OCEA Ocean Biomedical Inc

Ocean Biomedical, Inc. (NASDAQ: OCEA), a biopharma company working to accelerate the development of compelling discoveries from top research scientists, announced today that it is focusing its multi-pronged malaria program to address the chronic malaria crisis in sub-Saharan Africa while recognizing newly emerging global malaria challenges.

Based on discoveries by Scientific Co-founder, Jonathan Kurtis, MD, PhD, Ocean Biomedical is working on a multivalent mRNA-based malaria vaccine with potential to target several stages in the malaria cycle. Additionally, the company has discovered a new therapeutic approach with the potential to launch a whole new class of anti-malarials. Promising results from the malaria program include: 1) an mRNA-based vaccine that generates >90% killing of malaria parasites in non-human primates, 2) a monoclonal antibody that kills 94%-99% of malaria parasites in culture, and 3) a small molecule drug that kills 100% of parasites at low nanomolar concentrations. Multiple U.S. and global patents are held by Ocean Biomedical for both the vaccine and therapeutic approaches.

“Inducing parasite cell death via targeting PfGARP is a novel approach that has potential to launch a whole new class of anti-malarial interventions, including mRNA-based vaccines, small molecule drugs and our current monoclonal antibody,” said Dr. Kurtis. “Our monoclonal antibody and small molecule drug comes at a critical time because malaria parasites are developing resistance to current frontline therapeutics, and the currently approved vaccine offers only very limited protection.”

Chronic Global Suffering

Malaria is the greatest single-agent killer of children on the planet, killing approximately 627,000 individuals in 2022. In countries where malaria is still prominent, primarily in sub-Saharan Africa, families are devastated by the illness generation after generation, not only losing children but facing a lifetime of chronic physical and economic struggle for many of those who ‘survive’ the disease. Malaria continues to exact an ongoing toll that should be recognized as a first-order crisis but has failed to generate commensurate concern and funding because it affects the most marginalized individuals on the planet. Though some progress has been made in the recent decade, the first approved vaccine has proven to be less effective at preventing severe malaria in infants than traditional bed nets. A growing concern is that current malaria treatments are showing alarming signs of losing efficacy and there are no new approved treatments currently in reserve.

Emerging Needs and U.S. Cases

A recent uptick in malaria cases in Florida and Texas have drawn attention to changing conditions that are expanding current malaria endemic zones. In a 2022 report, the World Health Organization warned of a surge in mosquito-borne diseases due to global warming, which is increasing vector survival and biting rates. Already malaria cases are popping up in places that haven’t had to grapple with major outbreaks of the disease in over 100 years. A cluster of cases in the southern United States has caused alarm. Every year the U.S. sees around 2,000 travel-related malaria cases, but the recent cases are unusual because they have resulted from mosquito-based transmission occurring inside the United States.

Adding to the climate concerns, growing parasite resistance to current Artemisinin-based drug therapies is threatening recent progress achieved by anti-malarial campaigns, underscoring the urgent need to identify new anti-malarial drugs. To address rising resistance to current treatments, and the potential expansion of malaria zones, a better, more fully effective vaccine is needed, and new treatment approaches for severe malaria will likely be needed before the end of the decade.

“As the current drugs begin to fade, we are pleased to have a small molecule drug candidate that could offer a treatment option for severe malaria patients, and a monoclonal antibody that would be well-suited to use for malaria prophylaxis for travelers, military deployments, and short-term exposure areas,” commented Ocean Biomedical’s Chairman and Co-founder, Dr. Chirinjeev Kathuria.

The Science

Ocean Biomedical’s novel malaria vaccine program is based on groundbreaking discoveries by Dr. Kurtis that have revealed new insights into how malaria parasites maintain homeostasis in their hosts. Examining the differences between naturally resistant children and naturally susceptible children, Dr. Kurtis has discovered 3 antigens that are active in the red blood cell phase, controlling invasion of the cell, survival in the cell, and the egress of parasites into the bloodstream. Controlling the activity of those antigens, especially PfGARP, has shown great potential for controlling the ability of the parasite to survive and duplicate.

Building on his groundbreaking discovery that PfGARP is potentially a highly effective vaccine target for malaria, Dr. Kurtis has now discovered and produced a monoclonal antibody that binds to PfGARP and triggers the malaria parasite to kill itself. This recently patented approach will allow Dr. Kurtis’ team to pursue development of this monoclonal antibody as both a potential therapeutic drug for individuals with severe malaria infection as well as a potential short-term prophylactic treatment to prevent malaria infection in travelers, overseas deployed military and government personnel, and individuals living in areas with short malaria transmission seasons.

The data generated by his lab has demonstrated that the family of small molecule candidates 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. This combination of discoveries has allowed Ocean Biomedical to begin simultaneously pursuing the development of a novel malaria vaccine, and novel malaria therapeutics.

“Like all of Ocean Biomedical’s programs, this malaria treatment has the potential to meet large, unmet medical needs that can benefit our shareholders, and a large population globally,” said one of Ocean Biomedical’s Directors, Suren Ajjarapu.

“With the rising resistance to Artemisinin-based drugs in sub-Saharan Africa, it is imperative that we get new malaria therapeutics into the drug development pipeline,” said Elizabeth Ng, Ocean Biomedical’s CEO. “We are pleased to be working on multiple solutions to this ongoing global health crisis, and to have the opportunity to share it with some of the nation’s top malaria researchers.”

About Ocean Biomedical

Ocean Biomedical, Inc. (“Ocean Biomedical” or the “Company”) 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 www.oceanbiomedical.com.

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: the expected timing and success of investigational new drug (“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 any clinical benefit 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 other documents to be filed by the Company from time to time with the SEC and which are and will be available at www.sec.gov. 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 RelationsOCEANIR@westwicke.com

Ocean Biomedical Media RelationsOCEANPR@westwicke.com

Kevin Kertscher Communications DirectorSource: Ocean Biomedical, Inc.