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NEWS
Affimed Announces Acimtamig and AlloNK® Combination Granted Regenerative Medicine Advanced Therapy (RMAT) Designation by the U.S. Food and Drug Administration (FDA)
Thursday, 5th December at 6:30 am
Designation was based on early efficacy data demonstrating an 83.3% (10/12) overall response rate and a 50% (6/12) complete response rate, with a well-managed safety profile in Relapsed/Refractory Hodgkin Lymphoma patients
MANNHEIM, Germany, Dec. 05, 2024 (GLOBE NEWSWIRE) -- Affimed N.V. (NASDAQ: AFMD) ("Affimed", or the "Company"), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced that the U.S. FDA has granted RMAT designation to the combination therapy of Affimed's innate cell engager (ICE®) acimtamig and Artiva Biotherapeutic's AlloNK® (AB101) for the treatment of relapsed or refractory Hodgkin Lymphoma (R/R HL). The combination is being evaluated in the on-going LuminICE-203 multicenter, multi-cohort phase 2 trial.
RMAT designation is intended to expedite the development and review of regenerative medicine therapies, including cell therapies, that aim to address serious or life-threatening conditions. RMAT designation provides the same expedited review benefits as a Breakthrough Therapy Designation, but is exclusively focused on regenerative medicine products. This designation provides Affimed enhanced access to FDA resources including the potential for accelerated approval and priority review. These benefits could significantly reduce the time required to deliver the acimtamig and AlloNK® combination to R/R HL patients in need.
Thursday, 5th December at 6:30 am
Designation was based on early efficacy data demonstrating an 83.3% (10/12) overall response rate and a 50% (6/12) complete response rate, with a well-managed safety profile in Relapsed/Refractory Hodgkin Lymphoma patients
MANNHEIM, Germany, Dec. 05, 2024 (GLOBE NEWSWIRE) -- Affimed N.V. (NASDAQ: AFMD) ("Affimed", or the "Company"), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced that the U.S. FDA has granted RMAT designation to the combination therapy of Affimed's innate cell engager (ICE®) acimtamig and Artiva Biotherapeutic's AlloNK® (AB101) for the treatment of relapsed or refractory Hodgkin Lymphoma (R/R HL). The combination is being evaluated in the on-going LuminICE-203 multicenter, multi-cohort phase 2 trial.
RMAT designation is intended to expedite the development and review of regenerative medicine therapies, including cell therapies, that aim to address serious or life-threatening conditions. RMAT designation provides the same expedited review benefits as a Breakthrough Therapy Designation, but is exclusively focused on regenerative medicine products. This designation provides Affimed enhanced access to FDA resources including the potential for accelerated approval and priority review. These benefits could significantly reduce the time required to deliver the acimtamig and AlloNK® combination to R/R HL patients in need.
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Trytosaveabit : Hehehe! Grrrr! I seen the order book and put a bid in at 1.33! Grrr so close to filing it dropped to 1.40 before the order book started filing up! Hehehe. That woulda been sweet to fill a a dollar below 52 wk low. Hehehe
Jaguar8 OP Trytosaveabit : So tired still. My body is aching![[undefined]](https://static.moomoo.com/nnq/emoji/static/image/default/default-black.png?imageMogr2/thumbnail/36x36 "undefined")
Trytosaveabit Jaguar8 OP : I’m sorry! I really thought you would be tryin to get some sleep/rest! Did you get to stop for grub? I’m happy you are back home safe.
Jaguar8 OP Trytosaveabit : We went for dinner here at Pacific Grove. I was excited ordering the spicy shrimp Alfredo but omg, it was Thai like spicy.
So I didn’t end up eating even half
Trytosaveabit Jaguar8 OP : Oh man! Hehehe. So a bit too hot Eh! Did you bring it home to try again? Hehehe
Jaguar8 OP Trytosaveabit : No I didn’t bring it home. I just ate calamari and clam chowder. First time in that resto and am not impressed![[undefined]](https://static.moomoo.com/nnq/emoji/static/image/default/default-black.png?imageMogr2/thumbnail/36x36 "undefined")
Trytosaveabit Jaguar8 OP : Gotcha! Yeah im 100% a food snob! Hehehe. If it ain’t good I’ll let ya know! Hehehe
Jaguar8 OP Trytosaveabit : I know you are a good cook I remember![[undefined]](https://static.moomoo.com/nnq/emoji/static/image/default/default-black.png?imageMogr2/thumbnail/36x36 "undefined")
Trytosaveabit Jaguar8 OP : Hate to say it! But yup I’m a pretty great cook! Hehehe