Curated News
By: NewsRamp Editorial Staff
November 04, 2026
Heidelberg Pharma to Present New ATAC ADC Data at ASH 2026
TLDR
- Heidelberg Pharma will present HDP-101 Phase I/IIa data at ASH 2026, showcasing a novel BCMA ADC with potential in relapsed multiple myeloma.
- HDP-101 is an Amanitin-based ADC targeting BCMA; Phase I determined the RP2D, and Phase IIa is ongoing with consistent activity and favorable safety.
- Heidelberg Pharma's Amanitin ADCs offer new hope for patients with multiple myeloma and B-cell malignancies by addressing high unmet medical needs.
- Heidelberg Pharma uses Amanitin from the green death cap mushroom to create a new class of cancer therapies called ATAC technology.
Impact - Why it Matters
The data to be presented at ASH 2026 underscore the potential of Heidelberg Pharma’s Amanitin-based ATAC technology to address significant unmet needs in multiple myeloma and B-cell malignancies. For patients with relapsed or refractory multiple myeloma, HDP-101’s consistent clinical activity and favorable safety profile in heavily pretreated populations offer a promising new approach, especially given the FDA’s Orphan Drug and Fast Track designations. The early biological activity seen with HDP-102 in non-Hodgkin lymphoma, even at low doses, further validates the ATAC platform. However, the company’s decision to discontinue the HDP-102 study and seek partners highlights the challenges of clinical development and the need for collaboration to advance innovative therapies. These developments are important for investors, clinicians, and patients alike, as they shape the future treatment landscape and demonstrate the broader applicability of this novel payload technology.
Summary
Heidelberg Pharma AG (FSE: HPHA), a clinical-stage biotech company based in Ladenburg, Germany, will present new clinical data on its lead Amanitin-based antibody-drug conjugate (ADC) candidate, pamlectabart tismanitin (HDP-101), and its second candidate, HDP-102, at the 68th Annual Meeting of the American Society of Hematology (ASH), taking place in New Orleans from December 12 to 15, 2026. The oral presentation on HDP-101, an anti-BCMA ADC for relapsed or refractory multiple myeloma (RRMM), will be delivered by Professor Marc-Steffen Raab and will detail the Recommended Phase 2 Dose (RP2D) selection and preliminary antitumor activity from the Phase I/IIa study. The Phase I dose-escalation portion, which included ten patient cohorts, was completed in April 2026, and the Phase IIa expansion is progressing as planned. Pamlectabart tismanitin demonstrated consistent clinical activity with a favorable safety profile in heavily pretreated RRMM patients, supporting its potential as a novel payload BCMA-targeted therapy. HDP-101 has received Orphan Drug and Fast Track designations from the FDA.
In a poster session, Dr. Irina Mocanu will present data on HDP-102, a first-in-class CD37-targeted Amanitin-based ADC for relapsed or refractory B-cell malignancies. In the ongoing Phase I study, three patients were treated at 40 µg/kg in the first cohort, with the treatment well tolerated and initial signs of biological activity observed even at this low dose. Two patients showed stabilization of disease with regression and reduction of lymph nodes, and the safety committee recommended escalating the dose to 65 µg/kg for the second cohort. However, Heidelberg Pharma has made a strategic decision to discontinue the study and is now exploring partnership opportunities to continue the program. The company’s ATAC technology, which uses Amanitin derived from the green death cap mushroom, represents a new therapeutic modality, and its pipeline includes HDP-103 for metastatic castration-resistant prostate cancer and HDP-104 for gastrointestinal tumors, both of which have completed preclinical development and are available for partnering. More information is available at http://www.heidelberg-pharma.com/.
Source Statement
This curated news summary relied on content distributed by NewMediaWire. Read the original source here, Heidelberg Pharma to Present New ATAC ADC Data at ASH 2026
