Affimed Reports Third Quarter 2023 Financial Results and Highlights Operational Progress
Acimtamig (also known as AFM13) combination with AlloNK® (also known as AB-101): Initiated LuminICE-203. Company on track to report initial data in H1 2024.
Acimtamig: Received fast-track designation for the combination of acimtamig and AlloNK®.
LuminICE-203: Received encouraging feedback from the FDA on Type C meeting.
AFM13-104: Oral presentation of updated data of acimtamig in combination with cord blood-derived NK cells at the American Society of Hematology (ASH) 2023 Annual Meeting.
AFM24 combination with atezolizumab: On track to report data from three expansion cohorts in December 2023.
AFM28: Cleared third dose cohort without dose limiting toxicities; completed enrollment in the fourth cohort.
Cash runway into 2025: As of September 30, 2023, cash, cash equivalents and financial assets were €97.5 million.
MANNHEIM, Germany, Nov. 14, 2023 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD) (“Affimed” or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today reported financial results and provided an update on clinical and corporate progress for the third quarter of 2023.
“We initiated our phase 2 clinical study of acimtamig in combination with AlloNK® and received encouraging feedback on the design of our LuminICE-203 trial from the FDA,” said Dr. Adi Hoess, CEO of Affimed. “We also continued to make progress with AFM24 in combination with atezolizumab and advanced AFM28 in the dose escalation. This positions our company well to report further updates on all three clinical programs within the next few months.”
Program Updates
Acimtamig (CD30/CD16A)
Initiated LuminICE-203, a phase 2 clinical study to investigate acimtamig in combination with Artiva’s AlloNK® natural killer (NK) cells in patients with relapsed / refractory (r/r) classical Hodgkin lymphoma (HL). The study will also include a cohort of 20 r/r PTCL patients. The Company expects to report initial efficacy and safety data from the LuminICE-203 study in the first half of 2024.
Received encouraging feedback from FDA regarding questions for the Type C meeting:
The FDA is highly engaged in supporting the progress and design of the study evaluating the combination of acimtamig and AlloNK® as evidenced by the fast-track designation and Type C meeting feedback. According to written feedback for the Type C meeting, the LuminICE-203 study, designed based on the FDA’s recommendations and guidelines, could support accelerated approval, depending on the demonstrated magnitude of clinical benefit. In addition, the FDA agrees with Affimed’s approach to address the contribution of single components by adding a cohort to the study evaluating AlloNK®/IL-2 only.
AFM13-104 abstract selected for oral presentation at the ASH 2023 Annual Meeting. The oral presentation by Dr. Yago Nieto, M.D., Ph.D., professor of Stem Cell Transplantation and Cellular Therapy at MD Anderson at the ASH 2023 Annual Meeting will include data on a total of 42 r/r CD30-positive Hodgkin lymphoma (HL) and Non-Hodgkin lymphoma (NHL) patients enrolled in the study with 36 patients treated at the recommended phase 2 dose (RP2D). All patients were heavily pretreated and refractory to their most recent line of therapy with active progressive disease at the time of enrollment. The acimtamig precomplexed NK cells treatment followed by three weekly infusions of acimtamig achieved an overall response rate (ORR) of 94.4% with a complete response rate of 72.2% at RP2D. Acimtamig in combination with NK cells continues to demonstrate a good safety and tolerability profile with no cases of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS) or graft versus host disease (GVHD) of any grade. An in-depth analysis including updated EFS/OS data will be presented during Dr. Nieto’s oral presentation.
AFM24 (EGFR/CD16A)
On track to report data in December 2023 from the first three expansion cohorts of AFM24-102, a Phase 1/2a combination study of AFM24 and atezolizumab, in patients with advanced EGFR-expressing solid tumors. Expansion cohorts of the study enrolled patients with (1) EGFR-wildtype non-small cell lung cancer (NSCLC) (2) gastric /gastroesophageal junction adenocarcinoma and (3) a basket cohort evaluating pancreatic, hepatocellular, and biliary tract cancer.
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.
AFM24 combination with NK cells. The Company is continuing to investigate the possibility of a combination of AFM24 with an allogeneic, off-the-shelf NK cell product.
AFM28 (CD123/CD16A)
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.