CAMBRIDGE, Mass. - Cullinan Therapeutics, Inc. (NASDAQ:CGEM), a biopharmaceutical company, has announced the initiation of a global Phase 1b clinical trial for CLN-978, a novel T cell engager, targeting moderate to severe systemic lupus erythematosus (SLE) patients. This announcement follows the presentation of promising in vitro preclinical data at the annual American College of Rheumatology meeting, ACR Convergence 2024, in Washington, D.C.
The preclinical studies showed that CLN-978 induced T cell activation, B cell depletion, and cytokine production in human cells derived from SLE and rheumatoid arthritis patients, similar to those from healthy volunteers. These results support the potential of CLN-978 as a new therapeutic option for autoimmune diseases.
The U.S. Food and Drug Administration has cleared an Investigational New Drug Application for the trial, which is also approved to proceed in Australia. The study will focus on patients with a SLEDAI score of eight or greater who have not responded adequately to at least two treatments, including an immunosuppressive or biologic agent.
The trial's Part A will use a modified single-ascending dose design to establish a recommended target dose for further development. Part B will expand the dose exploration based on Part A's findings. The primary goal is to assess the safety of CLN-978, with secondary objectives including pharmacokinetics, B cell kinetics, immunogenicity, and clinical activity. Initial clinical data are anticipated in the fourth quarter of 2025.
Jeffrey Jones, MD, MBA, Chief Medical (TASE:PMCN) Officer of Cullinan Therapeutics, highlighted the potential of CLN-978, noting its convenience as a subcutaneously delivered treatment and its significant B cell depletion capabilities. He also emphasized the company's collaborative approach with investigators and the patient community to establish new care standards for patients.
Cullinan will host an in-person investor event on Saturday to discuss these developments with analysts and institutional investors. The session will feature discussions with clinicians and thought leaders in the field.
CLN-978, a CD19xCD3 bispecific T cell engager, is designed to target B cells, including those with low CD19 levels, and is engineered for high affinity binding. It is small in molecular size, allowing for efficient targeting and an extended serum half-life.
SLE is a chronic autoimmune disease affecting millions worldwide, with severe manifestations such as lupus nephritis. Current treatments focus on symptom management and lifelong immune suppression without altering the disease course.
This article is based on a press release statement from Cullinan Therapeutics.
In other recent news, Cullinan Oncology has made significant developments in its clinical trials and drug development. The company reported a lower-than-expected Q1 loss of $0.86 per share, beating the projected loss of $0.94. Cullinan Oncology received FDA approval for its Investigational New Drug (IND) application for CLN-978, a potential treatment for systemic lupus erythematosus (SLE).
Analyst firms H.C. Wainwright, BTIG, and UBS have reaffirmed their buy ratings for the company, with price targets of $28, $30, and $30 respectively. BTIG highlighted the potential advantages of Cullinan's CLN-978 over Chimagen's CMG1A46, indicating that CLN-978 could have a longer half-life and potentially less frequent dosing.
Cullinan has also presented promising clinical trial data for its drug zipalertinib, demonstrating a 40% objective response rate in treating non-small cell lung cancer. Lastly, Cullinan Oncology welcomed Mary Kay Fenton as its new Chief Financial Officer and elected Anne-Marie Martin, Ph.D., and David Meek as Class I directors to the Board.
InvestingPro Insights
As Cullinan Therapeutics (NASDAQ:CGEM) embarks on this promising Phase 1b clinical trial for CLN-978, investors may find additional context from InvestingPro's financial metrics and tips valuable.
According to InvestingPro data, Cullinan Therapeutics has a market capitalization of $910.1 million, reflecting investor interest in the company's potential. Despite the excitement surrounding the CLN-978 trial, it's important to note that the company is not currently profitable, with an adjusted operating income of -$187.36 million over the last twelve months as of Q3 2023.
An InvestingPro Tip highlights that Cullinan holds more cash than debt on its balance sheet, which could provide financial flexibility as it advances its clinical programs. This strong liquidity position is further supported by another tip indicating that the company's liquid assets exceed short-term obligations.
Interestingly, Cullinan's stock has shown a high return over the last year, with a 1-year price total return of 66.39% as of the latest data. This performance suggests investor optimism about the company's pipeline and potential.
For those considering an investment in Cullinan Therapeutics, it's worth noting that InvestingPro offers 7 additional tips for CGEM, providing a more comprehensive analysis of the company's financial health and market position.
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