Monday, October 08, 2018 4:17:10 PM
GLOBENEWSWIRE 4:15 PM ET 10/8/2018
Symbol Last Price Change
AFMD 4.63up +0.45 (+10.77%)
QUOTES AS OF 04:00:00 PM ET 10/08/2018
Heidelberg, Germany, October 8, 2018 - Affimed N.V. (AFMD) , a clinical stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies that harness the power of innate and adaptive immunity (NK and T cells), 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) and acute lymphoblastic leukemia (ALL). 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.
The SAEs occurred in patients enrolled in the highest dose cohorts of each study. Thirty-three patients have been treated in total in the two Phase 1 studies, with preliminary signs of clinical activity observed in several patients.
Affimed (AFMD) 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. Affimed(AFMD) intends to provide an update on AFM11 upon completion of the evaluation.
The clinical hold does not affect the ongoing development of Affimed's(AFMD) NK cell engager programs, which are based on targeting the NK cell receptor CD16A, a different approach than used for AFM11, which targets T cells through CD3.
About Affimed N.V.(AFMD)
Affimed (AFMD) engineers targeted immunotherapies, seeking to cure patients by harnessing the power of innate and adaptive immunity (NK and T cells). We are developing single and combination therapies to treat cancers and other life-threatening diseases. For more information, please visit www.affimed.com.
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as "anticipate," "believe," "could," "estimate," "expect," "goal," "intend," "look forward to", "may," "plan," "potential," "predict," "project," "should," "will," "would" and similar expressions. Forward-looking statements appear in a number of places throughout this release and include statements regarding our intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, the value of our ROCK® platform, our ongoing and planned preclinical development and clinical trials, our collaborations and development of our products in combination with other therapies, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates, our intellectual property position, our collaboration activities, our ability to develop commercial functions, expectations regarding clinical trial data, our results of operations, cash needs, financial condition, liquidity, prospects, future transactions, growth and strategies, the industry in which we operate, the trends that may affect the industry or us and the risks, uncertainties and other factors described under the heading "Risk Factors" in Affimed's(AFMD) filings with the Securities and Exchange Commission. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future.
Affimed Investor Contact:
Gregory Gin, Head of Investor Relations
E-Mail: IR@affimed.com
Affimed Media Contact:
Anca Alexandru, Head of Communications, EU IR
E-Mail: media@affimed.com
Image: Affimed(AFMD) logo.jpg
Source: Affimed N.V.(AFMD)
2018 GlobeNewswire, Inc.
" Money talks and bullshit walks "
Recent AFMD News
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 09/11/2024 11:41:27 AM
- Affimed to Present at the Cantor Global Healthcare Conference 2024 • GlobeNewswire Inc. • 09/10/2024 10:30:00 AM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 09/05/2024 10:36:26 AM
- Affimed Reports Second Quarter 2024 Financial Results & Business Update • GlobeNewswire Inc. • 09/05/2024 10:30:00 AM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 09/03/2024 12:03:56 PM
- Affimed Appoints Shawn M. Leland as Chief Executive Officer • GlobeNewswire Inc. • 09/03/2024 11:45:00 AM
- Affimed to Report Second Quarter 2024 Financial Results & Corporate Update on September 5, 2024 • GlobeNewswire Inc. • 08/29/2024 10:30:00 AM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 06/12/2024 11:56:26 AM
- U.S. Futures Rise on Fed Decision; Oil Gains on Demand Forecasts • IH Market News • 06/12/2024 11:13:28 AM
- Affimed Reports First Quarter 2024 Financial Results & Business Update • GlobeNewswire Inc. • 06/12/2024 10:30:00 AM
- Form 6-K/A - Report of foreign issuer [Rules 13a-16 and 15d-16]: [Amend] • Edgar (US Regulatory) • 06/06/2024 09:13:58 PM
- Affimed to Report First Quarter 2024 Financial Results & Corporate Update on June 12, 2024 • GlobeNewswire Inc. • 06/05/2024 10:30:00 AM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 06/03/2024 10:04:57 AM
- Affimed Provides Follow-up Data of AFM24 plus Atezolizumab Showing Durable Responses in Heavily Pretreated NSCLC EGFR Wild-type Patients and Positive Initial Data from the NSCLC EGFR Mutant Cohort • GlobeNewswire Inc. • 06/01/2024 05:02:00 PM
- Affimed Receives Fast Track Designation for Combination Therapy of AFM24 with Atezolizumab for EGFR Wild-Type Non-Small Cell Lung Cancer • GlobeNewswire Inc. • 05/29/2024 10:30:00 AM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 05/28/2024 10:51:29 AM
- Affimed Announces Annual General Meeting of Shareholders • GlobeNewswire Inc. • 05/28/2024 10:30:00 AM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 05/23/2024 09:22:59 PM
- Affimed Announces Positive Early Efficacy and Progression Free Survival Results of AFM24-102 Study in EGFR Wild-Type Non-Small Cell Lung Cancer at the Annual Meeting of the American Society of Clinical Oncology 2024 • GlobeNewswire Inc. • 05/23/2024 09:05:00 PM
- Affimed Announces Acceptance of an Abstract on Preclinical Data of its Innate Cell Engager AFM28 at the European Hematology Association 2024 Congress • GlobeNewswire Inc. • 05/14/2024 02:05:00 PM
- Affimed Announces Acceptance of AFM24 Clinical Abstract at the 2024 Annual Meeting of the American Society of Clinical Oncology • GlobeNewswire Inc. • 04/24/2024 08:05:00 AM
- Affimed Reports 2023 Financial Results and Operational Progress • GlobeNewswire Inc. • 03/28/2024 10:30:00 AM
- Affimed To Report Full Year 2023 Financial Results & Corporate Update on March 28, 2024 • GlobeNewswire Inc. • 03/21/2024 10:30:00 AM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 03/11/2024 08:05:48 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 03/06/2024 11:34:50 AM
FEATURED Element79 Gold Corp. Appoints Kevin Arias as Advisor to the Board of Directors, Strengthening Strategic Leadership • Sep 18, 2024 10:29 AM
Mawson Finland Limited Further Expands the Known Mineralized Zones at Rajapalot: Palokas step-out drills 7 metres @ 9.1 g/t gold & 706 ppm cobalt • MFL • Sep 17, 2024 9:02 AM
PickleJar Announces Integration With OptCulture to Deliver Holistic Fan Experiences at Venue Point of Sale • PKLE • Sep 17, 2024 8:00 AM
North Bay Resources Announces Mt. Vernon Gold Mine Bulk Sample, Sierra County, California • NBRI • Sep 11, 2024 9:15 AM
One World Products Issues Shareholder Update Letter • OWPC • Sep 11, 2024 7:27 AM
Kona Gold Beverage Inc. Reports $1.225 Million in Revenue and $133,000 Net Profit for the Quarter • KGKG • Sep 10, 2024 1:30 PM