Cullinan Shifts Focus From Oncology To Autoimmune Disorders, Raises $280M Via Equity

Cullinan Therapeutics Inc 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.