Affimed NV (NASDAQ: AFMD) is running for the top in the market this morning, and for good reason. The company announced positive initial clinical data surrounding AFM13, a drug under development for the treatment of cancer. Here’s the scoop:
Affimed Announces Positive Clinical Data
In the press release, Affimed announced positive initial data from a clinical study taking place at the University of Texas MD Anderson Cancer Center. The study is evaluating cord blood-derived natural killer (cbNK) cells pre-complexed with Affimed’s innate cancer engager (ICE) AFM13.
The company said that the data will be presented as part of the Major Symposia and Advances session at the virtual American Association for Cancer Research Annual Meeting.
In the release, the company reminded investors that the study is an open-label, non-randomized, single-center, dose-escalation trial evaluating the pre-complexing of AFM13 with cbNK cells followed by three weekly infusions of AFM13 as a monotherapy in adults with recurrent/refractory CD-30-positive lymphomas.
All told, the data has been positive to date. The company said that as of March 31, 2021, three patients have been dosed with two cycles of therapy in dose cohort 2. The company went on to explain that the study is currently enrolling patients in the second dose cohort of NK cells and is expected to provide further updates later this year.
Nonetheless, results to date have been positive. Not only is the treatment proving efficacious, there were no observed events of cytokine release syndrome, neurotoxicity syndrome, or graft-versus-host disease.
In a statement, Andreas Harstrick, M.D., CMO at Affimed, had the following to offer:
We are encouraged by the initial safety and efficacy data from this groundbreaking first in-human study. The finding of an objective response rate of 100% amongst our first four patients enrolled is impressive.
These initial results indicate AFM13 may have the potential to help NK cells target and destroy cancer cells. We plan to continue to develop and customize approaches that leverage the unique and differentiating features of our ICE® molecules in combination with adoptive NK cell transfer to provide options for treating a variety of hematologic and solid tumors.
The above statement was followed up by Dr. Rezvani, the developer of this treatment approach. Here’s what she had to offer:
There remains a high unmet need for effective treatments in relapsed/refractory (R/R) CD30+ lymphomas. We are encouraged by the data generated from the first patients treated with cbNK cells pre-complexed with AFM13.
The results suggest this combination is facilitating clinical responses with minimal toxicity, warranting further study as we continue to explore novel cell therapies for our patients.
The Bottom Line
All in all, now is an exciting time to own Affimed stock. With AFM13, the company is targeting a very difficult-to-treat cancer, and producing compelling results in doing so. So, it’s not surprising to see that investors have pushed the stock up by more than 30% in the premarket hours.