On April 9, 2021 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that positive initial clinical data from an investigator-sponsored study at The University of Texas MD Anderson Cancer Center evaluating cord blood-derived natural killer (cbNK) cells pre-complexed with Affimed’s innate cell engager (ICE) AFM13 (CD16A/CD30) (Press release, Affimed, APR 9, 2021, View Source [SID1234577785]).
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This approach was developed in the laboratory of Katy Rezvani, M.D., Ph.D., Professor of Stem Cell Transplantation and Cellular Therapy at MD Anderson, who is presenting the data as part of the Major Symposia and Advances sessions at the virtual American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. The presentation is available for viewing by registered participants through June 21, 2021. Dr. Rezvani will take part in a live panel discussion as part of the presentation on April 13, 2021 at 1:30 p.m. EDT.
"We are encouraged by the initial safety and efficacy data from this groundbreaking first in-human study. The finding of an objective response rate of 100% amongst our first four patients enrolled is impressive," said Andreas Harstrick, M.D., Chief Medical Officer of Affimed. "These initial results indicate AFM13 may have the potential to help NK cells target and destroy cancer cells. We plan to continue to develop and customize approaches that leverage the unique and differentiating features of our ICE molecules in combination with adoptive NK cell transfer to provide options for treating a variety of hematologic and solid tumors."
The open-label, non-randomized, single-center, dose-escalation trial is evaluating the pre-complexing of AFM13 with cbNK cells followed by three weekly infusions of AFM13 monotherapy in adult patients with recurrent/refractory CD30-positive lymphomas. The trial is led by Yago Nieto, M.D., Ph.D., Professor of Stem Cell Transplantation and Cellular Therapy at MD Anderson.
"There remains a high unmet need for effective treatments in relapsed/refractory (R/R) CD30+ lymphomas. We are encouraged by the data generated from the first patients treated with cbNK cells pre-complexed with AFM13," said Dr. Rezvani. "The results suggest this combination is facilitating clinical responses with minimal toxicity, warranting further study as we continue to explore novel cell therapies for our patients."
LOGO
As of March 31, 2021, three patients have been dosed with two cycles of therapy in dose cohort 1 (1×106 AFM13-cbNK/kg) and one patient has received a single cycle of therapy in dose cohort 2 (1×107 AFM13-cbNK/kg). The study is currently enrolling patients in the second dose cohort of NK cells, and further updates are expected later in 2021. Results from the first cycle of the first dose cohort are being presented by Dr. Rezvani at AACR (Free AACR Whitepaper), and Affimed is supplementing the data with best responses as of March 31, 2021, as summarized below.
Patient
number
cbNK Cell
Dose
Patient
Cancer Type
Prior Treatment
CRS/
Neurotoxicity/
GVHD
Best Response
Cohort 1 – completed
#1 1×106 / kg 43-year-old-male Hodgkin lymphoma 4 lines of therapy (ABVD, ICE, brentuximab vedotin, nivolumab + ruxolitinib) None Partial response
#2 1×106 / kg 31-year-old-male Hodgkin lymphoma 14 lines of therapy (ABVD, brentuximab vedotin, HDACi/P13Ki, pembrolizumab, nivolumab, allo-HSCT, hypercytoxan, ibrutinib, niraparib, bendamustine, everolimus) None Partial response
#3 1×106 / kg 53-year-old-female Hodgkin lymphoma 5 lines of therapy (ABVD, ICE, brentuximab vedotin, nivolumab, GemOx) None Complete response after cycle 2
Cohort 2 – ongoing (1 of 3 patients enrolled)
#4 1×107 / kg 26-year-old-male Hodgkin lymphoma 9 lines of therapy (ABVD, ICE + brentuximab vedotin, radiation, nivolumab, CD30-CART, TTI-622, brentuximab vedotin + bendamustine, allo-HSCT, brentuximab vedotin + bendamustine with brentuximab vedotin maintenance) None Complete response
ABVD = Adriamycin (doxorubicin), Bleomycin, Vinblastine, Dacarbazine (DTIC)
ICE = chemotherapy combination includes the drugs: ifosfamide, carboplatin, & etoposide phosphate
GemOx= gemcitabine, oxaliplatin
There were no observed events of cytokine release syndrome, neurotoxicity syndrome or graft-versus-host disease.
Response evaluation followed the Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC). All four patients had relapsed/refractory Hodgkin Lymphoma and were heavily pretreated, with between 4 and 14 previous lines of therapy which in all cases included brentuximab vedotin (Adcetris) and anti-PD1 antibodies. Of note, patient #4 had also previously received a CD30-CAR-T.
Conference Call/Webcast Details
Affimed will host a conference call and webcast on April 14, 2021, at 4:05 p.m. EDT to discuss the initial study findings. The conference call will be available via phone and webcast. To access the call, please dial +1 (646) 741-3167 for U.S. callers, or +44 (0) 2071 928338 for international callers, and reference passcode 1788338 approximately 15 minutes prior to the call.
A live audio webcast of the conference call will be available in the "Webcasts" section on the "Investors" page of the Affimed website at View Source A replay of the webcast will be accessible at the same link for 30 days following the call.
About the Phase 1 Study
The University of Texas MD Anderson Cancer Center is studying AFM13 in an investigator-sponsored Phase 1 trial in combination with cord blood-derived allogeneic NK cells in patients with recurrent or refractory CD30-positive lymphomas. The study is a dose-escalation trial of pre-complexed NK cells, with patients receiving 1×106 NK cells/kg in Cohort 1; 1×107 NK cells/kg in Cohort 2; and, 1×108 NK cells/kg in Cohort 3. The trial is designed to explore safety and activity and determine the recommended Phase 2 dose. In each cohort, the dose of the pre-complexed NK cells with AFM13 is to be followed by weekly doses of 200 mg AFM13 monotherapy for three weeks, with each patient evaluated for dose-limiting toxicities and responses on day 28.
MD Anderson has an institutional financial conflict of interest with Affimed related to this research and has therefore implemented an Institutional Conflict of Interest Management and Monitoring Plan.
Additional information about the study can be found at www.clinicaltrials.gov (NCT04074746).
About AFM13
AFM13 is a first-in-class innate cell engager (ICE) that uniquely activates the innate immune system to destroy CD30-positive hematologic tumors. AFM13 induces specific and selective killing of CD30-positive tumor cells, leveraging the power of the innate immune system by engaging and activating natural killer (NK) cells and macrophages. AFM13 is Affimed’s most advanced ICE clinical program and is currently being evaluated as a monotherapy in a registration-directed trial in patients with relapsed/refractory peripheral T-cell lymphoma or transformed mycosis fungoides (REDIRECT). The study is actively recruiting, and additional details can be found at www.clinicaltrials.gov (NCT04101331).