The U.S FDA has cleared GDA-201, which Gamida Cell Ltd (NASDAQ: GMDA) developed as an IND (investigational new drug). The drug is for treating diffuse and follicular large B cell lymphomas. Gamida intends to begin a Phase I/II study on patients this year.
According to Gamida Cell’s CEO, Julian Adams, the FDA’s decision to approve an IND of the cryopreserved drug is a major milestone. Moreover, it is a testament to Gamida Cell’s experience in the industry.
The company will conduct a Phase I/II trial
Adams adds that the company’s previous study on patients with large B lymphomas with fresh GDA-201 has positive findings. The company is now excited to move to its next step by conducting a phase I/II study on the preserved formulation. This study could help the company address the high unmet need for patients.
Gamida Cell developed GDA-201 using its NAM technology. The drug allows the company to enhance the functionality and number of Natural Killer (NK) cells. By doing this, the company enables the patient’s body to kill off tumour cells effectively.
The company previously conducted a Phase I/II study with fresh GDA-201, which showed that patients responded positively to the compound. Gamida had used 19 non-Hodgkin Lymphoma patients for the trial. The company found a positive response in 13 of them, while another exhibited a partial response.
The side Effects of GDA-201
Another study on 16 patients with multiple myeloma also showed no adverse effects due to the dose of GDA-201. The side effects that Gamida Cell found in patients with non-Hodgkin Lymphoma and multiple myeloma include anaemia, febrile neutropenia, neutropenia, hypertension, and thrombocytopenia. Fortunately, there wasn’t marrow aplasia or neurotoxicity.
The company developed GDA-201 to treat solid and haematological tumours. Gamida Cell is to combine the compound with other antibody therapies which physicians use in standard care. GDA-201 fixes the issues with NK cells less in number and cytotoxicity to tumour cells.
Gamida used NAM (Nicotamide) technology to improve the properties of cells in the human body, such as NK and stem cells. It also enables these cells to preserve their metabolic properties, making them potent for longer.