MedPath

Acimtamig

Generic Name
Acimtamig
Drug Type
Biotech
CAS Number
2738880-26-5
Unique Ingredient Identifier
ND470TT8Y3
Background

Acimtamig is a tetravalent bispecific chimeric anti-human CD30 x anti-human CD16A recombinant antibody construct.

Clinical Trials
Related News

Novel NK Cell Therapy with Bispecific Antibody Shows 93% Response Rate in Refractory Lymphoma

• Phase I trial results from MD Anderson Cancer Center demonstrate 92.9% overall response rate and 66.7% complete response rate in 42 heavily pretreated patients with CD30-positive lymphomas using cord blood-derived NK cells pre-complexed with AFM13. • The innovative approach combines natural killer cells with Affimed's bispecific antibody AFM13 (acimtamig), which binds to CD16A on NK cells and CD30 on lymphoma cells, enabling targeted elimination of cancer cells with a favorable safety profile. • At 20 months median follow-up, the therapy showed promising durability with 76.2% overall survival rate, with eleven patients maintaining complete response for at least 14 months and some up to 40 months post-treatment.

Acalabrutinib Receives FDA Approval for Previously Untreated Mantle Cell Lymphoma

• The FDA has granted traditional approval to acalabrutinib in combination with bendamustine and rituximab for untreated MCL patients ineligible for stem cell transplant. • The approval was based on the ECHO trial, which showed a 27% reduction in disease progression or death compared to chemoimmunotherapy alone. • Median progression-free survival was 66.4 months with acalabrutinib versus 49.6 months with chemoimmunotherapy, demonstrating a clinically significant improvement. • Acalabrutinib is now the first and only BTK inhibitor approved for first-line MCL treatment, offering a new option for this rare and aggressive cancer.

Affimed Advances in Innate Cell Engager Therapies for Cancer Treatment

Affimed, a leader in innate cell engager (ICE®) therapies, is making significant strides in the clinical development of novel treatments for solid and hematologic tumors. With over 500 patients treated, the company has demonstrated clinical efficacy across various indications, leveraging its proprietary IP targeting CD16A on NK cells and macrophages. Affimed's ongoing clinical programs, including AFM24, Acimtamig (AFM13), and AFM28, show promising results in treating advanced/metastatic NSCLC, R/R Classical HL, and R/R CD123+ AML, respectively. The company's innovative approach combines ICE® molecules with NK cell therapy and checkpoint inhibitors to enhance the immune system's ability to fight cancer.

Affimed's Acimtamig and AlloNK Combination Receives FDA RMAT Designation for Hodgkin Lymphoma

• The FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to Affimed's acimtamig and Artiva's AlloNK combination for relapsed/refractory Hodgkin Lymphoma. • The RMAT designation is based on early data from the LuminICE-203 trial, showing an 83.3% overall response rate and a 50% complete response rate. • The combination therapy is being evaluated in the Phase 2 LuminICE-203 trial, a multicenter, multi-cohort study. • The RMAT designation provides Affimed with enhanced access to FDA resources, potentially accelerating approval and priority review for the treatment.

Affimed N.V. Advances in Clinical Development of Novel Therapies for Solid and Liquid Tumors

Affimed N.V., a leader in innate cell engager (ICE®) technology, is making significant strides in the clinical development of novel therapies targeting solid and liquid tumors. With over 500 patients treated, the company has demonstrated clinical efficacy across various indications, leveraging its proprietary IP targeting CD16A on NK cells and macrophages. Affimed's pipeline includes promising candidates like AFM24, AFM13, and AFM28, each showing potential in addressing significant unmet needs in cancer treatment, particularly in non-small cell lung cancer (NSCLC), Hodgkin lymphoma (HL), and acute myeloid leukemia (AML).
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