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PR: Heidelberg Pharma Presented New Clinical Data for Lead ATAC Candidate Pamlectabart Tismanitin at IMS Annual Meeting 2026

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  • Recommended Phase 2 Dose (RP2D) of 175 µg/kg for pamlectabart tismanitin established based on Phase I data
  • Favorable safety profile observed across dose escalation, with the maximum tolerated dose (MTD) not reached
  • Phase IIa dose expansion in patients with relapsed or refractory multiple myeloma (RRMM) progressing according to plan

Ladenburg, Germany, 24 September 2026 – Heidelberg Pharma AG (FSE: HPHA), a clinical-stage biotech company developing innovative Antibody Drug Conjugates (ADCs), presented new data from its Phase I/IIa clinical study with its lead Amanitin-based ADC candidate, pamlectabart tismanitin (HDP-101), at the 23rd International Myeloma Society (IMS) Annual Meeting in Glasgow, UK.

The Phase I dose escalation part of the clinical study was completed in April 2026, after treating ten patient cohorts across a dose range of 20 to 218 µg/kg. Heidelberg Pharma’s Benefit and Risk Assessment team agreed with the recommendation of the study’s Safety Review Committee (SRC), which had conducted a comprehensive review of safety, tolerability and pharmacokinetic (PK) data from the ongoing trial, and selected the dose level from Cohort 9 – 175 µg/kg – as Recommended Phase 2 Dose (RP2D).

In the Phase I part of the study, 53 patients with relapsed or refractory multiple myeloma (RRMM) were dosed and included in the data analysis. All patients were heavily pretreated with a median of five prior lines of treatment. Pamlectabart tismanitin was well-tolerated and a maximum tolerated dose was not reached. All adverse events that occurred were reversible, and no treatment related grade 5 events were observed.

Clinical responses were observed from ≥90 µg/kg, with increasing efficacy at higher doses. Across Cohorts 5 – 9, the Overall Response Rate (ORR) was 42% (13 out of 31 evaluable patients), including seven partial responses (PR), three very good partial responses (VGPR), and three stringent complete responses (sCR). In Cohort 9 (175 µg/kg), two out of five evaluable patients achieved a response: one PR and one VGPR. Additionally, one patient achieved minimal response (MR) and one patient with non-measurable disease achieved complete response (CR). Two of these patients are still under treatment.

Dr. Dongzhou Jeffery Liu, Chief Executive Officer of Heidelberg Pharma: “The data presented at IMS further strengthen our confidence in pamlectabart tismanitin as a promising new BCMA-targeted ADC. The observed clinical activity and favorable safety profile in heavily pretreated RRMM patients highlight the potential of our Amanitin-based ADC product to address unmet needs in multiple myeloma patients. With the RP2D now established, we look forward to advancing into the Phase IIa study further evaluating the therapeutic potential of pamlectabart tismanitin.”

Heidelberg Pharma’s Phase I/IIa clinical study is a non-randomized, open-label, dose escalation trial actively enrolling patients with relapsed or refractory multiple myeloma or other BCMA-expressing plasma cell disorders. The study is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of pamlectabart tismanitin in this patient population.

The poster can be found on the Company’s website: Poster IMS 2026