AFM11 / Affimed - LARVOL DELTA

Prevalence of adverse events following bispecific antibody therapy in non-Hodgkin lymphoma: A meta-analysis. (ASCO 2024) - "The BsAbs included mosunetuzumab (13 studies), epcoritamab (10 studies), blinatumomab (5 studies), glofitamab (5 studies), odronextamab (2 studies), and AFM11 (1 study). BsAb is associated with nontrivial rates of infections and neutropenia. The rates of high grade CRS and ICANS are low. The heterogeneity of the findings could be attributed by an underreporting of TRAE and small sample sizes from various studies."

Adverse events • Retrospective data • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Infectious Disease • Lymphoma • Mantle Cell Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • CD20

"They even might consider dropping the NK cells altogether, switch to T-cell engagers and revive AFM11" (@WielandDeHoon)

Safety of AFM11 in the treatment of patients with B-cell malignancies: findings from two phase 1 studies. (PubMed, Trials) - P1 | "AFM11 treatment was associated with frequent neurological adverse reactions that were severe in some patients. In ALL, some signs of activity, albeit short-lived, were observed whereas no activity was observed in patients with NHL; therefore, further clinical development was terminated."

Journal • P1 data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma • CD19

A Phase 1 Study Investigating AFM11 in Patients with Relapsed/Refractory B Cell Precursor Acute Lymphoblastic Leukemia: Preliminary Results (ASH 2018) - "Pts with rapidly progressing disease receive pre-treatment with 200 mg cyclophosphamide and 10 mg/m2 dexamethasone over 3-5 days before initiating AFM11. Transient neurological events were observed and were consistent with those associated with other CD19-targeted therapies. Peripheral B cell reductions and complete remissions observed in pts treated in the higher dose cohorts suggest that AFM11 is active in pts with R/R B-ALL and that the study is nearing determination of the therapeutic dose and schedule."

Clinical • P1 data • Acute Lymphocytic Leukemia • Biosimilar • Gene Therapies • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Obesity • Oncology • Pain • Primary Immunodeficiency • Transplantation

"Pretty certain Genentech didn't partner with $afmd for AFM11, so the quote from @endpts is misleading, and if so should be corrected?" (@imasmallbio)

Functionally Defective T Cells After Chemotherapy of B-Cell Malignancies Can Be Activated by the Tetravalent Bispecific CD19/CD3 Antibody AFM11. (PubMed, J Immunother) - "T cells from B-cell lymphoma patients treated with either rituximab+bendamustine (R-Benda), rituximab+CHOP (R-CHOP), or with high-dose BEAM chemotherapy (HD-BEAM) and autologous HSCT were compared with T cells from healthy donors. In conclusion, T cells from lymphoma patients are reduced in number and have functional defects following treatment with certain chemotherapy regimens, also reducing AFM11 efficacy. Importantly, AFM11 was still able to trigger B-cell-directed T-cell immunity in all treatment groups."

Journal • Acute Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

"#AFM11 itself could be worth billions" (@marketreader8)

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

"$AFMD next official 1 week of December at #ASH18 - but some maybe Nov 20 or anytime the clinical hold is lifted on AFM11" (@dhovekamp42)

Clinical

"Really my good friend? $AFMD AFM 11 & 13 aren’t based on identical TandAb proprietary technology?" (@fezziwig2008)

"Now maybe the time to detect that $AFMD "CAR-T in a vial" AFM11 might be an cost effective, dose-able, and safe alternative from the shelf" (@dhovekamp42)

HEOR • Biosimilar

AFM11: Anticipated patent expiry in 2030 (Affimed) - Q4 YE 2016 Results

Patent expiry • Oncology

Safety Study to Assess AFM11 in Patients With Relapsed or Refractory Adult B-precursor ALL (clinicaltrials.gov) - P1; N=50; Not yet recruiting; Sponsor: Affimed GmbH

New P1 trial • Acute Lymphocytic Leukemia • Biosimilar • Hematological Malignancies • Leukemia • Oncology

Affimed places AFM11 (CD19/CD3-targeting T cell engager) phase 1 program on clinical hold (GlobeNewswire) - "Affimed...today announced that it has placed AFM11 (CD19/CD3-targeting T cell engager) on clinical hold, and has notified the global health authorities of its decision. AFM11 is being evaluated in two Phase 1 clinical studies for the treatment of patients with relapsed or refractory CD19 positive B-cell non-Hodgkin lymphoma (NHL) [NCT02106091] and acute lymphoblastic leukemia (ALL) [NCT02848911]. The clinical hold was initiated after the occurrence of Serious Adverse Events (SAEs) in three patients, which included a death in the ALL study and two life-threatening events in the NHL study...Affimed will be working closely with the global health authorities, the Safety Monitoring Committees, and the studies' clinical investigators to review the events, carefully assess all of the data and determine next steps for the AFM11 program."

DSMB • Regulatory • Trial suspension • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

AFM11: Presentation of data from P1 trial (NCT02848911) for r/r ALL at ASH on December 3, 2018 (Jefferies 2018 London Healthcare Conference, Affimed)

P1 data • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

AFM11: Presentation of data from P1 trial (NCT02848911) for r/r ALL at ASH on December 3, 2018 (Jefferies 2018 London Healthcare Conference, Affimed)

P1 data • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

Affimed: Annual Report 2015 - Anticipated expiry of patents related to engineered antibody format in 2019 and 2030

Anticipated patent expiry • Oncology

Affimed: UBS Global Healthcare Conference 2016 (Affimed) - Anticipated initiation of dose escalation P1 trial in ALL in Q3 2016

Anticipated new P1 trial • Acute Lymphocytic Leukemia • Oncology

Affimed reports financial results for second quarter 2018 and operational progress [AFM11] (GlobeNewswire) - "AFM11: Affimed's two clinical Phase 1 dose escalation trials with AFM11...in patients with r/r acute lymphocytic leukemia (ALL) [NCT02848911] and with r/r non-Hodgkin lymphoma (NHL) [NCT02106091], are actively recruiting patients and dose escalation is ongoing...Affimed plans to provide an update on AFM11 at a scientific or medical conference in the fourth quarter of 2018."

Enrollment status • P1 data • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Safety Study to Assess AFM11 in Patients With Relapsed or Refractory Adult B-precursor ALL (clinicaltrials.gov) - P1; N=17; Terminated; Sponsor: Affimed GmbH; N=50 ➔ 17; Trial completion date: Nov 2019 ➔ Apr 2019; Suspended ➔ Terminated; Trial primary completion date: Nov 2019 ➔ Sep 2018; Strategic decision was made to terminate the AFM11 development

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Trial termination

"$AFMD best take so far on Affimed ditching AFM11 by @JacobPlieth" (@dhovekamp42)

"AFM11 was always a no-hoper, but $AFMD ditching all T-cell engager work hints at broader tech problems. Via @Vantageanalysis https://t.co/GiNczevvyx" (@JacobPlieth)

"$AFMD to terminate AFM11 T cell engager Phase 1 program. To focus on the development of AFM13, AFM24 and preclinical innate cell engagers." (@BioStocks)

P1 data

Safety Study to Assess AFM11 in Patients With Relapsed and/or Refractory CD19 Positive B-cell NHL (clinicaltrials.gov) - P1; N=16; Terminated; Sponsor: Affimed GmbH; N=50 ➔ 16; Trial completion date: Jul 2019 ➔ Aug 2018; Suspended ➔ Terminated; Trial primary completion date: Jun 2019 ➔ Aug 2018; Non-favorable risk/benefit profile with studied dosing regimen

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Trial termination

Affimed Company Presentation (BIO 2019) - "Lead pipeline candidates include AFM13 (CD16A/CD30 in CD30+ve lymphomas) in Ph 2, AFM24 (CD16A/EGFR) targeting IND in mid-2019, and AFM11 (CD3/CD19) in Ph 1. Affimed also has a target-based research collaboration with Roche/Genentech to discover and develop novel innate cell engagers."