Affimed Announces Positive Results Demonstrating Safety and Efficacy of Acimtamig and AlloNK® Combination in Relapsed/Refractory Classical Hodgkin Lymphoma (R/R cHL) Patients

Rhea-AI Summary

Affimed (NASDAQ: AFMD) announced positive results from the LuminICE-203 phase 2 study, evaluating the combination of acimtamig with AlloNK® in relapsed/refractory classical Hodgkin Lymphoma patients. The trial included 22 heavily pretreated patients who had received a median of 5 prior therapies.

The combination demonstrated an overall response rate of 86% and a complete response rate of 55%. The treatment showed a well-manageable safety profile with no unexpected safety signals, and notably, no cases of graft-versus-host disease or immune effector cell-associated neurotoxicity syndrome were reported.

All patients had previously received intensive combination chemotherapy, PD(L)1 checkpoint inhibitors, and brentuximab vedotin, with approximately two-thirds having undergone stem cell transplant.

Positive

• High overall response rate of 86% in heavily pretreated patients
• Complete response rate of 55% in patients with treatment options
• Well-managed safety profile with no unexpected safety signals
• Successful validation of treatment in multi-center setting

Negative

• None.

Insights

Medical Research Analyst

This clinical trial data represents a significant breakthrough for Affimed's acimtamig/AlloNK® combination therapy. An 86% overall response rate and 55% complete response rate in heavily pretreated R/R cHL patients is remarkably high for this difficult-to-treat population. The safety profile appears robust with no GvHD or ICANS cases - critical safety concerns for cell therapies. The multicenter nature of the trial (10 U.S. sites) adds credibility to the results compared to single-center studies. The data is particularly compelling given the patient population had exhausted standard treatments including chemotherapy, PD(L)1 inhibitors and brentuximab vedotin, with many also failing stem cell transplants. This validates both the combination approach and the practicality of using an off-the-shelf cryopreserved NK cell product.

Financial Analyst

These positive clinical results could significantly impact Affimed's market position in the R/R cHL treatment landscape. The high response rates in a heavily pretreated population address an important unmet medical need, potentially positioning acimtamig/AlloNK® as a valuable late-line therapy. The successful validation of the co-administration approach with an off-the-shelf product is commercially significant, as it suggests better scalability and logistics compared to fresh NK cell preparations. For a company with a market cap of just $38.5 million, these results could attract partnership interests or impact valuation. The multicenter trial success also de-risks the development program, though ongoing enrollment and future regulatory milestones will be critical catalysts.

• The combination of acimtamig with AlloNK^® demonstrated an overall response rate of 86% and complete response of 55% in 22 heavily pretreated patients with R/R cHL, who have exhausted all standard of care treatments
• The combination showed a well-manageable safety profile with no unexpected safety signals

MANNHEIM, Germany, Dec. 08, 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 the presentation of data in a poster session at the 66th ASH Annual Meeting and Exposition. The dataset includes 22 patients from the run-in phase of the LuminICE-203 (AFM13-203) phase 2 open-label, multicenter, multi-cohort study. The trial evaluates the safety and efficacy of the combination of acimtamig (AFM13) with Artiva Biotherapeutics’ allogeneic NK cell AlloNK^® in patients with R/R cHL.

Acimtamig in combination with AlloNK^® demonstrated a high overall response rate (ORR) of 86% with complete response (CR) of 55%. All patients in the study were heavily pretreated with a median of 5 (range: 2-13) prior therapies. All patients had received intensive combination chemotherapy, PD(L)1 checkpoint inhibitors and brentuximab vedotin. In addition, about two third of the patients had also received a previous stem cell transplant. The combination regimen exhibited a well-managed safety profile with no unexpected safety signals. Importantly, no cases of graft-versus-host disease (GvHD) or immune effector cell-associated neurotoxicity syndrome (ICANS) were reported.

“We are excited to present this new data, which highlights the significant potential of acimtamig combined with AlloNK^® as a highly effective, innovative treatment option for patients with R/R cHL,” said Dr. Andreas Harstrick, Chief Medical Officer of Affimed. “There are no established treatment options for patients with R/R cHL who have failed combination chemotherapy, PD(L)1 and brentuximab vedotin. To see more than 50% of patients achieving a complete response is extremely encouraging and highlights the potential that this combination may provide an effective treatment option for these refractory patients. It is also important that these data were obtained in a multicenter trial with 10 sites across the U.S. enrolling patients.”

These findings are in line with previous data generated from the single center investigator-initiated study AFM13-104 (NCT04074746), which utilized fresh allogeneic NK cells precomplexed with acimtamig in a similar R/R cHL patient population. These results further validate the co-administration approach of acimtamig with an off-the-shelf, allogeneic, cryopreserved NK cell product (AlloNK^®) in a multi-center setting. Enrolment into the LuminICE-203 trial is ongoing.

About Acimtamig

Acimtamig (AFM13) is a first-in-class ICE^® that uniquely activates the innate immune system to destroy CD30-positive hematologic tumors. Acimtamig 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. Acimtamig is a tetravalent bispecific innate cell engager designed to act as a bridge between the innate immune cells and the tumor, creating the necessary proximity for the innate immune cells to destroy the tumor cells.

About LuminICE-203 (AFM13-203)

LuminICE-203 (AFM13-203) is a Phase 2 open-label, multicenter, multi-cohort study. The trial is evaluating the safety and efficacy of the combination of acimtamig (AFM13) with Artiva Biotherapeutics’ allogeneic NK cell AlloNK^® (AB-101) in patients with relapsed/refractory classical Hodgkin lymphoma and CD30-positive peripheral T cell lymphoma (NCT05883449).

The study builds on the unprecedented efficacy results from an investigator sponsored study, AFM13-104, which investigated acimtamig in combination with cord blood-derived NK cells in patients with refractory/recurrent CD30-positive Hodgkin or non-Hodgkin lymphoma (NCT04074746).

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 innate cell engagers (ICE^®) enable a tumor-targeted approach to recognize and kill a range of hematologic and solid tumors. ICE^® are generated on the Company’s proprietary ROCK^® platform which predictably generates customized molecules that leverage the power of innate immune cells to destroy tumor cells. A number of ICE^® molecules are in clinical development, being studied as mono- or combination therapy. Headquartered in Mannheim, Germany, Affimed is led by an experienced team of biotechnology and pharmaceutical leaders united by the 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 acimtamig (AFM13), AFM24, AFM28 and the Company’s other product candidates; the value of its ROCK^® platform; its ongoing and planned clinical trials; its corporate restructuring, the associated headcount reduction and the impact this may have on Company’s anticipated savings and total costs and expenses; 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 acimtamig in combination with NK cell therapy is based on acimtamig 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.

Affimed Investor Relations Contact

Alexander Fudukidis
Director, Investor Relations
E-Mail: a.fudukidis@affimed.com
Tel.: +1 (917) 436-8102

Affimed Media Contact

Mary Beth Sandin
Vice President, Marketing and Communications
E-Mail: m.sandin@affimed.com

FAQ

What were the response rates for Affimed's acimtamig and AlloNK combination in R/R cHL patients (AFMD)?

The combination achieved an overall response rate of 86% and a complete response rate of 55% in 22 heavily pretreated R/R cHL patients.

What safety results were reported for Affimed's acimtamig and AlloNK combination therapy (AFMD)?

The combination showed a well-manageable safety profile with no unexpected safety signals, and notably no cases of graft-versus-host disease (GvHD) or immune effector cell-associated neurotoxicity syndrome (ICANS).

How many prior therapies did patients receive in Affimed's LuminICE-203 trial (AFMD)?

Patients in the trial had received a median of 5 prior therapies, ranging from 2 to 13 treatments.