CGEM - Cullinan stock rises ~10% on FDA nod to start trial of blood cancer drug

• Cullinan Oncology ( NASDAQ: CGEM ) said the U.S. Food and Drug Administration (FDA) cleared its investigational new drug (IND) application seeking to start a trial of blood cancer drug CLN-978.
• The company will initially evaluate CLN-978 in a phase 1 trial to treat patients with relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL).
• "Consistent with our mission to create new standards of care for patients with cancer, CLN-978 has the potential to become a best-in-class treatment option for patients with B-cell malignancies by offering a highly potent off-the-shelf treatment that is delivered subcutaneously, resulting in more patient-friendly administration and potentially reduced toxicity," said Cullinan Chief Medical Officer Jeffrey Jones.
• The company noted that CLN-978 is a CD19/CD3 T-cell engaging antibody construct with a human serum albumin binding domain to increase serum half-life.
• In addition, Cullinan said that IND submission remains on track for CLN-617 in H1 2023.
• CGEM +9.64% to 11.49 premarket Jan. 24

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