Parasitemia

August 14, 2024 -- Two National Institutes of Health (NIH)-supported trials of an experimental malaria vaccine in healthy Malian adults found that all three tested regimens were safe. One of the trials enrolled 300 healthy women ages 18 to 38 years who anticipated becoming pregnant soon after immunization. That trial began with drug treatment to remove malaria parasites, followed by three injections spaced over a month of either saline placebo or the investigational vaccine at one of two dosages. Both dosages of the vaccine candidate conferred a significant degree of protection from parasite infection and clinical malaria that was sustained over a span of two years without the need for a booster dose—a first for any malaria vaccine. In an exploratory analysis of women who conceived during the study, the vaccine significantly protected them from malaria in pregnancy. If confirmed through additional clinical trials, the approach modeled in this study could open improved ways to prevent malaria in pregnancy. Spread by Anopheles mosquitoes, malaria parasites, including those of the species Plasmodium falciparum ( Pf ), can cause illness in people of any age. However, pregnant women, infants and very young children are especially vulnerable to life-threatening disease. Malarial parasitemia in pregnancy is estimated to cause up to 50,000 maternal deaths and 200,000 stillbirths in Africa each year. The trials were co-led by investigators from the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) and the University of Sciences, Techniques and Technologies, Bamako (USTTB), Mali. The investigational vaccine used in both trials was PfSPZ Vaccine, a radiation-attenuated vaccine based on Pf sporozoites (a stage of the parasite’s lifecycle), manufactured by Sanaria Inc., Rockville, Maryland. Multiple previous clinical trials of PfSPZ Vaccine have shown it to be safe, including in malaria-endemic countries such as Mali. In results published in 2022, for example, an NIAID-sponsored, placebo-controlled trial of a three-dose regimen of PfSPZ Vaccine in Burkina Faso found that the vaccine had up to 46% efficacy that lasted at least 18 months. In the first year of the current trial, 55 women became pregnant within 24 weeks of the third vaccine dose. Among these women, vaccine efficacy against parasitemia (whether before or during pregnancy) was 65% in those who received the lower dose vaccine and 86% in those who received the higher dose. Among 155 women who became pregnant across both study years, vaccine efficacy was 57% for those who received lower dose vaccine and 49% in those in the higher dosage group. Women who received the investigational vaccine at either of the dosages conceived sooner than those who received placebo, although this finding did not reach the level of statistical significance, reported the investigators. The researchers speculate that the PfSPZ Vaccine might avert malaria-related early pregnancy losses since parasitemia risk during the periconception period was reduced by 65 to 86%. “Preconception immunization is a new strategy to reduce mortality for women with malaria in pregnancy,” the researchers note. They plan to investigate the safety of PfSPZ Vaccine administered during pregnancy, then examine the efficacy of PfSPZ given preconception or during pregnancy in larger clinical trials. “Existing measures are not protecting women from malaria in pregnancy,” they added. “A safe and effective vaccine is urgently needed, and our results indicate PfSPZ Vaccine might be a suitable candidate,” they conclude. The PfSPZ Vaccine Study Team was led by Alassane Dicko, M.D., of the Malaria Research and Training Center (MRTC), USTTB, Mali, Stephen L. Hoffman, M.D., of Sanaria Inc., and Patrick E. Duffy, M.D., of the NIAID Laboratory of Malaria Immunology and Vaccinology. Joint co-first authors were Halimatou Diawara, M.D., of MRTC, and Sara A. Healy, M.D., NIAID. Additional information about the trials is available at clinicaltrials.gov using the identifiers NCT03510481 or NCT03989102. H Diawara et al. Safety and efficacy of PfSPZ Vaccine against malaria in healthy adults and women anticipating pregnancy in Mali: two randomised, double-blind, placebo-controlled, phase 1 and 2 trials . Lancet Infectious Diseases DOI: 10.1016/ S1473-3099(24)00360-8 (2024). Patrick E. Duffy, M.D., Chief, Laboratory of Malaria Immunology and Vaccinology, NIAID, is available to comment. To schedule interviews, please contact Anne A. Oplinger, (301) 402-1663, niaidnews@niaid.nih.gov . 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 www.nih.gov. Source: NIH Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Providence, RI, Oct. 24, 2023 (GLOBE NEWSWIRE) -- Ocean Biomedical, Inc. (NASDAQ:OCEA), today announced that its Chief Scientist, Jonathan Kurtis MD, PhD has received the prestigious Falk Medical Research Trust Transformational Award to advance a new class of anti-malarial drug candidates. Dr. Kurtis’ malaria drug program stems from his groundbreaking malaria vaccine research, targeting a critical stage of the malaria cycle. This program, which includes a therapeutic small molecule drug candidate for treating severe malaria, and a therapeutic antibody for short term malaria prevention, is designed to address the growing resistance to the current best-in-class Artemisinin-based medicines. “It has become increasingly apparent that a new, more effective class of anti-malarials is needed, especially to combat severe malaria,” said Dr. Jonathan Kurtis, one of Ocean’s Scientific Co-Founders. “We believe that our therapeutic candidates could provide a comprehensive defense against some of the most devastating forms of the disease, and I am grateful to the Falk Medical Research Trust for recognizing this new paradigm for malaria drug development.” About Ocean Biomedical’s Malaria Program After decades of vaccine development work, Dr. Kurtis and colleagues have made a series of discoveries that have allowed them to hone in on 3 key targets in the ‘blood stage’ of the malaria cycle, each critical to a different segment of that stage: invasion, intracellular development, and egress from the cell. Kurtis is working to optimize Ocean Biomedical’s vaccine candidate to potentially target all 3 segments of the blood stagesimultaneously, an advanced effort that even before the Covid-19 vaccine was using the mRNA delivery platform. Ocean’s malaria drug program grew out of the vaccine effort, and has already demonstrated that the family of small molecule drugs in development by Dr. Kurtis’ team are highly specific for PfGARP binding, are non-toxic in multiple in vitro and in vivo systems, have excellent pharmacokinetic properties, and rapidly clear parasitemia in animal models. Global Malaria Challenges Malaria is the greatest single cause of childhood death on the planet, killing approximately 600,000 individuals a year. Efforts to control and eventually eradicate malaria in sub-Saharan Africa have made progress in the past decade, but are being threatened by the expansion of malarial zones, new strains of mosquitos in urban areas, and growing resistance to current treatments. Artemisinin-based drug therapy remains the mainstay of treatment, but the spread of parasites resistant to this family of compounds underscores the urgent need to identify new anti-malarial drugs. About Dr. Jonathan Kurtis Jonathan Kurtis, MD-PhD is a Scientific Co-founder of Ocean Biomedical and currently serves as Chief Scientist for the company. Dr. Kurtis is the Chair of the Department of Pathology and Laboratory Medicine at Brown University, and the Executive Director of Brown’s MD-PhD program. An internationally recognized leader in malaria research and vaccine development, Kurtis has received the Baily K Ashford Medal in Tropical Medicine and is an elected member of the American Society of Clinical Investigation. Kurtis’ discovery research been published in dozens of prominent journals including Nature, and Science. Ocean Biomedical Ocean Biomedical, Inc. is a Providence, Rhode Island-based biopharma company with an innovative business model that accelerates the development and commercialization of scientifically compelling assets from research universities and medical centers. Ocean Biomedical deploys the funding and expertise to move new therapeutic candidates efficiently from the laboratory to the clinic to the world. Ocean Biomedical is currently developing five promising discoveries that have the potential to achieve life-changing outcomes in lung cancer, brain cancer, pulmonary fibrosis, and the prevention and treatment of malaria. The Ocean Biomedical team is working on solving some of the world’s toughest problems, for the people who need it most. To learn more, visit . Forward-Looking Statements The information included herein and in any oral statements made on behalf of Ocean Biomedical, Inc. (the “Company”) or otherwise in connection herewith include “forward-looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “estimate,” “plan,” “project,” “forecast,” “intend,” “will,” “expect,” “anticipate,” “believe,” “seek,” “target,” or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters, although not all forward-looking statements contain such identifying words. These forward-looking statements include, but are not limited to, statements regarding estimates and forecasts of financial and performance metrics and expectations; the expected timing and success of IND filings for our initial product candidates; statements regarding the expected timing of our IND-enabling studies; the frequency and timing of filing additional INDs; expectations regarding the availability and addition of future assets to our pipeline; the advantages of any of our pipeline assets and platforms; the potential benefits of our product candidates; potential commercial opportunities; the timing of key milestones for our programs; the future financial condition, results of operations, business strategy and plans, and objectives of management for future strategy and operations; and statements about industry trends and other companies in the industry. These forward-looking statements are based on various assumptions, whether or not identified herein, and on the current expectations of the Company’s management, and they are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by any investor as, a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Any discoveries announced by the Company are based solely on laboratory and animal studies. The Company has not conducted any studies that show similar efficacy or safety in humans. There can be no assurances that any treatment tested by the Company will prove safe or effective in humans, and that any clinical benefits of any such treatment is subject to clinical trials and ultimate approval of its use in patients by the FDA. Such approval, if granted, could be years away. Forward-looking statements are predictions, projections, and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. These forward-looking statements are not guarantees of future performance, conditions, or results, and involve a number of known and unknown risks, uncertainties, assumptions, and other important factors, many of which are outside the control of the Company that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements. You should carefully consider the foregoing factors and the other risks and uncertainties that are described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 and in the Company’s subsequent Quarterly Reports on Form 10-Q and other documents filed by the Company from time to time with the SEC and which are available at . These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. We do not undertake any obligation to update any forward-looking statements made by us. These forward-looking statements should not be relied upon as representing the Company’s assessments as of any date subsequent to the date of this release. Accordingly, undue reliance should not be placed upon the forward-looking statements. Contacts: Ocean Biomedical Investor Relations connect@oceanbiomedical.com Kevin Kertscher Communications Director

Patent for breakthrough approach to disrupting the malaria parasite’s life cycle adds to a growing global patent portfolio, with 25 patents issued and an additional 38 patents pending. Providence, RI, June 08, 2023 (GLOBE NEWSWIRE) -- Ocean Biomedical, Inc. (NASDAQ: OCEA) announced today that Scientific Co-founder Dr. Jonathan Kurtis, MD, PhD has been granted a new patent for his malaria vaccine discoveries that may be used to interdict the parasite at multiple stages in the malaria cycle. This extends patent protection for Dr. Kurtis’ novel discoveries that have defined the powerful roles of PfGARP and PfCDPK-5 in controlling the malaria parasite’s ability to aggressively multiply within its human host. This patent adds to Ocean Biomedical’s global patent portfolio for discoveries with potential to impact major unmet medical needs in infectious disease, oncology, and fibrosis. Ocean Biomedical’s breakthrough approach targets the blood-stage portion of the malaria lifecycle – the stage responsible for all clinical disease and death – and therefore has the potential of significantly greater efficacy compared with vaccines targeting other stages. Ocean Biomedical is working to optimize the formulation of this vaccine prior to IND submission and first-in-humans testing. In addition to this multi-pronged vaccine program, Dr. Kurtis has developed a related small molecule drug program to provide a new approach for treating the increasingly drug-resistant strains of malaria. This medicine will be an additional focus of Ocean Biomedical’s development pipeline in 2023 and will address a massive unmet need. Addressing a Global Unmet Need Malaria is the greatest single-agent killer of children on the planet, killing approximately 627,000 individuals in 2022. Artemisinin-based drug therapy remains the mainstay of treatment, but the spread of parasites resistant to this family of compounds threatens recent progress achieved by anti-malarial campaigns and underscores the urgent need to identify new anti-malarial drugs. Data has demonstrated that the family of small molecule drugs in development by Dr. Kurtis’ team are highly specific for PfGARP binding, are non-toxic in multiple in vitro and in vivo systems, have excellent pharmacokinetic properties, and rapidly clear parasitemia in animal models. Leadership Comments “Our current vaccine formulation has an impressive ability to induce parasite cell death and we are excited about the prospect of moving this towards IND status that will enable human testing,” commented Dr. Kurtis, a Scientific Co-founder and director of Ocean Biomedical and the Chair of Pathology and Laboratory Medicine at The Warren Alpert Medical School of Brown University. “The progress we have been able to make thus far in advancing novel targets is a testament to Ocean Biomedical’s innovative model and deep partnership with premier research institutions. We are hopeful that Dr. Kurtis’ discoveries will lead to a powerful vaccine that can save hundreds of thousands of lives, and we are proud to help advance this important work,” said Elizabeth Ng, Chief Executive Officer of Ocean Biomedical. “The resurgence of Falciparum malaria worldwide is increasingly alarming and we are pleased to receive this patent coverage in such an important malaria-zone country. We are working hard to accelerate the development of our novel vaccine candidate and a novel class of anti-malarials, which have the potential to save hundreds of thousands of lives,” said Dr. Chirinjeev Kathuria, Ocean Biomedical’s co-founder and Executive Chairman. About Ocean Biomedical Ocean Biomedical, Inc. is a Providence, Rhode Island-based biopharma company with an innovative business model that accelerates the development and commercialization of scientifically compelling assets from research universities and medical centers. Ocean Biomedical deploys the funding and expertise to move new therapeutic candidates efficiently from the laboratory to the clinic, to the world. Ocean Biomedical is currently developing five promising discoveries that have the potential to achieve life-changing outcomes in lung cancer, brain cancer, pulmonary fibrosis, and the prevention and treatment of malaria. The Ocean Biomedical team is working on solving some of the world’s toughest problems, for the people who need it most. To learn more, visit . Forward-Looking Statements The information included herein and in any oral statements made in connection herewith include “forward-looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “estimate,” “plan,” “project,” “forecast,” “intend,” “will,” “expect,” “anticipate,” “believe,” “seek,” “target” or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters, although not all forward-looking statements contain such identifying words. These forward-looking statements include, but are not limited to, statements regarding estimates and forecasts of financial and performance metrics and expectations. These statements are based on various assumptions, whether or not identified herein, and on the current expectations of the management of Ocean Biomedical, Inc. (the “Company”), and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by any investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Any discoveries announced by the Company are based solely on laboratory and animal studies. The Company has not conducted any studies that show similar efficacy or safety in humans. There can be no assurances that this treatment will prove safe or effective in humans, and that any clinical benefits of this treatment is subject to clinical trials and ultimate approval of its use in patients by the FDA. Such approval, if granted, could be years away. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside the control of the Company that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements. Important factors, among others, that may affect actual results or outcomes include but are not limited to: (i) the outcome of any legal proceedings that may be instituted against the Company; (ii) changes in the markets in which the Company competes, including with respect to its competitive landscape, technology evolution, or regulatory changes; (iii) changes in domestic and global general economic conditions; (iv) the risk that the Company may not be able to execute its growth strategies; (v) risks related to public health threats and responses to such threats, including supply-chain disruptions; (vi) the risk that the Company may not be able to develop and maintain effective internal controls; (vii) the risk that the Company may fail to keep pace with rapid technological developments to provide new and innovative products and services or may make substantial investments in unsuccessful new products and services; (viii) the Company’s ability to develop, license or acquire new therapeutics; (ix) the risk that the Company will need to raise additional capital to execute its business plan, which may not be available on acceptable terms or at all; (x) the risk that the Company may experience difficulties in managing its growth and expanding its operations; (xi) the risk of product liability or regulatory lawsuits or proceedings relating to the Company’s business; (xii) the risk of cyber-security or foreign-exchange losses; and (xiii) the risk that the Company is unable to secure or protect its intellectual property. You should carefully consider the foregoing factors and the other risks and uncertainties that are described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, and in other documents to be filed by the Company from time to time with the SEC and which are and will be available at . These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. We do not undertake any obligation to update any forward-looking statements made by us. These forward-looking statements should not be relied upon as representing the Company’s assessments as of any date subsequent to the date of this filing. Accordingly, undue reliance should not be placed upon the forward-looking statements. Ocean Biomedical Investor Relations OCEANIR@westwicke.com Ocean Biomedical Media Relations OCEANPR@westwicke.com Kevin Kertscher Communications Director Source: Ocean Biomedical, Inc.