Head of Bioanalytics

General Manager

Deputy General Manager

Assistant General Manager

Associate Scientific Manager

Principal Scientist

Scientist

Research Associate

PK, Immunogenicity (ADA & NAb) immunoassay development and validation / CRO liaison / Bioanalytical strategy / Regulatory compliance / Bioanalytical operations / Bioanalytical leadership

Pallavi Hajela

Affimed

Head of Drug Safety

Senior Pharmacovigilance Project Manager / Deputy EU QPPV / Stufenplanbeauftragter

Pharmacovigilance Project Manager / Stufenplanbeauftragter

PV Project Manager

Drug Safety Officer

Biochemist (Master Studies)

Medical Representative

Head of Drug Safety at Affimed

Riham Elbadri

Sr. Director Regulatory Affairs

Director Regulatory Affairs

Ass. Director, Global Regulatory Affairs Oncology

Sr. Regulatory Affairs Manager

Associate Director Regulatory Affairs

Manager Submission and Investigator Services

Wissenschaftlicher Mitarbeiter

Sr. Director Regulatory Affairs bei Affimed

Sandra Schmid

Senior Manager IT Compliance

MES System Consultant

IT Quality Manager

Senior Global IT Governance Consultant Compliance

IT Compliance

Unix Administrator

Joerg Kuhn

Senior Clinical Operation Program Manager at Affimed

Associate Director Clinical Operations

Senior Global Project Manager

PM/Regulatory Affairs Specialist

CRA/CPM

Aurelio Garofano

Senior Manager Regulatory Affairs

Regulatory Affairs Project Manager

Manager Regulatory Affairs- New Products EEA

Senior Manager Regulatory Affairs bei Affimed | Master of Science, Arzneimittelzulassung

Anita Szpala

Quality GMP manager

Quality Assurance Manager

Head pharmacist in oncology hospital

Fatemeh Raji

VP Regulatory Affairs

Head Of Regulatory Affairs

Head of Regulatory Affairs

Senior Manager Global Regulatory Affairs

Manager Global Regulatory Affairs

Global Regulatory CMC Manager

Scientific Writer Vaccines

Laboratory Technician

VP Regulatory Affairs at Affimed

Erika Johnson-Froneberg

Sr. Manager Quality Systems & CSV

QA/QM Unit Support

Freelancer QA/QM and Clinical Research (GCP) for various clients

QM & Regulatory MDR support

Clinical Trial Associate and Clinical Project Manager

Quality Manager for Risk Reports (FMEA) - Freelancer

Quality Management Specialist Region Europe

Quality Management Associate (GxP) and Medical Technician

Study Nurse and Health Professional

Michaela Sommer

Affimed is a clinical-stage biopharmaceutical company focused on developing cancer immunotherapies using its ROCK® (Redirected Optimized Cell Killing) platform.

Affimed N.V. (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 Innate Cell Engagers (ICE®), generated from its proprietary ROCK® platform, are bispecific antibodies, which target innate immune cells, e.g. natural killer (NK) cells and macrophages, to destroy tumor cells. Affimed’s ICE® enable a tumor-targeted approach to recognize and kill a range of hematologic and solid tumors with activity demonstrated as monotherapy and when given in combination with NK cells and other I-O therapeutics. Affimed has three active clinical programs focused on solid tumors and blood cancers. 

The lead candidate Acimtamig (AFM13) is in development for patients with CD30-positive lymphomas. Acimtamig combined with NK cells has demonstrated high objective response rates in heavily pretreated, relapsed / refractory (r/r) Hodkin lymphoma (HL) patients with a manageable safety profile in a clinical trial (AFM13-104). Affimed’s phase 2 study, LuminICE-203, is underway to investigate acimtamig in combination with AlloNK® (also known as AB-101), an off-the-shelf, allogeneic NK cell from Artiva Biotherapeutics, in patients with r/r HL with an exploratory arm planned in patients with r/r/ peripheral T-cell lymphoma (PTCL). 

AFM24 is in development for epidermal growth factor receptor (EGFR)-expressing solid tumors. Based on the data generated to date, the developmental focus of AFM24 is in combination with the anti-PD-L1 inhibitor atezolizumab in advanced stage EGFR-positive non-small cell lung cancer (NSCLC). 

AFM28 is being developed for patients with CD123-expressing acute myeloid leukemia (AML) in need of new therapeutic options. A first-in-human Phase 1 clinical study is underway (AFM28-101) and development in combination with allogeneic NK cell therapy is being explored.





Perceptive Advisors

German Federal Ministry of Education and Research (BMBF)

Silicon Valley Bank

Roche

Aeris Capital

OrbiMed

Novo Holdings

BioMedPartners

EQT life science

August 1st is #WorldLungCancerDay – started in 2012 as an effort to raise awareness of lung cancer, one of the most common and deadly cancers across the world, and to educate people about its risks, prevention, and symptoms in order to help increase early detection.

At Affimed, we are developing novel therapies for hard-to-treat cancers including advanced non-small cell lung cancer (NSCLC) where patients too often have limited options. 

We are united in our shared vision of leveraging the innate immune system to create a future where cancer no longer derails the lives of patients and their loved ones.

 #AFM24 #InnateImmunity #ImmunoOncology #WhyWeFightCancer

We are #AffimedProud of all of our colleagues who joined more than 5,000 runners worldwide in the 13th National Center for Tumor Diseases (NCT) Heidelberg Virtual Run this July to help raise money for #CancerResearch. 
 
 #nctrun
#nctlauf 
#WhyWeFightCancer
#TeamAffimed

This Sunday is #WorldCancerDay 2024 and it reminds us that there is still a lot of work to be done in the fight against cancer. 

At Affimed we remain committed to developing novel therapies for hard-to-treat cancers like relapsed/refractory blood cancers and solid tumors where patients too often have limited options. 

We are united in our shared vision of leveraging the innate immune system to create a future where cancer no longer derails the lives of patients and their loved ones.

 #InnateImmunity #ImmunoOncology #WhyWeFightCancer

Following our earlier promising #ASH23 update, we are also pleased to announce positive data for our innate cell engager (ICE®) #AFM24 in combination with the PD-L1 checkpoint inhibitor atezolizumab, in heavily pretreated EGFR-Wildtype Non-Small Cell Lung Cancer (#NSCLC) patients.
We are encouraged by these promising results, especially considering that patients in this setting are often left without viable treatment options.  

We will be hosting a webcast today, December 11 at 1:30 p.m. PST / 4:30 p.m. EST / 10:30 PM CET, to discuss the data in more detail. 

You can read the full press release at: https://lnkd.in/dJXhGpdk

We are proud to see continued strong and durable responses for our lead innate cell engager (ICE®), acimtamig (AFM13) in a patient population that is left with few options, presented at the #ASH23 Annual Meeting today. The results presented by the principal investigator Yago Nieto, M.D., Ph.D., Professor of Stem Cell Transplantation and Cellular Therapy at The University of Texas MD Anderson Cancer Center are unprecedented, especially for  patients who failed prior chemotherapy and are double-refractory to brentuximab vedotin (BV) and checkpoint inhibitors (CPIs).
 
Building on these results, we are well underway with our Phase 2 LuminICE-203 trial studying acimtamig in combination with AlloNK® (AB-101).  We are enrolling and dosing patients in the first two cohorts and look forward to sharing data in the first half of 2024.
 
We will host a webcast at 1:30 p.m. PST / 4:30 p.m. EST / 10:30 p.m. CET to review the data and provide a strategic update on acimtamig future development. 
 
Access additional details, including dial-in information in the press release at: https://lnkd.in/dFgSRtNQ

Heading to #ASH23? Be sure to check out the two presentations on our lead candidate, the innate cell engager (ICE®) acimtamig (AFM13).
 
At the American Society of Hematology Annual Meeting, we will provide updated results from the AFM13-104 phase 1/2 trial evaluating acimtamig (AFM13) in combination with cord blood-derived natural killer (cbNK) in patients with CD30-positive relapsed or refractory (r/r) Hodgkin and non-Hodgkin lymphomas. The oral presentation by Prof. Yago Nieto will take place on Monday, December 11, 2023 at 11:45 a.m. PST.
 
We will also feature the design of our phase 2 LuminICE-203 clinical trial investigating acimtamig in combination with Artiva’s AlloNK® (also known as AB-101), an allogeneic, non-genetically modified NK cell therapy candidate. The trial is based on the unprecedented results achieved in the AFM13-104 study and will evaluate the efficacy and safety of the combination in patients with r/r HL and certain r/r CD30+ PTCL subtypes. The Trial In Progress poster presentation will take place on Monday, December 11, 2023 from 6:00 p.m. PST – 8:00 p.m. PST. Poster #4855.
 
We look forward to seeing you there!

Photo	Title	Links
	Pallavi Hajela Head of Bioanalytics
	Riham Elbadri Head of Drug Safety
	Sandra Schmid Sr. Director Regulatory Affairs
	Joerg Kuhn Senior Manager IT Compliance
	Aurelio Garofano Senior Clinical Operation Program Manager at Affimed
	Anita Szpala Senior Manager Regulatory Affairs
	Fatemeh Raji Quality GMP manager
	Erika Johnson-Froneberg VP Regulatory Affairs
	Michaela Sommer Sr. Manager Quality Systems & CSV

COM:AFFIMED