NV’s related shares reached a new high price in 52 weeks after the company presented initial data from a Phase 1 trial of its AFM13, which shows potential to help NK cells target and destroy cancer cells.
Clinical stage immuno-oncology company NV stated (AFMD: NASDAQ), today announced “initial positive clinical data from a researcher-sponsored study at the MD Anderson Cancer Center at the University of Texas evaluating natural killer cells derived from cord blood (cbNK) pre-complexed with the Affimed (ICE®) innate cellular engager AFM13 (CD16A / CD30). “
Affimed stated that this new approach was developed by Katy Rezvani, M.D., Ph.D., Professor of Stem Cell Transplantation and Cell Therapy at the MD Anderson Cancer Center. The company added that Dr. Rezvani is presenting the data at the American Association for Cancer Research (AACR) virtual annual meeting as part of the Major Symposia and Advances sessions.
Affimed’s medical director, Andreas Harstrick, MD, commented: “We are excited by the initial safety and efficacy data from this groundbreaking first human study. The discovery of a 100% objective response rate among our first four enrolled patients is These initial results indicate that AFM13 may have the potential to help NK cells target and destroy cancer cells We plan to continue to develop and customize approaches that take advantage of the unique and differentiating features of our ICE® molecules in combination with the adoptive transfer of NK cells to provide options for the treatment of a variety of hematological and solid tumors. “
The company explained that the AFM13 Phase 1 study is being conducted by Yago Nieto, MD, Ph.D., Professor of Stem Cell Transplantation and Cell Therapy at MD Anderson and that the study was designed to “assess pre-complexation 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 great unmet need for effective treatments for relapsing / refractory (R / R) CD30 + lymphomas. We are excited about the data generated from the first patients treated with cbNK cells pre-complexed with AFM13, ”added Dr. Rezvani.
The company said it will hold a live conference call and webcast on April 14, 2021, at 4:05 pm. EDT to review the study’s initial findings. The webcast can be accessed at the following link of your website.
The company reported that AFM13 is currently being evaluated in a Phase 1 dose escalation study in combination with allogeneic NK cells derived from cord blood in patients with recurrent or refractory CD30-positive lymphomas. The main objective of the study is to verify safety and 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, he implemented a Plan for the Management and Monitoring of Conflicts of Institutional Interests”.
The company listed that “AFM13 is the first innate cell engagement (ICE®) that exclusively activates the innate immune system to destroy CD30 positive haematological tumors”. AFM13 is formulated and designed to attack and kill CD30 positive tumor cells, leveraging an individual’s innate immune system to envelop and activate natural killer cells (NK) and macrophages. The company reported that it is currently investigating the potential of AFM13 to be used as a monotherapy in the treatment of patients with transformed mycosis fungoides (REDIRECT) or relapsing / refractory peripheral T cell lymphoma.
Affimed N.V. is a clinical stage immuno-oncology company based in Heidelberg, Germany, with additional offices in New York. The company’s candidates for immunotherapy products are developed to harness the body’s own immune system to fight tumor cells. The company claims to use its proprietary ROCK® platform to specifically identify, target, recognize and kill a variety of hematological and solid tumors. Affimed said the ROCK platform employs an innovative approach that “predictably generates personalized innate cell (ICE®) engaging molecules that use patients’ immune cells to destroy tumor cells.”
Affimed NV started the day with a market capitalization of around US $ 828 million billion, with approximately 105 million shares outstanding and a sold stake of around 6%. AFMD shares opened 30% higher today, at $ 10.27 (+ $ 2.38, + 30.16%) over yesterday’s $ 7.89 closing price and hit a new high price of 52 weeks this morning from $ 10.70. The share traded today at between $ 9.23 to $ 10.70 per share and is currently trading at $ 9.51 (+ $ 1.62, + 20.53%).
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