Imugene has been exploring its allogeneic CAR-T therapy, azer-cel, in combination with IL-2 in patients with DLBCL who have failed at least three other previous lines of therapy. The results have been very good. Of the 16 patients in the study, seven have achieved a complete response (44%) and six a partial response, yielding an 81% overall response (complete response plus partial response). The response has also shown durability, with two patients maintaining their complete response after a year. The first patient in the current study was treated in November 2023.
In the first four patients treated with the combination therapy (azer-cel plus IL-2), a complete response was announced in two patients (50% CR) in September last year. In February this year, Imugene announced that a complete response was achieved in four of the seven patients treated with the combination therapy (57%) and two with stable disease (Overall Response Rate, or ORR, of 86%). All of those patients had failed at least four lines of therapy (including autologous CAR-T treatment).
In July, the company announced that from the 12 patients treated, six achieved a complete response and three a partial response (ORR of 75%). In August, the company reported an ORR of 79% from 14 patients treated, which was made up of six complete responses and five partial responses. Then last month an additional two patients were treated, with an ORR of 81% (seven complete responses and six partial responses from 16 patients). There were also two with stable disease, giving a disease control rate of 94%.
Around 30,000 patients are diagnosed each year in the US with DLBCL, with approximately 50,000 deaths each year. This translates to an average life expectancy of around seven months.
Expansion of Study
Imugene is now expanding the study to include patients with other lymphomas but before autologous CAR-T treatment.
Summary
Imugene is capitalized at $123 million. The company finished June with $21.9 million. It raised $25 million at $0.33 in the June quarter, which with its R&D tax rebate of $5.8 million, gives the company around 12 months of funding based on the June quarter spend. The continued positive results emerging from Imugene's DLBCL study continue to be impressive.
Imugene has been added to the Bioshares Model Portfolio.
Bioshares recommendation: Speculative Buy Class A.
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