. Baltimore. “I’m encouraged by the progress of Calimmune’s lead candidate, CAL-1, as it progresses through clinical trials, and I’m pleased to have a role in the future direction of the company.”

    About Calimmune

    Calimmune Inc. is a clinical-stage international gene therapy company developing novel treatments that have the potential to improve and protect the lives of patients by enhancing their immune system. Calimmune’s lead therapeutic candidate CAL-1, now in Phase I/II studies, is being evaluated as a one-time treatment for HIV/AIDS. The company is headquartered in Tucson, Arizona, with labs and branch offices in Pasadena, California and Sydney, Australia.

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  • Making LIFE Better: Calimmune Receives AZBio Fast Lane Honors

    news-preview

    Chandler, Ariz. September 21, 2015

    In recognition of its determination to provide hope to people around the world living with HIV/AIDS by developing a one-time or infrequent treatment therapy and for the progress they have made in both advancing clinical research and raising the funds needed for the journey, Calimmune, Inc. has been named a 2015 AZBio Fast Lane Company by the Arizona Bioindustry Association (AZBio).

    Calimmune is a clinical-stage, international gene therapy company that has assembled a world-class medical and scientific research team to develop innovative cell-based gene therapies for several disease indications, including HIV. Calimmune is also developing a rich product candidate pipeline to address the needs of different types of individuals at different states of HIV infection and with different levels of treatment experience.

    According to the World Health Organization (WHO), there were approximately 35 million people worldwide living with HIV/AIDS in 2013. Of these, 3.2 million were children (<15 years old). The AZBio Fast Lane Award recognizes companies that surpassed crucial milestones on the journey from discovery to development to delivery. Significant progress can be measured by activity in the past 18 months in the areas of clinical results, regulatory approvals, certifications, collaborations, funding awards, product launches, job growth or product sales milestones.

    “Calimmune’s progress in both the clinical trials process and in attracting the investments needed to support further testing is an excellent example of how, the combination of innovative technology, a dedicated team, and a passion for patients is making LIFE better” shared AZBio president and CEO Joan Koerber-Walker. “While today’s current therapies are helping patients manage their disease, today there is no cure. If Calimmune is successful in completing this journey, the result will be life-saving for HIV infected patients and life-changing for the people who love them.”

    Cal-1, the company’s lead therapeutic candidate, is a gene-based therapy engineered to control HIV infection and to protect individuals with HIV from progressing to AIDS. The therapy is currently being evaluated in Phase I/II studies. Cal-1 is designed to reduce production of CCR5, a protein on the surface of white blood cells that plays a critical role in enabling HIV to infect cells.

    It also has a second mechanism aimed at preventing viral fusion, the process by which the virus enters the cell. This dual approach was shown to be effective against broad strains of HIV in pre-clinical studies.

    In clinical trials for Cal-1, volunteers with HIV are infused with their own blood stem cells as well as mature T cells that have been treated with Cal-1. Cal-1 is intended to protect the treated cells against HIV and has the potential to provide a continuous means of controlling HIV after a single treatment. The initial study sites are Quest Clinical Research in San Francisco and The UCLA CARE Center.

    In 2015, Calimmune successfully completed its $15 million Series B financing round, led by AbbVie. Alexandria Venture Investments also joined with existing investors including RA Capital Healthcare Fund LP and Translational Accelerator LLC. Proceeds will be used to progress the company’s ongoing HIV/AIDS clinical trials, advance technology research programs and general corporate operations.

    Calimmune, Inc., HTG Molecular Diagnostics, Inc., and VisionGate, Inc. will be honored as AZBio Fast Lane Companies during the Tenth Annual AZBio Awards at the Phoenix Convention Center on October 1, 2015 in front of an audience of local, national, and international leaders.

    Recent recipients of the AZBio Fast Lane Award include: SenesTech, Cancer Prevention Pharmaceuticals, and Pinnacle Transplant Technologies. For a full list of past honorees, visit www.azbio.org/azbio-awards-2015/awards-history

    For registration and more information, go to www.azbioawards.com.

    About AZBio

    AZBio – The Arizona Bioindustry Association – is comprised of member organizations in business, research, government, and other professions involved in the biosciences. AZBio supports the members of the Arizona bioscience community by providing access to the key resources, connections, and information that support their ability to Connect, Collaborate, Innovate and Succeed thus supporting the growth of a thriving economic ecosystem for Arizona’s Bioscience Industry. The AZBio Awards are an exciting opportunity to connect with Arizona’s fastest growing industry sector. For more information visit www.AZBio.org and www.AZBio.TV.

    About Calimmune, Inc.

    Calimmune Inc. is a clinical-stage biotechnology company focused on developing novel gene therapies that have the potential to improve and protect the lives of patients by enhancing their immune systems. The company was founded in 2006 from technology developed in the labs of Nobel Laureate David Baltimore, Ph.D. (California Institute of Technology), Irvin Chen, Ph.D. (University of California, Los Angeles) and Inder M. Verma, Ph.D. (Salk Institute for Biological Studies). Calimmune’s lead product candidate for HIV, now in Phase I/II studies, is being evaluated as a one-time treatment to prevent HIV progression to AIDS. Calimmune is developing a full product pipeline of therapeutic candidates to address the unique needs of individuals at different stages of HIV infection and with various treatment histories. The company is headquartered in Tucson, Arizona with labs and branch offices in Pasadena, California and Sydney, Australia.

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  • Calimmune Completes $15 Million Series B Financing

    Proceeds Will Advance Clinical Trials for Gene-Based HIV/AIDS Therapies

    Tucson, Ariz., May 27, 2015

    Calimmune Inc., a clinical-stage gene therapy company, has successfully completed its $15 million Series B financing round, led by a large pharmaceutical company. Alexandria Equities LLC also joined with existing investors including RA Capital Healthcare Fund LP and Translational Accelerator LLC. Proceeds will be used to progress the company’s ongoing HIV/AIDS clinical trials, advanced technology research programs and general corporate operations.

    Cal-1, the company’s lead therapeutic candidate, is a gene-based therapy engineered to control HIV infection and to protect individuals with HIV from progressing to AIDS. The therapy is currently being evaluated in Phase I/II studies. Cal-1 is designed to reduce production of CCR5, a protein on the surface of white blood cells that plays a critical role in enabling HIV to infect cells. It also has a second mechanism aimed at preventing viral fusion, the process by which the virus enters the cell. This dual approach was shown to be effective against broad strains of HIV in pre-clinical studies.

    In clinical trials for Cal-1, volunteers with HIV are infused with their own blood stem cells as well as mature T cells that have been treated with Cal-1. By reducing CCR5 expression and preventing HIV viral fusion, Cal-1 may protect the treated cells against HIV and has the potential to provide a continuous means of controlling HIV after a single treatment. The initial study sites are Quest Clinical Research in San Francisco and The UCLA CARE Center.

    “Calimmune has assembled a world-class team and a comprehensive technology arsenal that harnesses the power of gene therapy to combat HIV and potentially a wide range of challenging diseases,” said Peter Kolchinsky, Ph.D., managing partner at RA Capital.

    “We are inspired by the support of such a high-caliber group of investors who share in our vision to provide enduring, perhaps lifelong, benefits to patients whose daily lives are severely compromised by currently incurable devastating diseases,” said Louis Breton, chief executive officer of Calimmune. “Over the past several decades, HIV/AIDS has shifted from a deadly disease to one that can largely be managed with medication. The next logical step in the evolution of HIV/AIDS patient care is finding a cure by enhancing the body’s own defenses.”

    The primary objectives of the Phase I/II trial for Cal-1 are to assess safety, determine the ease of use and feasibility for individuals living with HIV, and evaluate what, if any, side effects may exist.

    According to the World Health Organization, some 35 million people are living with HIV/AIDS worldwide. In the United States, the number of people living with HIV/AIDS exceeds 1.2 million. Infection with the human immunodeficiency virus (HIV) can lead to acquired immunodeficiency syndrome (AIDS), a disease that severely impairs immune function and leaves the body vulnerable to numerous secondary infections and complications.

    About Calimmune

    Calimmune Inc. is a clinical-stage biotechnology company focused on developing novel gene therapies that have the potential to improve and protect the lives of patients by enhancing their immune systems. The company was founded in 2006 from technology developed in the labs of Nobel Laureate David Baltimore, Ph.D. (California Institute of Technology), Irvin Chen, Ph.D. (University of California, Los Angeles) and Inder M. Verma, Ph.D. (Salk Institute for Biological Studies). Calimmune’s lead product candidate for HIV, now in Phase I/II studies, is being evaluated as a one-time treatment to prevent HIV progression to AIDS. Calimmune is developing a full product pipeline of therapeutic candidates to address the unique needs of individuals at different stages of HIV infection and with various treatment histories. The company is headquartered in Tucson, Arizona with labs and branch offices in Pasadena, California and Sydney, Australia.

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  • Calimmune Approved to Treat Second Group in HIV Stem Cell Gene Modification Study

    San Diego, Calif., June 25, 2014

    Calimmune Inc. today announced that encouraging results from a first group of participants indicates the company is ready to begin treating a second cohort in a clinical trial involving the use of Cal-1, an innovative gene-based stem cell therapy to help protect individuals infected with HIV from progressing to AIDS.

    Calimmune was given approval to move ahead following a review of safety data by their Data Safety Monitoring Board (DSMB). The DSMB confirmed that none of the participants experienced any serious adverse events or dangerous side effects from the therapy.

    “We are very excited and encouraged by this development,” says Louis Breton, Chief Executive Officer of Calimmune. “This recommendation from the DSMB is an important step in bringing this potential one time therapy to the patients, and takes us closer to our ultimate goal of eradicating AIDS.”

    Breton continued: “We are proud of our ongoing partnership with the California Institute for Regenerative Medicine (CIRM), and are most appreciative of their continued financial support of this critical effort.”

    The Phase I/II clinical trial focuses on a protein called CCR5 that plays a critical role in enabling HIV to infect cells. Blocking CCR5 expression may provide the cells a protective shield against HIV, which in turn would help retain immune system functionality.

    “The mission of CIRM is to efficiently accelerate the development of stem cell treatments for patients suffering from unmet medical conditions,” said, C. Randal Mills, Ph.D., President and CEO of CIRM. “While still early in clinical development, this announcement demonstrates real progress towards this mission. The accomplishment of Calimmune’s team is a great example of how CIRM partnerships are working to impact patient’s lives today.”

    In the first phase of this study 4 HIV-positive participants were infused with their own blood stem cells as well as mature T cells that had been modified to carry a gene that blocks production of CCR5. The hope is that those stem cells will then create a new blood system that is resistant to HIV. To guard against the virus forming resistance, the team has used a second mechanism to prevent the virus from fusing with the patient’s cells.

    The participants had all previously been on anti-retroviral drugs but had discontinued taking them because of side effects or treatment fatigue.

    The second group of 3-4 participants will not only get Cal-1 but will also get a preconditioning regimen with the aim of making the therapy more effective.

    The goal of the trial – which is being conducted in San Francisco and Los Angeles – is to assess the safety of the therapy, to determine the ease of use and feasibility of the approach for HIV/AIDS patients and to evaluate what, if any, side effects there may be.

    “With more than one million Americans living with HIV, there is clearly an urgent need for a therapy that does more than just hold the virus at bay,” says Jonathan Thomas, Ph.D., J.D., Chair of the stem cell agency’s governing Board. “Current medications are effective, but come with a big cost both in terms of dollars and side effects. Our goal is to find an approach that effectively cures people with HIV/AIDS.”

    About Calimmune

    Calimmune is a clinical-stage HIV gene medicines company focused on developing innovative cell-based therapies for HIV. The company’s stem cell technology was discovered in the labs of Nobel Laureate, Dr. David Baltimore (Caltech) and Dr. Irvin Chen (UCLA AIDS Institute). [company] is also developing a rich product candidate pipeline to address the needs of different types of individuals at different states of HIV infection and with different levels of treatment experience.

    About CIRM

    CIRM was established in November 2004 with the passage of Proposition 71, the California Stem Cell Research and Cures Act. The statewide ballot measure, which provided $3 billion in funding for stem cell research at California universities and research institutions, was overwhelmingly approved by voters, and called for the establishment of an entity to make grants and provide loans for stem cell research, research facilities, and other vital research.

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  • First Patient Treated in Clinical Trial Testing an Innovative Stem Cell Treatment for HIV/AIDS

    San Francisco, Calif., July 9, 2013

    Calimmune has treated the first patient in a clinical trial involving the use of an innovative gene-based stem cell therapy to help protect individuals infected with HIV from the effects of the AIDS virus.

    The Phase I/II clinical trial – which California’s stem cell agency, the California Institute for Regenerative Medicine (CIRM) is helping fund – focuses on a protein called CCR5 that plays a critical role in enabling HIV to infect cells. Blocking CCR5 may provide the cells a protective shield against HIV, which in turn would help retain immune system functionality.

    In this study 12 HIV-positive individuals will be infused with their own blood stem cells that carry a gene that has been modified to block production of CCR5. The hope is that those stem cells will then create a new blood system that is resistant to HIV. To guard against the virus forming resistance, the team has used a second mechanism to prevent the virus from fusing with the patient’s cells.

    “This study is an early but important step in an emerging area of scientific exploration, representing the culmination of more than a decade of research and development,” says Calimmune Chief Executive Officer Louis Breton. “We are optimistic that what we learn from this study may bring us closer to the day when a one-time or infrequent treatment could lessen, delay or provide an alternative to a lifetime of antiretroviral therapy.”

    The goal of the trial – which is being conducted in San Francisco and Los Angeles – is to assess the safety of the therapy, to determine the ease of use and feasibility of the approach for HIV/AIDS patients and to evaluate what, if any, side effects there may be.

    “CIRM funding of this Phase l/ll trial is an important milestone for us,” says Alan Trounson, PhD, President of the stem cell agency. “One of our goals is to support research that moves the most promising science out of the lab and into clinical trials in people. To be able to do that with a disease as devastating as HIV/AIDS highlights the importance of our funding and the potential impact it could have on the health of people around the world.”

    Jeff Sheehy, the Patient Advocate member of our governing Board for HIV/AIDS, and a longtime community activist, says regardless of the results the trial is important:

    “This trial will hopefully offer several important insights into the safety and feasibility of genetically modifying blood forming stem cells in an HIV patient as a potential therapy. We are very early in this research, and with this Phase I trial’s goal of establishing safety and the risks involved, I applaud the courage and altruism demonstrated by the patients who are willing to participate in this study.”

    According to the Centers for Disease Control and Infection (CDC) more than 1.2 million people in the US are living with HIV. This number is growing because new and more effective medications are keeping people alive longer with the infection. However, these medications – which have to be taken every day – are expensive and, over time, have side effects.

    For more information about this trial, visit www.clinicaltrials.gov (http://www.clinicaltrials.gov)

    About CIRM

    CIRM was established in November 2004 with the passage of Proposition 71, the California Stem Cell Research and Cures Act. The statewide ballot measure, which provided $3 billion in funding for stem cell research at California universities and research institutions, was overwhelmingly approved by voters, and called for the establishment of an entity to make grants and provide loans for stem cell research, research facilities, and other vital research.

    About Calimmune

    Calimmune is a clinical-stage HIV gene medicines company focused on developing innovative cell-based therapies for HIV. The company’s stem cell technology was discovered in the labs of Nobel Laureate, Dr. David Baltimore (Caltech) and Dr. Irvin Chen (UCLA AIDS Institute). Calimmune is also developing a rich product candidate pipeline to address the needs of different types of individuals at different states of HIV infection and with different levels of treatment experience.

    Read More