CAMBRIDGE, Mass. - Cullinan Therapeutics, Inc. (NASDAQ: CGEM), a biopharmaceutical company, received approval from the U.S. Food and Drug Administration (FDA) to proceed with Phase 1 clinical trials in the United States for its drug candidate CLN-978, targeting systemic lupus erythematosus (SLE), a chronic autoimmune disease. The clearance allows the company to expand its global trial to include U.S. patients with moderate to severe SLE.
The trial will focus on individuals with a Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score of eight or more who have not responded adequately to at least two standard treatments, including immunosuppressive or biologic agents. The study comprises two parts: Part A for dose escalation to determine the target dose for subsequent development, starting at 10 micrograms, and Part B for dose expansion to explore various dose schedules based on Part A results.
The primary goal of the study is to assess the safety of CLN-978 in treating active moderate to severe SLE, with secondary objectives including pharmacokinetics, B cell kinetics, immunogenicity, and clinical activity. Jeffrey Jones, MD, MBA, Chief Medical Officer at Cullinan Therapeutics, emphasized the significant unmet medical need for effective SLE treatments, as existing therapies often fail to fully control disease activity or prevent long-term organ damage.
CLN-978, described as a novel bispecific T cell engager, targets CD19 and is designed to deliver the potency of T cell redirecting therapy with the convenience of subcutaneous administration. The drug candidate has shown promise in preclinical studies, demonstrating redirected lysis of CD19-expressing target cells and engineered for high affinity binding to CD19 to efficiently target B cells.
The company had previously received clearance to initiate its global clinical trial in Australia in September. This development represents a potential advancement in the treatment of SLE, which affects an estimated 160,000 to 320,000 people in the U.S. and around 3.4 million individuals worldwide, predominantly women and people of color.
Cullinan Therapeutics is dedicated to developing a diversified portfolio of clinical-stage assets for both autoimmune diseases and cancer, with a focus on creating new standards of care for patients. This article is based on a press release statement.
In other recent news, Cullinan Oncology has been making significant strides in its clinical trials and drug development. H.C. Wainwright and BTIG have reaffirmed their Buy ratings for the company, with price targets of $28 and $30 respectively. This follows Cullinan's announcement of a lower-than-expected Q1 loss of $0.86 per share, beating the projected loss of $0.94.
The company has also gained approval from the Human Research Ethics Committee in Australia to commence a global Phase 1 trial for its drug CLN-978, designed to treat systemic lupus erythematosus (SLE). Morgan Stanley, despite reducing its price target for Cullinan to $38, has maintained an Overweight rating for the company.
In addition, Cullinan has presented promising clinical trial data for its drug zipalertinib, demonstrating a 40% objective response rate in treating non-small cell lung cancer. This data has been supported by TD Cowen and H.C. Wainwright, both of which have maintained a Buy rating on the company.
Lastly, Cullinan Oncology has 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. These developments highlight the company's ongoing progress in its clinical trials and drug development.
InvestingPro Insights
As Cullinan Therapeutics (NASDAQ: CGEM) advances its clinical trials for CLN-978, investors may find value in examining the company's financial health and market performance. According to InvestingPro data, Cullinan's market capitalization stands at $941.54 million, reflecting investor interest in its potential breakthrough treatments.
An InvestingPro Tip highlights that Cullinan holds more cash than debt on its balance sheet, which could provide the financial flexibility needed to support its ongoing clinical trials and research efforts. This strong liquidity position is further underscored by another tip indicating that the company's liquid assets exceed short-term obligations, potentially allowing for sustained investment in its drug development pipeline.
Despite these positive financial indicators, it's worth noting that Cullinan is not currently profitable, with an adjusted operating income of -$183.3 million over the last twelve months as of Q2 2023. This is consistent with the early-stage nature of many biopharmaceutical companies focused on research and development.
Interestingly, Cullinan's stock has shown a high return over the last year, with a one-year price total return of 82.06% as of the latest data. This performance suggests that investors are optimistic about the company's prospects, possibly driven by developments such as the FDA approval for CLN-978 clinical trials.
For those considering an investment in Cullinan Therapeutics, it's important to note that InvestingPro offers additional tips and insights beyond what's mentioned here. In fact, there are 7 more InvestingPro Tips available for CGEM, which could provide a more comprehensive view of the company's investment potential.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.