RO7297089 / Affimed, Roche - LARVOL DELTA

Phase I Study of Safety and Pharmacokinetics of RO7297089, an Anti-BCMA/CD16a Bispecific Antibody, in Patients with Relapsed, Refractory Multiple Myeloma. (PubMed, Clin Hematol Int) - P1 | "RO7297089 was well tolerated at doses up to 1850 mg, and the efficacy data supported activity of RO7297089 in multiple myeloma. Combination with other agents may further enhance its potential as an innate immune cell engager in multiple myeloma."

Journal • P1 data • PK/PD data • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Oncology • Thrombocytopenia • FCGR3A

"Strategy is combo’ing RO7297089 with fresh NK cells $AFMD" (@Biotech777)

A Phase I Study of RO7297089, a B‑Cell Maturation Antigen (BCMA)-CD16a Bispecific Antibody in Patients with Relapsed/Refractory Multiple Myeloma (RRMM) (ASH 2021) - P1 | "Treatment with RO7297089 was well-tolerated at the dose levels tested, although infusion reactions necessitated long infusion duration for the first dose. Modest activity has been observed to date with doses up to 1080 mg. There were no DLTs and a recommended phase 2 dose has not been identified."

Clinical • IO biomarker • P1 data • Anemia • Back Pain • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Musculoskeletal Pain • Oncology • Pain • Pulmonary Disease • Thrombocytopenia • CRP • FCGR3A

Nonclinical Pharmacokinetics, Pharmacodynamics, and Translational Model of RO7297089, A Novel Anti-BCMA/CD16A Bispecific Tetravalent Antibody for the Treatment of Multiple Myeloma. (PubMed, AAPS J) - "Based on model simulations, we propose more frequent dosing of RO7297089 compared to regular monthly frequency in the clinic at the beginning of treatment to ensure sustained target engagement. This study demonstrates a translational research strategy for collecting relevant nonclinical data, establishing a TMDD model, and using simulations from this model to inform clinical dose regimens."

IO biomarker • Journal • PK/PD data • Hematological Malignancies • Multiple Myeloma • Oncology • FCGR3A

GO41582: A Study Evaluating The Safety And Pharmacokinetics Of Escalating Doses Of RO7297089 In Patients With Relapsed Or Refractory Multiple Myeloma (clinicaltrials.gov) - P1 | N=27 | Completed | Sponsor: Genentech, Inc. | Active, not recruiting ➔ Completed | N=80 ➔ 27

Enrollment change • Trial completion • Hematological Malignancies • Multiple Myeloma • Oncology

GO41582: A Study Evaluating The Safety And Pharmacokinetics Of Escalating Doses Of RO7297089 In Patients With Relapsed Or Refractory Multiple Myeloma (clinicaltrials.gov) - P1 | N=80 | Active, not recruiting | Sponsor: Genentech, Inc. | Trial completion date: May 2023 ➔ Feb 2022 | Trial primary completion date: May 2023 ➔ Jan 2022

Trial completion date • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

A BCMA/CD16A bispecific innate cell engager for the treatment of multiple myeloma. (PubMed, Leukemia) - "Preclinical toxicology data suggested a favorable safety profile as in vitro cytokine release was minimal and no RO7297089-related mortalities or adverse events were observed in cynomolgus monkeys. These data suggest good tolerability and the potential of RO7297089 to be a novel effective treatment of MM patients."

IO biomarker • Journal • Hematological Malignancies • Multiple Myeloma • Oncology • FCGR3A

""Genentech decided to stop the phase 1 study of RO7297089". maybe they just paused it?" (@maddstone1)

P1 data

A Study Evaluating The Safety And Pharmacokinetics Of Escalating Doses Of RO7297089 In Patients With Relapsed Or Refractory Multiple Myeloma (clinicaltrials.gov) - P1; N=80; Recruiting; Sponsor: Genentech, Inc.; Active, not recruiting ➔ Recruiting

Clinical • Enrollment open • Hematological Malignancies • Multiple Myeloma • Oncology

A Study Evaluating The Safety And Pharmacokinetics Of Escalating Doses Of RO7297089 In Patients With Relapsed Or Refractory Multiple Myeloma (clinicaltrials.gov) - P1; N=80; Active, not recruiting; Sponsor: Genentech, Inc.; Recruiting ➔ Active, not recruiting

Enrollment closed • Hematological Malignancies • Multiple Myeloma • Oncology

"Do you see Roche trying to comboing AFM26 with cbNK cells?" (@8thKingofRome)

"RG6296 = AFM26 ex $AFMD RG6247 = 4D-110 ex $FDMT 4DMT/4D-125 also ex $FDMT $RHHBY" (@JacobPlieth)

"$AFMD sechs wichtige Monate unterwegs. Es ist Zeit, die Asse fallen zu lassen und sich einen Namen zu machen! #ASCO21 #ASH2021 #AFM24 #AFM26 #Roche #Genentech #RockICE #AFM28 #AFM32 #NEWDEAL" (@WWokna)

Affimed announces oral presentation and five poster presentations at the 2018 American Society of Hematology Annual Meeting (GlobeNewswire) - "Presentations...include 6-month follow-up data from the clinical study of AFM13...in combination with Merck's Keytruda® (pembrolizumab), interim data from Columbia University on AFM13 in relapsed or refractory CD30-positive lymphoma with cutaneous manifestation including translational data, and preclinical data from The University of Texas MD Anderson Cancer Center on cord blood-derived allogeneic NK cells in combination with AFM13. Additional abstracts...include updates on the...role of AFM13 activating CD16A expressing macrophages to eliminate tumor cells, as well as preclinical data supporting further development of Affimed's partnered ROCK®-based development candidate AFM26 (BCMA/CD16A) as a promising treatment for patients with multiple myeloma...Preliminary results, including clinical activity and safety, from a dose escalation trial in relapsed/refractory acute lymphoblastic leukemia for AFM11...will also be presented."

Clinical data • Preclinical • Hematological Malignancies • Lymphoma • Multiple Myeloma • Oncology

"Preclinical Characterization of #AFM26, a Novel B Cell Maturation Antigen (#BCMA)-Directed Tetravalent Bispecific Antibody for High Affinity Retargeting of NK Cells Against Myeloma https://t.co/iRKyD5knXy. $AFMD #ASH18" (@portefeuillefun)

Bispecific • Preclinical • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Oncology

"#AFM26" (@MadsDegnbol)

"Genentech IMO is very restrictive to even not allow $AFMD #AFM26 (BCMA) 2b confirmed under the contract 4 good reason https://t.co/vsc04V8dDS" (@dhovekamp42)