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Celularity Presents Data of The Effect of Its T-Cell Platform on Multiple Hematological And Solid Tumors at the American Society of Clinical Oncology (ASCO) Annual Meeting

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Celularity has presented promising in vivo data at the ASCO Annual Meeting showing the potential of its T-cell therapy platform, PT-CD16VS, in targeting multiple hematological and solid tumors. The platform leverages genetically modified allogeneic cell therapy derived from human placental circulating T (P-T) cells and can be combined with various monoclonal antibodies. Previous data at AACR demonstrated efficacy against HER2-positive cancers, and the recent findings extend this potential to a broader range of cancers. The company is also expanding its pipeline to tackle aging-related healthcare issues such as cellular senescence.

Positive
  • PT-CD16VS shows potent in vitro and in vivo activity.
  • Potential to target multiple hematological and solid tumors.
  • Combines with various approved monoclonal antibodies.
  • Previous success against HER2-positive cancers.
  • Expanding pipeline to address aging-related healthcare challenges.
  • State-of-the-art manufacturing facility enhances capabilities.
Negative
  • The data presented are still preclinical, not yet proven in human trials.
  • No mention of clear timelines for clinical trials or market introduction.
  • Potential challenges in scaling up the therapy for broader clinical use.

Insights

Celularity's presentation of data on their T-cell platform at the ASCO Annual Meeting merits attention, particularly for its promising implications in cancer treatment. The key innovation here is the use of placental-derived T-cells, specifically PT-CD16VS, which have demonstrated potent activity both in vitro and in vivo. This signifies not only a potential breakthrough in leveraging the placenta's unique properties but also an advance in addressing cancers that are notoriously difficult to treat.

One notable point is the platform's use of a 'universal receptor' approach. This strategy helps to overcome one of the major challenges in current cancer therapies: antigen escape. Essentially, antigen escape occurs when cancer cells change to avoid being targeted by immune cells. By using a universal receptor, Celularity's T-cells can be combined with various antibodies, making them more adaptable and potentially more effective against a range of cancers.

Furthermore, the broader applicability of PT-CD16VS across multiple hematological and solid tumors, as demonstrated in the data, strongly suggests a versatile and robust treatment option. This is contrasted with many traditional therapies that are often limited to specific types of cancer.

Additionally, Celularity’s integration of their therapy platform with antibodies like trastuzumab offers a promising avenue for treating HER2-positive cancers, which are known for their aggressiveness and poor prognosis with standard treatments.

The implications of Celularity's new data are significant from a market perspective as well. The use of placental-derived T-cells for a wide range of cancers could position Celularity as a key player in the biotechnology and pharmaceutical industries. Investors should take note of the potential market size here; the global oncology market is immense and new, effective treatments are always in demand.

Celularity's approach of using a universal receptor in their T-cells may provide a competitive edge, as it could reduce the time and cost associated with developing personalized therapies for each cancer type. This scalability can make treatments more accessible and affordable, potentially leading to higher adoption rates and a larger market share.

Moreover, the company’s focus on not just cancer but also aging-related conditions could open multiple revenue streams. The combined market for oncology and anti-aging therapeutics is huge and the ability to tap into both markets with a single platform is a compelling value proposition.

Investors should also consider the ongoing advancements in Celularity’s pipeline. Continued success in clinical trials and eventual FDA approval would likely drive significant market interest and potentially increase the company's valuation.

Company presents results from in vivo studies of PT-CD16VS, a genetically modified allogeneic cell therapy derived from human placental circulating T (P-T) cells, in combination with various monoclonal antibodies

FLORHAM PARK, N.J., June 03, 2024 (GLOBE NEWSWIRE) -- Celularity Inc. (NASDAQ: CELU) (“Celularity”), a regenerative and cellular medicine company developing placental-derived allogeneic cell therapies and advanced biomaterial products, announced today that it presented in vivo data from its T-cell therapy platform at this year’s ASCO Annual Meeting in Chicago. These data show that PT-CD16VS, Celularity’s T-Cell preclinical asset, has potent in vitro and in vivo activity and has the potential to be combined with various monoclonal antibodies to target multiple cancers. Please find the link to the abstract here.

Celularity has adopted a “universal receptor” approach to develop a platform of genetically modified T-cells expressing a proprietary CD16 to be combined with various approved antibodies to address multiple cancers and other conditions.

Data demonstrating PT-CD16VSs activity in combination with trastuzumab against HER2-positive cancers has already been presented at AACR in April. These data further build on this to demonstrate much broader potential across multiple hematological and solid tumors.

“These important data further demonstrate the potential of combining Celularity’s placental-derived cell therapy platform with currently available antibody therapies to address difficult-to-treat cancers and avoid some of the challenges of traditional cell therapy, including antigen escape and tolerability,” said Dr. Robert Hariri, Celularity’s CEO and Founder. “We are also continuing to advance our pipeline to address aging-related healthcare challenges beyond cancer including cellular senescence. This work highlights the deep expertise and capabilities in cell therapy resident at Celularity and our ability to modify and engineer those cells in our state-of-the-art manufacturing facility.”

About Celularity
Celularity Inc. (NASDAQ: CELU) is an innovative regenerative and cellular medicine company. It is developing and commercializing advanced biomaterial products and allogeneic, cryopreserved, placental-derived cell therapies, all derived from the postpartum placenta. What sets Celularity apart is its therapeutic programs that target aging-related diseases, including degenerative diseases, cancer, and immune disorders, using mesenchymal-like adherent stromal cells (MLASCs), T-cells engineered with CAR (CAR T-cells), and genetically modified and unmodified natural killer (NK) cells. Celularity’s unique approach, harnessing the placenta’s biology and ready availability, is paving the way for therapeutic solutions that address significant unmet global needs for effective, accessible, and affordable therapies.

Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of the U.S. 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, without limitation, the potential for Celularity’s PT-CD16VS preclinical product candidate to be combined with various monoclonal antibodies to target multiple cancers and other conditions, the broad potential of PT-CD16VS as a treatment option for multiple hematological and solid tumors, the ability of Celularity’s placental-derived cell therapy platform to address difficult-to-treat cancers and avoid some of the challenges of traditional cell therapy, Celularity’s ability to advance its pipeline to address aging-related healthcare challenges beyond cancer including cellular senescence, among others. Many factors could cause actual results to differ materially from those described in these forward-looking statements, including but not limited to: Celularity’s liquidity situation; the volatility in Celularity’s stock price; inherent risks in biotechnological development, including with respect to the development of novel cellular therapies; 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, Senior Vice President
Celularity Inc.
Carlos.ramirez@celularity.com

Media Contact: 

Ali Nagy
KCSA Strategic Communications
anagy@kcsa.com


FAQ

What did Celularity present at the ASCO Annual Meeting?

Celularity presented in vivo data on its T-cell therapy platform, PT-CD16VS, showing its potential to target multiple hematological and solid tumors.

What is PT-CD16VS?

PT-CD16VS is a genetically modified allogeneic cell therapy derived from human placental circulating T (P-T) cells, developed by Celularity.

How does PT-CD16VS work against cancers?

PT-CD16VS can be combined with various monoclonal antibodies to target and treat multiple cancers.

Has PT-CD16VS shown success against specific cancers?

Yes, PT-CD16VS has demonstrated efficacy against HER2-positive cancers.

What are the future plans for Celularity's T-cell therapy platform?

Celularity plans to advance its pipeline to address aging-related healthcare challenges, including cellular senescence.

What makes Celularity's approach unique?

Celularity uses placental-derived cell therapies, harnessing the placenta’s biology to develop effective, accessible, and affordable treatments.

What are the potential challenges for PT-CD16VS?

Potential challenges include proving efficacy in human trials and scaling up the therapy for broader clinical use.

Celularity Inc.

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