Clinical-stage immuno-oncology company Affimed NV (AFMD:NASDAQ), today announced "positive initial clinical data from an investigator-sponsored study at The University of Texas MD Anderson Cancer Center evaluating cord blood-derived natural killer (cbNK) cells pre-complexed with Affimed's innate cell engager (ICE®) AFM13 (CD16A/CD30)."
Affimed stated that this novel approach was developed by Katy Rezvani, M.D., Ph.D., Professor of Stem Cell Transplantation and Cellular Therapy at the MD Anderson Cancer Center. The firm added that Dr. Rezvani is presenting the data at the virtual American Association for Cancer Research (AACR) Annual Meeting as a part of the Major Symposia and Advances sessions.
Affimed's Chief Medical Officer Andreas Harstrick, M.D., commented, "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 company explained that the Phase 1 trial of AFM13is being led by Yago Nieto, M.D., Ph.D., Professor of Stem Cell Transplantation and Cellular Therapy at MD Anderson and that the study was designed in order to "evaluate the pre-complexing of AFM13 with cbNK cells followed by three weekly infusions of AFM13 monotherapy in adult patients with recurrent/refractory CD30-positive lymphomas."
"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," Dr. Rezvani added.
The company advised the it will be hosting a conference call and live webcast on April 14, 2021, at 4:05 p.m. EDT to go over the initial findings from the study. The webcast can be accessed at the following link from its website.
The company advised that AFM13 is currently being evaluated in a Phase 1 dose-escalation study in combination with cord blood-derived allogeneic NK cells in patients with recurrent or refractory CD30-positive lymphomas. The primary goal in the trial is to verify safety and to establish a recommended dosage for Phase 2 going forward.
The report pointed out that as "MD Anderson has an institutional financial conflict of interest with Affimed related to this research, it has therefore implemented an Institutional Conflict of Interest Management and Monitoring Plan."
The company listed that "AFM13 is a first-in-class innate cell engager (ICE®) that uniquely activates the innate immune system to destroy CD30-positive hematologic tumors." AFM13 is formulated and designed to attack and kill CD30-positive tumor cells by leveraging an individual's innate immune system to engage and activate natural killer (NK) cells and macrophages. The firm reported that it is presently investigating the potential for AFM13 to be used as a monotherapy in treatment of patients with transformed mycosis fungoides (REDIRECT) or relapsed/refractory peripheral T-cell lymphoma.
Affimed N.V. is a clinical-stage immuno-oncology company headquartered in Heidelberg, Germany with additional offices in New York. The company's immunotherapy product candidates are developed to harness the body's own immune system to fight tumor cells. The firm claims that it uses its proprietary ROCK® platform to specifically indentify, target, recognize and kill a range of hematologic and solid tumors. Affimed stated that the ROCK platform employs an innovative approach that "predictably generates customized innate cell engager (ICE®) molecules which use patients' immune cells to destroy tumor cells."
Affimed NV started the day with a market capitalization of around $828 million billion with approximately 105 million shares outstanding and a short interest of about 6%. AFMD shares opened 30% higher today at $10.27 (+$2.38, +30.16%) over yesterday's $7.89 closing price and reached a new 52-week high price this morning of $10.70. The stock has traded today between $9.23 to $10.70 per share and is currently trading at $9.51 (+$1.62, +20.53%).[NLINSERT]
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