AFM24 / Affimed, Xoma - LARVOL DELTA

First-in-Human Phase 1 study of a CD16A bispecific innate cell engager, AFM24, targeting EGFR-expressing solid tumors. (PubMed, Clin Cancer Res) - "AFM24 was well tolerated with 480 mg established as the RP2D. AFM24 could be a novel therapy for patients with EGFR-expressing solid tumors with suitable tolerability and appropriate pharmacokinetic properties for further development in combination with other immuno-oncology therapeutics."

Journal • P1 data • Hematological Disorders • Hematological Malignancies • Oncology • Solid Tumor • EGFR • FCGR3A

First-in-Human Phase 1 study of a CD16A bispecific innate cell engager, AFM24, targeting EGFR-expressing solid tumors (Clin Cancer Res) - P1/2a | N=85 | NCT04259450 | Sponsor: Affimed GmbH | "In the dose escalation phase, 35 patients received AFM24 weekly across seven dose cohorts (14–720 mg). One patient experienced a DLT of Grade 3 infusion-related reaction (IRR). IRRs were mainly reported after the first infusion; these were manageable with premedication and a gradual increase in infusion rate. Pharmacokinetics were dose-proportional and CD16A receptor occupancy on NK cells approached saturation between 320–480 mg. Paired tumor biopsies demonstrated activation of innate and adaptive immune responses within the tumor. Best objective response was stable disease in 10/35 patients; four had stable disease for 4.3–7.1 months."

P1 data • Solid Tumor

Post-Hoc Exposure-Response Analysis (GlobeNewswire) - "A post-hoc exposure-response analysis was conducted including NSCLC EGFRwt and EGFRmut subjects (n= 44) treated with 480 mg AFM24 in both the AFM24-101 monotherapy study or the AFM24-102 AFM24 combination with atezolizumab study.....The high exposure group showed an ORR of 46% and a PFS of 7.4. A sensitivity analysis using quartiles of exposure supported a clear relationship between exposure and outcome indicating that higher doses of AFM24 will likely result in improved efficacy. The PK profile of 720 mg AFM24 weekly, as tested successfully in the phase 1 trial and further pharmacokinetic modelling indicate that 720 mg will achieve exposure levels that are equal or above the plasma concentrations observed for the high exposure group."

Retrospective data • Non Small Cell Lung Cancer

Affimed Reports Positive Clinical Update on AFM24/Atezolizumab Combination Therapy in Non-Small Cell Lung Cancer (NSCLC) (GlobeNewswire) - P1/2a | N=148 | AFM24-102 (NCT05109442) | Sponsor: Affimed GmbH | "In 33 heavily pretreated NSCLC EGFR wild-type (EGFRwt) patients the combination of AFM24 and atezolizumab shows an overall response rate (ORR) of 21% (6 confirmed responses, 1 response awaiting confirmatory scan) and a disease control rate (DCR) of 76%; tumor shrinkage was observed in 48% of patients; preliminary median progression free survival (PFS) is 5.6 months and 36% of patients remain on treatment; In 17 heavily pretreated NSCLC EGFR mutant (EGFRmut) patients the combination shows an ORR of 24% and a DCR of 71%; tumor shrinkage was observed in 41% of patients; median PFS is 5.6 months and 5 patients (29%) are on treatment for over 10 months; Both cohorts demonstrated a well-manageable side effect profile with no new safety signals identified."

P1/2 data • Non Small Cell Lung Cancer

Affimed to Host Investor Conference Call Highlighting Clinical Data from AFM24 in Combination with Atezolizumab in Non-Small Cell Lung Cancer (GlobeNewswire) - "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."

P1/2 data • Non Small Cell Lung Cancer

Affimed Reports Third Quarter 2024 Financial Results & Business Update (GlobeNewswire) - "Upcoming Milestones: i) LuminICE-203: Efficacy update of four cohorts to be presented at ASH 2024. ii) AFM24-102: ORR and safety data from the EGFRwt cohort to be presented at a Company conference call on December 17, 2024. iii) AFM28-101: Updated data from the dose escalation to be presented at ASH 2024."

P1 data • P1/2 data • P2 data • Acute Myelogenous Leukemia • Hematological Malignancies • Hodgkin Lymphoma • Oncology • Peripheral T-cell Lymphoma • Solid Tumor

AFM24-102: Study to Assess AFM24 in Combination with Atezolizumab in Selected Advanced/Metastatic EGFR-expressing Cancers (clinicaltrials.gov) - P1/2 | N=148 | Recruiting | Sponsor: Affimed GmbH | Trial completion date: Jun 2025 ➔ Nov 2025 | Trial primary completion date: Sep 2024 ➔ Feb 2025

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Gastric Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • EGFR

Leveraging innate and adaptive immunity with AFM24 and atezolizumab in metastatic gastric cancer (ESMO 2024) - P1/2 | "AFM24 plus atezolizumab showed early signs of activity in relapsed/refractory mGC/mGEJC pts, including patients with signet ring cell gastric adenocarcinoma. No new or unexpected toxicities were reported. This chemotherapy-free approach could be a therapeutic alternative and warrants further study."

IO biomarker • Metastases • Tumor mutational burden • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • EGFR • FCGR3A • TMB

Affimed Reports Second Quarter 2024 Financial Results & Business Update (GlobeNewswire) - P1/2 | N=148 | NCT05109442 | Sponsor: Affimed GmbH | "24 heavily pretreated EGFRmut NSCLC patients are in the trial; in 17 patients that are response evaluable per protocol, 1 CR, 3 PRs and 8 SDs were observed. All responses have been confirmed by follow-up scan. ORR is 23.5% (4/17) and DCR is 70.6% (12/17). Median follow-up is > 7 months and 8 out of the 17 patients continue on treatment. All 4 responders remained on treatment for at least 7 months...Mature PFS data from EGFRmut and EGFRwt cohorts expected to be presented at a future conference in H1 2025."

P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Study to Assess AFM24 in Advanced Solid Cancers (clinicaltrials.gov) - P1/2 | N=85 | Completed | Sponsor: Affimed GmbH | Active, not recruiting ➔ Completed | Trial completion date: Dec 2024 ➔ Jun 2024

Trial completion • Trial completion date • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • KRAS

Preliminary results from the phase 2 study of AFM24 in combination with atezolizumab in patients with EGFR wild-type (EGFR-WT) non-small cell lung cancer (NSCLC). (ASCO 2024) - P1/2 | "AFM24 with atezolizumab shows remarkable signs of clinical efficacy, even in patients with resistance to prior CPI, and a well-tolerated and manageable safety profile in patients with EGFR-WT NSCLC. The study is ongoing and up to 40 patients will be enrolled into this cohort."

Clinical • Combination therapy • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • FCGR3A • PD-1

Affimed Reports First Quarter 2024 Financial Results & Business Update (GlobeNewswire) - "Upcoming Milestones: (i) Data readout from the 12 patients in cohorts 1 and 2 of the LuminICE-203 (AFM13 combination with AlloNK cells) study in Q3 2024; (ii) ORR and PFS data from the 25 patients in the EGFRmut cohort of the AFM24-102 study in Q3 2024; (iii) ORR and PFS data from the 40 patients in the EGFRwt cohort of the AFM24-102 study in Q4 2024."

P1/2 data • P2 data • Hodgkin Lymphoma • Peripheral T-cell Lymphoma • Solid Tumor

Affimed Provides Follow-up Data of AFM24 plus Atezolizumab Showing Durable Responses in Heavily Pretreated NSCLC EGFR Wild-type Patients and Positive Initial Data from the NSCLC EGFR Mutant Cohort (GlobeNewswire) - P1/2a | N=148 | NCT05109442 | Sponsor: Affimed GmbH | "As of the updated data cutoff on May 13, 2024 for the 17 EGFRwt patients previously reported on, 15 patients were response-evaluable. Four confirmed objective responses were seen: 1 complete response (CR) and 3 partial responses (PR). In addition, 8 patients achieved stable disease (SD), resulting in a disease control rate of 71%. Median progression-free survival was 5.9 months with median follow-up of 7.4 months....As of May 21, 2024, 21 heavily pretreated EGFRmut patients (median of 3 prior therapies) had received the combination therapy of which 13 were response-evaluable. The combination of AFM24 with atezolizumab showed encouraging signals of clinical activity including 1 CR, 3 PRs and 6 patients with SD. As of the data cut-off, all responses were on-going....Recruitment in both cohorts is ongoing, and further updates are expected in H2 2024."

P1/2 data • Non Small Cell Lung Cancer

Affimed Receives Fast Track Designation for Combination Therapy of AFM24 with Atezolizumab for EGFR Wild-Type Non-Small Cell Lung Cancer (GlobeNewswire) - "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....The FDA’s decision is based on initial activity observed in the first evaluable patients of the phase 2 part of the AFM24-102 study of AFM24 in combination with atezolizumab in heavily pretreated patients with NSCLC EGFRwt."

Fast track • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Affimed Announces Positive Early Efficacy and Progression Free Survival Results of AFM24-102 Study in EGFR Wild-Type Non-Small Cell Lung Cancer at the Annual Meeting of the American Society of Clinical Oncology 2024 (GlobeNewswire) - P1/2a | N=148 | NCT05109442 | Sponsor: Affimed GmbH | "Affimed N.V...announced that an update from the Company’s AFM24-102 study in advanced EGFR wild-type (EGFRwt) non-small cell lung cancer (NSCLC) will be presented at the annual meeting of the American Society of Clinical Oncology....As of the March 18 cut-off for the poster, 17 patients with EGFRwt NSCLC received the combination treatment and 15 patients were response evaluable. One patient showed a confirmed complete response, and three patients showed confirmed partial responses (PR). In addition, seven patients achieved stable disease, resulting in a disease control rate of 73.3% (11/15 patients). Median progression-free survival was 5.9 months....The full data set will be presented by Dr. Hye Ryun Kim, Professor at Yonsei University College of Medicine, Seoul, Korea, at ASCO on June 1, 2024..."

P1/2 data • Non Small Cell Lung Cancer

Affimed Announces Acceptance of AFM24 Clinical Abstract at the 2024 Annual Meeting of the American Society of Clinical Oncology (GlobeNewswire) - "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."

P2 data • Non Small Cell Lung Cancer

Safety, Tolerability, and Anti-Tumor Activity of AFM24 in Combination With SNK01 in Subjects With Advanced/Metastatic EGFR-Expressing Cancers (clinicaltrials.gov) - P1/2 | N=11 | Terminated | Sponsor: NKGen Biotech, Inc. | N=121 ➔ 11 | Trial completion date: Nov 2025 ➔ Sep 2023 | Active, not recruiting ➔ Terminated | Trial primary completion date: Nov 2025 ➔ Sep 2023; Affimed and NKGen have mutually decided to discontinue the study. Affimed will evaluate the best options to advance this project with an allogeneic off-the-shelf NK cell product while NKGen will focus on CNS with SNK01.

Combination therapy • Enrollment change • Metastases • Trial completion date • Trial primary completion date • Trial termination • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Affimed Provides Clinical Response Update on AFM24-102 Trial in EGFR-wildtype Non-Small Cell Lung Cancer (GlobeNewswire) - P1/2a | N=148 | NCT05109442 | Sponsor: Affimed GmbH | "Affimed...provided an update on the clinical response data for the ongoing AFM24-102 phase 1/2a study in EGFRwt NSCLC. As of January 4, 2024, updated information on the 4 responses in the 15 patients treated in the EGFRwt NSCLC cohort, now show 1 confirmed complete response (CR), 2 confirmed partial responses (PR) and 1 unconfirmed PR awaiting confirmation. Initial data as presented on December 11, 2023, showed 1 confirmed PR as well as 1 unconfirmed CR, and 2 unconfirmed PRs....Based on the promising response data from the EGFRwt NSCLC cohort, Affimed will expand enrollment to 40 patients. Additionally, the Company reported that enrollment of the EGFRmut NSCLC cohort is ongoing. Data from both cohorts are expected in H1 2024."

Enrollment status • P1/2 data • Non Small Cell Lung Cancer

Affimed Announces Positive Data for AFM24 in Combination with the PD-L1 Checkpoint Inhibitor Atezolizumab in Heavily Pre-treated EGFR-Wildtype Non-Small Cell Lung Cancer Patients (GlobeNewswire) - P1/2 | N=148 | NCT05109442 | Sponsor: Affimed GmbH | "Responses observed in 4 of 15 patients, including 1 confirmed partial response (PR), 1 unconfirmed complete response (CR) awaiting confirmation, 2 unconfirmed PRs awaiting confirmation; an additional 7 of 15 patients exhibiting stable disease (SD) leading to a disease control rate of 73%.Tumor shrinkage observed in 7 of 15 (47%) patients. All patients were pretreated with and ultimately progressed while on PD-[L]1 targeting therapy. The majority of patients experienced only mild to moderate treatment-related adverse events, confirming a well-manageable safety profile in combination with atezolizumab....Affimed also announced that it has discontinued enrollment in AFM24-102 into the gastric cancer cohort and the basket cohort evaluating pancreatic cancer, biliary tract cancer and hepatocellular carcinoma."

P1/2 data • Trial status • Biliary Tract Cancer • Cholangiocarcinoma • Gastric Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Affimed to Host Investor Conference Call Highlighting Clinical Data for Acimtamig (AFM13) and AFM24 (GlobeNewswire) - "Affimed N.V...announced today that it will host a conference call on December 11 at 1:30 p.m. PST / 4:30 p.m. EST to review clinical data presented from the combination trial of acimtamig with cord-blood derived NK cells during the 65th American Society of Hematology (ASH) Annual Meeting in San Diego, CA. During the call, the Company will also provide a clinical data update from the AFM24-102 trial."

P1/2 data • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology • Solid Tumor

Affimed Reports Third Quarter 2023 Financial Results and Highlights Operational Progress (GlobeNewswire) - "Based on the results from the AFM24 monotherapy study, a fourth expansion cohort of patients with EGFR-mutant NSCLC has been added to the AFM24-102 study and is enrolling and treating patients. Data from this cohort is expected in the first half of 2024....AFM28 is investigated in a multi-center Phase 1 open-label, dose-escalation study (AFM28-101), in r/r AML. Dose level three was completed with no dose-limiting toxicities; completed enrollment in the fourth dose cohort. Clinical development of AFM28 is planned as both single-agent and in combination with an allogeneic off-the-shelf NK cell product....Data release from the first three expansion cohorts of the Phase 1/2a study AFM24+atezolizumab combination study planned in December 2023....Further progress updates from AFM28-101 dose escalation planned in H1 2024."

P1 data • P1/2 data • Trial status • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Study to Assess AFM24 in Advanced Solid Cancers (clinicaltrials.gov) - P1/2 | N=85 | Active, not recruiting | Sponsor: Affimed GmbH | Recruiting ➔ Active, not recruiting | N=155 ➔ 85 | Trial primary completion date: Apr 2024 ➔ Jul 2023

Enrollment change • Enrollment closed • Metastases • Trial primary completion date • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

Study to Assess AFM24 in Combination With Atezolizumab in Selected Advanced/Metastatic EGFR-expressing Cancers (clinicaltrials.gov) - P1/2 | N=148 | Recruiting | Sponsor: Affimed GmbH | N=105 ➔ 148

Combination therapy • Enrollment change • Metastases • Gastric Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Safety, Tolerability, and Anti-Tumor Activity of AFM24 in Combination With SNK01 in Subjects With Advanced/Metastatic EGFR-Expressing Cancers (clinicaltrials.gov) - P1/2 | N=121 | Active, not recruiting | Sponsor: NKGen Biotech, Inc. | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Metastases • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Affimed Announces an ASCO Breakthrough Poster Presentation with Clinical Data of AFM24 in Combination with NKGen Biotech’s SNK01 NK Cells (GlobeNewswire) - P1/2a | N=121 | NCT05099549 | Sponsor: NKGen Biotech, Inc. | "Affimed N.V....announced that an abstract with clinical trial results of its innate cell engager (ICE®) AFM24 in combination with NKGen Biotech’s SNK01...has been accepted for a poster presentation at the ASCO Breakthrough conference from 3-5 August 2023 in Yokohama, Japan. The presentation includes dose escalation phase data on safety and efficacy of the phase 1 study in patients with advanced or metastatic EGFR-expressing solid tumors (NCT05099549). As of June 2023, seven patients with a mean number of five prior therapies received the combination of AFM24 and SNK01. No unexpected or dose-limiting toxicities were observed, and the PK properties were similar to AFM24 monotherapy. The best objective response was stable disease in three out of the seven patients, including patients with heavily pretreated microsatellite stable colorectal cancer (MSS CRC)."

P1 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor