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Affimed N.V.(NasdaqGM:AFMD) added to Russell 2000 Value Index

2022-06-24 00:00:00

Affimed N.V.(NasdaqGM:AFMD) added to Russell 2000 Value Index

Affimed N.V.(NasdaqGM:AFMD) added to Russell 3000 Value Index

2022-06-24 00:00:00

Affimed N.V.(NasdaqGM:AFMD) added to Russell 3000 Value Index

Affimed N.V.(NasdaqGM:AFMD) added to Russell 2500 Value Index

2022-06-24 00:00:00

Affimed N.V.(NasdaqGM:AFMD) added to Russell 2500 Value Index

Affimed N.V.(NasdaqGM:AFMD) added to Russell Small Cap Comp Value Index

2022-06-24 00:00:00

Affimed N.V.(NasdaqGM:AFMD) added to Russell Small Cap Comp Value Index

Affimed N.V.(NasdaqGM:AFMD) added to Russell Microcap Value Index

2022-06-24 00:00:00

Affimed N.V.(NasdaqGM:AFMD) added to Russell Microcap Value Index

Affimed N.V.(NasdaqGM:AFMD) added to Russell 3000E Value Index

2022-06-24 00:00:00

Affimed N.V.(NasdaqGM:AFMD) added to Russell 3000E Value Index

Affimed Presents Preclinical Data of Novel Innate Cell Engager AFM28 at the Annual Meeting of the European Hematology Association (EHA)

2022-06-10 14:31:00

Affimed N.V. presented a poster at the Annual Meeting of the European Hematology Association (EHA) in Vienna, Austria. The data demonstrate the cytotoxic potential of the CD123/CD16A-targeting bispecific innate cell engager (ICE®) AFM28 which is in development as a novel treatment for patients with myeloid diseases, e.g. relapsed/refractory (R/R) acute myeloid leukemia (AML). AFM28 binds to natural killer (NK) cells and CD123-positive tumor cells and demonstrated the induction of tumor cell killing in vitro and a good tolerability and strong anti-tumor activity in vivo. The data presented at EHA provide validation of the mechanism of action (MoA) as well as preclinical proof-of-concept for AFM28 in a range of in vitro and in vivo assays. AFM28 exhibited high-affinity binding to CD16A expressed on NK cells and high avidity conferring long cell surface retention in comparison to Fc-enhanced anti-CD123 antibody. Moreover, AFM28 demonstrated the ability to destroy CD123-positive tumor cell lines and primary leukemic cells via antibody-dependent cell-mediated cytotoxicity (ADCC). Importantly, AFM28 was active irrespective of mutational status of tumor cells and also induced depletion when CD123 expression was very low. Strikingly, AFM28 was also active against cells not killed by an Fc-enhanced CD123-targeting comparator antibody suggesting the potential for improved clinical effectiveness. Moreover, AFM28 also depleted leukemic cells from patient bone marrow without destroying CD34-positive/CD123-negative cells, suggesting sparing of hematopoietic stem and progenitor cells. In vivo studies in an AML murine model demonstrated anti-tumor efficacy, and cynomolgus toxicology models predicted pharmacodynamic activity with a well-tolerated safety profile and low risk of cytokine release syndrome. Efficient depletion of leukemic blasts and leukemic stem cells is critical for inducing long-term remission in AML patients. As both cell types express CD123, AFM28’s ability to redirect NK cells to this target killing both leukemic blasts and leukemic stem cells makes this an attractive treatment strategy. Currently, there are no curative immunotherapies available, the only option is allogenic hematopoietic stem cell transplantation (allo-HSCT). Affimed plans to initiate clinical development of AFM28 with a first-in-human phase 1 monotherapy trial in adult patients with R/R AML in the second half of 2022. In addition, Affimed plans to investigate AFM28 in combination with allogeneic NK cell therapy after a safe starting dose has been determined.

Affimed N.V. Announces Highlights Trial Designs of Three AFM24 Ongoing Clinical Studies At the Annual Meeting of the American Society of Clinical Oncology

2022-05-26 21:05:00

Affimed N.V. announced that three abstracts of clinical trial designs of its AFM24 innate cell engager have been published and will be presented at the American Society of Clinical Oncology Annual Meeting, taking place on June 3-7, 2022 in Chicago, IL. The Trial in Progress posters provide background information and introduce the study designs of the three ongoing AFM24 studies in which patients with a variety of EGFR-positive solid tumors are treated with AFM24 monotherapy or in combinations with either Roche’s checkpoint inhibitor, atezolizumab, or NKGen Biotech’s autologous NK cell product, SNK01. Affimed’s ICE® molecules are tetravalent, bispecific and therefore can bind to tumor cell-surface antigens and CD16A expressed on natural killer cells and macrophages, inducing antibody-dependent cellular cytotoxicity and antibody dependent cellular phagocytosis, respectively. AFM24 activates the innate immune system to kill cancer cells by binding to CD16A on innate immune cells and EGFR, a protein widely expressed on solid tumors. AFM24 utilizes the patient’s innate immunity to redirect and activate immune cells, overcoming resistance to current therapies. The primary mode of action of AFM24 is to redirect NK cells and macrophages to EGFR+ tumor cells inducing antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis, respectively. Preclinical studies showed AFM24 induced killing of EGFR+ tumor cell lines independent of EGFR expression level and independent of mutations in the EGFR signaling pathway. In vivo studies in cynomolgus monkeys demonstrated a favourable safety profile. An ongoing phase 1/2a, first-in-human study is evaluating AFM24 in patients with locally advanced or metastatic, treatment refractory solid tumors that are known to express EGFR. The phase 1 dose escalation study was designed to establish the maximum tolerated dose and the recommended phase 2 dose of AFM24 and evaluate the safety, efficacy, immunogenicity, pharmacokinetic and pharmacodynamic responses. AFM24 was administered intravenously once weekly until disease progression, intolerable toxicity, patient withdrawal, or termination of treatment at investigator’s discretion. AFM24 had a well-managed safety profile and the RP2D was established at 480 mg. In parallel to the continuing dose escalation phase, a phase 2a dose expansion study was initiated, and the first patient was enrolled in January 2022. This Simon two-stage study will assess AFM24 at the RP2D in patients with different EGFR-expressing tumors. The trial will progress to the second stage unless the null hypothesis, that the true tumor response rate is below a specific value, is confirmed at the end of stage one. Eligible patients must have positive histological or cytological staining of EGFR in >1% of tumor cells. The primary endpoint of the study is to establish the overall response rate in three disease-specific cohorts. These include patients with clear cell renal cell carcinoma (ccRCC), KRAS wild-type colorectal cancer (KRASwt CRC) and EGFR-mutant non-small cell lung cancer (EGFRmut NSCLC). Secondary endpoints include treatment-emergent adverse events, serious adverse events, PK, PD, and immunogenicity. Anti-programmed death-ligand 1 (PD-L1) immune checkpoint inhibitors which enhance anti-tumor activity of a patient’s adaptive immunity, have already demonstrated efficacy as monotherapy and are playing an increasingly prominent role in cancer treatment. The combination of AFM24 and PD-L1 inhibitor, atezolizumab, may represent a promising new treatment modality, enhancing both the innate and adaptive immune responses to target EGFR+ tumor cells. An ongoing phase 1/2a open-label, non-randomized, multicenter, dose escalation (phase 1) and dose expansion (phase 2) study was initiated in November 2021 to evaluate the safety, tolerability and efficacy of AFM24 in combination with atezolizumab. The primary aim of the phase 1 study is to determine the maximum tolerated dose and the RP2D of AFM24. Eligible patients must have advanced, histologically confirmed EGFR+ disease and confirmed disease progression after treatment with =1 prior therapy. A standard 3+3 design will be used to determine the RP2D. Escalating doses of AFM24 will be given to each cohort as weekly intravenous (IV) infusions. The starting dose and at least two planned dose escalations are based on results from the ongoing AFM24 monotherapy trial. Atezolizumab is given at a fixed dose of 840 mg biweekly IV infusion. Patients will receive AFM24 and atezolizumab treatment until disease progression, intolerable toxicity, patient withdrawal, or termination of treatment at investigator’s discretion. The phase 2a study will establish the overall response rate and safety of the combination therapy in patients with advanced/metastatic, or treatment refractory gastric, esophagogastric, hepatocellular, hepatobiliary, pancreatic, or non-small cell lung cancer. For both phases, secondary endpoints include treatment-emergent adverse events, serious adverse events, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity. The AFM24 combination study with SNK01 autologous natural killer cells (NCT05099549) includes information about the dose-escalation and dose-expansion phase of AFM24 in combination with SNK01 autologous NK cells in patients with advanced EGFR+ solid tumors. Autologous NK cell transfer represents a promising treatment strategy, with ex vivo expansion and activation enhancing the specificity and anti-tumor activity of NK cells. The efficacy of this approach may be enhanced through the addition of tumor-targeting antibodies, augmenting NK-cell mediated ADCC. An ongoing phase 1/2a open-label, non-randomized, multicenter, dose escalation (phase 1) and dose expansion (phase 2) study were initiated in November 2021 to evaluate the safety, tolerability and efficacy of AFM24 in combination with SNK01 autologous NK cells in patients with advanced EGFR+ solid tumors. The primary aim of the phase 1 study is to determine the maximum tolerated dose and RP2D of AFM24 in combination with SNK01 at a fixed dose of NK cells using a standard 3+3 design.

Affimed N.V. Presents at 2022 Jefferies Global Healthcare Conference, Jun-08-2022 01:00 PM

2022-05-26 10:30:00

Affimed N.V. Presents at 2022 Jefferies Global Healthcare Conference, Jun-08-2022 01:00 PM. Venue: Marriott Marquis, New York City, New York, United States. Speakers: Adi Hoess, CEO, MD & Member of Management Board.

Affimed N.V. to Report Q1, 2022 Results on Jun 01, 2022

2022-05-24 10:30:00

Affimed N.V. announced that they will report Q1, 2022 results on Jun 01, 2022

Affimed N.V., Annual General Meeting, Jun 22, 2022

2022-05-24 10:30:00

Affimed N.V., Annual General Meeting, Jun 22, 2022, at 09:00 Central European Standard Time. Location: the Radisson Blu Hotel, Amsterdam City Center, Rusland 17, 1012 CK Amsterdam Netherlands

Affimed N.V., Q1 2022 Earnings Call, Jun 01, 2022

2022-05-24 10:30:00

Affimed N.V., Q1 2022 Earnings Call, Jun 01, 2022

Affimed N.V. Presents Data on Innate Cell Engagers Afm24 and Afm28 at 19th Meeting of the Society for Natural Immunity

2022-05-16 12:00:00

Affimed N.V. announced the presentation of new data on AFM24 and AFM28 in two posters at the 19th Meeting of the Society for Natural Immunity (NK2022). The AFM24 presentation showed correlative science data of the exposure and pharmacodynamic effects of the compound in patients with epidermal growth factor receptor (EGFR)-expressing solid tumors from the ongoing phase 1/2a study. The poster featured an analysis of the longitudinal effects of AFM24, a CD16A/EGFR-targeting bispecific innate cell engager (ICE®), in patients treated in the AFM24-101 phase 1/2a clinical study, confirming the mechanism of action of AFM24 on the innate immune system. The correlative science data further supports the rationale for combining different therapeutic approaches in patients with EGFR-expressing solid tumors. AFM24 engages CD16A on natural killer (NK) cells and macrophages with higher affinity than monoclonal antibodies, and triggers antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), respectively, directed at EGFR-expressing cancer cells. Preclinical data have shown that AFM24 can induce NK cell-mediated killing of EGFR-positive solid tumor cell lines, independent of EGFR mutational status. The analysis also showed activation of cytotoxic T cells in the periphery, and infiltration of T cells into the tumor bed, suggesting stimulation of anti-cancer immunity beyond the innate immune system and the possible engagement of the adaptive immune system. These data support the rationale for AFM24 as monotherapy and the two combinations that are currently under way in separate phase 1/2a studies – with autologous NK cell therapy and with immune checkpoint inhibition. The AFM28 poster featured preclinical data on the anti-leukemic activity of the compound when pre-complexed and co-administered with allogeneic NK cells. AFM28 is a novel ICE® binding to CD16A on NK cells, and CD123 on acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) tumor cells. The novel bispecific engager binds with high affinity to NK cells stimulating them to destroy CD123-positive tumor cells via ADCC. In addition, AFM28 exhibits greater cell surface retention than conventional monoclonal antibodies, including Fc-enhanced IgG1.

Affimed N.V. Presents at Berenberg Emerging Biotech Conference 2022, May-19-2022

2022-05-12 11:59:00

Affimed N.V. Presents at Berenberg Emerging Biotech Conference 2022, May-19-2022 .

Affimed N.V. has filed a Follow-on Equity Offering.

2022-04-12 00:00:00

Affimed N.V. has filed a Follow-on Equity Offering. Security Name: Common Shares Security Type: Common Stock

Affimed N.V. has completed a Follow-on Equity Offering in the amount of $90 million.

2022-04-12 00:00:00

Affimed N.V. has completed a Follow-on Equity Offering in the amount of $90 million. Security Name: Common Shares Security Type: Common Stock Securities Offered: 22,500,000 Price\Range: $4 Discount Per Security: $0.24

Affimed N.V. Announces Data from the Dose Escalation Phase of the Phase 1/2A Study with the company’s Innate Cell Engager

2022-04-11 10:33:00

Affimed N.V. announced data from the dose escalation phase of the phase 1/2a study with the Company’s Innate Cell Engager (ICE®) AFM24 as monotherapy at the Annual Meeting of the American Association of Cancer Research (AACR). A poster will be presented on April 11 during the Phase I Clinical Trials 1 session. The poster presentation includes data of 29 heavily pretreated patients with a variety of tumors known to express EGFR, who have received AFM24 as weekly infusions across six dose levels from 14 mg to 480 mg. AFM24 demonstrated a well-managed safety profile. The most frequent treatment-emergent adverse events were infusion-related reactions, nausea and headache. Stable disease was observed as best response in 8 of 24 response-evaluable patients. The pharmacokinetic and CD16A receptor occupancy data demonstrate good target engagement at doses of 320 mg and 480 mg. Pharmacodynamic activity was observed at doses of 160 mg and higher. The recommended phase 2 dose was determined at 480 mg based on safety and tolerability, exposure and CD16A receptor occupancy. The maximum tolerated dose was not reached by the treatment regimen up to 480 mg. Enrollment in the dose escalation has continued at a dose of 720 mg for the purpose of collecting additional data on safety and tolerability.

Affimed Presents Updated Clinical Data from Phase 1/2 Study of AFM13 Precomplexed with Cord Blood-Derived NK Cells at AACR Annual Meeting

2022-04-10 16:05:00

Affimed N.V. provided a data update from the ongoing study of the Company’s lead innate cell engager (ICE®) AFM13 precomplexed with cord blood-derived natural killer (cbNK) cells. AFM13 is currently being investigated at The University of Texas MD Anderson Cancer Center in a phase 1/2 study in patients with CD30-positive relapsed or refractory Hodgkin and non-Hodgkin lymphomas. The investigator-sponsored study is led by Yago Nieto, M.D., Ph.D., professor of Stem Cell Transplantation and Cellular Therapy at MD Anderson. The study shows a 100% objective response rate (ORR) and an improvement of complete response (CR) rate to 62% at the recommended phase 2 dose (RP2D) in 13 patients after 2 cycles of therapy. The results will be presented during the Clinical Plenary Session on cellular immunotherapies at the American Association for Cancer Research (AACR) Annual Meeting 2022 and will also be covered during an AACR press conference April 10, 2022. As of the cut-off date, the study had enrolled 22 patients with relapsed or refractory CD30+ Hodgkin and non-Hodgkin lymphoma having received a median of seven prior lines of therapy, of whom 19 were evaluable for response. Thirteen response-evaluable patients were treated at the RP2D, including 12 patients with Hodgkin Lymphoma and one patient with non-Hodgkin Lymphoma. Each treatment cycle consists of lymphodepleting chemotherapy with fludarabine and cyclophosphamide followed two days later by a single infusion of cytokine-preactivated and expanded cord blood-derived NK cells that are pre-complexed with AFM13. Three weekly infusions of AFM13 (200 mg) monotherapy are subsequently administered and responses are assessed by the investigator on day 28 by FDG-PET. All 13 patients treated at the recommended phase 2 dose (108 NK/Kg) achieved a response by Lyric criteria. Of these 13 patients, 8 patients (62%) demonstrated a CR after two cycles of treatment, which represents an increase from 5 patients (38%) demonstrating CR after one cycle of treatment previously announced in December 2021. For the 13 patients treated at the RP2D, median duration of response has not yet been reached. As of the cutoff date, assessment of durability shows: Seven patients remain in CR at median follow-up of 6.5 months, including two patients who remain in response after 10 months and two patients who received stem cell transplant and remain in response at 6.5 months. One patient with a CR experienced disease progression after 7.9 months. Of the five patients with a PR, one remains in response at 6.3 months and four patients progressed between 2.9 and 4.3 months after initial infusion. The treatment was well tolerated, with minimal side effects beyond the expected myelosuppression from the preceding lymphodepleting chemotherapy. No instances of cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, or graft versus host disease were observed. There were six infusion-related reactions in 110 infusions (5.4%) of AFM13 alone and no reactions to the cord blood-derived NK cells precomplexed with AFM13. The trial was originally designed to include up to two cycles. To assess durability beyond two cycles, an amendment has been approved by the U.S. Food and Drug Administration to increase the length of treatment from two up to four cycles, enabling longer follow up of patients.

Affimed N.V. Presents at AACR Annual Meeting 2022, Apr-10-2022 01:00 PM

2022-04-08 17:23:00

Affimed N.V. Presents at AACR Annual Meeting 2022, Apr-10-2022 01:00 PM. Venue: Ernest N. Morial Convention Center, New Orleans, Louisiana, United States.

Affimed N.V. Presents Findings from the Dose-Escalation Phase of the First-In-Human Study of AFM24 in Patients with EGFR-Positive Solid Tumors

2022-04-08 17:23:00

Affimed N.V. announced data from the dose escalation phase of the phase 1/2a study with the Company’s Innate Cell Engager AFM24 as monotherapy at the Annual Meeting of the American Association of Cancer Research. A poster will be presented on April 11 during the Phase I Clinical Trials 1 session. The poster presentation includes data of 29 heavily pretreated patients with a variety of tumors known to express EGFR, who have received AFM24 as weekly infusions across six dose levels from 14 mg to 480 mg. AFM24 demonstrated a well-managed safety profile. The most frequent treatment-emergent adverse events were infusion-related reactions, nausea and headache. Stable disease was observed as best response in 8 of 24 response-evaluable patients. The pharmacokinetic and CD16A receptor occupancy data demonstrate good target engagement at doses of 320 mg and 480 mg. Pharmacodynamic activity was observed at doses of 160 mg and higher. The recommended phase 2 dose was determined at 480 mg based on safety and tolerability, exposure and CD16A receptor occupancy. The maximum tolerated dose was not reached by the treatment regimen up to 480 mg. Enrollment in the dose escalation has continued at a dose of 720 mg for the purpose of collecting additional data on safety and tolerability. Affimed is enrolling patients in three open label phase 1/2a studies, evaluating the activity of AFM24 as monotherapy, and in combination with Roche’s anti-PD-L1 checkpoint inhibitor atezolizumab as well as in combination with SNK01, NKGen Biotech’s NK cell product. AFM24 is a tetravalent, bispecific innate cell engager that activates the innate immune system by binding to CD16A on innate immune cells and EGFR, a protein widely expressed on solid tumors, to kill cancer cells. Generated by Affimed’s fit-for-purpose ROCK® platform, AFM24 represents a distinctive mechanism of action that uses EGFR as a docking site to engage innate immune cells for tumor cell killing through antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis. Affimed is evaluating AFM24 as a monotherapy for patients with advanced EGFR-expressing solid malignancies whose disease has progressed after treatment with previous anticancer therapies. The first-in-human Phase 1/2a open-label, non-randomized, multi-center, multiple ascending dose escalation and expansion study and can be found at www.clinicaltrials.gov using the identifier NCT04259450. Furthermore, AFM24 is evaluated in a phase 1/2a study in combination with Roche’s anti-PD-L1 checkpoint inhibitor atezolizumab. Affimed and NKGen Biotech have initiated a Phase 1/2a study, investigating AFM24 in combination with SNK01, NKGen Biotech’s NK cell product.

Joh. Berenberg, Gossler & Co. KG, Berenberg Emerging Biotech Conference 2022, May 19, 2022

2022-04-08 04:47:00

Joh. Berenberg, Gossler & Co. KG, Berenberg Emerging Biotech Conference 2022, May 19, 2022.

Affimed N.V. Presents at Wells Fargo Annual Biotech Forum, Apr-12-2022

2022-03-29 20:00:00

Affimed N.V. Presents at Wells Fargo Annual Biotech Forum, Apr-12-2022 . Venue: Miami, Florida, United States. Speakers: Adi Hoess, CEO, MD & Member of Management Board, Alexander Fudukidis, Head of Investor Relations, Angus W. Smith, CFO & Member of Management Board.

Wells Fargo Securities, LLC, Wells Fargo Annual Biotech Forum, Apr 12, 2022 through Apr 13, 2022

2022-03-29 11:02:00

Wells Fargo Securities, LLC, Wells Fargo Annual Biotech Forum, Apr 12, 2022 through Apr 13, 2022. Venue: Miami, Florida, United States.

Affimed N.V. to Report Fiscal Year 2021 Results on Mar 31, 2022

2022-03-24 10:31:00

Affimed N.V. announced that they will report fiscal year 2021 results on Mar 31, 2022

Affimed N.V., 2021 Earnings Call, Mar 31, 2022

2022-03-24 10:31:00

Affimed N.V., 2021 Earnings Call, Mar 31, 2022

Jefferies LLC, 2022 Jefferies Global Healthcare Conference, Jun 08, 2022 through Jun 10, 2022

2022-02-14 21:00:00

Jefferies LLC, 2022 Jefferies Global Healthcare Conference, Jun 08, 2022 through Jun 10, 2022. Venue: Marriott Marquis, New York City, New York, United States.

Affimed N.V. Announces Publication of Preclinical Data Demonstrating Cytotoxic Potency and Efficacy of NK Cells Precomplexed with Innate Cell Engagers After Freezing & Thawing

2022-02-09 21:05:00

Affimed N.V. announced the publication of pre-clinical data demonstrating the cytotoxic potency and efficacy of NK cells precomplexed with ICE molecules after one cycle of cryopreservation. This is an important prerequisite for the development of off-the-shelf products which may allow accessibility to the novel treatment option for patients in need. The data show experimental results of NK cells precomplexed with three bispecific, tetravalent ICE molecules targeting the validated tumor target EpCAM and one of the NK cell-activating receptors CD16A, NKG2D or NKp46. NK cells precomplexed to the EpCAM/CD16A ICE molecule demonstrated superior cytotoxicity against EpCAM-positive tumor cells in comparison to complexes with EpCAM/NKG2D and EpCAM/NKp46 ICE formats. This effect may potentially be driven by a stronger NK cell activation through CD16A as compared to NKG2D or NKp46. After one cycle of cryopreservation, this effect continued - notably, NK cells precomplexed with all three ICE constructs retained their cytotoxicity after freezing and thawing.

American Association For Cancer Research, AACR Annual Meeting 2022, Apr 08, 2022 through Apr 14, 2022

2022-01-13 18:45:00

American Association For Cancer Research, AACR Annual Meeting 2022, Apr 08, 2022 through Apr 14, 2022. Venue: Ernest N. Morial Convention Center, New Orleans, Louisiana, United States.

Affimed N.V. to Discuss Treatment of Cd30-Positive Lymphoma Patients with Cord Blood-Derived Natural Killer Cells Pre-Complexed with Innate Cell Engager AFM13

2021-12-09 12:30:00

Affimed N.V. will host a financial community call to discuss recent findings from the investigator sponsored tria at The University of Texas MD Anderson Cancer Center investigating the treatment of CD30-positive lymphoma patients with its innate cell engager AFM13, pre-complexed with cord blood-derived natural killer cells. A treatment cycle consists of lymphodepleting chemotherapy with fludarabine and cyclophosphamide followed two days later by a single infusion of cytokine-preactivated and expanded cbNK cells that are pre-complexed with AFM13, followed by three weekly infusions of AFM13 monotherapy. Responses are assessed on day 28 by FDG-PET and patients can receive up to two cycles. Three patients were treated with 1×106, three patients with 1×10 7 and 13 patients with 1×108 AFM13-pre-complexed cbNK cells per kg body weight. Nine patients treated in the dose escalation phase of the study had follow-up at 6 months. Of note, the three patients treated at the RP2D remain in remission at 6 months after start of treatment, two without additional treatment and one on anti-PD-1 antibody maintenance. In the four responders out of six treated at the two lower dose levels, one patient, who started treatment in September 2020, remains in remission after consolidation autologous stem cell transplant, and three relapsed at 3.4, 4.8 and 6.3 months after start of therapy. The University of Texas MD Anderson Cancer Center is studying AFM13 in an investigator-initiated phase 1-2 trial in combination with cord blood-derived allogeneic NK cells in patients with recurrent or refractory CD30-positive lymphomas. The first phase of this study involves dose escalation of pre-complexed NK cells, with patients receiving lymphodepleting chemotherapy followed by 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 to determine the recommended phase 2 dose and evaluate its activity. The recommended phase 2 dose was determined as 1×108 NK cells/kg. In each cohort, the dose of the pre-complexed NK cells with AFM13 is 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. AFM13 is a first-in-class innate cell engager 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 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. The study is actively recruiting.

Affimed N.V. Initiates Patient Recruitment for A Phase 1/2A Trial of Innate Cell Engager Afm24 in Combination with Roche’S Anti-Pd-L1 Checkpoint Inhibitor Atezolizumab

2021-12-08 11:30:00

Affimed N.V. announced the initiation of patient recruitment for the open-label, multi-center phase 1/2a study evaluating the safety, tolerability, pharmacokinetics and efficacy of the innate cell engager (ICE®) AFM24 in combination with Roche’s atezolizumab, an anti-PD-L1 checkpoint inhibitor. AFM24 is Affimed’s tetravalent, bispecific epidermal growth factor receptor (EGFR)- and CD16A-targeting ICE®, developed for the treatment of patients with solid tumors. The study will consist of two parts. The first part is a dose escalation phase, aiming to determine the maximum tolerated dose/recommended phase 2 dose of AFM24 in combination with atezolizumab. In the second part, the expansion phase (phase 2a), the goal is to collect preliminary evidence of efficacy as well as to confirm the safety of the therapeutic combination. The trial will include patients with solid tumors, including non-small cell lung cancer (NSCLC, EGFR-wildtype), gastric- and gastroesophageal junction adenocarcinoma and pancreatic/hepatocellular/biliary tract cancer. All patients have failed =1 prior line of treatment before receiving the combination of AFM24 and atezolizumab. Preclinical studies of AFM24 have demonstrated a good safety profile and anti-tumor activity. AFM24 monotherapy is currently being investigated in adult patients with advanced EGFR-positive solid malignancies in an open-label, non-randomized, multi-center, multiple ascending dose escalation/expansion study.

Affimed N.V. - Analyst/Investor Day

2021-11-22 12:11:00

To consider discuss the results to date, the current treatment landscape for CD30+ lymphomas, and next steps for the study

Affimed Announces Interim Clinical Results from the Investigator-Initiated Phase 1-2 Study At the University of Texas MD Anderson Cancer Center

2021-11-22 12:11:00

Affimed N.V. announced interim clinical results from the investigator-initiated phase 1-2 study at The University of Texas MD Anderson Cancer Center, evaluating cbNK cells pre-complexed with Affimed’s innate cell engager (ICE®) AFM13. As of October 31, 2021, a total of 18 patients with CD30-positive relapsed or refractory Hodgkin and non-Hodgkin lymphomas (16 and 2 patients, respectively) were treated with the novel combination of cbNK cells pre-complexed with AFM13. A treatment cycle consists of lymphodepleting chemotherapy with fludarabine and cyclophosphamide followed two days later by a single infusion of cytokine-preactivated and expanded cbNK cells that are pre-complexed with AFM13, followed by three weekly infusions of AFM13 (200 mg) monotherapy. Responses are assessed on day 28 by FDG-PET and patients can receive up to two cycles. Three patients were treated with 1x106, three patients with 1x107 and 12 patients with 1x108 AFM13-pre-complexed cbNK cells per kg body weight. As of the cutoff date, 16 of 18 patients had achieved an objective response to the treatment according to investigator assessment, with seven complete responses and nine partial responses. Eleven of twelve patients treated at the recommended phase 2 dose level of 108 cbNK cells per kg had Hodgkin Lymphoma. In this cohort of patients treated at the recommended phase 2 dose, 100% responded after the first cycle of treatment with five CRs and seven PRs according to investigator assessment. Each of the patients in this cohort is eligible for a second treatment cycle, and updated data from this cohort will be reported at a later date. Treatment was well tolerated with five reported cases of transient infusion related reactions after the monotherapy infusions of AFM13. Of note, there were no instances of serious adverse events such as cytokine release syndrome, immune cell-associated neurotoxicity syndrome or graft-versus-host disease.

Affimed N.V. Announces Preclinical Data of its Innate Cell Engagers at the 36th Annual Meeting of the Society for Immunotherapy of Cancer

2021-11-12 12:01:00

Affimed N.V. announced that three posters with preclinical data of its innate cell engagers (ICE®) are presented at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC). The data highlight Affimed’s preclinical initiatives to further elucidate the mechanisms of action for its lead ICE® candidates AFM13 and AFM24, providing evidence that both ICE® molecules increased the number of NK cells which functioned as serial killers against cancer as well as the role of macrophages in the anti-tumor activity of AFM24. The poster based on abstract 894 displays data generated through a collaboration with Prof. Björn Önfelt’s group at the Karolinska Institutet, Stockholm. In the study, microchip technology was used for two ICE® drug candidates, AFM13 and AFM24, at single cell resolution to better understand their mode of action. Both ICE® molecules enhanced NK cell cytotoxicity and increased the number of serial killers, i.e. NK cells which kill a number of tumor cells sequentially. Shedding inhibition of the innate immune cell surface protein CD16 resulted in the maintained cytotoxic effect of either ICE® molecule demonstrating that stabilization of CD16 is not required for effective tumor cell killing by ICE® drug candidates. Two additional posters (abstracts 880 and 881) present data on AFM24’s ability to induce antibody dependent cellular phagocytosis (ADCP). AFM24, the bispecific ICE® targeting EGFR and CD16A, led to enhanced macrophage-mediated ADCP on various EGFR-expressing tumor cell lines, irrespective of their EGFR-pathway mutational status. To refine the prediction of in vivo tumor responses to AFM24, Affimed has established 2D and 3D assay conditions in patient-derived xenograft (PDX) cell lines. The 3D model is designed to replicate intrinsic physiological conditions. Early results show that AFM24 can induce ADCP in tumor cells in 2D PDX cell cultures, engaging M0, M1 and M2 macrophage subsets context-dependently. ADCP is potentially instrumental for AFM24’s mechanism of action, especially in macrophage-rich tumors. AFM24 is currently investigated as monotherapy in a Phase 1/2a study in patients with EGFR-expressing solid tumors in need of alternative treatment options. In addition, Affimed and NKGen Biotech have initiated a clinical study to investigate AFM24 in combination with NK cells. Affimed expects to initiate an additional clinical study with an anti-PD-L1 checkpoint inhibitor before the end of 2021.

Affimed N.V. has filed a Shelf Registration in the amount of $250 million.

2021-11-10 00:00:00

Affimed N.V. has filed a Shelf Registration in the amount of $250 million. Security Name: Common Shares Security Name: Debt securities Security Name: Warrants Security Name: Purchase Contracts Security Name: Units Transaction Features: Omnibus/Universal Shelf Registration

Affimed N.V. has filed a Follow-on Equity Offering in the amount of $100 million.

2021-11-10 00:00:00

Affimed N.V. has filed a Follow-on Equity Offering in the amount of $100 million. Security Name: Common Shares Security Type: Common Stock Transaction Features: At the Market Offering

Affimed N.V. Presents at 12th Annual Jefferies Global Healthcare Conference, Nov-18-2021 03:00 AM

2021-11-09 11:30:00

Affimed N.V. Presents at 12th Annual Jefferies Global Healthcare Conference, Nov-18-2021 03:00 AM. Venue: London, United Kingdom. Speakers: Adi Hoess, CEO, MD & Member of Management Board.

Affimed N.V. Presents at Stifel 2021 Virtual Healthcare Conference, Nov-15-2021 08:00 AM

2021-11-09 11:30:00

Affimed N.V. Presents at Stifel 2021 Virtual Healthcare Conference, Nov-15-2021 08:00 AM. Venue: New York, New York, United States. Speakers: Adi Hoess, CEO, MD & Member of Management Board.

Affimed N.V. and NKGen Biotech Announces Initiation of Patient Recruitment in a First-in-human Phase 1/2a Trial of Innate Cell Engager AFM24 in Combination with Autologous NK Cell Product SNK01

2021-11-08 11:30:00

Affimed N.V. and NKGen Biotech announced the initiation of patient recruitment in the open-label, multi-center phase 1/2a study (NCT05099549) evaluating the safety, tolerability, and anti-tumor activity of the innate cell engager (ICE®) AFM24 (Affimed’s tetravalent, bispecific epidermal growth factor receptor (EGFR)- and CD16A-binding ICE®) in combination with SNK01 (ex vivo expanded and activated autologous NK cell therapy from NKGen Biotech). The objective of the phase 1 dose escalation is to evaluate safety and tolerability data for escalating AFM24 doses in combination with a fixed dose of SNK01 and to determine the maximum tolerated and recommended phase 2 dose for the expansion phase. Phase 2a will investigate additional tolerability, safety and anti-tumor activity. The trial will include patients with non-small cell lung cancer (NSCLC, EGFR-wildtype), squamous cell carcinoma of the head and neck (SCCHN), as well as patients with microsatellite instability (MSI) low/DNA mismatch repair proficient colorectal cancer (CRC) regardless of KRAS mutational status. The clinical study is supported by preclinical data generated through the collaboration of Affimed and NKGen Biotech, including data that were recently presented at the AACR-NCI-EORTC conference on Molecular Targets and Cancer Therapeutics. In the preclinical studies, AFM24 demonstrated robust binding to SNK01 cells and enhancement of the cytotoxic activity of SNK01 cells towards EGFR-positive A-431 cells, compared to untargeted SNK01 cells. In addition, markers for NK cell degranulation and intracellular IFN? were increased in the combined therapy, indicating increased anti-tumor activity. AFM24 is a tetravalent, bispecific innate cell engager (ICE®) that activates the innate immune system by binding to CD16A on innate immune cells and EGFR, a protein widely expressed on solid tumors, to kill cancer cells. Generated by Affimed’s fit-for-purpose ROCK® platform, AFM24 represents a distinctive mechanism of action that uses EGFR as a docking site to engage innate immune cells for tumor cell killing through antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis. In addition to the AFM24-103 study presented here, Affimed is evaluating AFM24 as a monotherapy (AFM24-101) for patients with advanced EGFR-expressing solid malignancies whose disease has progressed after treatment with previous anticancer therapies. The first-in-human phase 1/2a open-label, non-randomized, multi-center, multiple ascending dose escalation and expansion study and can be found at www.clinicaltrials.gov using the identifier NCT04259450. SNK01 is a cell-based, patient-specific, ex vivo expanded and activated autologous NK cell therapy agent, manufactured from the patient’s leukapheresis or whole blood. NK cells are a subset of cytotoxic lymphocytes with the ability to directly attack virally infected cells or cancer cells and carry out immunoregulatory functions by the secretion of cytokines and chemokines.

Affimed Announces New Innate Cell Engager AFM28 Targeting CD123 to Treat Acute Myeloid Leukemia

2021-11-04 13:06:00

Affimed N.V. announced that AFM28, its novel Innate Cell Engager (ICE®), is designed to treat patients with Acute Myeloid Leukemia (AML) and other CD123+ myeloid malignancies, such as high-risk myelodysplastic syndrome (MDS). Affimed will describe AFM28 in a poster covering initial preclinical data at the upcoming ASH conference. The company plans to submit an IND application in the first half of 2022, and initiate a first-in-human study in the second half of 2022. AFM28 was developed on Affimed’s proprietary ROCK® platform and is a bispecific, tetravalent ICE® that targets CD16A on NK cells and macrophages as well as CD123 on leukemic cells and leukemic stem cells in AML. The high affinity to CD123 and to CD16A is initiating antibody-dependent cell-mediated cytotoxicity (ADCC) against CD123+ tumor cells. Preclinical data demonstrate that AFM28 induces tumor cell lysis more potently than conventional anti-CD123 antibodies, even at low CD123 expression. Further, AFM28 shows a 100-fold more potent NK cell activation in an ex vivo analysis, compared to Fc-enhanced IgG1 antibodies. In a preclinical toxicology study in cynomolgus monkey, AFM28 was safe and well-tolerated and exhibited the expected pharmacodynamic activity suggesting a good safety profile and the potential to eliminate CD123+ cells in vivo. Clinical investigation of AFM28 is planned as monotherapy and in combination with allogeneic NK cell therapy.

SVB Leerink LLC, 11th SVB Leerink Annual Global Healthcare Conference 2022, Feb 14, 2022 through Feb 18, 2022

2021-10-29 14:57:00

SVB Leerink LLC, 11th SVB Leerink Annual Global Healthcare Conference 2022, Feb 14, 2022 through Feb 18, 2022. Venue: New York, New York, United States.

Affimed N.V. to Report Q3, 2021 Results on Nov 10, 2021

2021-10-29 10:30:00

Affimed N.V. announced that they will report Q3, 2021 results on Nov 10, 2021

Affimed N.V., Q3 2021 Earnings Call, Nov 10, 2021

2021-10-29 10:30:00

Affimed N.V., Q3 2021 Earnings Call, Nov 10, 2021

Affimed Announces Acceptance of Three Abstracts with Preclinical Data on Its Innate Cell Engagers At the 36Th Annual Meeting of the Society for Immunotherapy of Cancer

2021-10-01 12:05:00

Affimed N.V. announced that three abstracts with preclinical data of its innate cell engagers have been accepted for poster presentation at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), which will be held on November 10-14, 2021. Abstract details: Title: Tetravalent, bispecific innate cell engager AFM24 enhances macrophage mediated tumor cell phagocytosis. Abstract ID: 880. Authors: Sheena Pinto, Susanne Wingert, Jens Pahl, Armin Beez, Sabrina Purr, Uwe Reusch, Arndt Schottelius and Joachim Koch. Title: Enhanced antibody-mediated phagocytosis and antibody-mediated cell cytotoxicity using tetravalent, bispecific innate cell engagers (ICE®) in 3D spheroids. Abstract ID: 881. Authors: Sheena Pinto, Savannah Jackson, Julia Knoch, Christian Breunig, Arndt Schottelius and Joachim Koch. Title: The bispecific innate cell engagers AFM13 (CD30/CD16A) and AFM24 (EGFR/CD16A) increase the fraction of tumor target-responsive NK cells and boost serial killing. Abstract ID: 894.

Affimed N.V. Presents at Citi’s 16th Annual BioPharma Virtual Conference, Sep-08-2021

2021-08-26 10:34:00

Affimed N.V. Presents at Citi’s 16th Annual BioPharma Virtual Conference, Sep-08-2021 . Venue: New York, United States.

Affimed N.V. Presents at Morgan Stanley 19th Annual Global Healthcare Conference, Sep-10-2021

2021-08-26 10:34:00

Affimed N.V. Presents at Morgan Stanley 19th Annual Global Healthcare Conference, Sep-10-2021 . Venue: New Windsor, United States.

Affimed N.V. Presents at Cantor Global Healthcare 2021 Conference, Sep-27-2021 10:00 AM

2021-08-26 10:34:00

Affimed N.V. Presents at Cantor Global Healthcare 2021 Conference, Sep-27-2021 10:00 AM. Venue: New York, United States.

Affimed N.V. to Report Q2, 2021 Results on Sep 08, 2021

2021-08-23 10:30:00

Affimed N.V. announced that they will report Q2, 2021 results on Sep 08, 2021

Affimed N.V., Q2 2021 Earnings Call, Sep 08, 2021

2021-08-23 10:30:00

Affimed N.V., Q2 2021 Earnings Call, Sep 08, 2021

Affimed N.V. Announces Publication of Comprehensive Preclinical Data Demonstrating the Therapeutic Potential of AFM24 in EGFR-expressing Tumors

2021-07-30 10:30:00

Affimed N.V. announced the publication of a comprehensive preclinical in vitro and in vivo data package of its innate cell engager (ICE®) AFM24 (CD16A/EGFR) in mAbs. The published data were the basis for the Investigational New Drug (IND) clearance for Affimed’s ongoing Phase 1/2a study with AFM24 monotherapy in patients with EGFR expressing solid tumors. The preclinical data demonstrates AFM24’s unique mechanism of action that harnesses the innate immune system to induce tumor cell killing via antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cell phagocytosis (ADCP). AFM24 is a tetravalent, bispecific innate cell engager (ICE®) that activates the innate immune system by binding to CD16A on innate immune cells and EGFR, a protein widely expressed on solid tumors, to kill cancer cells. Generated by Affimed’s fit-for-purpose ROCK® platform, AFM24 represents a distinctive mechanism of action that uses EGFR as a docking site to engage innate immune cells for tumor cell killing through antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis.Affimed is evaluating AFM24 as a monotherapy for patients with advanced EGFR-expressing solid malignancies whose disease has progressed after treatment with previous anticancer therapies.In addition, Affimed is planning to initiate further studies evaluating AFM24 in combination with Roche’s atezolizumab, an anti-PD-L1 checkpoint inhibitor and, separately, an investigation of AFM24 in combination with NKGen Biotech’s autologous NK cell product.

Affimed N.V. Presents at Wells Fargo 2021 Virtual Healthcare Conference, Sep-09-2021 08:00 AM

2021-07-22 14:24:00

Affimed N.V. Presents at Wells Fargo 2021 Virtual Healthcare Conference, Sep-09-2021 08:00 AM. Speakers: Adi Hoess, CEO, MD & Member of Management Board, Alexander Fudukidis, Head of Investor Relations, Andreas Harstrick, Chief Medical Officer, Angus W. Smith, Chief Financial Officer, Arndt J. G. Schottelius, Chief Scientific Officer, Nathalie Knappe, Manager, EU Investor Relations.

Wells Fargo Securities, LLC, Wells Fargo 2021 Virtual Healthcare Conference, Sep 09, 2021 through Sep 10, 2021

2021-07-22 09:08:00

Wells Fargo Securities, LLC, Wells Fargo 2021 Virtual Healthcare Conference, Sep 09, 2021 through Sep 10, 2021.

Stifel, Nicolaus & Company, Incorporated, Stifel 2021 Virtual Healthcare Conference, Nov 15, 2021 through Nov 17, 2021

2021-07-08 08:44:00

Stifel, Nicolaus & Company, Incorporated, Stifel 2021 Virtual Healthcare Conference, Nov 15, 2021 through Nov 17, 2021. Venue: New York, New York, United States.