This section highlights FDA-related milestones and regulatory updates for drugs developed by Affimed (AFMD).
Over the past two years, Affimed has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
AB101, AFM13-203, AFM24, and AFM24-102. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
AB101 - FDA Regulatory Timeline and Events
AB101 is a drug developed by Affimed for the following indication: For the treatment of relapsed or refractory Hodgkin Lymphoma (R/R HL).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- AB101
- Announced Date:
- December 5, 2024
- Indication:
- For the treatment of relapsed or refractory Hodgkin Lymphoma (R/R HL).
Announcement
Affimed N.V. announced that the U.S. FDA has granted RMAT designation to the combination therapy of Affimed's innate cell engager (ICE®) acimtamig and Artiva Biotherapeutic's AlloNK® (AB101) for the treatment of relapsed or refractory Hodgkin Lymphoma (R/R HL).
AI Summary
Affimed N.V. announced that the U.S. FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to the combination therapy of its innate cell engager (ICE®) acimtamig and Artiva Biotherapeutic’s AlloNK® (AB101) for relapsed or refractory Hodgkin Lymphoma (R/R HL). This RMAT designation is designed to speed up development and review processes for regenerative medicine therapies and provides benefits similar to Breakthrough Therapy Designation, such as accelerated approval and priority review. The move follows early clinical data showing promising results, including an 83.3% overall response rate and a 50% complete response rate in a small patient group, along with a well-managed safety profile. The designation is a key step in bringing this innovative treatment, which aims to offer new hope to patients with few current options, closer to clinical use.
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AFM13-203 (LuminICE-203) - FDA Regulatory Timeline and Events
AFM13-203 (LuminICE-203) is a drug developed by Affimed for the following indication: Tetravalent bispecific innate cell engager.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- AFM13-203 (LuminICE-203)
- Announced Date:
- December 8, 2024
- Indication:
- Tetravalent bispecific innate cell engager
Announcement
Affimed N.V. announced the presentation of data in a poster session at the 66th ASH Annual Meeting and Exposition
AI Summary
Affimed N.V. announced that it will present new data in a poster session at the 66th ASH Annual Meeting and Exposition. The presentation highlights findings from the run-in phase of the LuminICE-203 phase 2 study. In this trial, the combination of acimtamig with AlloNK® was tested in 22 heavily pretreated patients with relapsed/refractory classical Hodgkin lymphoma who had no remaining standard treatment options. The treatment showed an overall response rate of 86%, with a complete response rate of 55%. Additionally, the combination exhibited a well-manageable safety profile with no unexpected side effects, which is promising for patients who have already undergone several therapies. These encouraging results support further exploration of this innovative treatment option, offering hope for improved outcomes in a patient population with limited alternatives.
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AFM24 + Atezolizumab - FDA Regulatory Timeline and Events
AFM24 + Atezolizumab is a drug developed by Affimed for the following indication: Solid tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- AFM24 + Atezolizumab
- Announced Date:
- March 25, 2025
- Indication:
- Solid tumors
Announcement
Affimed N.V. announced an abstract on AFM24 dose optimization using exposure response analysis has been accepted for presentation as a poster at the Annual Meeting of the American Association for Cancer Research (AACR) taking place April 25-30, 2025 in Chicago, Illinois.
AI Summary
Affimed N.V. announced that its abstract on AFM24 dose optimization using exposure response analysis has been accepted for poster presentation at the Annual Meeting of the American Association for Cancer Research (AACR) in Chicago, Illinois, from April 25-30, 2025. The study will focus on the use of AFM24, both as monotherapy and in combination with Atezolizumab, for patients with advanced/metastatic non-small cell lung cancer. The poster session is scheduled for Tuesday, April 29, 2025, from 9:00 AM to 12:00 PM CDT and will be displayed in Poster Section 49. The accepted abstract details the optimization of dosing strategies through analysis of exposure and response to better guide therapy. This presentation highlights the company’s effort to improve treatment outcomes for cancer patients by refining antibody-dependent targeting approaches. Future details will be published online on April 25, 2025.
Read Announcement- Drug:
- AFM24 + Atezolizumab
- Announced Date:
- May 29, 2024
- Estimated Event Date Range:
- June 1, 2024 - June 1, 2024
- Target Action Date:
- June 1, 2024
- Indication:
- Solid tumors
Announcement
Affimed N.V. announced that Data from the AFM24-102 study in this patient population will be presented at the upcoming annual meeting of the American Society of Clinical Oncology on June 1, 2024.
AI Summary
Affimed N.V. announced that data from its AFM24-102 Phase 1/2a study will be presented at the upcoming American Society of Clinical Oncology (ASCO) annual meeting on June 1, 2024. The study evaluates the efficacy and safety of the novel innate cell engager AFM24 in combination with the checkpoint inhibitor atezolizumab for advanced or metastatic non‐small cell lung cancer (NSCLC) patients whose tumors do not carry activating EGFR mutations. This patient group has already been resistant to previous PD-(L)1 targeted therapies and platinum‐based chemotherapy, underscoring an urgent need for new treatment options.
Affimed’s upcoming ASCO presentation is expected to provide important insights into how this combination therapy may overcome resistance seen in earlier treatments, offering hope to patients who have exhausted standard care options.
Read Announcement- Drug:
- AFM24 + Atezolizumab
- Announced Date:
- May 29, 2024
- Indication:
- Solid tumors
Announcement
Affimed N.V. announced that the FDA has granted Fast Track designation to the combination of its innate cell engager (ICE®) AFM24 with atezolizumab for the treatment of patients with advanced and/or metastatic non-small cell lung cancer (NSCLC) not harboring any activating EGFR mutations (EGFR wild-type) after progression on PD-(L)1 targeted therapy and platinum-based chemotherapy.
AI Summary
Affimed N.V. announced that the FDA has granted Fast Track designation for its novel combination therapy using its innate cell engager AFM24 with the checkpoint inhibitor atezolizumab. This designation is for advanced and/or metastatic non‐small cell lung cancer (NSCLC) patients who do not have activating EGFR mutations (EGFR wild-type) and have already progressed on PD-(L)1 targeted therapy and platinum-based chemotherapy.
Fast Track status will help speed up the review and development process by allowing more frequent interactions with the FDA. The decision is based on promising initial results from the phase 2 part of the AFM24-102 study, showing meaningful responses in patients who have few treatment options left. This step provides hope for a new treatment approach that may better address the unmet needs of patients facing this life-threatening disease.
Read Announcement- Drug:
- AFM24 + Atezolizumab
- Announced Date:
- April 24, 2024
- Indication:
- Solid tumors
Announcement
Affimed N.V announced that an abstract presenting preliminary data from the phase 2 combination study of AFM24, its innate cell engager (ICE®), in combination with atezolizumab, Roche's checkpoint inhibitor, in patients with EGFR-wildtype (EGFRwt) non-small cell lung cancer (NSCLC) has been accepted for poster presentation at 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.
AI Summary
Affimed N.V. announced that preliminary data from its phase 2 study evaluating AFM24—an innate cell engager (ICE®)—in combination with Roche’s checkpoint inhibitor atezolizumab in patients with EGFR wild-type non-small cell lung cancer has been accepted for poster presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. The poster session, titled “Preliminary results from the phase 2 study of AFM24 in combination with atezolizumab in patients with EGFR wild-type (EGFR-WT) NSCLC,” will feature abstract number 2522 and is scheduled for presentation on Saturday, June 1, 2024, during the Developmental Therapeutics—Immunotherapy session.
This study explores how AFM24 uses the EGFR protein on tumor cells as a docking site, activating the innate immune system to kill cancer cells through mechanisms like antibody-dependent cellular cytotoxicity and phagocytosis. The early findings could offer new insights into combining targeted immunotherapy with checkpoint inhibitors for more effective lung cancer treatments.
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AFM24-102 - FDA Regulatory Timeline and Events
AFM24-102 is a drug developed by Affimed for the following indication: Solid Tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- AFM24-102
- Announced Date:
- December 17, 2024
- Indication:
- Solid Tumors
Announcement
Affimed N.V. announced updated clinical data from the ongoing AFM24-102 trial of AFM24/atezolizumab combination therapy in heavily pretreated NSCLC patients. Results continue to demonstrate meaningful clinical activity in both NSCLC EGFRwt and EGFRmut patients with good tolerability.
AI Summary
Affimed N.V. announced promising updates from its ongoing AFM24-102 trial using a combination of AFM24 and atezolizumab in heavily pretreated NSCLC patients. In the EGFR wild-type group, the treatment achieved a 21% overall response rate and a 76% disease control rate, with nearly half of the patients showing tumor shrinkage and a median progression-free survival of 5.6 months. Similarly, in EGFR mutant patients, a 24% overall response rate and a 71% disease control rate were observed, with 41% of the patients showing tumor shrinkage and the same median progression-free survival. The combination therapy was well tolerated with manageable side effects. A post hoc analysis suggested that higher exposure to AFM24 leads to better responses, longer progression-free survival, and improved overall survival, supporting the move to a higher dose in future studies.
Read Announcement- Drug:
- AFM24-102
- Announced Date:
- December 9, 2024
- Indication:
- Solid Tumors
Announcement
Affimed N.V announced today that it will host a conference call on Tuesday, December 17, at 8:30 a.m. EST / 14:30 CET to review clinical data from AFM24-102, the combination trial of its AFM24 innate cell engager ICE® with atezolizumab in non-small cell lung cancer.
AI Summary
Affimed N.V. announced that it will host a conference call on Tuesday, December 17, at 8:30 a.m. EST (14:30 CET) to present clinical data from its AFM24-102 study. This trial is a combination therapy that pairs the company’s AFM24 innate cell engager, ICE®, with the immunotherapy drug atezolizumab, specifically targeting non-small cell lung cancer.
The conference call will be accessible via phone and webcast. Listeners can join through the Affimed website’s Investors section, where a live audio webcast and dial-in details will be provided. The call is set to review key clinical findings from the trial, offering insights into the potential benefits of combining the ICE® technology with established cancer treatments.
Read Announcement- Drug:
- AFM24-102
- Announced Date:
- June 1, 2024
- Indication:
- Solid Tumors
Announcement
Affimed N.V. announced longer follow-up data from the EGFRwt cohort and initial clinical efficacy data from the EGFRmut cohort from the on-going AFM24-102 study in NSCLC.
AI Summary
Affimed N.V. announced updated longer follow-up results from the EGFR wild-type (EGFRwt) cohort and early clinical efficacy data from the EGFR mutant (EGFRmut) cohort in the on-going AFM24-102 trial in NSCLC. In the EGFRwt group, 15 patients were evaluable and showed four confirmed objective responses – one complete and three partial responses – with three of the responses lasting over seven months. This group achieved a median progression-free survival of 5.9 months and a disease control rate of 71%. In the EGFRmut cohort, 13 evaluable patients also demonstrated promising clinical activity, including one complete and three partial responses, despite previous resistance to checkpoint inhibitors. The combination of AFM24 and atezolizumab has shown encouraging signs of synergy in these heavily pretreated NSCLC patients, with a manageable safety profile featuring mainly mild to moderate side effects.
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