On December 7, 2018 Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company committed to improving patient outcomes through the power of the innate immune system, reported its registrational pathway, updated clinical development plans and the estimated market opportunity for the Company’s lead candidate AFM13 – a first-in-class innate cell engager – at its Research & Development Day in New York City (Press release, Affimed, DEC 7, 2018, View Source [SID1234531950]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Affimed plans to initiate a Phase 2 study evaluating the safety and efficacy of AFM13 as monotherapy in relapsed or refractory peripheral T cell lymphoma (PTCL) and transformed mycosis fungoides (TMF), a subset of cutaneous T cell lymphoma (CTCL) in the first half of 2019. Based on preliminary feedback from the U.S. Food and Drug Administration (FDA) and on data presented at this week’s America Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, Affimed believes that results from an open-label, single-arm Phase 2 study could form the basis for a Biologics License Application (BLA) submission and support an accelerated approval, given the unmet medical need for safe and effective new treatments in this hard-to-treat population.
"We believe that the clinical development plan shared today for AFM13 provides potential for accelerated approval and helps to lay the groundwork for further investigations of CD16A innate immune engagers," said Dr. Adi Hoess, Affimed’s CEO. "Through our fit-for-purpose ROCK platform, we continue to generate novel engagers, like AFM13, to broaden our leadership in innate immunity. We look forward to continuing this important work to enhance current immuno-oncology approaches, with the ultimate goal of giving patients back the body’s innate ability to fight cancer."
The broader clinical development strategy for AFM13 includes expanding into other CD30-positive lymphoma indications and additional treatment lines with significant unmet need. In collaboration with strategic partners, Affimed plans to investigate AFM13 in combination with other immunotherapy agents, such as an anti-PD-1/PD-L1 antibody agent and with adoptive NK cell transfer.
"AFM13’s clinical profile to date is very encouraging," said Dr. Leila Alland, Chief Medical Officer of Affimed. "The recently presented data at ASH (Free ASH Whitepaper) increase our confidence that AFM13 holds significant therapeutic value for patients with CD30-positive lymphoma. Our team is looking forward to initiating the registrational study for AFM13 in the first half of 2019 and it is our commitment to develop this potential treatment for patients as quickly as possible."
"Our market research suggests a sizable near-term commercial opportunity for AFM13 with an estimated initial eligible population of about 2,500 patients per year with relapsed or refractory PTCL in the U.S.," said Denise Mueller, Head of Commercial Strategy and Business Development of Affimed. "We believe our clinical development plan for AFM13 combination therapies will further expand the market potential of AFM13 in CD30-positive lymphoma indications such as Hodgkin lymphoma and T cell lymphoma."
Additional Research & Development Day Program Highlights
Dr. Steven M. Horwitz, Associate Attending, Division of Hematologic Oncology, Memorial Sloan Kettering Cancer Center, presented on the current treatment landscape and unmet needs in patients with peripheral and cutaneous T cell lymphomas and Hodgkin lymphoma.
Dr. Ahmed Sawas, Assistant Professor of Medicine, Columbia University College of Physicians and Surgeons and the New York-Presbyterian Hospital, Principal Investigator of the investigator-sponsored Phase 1b/2a trial of AFM13 in CD30-positive lymphoma with cutaneous manifestation led by Columbia University Medical Center, discussed data from the study recently presented at the ASH (Free ASH Whitepaper) Annual Meeting.
Affimed reviewed the updated data from the Phase 1b study of AFM13 as a combination therapy with Merck’s anti-PD-1 antibody Keytruda (pembrolizumab) in relapsed or refractory Hodgkin lymphoma (HL) patients that was presented at the ASH (Free ASH Whitepaper) Annual Meeting.
Dr. Yago Nieto, Professor of Medicine, Department of Stem Cell Transplantation, The University of Texas MD Anderson Cancer Center, discussed data from the preclinical research of cord blood derived natural killer cells loaded with AFM13 as off-the-shelf cell therapy for CD30-positive malignancies conducted under Affimed’s sponsored research collaboration with MD Anderson. He concluded that the encouraging data observed in this study, which was featured in an oral presentation at the ASH (Free ASH Whitepaper) Annual Meeting, provide a strong rationale for clinically investigating the strategy of an off-the-shelf adoptive immunotherapy with AFM13-loaded CB-NK cells in patients with relapsed/refractory CD30+ malignancies. Dr. Nieto outlined plans to conduct a clinical study in patients with CD30-positive lymphoma.
Webcast Information
The archived webcast and slides of the presentation are available under the "News & Events" section of Affimed’s website at View Source and will be available for 30 days following the event.
About AFM13
AFM13 is a first-in-class tetravalent, bispecific NK cell engager that specifically binds to CD30 on tumor cells and to CD16A on NK cells. AFM13 is being developed in Hodgkin lymphoma (HL) and in other CD30-positive lymphomas. AFM13 has shown a favorable safety profile and signs of therapeutic efficacy in a monotherapy setting in studies in HL and CD30-positive lymphoma with cutaneous manifestation. In addition, data from a combination study of AFM13 with Merck’s anti-PD-1 antibody Keytruda (pembrolizumab) supports proof of principle for the combination of NK cell engagement with checkpoint inhibition. AFM13 has been granted orphan drug designation by the U.S. Food and Drug Administration.
About Affimed’s ROCK Platform
Affimed’s proprietary, versatile and modular ROCK (Redirected Optimized Cell Killing) platform enables the generation of first-in-class, tetravalent, multi-specific immune cell engagers. Based on its modularity, ROCK allows for antibody engineering of highly customizable innate immune cell and T cell engagers to generate clinical candidates tailored to multiple disease indications and settings, including generation of molecules against validated oncology targets to address the limitations of existing treatments of hematologic and solid tumors.