Affimed Reports Promising Phase 1 Efficacy and Safety Data for AFM28 in Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)

Rhea-AI Summary

Affimed announced promising Phase 1 data for AFM28 in treating relapsed/refractory Acute Myeloid Leukemia (R/R AML). The study, involving 29 heavily pretreated patients, demonstrated a 40% composite complete remission rate at the highest dose level (300 mg). Key findings include:

- Well-managed safety profile with mainly Grade 1 and 2 infusion-related reactions in 45% of patients
- No neurotoxicity or immune-related side effects
- One complete remission at 250 mg dose level with 6.5-month treatment duration
- At 300 mg dose level, achieved 1 CR and 3 CRi in 10 evaluable patients

The study included patients with a median of two prior treatment lines, with 86% having adverse risk profiles. Based on these results, evaluation of higher dose levels is planned.

Positive

• 40% composite complete remission rate achieved at 300 mg dose level
• Favorable safety profile with only mild to moderate side effects
• Clinical efficacy demonstrated in heavily pretreated patients
• Four of 10 patients still on treatment with potential for deeper responses

Negative

• Only 40% response rate at highest dose level, leaving majority of patients unresponsive
• 45% of patients experienced infusion-related reactions
• duration of response data available

• AFM28, a bispecific, tetravalent innate cell engager (ICE^®) targeting CD123 and CD16A, achieved a 40% composite complete remission rate (CRcR) at the highest dose level (300 mg) in heavily pretreated R/R AML patients
• AFM28 demonstrates a favorable safety profile: Grade 1 and 2 Infusion related reactions (IRRs) were the main related side effect, occurring in 45% of patients; no signs of neurotoxicity or immune-related side effects were observed
• Based on the good safety profile and likely dose-effect relationship, the evaluation of higher dose levels is planned
  

MANNHEIM, Germany, Dec. 09, 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 oral presentation of data on AFM28 at the 66th ASH Annual Meeting and Exposition. The data, derived from the first-in-human Phase 1 study of AFM28, showed promising results in R/R AML, with signs of clinical efficacy and a well-managed safety profile at doses up to 300 mg weekly.

The study included 29 heavily pretreated R/R AML patients across six AFM28 dose levels. The median number of prior treatment lines was two and 86% of patients had an adverse risk profile according to the 2022 guidelines from the European LeukemiaNet (ELN2022). AFM28 was administered intravenously once a week across six dose levels, ranging from 25 mg to 300 mg. AFM28 was well tolerated, and the most common treatment-emergent adverse events were IRRs, observed in 45% of patients. All IRRs were mild to moderate (Grade 1 or 2). One patient demonstrated grade 1 cytokine release syndrome (CRS). No neurotoxicity or signs for immune-effector related side effects were seen.

One of six patients treated at 250 mg showed a CR and stayed on treatment for 6.5 months. At the 300 mg dose level, 1 CR and 3 CRi were seen in 10 evaluable patients for a CRcR of 40%. Four of 10 patients are still on treatment with the option to deepen responses.

“Achieving a 40% composite complete remission rate with AFM28 in R/R AML is a significant milestone, especially in this difficult-to-treat patient population. Importantly, we see activity independent of mutational status, including patients with negative prognostic molecular profiles. Safety has been manageable which provides the basis for further development of AFM28 either as single agent or in combination regimens,” said Dr. Andreas Harstrick, MD, Chief Medical Officer at Affimed.

The AFM28 Phase 1 study is on-going.

About AFM28

AFM28, a tetravalent, bispecific CD123- and CD16A-binding ICE^®, is designed to bring our immunotherapeutic approach to patients with acute myeloid leukemia (AML). It engages NK cells to initiate leukemic cell killing via antibody-dependent cellular cytotoxicity, even at low CD123 expression levels. AFM28 is currently in clinical development as monotherapy in patients with R/R AML (NCT05817058).

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 Phase 1 efficacy results for AFM28 in R/R AML patients?

AFM28 achieved a 40% composite complete remission rate (CRcR) at the 300 mg dose level, with 1 CR and 3 CRi in 10 evaluable patients.

What were the main side effects reported in the AFM28 Phase 1 trial?

The main side effects were Grade 1 and 2 infusion-related reactions (IRRs) occurring in 45% of patients, with one case of grade 1 cytokine release syndrome. No neurotoxicity or immune-related side effects were observed.

How many patients were included in the AFM28 Phase 1 trial?

The study included 29 heavily pretreated R/R AML patients across six AFM28 dose levels, ranging from 25 mg to 300 mg weekly.

What is the current status of the AFM28 clinical trial?

The Phase 1 study is ongoing, with plans to evaluate higher dose levels based on the favorable safety profile and dose-effect relationship observed.