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Celularity Inc. (NASDAQ: CELU), headquartered in Florham Park, N.J., is a trailblazer in the field of cellular medicine. As a clinical-stage biotechnology company, Celularity is at the forefront of developing off-the-shelf, placental-derived allogeneic cell therapies. Its innovative products include unmodified natural killer (NK) cells, genetically-modified NK cells, T-cells engineered with a chimeric antigen receptor (CAR T-cells), and mesenchymal-like adherent stromal cells (ASCs). These therapies target a diverse range of conditions such as cancer, infectious diseases, and degenerative disorders.
Celularity is also a pioneer in the development and manufacture of advanced biomaterials derived from the postpartum placenta. The unique biology and availability of the placenta allow Celularity to create accessible, effective, and affordable therapeutic solutions that address significant global health challenges.
Recent Achievements and Current Projects:
- The company has received IND clearance from the FDA and is set to begin a Phase 1/2 study in 2024 with its placental-derived cell therapy.
- The Healthcare Common Procedure Coding System (HCPCS) Q code approval for Biovance® 3L has been granted by the Centers for Medicare and Medicaid Services (CMS). This code enhances the use of Biovance® 3L for wound care in office settings, enabling broader adoption and growth.
- Celularity has presented promising data from in vivo studies of its PT-CD16VS, a genetically modified allogeneic cell therapy, in combination with various monoclonal antibodies. This data highlights the therapy’s potential in treating HER2-positive cancers and other conditions.
Financial Condition and Partnerships:
The company’s financial health is under scrutiny as it works to regain compliance with Nasdaq listing requirements. Celularity is actively developing a plan to submit to Nasdaq by June 17, 2024, to address its delinquent reports. Meanwhile, the company anticipates continued growth through its advanced cell therapies and biomaterials.
Celularity’s partnerships, particularly in the field of regenerative medicine, exemplify its commitment to innovation and excellence. The company’s state-of-the-art manufacturing facility further supports its ability to produce advanced cell therapies at scale, aiming to meet the unmet needs of patients worldwide.
For more detailed information and the latest updates, visit the official website www.celularity.com.
Celularity Inc. (Nasdaq: CELU) announced that the FDA has granted Fast Track Designation for its CYNK-001, a non-genetically modified NK cell therapy aimed at treating acute myeloid leukemia (AML). The designation aims to expedite the development of treatments for serious conditions with unmet medical needs. CYNK-001 also holds orphan drug designation for malignant gliomas. The therapy utilizes placental-derived NK cells and aims to improve responses and durability in patients suffering from AML.
Celularity (NASDAQ: CELU) presented preclinical data on its placental-derived NK cell therapies (CYNK-101 and CAR19-CYNK) at the 63rd American Society of Hematology Meeting in Atlanta from December 11-14, 2021. Both therapies showed promise in treating hematological malignancies. CYNK-101 demonstrated effective synergy with daratumumab, avoiding fratricide and off-tumor effects. CAR19-CYNK displayed enhanced tumor cell killing against resistant lymphoma. These findings highlight Celularity's innovative approach to cellular therapies drawn from placental cells.
Celularity Inc. (Nasdaq: CELU) has received FDA clearance for its Investigational New Drug (IND) application to evaluate CYNK-101, a genetically engineered NK cell therapy, in combination with chemotherapy, trastuzumab, and pembrolizumab for advanced HER2/neu positive gastric cancer. The Phase 1/2a trial aims to assess the safety and preliminary efficacy of this combination. Notably, gastric cancer ranks fifth in global incidence, with poor survival rates in advanced stages. Celularity seeks to enhance treatment outcomes by leveraging placental-derived NK cell therapy.
Celularity Inc. (Nasdaq: CELU) presented preclinical data on its allogeneic NK cell therapy, CYNK-101, at the Society for Immunotherapy of Cancer Annual Meeting from November 10-14, 2021. CYNK-101, derived from genetically modified human placental CD34+ cells, demonstrated enhanced antibody-dependent cellular cytotoxicity against EGFR+ tumors when combined with Cetuximab. This research suggests potential applications in treating non-small cell lung cancer and head and neck cancers. Celularity aims to develop innovative therapies targeting unmet medical needs.
Celularity Inc. (Nasdaq: CELU) reported third-quarter financial results on Nov. 12, 2021, with revenues of $7.3 million, notably driven by the termination of the Sanuwave license agreement. However, research and development expenses surged by $12.5 million, largely due to increased clinical trial costs and stock-based compensation. The net income for Q3 2021 reached $49.9 million, translating to $0.47 per share (basic). Year to date, the company recorded a net loss of $96.1 million. The firm is advancing its placental-derived cell therapies, highlighting collaborations and innovative approaches targeting cancer.
Celularity Inc. (Nasdaq: CELU) and Oncternal Therapeutics, Inc. (Nasdaq: ONCT) have announced a research collaboration to develop placental-derived cellular therapies targeting the ROR1 receptor. This partnership aims to combine Oncternal's ROR1-targeted monoclonal antibody, cirmtuzumab, with Celularity’s natural killer (NK) cells and investigate ROR1-targeted CAR gene modifications. ROR1 is associated with aggressive tumor behavior in various cancers. Both companies believe that this collaboration may enhance therapeutic options for patients with solid tumors and hematological malignancies.
Celularity Inc. has appointed Dr. Andrew L. Pecora as President, effective immediately. With over 25 years in biotechnology, Dr. Pecora will advance Celularity’s clinical pipeline toward FDA approval, reporting to CEO Dr. Robert J. Hariri. His experience includes leadership roles in cellular medicine and drug development, enhancing the company’s strategic vision. Celularity specializes in placental-derived therapies for cancer and infectious diseases, conducting innovative work in allogeneic cell therapies.
Celularity Inc. (Nasdaq:CELU) secured approximately $138 million in funding through a merger with GX Acquisition Corp. and a PIPE investment. The company expanded its Phase 1 trial for CYNK-001 to include difficult-to-treat patients with acute myeloid leukemia. Additionally, the FDA granted Orphan Drug Designation for CYNK-001. Celularity formed strategic partnerships with Imugene Ltd and Palantir to enhance its therapeutic developments and data analysis capabilities. However, second quarter revenues decreased by $0.3 million, with a net loss of $64.5 million.
Imugene Ltd and Celularity Inc have entered a research collaboration to explore the combination of Imugene’s CF33-CD19 oncolytic virus with Celularity’s CD19-targeting CAR T-cell therapy, CyCART-19, aimed at treating solid tumors. The partnership plans to initiate nonclinical studies in 2021, leveraging Celularity’s advanced T-cell therapy, which demonstrates sustained efficacy against tumors. The collaboration could potentially expand CAR T-cell therapy's application beyond hematological malignancies, enhancing treatment options for solid tumors. The first clinical trial is anticipated to start in 2022.
Celularity, Inc. announced the successful closing of its merger with GX Acquisition Corp., with gross proceeds of approximately $138 million. Common stock will trade on Nasdaq as CELU starting July 19, 2021. The company aims to innovate cancer treatment through placental-derived cell therapies, having multiple clinical programs for acute myeloid leukemia and glioblastoma. Notable partnerships with Palantir and Arthrex are also anticipated to enhance growth and revenue.
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