News Article | October 26, 2016
A new device could speed up the process of genetically modifying blood stem cells to treat diseases and expand access to gene therapy worldwide A table-top device that enables medical staff to genetically manipulate a patient's blood to deliver potential new therapies for cancer, HIV and other diseases would eliminate the need for multi-million-dollar "clean rooms," making gene therapy more possible for even the poorest of countries. The so-called "gene therapy in a box," developed by scientists at Fred Hutchinson Cancer Research Center, delivered modified blood stem cells that were as good as -- or better -- than those manufactured in highly regulated clean rooms -- and required less than half the staff, according to a study that will be published on Oct. 20 in Nature Communications. The adapted cells also successfully repopulated the blood system when tested in two different animal models, the study noted. It hasn't been tested in humans. The portable device suggests a solution to one of the most vexing challenges of gene therapy: How to make these emerging, high-tech treatments accessible and affordable beyond a handful of specialized research centers to clinics worldwide. "We either had to think about how to build million-dollar-infrastructure and clean-room facilities in clinics all around the world, which is not feasible, or we had to think about simplifying this process into what I originally envisioned as a black box," said Fred Hutch researcher Dr. Jennifer Adair, the study's lead author. "This was the first proof that 'gene therapy in a box' could work." Gene therapies or cell therapies that involve genetically modified cells today are available at only a limited number of research centers that can afford the necessary technology and the highly trained staff. Adair said there are a dozen or so worldwide. No gene therapies are approved yet for use in the United States. But thousands of patients with at least 15 or 20 inherited or infectious diseases and cancers are being treated with experimental therapies, and many are showing promise. The semi-automated "point of care" delivery system developed by Adair's team using instrumentation available from Miltenyi Biotec reduces the space required to produce the modified cells from 500 square feet to less than 5 square feet and the staffing from five or 10 people to one or two, according to oncologist Dr. Hans-Peter Kiem, a Fred Hutch and University of Washington cell and gene therapy researcher and the paper's senior author. "This is truly transformative," Kiem said. "It will change the way we manufacture and deliver cell and gene therapy products and will have a major impact on making stem cell gene therapy and transplantation and likely also immunotherapy available to patients with genetic diseases, HIV and cancer worldwide." The "box" itself costs about $150,000 to purchase -- a one-time investment that would be used for thousands of patients. An individual kit specific to the disease being treated would cost about $26,000, Adair said. Though not inexpensive, the box could drive down costs of gene therapy because it requires less infrastructure and staffing. Even putting aside the clean-room and other infrastructure costs, it could be less than what cell-based gene therapy treatment costs research institutions now -- between $38,000 and $55,000, according to Adair. What's more, the cost of what could be a one-time treatment compares favorably to lifetime care for many diseases. Take HIV, for example: lifetime treatment with antiretroviral drugs to suppress the virus is estimated to cost about $600,000. The innovation can be traced to 2008, when Kiem hired Adair to run a clinical trial for a gene therapy to treat glioblastoma, the deadliest form of brain cancer. The study called for extracting a patient's blood stem cells and inserting a special "resistance" gene designed in the laboratory to protect blood cells from damage by chemotherapy drugs. Infused back into the patient, the resistant cells would multiply and allow glioblastoma patients to receive higher doses of the cancer-killing chemo than they otherwise could withstand. Stem cell-based gene therapy involves removing blood or bone marrow from patients, separating out the stem cells -- which give rise to all blood and immune cells in the body -- and using a deactivated virus to transfer genetic instructions for treating or preventing a disease into the cells. (Scientists also are investigating the use of targeted nucleases such as CRISPR to edit genes, but most gene therapies now being tested in humans rely on viral vectors.) After being infused back into the patient, the stem cells propagate new cells that carry the modification. For Adair, the idea for gene therapy in a box was planted in 2009. She was on her way home in a taxi at 1 a.m. after having delivered genetically modified cells to the first patient in the newly launched brain cancer trial. Snatching only a few hours for sleep, Adair spent most of four days in a strictly regulated clean room where every bathroom break meant having to wash and suit up again in sterile clothing. The 96-hour marathon of time-sensitive, near-constant work left her physically and mentally exhausted. "How are we ever going to be able to do this for more than one cancer patient a week?" she remembered thinking. "It just seemed harrowing." Fast-forward five years, and blood stem cell-based gene therapy, though still experimental, was exploding. Patients in that early-phase brain cancer trial were living months or even years longer than most people with glioblastoma survive. Adair was running additional clinical trials, including one for a rare blood disorder called Fanconi anemia, and Kiem got a grant to investigate cell and gene therapy for curing HIV, the virus that causes AIDS -- once considered unimaginable. It was at a 2014 conference on that HIV cure research that Adair had her second epiphany, this time about costs. More than 25 million of the estimated 36.7 million people worldwide living with HIV are in sub-Saharan Africa, according to the World Health Organization. No country there could support multi-million-dollar clean rooms or afford the sky-high costs of whatever therapies might come out of them. Adair remembers sitting at the conference and thinking, "If we cure HIV in a patient in the U.S., how are we ever going to get this to the countries that need it?'" 'Why not now?' Adair had heard other gene therapy researchers dismissing questions about accessibility by saying, "First we have to show gene therapy works, and then we'll worry about that." "Why not now?" she remembered thinking. "Is there a way we could do this, in a simplified fashion?" With Kiem's encouragement, when Adair became head of her own lab in 2014, she used her Fred Hutch start-up funding to work on finding a way to make these still experimental therapies available and affordable wherever they are needed. In the brain cancer clinical trial, Adair used a first-generation device made by Miltenyi Biotec to separate the stem cells from other blood cells. It involved adding specialized metal beads to bone marrow removed from patients, then used a magnet to pull out the stem cells. But when she started working on a clinical trial for Fanconi anemia, a rare genetic disorder that leads to bone marrow failure, she needed something faster. Such patients have a tiny number of stem cells to begin with, and those are very susceptible to damage from exposure to ambient oxygen. To limit their exposure time, Adair had to find a way to speed up the process of separating and modifying the cells. Serendipitously, Miltenyi had just sent over a demonstration model of a second-generation machine that automated and sped up the bead and magnet process and also happened to be capable of processing the exact volumes of bone marrow Adair needed for the trial. Working with Miltenyi's Tim Waters, Adair directed reprogramming of the device to see if it could meet her timetable. When initial tests worked, the Hutch bought the new machine and got federal approval to use it in the Fanconi anemia trial, treating the first patient in 2014. The whole time she was thinking, "I want to make this device do everything." The Miltenyi machine, called the CliniMACS Prodigy™, was small enough. It was a closed system, meaning no exposure to ambient air. It could be automated. Its interface was similar to an apheresis machine, another clinical device that separates blood into its components and which hospital staffs in many developing countries already are trained to use. Adair shared her grand vision with Waters, who is a co-author on the Nature Communications paper. It called for reconfiguring and reprogramming the device to do all of the steps, including the clean-room jobs of adding the viral vector and removing residual reagents, then developing components specific to each disease that would be available in "kits" and kept in pharmacy freezers. Included in each kit would be disposable tubing to carry the patient's blood cells from a sterile bag into the machine. A nurse would attach the bag to the machine, add chemical reagents from the kit to pull out the stem cells, nutrients to support the growth of those cells and the viral vector engineered to do the gene transfer for that disease. Additional disposable tubing would carry the modified cells to a second sterile bag that would go right into the patient's IV. Reconfiguring the device meant tedious calculations, mechanical tests and relearning physics principles she'd forgotten from college -- things she hadn't imagined ever doing, said Adair. Adair and her team, which includes other Fred Hutch researchers and scientists at Washington State University, spent the last 18 months developing the device, comparing the products produced to those manufactured in clean rooms and testing the modified cells in animal models, key prerequisites to obtaining U.S. Food and Drug Administration consent to test the products in humans. She is hoping to send a box to a clinic that is not in a high-tech research center to test its ease of use. "There are probably 1,000 modifications that could improve how efficient it is," she said. "But by making a platform that doesn't require you to be at one of the expert academic institutions for gene therapy, we're facilitating more people being able to explore these processes and potentially incorporate their own changes." At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch's pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer with minimal side effects. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation's first and largest cancer prevention research program, as well as the clinical coordinating center of the Women's Health Initiative and the international headquarters of the HIV Vaccine Trials Network.
News Article | December 3, 2016
Results of early-phase trial of patients with chronic lymphocytic leukemia will be presented by Fred Hutch researchers at the American Society of Hematology Annual Meeting and Exposition SEATTLE - In a small, early phase trial, a high percentage of patients who had exhausted most traditional treatments for chronic lymphocytic leukemia saw their tumors shrink or even disappear after an infusion of a highly targeted, experimental CAR T-cell immunotherapy developed at Seattle's Fred Hutchinson Cancer Research Center. Fred Hutch researchers will present their findings in an oral presentation at 7:45 a.m. Dec. 3 at the American Society of Hematology Annual Meeting and Exposition in San Diego. Almost all of the 24 patients in the study had cancer that had advanced despite treatment with a newly approved drug called ibrutinib - an ominous indicator for patient survival. Most patients also had chromosomal markers in their leukemia cells that put them at high risk - "predictors of a bad response to most standard therapies," said Dr. Cameron Turtle, a hematologist/oncologist in the Clinical Research Division at Fred Hutch who co-leads the trial with colleagues Drs. David Maloney and Stanley Riddell. Turtle's presentation will focus on the results in a subgroup of patients who received the CAR T-cell infusion using preferred chemotherapy and CAR T-cell doses that evolved from recent trial data. Fourteen of the 19 restaged patients experienced a partial or complete regression of the disease in their lymph nodes. Of the 17 who had leukemia in their marrow when they enrolled in the trial, 15 saw the marrow become cancer-free after receiving CAR T-cells. "These are all heavily pretreated patients who've gone through many previous therapies," Turtle said. "It's very pleasing to see patients with refractory disease respond like this." Participants with the highest number of CAR T-cells in their blood after infusion were the most likely to have their disease disappear from bone marrow after CAR T-cell infusion. Side effects included high fevers, due to activation of CAR T-cells, and neurologic symptoms. Although one patient died from severe toxicity, the side effects experienced by other patients in the study were temporary. In a separate poster presentation from 5:30 to 7:30 p.m. on Dec. 3, the researchers will share their findings in a detailed characterization of the side effects of CD19 CAR T-cells. The poster session presentation is embargoed until 9 a.m. Dec. 3 - just over an hour after the embargo lifts for the CLL study results. Turtle and his colleagues identified certain biomarkers in patients' blood the day after infusion that were associated with the later development of the most severe toxicities. The researchers hope these biomarkers could eventually lead to tests to predict and mitigate the most serious side effects. CAR T-cell therapy is accomplished by engineering T cells extracted from each patient's blood. A modified virus delivers genetic instructions into the cells for making a CAR, or chimeric antigen receptor, a synthetic molecule that allows T cells to recognize and kill cells bearing a particular target. In this case, the target is CD19, a molecule found on the surface of certain blood cells, including CLL cells, and the T cells are a carefully selected, one-to-one combination of two functionally different subsets if T cells. After the CAR T-cells are grown in the lab and the patient has received chemotherapy, the new CAR T-cells are infused back into the patient. CD19 CAR T-cell studies at Fred Hutch are unique because the researchers engineer specific subsets of cells from the patient and formulate the cell product to be uniform. By creating CAR T-cells with a defined composition of T cell subsets, the researchers can improve the link between the dose of cells a patient receives and what they experience afterward - not just benefits, but also potential side effects. Patients in the trial are seen at Seattle Cancer Care Alliance, Fred Hutch's clinical care partner. Funding for this study was provided by NCI (National Cancer Institute) R01 CA136551; NIDDK (National Institute of Diabetes and Digestive and Kidney Diseases) P30 DK56465; NCI P30 CA15704; Life Science Discovery Fund; Juno Therapeutics and philanthropists. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch's pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer with minimal side effects. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation's first and largest cancer prevention research program, as well as the clinical coordinating center of the Women's Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Private contributions are essential for enabling Fred Hutch scientists to explore novel research opportunities that lead to important medical breakthroughs. For more information, visit fredhutch.org or follow Fred Hutch on Facebook, Twitter or YouTube.
News Article | March 1, 2017
SEATTLE -- Mar. 1, 2017 -- Fred Hutchinson Cancer Research Center today announced the recipients of the Harold M. Weintraub Graduate Student Award, which recognizes the outstanding achievement of graduate studies in the biological sciences. The thirteen award recipients were chosen by a selection committee of Fred Hutch faculty members and students for the quality, originality and significance of their work, and for representation of a diverse range of research topics. The 2017 awardees attend universities across the U.S. -- from Caltech to the Massachusetts Institute of Technology to Baylor College -- and one international recipient who attends the Weizmann Institute of Science in Israel. Their studies explore areas as far ranging as evolvability and order in the nervous system, how microbiome dynamics may control host immunity and metabolism and innovative treatment strategies for mitochondrial disease. Named for the late Dr. Harold Weintraub, the award honors Weintraub's scientific leadership in the field of molecular biology and his legacy as an extraordinary mentor, colleague, collaborator and friend. He was passionate about understanding how a certain protein drives cell development, investigating RNA interference, and applying molecular manipulations pioneered in his lab to other areas of medical research, such as stem cell transplantation. Weintraub helped found the Basic Sciences Division at Fred Hutch and died of brain cancer in 1995 at age 49. "Hal was one of the most outstanding scientists of his generation, as well as one of the most unpretentious," said Dr. Mark Groudine, molecular biologist and special advisor to the director's office at Fred Hutch. "Hal had the knack of identifying the important questions in biology and designing experimental approaches that were creative, simple and elegant." Weintraub Award recipients will travel to Seattle for an award symposium held May 5, 2017 on the Fred Hutch campus. At the symposium, recipients will give scientific presentations and have the opportunity to convene with other students and faculty members. Each awardee will receive a certificate, travel expenses and honorarium from The Weintraub and Groudine Fund, created to foster intellectual exchange through supporting programs for graduate students, fellows and visiting scholars. "By nurturing colleagues, students and postdocs, and helping all of us become better scientists, Hal was instrumental in establishing the collegial atmosphere at the Hutchinson Center. We believe having a symposium recognizing the achievements of young scientists is a great way to honor Hal and the recipients of this award," said Groudine. Photos of the award recipients are available upon request. Previous recipients of the Weintraub Award can be found here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of -renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch's pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer with minimal side effects. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation's first and largest cancer prevention research program, as well as the clinical coordinating center of the Women's Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Private contributions are essential for enabling Fred Hutch scientists to explore novel research opportunities that lead to important medical breakthroughs. For more information visit fredhutch.org or follow Fred Hutch on Facebook, Twitter or YouTube.
News Article | November 27, 2016
The first HIV vaccine efficacy study to launch anywhere in seven years is now testing whether an experimental vaccine regimen safely prevents HIV infection among South African adults. The study, called HVTN 702, involves a new version of the only HIV vaccine candidate ever shown to provide some protection against the virus. HVTN 702 aims to enroll 5,400 men and women, making it the largest and most advanced HIV vaccine clinical trial to take place in South Africa, where more than 1,000 people become infected with HIV every day. "If deployed alongside our current armory of proven HIV prevention tools, a safe and effective vaccine could be the final nail in the coffin for HIV," said Anthony S. Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health and a co-funder of the trial. "Even a moderately effective vaccine would significantly decrease the burden of HIV disease over time in countries and populations with high rates of HIV infection, such as South Africa." The experimental vaccine regimen being tested in HVTN 702 is based on the one investigated in the RV144 clinical trial in Thailand led by the U.S. Military HIV Research Program and the Thai Ministry of Health. The Thai trial delivered landmark results in 2009 when it found for the first time that a vaccine could prevent HIV infection, albeit modestly. The new regimen aims to provide greater and more sustained protection than the RV144 regimen and has been adapted to the HIV subtype that predominates in southern Africa, a region that includes the country of South Africa. "The people of South Africa are making history by conducting and participating in the first HIV vaccine efficacy study to build on the results of the Thai trial," said HVTN 702 Protocol Chair Glenda Gray, M.B.B.C.H., F.C.Paed. (SA). "HIV has taken a devastating toll in South Africa, but now we begin a scientific exploration that could hold great promise for our country. If an HIV vaccine were found to work in South Africa, it could dramatically alter the course of the pandemic." Dr. Gray is president and chief executive officer of the South African Medical Research Council; research professor of pediatrics at the University of the Witwatersrand, Johannesburg; and a founding director of the Perinatal HIV Research Unit at Chris Hani Baragwanath Hospital in Soweto, South Africa. Co-chairing the protocol with Dr. Gray are Linda-Gail Bekker, M.D., Ph.D.; Fatima Laher, M.D.; and Mookho Malahleha, M.B.Ch.B., M.P.H. Dr. Bekker is deputy director of the Desmond Tutu HIV Centre at the University of Cape Town and chief operating officer of the Desmond Tutu HIV Foundation in Cape Town, South Africa. Dr. Laher is a director of the Perinatal HIV Research Unit at Chris Hani Baragwanath Hospital. Dr. Malahleha is deputy director of Setshaba Research Centre in Soshanguve, South Africa. The experimental vaccine regimen tested in the Thai trial was found to be 31.2 percent effective at preventing HIV infection over the 3.5-year follow-up after vaccination. In the HVTN 702 study, the design, schedule and components of the RV144 vaccine regimen have been modified in an attempt to increase the magnitude and duration of vaccine-elicited protective immune responses. As the regulatory sponsor of HVTN 702, NIAID is responsible for all operational aspects of this pivotal Phase 2b/3 trial, which is enrolling HIV-uninfected, sexually active men and women aged 18 to 35 years. The NIAID-funded HIV Vaccine Trials Network (HVTN) is conducting the trial at 15 sites across South Africa. Results are expected in late 2020. HVTN 702 begins just months after interim results were reported for HVTN 100, its predecessor clinical trial, which found that the new vaccine regimen was safe for the 252 study participants and induced comparable immune responses to those reported in RV144. HVTN 100 and HVTN 702 are part of a larger HIV vaccine research endeavor led by the Pox-Protein Public-Private Partnership, or P5--a diverse group of public and private organizations committed to building on the success of the RV144 trial. The P5 aims to produce an HIV vaccine that could have a significant public health benefit in southern Africa and to advance scientists' understanding of the immune responses associated with preventing HIV infection. P5 members include NIAID, the Bill & Melinda Gates Foundation, the South African Medical Research Council, HVTN, Sanofi Pasteur, GSK and the U.S. Military HIV Research Program. The HVTN 702 vaccine regimen consists of two experimental vaccines: a canarypox vector-based vaccine called ALVAC-HIV and a two-component gp120 protein subunit vaccine with an adjuvant to enhance the body's immune response to the vaccine. The vaccines do not contain HIV and therefore do not pose any danger of HIV infection to study participants. Both ALVAC-HIV (supplied by Sanofi Pasteur) and the protein vaccine (supplied by GSK) have been modified from the versions used in RV144 to be specific to HIV subtype C, the predominant HIV subtype in southern Africa. Additionally, the protein subunit vaccine in HVTN 702 is combined with MF59 (also supplied by GSK), a different adjuvant than the one used in RV144, in the hope of generating a more robust immune response. Finally, the HVTN 702 vaccine regimen includes booster shots at the one-year mark in an effort to prolong the early protective effect observed in RV144. The study volunteers are being randomly assigned to receive either the investigational vaccine regimen or a placebo. All study participants will receive a total of five injections over one year. The safety of HVTN 702 study participants will be closely monitored throughout the trial, and participants will be offered the standard of care for preventing HIV infection. Study participants who become infected with HIV in the community will be referred to local medical providers for care and treatment and will be counseled on how to reduce their risk of transmitting the virus. HVTN 702 is one of many NIAID-supported HIV prevention trials in progress in southern Africa. These include the AMP Studies, which are testing infusions of the VRC01 antibody; the open-label HOPE study, which is examining a dapivirine vaginal ring; and HPTN 076 and 077, which are studying long-acting injectable rilpivirine and cabotegravir, respectively. NIAID conducts and supports research--at NIH, throughout the United States, and worldwide--to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website. About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www. .
News Article | November 11, 2016
ATLANTA, GA--(Marketwired - Nov 11, 2016) - GeoVax Labs, Inc. ( : GOVX), a biotechnology company developing human vaccines using its novel platform technology, announced its financial results for the three and nine months ended September 30, 2016 and provided the following corporate update. HIV Vaccine Program -- GeoVax's most advanced program is a prophylactic vaccine for the Clade B subtype of HIV, the most common form of HIV in North America, Western Europe and Japan. This program has successfully completed Phase 1 and Phase 2a human clinical trials. The next human clinical trial of GeoVax's preventive HIV vaccine (GOVX-B11) - a Phase 1 trial, designated HVTN 114, will investigate the ability of late boosts to increase the antibody responses elicited by GOVX-B11. HVTN 114 will be conducted by the HIV Vaccine Trials Network (HVTN) with funding from the National Institute of Allergy and Infectious Diseases (NIAID). HVTN has informed GeoVax that it expects this trial to commence in January 2017. During the third quarter, NIAID awarded the Company a Staged Vaccine Development contract of up to $7.8 million for the production of the DNA component of GOVX-B11 in sufficient quantities for advanced human clinical trials, including a phase 2b efficacy trial. GeoVax also continues work under two research grants from NIAID in support of its clinical program, as well as advancing development of a vaccine candidate for the subtype of HIV affecting Sub-Saharan Africa. Zika Vaccine Program -- In response to the 2016 Zika epidemic, GeoVax is developing a vaccine using its MVA-VLP expression technology and entered into collaborations with the University of Georgia Research Foundation and the Centers for Disease Control and Prevention (CDC) for preclinical testing support. During the third quarter, the Company demonstrated VLP production from its vaccine candidate and has now commenced preclinical animal studies. Hemorrhagic Fever Vaccine Program -- GeoVax's Hemorrhagic Fever vaccine program is focused on developing a tetravalent vaccine designed to protect against all major hemorrhagic fever viruses (Ebola, Sudan, Marburg, Lassa) endemic in African countries. The Company has proven 100% protection in rodent and non-human primate challenge studies for its Ebola vaccine, and has demonstrated VLP production for each of the other individual vaccines. GeoVax is now preparing for additional challenge studies for the full tetravalent vaccine, which are expected to commence during the fourth quarter of 2016. Immuno-Oncology Program -- GeoVax is evaluating the utility of its MVA-VLP vaccine platform for expressing an abnormal form of the cell surface-associated Mucin 1 (MUC1) protein that is associated with multiple types of cancer. The objective will be to harness a patient's own immune system to fight their cancer. The Company's approach may be useful for a number of solid tumors such as non-small cell lung cancer, colorectal carcinoma, breast cancer, and renal cell carcinoma. The Company recently announced a collaboration with ViaMune, Inc. for co-development of each company's cancer immunotherapy programs. Upon successful completion of the initial experiments, GeoVax and ViaMune have agreed to contribute their respective intellectual property to a joint venture for further development and commercialization. The goal of the joint venture would be to develop vaccine products for the treatment of multiple cancer indications. Other Programs / New Initiatives -- During the third quarter, GeoVax continued its work to design and test a vaccine for treatment of chronic Hepatitis B infections. The Company is also currently exploring expansion of its MVA-VLP vaccine platform to other high-value disease indications. Management Commentary Robert T. McNally, PhD, GeoVax's President & CEO, commented, "This year is shaping up to be one of the most productive years in our Company's history, in terms of the scientific progress we have made with our MVA-VLP technology. I am pleased with how each of our programs are advancing and we are laying the groundwork for a very successful 2017. In addition to the ongoing government support for our HIV program, we await decisions from the NIH regarding some very significant grant and contract applications for our Zika and Hemorrhagic Fever vaccine programs which, if awarded, will enable efficient and effective capital deployment during 2017 to rapidly advance these programs." Financial Review GeoVax reported a net loss of $464,200 ($0.01 per share) for the three months ended September 30, 2016, compared to $619,899 ($0.02 per share) for the same period in 2015. For the nine months ended September 30, 2016, the Company's net loss was $2,336,314 ($0.06 per share) as compared to $1,996,556 ($0.06 per share) in 2015. The Company reported revenues of $440,106 and $653,986 for the three-month and nine-month periods of 2016, respectively, related to grants from the NIH in support of its HIV/AIDS vaccine development efforts. This compares to $93,130 and $268,028 of grant revenue reported for the comparable periods of 2015. As of September 30, 2016, there is $680,419 in approved grant funds remaining and available for use. Research and development (R&D) expenses were $683,939 and $1,519,519 for the three-month and nine-month periods of 2016, respectively, as compared to $378,521 and $1,166,803 for the comparable periods of 2015. R&D expenses include direct costs funded by NIH grants, as well as other vaccine manufacturing and testing costs. General and administrative (G&A) expenses were $220,707 and $1,472,030 for the three-month and nine-month periods of 2016, respectively, as compared to $335,932 and $1,102,262 for the comparable periods of 2015. GeoVax reported cash balances of $511,096 at September 30, 2016, as compared to $1,060,348 at December 31, 2015. Summarized financial information is attached. Further information concerning the Company's financial position and results of operations are included in its Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission. About GeoVax GeoVax Labs, Inc., is a clinical-stage biotechnology company developing human vaccines against infectious diseases using its MVA-VLP vaccine platform. The Company's development programs are focused on vaccines against HIV, Zika Virus, and hemorrhagic fever viruses (Ebola, Sudan, Marburg, Lassa). GeoVax also recently began programs to evaluate the use of its MVA-VLP platform in cancer immunotherapy, and for therapeutic use in chronic Hepatitis B infections. GeoVax's vaccine platform supports in vivo production of non-infectious VLPs from the cells of the very person receiving the vaccine, mimicking a natural infection, stimulating both the humoral and cellular arms of the immune system to recognize, prevent, and control the target infection. For more information, visit www.geovax.com. Forward-Looking Statements Certain statements in this document are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act. These statements are based on management's current expectations and are subject to uncertainty and changes in circumstances. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax can develop and manufacture its vaccines with the desired characteristics in a timely manner, GeoVax's vaccines will be safe for human use, GeoVax's vaccines will effectively prevent targeted infections in humans, GeoVax's vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete vaccine development, there is development of competitive products that may be more effective or easier to use than GeoVax's products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements, and does not intend to do so. More information about these factors is contained in GeoVax's filings with the Securities and Exchange Commission including those set forth at "Risk Factors" in GeoVax's Form 10-K.
News Article | December 12, 2016
SEATTLE (Dec. 12, 2016) - New recommendations from breast cancer experts on sentinel lymph node biopsy reinforce the most recent "less-is-more" guidelines for early-stage disease. But a Fred Hutch researcher who helped create the guidelines said many surgeons still perform full lymph node dissection routinely. "The new guidelines, first established in 2014, seem to have been embraced within academic centers and larger hospitals and cancer centers, but compliance is still quite variable elsewhere," said Dr. Gary Lyman, first author of the new set of recommendations, published in the Dec. 12 issue of the Journal of Clinical Oncology. Sentinel node biopsy is a surgical procedure used in evaluating patients and planning treatment for early-stage breast cancer. The new guidelines echo a more conservative approach first recommended in 2014 where surgeons were advised NOT to automatically harvest all lymph nodes if cancer was found in a sentinel node. This was a dramatic shift from 2005's recommendation that surgeons use sentinel node biopsies to stage the cancer and then go on to perform axillary lymph node dissection, removing all lymph nodes under the patient's arm (or arms) if any disease was found in the sentinel node. "In smaller hospitals, particularly in rural areas, many women are still being told they need a full axillary dissection. There are economic issues, geographic issues and education issues for both clinicians and patients," said Lyman, a Fred Hutch researcher, breast cancer oncologist and co-director of HICOR. Research by Lyman and others led to the dramatic change in recommendations over the past decade. Now surgeons are advised to forego routine axillary lymph node dissection in most women with no evidence of cancer on sentinel node biopsy or if cancer is found in only one to two sentinel nodes. As a result, the majority of women receiving lumpectomy and whole breast radiation can also forego a full lymph node dissection. This is important because axillary lymph node dissection can have a dramatic effect on patients' quality of life, leading to lymphedema, infections, reduced range of motion and other painful and costly side effects. "There are cautions. The sentinel node biopsy has to be well-conducted, the tumor should not be greater than 5 centimeters in size, and there should be no other major risk factors. However, approximately two thirds of women meet these criteria," Lyman said. "Full removal is always an option, and some women want to have all of the lymph nodes taken out. But given the down side of the full axillary dissection in terms of quality of life and possible complications, many women who have a lower risk say, 'I want to avoid those problems.'" Sentinel node biopsies are done on early-stage breast cancer patients to stage their cancer and determine if it has infiltrated the lymph node system, a common signal of cancer spread. Lyman is a major policymaker for ASCO, the American Society of Clinical Oncology. He is also a thought leader in the field of value-based cancer care and precision oncology. Working with many other colleagues, this longtime researcher helped pioneer sentinel lymph node biopsy in breast cancer patients 20 years ago and has been instrumental in shaping policy for breast cancer treatment and surgery ever since. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch's pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer with minimal side effects. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation's first and largest cancer prevention research program, as well as the clinical coordinating center of the Women's Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Private contributions are essential for enabling Fred Hutch scientists to explore novel research opportunities that lead to important medical breakthroughs. For more information visit fredhutch.org or follow Fred Hutch on Facebook, Twitter or YouTube. "The standard of care used to be to take them all but the data has been quite compelling over the last few years. Now, it's generally accepted that a complete lymph node dissection isn't necessary for all patients." "This is part of an overall trend in the breast cancer setting to not do more than we need to, based on the evidence. Of course, we're doing less and less extensive surgery - from radical mastectomy to lumpectomy. And even now with lumpectomies, we're not taking more tissue than is really needed." "It's been part of the trajectory of not doing more than necessary but we still have our work to do. Education is important. If they're in high risk subgroups, a full ALND could be justified, but women need to be informed so they ask the right questions and don't just accept what they're told out of the gate." "If a woman has only one or two sentinel lymph nodes that are cancerous and if the tumor is not too big and not too aggressive, there's no value in doing a complete lymph node dissection." Citation: Journal of Clinical Oncology, "Sentinel Lymph Node Biopsy for Patients with Early-Stage Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update 2016" Dec. 12, 2016 New recommendations from breast cancer experts on sentinel lymph node biopsy reinforce the most recent "less-is-more" guidelines for early-stage disease. But according to Dr. Gary Lyman, a Fred Hutch researcher who helped create the guidelines, many surgeons still perform full lymph node dissection.
News Article | December 1, 2016
Everyone Encouraged to Get Tested for HIV ATLANTA, GA--(Marketwired - Dec 1, 2016) - In recognition of World AIDS Day on December 1, GeoVax Labs, Inc. ( : GOVX), a biotechnology company specializing in developing human vaccines, encourages everyone to get tested for HIV, the virus that causes AIDS. Around the world, about 35 million people are living with HIV. In the United States, about 50,000 people become infected with HIV every year. World AIDS Day is a global initiative to raise awareness, fight prejudice, and improve education about HIV and AIDS. In the United States, about 1 in 5 people who have HIV don't know they are infected, and the only way to know one's infection status is to be tested. In fact, the U.S. Office of Disease Prevention and Health Promotion recommends that everyone aged 15 to 65 should be tested at least once. To find an HIV testing location near you, use the online locator at https://locator.aids.gov. Getting tested is important for both the individual and for world health. For the individual, early detection will allow sooner intervention with anti-retroviral medication and prevention of the infection progressing to AIDS, thus allowing a near-normal life. But just as importantly, drug treatment means the infected individual will be much less likely to spread HIV to others. GeoVax is committed to an AIDS-free generation through vaccine development. Our HIV vaccine candidate is currently progressing through human clinical trials conducted by the HIV Vaccine Trials Network (HVTN) with support from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). To learn more about our work to fight HIV, visit www.geovax.com. GeoVax Labs, Inc., is a clinical-stage biotechnology company developing human vaccines against infectious diseases using its Modified Vaccinia Ankara-Virus Like Particle (MVA-VLP) vaccine platform. The Company's development programs are focused on vaccines against HIV, Zika Virus, hemorrhagic fever viruses (Ebola, Sudan, Marburg, and Lassa) and malaria. GeoVax also is evaluating the use of its MVA-VLP platform in cancer immunotherapy, and for therapeutic use in chronic Hepatitis B infections. GeoVax's vaccine platform supports in vivo production of non-infectious VLPs from the cells of the very person receiving the vaccine, mimicking a natural infection, stimulating both the humoral and cellular arms of the immune system to recognize, prevent, and control the target infection. For more information, visit www.geovax.com.
News Article | February 24, 2017
A new discovery by researchers at the Fred Hutchinson Cancer Research Center in Seattle makes an important step in identifying which specific T cells within the diverse army of a person's immune system are best suited to fight cancer. The findings will be published February 24 in Science Immunology. "We found that the cells in each patient's immune system that will ultimately have a clinical effect are incredibly rare," said Dr. Aude Chapuis, lead author of the paper and a member of the Clinical Research Division at Fred Hutch. "Knowing what we've found, we can now refine the selection of the cells that we will ultimately use for adoptive T cell transfer, so that the cells persist and keep the tumors at bay longer in our patients." Dr. Chapuis is an expert in adoptive T cell transfer, a new class of treatments that use immune T cells to fight cancer. It works by obtaining T cells from the patient's own blood, priming them to seek and destroy cancerous cells, multiplying them in the lab and then returning them to the patient. In some treatment settings, the cancer-targeting T cells are instead obtained from a healthy donor's blood. But since each infusion contains thousands of varieties of T cells each with varying cancer-killing capabilities, it's been unclear which ones offer the most effective anti-cancer punch. Making it more complicated, the cells' anti-cancer properties change as they grow in the lab. The offspring or "clones" they create differ from the originals. It's like a "black box," Dr. Chapuis said, in that scientists have rarely been able to identify the composition of cells that are leading the attack on cancer. A newly developed method of tracking cells lets light into that black box. "High throughput T cell receptor sequencing allows us to distinguish the cells and figure out where they came from, which ones grow in culture and which ones persist after being transferred to the patient," said Dr. Chapuis, who is also an assistant professor in the University of Washington's School of Medicine. "We can finally track in detail what's going on when doing adoptive T cell transfers," she said. The method distinguishes T cells from each other according to the nature of their receptor, which is T cells' weapon against cancer. Adaptive Biotechnologies Corp, a spinout of Fred Hutch, developed high-throughput receptor sequencing for immune cells. The technology gives each T cell receptor a "bar code," allowing the researchers to track all of the diverse members of an individual patient's T cell army. Following the bar codes of the T cell receptors, Fred Hutch scientists are tracking thousands of immune cells after being transferred into patients. They then examined how the cells in the mix related to responses to adoptive T cell therapy treatment in 10 metastatic melanoma patients. The researchers found that in the two patients who went into complete remission after T cell infusion, the specific T cells that ended up dominating the patient's cancer-fighting army after infusion were extremely rare in their bodies originally. The method also allowed the researchers to directly observe in humans that the T cells likely having the most powerful effect tended to be younger, suggesting that they had better capabilities to proliferate and survive -- characteristics essential for long-term tumor control. Dr. Chapuis and her collaborators are now looking at how to select out the powerful but rare immune cells and increase their population before being infused into patients. They're testing the approach in two current clinical trials in lung cancer patients (ClinicalTrials.gov identifier NCT02408016) and acute myeloid leukemia patients (NCT02770820). The Cancer Research Institute and Stand Up To Cancer program funded the research. The Fred Hutchinson Cancer Research Center has licensed technology to Adaptive Biotechnologies Corp and owns a stake in the company. In addition to Dr. Chapuis, the other corresponding author of the paper is Cassian Yee, who did the work while at Fred Hutch and is now at the MD Anderson Cancer Center. Other co-authors are Cindy Desmarais, Ryan Emerson, Thomas Schmitt, Kendall Shibuya, Ivy Lai, Felecia Wagener, Jeffrey Chou, Ilana Roberts, David Coffey, Edus Warren, Harlan Robins and Philip Greenberg. Learn more about Dr. Chapuis' research in a video: https:/ At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch's pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation's first cancer prevention research program, as well as the clinical coordinating center of the Women's Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Private contributions are essential for enabling Fred Hutch scientists to explore novel research opportunities that lead to important medical breakthroughs. For more information visit fredhutch.org or follow Fred Hutch on Facebook, Twitter or YouTube.
News Article | December 5, 2016
SEATTLE - Dec. 5, 2016 - Fred Hutchinson Cancer Research Center announced promising results from an early trial in which patients with high-risk acute myeloid leukemia received genetically engineered immune cells. Of the 12 AML patients who received this experimental T-cell therapy after a transplant put their disease in remission, all are still in remission after a median follow-up of more than two years. Giving these cells when disease is in remission after transplant "might actually be helping patients who have a high risk of relapsing to not relapse down the line," said Dr. Aude Chapuis, cancer physician and immunotherapy researcher at Fred Hutch, one of the study's leaders. Chapuis presented these results at the 2016 annual meeting of the American Society of Hematology in San Diego, California. The findings in this group of trial participants contrast with the outcomes the researchers observed in a cohort of similar patients who received transplants around the same time but did not receive engineered T cells. In all of these transplant-only patients, the transplants produced remissions, but more than a quarter of them relapsed within just 10 months. In the experimental T-cell therapy tested in this trial, certain T cells from each patient's transplant donor were genetically engineered to produce receptors that allowed the T cells to recognize, very specifically, a target molecule called WT1. WT1 is 10 to 1,000 times more common in leukemia cells than their noncancerous cousins, making it a natural target for therapies designed to destroy cancer cells while leaving most healthy cells alone. This is the team's first trial of this strategy, which was initially developed in the lab of Dr. Phil Greenberg, one of the study's leaders and the head of Fred Hutch's Program in Immunology. Because it was the first study of this particular approach, the researchers focused on a high-risk group -- AML patients undergoing bone marrow transplant who had certain genetic or disease characteristics that decrease the chance of long-term transplant success -- "a hard population of patients," Chapuis said, many of whom "were horribly sick." Each patient's therapy was created just for them in a specialized Fred Hutch facility. Certain T cells from each patient's matched donor were given the genetic instructions to make a receptor that specifically reacts to WT1. Then came a blood stem cell transplant: Patients' leukemic bone marrow and blood cells were destroyed and replaced with healthy cells from their donors. A month later, when the team examined these 12 patients' marrow, they found no trace of the cancers. Rapidly thereafter, once the transplanted cells fully engrafted, each patient then received up to 10 billion of the genetically engineered donor cells, infused into their arm through an IV. Chapuis's role in this trial is on the laboratory side of the research, ensuring the quality of the genetically engineered cell products and monitoring the activity of the cells after infusion. She co-leads this research with Greenberg and Dr. Dan Egan of Fred Hutch, the trial's principal investigator and the care provider for trial participants. The study was supported by funding from the National Institutes of Health and spinoff Juno Therapeutics, of which Greenberg is a scientific co-founder. Outside of this trial, Chapuis treats cancer patients at Fred Hutch's clinical care partner, Seattle Cancer Care Alliance. Watching her patients undergo bone marrow transplant ? itself the first clear and reproducible example of cancer immunotherapy, developed at Fred Hutch ? has made her want to work toward something better. "That's my source of inspiration. I'm always horrified by the intense treatment that we inflict on bone marrow transplant patients and the hardship that we make them go through. And I really think we can do better," Chapuis said. "That's why I'm doing this." At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch's pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer with minimal side effects. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation's first and largest cancer prevention research program, as well as the clinical coordinating center of the Women's Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Private contributions are essential for enabling Fred Hutch scientists to explore novel research opportunities that lead to important medical breakthroughs. For more information, visit fredhutch.org or follow Fred Hutch on Facebook, Twitter or YouTube.
News Article | December 7, 2016
Scientists have found a way to detect earlier if a deadly cancer, Merkel cell carcinoma (MCC), is recurring in patients, according to a paper to be published 11 a.m. Eastern time, Dec. 7, in the journal Cancer. The test works by measuring the presence of a novel marker - an antibody to a cancer-driving protein from the virus that causes MCC. It enables clinicians to identify which of the patients who successfully undergo treatment for MCC are most at risk of recurrence and makes it easier, more effective and less costly to see when the cancer is just starting to return. The paper's senior author is Dr. Paul Nghiem, a member of Fred Hutchinson Cancer Research Center, the head of the Division of Dermatology at the University of Washington medical school and a clinician at the Seattle Cancer Care Alliance. Its 18 co-authors are from Fred Hutch, UW medical school and SCCA. The research builds on a key discovery revealed earlier this year in another study by Nghiem and colleagues --that the immune system can be mobilized to effectively attack MCC, a rare cancer that kills one of every three who develop it. The reason the new blood test matters is that detecting MCC early can be the difference between life and death. The cancer has an extremely high recurrence rate: It is several times more likely to recur than melanoma and hundreds of times more likely than basal cell carcinoma; even patients who have the earliest, lowest-risk stage of this cancer have a 20 percent risk of it coming back. "Catching and treating the recurrence before it has a chance to grow large - the difference between a cancer the size of a grape and one the size of a grapefruit - enhances the chances that immune therapy will work," said Nghiem. The latest study involved 219 patients whose initial MCC had been effectively treated with surgery and/or radiation. The researchers examined how well the test detected MCC compared with radiologic imaging, which is the prevailing practice. The findings show that over a five-year period, the test was better at picking up small traces of the cancer when it first returns. In many cases, the blood test suggested the cancer was recurring well before tumors were visible by imaging. Compared with traditional imaging, the test is also much less expensive and spares patients exposure to the radiation and contrast dye associated with imaging. Nghiem says that all of his MCC patients now get the test at the time of diagnosis. Clinicians can get the test for their patients by sending blood samples to a clinical lab at the University of Washington. Physicians at Mayo Clinic, Stanford and UC San Francisco as well as in individual practices around the country are already frequently using the test. This study documents the strengths and limitations of the blood test and will likely lead to it being offered to MCC patients more broadly. The new test costs about $200, and the UW lab does not expect to profit from it. (At present they are not fully covering their costs.) The researchers say that the test is not practical for the initial diagnosis of MCC because the disease is so uncommon; instead, its main use is to detect recurrences earlier. The test has different implications for MCC patients who do not produce these antibodies - nearly half of those in the study. It doesn't track Merkel cell carcinoma recurrence in this group, because such patients will not produce these antibodies even when the cancer returns. Still, getting the test done once is useful for all patients, including those found not to produce the antibodies. Because those who test negative are 42 percent more likely to have a recurrence, doctors should order more frequent imaging for them. When the recurring MCC is caught early, these patients may particularly benefit from immune therapy. The importance of this test goes beyond the improvement in treatment for patients with MCC. "The findings highlight how monitoring the robustness of the immune system provides key insights into cancer treatment, and they are emblematic of a broader shift in how physicians can track disease," said Nghiem. "It underscores a key tenet of immune therapy - that your immune system is naturally attuned to fighting cancer and the challenge is how best to harness that." The research was supported by grants from the National Institutes of Health and the National Center for Advancing Translational Sciences and by the Merkel Cell Carcinoma Patient Gift Fund at the University of Washington. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch's pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer with minimal side effects. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation's first and largest cancer prevention research program, as well as the clinical coordinating center of the Women's Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Private contributions are essential for enabling Fred Hutch scientists to explore novel research opportunities that lead to important medical breakthroughs. For more information visit fredhutch.org or follow Fred Hutch on Facebook, Twitter or YouTube.