AFVT-2101 / Roivant, Affimed - LARVOL DELTA

Affimed Reports First Quarter 2023 Financial Results and Highlights Operational Progress (GlobeNewswire) - "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 continues in the second dose cohort to confirm 480 mg AFM24 weekly as the RP2D....The Company expects to complete the dose escalation part of the study during 2023 and present data from the study during the second half of 2023....At AACR 2023, Affivant presented two posters highlighting preclinical data that demonstrated the potent anti-tumor activity and tolerability profile of AFVT-2101. Affivant disclosed that it expects to initiate phase 1 clinical trials in 2023."

New P1 trial • P1/2 data • Trial status • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Preclinical safety & pharmacokinetics of AFVT-2101, a tetravalent FRα x CD16A bispecific innate cell engager for the treatment of solid tumors (AACR 2023) - "AFVT-2101 was well-tolerated with no test article-related adverse effects on clinical observations, bodyweight, clinical chemistry, hematology, coagulation, anatomic pathology, or immunotoxicity parameters. The no observed adverse effect level (NOAEL) was determined to be 150 mg/kg under the conditions of the study.The safety profile is being further evaluated in an ongoing pivotal 4-week GLP study incorporating standard toxicology endpoints, safety pharmacology (CNS, CV, and respiratory), gross and anatomic pathology, as well as cytokine, immunophenotyping, receptor occupancy, TK, and ADA analyses.In conclusion, AFVT-2101 is well-tolerated in NHPs with a pharmacokinetic and safety profile consistent with its intended clinical application."

PK/PD data • Preclinical • Oncology • Solid Tumor • FCGR3A • FOLR1

AFVT-2101: A FRα × CD16A bispecific innate cell engager for the treatment of solid tumors (AACR 2023) - "Further, AFVT-2101 is more efficacious and potent in both ADCC and ADCP assays than farletuzumab, an Fc-competent monoclonal antibody targeting FRα, which shares the same VH/VL sequence as AFVT-2101. Moreover, the innate immune engager significantly restrains in vivo tumor growth and induces pharmacodynamic changes in line with TME repolarization. AFVT-2101 engages innate immune cells in a target-restricted manner and potentially imparts an efficacious clinical profile with favorable tolerability."

Oncology • Solid Tumor • FCGR3A • FOLR1

Affimed Reports 2022 Financial Results and Operational Progress (GlobeNewswire) - "Affivant Sciences submitted two preclinical abstracts for AFVT-2101 (formerly AFM32) which have been accepted for poster presentation at the AACR annual meeting in April 2023. Affivant expects to submit an IND for AFVT-2101 in the first half of 2023."

IND • Preclinical • Oncology

Affimed Reports Third Quarter 2022 Financial Results and Highlights Recent Clinical and Corporate Progress (GlobeNewswire) - "Affimed expects to report topline data from the phase 2 REDIRECT study (AFM13-202) of AFM13 monotherapy in patients with relapsed / refractory (r/r) CD30-positive peripheral T-cell lymphoma (PTCL) in mid-December....Affimed submitted a pre-IND meeting request for the AFM13 and AB-101 co-administered combination therapy to the U.S. Food and Drug Administration (FDA) requesting feedback on the clinical trial design in relapsed/refractory (r/r) Hodgkin lymphoma with an exploratory arm evaluating the combination in r/r CD30-positive peripheral T-cell lymphoma and potential path to registration. The FDA is expected to provide feedback by Q1 2023. The companies expect to submit an Investigational New Drug (IND) application to the FDA in H1 2023....Roivant presented a poster at SITC that AFVT-2101/AFM32...The company announced that it is expecting to enter phase 1 clinical trial in 2023."

FDA event • IND • New P1 trial • P2 data • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma

AFVT-2101, an innate immune-cell engager that selectively targets FOLR1 expressing tumor cells to safely harness potent anti-cancer responses (SITC 2022) - "Further, AFVT-2101 is demonstrated to be more efficacious and potent in both ADCC and ADCP assays than farletuzumab, an Fc competent monoclonal antibody targeting FOLR1 which shares the same VH/VL sequence as AFVT-2101. We show that AFVT-2101 induces moderate concentration-dependent pro-inflammatory cytokine release in a target-restricted manner, confirming a potent but safe in vitro profile of AFVT-2101. Download figure Open in new tab Download powerpoint Abstract 1212 Figure 1 Structure of AFVT-2101"

Oncology • FCGR3A • FOLR1 • IFNG • TNFA

Affivant to Present Data on AFVT-2101 at 37th Annual Meeting of SITC (GlobeNewswire) - "Affivant...will present a poster at the 37th Annual Meeting of The Society for Immunotherapy of Cancer (SITC) highlighting preclinical data for AFVT-2101 (previously AFM32)....The poster shows that AFVT-2101 binds selectively to CD16A (both 158V and 158F variants). Physiological levels of competing IgG do not alter binding efficacy. AFVT-2101 induces potent and selective ADCC, even on FRα low expressing cell lines. AFVT-2101 is also shown to induce efficient ADCP in vitro."

Preclinical • Oncology