Drugs / HDP-101
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT07529782 | Mar → Jun 2026 overdue | plasma cell myeloma | Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04879043 | Feb 2022 → Mar 2028 expected | plasma cell myeloma | Heidelberg Pharma AG | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 23
| Date | Issuer | Release |
|---|---|---|
| 2026-09-07 | Heidelberg Pharma AG | Results PR: Heidelberg Pharma to Present New Clinical Data on Lead ATAC Candidate Pamlectabart Tismanitin at International Myeloma Society Annual Meeting 2026 heidelberg-pharma.com ↗
Pamlectabart tismanitin demonstrated consistent clinical activity with a favorable safety profile in heavily pretreated RRMM patients supporting the potential of the candidate as a novel payload BCMA-targeted ADC therapy. |
| 2026-08-26 | Heidelberg Pharma AG | Regulatory PR: Heidelberg Pharma AG and Huadong Medicine Receive NMPA Approval for Clinical Trial of HDP-101 Combination Therapy in China heidelberg-pharma.com ↗ |
| 2026-04-09 | Heidelberg Pharma AG | Results AH: Heidelberg Pharma Determines Recommended Dose for Phase II Trial with ADC Candidate HDP-101 heidelberg-pharma.com ↗ |
| 2025-12-17 | Heidelberg Pharma AG | Results Letter from the CEO heidelberg-pharma.com ↗
The results from Cohort 8 in our clinical phase I study give us great cause for optimism: Four out of seven evaluable patients responded to the therapy in Cohort 8. |
| 2025-11-06 | Heidelberg Pharma AG | Results PR: Heidelberg Pharma’s Lead ATAC Candidate HDP-101 Shows Progress in Phase I/IIa Trial in Multiple Myeloma heidelberg-pharma.com ↗
These findings are highlighted by observed stringent complete remissions in two patients from Cohort 8. |
| 2025-11-03 | Heidelberg Pharma AG | Results Heidelberg Pharma to Present New Clinical Data of Lead ADC Candidate HDP-101 at the World ADC Congress 2025 and to Host Webinar heidelberg-pharma.com ↗ |
| 2025-10-23 | Heidelberg Pharma AG | Regulatory PR: Heidelberg Pharma’s Lead ADC Candidate HDP-101 Granted Fast Track Designation by US FDA for the Treatment of Multiple Myeloma heidelberg-pharma.com ↗
The FDA’s granting of Fast Track Designation is fantastic news for Heidelberg Pharma and underscores the potential of HDP-101 for the treatment of severely ill and heavily pretreated patients. |
| 2025-10-09 | Heidelberg Pharma AG | Results Heidelberg Pharma Reports on the First Nine Months of Financial Year 2025 heidelberg-pharma.com ↗
In cohorts 5 to 8, we observed an overall response rate of 36%, and in cohort 8, the preliminary overall response rate is 50%. |
| 2025-09-25 | Heidelberg Pharma AG | Results PR: Heidelberg Pharma Advances to Cohort 9 in Phase I/IIa Trial of Lead ATAC Candidate HDP-101 in Multiple Myeloma heidelberg-pharma.com ↗
Patients showed biological activity of HDP-101, and a very good partial response has already been observed in one patient. |
| 2025-09-04 | Heidelberg Pharma AG | Results PR: Heidelberg Pharma Announces New Clinical Data on Lead ATAC Candidate HDP-101 to be Presented at International Myeloma Society Annual Meeting 2025 heidelberg-pharma.com ↗
Treatment with HDP-101 was well tolerated and the study has shown very encouraging results, including one patient from the fifth cohort in whom no tumor cells are detectable on a permanent basis. |
| 2025-05-14 | Heidelberg Pharma AG | Results PR: Heidelberg Pharma to Present Promising New Clinical Data on its Lead ATAC Candidate HDP-101 at EHA 2025 heidelberg-pharma.com ↗
HDP-101 is showing encouraging results, including an ongoing complete response in a female patient from cohort 5 who had been heavily pretreated and who has been treated continuously with HDP-101 alone for more than 19 months. |
| 2025-01-13 | Heidelberg Pharma AG | Results PR: Heidelberg Pharma Progresses into Cohort 7 in a Phase I/IIa Study with BCMA ATAC Candidate HDP-101 Targeting Multiple Myeloma heidelberg-pharma.com ↗
HDP-101 was well tolerated across all 10 patients in Cohort 6 dosed with 90 µg/kg, with no dose-limiting toxicities (DLTs) detected in any of the three parallel treatment arms. |
| 2024-11-06 | Heidelberg Pharma AG | Results PR: Heidelberg Pharma: Promising New Clinical Data on Lead ADC-Candidate HDP-101 to be Presented at ASH Annual Meeting 2024 heidelberg-pharma.com ↗
Currently advancing in its sixth cohort, the study has shown encouraging results, including complete remission in one patient from the fifth cohort who had been previously treated multiple times and had received several courses of HDP-101. |
| 2024-10-01 | Heidelberg Pharma AG | Results PR: Heidelberg Pharma: New Clinical Data on Lead ADC Candidate HDP-101 Presented at IMS 2024 Demonstrating Complete Remission in One Patient heidelberg-pharma.com ↗
Clinical data from the fifth cohort demonstrated complete remission in one patient who had been heavily pre-treated. |
| 2024-04-25 | Heidelberg Pharma AG | Results PR: Heidelberg Pharma AG: Interim Management Statement on the First Three Months of 2024 heidelberg-pharma.com ↗
In three patients from the fifth cohort, we have observed an objective improvement in the disease ("partial remission"). |
| 2024-03-27 | Heidelberg Pharma AG | Regulatory PR: Heidelberg Pharma granted orphan drug designation by FDA for its proprietary ATAC candidate HDP-101 heidelberg-pharma.com ↗
Heidelberg Pharma AG (FSE: HPHA), a clinical stage biotech company developing innovative Antibody Drug Conjugates (ADCs), is pleased to announce that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for the treatment of multiple myeloma to its lead candidate HDP-101. |
| 2024-03-25 | Heidelberg Pharma AG | Results PR: Heidelberg Pharma announces financial figures and reports on successful business performance in 2023 heidelberg-pharma.com ↗
We are pleased that the results we’ve seen to date from our ongoing clinical trial with lead ATAC candidate HDP-101 provide first signs of the great potential of the unique compound Amanitin for the treatment of multiple myeloma. |
| 2024-03-18 | Heidelberg Pharma AG | Results PR: Heidelberg Pharma announces progress into Cohort 6 with its proprietary ATAC candidate HDP-101 in Phase I/IIa multiple myeloma study heidelberg-pharma.com ↗
Data from HDP-101 dose escalation shows first objective responses and partial remissions in Cohort 5 |
| 2023-11-02 | Heidelberg Pharma AG | Results PR: Heidelberg Pharma Presents New Clinical Data from its Lead Candidate HDP-101 at the ASH Annual Meeting 2023 heidelberg-pharma.com ↗
So far, HDP-101 has shown to be safe and well tolerated, and we will continue dose escalation in the fifth patient cohort (100 µg/kg) as planned. |
| 2023-10-12 | Heidelberg Pharma AG | Results PR: Heidelberg Pharma AG: Interim Management Statement on the First Nine Months of 2023 heidelberg-pharma.com ↗
Patient from third cohort continues to be dosed and shows stable disease |
| 2023-09-19 | Heidelberg Pharma AG | Results PR: Heidelberg Pharma Provides Update on Phase I/IIa Clinical Trial with Lead Candidate HDP-101 heidelberg-pharma.com ↗
The Safety Review Committee's (SRC) evaluation of patient data concluded that no dose-limiting toxicities have occurred to date. |
| 2022-12-14 | Heidelberg Pharma AG | Results PR: Encouraging Clinical Data from Two Antibody Drug Conjugates Based on Heidelberg Pharma’s ATAC Technology Presented at the ASH Annual Meeting 2022 heidelberg-pharma.com ↗
Preliminary results from the first two patient cohorts showed good tolerability. |
| 2022-11-10 | Heidelberg Pharma AG | Results PR: Heidelberg Pharma and Partner Magenta to Present Initial Clinical Data on their Antibody Drug Conjugates at the ASH Annual Meeting 2022 heidelberg-pharma.com ↗
Up to now, HDP‑101 has shown good tolerability in late stage relapsed and/or refractory multiple myeloma patients. |
All press releases naming this drug 28 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | HDP-101 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07529782 ↗ |
| Route | Intravenous | “Participants will receive HDP-101 intravenously” NCT04879043 ↗ |