- The mixture of acimtamig with AlloNK ® demonstrated an total response charge of 86% and full response of 55% in 22 closely pretreated sufferers with R/R cHL, who’ve exhausted all commonplace of care therapies
- The mixture confirmed a well-manageable security profile with no sudden security indicators
MANNHEIM, Germany, Dec. 08, 2024 (GLOBE NEWSWIRE) — Affimed N.V. (Nasdaq: NASDAQ:) (Affimed, or the Firm), a clinical-stage immuno-oncology firm dedicated to giving sufferers again their innate skill to battle most cancers, in the present day introduced the presentation of information in a poster session on the 66th ASH Annual Assembly and Exposition. The dataset consists of 22 sufferers from the run-in part of the LuminICE-203 (AFM13-203) part 2 open-label, multicenter, multi-cohort research. The trial evaluates the protection and efficacy of the mix of acimtamig (AFM13) with Artiva Biotherapeutics’ allogeneic NK cell AlloNK ® in sufferers with R/R cHL.
Acimtamig together with AlloNK ® demonstrated a excessive total response charge (ORR) of 86% with full response (CR) of 55%. All sufferers within the research had been closely pretreated with a median of 5 (vary: 2-13) prior therapies. All sufferers had acquired intensive mixture chemotherapy, PD(L)1 checkpoint inhibitors and brentuximab vedotin. As well as, about two third of the sufferers had additionally acquired a earlier stem cell transplant. The mixture routine exhibited a well-managed security profile with no sudden security indicators. Importantly, no circumstances of graft-versus-host illness (GvHD) or immune effector cell-associated neurotoxicity syndrome (ICANS) had been reported.
We’re excited to current this new knowledge, which highlights the numerous potential of acimtamig mixed with AlloNK ® as a extremely efficient, modern therapy choice for sufferers with R/R cHL, mentioned Dr. Andreas Harstrick, Chief Medical (TASE:) Officer of Affimed. There are not any established therapy choices for sufferers with R/R cHL who’ve failed mixture chemotherapy, PD(L)1 and brentuximab vedotin. To see greater than 50% of sufferers attaining an entire response is extraordinarily encouraging and highlights the potential that this mix might present an efficient therapy choice for these refractory sufferers. It’s also necessary that these knowledge had been obtained in a multicenter trial with 10 websites throughout the U.S. enrolling sufferers.
These findings are in step with earlier knowledge generated from the only middle investigator-initiated research AFM13-104 (NCT04074746), which utilized recent allogeneic NK cells precomplexed with acimtamig in an identical R/R cHL affected person inhabitants. These outcomes additional validate the co-administration strategy 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 prompts the innate immune system to destroy CD30-positive hematologic tumors. Acimtamig induces particular and selective killing of CD30-positive tumor cells, leveraging the facility of the innate immune system by partaking and activating pure killer (NK) cells and macrophages. Acimtamig is a tetravalent bispecific innate cell engager designed to behave as a bridge between the innate immune cells and the tumor, creating the required proximity for the innate immune cells to destroy the tumor cells.
About LuminICE-203 (AFM13-203)
LuminICE-203 (AFM13-203) is a Part 2 open-label, multicenter, multi-cohort research. The trial is evaluating the protection and efficacy of the mix of acimtamig (AFM13) with Artiva Biotherapeutics’ allogeneic NK cell AlloNK ® (AB-101) in sufferers with relapsed/refractory classical Hodgkin lymphoma and CD30-positive peripheral T cell lymphoma (NCT05883449).
The research builds on the unprecedented efficacy outcomes from an investigator sponsored research, AFM13-104, which investigated acimtamig together with twine blood-derived NK cells in sufferers with refractory/recurrent CD30-positive Hodgkin or non-Hodgkin lymphoma (NCT04074746).
About Affimed N.V.
Affimed (Nasdaq: AFMD) is a clinical-stage immuno-oncology firm dedicated to giving sufferers again their innate skill to battle most cancers by actualizing the untapped potential of the innate immune system. The Firm’s innate cell engagers (ICE ®) allow a tumor-targeted strategy to acknowledge and kill a spread of hematologic and strong tumors. ICE ® are generated on the Firm’s proprietary ROCK ® platform which predictably generates custom-made molecules that leverage the facility of innate immune cells to destroy tumor cells. A lot of ICE ® molecules are in medical improvement, being studied as mono- or mixture remedy. Headquartered in Mannheim, Germany, Affimed is led by an skilled crew of biotechnology and pharmaceutical leaders united by the daring imaginative and prescient to cease most cancers from ever derailing sufferers’ lives. For extra concerning the Firm’s individuals, pipeline and companions, please go to: www.affimed.com.
Ahead-Trying Statements
This press launch comprises forward-looking statements. All statements apart from statements of historic reality are forward-looking statements, which are sometimes indicated by phrases comparable to anticipate, consider, might, estimate, count on, purpose, intend, stay up for, might, plan, potential, predict, challenge, ought to, will, would and related expressions. Ahead-looking statements seem in quite a lot of locations all through this launch and embrace statements concerning the Firm’s intentions, beliefs, projections, outlook, analyses and present expectations regarding, amongst different issues, the potential of acimtamig (AFM13), AFM24, AFM28 and the Firm’s different product candidates; the worth of its ROCK ® platform; its ongoing and deliberate medical trials; its company restructuring, the related headcount discount and the impression this may occasionally have on Firm’s anticipated financial savings and complete prices and bills; its collaborations and improvement of its merchandise together with different therapies; the timing of and its skill to make regulatory filings and procure and keep regulatory approvals for its product candidates; its mental property place; its collaboration actions; its skill to develop industrial features; medical trial knowledge; its outcomes of operations, money wants, monetary situation, liquidity, prospects, future transactions, development and methods; the trade through which it operates; the macroeconomic developments which will have an effect on the trade or the Firm, such because the instability within the banking sector skilled within the first quarter of 2023; impacts of the COVID-19 pandemic, the advantages to Affimed of orphan drug designation; the impression on its enterprise by political occasions, warfare, terrorism, enterprise interruptions and different geopolitical occasions and uncertainties, such because the Russia-Ukraine battle; the truth that the present medical knowledge of acimtamig together with NK cell remedy relies on acimtamig precomplexed with recent allogeneic twine blood-derived NK cells from The College of Texas MD Anderson Most cancers Heart, versus Artiva’s AB-101; and different uncertainties and elements described below the heading Threat Components in Affimed’s filings with the SEC. Given these dangers, uncertainties, and different elements, you shouldn’t place undue reliance on these forward-looking statements, and the Firm assumes no obligation to replace these forward-looking statements, even when new info turns into obtainable sooner or later.
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, Advertising and Communications
E-Mail: m.sandin@affimed.com
Supply: Affimed N.V.
