Data from the investigator-initiated trial is being presented today at the
A total of 42 patients were enrolled in the study with 36 patients treated at the RP2D. 32 of the 36 patients treated at the RP2D were HL patients. All 32 HL patients were heavily pretreated with multiple lines of chemotherapy, all had previously received CPIs and BV, and were refractory to their most recent line of therapy with active progressive disease at the time of enrollment. Across all dose levels, the treatment regimen achieved an ORR of 93% with a CR rate of 67%; among the 32 HL patients treated at the RP2D the treatment regimen achieved an ORR of 97% and a CR rate of 78%. In addition, the treatment regimen demonstrated a good safety and tolerability profile with no cases of CRS, ICANS or GvHD of any grade. Mild to moderate infusion related reactions (IRRs) were seen in 7.7% of the acimtamig infusions.
Across all dose levels, median event free survival (EFS) was 8.8 months and median overall survival (OS) was not reached. For the HL patients treated at the RP2D, median EFS was 9.8 months - with 84% patients alive at 12 months. The median DoR was 8.8 months and 72% CR assessed at 6 months for HL patients treated at the RP2D; 30% of patients with complete response remained in CR beyond 12 months.
When we conduct studies in a patient population that has failed their previous line of therapy, demonstrating even a modest response is encouraging. To see this magnitude of responses in terms of ORR (97%) and CR (78%) is remarkable and fuels our commitment to bring this therapy to more patients, said Dr.
About the AFM13-104 Phase Study
MD Anderson has an institutional financial conflict of interest with Affimed related to this research and has therefore implemented an Institutional Conflict of Interest Management and Monitoring Plan.
About Acimtamig
Acimtamig (AFM13) is a first-in-class innate cell engager (ICE) that uniquely activates the innate immune system to destroy CD30-positive hematologic tumors. Acimtamig induces specific and selective killing of CD30-positive tumor cells, leveraging the power of the innate immune system by engaging and activating natural killer (NK) cells and macrophages. Acimtamig is a tetravalent bispecific innate cell engager designed to act as a bridge between the innate immune cells and the tumor creating the necessary proximity for the innate immune cells to specifically destroy the tumor cells.
About
Affimed (Nasdaq: AFMD) is a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer by actualizing the untapped potential of the innate immune system. The Company s proprietary ROCK platform enables a tumor-targeted approach to recognize and kill a range of hematologic and solid tumors, enabling a broad pipeline of wholly-owned and partnered single agent and combination therapy programs. The ROCK platform predictably generates customized innate cell engager (ICE) molecules, which use patients immune cells to destroy tumor cells. This innovative approach enabled Affimed to become the first company with a clinical-stage ICE. Headquartered in Mannheim,
About AlloNK and Artiva
Artiva is an immunotherapy company with the ability to produce off-the-shelf, allogeneic NK cell therapies at a massive scale. Artiva s mission is to develop effective, safe and accessible cell therapies for patients with devastating autoimmune diseases and cancers. Artiva s lead program, AlloNK (also known as AB-101), is an allogenic, non-genetically modified NK cell therapy candidate designed to enhance the antibody-dependent cellular cytotoxicity (ADCC) effect of monoclonal antibodies or NK cell engagers. AlloNK is a cryopreserved, off-the-shelf therapy with the potential to be administered in the community setting. Using the company s cell therapy manufacturing platform, Artiva can generate thousands of doses of cryopreserved, infusion-ready AlloNK cells from a single umbilical cord blood unit while retaining high and consistent expression of CD16 and other activating NK receptors. Artiva is headquartered in
Forward-Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as anticipate, believe, could, estimate, expect, goal, intend, look forward to, may, plan, potential, predict, project, should, will, would and similar expressions. Forward-looking statements appear in a number of places throughout this release and include statements regarding the Company s intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, the potential of acimtamig, AFM24, AFM28 and the Company s other product candidates, the value of its ROCK platform, its ongoing and planned preclinical development and clinical trials, its collaborations and development of its products in combination with other therapies, the timing of and its ability to make regulatory filings and obtain and maintain regulatory approvals for its product candidates, its intellectual property position, its collaboration activities, its ability to develop commercial functions, clinical trial data, its results of operations, cash needs, financial condition, liquidity, prospects, future transactions, growth and strategies, the industry in which it operates, the macroeconomic trends that may affect the industry or the Company, such as the instability in the banking sector experienced in the first quarter of 2023, impacts of the COVID-19 pandemic, the benefits to Affimed of orphan drug designation, the impact on its business by political events, war, terrorism, business interruptions and other geopolitical events and uncertainties, such as the
Contact:
Alexander Fudukidis
Email: a.fudukidis@affimed.com
Tel: +1 (917) 436-8102
Email: m.sandin@affimed.com
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