ImmunoScience launches a private placement offering via Reg D, 506(C) to accredited investors.
ImmunoScience has launched a private placement offering to raise a minimum of $7 million and a maximum of $25 million via its investor portal and to allow accredited investors invest. ImmunoScience is using this novel approach upon the advice of its financial guides and is confident of success because revolutionary biopharma companies like ImmunoScience are rarely available to investors before an IPO.
ImmunoScience receives letter from UK authorities about additional audit and documentation.
ImmunoScience received a response from the UK MHRA. There were no issues with the safety and trial design. However, the UK authorities are requiring an on-site audit of the GMP process as well as certain additional documents required by European regulations. Our CRO has suggested that we complete the requirements pointed out and reapply in order to get a final approval.
ImmunoScience applies for clinical trials in the UK to regulatory bodies.
ImmunoScience, with the assistance of our CRO, Advyzom, completed all the necessary requirements and submitted a full application package to the UK regulatory body, the MHRA.
Scientists at Guys Hospital London agree to conduct Phase I trial for ImmunoScience in the UK.
After several months of documentary exchange and conferences, Guy's/St. Thomas Hospitals' chief HIV research scientist, Dr. Julie Cox and her team have agreed to be the principal investigators for the Contre Vir™ project and collaborate with ImmunoScience.
ImmunoScience scientists publish two papers in peer reviewed journals.
After months of diligent work, two papers have been published in peer reviewed journals by ImmunoScience scientists.
The first paper is Nef Deletion in HIV-1eli Eliminates Peripheral CD4 T-Cell Loss in a Humanized BLT Mouse Model of HIV Disease.
The second paper is The Effect of nef-Deleted SIV Administration on Disease Progression in SIV-Infected Rhesus Macaques.
These papers show that the SIV version of Contre Vir™ is safe in infected animals while Contre Vir™ in humanized mice eliminates blood cell loss.
Scientists at ImmunoScience build a library of cancer markers and begin working on inserting the markers into the proprietary vector.
After 19 months of work, ImmunoScience scientists have built a library of cancer markers for most common cancers such as melanoma, breast, colon, prostate and lung to name a few. Work is also almost complete on developing the shRNA segments to inhibit two factors that cancers use to evade the immune system. We have also identified a robust process to manufacture the vaccine but it will take additional work before it can be scaled up. Work shall soon begin on finding ways to insert these markers into our vector in such a way that the vector's viability is preserved.
ImmunoScience gets conditional green light for a trial in South Africa once a trial in UK is initiated.
After a presentation by ImmunoScience's team comprised of Dr. Apte, Dr. Fon Tam and Dr. Christina Carnegie to the whole board of Medicines Control Council, the board was extremely encouraged about this study and were supportive of it being carried out in South Africa. Unfortunately, South African law does not allow "first in human" trials of drugs manufactured outside South Africa and ImmunoScience was asked to reapply after the trials begin in the UK.
ImmunoScience obtains a CE Mark for Salivax™ HIV.
BSi (British Standards Institution) has awarded a CE Mark for ImmunoScience's Salivax™ HIV kit. This was a very difficult process and which involved scientifically convincing Paul Ehrlich Institute in Germany (which carries out the tests for BSi's clients) of the scientific accuracy of our test kits. The process took a long time because this is the ONLY time a solely saliva based diagnostic kit has received the CE Mark. Obtaining the CE Mark opens up European and many other markets which look at the CE Mark as an authority. We congratulate the ImmunoScience scientists who were instrumental in this significant and noteworthy step.
ImmunoScience applies for approval for Phase I trials in South Africa.
ImmunoScience, in collaboration with the Johannesberg CRO, OnQ Consulting completed an application to South Africa's drug regulators, the medicines control council. South Africa with a large number of HIV infected patients and with advanced infrastructure is ideally suited for studying Contre Vir™ and local scientists and collaborators are excited about being involved in this significant study.
ImmunoScience successfully completes a study in humanized mice.
ImmunoScience, in collaboration with BATS Laboratories, completed a study of Contre Vir™ in humanized (BLT) Mice. These mice are immune compromised and are given a transplant of human bone marrow, liver and thymus to give them a human immune system. The study's results are encouraging and will be presented in an upcoming paper.
ImmunoScience scientists begin research on cancer vaccine.
ImmunoScience scientists Dr. Jared Clever and Dr. Saipiroon (Fon) Tam have started the work on ImmunoScience's polyvalent therapeutic vaccine for cancer. A vector was obtained and is being successfully grown in a specific cell line. The vector's genome has been sequenced and work has begun on creating a library of cancer markers to be introduced into the genome. Other ImmunoScience scientists are working on creating shRNA loops to disrupt two mechanisms used by cancer to evade the immune system.
ImmunoScience successfully completes a second Macaque (monkey) study of SIV infected animals at CA Primate Research Center.
ImmunoScience scientists completed a second Rhesus Macaque study in collaboration with the California Primate Research Center at UC Davis. 16 animals were infected with SIV and 8 were given the nef-deficient version of SIV as a vaccine after their AIDS was established. This study was not geared towards efficacy testing because there is no exact SIV version of Contre Vir™ possible due to genomic and behavioral differences between the two viruses. However, the study conclusively proved that giving a nef-deficient virus to already infected animals is safe and causes no adverse consequences.
ImmunoScience concludes audit by Uganda National Drug Authority at its facilities in California in expectation of Phase I Clinical trials.
A team of Ugandan National Drug Authority (NDA) came to Dublin, California to audit ImmunoScience's GMP processes and documentation. They spent one week at the facility going through every aspect of the manufacturing process and gave a GMP certificate which is valid of three years.
ImmunoScience partners with Joint Clinical Research Center (JCRC) in Uganda to conduct Phase I Clinical trials for its therapeutic HIV vaccine.
ImmunoScience scientists met with JCRC Direcetor Dr. Peter Mugyenyi, Deputy Director Dr. Cissy Kityo and others to perform clinical trials of Contre Vir™ in Uganda as permitted by Ugandan law. JCRC is a preeminent research and treatment institution in East Africa dedicated to serving over 100,000 HIV infected patients and its scientists are excited about the prospects for a functional cure of HIV.
ImmunoScience successfully completes animal studies at UC Davis, CA.
After completing animal studies in mice at BATS labs, the second phase of testing in monkeys (rhesus macaques) was completed at UC Davis Primate Center. No toxicity was observed in any of the monkeys tested. This allows ImmunoScience to move to the next set of trials in monkeys to prove that the vaccine is safe in SIV infected monkeys.
ImmunoScience reaches GMP milestone at its facilities in Dublin, CA.
After having had a failure with a contract manufacturer, ImmunoScience embarked upon constructing its own biosafety level-3 (BSL-3) facility in Dublin, California. Our scientists were quickly able to develop a robust process and have now manufactured several batches adhering to strict GMP standards as established by the US FDA. In addition to the scientists, our quality assurance and regulatory affairs staff played a very important role in getting all the required documentation compiled and in order. We are very proud of this achievement.
ImmunoScience presents at AIDS 2012 in Washington, D.C.
ImmunoScience exhibited SalivaxTM
-HIV, the company’s rapid test for HIV that uses saliva as a testing medium, and unveiled SalivaxTM-HBV and SalivaxTM
-HCV at the XIX International AIDS Conference in Washington D.C., USA. Overall, the device received positive reviews from those who viewed it firsthand. ImmunoScience plans to apply for FDA approval for SalivaxTM
-HBV and SalivaxTM
-HCV in the coming months.
Subhagya Wadekar, PhD. joins ImmunoScience's scientific research team as a scientist
Dr. Wadekar comes to ImmunoScience with an award-winning background in the field of biotechnology. Her research extensive research of bacteria and cell culture has contributed greatly to the field of cancer studies, and she received the National Research Award from the National Cancer Institute. She received her undergraduate degree from University of Toledo, then stayed to pursue and graduate with a Ph.D. in Biomedical Sciences, with a focus on Molecular and Cellular Biology. Dr. Wadekar has presented her findings throughout the United States, as well as in Canada and the National Institute of Virology in Pune, India.
Professor Luc Montagnier, Ph.D. joins the Scientific Advisory Board
It is with great pride that ImmunoScience welcomes Nobel Laureate Luc Montagnier to its Scientific Advisory Board. In 1983, Dr. Montagnier led the team which first isolated HIV1, and in 1985, he isolated the second AIDS virus, HIV2, from West African patients. He received his Ph.D. in virology at University of Paris, France, and is a Professor emeritus and Director of the World Foundation for AIDS Research and Prevention, which is based in Paris. Dr. Montagnier is the author and co-author of 350 scientific publications, and is named on over 750 patents. For his discovery of the HIV virus, Dr. Montagnier won the 2008 Nobel Prize in Medicine along with Dr. Françoise Barré-Sinoussi .Dr. Montagnier joins a distinguished group of scientists who currently serve on ImmunoScience’s scientific advisory board.
ImmunoScience receives ISO 13485:2003 Certification
ImmunoScience receives ISO Certification for its Pleasanton facility. ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems.
Christopher Rold, Ph.D. and Jared L. Clever, Ph.D. join ImmunoScience's team
Dr. Clever is a virologist with over 15 years of scientific experience, and joins the ImmunoScience team with a background of work with cell culture, retroviral concentration and purification, and harvesting infectious viral supernatants. Dr. Clever also studied vascular and skeletal muscle regeneration after injury during his capacity as a research pathologist, and has completed and published an extensive mutagenesis study of RNA structures in HIV, as well as numerous publications.
Dr. Rold joins the vaccine development team at ImmunoScience with extensive experience in microbiology and immunology. A biology major at The Johns Hopkins University, Dr. Rold received a Bachelor's degree before continuing on to Vanderbilt University to receive a Doctorate in Microbiology and Immunology in the Department of Microbiology and Immunology. His years of involvement with the HIV/AIDS Research Training Program and dedicated research in the fields of cellular and molecular biology will make Dr. Rold an integral part of the ImmunoScience research team.
Richard Fields, Esq. joins Board of Directors
Mr. Fields joins the ImmunoScience Board of Directors as a Senior Associate at Tapestry Networks. With a focus on government studies, Mr. Fields graduated magna cum laude from Clark University with a Bachelor of Arts degree, then graduated with additional honors from the University of Chicago Law School where he received a JD. He also acts as President of the Boys and Girls Clubs of Middlesex Couty, Inc., and comes to ImmunoScience with extensive non-profit organizational experience.
ImmunoScience presents at AIDS 2010 in Vienna, Austria
ImmunoScience exhibited SalivaxTM-HIV, the company’s rapid test for HIV that uses saliva as a testing medium, at the XVIII International AIDS Conference in Vienna, Austria. Overall, the device received positive reviews from those who viewed it firsthand. ImmunoScience plans to enter the European market and is in the process of acquiring the CE Mark which provides approval for sale in Europe and in other countries around the world.
J. Kermit Birchfield, Esq. joins ImmunoScience's Board of Directors
Mr. Birchfield is an independent business consultant, and serves on numerous boards, including his current work as Managing Director of Century Partners, Inc. A graduate of Roanoke College, Mr. Birchfield took his Bachelor of Science degree to the University of Virginia, where he received his JD. He comes to ImmunoScience with a strong background in financial work and will serve as a valuable member of the Board of Directors at ImmunoScience.
ImmunoScience presents at the National AIDS Conference in Hyderabad, India
In partnership with the Koya Group, ImmunoScience exhibited SalivaxTM
-HIV, the company’s rapid test for HIV that uses saliva as a testing medium, at India’s National HIV/AIDS Conference in Hyderabad. ImmunoScience plans to enter the Indian IVD market in the near future with this revolutionary test device. In addition, Dr. Sateesh Apté received a prize for his presentation of Contre Vir, a therapeutic vaccine for the permanent treatment of HIV.
(Ret.) Major Geneneral Grinalds is named Chairman of the Board
Maj. Gen. Grinalds has been named Chairman of the Board at ImmunoScience, replacing Hiten Davé. In 1997, Maj. Gen. Grinalds was named president of The Citadel, The Military College of South Carolina, where he served until retirement in 2005. During his tenure the college successfully transitioned to coeducation in the traditionally male Corps of Cadets. Under his leadership, The Citadel also established milestones in fundraising, academics, facilities, admissions, public relations and, most importantly, reinforcing principled leadership as the premier objective of a Citadel education. Maj. Gen. Grinalds retired from active military duty in 1991 after 32 years of military service, including command at platoon, company, battalion, and regimental levels, culminating in command of the Marine Corps Recruit Depot/Western Recruiting Region San Diego. He was responsible for recruiting and basic training of all Marines enlisted west of the Mississippi River. Because of his extensive leadership and directorial skills, ImmunoScience is confident this change will be of great benefit to the efficiency and continued development of the ImmunoScience team.
Dr. Christina Carnegie joins ImmunoScience's Board of Directors
With a resume rich with drug development and pharmaceutical research, Dr. Carnegie will be a tremendous addition to the ImmunoScience Board of Directors. Dr. Carnegie has over 20 years of healthcare industry experience in both the United States and the United Kingdom. She was qualified in medicine at King's College Hospital in London, and specialized in anesthesia and then pharmaceutical medicine at University of London, gaining both a Bachelor of Science and a Master's degree. Because of her extensive knowledge of clinical development of ethical pharmaceuticals and medical devices, Dr. Carnegie will prove to be a valuable presence on the Board of Directors.
(Ret.) Major General John S. Grinalds joins ImmunoScience's Board of Directors
Maj. Gen. Grinalds joins the ImmunoScience team with a record of exemplary service both in the Marine Corps and as president of The Citadel, The Military College of South Carolina. His work has received numerous awards and recognitions for its significant contributions to the preservation of freedom, ethical standards and a reputation for excellence. Maj. Gen. Grinalds graduated with honors and a Bachelor of Science degree from the United States Military Academy in 1959, then went on to graduate, again with honors, from Brasenose College, Oxford University as a Rhodes Scholar, and earned both a Bachelor's and a Master's degree in geography. After serving as a White House Fellow in 1971, he completed his MBA at Harvard Business School in 1974. ImmunoScience is honored to welcome Maj. Gen. Grinalds to its Board of Directors.
ImmunoScience moves into its new facility in Pleasanton, CA.
After much anticipation, ImmunoScience is excited and ready to begin work in its new headquarters at 6670 Owens Drive in Pleasanton. Right in the heart of the East Bay Area, this new facility accommodates the employees of ImmunoScience to work with ultimate efficiently and productivity. It is here that ImmunoScience manufactures SalivaxTM
, a rapid, in vitro diagnostic (IVD) that uses saliva.