On January 9, 2023 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, reported that the U.S. Food and Drug Administration (FDA) has issued a written response to the Company’s pre-IND meeting request for the AFM13 and Artiva Biotherapeutics, Inc. ("Artiva")’s AB-101 co-administered combination therapy in relapsed/refractory (r/r) Hodgkin lymphoma (HL) and the exploratory arm evaluating the combination in r/r CD30-positive peripheral T-cell lymphoma (PTCL). Based on the written response, Affimed remains on track to submit an IND in the first half of 2023 and, subject to FDA clearance of the IND, to initiate a clinical study during 2023 (Filing, 6-K, Affimed, JAN 9, 2023, View Source [SID1234626017]).
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"We remain excited about the clinical and commercial potential of the AFM13/AB-101 combination therapy for CD30-positive HL and PTCL patients and look forward to initiating clinical development during 2023," said Dr. Adi Hoess, CEO of Affimed. "We believe there is significant unmet need to help patients in these difficult cancer indications with limited treatment options and continue to make progress across our pipeline. We are looking forward to sharing key clinical milestones in 2023 and beyond."
In November 2022, Affimed announced that it had entered into a strategic partnership to jointly develop, manufacture and commercialize a combination therapy comprised of Affimed’s Innate Cell Engager (ICE) AFM13 and Artiva’s cord blood-derived, cryopreserved off-the-shelf allogeneic NK cell product candidate, AB-101, to accelerate clinical development and address the high unmet need of CD30-positive lymphoma patients.
Other Clinical Stage Program Updates
AFM24 (EGFR/CD16A)
Affimed expects to report data from all three ongoing AFM24 studies at scientific conferences in Q2/Q3 2023.
AFM24-101: Affimed continues to enroll patients in the expansion phase of the AFM24 monotherapy study at the RP2D. The expansion cohorts include patients with renal cell carcinoma (clear cell), non-small cell lung cancer (EGFR mutant) and colorectal cancer.
AFM24-102: Enrollment is completed in the 480 mg dose escalation cohort of the phase 1/2a combination study of AFM24 with the anti-PD-L1 checkpoint inhibitor atezolizumab (Tecentriq) in patients with advanced epidermal growth factor receptor-expressing solid tumors. AFM24-102 includes patients with non-small cell lung cancer (EGFR wildtype), gastric and gastroesophageal junction adenocarcinoma and pancreatic/hepatocellular/biliary tract cancer. No dose-limiting toxicities (DLTs) have been observed thus far in the dose escalation. Expansion cohorts are expected to begin enrollment in Q1 2023.
Data from the first cohort (4 patients at 160 mg dose) of the phase 1 dose escalation study presented at the annual meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in November 2022 showed that clinical activity was observed in two patients. A patient with gastric cancer and skin metastases who had rapidly progressed following four prior lines of therapy, including a PD-1 inhibitor, achieved a partial response. A second patient with pancreatic adenocarcinoma showed stable disease beyond four months. Patients being enrolled in the study are required to have progressed or relapsed on standard of care therapies.
AFM24-103: In the phase 1/2a combination study of AFM24 with SNK01, NKGen Biotech’s ex vivo expanded and activated autologous NK cell therapy, enrollment has been completed in the dose cohort of 480 mg AFM24 weekly, with no DLTs observed to date.
AFM24-103 is focused on the treatment of patients with non-small cell lung cancer (NSCLC, EGFR-wildtype), squamous cell carcinoma of the head and neck, and colorectal cancer.
AFM28 (CD123/CD16A)
Affimed’s AFM28 ICE targets CD16A on NK cells and macrophages, and CD123 on leukemic blasts and leukemic stem cells that are prevalent in acute myeloid leukemia (AML).
In December 2022, CTAs were cleared in France and Spain, and the Company expects to initiate a phase 1 clinical study in Q2 2023.
Financial Update
As of December 31, 2022, preliminary unaudited cash and cash equivalents were approximately €190 million, with an anticipated cash runway into 2025.
Partnerships and Collaborations
Partnered programs with Genentech and Affivant (a Roivant company) continue to progress. Affimed is eligible for additional proceeds including pre-clinical milestones as well as milestones based on early regulatory achievements. Affivant expects to file an IND for AFVT-2101 (formerly AFM32) in the first half of 2023.