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INOVIO Provides an Update on Lassa Fever and MERS Programs

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INOVIO (NASDAQ: INO) has announced the discontinuation of its product candidates for Lassa Fever (INO-4500) and Middle East Respiratory Syndrome (MERS) (INO-4700) after initial study analyses by CEPI. Despite well-tolerated trials in Ghana and Jordan, the two-dose regimen did not meet the selection criteria for further development. INOVIO emphasizes its commitment to its DNA medicine candidates and future collaborations with CEPI. The company plans to publish data to support ongoing research.

Positive
  • INO-4500 and INO-4700 were well-tolerated in clinical trials.
  • Potential for future collaboration with CEPI on DNA medicine development.
Negative
  • Discontinuation of INO-4500 and INO-4700 due to not meeting CEPI's selection criteria.
  • INO-4500 was the first to enter human trials in West Africa but is now halted.

PLYMOUTH MEETING, Pa., Nov. 17, 2022 /PRNewswire/ -- INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and prevent infectious diseases, cancer, and diseases associated with HPV, today announced that it has agreed with its collaborator, the Coalition for Epidemic Preparedness Innovations (CEPI), to discontinue development of product candidates targeting Lassa Fever (INO-4500) and Middle East Respiratory Syndrome (MERS) (INO-4700), following initial analyses of data from studies conducted by INOVIO and funded by CEPI.

Dr. Jacqueline Shea, INOVIO's President and Chief Executive Officer, said, "For the past four years, we have been pleased to collaborate with CEPI on its mission of accelerating the development of vaccines against epidemic and pandemic threats so that they can be accessible to all people in need. Although INO-4500 and INO-4700 were well-tolerated by participants in our clinical trials and generated immune responses, the two-dose regimen did not meet CEPI's selection criteria for further development. We continue to believe in the potential of our DNA medicine candidates based on their characteristics, including the ability to elicit durable T-cell responses, which could be important in the prevention and treatment of infectious diseases. INOVIO welcomes the opportunity to collaborate with CEPI in the future."

The INO-4500 Lassa Fever trial was a Phase 1b study involving 220 participants in Ghana. With this trial, INO-4500 was the first product candidate to enter human clinical trials in West Africa targeting Lassa Fever. The INO-4700 trial was a Phase 2 study targeting the prevention of MERS. The first cohort of the trial involved 192 participants in Jordan, Kenya, and Lebanon. INOVIO intends to publish data to aid subsequent research.

About INOVIO

INOVIO is a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-associated diseases, cancer, and infectious diseases. INOVIO's DNA medicines in development are delivered using its investigational proprietary smart device to produce immune responses against targeted pathogens and cancers. For more information, visit www.inovio.com.

Contacts

Investors & Media:
Gene Kim, (267) 589-9471, gene.kim@inovio.com
Thomas Hong, (267) 440-4298, thomas.hong@inovio.com

Forward-Looking Statement

This press release contains certain forward-looking statements relating to our business, our expectations regarding our research and development programs, including the planned publication of data from clinical trials. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials, product development programs and commercialization activities and outcomes, the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA medicines, our ability to support our pipeline of DNA medicine products, the ability of our collaborators to attain development and commercial milestones for products we license and product sales that will enable us to receive future payments and royalties, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by us or collaborators, including alternatives that may be more efficacious or cost effective than any therapy or treatment that we and our collaborators hope to develop, issues involving product liability, issues involving patents and whether they or licenses to them will provide us with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether we can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of our technology by potential corporate or other partners or collaborators, capital market conditions, the impact of government healthcare proposals and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2021, our Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, and other filings we make from time to time with the Securities and Exchange Commission. There can be no assurance that any product candidate in our pipeline will be successfully developed, manufactured, or commercialized, that the results of clinical trials will be supportive of regulatory approvals required to market products, or that any of the forward-looking information provided herein will be proven accurate. Forward-looking statements speak only as of the date of this release, and we undertake no obligation to update or revise these statements, except as may be required by law.

Cision View original content:https://www.prnewswire.com/news-releases/inovio-provides-an-update-on-lassa-fever-and-mers-programs-301682063.html

SOURCE INOVIO Pharmaceuticals, Inc.

FAQ

What did INOVIO announce on November 17, 2022?

INOVIO announced the discontinuation of its Lassa Fever and MERS product candidates after initial study results.

What are the product candidates INO-4500 and INO-4700?

INO-4500 targets Lassa Fever and INO-4700 targets MERS, both of which failed to meet CEPI's criteria for further development.

Where were the clinical trials for INO-4500 and INO-4700 conducted?

The INO-4500 trial was conducted in Ghana, while the INO-4700 trial involved participants in Jordan, Kenya, and Lebanon.

What impact does the discontinuation of INO-4500 and INO-4700 have on shareholders?

The discontinuation represents a setback in INOVIO's pipeline, potentially impacting investor confidence and stock performance.

Inovio Pharmaceuticals, Inc.

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