Cullinan Therapeutics Surges on Promising Leukemia Drug Data
Phase 1 results for its novel T-cell engager, CLN-049, showed a 31% complete response rate in heavily pretreated AML patients, bolstering analyst confidence.
Shares of Cullinan Therapeutics (NASDAQ: CGEM) jumped more than 9% in Monday trading after the biopharmaceutical company presented compelling new data for its experimental treatment for acute myeloid leukemia (AML), a particularly aggressive form of blood cancer.
The Cambridge-based firm showcased the Phase 1 trial results for its drug candidate, CLN-049, in an oral presentation at the 67th American Society of Hematology (ASH) Annual Meeting, a key event for the hematology community. The stock climbed to $11.59 as investors reacted to signs of potent activity in a patient population with limited treatment options.
The study focused on patients with relapsed or refractory (R/R) AML who had undergone multiple prior lines of therapy. According to the company's announcement, the data revealed a 31% rate of complete remission or complete remission with partial hematologic recovery (CR/CRh) at the highest dose level tested. Across all clinically active doses, the drug achieved a 25% CR/CRh rate, demonstrating a consistent and meaningful response.
CLN-049 is a novel T-cell engager designed to bind to both the FLT3 protein on leukemia cells and the CD3 protein on T-cells, effectively building a bridge that directs the patient's own immune system to attack the cancer. The data is particularly encouraging because it showed activity in patients with TP53 mutations, a subgroup known for poor prognosis and resistance to standard therapies.
This positive clinical update comes just a week after Cullinan announced that the U.S. Food and Drug Administration had granted Fast Track designation to CLN-049 for R/R AML. The designation is intended to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need, signaling the agency's recognition of the drug's potential.
The results have solidified Wall Street's optimistic view of the company, which has a market capitalization of approximately $625 million. Analysts at firms including JonesTrading and BTIG have recently reiterated "Buy" ratings on the stock. The consensus 12-month price target sits at $27.00, suggesting a potential upside of more than 130% from its current trading level.
Acute myeloid leukemia is the most common type of acute leukemia in adults, and the prognosis for patients who relapse or do not respond to initial therapy is grim. The current treatment landscape for R/R AML lacks approved immunotherapies, creating a significant opportunity for innovative approaches like CLN-049.
While the data is from an early-stage Phase 1 trial focused primarily on safety and determining the proper dose, the high response rate in this difficult-to-treat population provides a strong proof-of-concept for Cullinan. The company is expected to use these results to guide its strategy for later-stage pivotal trials, which will be necessary for seeking regulatory approval. For investors, the ASH presentation marks a significant de-risking event for one of the key assets in Cullinan's oncology pipeline, providing a clearer path forward for its potential blockbuster therapy.