Cullinan Therapeutics Inc (NASDAQ:CGEM), formerly Cullinan Oncology Inc, announced its plans to expand into autoimmune diseases and intends to pursue the development of CLN-978 in autoimmune diseases, with systemic lupus erythematosus (SLE) as a first indication.
In SLE, the immune system of the body mistakenly attacks healthy tissue.
The company believes that CLN-978 has the potential to be a first-in-class, off-the-shelf, disease-modifying treatment in autoimmune diseases with a differentiated safety profile.
The company plans to submit an investigational new drug application to study CLN-978 in patients with SLE in the third quarter of 2024 and is also planning for future development in other autoimmune diseases.
Cullinan Therapeutics has discontinued enrollment in its B cell non-Hodgkin lymphoma (B-NHL) study to focus ongoing development on autoimmune indications.
Recent data demonstrated the potential of CD19-directed CAR T therapies in 15 patients with autoimmune diseases.
The company shared initial clinical observations from its Phase 1 dose escalation trial of CLN-978 in B cell non-Hodgkin lymphoma.
Clinical observations from three patients treated in a Phase 1 dose escalation trial of patients with B-NHL show that CLN-978 was clinically active at the initial starting dose of 30 μg administered subcutaneously once weekly.
Two of the three patients experienced objective clinical benefit, including one who experienced a complete response.
Grade 1 cytokine release syndrome occurred in two patients, and no patients experienced immune effector cell-associated neurotoxicity syndrome.
The company also announced a $280 million private placement. The proceeds from the private placement, combined with current cash, cash equivalents, short-term investments, and interest receivable, are expected to fund Cullinan's current operating plan into 2028.
Monday, William Blair initiated coverage on Cullinan with an Outperform rating and a $35-per-share fair value based on the potential of the company's diversified pipeline of assets, including CLN-619 in endometrial cancer, CLN-978 in B-cell malignancies and autoimmune diseases.
The analyst says the company's strategy, which is flexible across different treatment methods and emphasizes developing new drugs and licensing existing ones, has led to a diverse portfolio of unique assets.
This approach consistently offers chances for significant value growth based on clinical results.
The success of zipalertinib and CLN-619 so far demonstrates the effectiveness of this strategy. With many projects, the company can focus on advancing programs that show promise as standalone treatments.
Price Action: CGEM shares are up 3.75% at $17.70 on the last check Tuesday.