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Celularity to Present Data Showing Cancer Tumor Reduction by Off-the-Shelf Cell Therapy Derived from Human Placental Cells

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Celularity Inc. (NASDAQ: CELU) presented in vivo data on PT-CD16, a genetically modified cell therapy, at the AACR Annual Meeting 2024. The data showcased strong anti-tumor activity against gastric cancer. The company aims to combine cell therapies with approved antibodies for treating various cancers and conditions. The study revealed significant tumor volume reduction when PT-CD16VS was combined with trastuzumab compared to standard treatments.
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The presentation of in vivo data from Celularity's T-cell therapy platform at the AACR Annual Meeting is a significant milestone in the field of oncology and biotechnology. The data concerning PT-CD16, a genetically modified allogeneic cell therapy, suggests a robust anti-tumor activity against gastric cancer, which could have a substantial impact on the treatment landscape for HER2-positive cancers.

From a medical research perspective, the combination of PT-CD16VS with trastuzumab and its comparison with the current standard of care, Enhertu, indicates a potential improvement in therapeutic outcomes. The significant reduction in tumor volume with the combination therapy could translate into better patient responses and survival rates. This is particularly relevant as HER2-positive cancers are known to be aggressive and have limited treatment options.

Understanding the underlying mechanism of action, which involves the use of placental-derived T cells, could provide insights into new avenues of immunotherapy. The ability to engineer these cells in a state-of-the-art manufacturing facility underscores Celularity's capability to potentially scale up production, which is crucial for commercialization and accessibility.

Celularity's announcement is poised to have a ripple effect within the biotechnology sector, particularly for companies engaged in cell therapy and oncology. The progress of PT-CD16VS through preclinical studies and its potential to address HER2-positive cancers puts Celularity in a competitive position within the industry. The biotech market often reacts favorably to such promising preclinical data, especially when it demonstrates superiority to existing treatments.

Investors and stakeholders should note the strategic implications of combining cell therapy assets with approved antibodies, which may offer a unique value proposition and diversification of Celularity's product portfolio. The advancement of their pipeline to address aging-related healthcare challenges also indicates a broader application of their technology, which could open additional markets and revenue streams.

It is important to monitor the company's progress through clinical trials and subsequent regulatory milestones, as these are critical steps that will determine the commercial viability of their therapies. The biotech industry is known for its volatility and while promising, these developments must be viewed within the context of regulatory risks and the high costs associated with bringing new therapies to market.

The financial implications of Celularity's presentation at the AACR Annual Meeting could be significant for the company's stock performance. Preclinical success often leads to increased investor confidence, potentially driving up the stock price. However, it's important to remain cautious until further clinical data is available, as the transition from preclinical to clinical success is not guaranteed.

Investors should consider the potential market size for HER2-positive cancer treatments and the competitive landscape. The ability of Celularity's PT-CD16VS to potentially outperform the current standard of care could lead to a substantial market share if the therapy is approved. Moreover, Celularity's focus on aging-related healthcare challenges suggests a long-term strategic vision that targets a growing demographic.

It's also worth noting that advancements in cell therapy can attract partnership opportunities, licensing deals, or even acquisition interest from larger pharmaceutical companies looking to expand their oncology pipelines. Such strategic moves could provide additional capital and resources to Celularity, aiding in the development and commercialization of their therapies.

Company presenting an in vivo study of PT-CD16, a genetically modified allogeneic cell therapy derived from human placental circulating T (P-T) cells at AACR Annual Meeting 2024

FLORHAM PARK, N.J., March 07, 2024 (GLOBE NEWSWIRE) -- Celularity Inc. (NASDAQ: CELU) (“Celularity”), a biotechnology company developing placental-derived allogeneic cell therapies and biomaterial products, announced today that it will present in vivo data from its T-cell therapy platform at this year’s AACR Annual Meeting. These data, which highlight the platform’s robust anti-tumor activity against gastric cancer will be presented on April 9th, 2024. Please find the link to the abstract here.

Celularity is developing a platform to combine a broad portfolio of cell therapies with various approved antibodies to address multiple cancers and other conditions. Celularity’s preclinical asset, PT-CD16VS, is initially being developed in combination with trastuzumab, a cancer drug, for treating HER2-positive cancers. The data in this study demonstrates that treatment with PT-CD16VS in combination with trastuzumab resulted in a significant reduction in tumor volume compared to treatment with trastuzumab alone, as well as with Enhertu alone, which is the current standard of care.

“These data demonstrate the promise and potential of combining Celularity’s cell therapy assets with currently available therapies to address difficult-to-treat cancers,” said Dr. Robert Hariri, Celularity’s CEO and Founder. “With this study, we are also advancing our pipeline to address aging-related healthcare challenges, including cancer. This work highlights the deep expertise and capabilities in cell therapy resident at Celularity, employing our platform of placental-derived cell products and our ability to engineer those cells in our state-of-the-art manufacturing facility.”  

Dr. Adrian Kilcoyne, Chief Medical Officer, added, “As we continue to focus on first-in-class and best-in-class cell therapy assets, Celularity is realizing the broad potential of our extensive cell therapy portfolio across T-cells, natural killer (NK) cells, mesenchymal stem cells (MSCs), and exosomes.”

The AACR Annual Meeting will be held from April 5 to 10, 2024, in San Diego, CA.

Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of U.S. The Private Securities Litigation Reform Act of 1995, as well as within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “can,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “forecast,” “intends,” “may,” “might,” “outlook,” “plan,” “possible,” “potential,” “predict,” “project,” “seek,” “should,” “strive,” “target,” “will,” “would” and the negative of terms like these or other comparable terminology, and other words or terms of similar meaning. The forward-looking statements in this press release include statements regarding the ability of placental circulating T cells that are genetically modified to express a proprietary CD16 variant and endogenous T cell receptor (TCR) knockout (PT-CD16VS) in combination with Trastuzumab to significantly reduce in tumor volume compared to Trastuzumab alone and Enhertu alone; the potential of combining Celularity’s cell therapy assets with currently available therapies to address difficult to treat cancers; Celularity’s ability to advance our pipeline to address aging related healthcare challenges, including cancer; the broad potential of Celularity’s cell therapy portfolio, among others. Many factors could cause actual results to differ materially from those described in these forward-looking statements, including but not limited to: the inherent risks in biotechnological development, including with respect to the development of novel cellular therapies, and the clinical trial and regulatory approval process; and risks associated with Celularity’s current liquidity, as well as developments relating to Celularity’s competitors and industry, along with those risk factors set forth under the caption “Risk Factors” in Celularity’s annual report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 31, 2023, and other filings with the SEC. If any of these risks materialize or underlying assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Celularity does not presently know, or that Celularity currently believes are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, these forward-looking statements reflect Celularity’s current expectations, plans, or forecasts of future events and views as of the date of this communication. Subsequent events and developments could cause assessments to change. Accordingly, forward-looking statements should not be relied upon as representing Celularity’s views as of any subsequent date, and Celularity undertakes no obligation to update forward-looking statements to reflect events or circumstances after the date hereof, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

Investor Contact
Carlos Ramirez
Celularity Inc.
carlos.ramirez@celularity.com

Media Contact
Caitlin Kasunich / Ali Nagy
KCSA Strategic Communications
ckasunich@kcsa.com / anagy@kcsa.com


FAQ

What did Celularity present at the AACR Annual Meeting 2024?

Celularity presented in vivo data on PT-CD16, a genetically modified cell therapy, showcasing robust anti-tumor activity against gastric cancer.

What is the preclinical asset being developed by Celularity?

Celularity's preclinical asset, PT-CD16VS, is being developed in combination with trastuzumab, a cancer drug, for treating HER2-positive cancers.

Who is Celularity's CEO and Founder?

Dr. Robert Hariri is Celularity's CEO and Founder.

When will Celularity present the data on PT-CD16 at the AACR Annual Meeting?

Celularity will present the data on PT-CD16 at the AACR Annual Meeting on April 9th, 2024.

What is the focus of Celularity's pipeline according to Dr. Robert Hariri?

Dr. Robert Hariri mentioned that Celularity's pipeline aims to address aging-related healthcare challenges, including cancer, by combining cell therapy assets with currently available therapies.

Celularity Inc.

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About CELU

Celularity, Inc. headquartered in Florham Park, N.J., is a clinical stage biotechnology company leading the next evolution in cellular medicine by developing off-the-shelf placental-derived allogeneic cell therapies, including unmodified natural killer (NK) cells, genetically-modified NK cells, T-cells engineered with a CAR (CAR T-cells), and mesenchymal-like adherent stromal cells (ASCs) targeting indications across cancer, infectious and degenerative diseases. In addition, Celularity develops and manufactures innovative biomaterials also derived from the postpartum placenta. Celularity believes that by harnessing the placenta’s unique biology and ready availability, it will be able to develop therapeutic solutions that address significant unmet global needs for effective, accessible, and affordable therapies.