AB-202

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 presentationAn 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 (r/r) peripheral T-cell lymphoma (PTCL) HEIDELBERG, Germany, June 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 two abstracts have been accepted for presentation at the 17th International Conference on Malignant Lymphoma (17-ICML) taking place in Lugano, Switzerland on June 13-17, 2023. A poster presentation will share a preclinical data set of Affimed’s innate cell engager (ICE®) AFM13 in combination with Artiva Biotherapeutics Inc.’s (“Artiva”) off-the-shelf NK cell AB-101. An additional encore oral presentation will show the final results of the phase 2 REDIRECT study with AFM13 monotherapy in a r/r PTCL patient population. The preclinical data set shows that AFM13 binds homogenously to thawed AB-101, directs the NK cells to CD30-positive tumor cells and enhances the cytotoxic activity of AB-101 against the tumor cells. Associated with the AFM13-induced cytotoxic activity was an increased functional activation status of AB-101 demonstrated through degranulation and IFN-γ production. Importantly, in a mouse xenograft model, adoptive transfer of AB-101 in combination with AFM13 conferred tumor growth control. The data of AFM13 in combination with the allogeneic, cryopreserved, off-the-shelf, cord blood-derived AB-101 NK cells demonstrate synergistic anti-tumor activity in vivo. Building on the unprecedented efficacy results of the phase 1 study with AFM13 in combination with fresh cord blood-derived NK cells (NCT04074746), as reported at ASH 2022, the Company recently received Food and Drug Administration (FDA) IND clearance and is expecting to initiate a phase 2 study, LuminICE-203, with AFM13 and AB-101 in patients with r/r classical Hodgkin lymphoma in Q3 2023. The study will also include a cohort of 20 PTCL patients. “These preclinical data of AFM13 + AB-101 as well as the clinical data from the phase 1 combination study demonstrate that AFM13 plus NK cells can achieve remarkable cytotoxicity against CD30-positive cancers,” said Dr. Arndt Schottelius, Chief Scientific Officer at Affimed. “As a next step we want to bring this therapeutic approach to more patients in need and we look forward to initiate the LuminICE-203 study.” Details of the AFM13 + AB-101 poster presentation are as follows: Title: AFM13 enhances the anti-tumor activity of AB-101 towards CD30+ tumors, conferring tumor growth control in vivo Presenting Author: Jens Pahl Poster Presentation Time: Thursday, 15 June 2023, 12:30 - 13:00 CET Poster and Abstract Book Code: 419 In addition, an encore presentation of the final results of the phase 2 REDIRECT study will be given by Dr. Won Seog Kim, Professor of Hematology-Oncology at Samsung Medical Center in Seoul and a principal investigator of the study. AFM13 monotherapy exhibited clinical efficacy in a heavily pre-treated CD30-positive r/r PTCL population and a well-managed safety profile. Details of the REDIRECT oral presentation are as follows: Title: AFM13 in patients with CD30-positive relapsed or refractory (R/R) peripheral T cell lymphoma (PTCL): Results from the Phase 2 REDIRECT study Presenting Author: Won Seog Kim Session: Focus on… Session: T-Cell Lymphomas Presentation Time: Thursday, 15 June 2023, 17:00 - 18:00 CET Poster and Abstract Book Code: 126 More details about the 17-ICML conference are available online at Home - ICML About AFM13 AFM13 is a first-in-class tetravalent bispecific 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 was evaluated as monotherapy in a phase 2 trial in patients with relapsed/refractory peripheral T-cell lymphoma (REDIRECT, NCT04101331). In addition, 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 (NCT04074746). The company reported data from this study at ASH 2022 annual meeting. To find out more about AFM13 and the studies, please visit: www.affimed.com. About AB-101 AB-101 is Artiva’s non-genetically modified, cord blood-derived, allogeneic, cryopreserved, ADCC-enhancing NK cell therapy candidate for use in combination with monoclonal antibodies or innate-cell engagers in the out-patient setting. Artiva selects cord blood units with the high affinity variant of the receptor CD16 and a KIR-B haplotype for enhanced product activity. Using Artiva’s AlloNK® platform, Artiva can generate thousands of doses of pure, cryopreserved, infusion-ready NK cells from a single umbilical cord blood unit while retaining high and consistent expression of CD16 and other tumor-engaging receptors, without the need for engineering. Artiva is conducting a Phase 1/2 multicenter clinical trial (ClinicalTrials.gov Identifier: NCT04673617) to assess the safety and clinical activity of AB-101 alone and in combination with the anti-CD20 monoclonal antibody, rituximab, in patients with relapsed or refractory B-cell-non-Hodgkin lymphoma (B-NHL) who have progressed beyond two or more prior lines of therapy. This study is progressing at multiple clinical sites across the U.S., and AB-101 is administered weekly in the out-patient setting over one-month cycles and with up to four cycles to assess therapeutic efficacy and durability. Artiva presented data from the first-in-human phase 1/2 clinical trial of AB-101 in combination with rituximab in R/R non-Hodgkin lymphoma at the 2023 ASCO Annual Meeting. About Affimed N.V. Affimed (Nasdaq: AFMD) is a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer by actualizing the untapped potential of the innate immune system. The Company’s proprietary ROCK® platform enables a tumor-targeted approach to recognize and kill a range of hematologic and solid tumors, enabling a broad pipeline of wholly-owned and partnered single agent and combination therapy programs. The ROCK® platform predictably generates customized innate cell engager (ICE®) molecules, which use patients’ immune cells to destroy tumor cells. This innovative approach enabled Affimed to become the first company with a clinical-stage ICE®. Headquartered in Heidelberg, Germany, with offices in New York, NY, Affimed is led by an experienced team of biotechnology and pharmaceutical leaders united by a bold vision to stop cancer from ever derailing patients’ lives. For more about the Company’s people, pipeline and partners, 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 the Company’s intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, the potential of AFM13, AFM24, AFM28 and the Company’s other product candidates, the value of its ROCK® platform, its ongoing and planned preclinical development and clinical trials, its collaborations and development of its products in combination with other therapies, the timing of and its ability to make regulatory filings and obtain and maintain regulatory approvals for its product candidates, its intellectual property position, its collaboration activities, its ability to develop commercial functions, clinical trial data, its results of operations, cash needs, financial condition, liquidity, prospects, future transactions, growth and strategies, the industry in which it operates, the macroeconomic trends that may affect the industry or the Company, such as the instability in the banking sector experienced in the first quarter of 2023, impacts of the COVID-19 pandemic, the benefits to Affimed of orphan drug designation, the impact on its business by political events, war, terrorism, business interruptions and other geopolitical events and uncertainties, such as the Russia-Ukraine conflict, the fact that the current clinical data of AFM13 in combination with NK cell therapy is based on AFM13 precomplexed with fresh allogeneic cord blood-derived NK cells from The University of Texas MD Anderson Cancer Center, as opposed to Artiva’s AB-101 and other uncertainties and factors described under the heading “Risk Factors” in Affimed’s filings with the SEC. Given these risks, uncertainties, and other factors, you should not place undue reliance on these forward-looking statements, and the Company assumes no obligation to update these forward-looking statements, even if new information becomes available in the future. Investor Relations Contact Alexander FudukidisDirector, Investor RelationsE-Mail: a.fudukidis@affimed.comTel.: +1 (917) 436-8102 Media Contact Mary Beth Sandin Vice President, Marketing and CommunicationsE-Mail: m.sandin@affimed.com

SAN DIEGO--( BUSINESS WIRE )-- Artiva Biotherapeutics, Inc. , a clinical stage company whose mission is to deliver highly effective, off-the-shelf, allogeneic natural killer (NK) cell-based therapies, announced today the presentation of initial data from the dose-escalation stage of its ongoing Phase 1/2 clinical trial of AB-101. AB-101 is a non-genetically modified, cord blood-derived, allogeneic, cryopreserved, ADCC-enhancing NK cell product candidate being investigated in combination with rituximab for the treatment of relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL). The presentation will take place on Monday, June 5, during the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. “We believe these data support the differentiated therapeutic and favorable safety profile of AB-101, an off-the-shelf NK cell product candidate administered in the outpatient setting, particularly in a post CAR-T patient population that has limited therapeutic options,” said Thorsten Graef, M.D., Chief Medical Officer of Artiva. “We report seven patients treated at the first dose level of one billion cells per dose in combination with rituximab, and we are encouraged by the initial clinical benefit we are seeing in patients with relapsed/refractory B-cell non-Hodgkin lymphoma who have failed multiple lines of prior treatment.” “Given the limited persistence of allogeneic NK cells, we believe our ability to deliver multiple doses over several months, much in line with the dosing of monoclonal antibodies, could help drive deep and durable responses. In this trial, we have patients who have received 16 doses of AB-101 over the course of several months because our highly scalable AlloNK® platform can manufacture thousands of cryopreserved doses of AB-101 from a single umbilical cord,” added Fred Aslan, M.D., Chief Executive Officer of Artiva. “We believe AB-101 could be a broad ADCC-enhancer with the potential to be combined with multiple therapeutic antibodies or NK cell engagers across different indications.” Phase 1 Dose-Escalation Efficacy Data The Phase 1/2 clinical trial in B-NHL is assessing AB-101 in an outpatient treatment regimen delivered in cycles, with each cycle consisting of three days of conditioning chemotherapy (250 mg/m 2 or 500 mg/m 2 of cyclophosphamide and 30 mg/m 2 of fludarabine) followed by four weekly doses of AB-101 at one billion or four billion cells per dose, each with IL-2 cytokine support. Monotherapy consists of one cycle only, while combination therapy allows for up to four cycles, each with two to three doses of rituximab (375 mg/m 2 ). Patients had received a median of four prior lines of therapy, and 67% were refractory to the prior line of therapy. Approximately two-thirds have aggressive B-NHL. In the rituximab combination cohort, 89% had been treated with prior CAR-T therapy. The Objective Response Rate (ORR) in seven efficacy evaluable patients treated with one billion cells per dose of AB-101 in combination with rituximab was 57.1% overall, including three Complete Responses (CRs) and one Partial Response (PR).​ Three of the responses were seen in patients who failed prior CAR-T therapy, and at the time of the data cut, three patients had ongoing responses and were progression free for 5+, 7+ and 9+ months.​ Phase 1 Dose-Escalation Safety Data At the time of the data cut, 15 patients in the monotherapy and nine patients in the combination cohorts were evaluable for assessment of safety. AB-101 was well tolerated at one and four billion cells per dose. Up to 16 doses of AB-101 at one billion cells per dose were successfully administered in combination with rituximab in an outpatient setting. Myelosuppression, consistent with standard lymphodepletion regimens, was the most common Grade ≥ 3 toxicity, but was manageable with standard of care. No prolonged cytopenias were observed. No observations of ICANS / neurotoxicity or GvHD were noted even after 16 doses per patient.​ Two patients (8%) had Grade 1 reports of CRS, based on low-grade fevers which resolved within five to 24 hours without the usage of steroids and/or tocilizumab.​​ The most common SAEs reported in the monotherapy cohort were febrile neutropenia (Grade 3+, n=2) and malignant neoplasm progression (Grade 3+, n=2; Grade 1-2, n=1). In the combination cohort, only one unrelated Grade 3 SAE of pyrexia was noted.​ There were no treatment-related AEs leading to discontinuation of AB-101.​ Details of the poster presentation can be found here . About AB-101 AB-101 is a non-genetically modified, cord blood-derived, allogeneic, cryopreserved, ADCC-enhancing NK cell therapy candidate for use in combination with monoclonal antibodies or innate-cell engagers in the out-patient setting. Artiva selects cord blood units with the high affinity variant of the receptor CD16 and a KIR-B haplotype for enhanced product activity. Using the Company’s AlloNK® platform, Artiva can generate thousands of doses of pure, cryopreserved, infusion-ready NK cells from a single umbilical cord blood unit while retaining the high and consistent expression of CD16 and other tumor-engaging receptors, without the need for engineering. We believe this makes AB-101 an optimal adjunct therapy to targeted, ADCC-mechanistic biologics. Artiva is conducting a Phase 1/2 multicenter clinical trial (ClinicalTrials.gov Identifier: NCT04673617) to assess the safety and clinical activity of AB-101 alone and in combination with the anti-CD20 monoclonal antibody, rituximab, in patients with relapsed or refractory B-cell-non-Hodgkin lymphoma (B-NHL) who have progressed beyond two or more prior lines of therapy including CAR-T therapy. This study is progressing at multiple clinical sites across the U.S., and AB-101 is administered weekly in the out-patient setting over one-month cycles and with up to four cycles to assess therapeutic efficacy and durability. Artiva is also collaborating with Affimed N.V. in developing a combination therapy, comprised of AB-101 and the Innate Cell Engager AFM13, for the treatment of patients with relapsed/refractory CD30-positive lymphomas. About Artiva Biotherapeutics Artiva’s mission is to deliver highly effective, off-the-shelf, allogeneic NK cell-based therapies utilizing our Manufacturing-First approach, that are safe and accessible to cancer patients. Artiva’s pipeline includes AB-101, an ADCC enhancer NK-cell therapy candidate for use in combination with monoclonal antibodies or innate-cell engagers. Artiva is currently advancing a Phase 1/2 clinical trial of AB-101 in combination with rituximab for the treatment of relapsed or refractory B-cell lymphomas and is also combining AB-101 with Affimed N.V.’s Innate Cell Engager AFM13 for the treatment of patients with relapsed/refractory CD30-positive lymphomas. Artiva’s pipeline also includes AB-201, an anti-HER2 CAR-NK cell therapy candidate for the treatment of HER2-overexpressing tumors, such as breast, gastric, and bladder cancers, and for which an IND has been allowed by FDA, and a pipeline of CAR-NK candidates targeting both solid and hematopoietic cancers. Artiva has entered into therapeutic NK cell collaborations with Merck Sharp & Dohme and with Affimed N.V. Artiva’s AlloNK® platform incorporates cell expansion, activation, and engineering technology developed by Artiva’s strategic partner, GC Cell Corporation, a member of the GC family of companies, a leading healthcare company in Korea. Artiva is headquartered in San Diego. For more information, visit www.artivabio.com .