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transgene myvac Orchestrating a brighter world NEC PRESS RELEASE Transgene and NEC announce positive preliminary data from Phase I studies of TG4050 , a novel individualized neoantigen cancer vaccine ✓ Positive initial data generated in the first six patients treated with TG4050 demonstrate the strong potential of this individualized immunotherapy in ovarian cancer and head and neck cancer . ○ TG4050 induced robust anti - tumor cellular immune responses against multiple neoantigen targets in all evaluable patients ( 4/4 ) . 。 TG4050 monotherapy was also associated with the first signs of clinical activity . TG4050 was well tolerated , with no related Serious Adverse Events reported across the two studies to date . ✓ Additional patients are being enrolled , with the aim to treat up to 43 patients across the two multicenter trials ( USA , UK , France ) . ✓ Further data will be released at a major oncology conference over the coming months and will provide the insight needed to prepare Phase II trials . Webcasts tomorrow with Key Opinion Leaders on November 23 , 2021 , at 8:30 a.m. CET in French and at 3 p.m. CET ( 8:00 a.m. ET ) in English ( details at the end of the release ) . Strasbourg , France & Tokyo , Japan , November 22 , 2021 , 5:45 pm CET - Transgene ( Euronext Paris : TNG ) , a biotech company that designs and develops virus - based immunotherapies for the treatment of cancer , and NEC Corporation ( NEC ; TSE : 6701 ) , a leader in IT , network and Al technologies , today announce positive preliminary immunogenicity and clinical data on TG4050 , their jointly developed individualized neoantigen cancer vaccine . TG4050 is the first candidate based on Transgene's myvacⓇ platform . Powered by NEC's cutting - edge Al capabilities , it is being evaluated in two ongoing multicenter Phase I trials in patients with ovarian cancer and head and neck cancer . " We are extremely pleased to demonstrate the ability of TG4050 to effectively prime the immune system of the first patients who received this novel treatment and observe first signals of clinical activity . We believe this establishes the potential role of TG4050 as a new approach for individualized cancer vaccination . TG4050 appears to demonstrate a favorable safety profile thus far . We have also confirmed the feasibility of the ' needle to needle ' process with these two multicenter international Phase I trials , using our own manufacturing facility . Strikingly , when supported by NEC's powerful prediction tool , the myvacⓇ viral vector used in TG4050 , which has been genetically optimized to improve immunogenicity and peptides presentation , induced robust and consistent response against class I and class II epitopes . We are working hard to complete the studies to further confirm these findings and generate additional immune and clinical data . We are very excited by the potential of TG4050 and hope to share additional data at a major oncology congress in 2022 . Based on the additional data , we will identify the most appropriate path to take TG4050 forward , " commented Hedi Ben Brahim , Chairman and CEO of Transgene . Page 1/6