The preliminary results from the phase 2 study investigating AFM24 in combination with the checkpoint inhibitor atezolizumab in patients with EGFR wild-type non-small cell lung cancer have been accepted for poster presentation MANNHEIM, Germany, April 24, 2024 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today... Read More

AFM24 combination with atezolizumab (AFM24-102): Follow-up of the Phase 1/2a combination study confirmed four responses in the non-small cell cancer (NSCLC) EGFR -wildtype cohort: one complete response (CR), three partial responses (PR), and seven stable disease patients in the 15 heavily pretreated patients who were evaluated. Mature progression free survival (PFS) data from the 15 EGFR -wildtype NSCLC patients and initial... Read More

MANNHEIM, Germany, March 21, 2024 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD) (“Affimed” or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, announced today that it will release full year 2023 results and corporate update on March 28, 2024. The Company will host a conference call at 8:30 a.m. EDT / 13:30 CET. The conference call will be... Read More

MANNHEIM, Germany, March 06, 2024 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD) (“Affimed” or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, announced that the Company, with prior approval of the Company’s supervisory board and management board, intends to effect a 1-for-10 reverse stock split of its outstanding common shares, par value €0.01... Read More

Data update from AFM24-102 Phase 1/2a combination study includes 15 heavily pre-treated patients from the EGFR- wildtype (wt) non-small cell lung cancer (NSCLC) expansion cohort Follow-up shows three of the initially reported responses have now been confirmed (1 CR, 2 PR) and one still awaiting a confirmatory scan Study to be expanded to a total of 40 EGFR wt NSCLC patients Enrollment in the EGFR- mutant (mut) NSCLC cohort... Read More

Dr. Adi Hoess to step down as CEO and Management Board Member Dr. Andreas Harstrick appointed Interim CEO Strategic restructuring reducing headcount by up to 50%, extending cash runway into H2 2025 Go forward organization will focus on advancing clinical programs Company confirms guidance on data readouts for AFM24-102 and LuminICE-203 in H1 2024 MANNHEIM, Germany, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq:... Read More

MANNHEIM, Germany, Jan. 03, 2024 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD) (“Affimed” or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced that it has reached a definitive agreement to sell its wholly-owned subsidiary, AbCheck s.r.o., to Ampersand Biomedicines. Under the terms of the agreement, Ampersand Biomedicines will... Read More

Data update from AFM24-102 Phase 1/2a combination study includes 15 heavily pre-treated patients from the EGFR-wildtype non-small cell lung cancer (NSCLC) expansion cohort Responses observed in 4 of 15 patients, including 1 confirmed partial response (PR), 1 unconfirmed complete response (CR) awaiting confirmation, 2 unconfirmed PRs awaiting confirmation; an additional 7 of 15 patients exhibiting stable disease (SD) leading... Read More

In 32 patients with relapsed/refractory (r/r) Hodgkin lymphoma (HL) treated at the recommended phase 2 dose level (RP2D), the objective response rate (ORR) was 97% and the complete response (CR) rate was 78% In this cohort median EFS was 9.8 months with 84% patients alive at 12 months, and median duration of response (DoR) was 8.8 months Patients were heavily pretreated (median of 7 prior lines), all had previously received... Read More

Review clinical data of acimtamig in combination with cord-blood derived NK cells presented at ASH 2023; provide progress update on the LuminICE-203 Review clinical data for AFM24 in solid tumors Conference call/webcast on Monday, December 11, 2023 at 1:30 p.m. PST / 4:30 p.m. EST / 22:30 CET MANNHEIM, Germany, Dec. 04, 2023 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD) (“Affimed”, or the “Company”), a clinical-stage... Read More

Acimtamig (also known as AFM13) combination with AlloNK ® (also known as AB-101): Initiated LuminICE-203. Company on track to report initial data in H1 2024. Acimtamig: Received fast-track designation for the combination of acimtamig and AlloNK ® . LuminICE-203: Received encouraging feedback from the FDA on Type C meeting. AFM13-104: Oral presentation of updated data of acimtamig in combination with cord blood-derived NK... Read More

MANNHEIM, Germany, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD) (“Affimed” or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced that the International Nonproprietary Names (INN) Expert Committee of the World Health Organization (WHO) has selected "acimtamig" for the nonproprietary name of the Company’s... Read More

MANNHEIM, Germany, Nov. 07, 2023 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, announced today that it will release third quarter 2023 results and corporate update on Tuesday, November 14, 2023. The Company will host a conference call at 8:30 a.m. EST / 14:30 CET. The conference call will be available via phone... Read More

Addition of Affimed’s innate cell engager (ICE ® ) improves cytotoxicity of natural killer (NK) cells and CAR-NK cells NK cells with ICE ® show at least comparable anti-tumor cell efficacy to CAR-NK cells with ICE ® ICE ® combined with NK cells obviate the need for complex and costly manufacturing compared to CAR-NK cells ICE ® offer flexibility to be used with NK cells from different sources MANNHEIM, Germany, Nov. 03, 2023... Read More

In 36 patients with CD30-positive lymphoma treated at the recommended Phase 2 dose level (RP2D), the combination treatment of AFM13 with allogeneic NK cells shows a 94.4% objective response rate and a 72.2% complete response rate as of the July 2023 cut-off date for data included in the abstract Patients were heavily pretreated (median of 7 prior lines) and refractory to their most recent line of therapy Patients received up... Read More

MANNHEIM, Germany, Nov. 01, 2023 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD) (“Affimed” or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced that the Company’s management will participate in the following investor conferences during the month of November 2023. Truist Securities BioPharma Symposium (November 8-9, 2023) Date:... Read More

MANNHEIM, Germany, Oct. 04, 2023 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD) (“Affimed”, or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, announced today that it has received approval from the Listing Qualifications Department of the Nasdaq Stock Market (“Nasdaq”) to transfer the listing of its shares from the Nasdaq Global Market to the... Read More

MANNHEIM, Germany, Sept. 27, 2023 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD) (“Affimed”, or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced that an abstract with a comparison of NK cell redirected by the Company’s innate cell engagers (ICE ® ) versus CAR-NK cells has been accepted for poster presentation at the 38th Annual... Read More

MANNHEIM, Germany, Sept. 21, 2023 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD) (“Affimed”, or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, announced today that its Chief Financial Officer, Angus Smith, will participate in a fireside chat at the Cantor Global Healthcare Conference 2023 on Thursday, September 28, 2023 at 1:15 p.m. Eastern... Read More

AFM13 in combination with AlloNK® (also known as AB-101) will be investigated in the LuminICE-203 open-label, multi-center, multi-cohort, phase 2 study evaluating the efficacy and safety of the treatment in patients with relapsed/refractory Hodgkin lymphoma The FDA’s fast track designation is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet... Read More

HEIDELBERG, Germany, Sept. 07, 2023 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, announced today that its Chief Executive Officer, Dr. Adi Hoess, will present at the H.C. Wainwright 25 th Annual Global Investment Conference on Tuesday, September 12, 2023 at 11:00 a.m. Eastern Daylight Time / 17:00 Central... Read More

By coupling the chromatography method FcRn-HPLC to a pH monitor, an optimized FcRn-pH-HPLC methodology was developed allowing correlation of antibodies’ serum half-life with FcRn column dissociation pH Leveraging the full potential of FcRn-pH-HPLC enables Affimed an early selection of innate cell engagers (ICE ® ) with tailored pharmacokinetic (PK) profiles and to thereby develop drug candidates with optimal developability,... Read More

AFM13 combination with AB-101 NK cells (LuminICE-203): On track to report initial efficacy and safety data in the first half 2024; Type C meeting request submitted to FDA to clarify requirements for accelerated approval. AFM24 monotherapy: Clinical activity in 7 out of 15 heavily pretreated patients with EGFRmut non-small cell lung cancer (NSCLC), including 2 confirmed partial responses. AFM24 combinations: Affimed plans to... Read More

HEIDELBERG, Germany, Aug. 03, 2023 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, announced today that it will release second quarter 2023 results and corporate update on Thursday, August 10, 2023. The Company will host a conference call at 8:30 a.m. EDT / 14:30 CET. The conference call will be available via... Read More

Stable disease was observed in three out of seven heavily pretreated patients No dose-limiting toxicities or unexpected toxicities were observed HEIDELBERG, Germany, July 31, 2023 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD) (“Affimed”, or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced that an abstract with clinical trial... Read More

HEIDELBERG, Germany, June 22, 2023 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD) (“Affimed”, or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced the appointment of Dr. Constanze Ulmer-Eilfort to its Supervisory Board. Dr. Ulmer-Eilfort’s appointment was approved during the Annual General Meeting of Shareholders which took place... Read More

A pre-clinical data set of AFM13 in combination with Artiva Biotherapeutics Inc.’s allogeneic NK cell AB-101 shows that AFM13 enhances the cytotoxic activity of AB-101 against tumor cells and has been accepted for poster presentation An encore oral presentation will share the safety and efficacy results from the phase 2 REDIRECT study, investigating AFM13 monotherapy in patients with CD30-positive relapsed or refractory... Read More

Data update from AFM24-101 phase 1/2 monotherapy study includes 15 patients from the EGFR mutant non-small cell lung cancer (NSCLC) cohort AFM24 showed clinical activity in 7 out of 15 heavily pre-treated patients with tumor reductions, including 2 confirmed partial responses and 5 patients exhibiting stable disease In line with previous results, the majority of patients experienced only mild to moderate treatment-related... Read More

HEIDELBERG, Germany, May 30, 2023 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD) (“Affimed”, or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, announced today that its Chief Executive Officer, Dr. Adi Hoess, will present at the 2023 Jefferies Healthcare Conference on Wednesday, June 7, 2023 at 8:30 a.m. Eastern Daylight Time / 14:30 Central... Read More

AFM24-101 phase 1/2 results in 10 patients from the non-small cell lung cancer (NSCLC) cohort demonstrated clinical activity and a well-managed safety profile in heavily pretreated patients with EGFR mutant NSCLC; updated interim analysis data of 15 patients from the NSCLC cohort will be presented at ASCO on June 3, 2023 AFM24-101 phase 1/2 interim results from the colorectal cancer (CRC) cohort show AFM24 was well tolerated... Read More

AFM13 combination with AB-101 NK cells: Received IND clearance from the FDA for a phase 2 clinical trial investigating the combination therapy in relapsed/refractory (r/r) classical Hodgkin Lymphoma (cHL) and peripheral T Cell Lymphoma (PTCL). Affimed expects to initiate clinical trial in Q3 2023 and report initial data in H1 2024 AFM24 monotherapy: Data from non-small cell lung cancer (NSCLC) expansion cohort accepted for... Read More

Phase 2 combination study of AFM13 with AB-101 in relapsed or refractory (r/r) classical Hodgkin Lymphoma (cHL) will be an open-label, multi-center, multi-cohort study with a safety run-in followed by dose optimization and expansion phase Primary endpoints of the study are to assess the antitumor activity by objective response rate (ORR) including complete responses (CR) and partial responses (PR) Secondary endpoints of the... Read More

HEIDELBERG, Germany, May 22, 2023 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD) (“Affimed” or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, announced today that its 2023 Annual General Meeting of Shareholders (the “Annual Meeting”) will be held on June 21, 2023 at 14:00 CET at the NH Collection Amsterdam Barbizon Palace, Prins Hendrikkade... Read More

HEIDELBERG, Germany, May 16, 2023 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, announced today that it will release first quarter 2023 results and corporate update on Tuesday, May 23, 2023. The Company will host a conference call at 8:30 a.m. EDT / 14:30 CET. The conference call will be available via phone and... Read More

A post-hoc subgroup analysis from the AFM13 REDIRECT study in patients with relapsed/refractory (r/r) peripheral T cell lymphoma (PTCL) is accepted as a poster presentation A trial in progress abstract of the phase 1 dose escalation study to assess safety and tolerability of AFM28 monotherapy in patients with r/r CD123-positive acute myeloid leukemia (AML) is accepted for online publication HEIDELBERG, Germany, May 11, 2023... Read More

AFM24-101 phase 1/2 interim results from the non-small cell lung cancer cohort accepted for poster presentation AFM24-101 phase1/2 interim results from the colorectal cancer cohort accepted for online publication HEIDELBERG, Germany, April 26, 2023 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced... Read More

The poster presentation highlights the relevance of CD16A shedding for serial killing by AFM13-engaged natural killer (NK) cells It demonstrates the potential of AFM13 to induce serial killing, even in tumor cells with low target expression HEIDELBERG, Germany, April 17, 2023 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to... Read More

AFM13 demonstrated robust activity on the primary end point with an objective response rate (ORR) of 32.4% and 10.2% complete response rate (CR) in Intent to Treat (ITT) population Patients with Angioimmunoblastic T cell lymphoma (AITL), one of the most frequent subtypes of peripheral T Cell Lymphoma (PTCL), exhibited the highest ORR (53.3%) and CR (26.7%) Other measures of efficacy included median duration of response (DoR)... Read More

HEIDELBERG, Germany, April 06, 2023 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, announced today that it has received a written notice (the “Notice”), dated April 4, 2023, from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) indicating that, for the last thirty consecutive... Read More

HEIDELBERG, Germany, March 29, 2023 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, announced today that the first patient was dosed in a phase 1 multicenter, open label, first-in-human dose escalation study of the innate cell engager (ICE ® ) AFM28 monotherapy in patients with CD123-positive relapsed/refractory... Read More

AFM13 combination with AB-101 NK cells: On track for IND filing in H1 2023 and initiation of clinical study in 2023 AFM13 monotherapy REDIRECT data: Oral presentation at the AACR annual meeting AFM24: Data from the three ongoing studies expected to be presented at scientific conferences in Q2 or Q3 of 2023 AFM28: Clinical phase 1 study is open and recruiting; clinical trial applications now approved in four European... Read More

HEIDELBERG, Germany, March 16, 2023 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, announced today that it will release full year 2022 results and corporate update on Thursday, March 23, 2023. The Company will host a conference call at 8:30 a.m. EDT / 13:30 CET. The conference call will be available via phone... Read More

An oral presentation on the safety and efficacy from the AFM13 phase 2 monotherapy clinical study (“REDIRECT”) in patients with CD30-positive relapsed or refractory (R/R) peripheral T-cell lymphoma (PTCL) A poster presentation from the collaboration with Prof. Björn Önfelt at the KTH Royal Institute of Technology and Karolinska Institute in Stockholm with findings from the study investigating the impact of CD16A shedding on... Read More

PLZEN, Czech Republic, March 09, 2023 (GLOBE NEWSWIRE) -- AbCheck s.r.o. , a technology company delivering disruptive antibody discovery and development solutions for challenging targets, announced today that it has successfully completed the technology development activities specified under the terms of its research grant entitled “Research and development of a unique biotechnology for the isolation of antibodies with a... Read More

HEIDELBERG, Germany, Feb. 22, 2023 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, announced today its Chief Executive Officer, Dr. Adi Hoess, will participate in a fireside chat at the H.C. Wainwright Cell Therapy Conference on Tuesday, February 28, 2023, at 8:30 a.m. EST / 14:30 CET. A live webcast of the... Read More

PLZEN, Czech Republic, Feb. 21, 2023 (GLOBE NEWSWIRE) -- AbCheck s.r.o ., a technology company delivering disruptive antibody discovery and development solutions for challenging targets, announced today that it has entered into a collaboration with a biotech company developing antibodies targeting peripheral neural response, funded by a top-tier European Venture Capital firm. Under the terms of the agreement, AbCheck will... Read More

HEIDELBERG, Germany, Feb. 08, 2023 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, announced today its Chief Executive Officer, Dr. Adi Hoess, will present at the SVB Securities 2023 Global Biopharma Conference on Tuesday, February 14, 2023 at 2:20 p.m. EST / 20:20 CET. A live webcast of the presentation will be... Read More

AFM13 combination with Artiva’s AB-101 NK cells: Received written feedback to pre-investigational new drug (IND) meeting request which supports plan for IND filing in H1 2023 and initiation of clinical study during 2023 AFM24: Data updates from the three AFM24 ongoing studies are expected at scientific conferences in Q2/Q3 2023 AFM28: Clinical trial application (CTA) cleared in France and Spain with additional filings in... Read More

AFM28 monotherapy receives authorization of a Clinical Trial Application (CTA) for the phase 1 study by the French National Agency for the Safety of Medicines and Health Products (ANSM) Initiation of AFM28 clinical development in the first half of 2023 on track HEIDELBERG, Germany, Dec. 22, 2022 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD) (“Affimed”, or the “Company”), a clinical-stage immuno-oncology company committed... Read More

AFM28 efficiently directs allogeneic NK cells to CD123-positive leukemic cells, including leukemic stem and progenitor cells, inducing their depletion in samples of patients with Acute Myeloid Leukemia (AML) and myelodysplastic syndrome (MDS) Leukemia cell lysis was independent of differences in CD123 expression levels and mutational status suggesting broad activity of AFM28-redirected NK cells and the potential for deep... Read More

Data from REDIRECT establish that AFM13 monotherapy is effective in the treatment of relapsed/refractory peripheral T cell lymphoma (r/r PTCL) patients with a differentiated safety profile AFM13 demonstrated robust activity on the primary end point with an objective response rate (ORR) of 32.4% Other measures of efficacy included median duration of response (DoR) of 2.3 months, median progression free survival (PFS) of 3.5... Read More