AIEA, HI, United States

Hawaii Biotech, Inc.

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A West Nile virus vaccine for human use is described that preferably contains a recombinantly produced form of truncated West Nile virus envelope glycoprotein and aluminum adjuvant. The vaccine is acceptable for use in the general population, including immunosuppressed, immunocompromised, and immunosenescent individuals. The vaccine is safe and effective for use in all healthy and at-risk populations. A pharmaceutically acceptable vehicle may also be included in the vaccine.


News Article | September 28, 2017
Site: www.eurekalert.org

University of Hawaii vaccine researcher Axel Lehrer, PhD, has received a nearly $6.3 million grant to test whether the Ebola vaccine formula he has developed will protect against two additional viruses in the same family. The Ebola vaccine UH has created is "heat stable," which means it does not need refrigeration, and could be easily transported and stored in the hottest climates on Earth, like Africa, where the deadly viruses have struck in the past. Expanding the heat-stable vaccine to work against all three of the related viruses could speed up the protection of health workers and others as soon as an outbreak occurs. That is because the first inoculations could occur even before public health experts know which exact type of hemorrhagic fever has struck. The U.H. medical school is partnering with two biomedical companies - Honolulu-based Hawaii Biotech, Inc. and New Jersey-based Soligenex, Inc. - to develop the potentially trivalent (works on all three viruses) vaccine. Dr. Lehrer believes that when the new work funded by this grant is completed; the next step would be to obtain funding (perhaps a combination of public funding and corporate funding) to move the vaccine into a clinical trial. With funding, and the necessary drug regulatory approvals, he believes his heat-stable vaccine candidate could be ready to be on the market within five to ten years. Grant: 1R01AI132323-01 - (Axel Lehrer - 06/20/2017-05/31/2022) Funding agencies: National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health Project Title: Preclinical Development of a Thermostable Trivalent Filovirus Vaccine All collaborations: University of Texas Medical Branch, Bioqual Inc., Soligenix, Inc, Hawaii Biotech Inc. Total Cost: $6,286,072 00:-:15 "Yes, we hope to have a vaccine that will address all three of the filoviruses that are the most human pathogenic ones, and we are trying to have a heat-stable product that can be used where it is most needed." :15-:40 "The current grant is focused on finishing preclinical development that means we are working on the production of the antigens, te are working on the formulation to develop this heat stable trivalent vaccine and the a proper efficacy testing to establish proof of concept." : 40-:45 "So it basically would be enabling us to go right into the clinic after this is completed." :45-1:00 "And at that point hopefully there would be more public funding including some funding from our corporate partners that are helping with this development effort." B-Roll: Shows Dr. Lehrer working in his Kakaako lab, shots of the heat stable vaccine being moved up and down (like a see saw) on a machine in the lab Courtesy: JABSOM or UH Medical School


Previous collaborations with Axel Lehrer, PhD of the Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine (JABSOM), UH Manoa and Hawaii Biotech, Inc. (HBI) demonstrated the feasibility of developing a heat stable subunit Ebola vaccine.  Under the terms of the subaward, Soligenix will continue to support vaccine formulation development with its proprietary vaccine thermostabilization technology, ThermoVax®.  Ultimately, the objective is to produce a thermostable trivalent filovirus vaccine for protection against Ebola and related diseases, allowing worldwide distribution without the need for cold storage. The most advanced Ebola vaccines involve the use of vesicular stomatitis virus (VSV) and adenovirus vectors – live, viral vectors which complicate the manufacturing, stability and storage requirements.  Dr. Lehrer's vaccine is based on highly purified recombinant protein antigens, circumventing many of these manufacturing difficulties.  Dr. Lehrer and HBI have developed a robust manufacturing process for the required proteins.  Thermostabilization may allow for a product that can avoid the need for cold-chain distribution and storage, yielding a vaccine ideal for use in both the developed and developing world. "Filoviruses are endemic in areas of the world where the power supply can be uncertain, making a thermostable Ebola vaccine particularly valuable," stated Dr. Lehrer, Assistant Professor, Department of Tropical Medicine, Medical Microbiology and Pharmacology at the JABSOM.  "We are delighted to have been awarded this grant to further develop a thermostabilized subunit vaccine for Ebola and look forward to continuing our collaboration with Soligenix." "We believe that creating a vaccine with enhanced stability at elevated temperatures, which can obviate the costs and logistical burdens associated with cold chain storage and distribution, has the potential to provide a distinct advantage over other Ebola vaccines currently in development," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "Work with the Ebola vaccine expands upon our thermostabilization platform which has already been successfully utilized with other heat sensitive vaccine candidates, such as for ricin toxin, and anthrax.  We continue to actively pursue government grants and contracts across our entire biodefense and biotherapeutics pipeline and are appreciative of the ongoing support, with non-dilutive awards now exceeding $8M in 2017." Ebola Virus Disease (EVD) is caused by one of five species of Ebolavirus, four of which cause disease in humans, including its best-known member, Zaire Ebolavirus (Ebola virus).  All species of Ebolavirus belong to the Filoviridae family, a family that further contains the equally human pathogenic Marburgvirus.  The Ebola virus is believed to be harbored in various animal species in Africa, although the specific reservoir host is still unknown.  There have been several known EVD outbreaks in Africa since 1976, with the largest outbreak starting in 2014 in Western Africa. Transmission of Ebola requires direct contact of bodily fluids from an infected person or contact with infected animals.  The mortality rate from Ebola infection is extremely high, and can sometimes be affected by the quality of supportive care available with a focus on early initiation of treatment.  Symptoms of Ebola virus infection include high fever, severe headache, muscle pain, weakness, fatigue, diarrhea, vomiting, abdominal pain and unexplained hemorrhage.  Resolution of the disease largely depends on the patient's own immune system.  There is no approved treatment and no approved vaccine for Ebola, although research into both has accelerated since the onset of the 2014 outbreak. The Ebola outbreak in 2014 primarily spanned three West African countries, and involved over 26,000 confirmed/probable/suspected cases with an estimated death toll of over 11,000 people according to the Centers for Disease Control and Prevention (CDC), including some cases in Europe and the United States.  The widespread nature of the infection and its devastating impact has further illustrated the need to develop an Ebola vaccine to prevent future and possibly more significant outbreaks. The ThermoVax® technology is designed to eliminate the cold chain production, distribution and storage logistics required for most vaccines. The technology utilizes precise lyophilization of protein immunogens with conventional aluminum adjuvants in combination with secondary adjuvants for rapid onset of protective immunity with the fewest number of vaccinations. Cold chain requirements add considerable cost to the production and storage of current conventional vaccines. Elimination of the cold chain would also enhance the utility of these vaccines for emerging markets and for other applications requiring but lacking reliable cold chain capabilities. For vaccines that are intended for long-term stockpiling, such as for use in biodefense or in pandemic situations, the utilization of ThermoVax® has the potential to facilitate easier storage and distribution of Strategic National Stockpile vaccines in emergency situations. The underlying ThermoVax® technology has been developed by Drs. John Carpenter and Theodore Randolph at the University of Colorado. By employing ThermoVax® during the final formulation of RiVax®, the vaccine has demonstrated enhanced stability and the ability to withstand temperatures at least as high as 40 degrees Celsius (104 degrees Fahrenheit) for up to one year. Similar stabilization at temperatures as high as 50 degrees Celsius for up to 3 months (maximum timepoint tested) have also been demonstrated with other antigens (e.g., human papillomavirus, Ebola and anthrax). About John A. Burns School of Medicine, University of Hawai'i at Manoa The University of Hawai'i at Manoa is one of the most ethnically diverse institutions of higher education. Hawai'i's cultural diversity and geographical setting affords the John A. Burns School of Medicine (JABSOM) a unique research environment to excel in health disparity research. JABSOM faculty bring external funding of about $42 million annually into Hawai'i. Hawaii Biotech (HBI) is a privately held biotechnology company focused on the development of prophylactic vaccines for established and emerging infectious diseases and anti-toxin drugs for biological threats. HBI has developed proprietary expertise in the production of recombinant proteins that have application to the manufacture of safe and effective vaccines, diagnostic kits, and as research tools. HBI completed successful first-in-human Phase 1 clinical studies with both West Nile virus and dengue vaccines in healthy human subjects. HBI has developed a product pipeline of recombinant subunit vaccines, including vaccine candidates for West Nile virus, tick-borne flavivirus, malaria, Crimean-Congo hemorrhagic fever, and Ebola.  The company is also continuing the development of small molecule anti-toxin drugs for anthrax and botulism. HBI, founded in Hawaii in 1982, is headquartered in suburban Honolulu. For more information, please visit: www.hibiotech.com. Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201). Our Vaccines/BioDefense business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, OrbeShield®, our GI acute radiation syndrome therapeutic candidate and SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease. The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®.  To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA). For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com. This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements.  These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements.  Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to the timing or success of the Phase 3 clinical trial of SGX942 (dusquetide) as a treatment for oral mucositis in patients with head and neck cancer receiving chemoradiation therapy and the Phase 3 clinical trial of SGX301 (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K.  Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.


Johnson A.T.,Hawaii Biotech, Inc.
Journal of Chemical Education | Year: 2015

At present, small molecule drug design follows a retrospective path when considering what analogs are to be made around a current hit or lead molecule with the focus often on identifying a compound with higher intrinsic potency. What this approach overlooks is the simultaneous need to also improve the physicochemical (PC) and pharmacokinetic (PK) properties of these compounds, and illustrates the multivariate problem the chemist must face when targeting new analogs for synthesis. To address this problem, a simple method is presented which allows the chemist to integrate PC properties into small molecule drug design in a prospective manner, prioritize new target molecules for synthesis, and potentially shorten the path to the clinic. This simple method also provides a tool for the student of medicinal chemistry to see how changes in PC properties and intrinsic potency can influence drug-like properties of small molecules during the drug discovery process. © 2014 The American Chemical Society and Division of Chemical Education, Inc.


Grant
Agency: Department of Defense | Branch: Army | Program: SBIR | Phase: Phase I | Award Amount: 99.89K | Year: 2015

Dengue virus (DENV) is a mosquito-borne flavivirus that poses a tremendous public health threat throughout the world. The U.S. military has also been challenged by dengue for over a hundred years and the pursuit of an effective DENV vaccine is a high priority for the Department of Defense (DoD). Despite over 70 years of efforts, there is still no registered dengue vaccine. While significant progress has been made in the last decade, challenges still remain. To help enhance development of a DENV vaccine candidate there two key areas that need to be addressed; robust immunogenicity, both antibody titers and durability, and shorting the duration of immunization schedule. This application is directed at demonstrating the enhanced immunogenicity of formulations comprised of an inactivated DENV and novel adjuvants. The use of novel adjuvants with the potential for clinical use will help accelerate the development of an enhanced inactivated DENV vaccine. For the first phase of this effort the technical objectives are to first screen and select formulations with robust immunogenicity and then to demonstrate protective efficacy in a lethal mouse challenge model. In this manner we will demonstrate the feasibility of developing an adjuvanted-inactivated dengue vaccine with enhanced and durable immune responses.


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 2.11M | Year: 2015

DESCRIPTION provided by applicant The tick borne flavivirus TBFV group includes a number of important human pathogens that result in serious encephalitic or hemorrhagic diseases that are either Category B or C priority pathogens The TBFV are considered to be emerging or re emerging pathogens due to increases in the number of human cases the expansion of geographic distribution and emergence of new viruses This application is directed at the development of a multivalent TBFV vaccine that provides broad cross protection against at least five viruses in this group Central European subtype of tick borne encephalitis TBE TBEV Eu Far Eastern subtype TBE FE Alkhurma hemorrhagic fever virus AHFV Kyasanur Forest disease virus KFDV and Omsk hemorrhagic fever virus OHFV Inactivated vaccines exist for TBEV Eu TBE FE and KFD in some endemic countries but there are no vaccines for AHFV and OHFV The development of monotypic vaccines against individual pathogens provides a strategy to mitigate the threat posed on a regional basis however the number of different viruses in the TBFV group poses a challenge in providing protection against all of the viruses in the group Furthermore there is no registered TBFV vaccine in the U S The lack of a vaccine in the U S has been deemed an unmet need by NIAID An approach to provide broad protection against the TBFV group is the development of a multivalent vaccine that provides cross protection against most if not all of the TBFVs This vaccine will be developed by evaluating various combinations of soluble recombinant subunits proteins representing the envelope E protein from these five TBFVs Preliminary data with recombinant TBEV Eu has established a proof of principle for the potential of this approach The monovalent rTBEV EU vaccine has been demonstrated to provide monotypic and partial cross protection and will serve as the core on which the multivalent vaccine will be established The Specific Aims of this project are development and evaluation of the immunogenicity and cross reactive potential cross virus neutralizing ability of additional E subunit proteins for inclusio in the multivalent vaccine assess the cross protective potential of selected combinations of recombinant TBFV E proteins in a mouse challenge model and assess the potency of the selected multivalent vaccine to support further development of the vaccine To accomplish these goals an established stable insect expression system with demonstrated FDA regulatory experience will be utilized to produce the recombinant E proteins This includes the use of a modern adjuvant that has potential for advancement to human clinical trials The selection of the multivalent candidate vaccine will focus on a vaccine composition with the least number of components E proteins that provides the greatest level of cross protection To accomplish the objectives of the proposed research a strong multidisciplinary team of scientists has been assembled that provides the means to develop and evaluate a successful multivalent TBFV cross protective vaccine The development of multivalent TBFV vaccine would be of great value and in line with the priorities of NIH NIAID to develop multivalent and cross protective vaccine technologies PUBLIC HEALTH RELEVANCE The proposed research is focused on developing a candidate vaccine that protects against a family of related viruses in the tick borne flavivirus TBFV group which causes disease in humans The vaccine candidate would be a single multivalent vaccine that would provide protection against many viruses in the TBFV group The approach is based on a technology to produce vaccine components comprised of recombinant subunit envelope proteins Although TBFVs are normally found outside the U S they are identified as priority pathogens so a multivalent vaccine would help meet the mission of providing protection for U S citizens against several priority pathogens biothreat agents with a single vaccine Such a multivalent TBFV vaccine can be utilized to protect military and state department personnel first responders and U S TBFV virus researchers who are currently forced to go abroad for vaccination in addition to travelers or people at risk in endemic areas


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 300.00K | Year: 2016

DESCRIPTION provided by applicant Chikungunya virus CHIKV is an alphavirus classified as a category C priority pathogen that causes fever rash and arthralgia in humans In the past decade CHIKV outbreaks have spread beyond the endemic regions of Africa and Asia first to the islands in the Indian Ocean and most recently to the Americas The World Health Organization has reported that as of October over suspected cases of Chikungunya have been recorded in the Caribbean islands Latin American countries and some South American countries Due to this geographic expansion of its range and the increase in the number of human cases CHIKV is considered to be a re emerging pathogen a contributing factor to this re emergence is the virus adapting to transmission by Aedes albopictus mosquitoes Currently there are no licensed vaccines or therapeutics to protect against infection with CHIKV As with many viral infections supportive care is the only available treatment Given the severe morbidity caused by CHIKV its swift emergence and the lack of any targeted interventions a preventative vaccine would provide an effective means to reduce the burden caused by this disease This application is directed at the development of a CHIKV recombinant subunit vaccine There are several candidate vaccines under development using a variety of platform technologies including inactivated viruses live attenuated viruses chimeric live attenuated viruses virus like particles and subunits As with all vaccines and in particula for priority pathogens such as CHIKV which requires BSL handling a combination of safety and economics in manufacturing are of paramount importance The proposed recombinant subunit approach provides a means to deliver a safe and stable manufacturing platform and allow for easy adjustment of dosing in order to elicit a robust immune response providing strong protection against CHIKV infection To accomplish this goal recombinant subunit proteins focused on specific domains with relevant epitopes from the CHIKV envelope glycoproteins will be evaluated The Specific Aims of this project are produce recombinant CHIKV E subunit proteins demonstrate immunogenicity of candidate vaccines in mice and demonstrate protective efficacy of candidate vaccines in mice To achieve these goals the recombinant E subunit proteins will be produced in an established stable insect expression system for which multiple IND applications have now been filed A candidate vaccine will be selected on the basis of a composition that maintains native like protein structure and which elicits a relevant and robust immune response that is capable of preventing disease following CHIKV challenge A collaboration between Hawaii Biotech and Baylor College of Medicine has been established to develop and evaluate a successful a CHIKV vaccine The development of CHIKV recombinant subunit vaccine would be of great value in slowing the spread of this re emerging Category C virus and preventing the severe morbidity caused by CHIKV infection PUBLIC HEALTH RELEVANCE The proposed research is focused on development of a candidate vaccine that protects against Chikungunya virus CHIKV which causes disease in humans The vaccine will be based on technology which allows for production recombinant subunit envelope proteins Although CHIKV is not yet established in the U S recent epidemics in the Americas provide the potential for the virus to become endemic in the U S CHIKV is also classified as a category C priority pathogen The proposed vaccine would be used to protect U S citizens against the potential spread of this virus as well as protect military and state department personnel and travelers that may be at risk in endemic areas The vaccine could also protect the populations of countries where the virus is already established


Patent
Hawaii Biotech, Inc. | Date: 2016-04-14

Compounds of formula I are provided: R_(1 )is an alkoxy or O(CH_(2))_(p)X, p is an integer from 2 to 3 and X is OH, NH_(2), or CO_(2)H, m is an integer from 0 to 5, n is an integer from 0 to 5, each R_(2 )is independently selected from hydrogen, alkenyl, hydroxyalkyl, alkoxymethyl, heterocyclyl, hetereocyclylmethyl, amino, amido, hydroxamido, any of which may be optionally substituted with one or more of acyl, alkyl, alkoxy, hydroxyalkyl, or halogen, each R_(3 )is independently selected from hydrogen, halogen, alkyl, alkenyl, carboxy, hydroxymethyl, amido, and at least one of R_(2 )and R_(3 )is not hydrogen.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 530.90K | Year: 2012

DESCRIPTION (provided by applicant): Emerging and reemerging infectious diseases continue to pose serious health threats world-wide. Consequently, the development of measures to mitigate the natural, as well as potential bioterrorist threats of these infectious diseases is an important endeavor. The NIAID Strategic Plan for Biodefense Research is specifically directed at promoting research that can provide solutions to mitigate the threat posed by Category A, B, and C priority pathogens. The development ofvaccines against these pathogens provides a strategy to mitigate the potential threat. Crimean-Congo hemorrhagic fever virus (CCHFV) is a significant human pathogen due to it ability cause severe disease and its high fatality rate. CCHFV is classified as acategory C priority pathogen due the concern that it could be used as a biological agent. There is currently no effective vaccine or therapy that is widely available to mitigate such a threat. New technologies and production methods may offer the most effective responses to such disease threats. The proposed research aims to develop a vaccine to protect against disease caused by infection with CCHFV using a stable insect cell line expression platform that has previously been used to produce vaccine candidates for other priority pathogens. The platform is based on the production of recombinant subunit proteins that maintain structural and immunogenic integrity. Candidate vaccines against dengue and West Nile virus have already been produced in this system and both have entered clinical trials. Thus, this platform can be scaled for cGMP production and meet FDA regulatory requirements. The expression of the CCHFV Gn and Gc envelope glycoprotein will be evaluated. The complex nature of viral envelope glycoproteins presents challenges in designing and expressing recombinant subunits that maintain native-like structure. The platform proposed for use in this project has the demonstrated capability of producing complex viral envelope proteins with native-like conformation. Successfully expressed recombinant products will be evaluated for immunogenic potential using two novel adjuvant formulations that have dose sparing potential. Based on immunogenicity studies, selected combinations of recombinant proteins and adjuvant will be evaluated in protective efficacy studies utilizing a recently developed mouse challenge model for CCHFV. In addition to vaccine development, the protein subunits produced can be used for development of diagnostic reagents, as well as targets forantiviral drug development. The successful development of a CCHFV vaccine utilizing this stable insect cell platform will not only meet the need for a safe and effective vaccine against CCHFV, it will also help to demonstrate the utility of the platform and pave the way for the development of additional vaccines against NIAID viral priority pathogens. PUBLIC HEALTH RELEVANCE: The proposed research is focused on the development of a vaccine to protect against disease caused by Crimean-Congo hemorrhagic fever virus (CCHFV), which is a member of the Bunyaviridae family and is the causative agent of a clinical febrile illness with a propensity to cause significant hemorrhagic fever. Due to the hemorrhagic nature of the disease and the high mortality rate, CCHF has been classified as a NIAID category C priority pathogen. Threat of CCHF as an emerging disease continues as the number of cases continues to increase. The development of vaccines against viral diseases on the NIAID priority pathogens list hasproven to be a challenging endeavor. Aside from vaccines for yellow fever and Japanese encephalitis, no other licensed vaccines have been developed for any of the other viral priority pathogens. The proposed work to develop a CCHF vaccine is based on a cell culture expression system that has been demonstrated to be capable of meeting FDA regulatory requirements and producing safe vaccine candidates. The vaccine manufacturing platform is based on the expression of recombinant subunit proteins in stably transformed insect cells. The successful development of a CCHF recombinant subunit vaccine based on this platform supports the concept that a single platform can be utilized to produce vaccines against a number of viral priority pathogens.


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