Affimed Stock Price, News & Analysis

AbCheck s.r.o. has announced a collaboration with a biotech company focused on developing antibodies for peripheral neural response, backed by a European Venture Capital firm. This agreement entails utilizing AbCheck's advanced antibody discovery technologies to create antibodies targeting a challenging undisclosed profile. The company's microfluidics technology facilitates functional screening of millions of cells daily, enhancing drug discovery success rates. Dr. Volker Lang highlighted their commitment to delivering promising candidates for clinical development, aiming to provide novel treatment options for severe neurological disorders.

Affimed N.V. (Nasdaq: AFMD) announced that Dr. Adi Hoess, the CEO, will present at the SVB Securities 2023 Global Biopharma Conference on February 14, 2023, at 2:20 p.m. EST / 20:20 CET. The presentation will be available via a live webcast on Affimed's website, with a replay accessible for 30 days post-event. Affimed is focused on immuno-oncology, utilizing its proprietary ROCK® platform to develop innovative treatments targeting hematologic and solid tumors. The company aims to empower patients' innate immune responses against cancer, making strides in personalized cancer therapy.

Affimed N.V. (Nasdaq: AFMD) announced progress in its immuno-oncology pipeline, including support from the FDA for an IND filing of AFM13 combined with Artiva’s AB-101 for r/r Hodgkin lymphoma, planned for H1 2023. The AFM24 studies will present data updates in Q2/Q3 2023, while phase 1 study initiation for AFM28 is expected in Q2 2023, following CTA clearance in France and Spain. As of Dec 31, 2022, the company reported cash and equivalents of approximately €190 million, anticipated to fund operations into 2025.

Affimed N.V. (Nasdaq: AFMD) has received authorization from the French National Agency for the Safety of Medicines and Health Products (ANSM) for a clinical trial application (CTA) for its AFM28 in a phase 1 study targeting relapsed/refractory acute myeloid leukemia (AML). The trial, set to initiate in the first half of 2023, aims to investigate the safety and tolerability of AFM28, a bispecific Innate Cell Engager. This marks a significant milestone in Affimed's strategy to provide viable treatment options for AML patients, addressing a critical need in oncology.

Affimed N.V. (Nasdaq: AFMD) presented promising preclinical data for its Innate Cell Engager (ICE®) AFM28 at the 64th ASH Annual Meeting, targeting CD123-positive leukemic cells in patients with Acute Myeloid Leukemia (AML) and myelodysplastic syndrome (MDS).

AFM28 effectively redirected NK cells to deplete leukemic stem cells, showing potential for deep anti-leukemic responses. The program has demonstrated strong anti-tumor activity while maintaining a favorable safety profile. A first-in-human study is planned for the first half of 2023, highlighting AFM28 as a viable treatment option for refractory AML patients.

Affimed announced positive data from its phase 2 REDIRECT study on AFM13 monotherapy for relapsed/refractory peripheral T cell lymphoma (r/r PTCL). The treatment achieved an objective response rate (ORR) of 32.4% and a complete response rate (CR) of 10.2%. Key outcomes included a median duration of response of 2.3 months, median progression-free survival of 3.5 months, and median overall survival of 13.8 months. The company will now focus on investigating a combination therapy with NK cells, rather than seeking accelerated approval for monotherapy.

Affimed has reported promising results from its phase 1/2 study of AFM13 combined with cord blood-derived NK cells in patients with CD30-positive Hodgkin and Non-Hodgkin lymphomas. Among 31 Hodgkin lymphoma patients, an impressive objective response rate (ORR) of 97% and a complete response (CR) rate of 77% were observed. Notably, all participants had failed previous treatments. The study showed a favorable safety profile, with no significant adverse events reported. Affimed continues to explore the market potential for AFM13, aiming to address unmet needs in this patient population.

Affimed N.V. (Nasdaq: AFMD) announced an investor event to review clinical data and development plans for AFM13 in CD30 expressing malignancies. This event will take place on December 10, 2022, at 4:00 p.m. CST during the 64th American Society of Hematology Annual Meeting in New Orleans. AFM13 has shown promising efficacy in Hodgkin Lymphoma and T cell lymphoma, with high response rates in both monotherapy and combination trials. Affimed recently partnered with Artiva to further develop AFM13 with NK cell therapies. A webcast of the event will be available for those unable to attend.

Affimed reported Q3 2022 results highlighting a revenue increase to €14.9 million, up from €8.7 million year-over-year, primarily from collaborations with Genentech and Roivant. The company has entered a partnership with Artiva Biotherapeutics to advance AFM13 for CD30-positive lymphomas. AFM13's combination therapy maintains a 100% overall response rate in trials. Operating cash usage was €19 million, with cash reserves at €222.9 million expected to last through mid-2024. The net loss for Q3 was €16.5 million, or €0.11 per share, showing slight improvement from the previous year.