Framingham, MA – October 20, 2021.  Kephera Diagnostics has been awarded a $1,999,961 million Phase II Small Business Innovative Research (SBIR) contract by the National Cancer Institute, an agency of the National Institutes of Health, for a test for liver fluke infection, the Company announced today.  Kephera had previously received a $300,000 Phase I contract to develop and demonstrate the feasibility of its test.

Liver flukes are acquired by eating raw freshwater fish that are infected with the parasites. They are endemic in large parts of Asia, including China, Korea and Southeast Asia, with estimates of up to 45 million people infected.   The parasites live in the bile ducts and can apparently survive for decades, with symptoms ranging from mild to severe depending on parasite burden and duration of infection. Infection can be treated effectively by relatively inexpensive and accessible drugs. However, long-term infection with liver flukes has been linked to cholangiocarcinoma, cancer of the bile duct, a relatively uncommon but highly lethal cancer which may occur years later.  For this reason, liver fluke is one of only two parasites that have been designated as biological carcinogens by the World Health Organization.

Liver fluke infection has been raised as a possible risk factor for cholangiocarcinoma in U.S. personnel who served in Vietnam between 1961-1975, who are estimated to number over 600,000 today.  An earlier study found evidence of an elevated rate of exposure to the parasites in a group of Vietnam veterans, based on an antibody test carried out in Korea. Recent reports show a 6-fold increase in claims for bile duct cancer submitted to the Dept. of Veterans Affairs (VA) over the past two decades.  Based on these findings, Sen. Chuck Schumer of New York has advocated for further investigation, and a bill (H.R. 1273) named the “Vietnam Veterans Liver Fluke Cancer Study Act” was introduced in Congress by Rep. Lee Zeldin of New York in 2021, where it is now under review by the House Veterans’ Affairs Committee. The house bill would require ongoing studies to determine the prevalence of liver fluke and cholangiocarcinoma in veterans.

The Phase II NCI contract will allow Kephera to complete development of its test for liver fluke infection, obtain regulatory approvals, and launch it through the Company’s CLIA laboratory for screening of veterans and others who may be at risk for infection based on having lived or travelled in endemic countries.  The test, which will ultimately be offered in both laboratory and point-of-care formats, will detect antibodies to specific parasite markers.  Kephera scientists will work with collaborators at the National Institute of Malaria, Parasitology and Entomology in Vietnam, the country’s leading institution for research on human pathogenic parasites, and the Hanoi University of Public Health.

“The award of this Phase II contract from NCI validates our work on development of the liver fluke test and is a major step forwards for Kephera Diagnostics, advancing our mission to improve diagnostics for people affected by emerging and neglected infectious diseases worldwide” said Dr. Andrew Levin, Chief Executive Officer of Kephera Diagnostics and Principal Investigator under the contract.  “We look forward to making the test available for the screening of U.S. veterans for liver fluke, as a tool to address this significant public health need”.

This project has been funded in whole or in part with Federal funds from the National Cancer Institute, National Institutes of Health, Department of Health and Human Services, under Contract No. 75N91021C00047.

About Kephera Diagnostics

Kephera Diagnostics is a startup that aims to address the public health challenges of global infectious diseases with new point of care assay technology.  Our mission is to promote more effective and more affordable medical treatment through faster, point-of-care diagnosis.  We collaborate with a global community of researchers to develop and translate new technologies into accessible products for clinical diagnostics and research applications.  Kephera has recently been funded for development of new tests for several infectious diseases of global significance.

Contact:
Andrew Levin, PhD
Chief Executive Officer
617-834-0950 cell
alevin@kephera.com

National Institutes of Health awards contract to develop a test-of-cure for Chagas disease

Framingham, MA – September 23, 2021.  The National Institute of Allergy and Infectious Diseases (NIAID), an agency of the National Institutes of Health (NIH), has awarded a Phase I, $300,000 Small Business Innovative Research (SBIR) contract to Kephera Diagnostics to develop a new test for Chagas disease, the company announced today.  The contract, awarded in response to a targeted solicitation from NIAID aimed at improving diagnostic resources for Chagas disease, will support the development and preliminary evaluation of a test that can discriminate active from successfully treated Chagas disease.

Chagas disease, caused by the parasite Trypanosoma cruzi, is primarily transmitted by an insect called the kissing bug which is found throughout most of Latin America, and is now expanding into the U.S.  It is the most prevalent parasitic disease in the western hemisphere, infecting 6-7 million people with over 70 million at risk.   Moreover, CDC estimates approximately 300,000 cases in the U.S., principally among individuals who acquired it in endemic countries, although some autochthonous infections have also been reported. Chagas can also be transmitted congenitally, via consumption of food contaminated by kissing bugs, and by blood transfusion or organ transplantation.  Infection can lead to chronic disease lasting decades, with a higher risk of death due to cardiac or digestive system impairment; up to one third of infections result in  debilitating symptoms, while the remainder are asymptomatic.  Treatment for Chagas disease currently relies on two drugs, benznidazole and nifurtimox, which have recently been approved by the U.S. Food and Drug Administration for pediatric use.

Though highly effective when used during acute infection, the drugs’ efficacy decreases in chronic stage disease, treatment can be lengthy, and adverse effects are common and occasionally serious. With current methods, confirming whether a patient has been cured or not is a challenging and protracted process. At present, no test-of-cure is commercially available.  The lack of a test-of-cure has also slowed down the development of new drugs for Chagas disease, as their efficacy can be difficult to measure in clinical studies.

“Chagas disease affects more than 300,000 people in the US but to date has been neglected. The lack of a test-of-cure has been a critical gap in care. We are excited to participate in this collaborative effort to address this issue and improve care for our patients” said Dr. Natasha Hochberg of Boston University and Boston Medical Center, who will be a collaborator under the contract.

With the contract funding, Kephera plans to develop a test that will indicate the presence of active T. cruzi infection based on detection of T. cruzi biomarkers in blood samples. The test will be translated into both laboratory-based and point-of-care formats to address the needs of clinical and field settings.

“We are very pleased to have been selected by NIAID for this award,” said Dr. Andrew Levin, Chief Executive Officer of Kephera Diagnostics and Principal Investigator under the contract.  “We look forward to working with our colleagues at Boston University to develop a test-of-cure for Chagas disease, which we believe will provide a major tool to aid in clinical and public health management of the disease, and is in line with Kephera’s focus on improving diagnostics for emerging and neglected diseases.

The contract awarded to Kephera Diagnostics is NIH Award No. 75N93021C00062.

About Kephera Diagnostics

Kephera Diagnostics is a startup that aims to address the public health challenges of global infectious diseases with new point of care assay technology.  Our mission is to promote more effective and more affordable medical treatment through faster, point-of-care diagnosis.  We collaborate with a global community of researchers to develop and translate new technologies into accessible products for clinical diagnostics and research applications.  Kephera has recently been funded for development of new tests for several infectious diseases of global significance.

Contact:

Andrew Levin, PhD
Chief Executive Officer and Chief Scientific Officer
617-834-0950 cell
alevin@kephera.com

Kephera Diagnostics, LLC
One Grant St., Suite 300
Framingham, MA 01702 USA

Framingham, MA – July 13, 2021 – Kephera Diagnostics announced today the launch of a quantitative test to measure the level of antibodies elicited by vaccination against COVID-19, as well as by COVID-19 infection. The test will be available as a service through Kephera’s CLIA-certified laboratory.

Kephera’s COVI-QUANT™ test measures the level of IgG antibodies to the spike protein, a viral component which is the key antigen in current COVID-19 vaccines. The test will enable individuals to assess their immune response to vaccination or to infection, and to monitor their antibody level for changes over time. At this point, the duration of immunity to COVID-19 conferred by vaccination remains unknown, and measuring antibody levels periodically after vaccination can provide insight into changes in the immune response. As the immune response can also differ significantly between individuals, the test will allow people to compare their antibody levels with those in demographically similar populations of vaccinated and infected individuals, using a tool to be made available on the company’s website. This information is expected to be especially useful for those with health conditions that hinder development of a typical immune response. Recent studies have shown that people with immunocompromising conditions due to age, inherent illnesses, infection, organ transplantation, cancer treatment and other causes tend to develop a much weaker antibody response than the rest of the population, which could put them at greater risk of infection by the virus. Kephera’s COVI-QUANT™ test provides an objective measurement of antibody levels based on an international standard developed by the World Health Organization. The test currently uses a standard blood sample, with a less-invasive finger prick dried blood spot option coming soon.

“We are very excited to offer our newly developed COVI-QUANT™ test for quantitative measurement of COVID-19 antibody levels” said Dr. Andrew Levin, Kephera’s Chief Executive Officer. “Measuring the antibody response to vaccination or infection provides objective information on the strength of the immune response. This could help those individuals who may be at higher risk due to certain health conditions to learn more about their immune response to the vaccine.  We believe that measurement of antibody levels will contribute to our understanding of the relationship between the antibody response and immunity to viral infection.”

Visit https://kepheradx.com/covid-19-testing/ or contact the company directly at info@kephera.com for details on how to submit blood samples for testing.

About Kephera Diagnostics

Kephera Diagnostics, LLC is a young and growing diagnostics company that aims to address the public health challenges of global infectious diseases with new point of care assay technology.  Our mission is to promote more effective and more affordable medical treatment through faster, point-of-care diagnosis. We collaborate with a global community of researchers to develop and translate new technologies into accessible products for clinical diagnostics and research applications. Kephera has recently been funded for development of new tests for several infectious diseases of global significance.

Contact:

Andrew Levin, Ph.D.
Chief Executive Officer
Kephera Diagnostics, LLC
1 Grant St., Suite 300
Framingham, MA 01702
617 834 0950 cell
alevin@kephera.com

Baker-Polito Administration and Massachusetts Life Sciences Center Announce More Than $1.5 Million to Support Development and Acceleration of Coronavirus Testing Solutions

The full text of this announcement can be viewed at https://www.mass.gov/news/baker-polito-administration-and-massachusetts-life-sciences-center-announce-more-than-15

BOSTON — Today, the Baker-Polito Administration announced that more than $1.5 million has been awarded to four projects that seek to increase testing capacity and provide solutions for coronavirus testing. The funding is through the Accelerating Coronavirus Testing Solutions (A.C.T.S.) Program, designed and administered by the Massachusetts Life Sciences Center, which supports projects focused on two core areas: accelerating the development of at-home or point-of-care testing methods that are simpler and faster, and new and innovative solutions that address existing supply chain bottlenecks. Among the four initial A.C.T.S. awardees are two companies: Framingham-based Kephera Diagnostics and Wellesley-based Virex Health; and two research hospitals: Beth Israel Deaconess Medical Center and Brigham and Women’s Hospital.

“We are committed to continuing to find ways to expand testing innovations and solutions as we continue to fight COVID-19,” said Governor Charlie Baker. “I applaud the efforts of these companies and institutions and I look forward to adding new and innovative solutions and continuing to work together to combat the pandemic.

“These investments represent the robustness of Massachusetts’ life sciences ecosystem in action, demonstrating our Commonwealth’s ability to lead the way in bringing health care innovations to patients,” said Lt. Governor Karyn Polito. “We need multiple tools in this fight against COVID-19 and remain committed to providing resources to expand access and capacity for testing, which remains a foundational piece of safely reopening the Massachusetts economy.”

The MLSC launched a Request for Proposals for A.C.T.S. this past October, open to for-profit companies and not-for-profit institutions submitting proposals that directly address the critical, near-term impact through innovative solutions that would support the process of safely reopening the Massachusetts economy. The MLSC brought together an external advisory panel of experts from academia and industry, including entrepreneurs, clinicians, scientists, clinical diagnostic lab managers, and public health experts, to assist in reviewing the proposals.

“As we work together to overcome the challenges this pandemic has created,  we know that returning to everyday activities as safely as possible is tied to our ability to identify infected individuals, and that is only done via testing,” said Massachusetts Housing & Economic Development Secretary Mike Kennealy, who serves as Co-Chair of the MLSC Board of Directors. “We are excited about the impact these four efforts are bringing to the table in accelerating coronavirus testing solutions with a particular focus on making it easier and quicker to perform tests that can be done by patients outside of a traditional health care setting.”

“These innovative initiatives and the A.C.T.S. program itself underscore the importance of this Administration’s historic investment in the life sciences, from its top research universities and academic medical centers, STEM education, R&D infrastructure, talent, and life science companies,” said Secretary for Administration and Finance Michael J. Heffernan, who serves as Co-Chair of the MLSC Board of Directors. “There are many lessons to be learned from the current pandemic, but we remain determined our support for Massachusetts’ research and development capabilities and innovation
infrastructure to accelerate the development of improved testing capabilities in the fight against COVID-19.”

“While there remains many unknowns yet to be fully explored, as we work in the present and look to the future, we do know testing will be vital to ensuring continued protection from COVID-19,” said MLSC President and CEO Kenneth Turner. “The mission of the MLSC remains more important than ever. We will continue to support novel innovations in the battle against this deadly virus, which matches the ongoing work of the MLSC to support the life sciences ecosystem and expand the capabilities of Massachusetts companies and research institutions.”

While Massachusetts has had a number of successes in supporting initial manufacturing needs through the Manufacturing Emergency Response Team (M-ERT), which included PPE and materials for PCR testing, as the pandemic evolved bottle necks in testing modalities became apparent. This program seeks to identify innovative solutions that can expand the breadth and depth of testing occurring in the Commonwealth. Increasing the number and accessibility of testing methods can provide new options and opportunities to testing centers, as well as alleviate certain costs at testing sites for equipment related to administering and processing tests. Novel testing modalities identified have the ability to provide alternatives to current testing stopgaps, expand the number of settings tests can be administered, and provide further validation of tests already available.

“Massachusetts has cultivated an environment where the life sciences can thrive,” said House Speaker Ronald Mariano. “By funding critical research into accelerated coronavirus testing, Massachusetts is leveraging the expertise of our world-class research institutions for the benefit of all our residents and for a strong recovery from the pandemic.”

“Massachusetts’ innovative life sciences community, long a source of innovation and economic strength in our Commonwealth, is playing a pivotal role in saving lives during this global pandemic,” said Senate President Karen E. Spilka. “This critical initiative will use the unparalleled expertise of Framingham’s Kephera Diagnostics and three other recipients to rapidly develop additional COVID-19 testing”

“We are thrilled to have been selected by the MLSC for an award under the ACTS program, and grateful for the funding that will allow us to bring our COVID-19 rapid test through the final stages of development and regulatory review to commercial readiness,” said Dr. Andrew Levin, Kephera’s founder and CEO. “This project would not have been possible without the great network of collaborations with other companies and medical institutions that we have established here in Massachusetts.”

Applicants were required to provide solutions that improve testing modalities and provide innovative solutions to areas that hinder the ability to quickly and effectively combat and contain the COVID-19 pandemic. Proposals were evaluated based on an applicant’s ability to: address and execute in a defined priority area; time to patient and/or implementation success, ability to leverage additional resources (e.g. funding, supplies, equipment) of the Massachusetts life sciences industry cluster; probability of scaling in Massachusetts; and potential to drive economic development and contribute to larger ecosystem in the Commonwealth.

The MLSC has been proud to be part of the Commonwealth’s ongoing effort to respond to the COVID-19
outbreak, including contributing funding and resources to the M-ERT and the Massachusetts Consortium on Pathogen Readiness. These recent contributions are in addition to the Center’s continued administration of various programs and other initiatives to support the life sciences sector. At the onset of the COVID-19 pandemic, the MLSC’s Board of Directors authorized an expenditure of $5 million from the Center’s Investment Fund and $5 million from its Capital Fund to support academic and/ or industry partners engaged in responding to the imminent public health threat. While the MLSC capitalized the A.C.T.S. program with $3.6 million, the MLSC is prepared to deploy additional funds to support A.C.T.S. and other efforts as part of the Commonwealth’s broader response.

About the Massachusetts Life Sciences Center

The Massachusetts Life Sciences Center (MLSC) is an economic development investment agency dedicated to supporting the growth and development of the life sciences in Massachusetts, home to the most verdant and productive life sciences ecosystem in the world. Through public-private funding initiatives, the MLSC supports innovation, research and development, commercialization, and manufacturing activities in the fields of biopharma, medical device, diagnostics, and digital health. Since its creation in 2007, the MLSC has strategically deployed more than $796 million in Massachusetts, through a combination of grants, loans, capital infrastructure investments, tax incentives, and workforce programs. These investments have created thousands of jobs and propelled the development of new therapies, devices, and scientific advancements that are improving patient health and well-being in Massachusetts and beyond.