PRESS RELEASE

Heidelberg Pharma Presents New Clinical Data from its Lead Candidate HDP-101 at the ASH Annual Meeting 2023

Ladenburg, Germany, 2 November 2023 – Heidelberg Pharma AG (FSE: HPHA) will present new findings of its clinical Phase I/IIa study with the proprietary ADC candidate HDP-101 at the 65^th Annual Meeting of the American Society of Hematology (ASH).

Dr. András Strassz, Chief Medical Officer at Heidelberg Pharma, commented: “We are very pleased with the progress of patient enrollment in our clinical trial with HDP-101. 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.”

Poster title: HDP-101, an Anti-BCMA Antibody-Drug Conjugate with a Novel Payload Amanitin in Patients with Relapsed Multiple Myeloma, Initial Findings of the First in Human Study

Presentation details

Abstract:  #3334
Session:  652. Multiple Myeloma: Clinical and Epidemiological: Poster II
Time and location: Sunday, 10^th December 2023, 6:00 pm - 8:00 pm PST, Hall G-H

Dr. Strassz will present the poster showing safety data and preliminary findings from four patient cohorts of the ongoing open-label, multicenter Phase I/IIa trial evaluating HDP-101 in multiple myeloma. He will also be available to answer questions.

HDP-101 is a BCMA antibody-Amanitin conjugate for the treatment of relapsed or refractory multiple myeloma, a bone marrow cancer with high unmet medical need. The first part of the trial is a Phase I dose escalation study to determine an optimal and safe dose of HDP-101 for the Phase II part of the study.

The first four patient cohorts and dose levels of the clinical study have been completed and proved to be safe and well tolerated. Currently, the trial is enrolling patients in the fifth cohort.

About Heidelberg Pharma's proprietary ATAC technology
Antibody Drug Conjugates (ADCs) combine the high affinity and specificity of antibodies with the efficacy of small toxic molecules to fight cancer. Heidelberg Pharma works with ADCs based on its proprietary ATAC technology using Amanitin as the active ingredient. Amanitin belongs to the amatoxin molecules, bicyclic peptides that occur naturally in the green deathcap mushroom. Amatoxins act by inhibiting RNA polymerase II, which leads to so-called programmed cell death (apoptosis) in cells. Inhibition of RNA polymerase II is a new mode of action for cancer therapy. In preclinical studies, ATACs have shown very high efficacy, overcoming common resistance mechanisms and also targeting dormant tumor cells.

About Heidelberg Pharma
Heidelberg Pharma is an oncology specialist and the first company to develop the toxin Amanitin into cancer therapies using its proprietary ATAC technology and to advance the biological mode of action of the toxin as a novel therapeutic principle. The proprietary technology platform is being applied to develop the company’s own therapeutic ATACs as well as in third-party collaborations.

The proprietary lead candidate HDP-101 is a BCMA-ATAC in clinical development for multiple myeloma. Further ATAC candidates are being developed against different targets such as CD37, PSMA or GCC each in the indications non-Hodgkin's lymphoma, metastatic castration-resistant prostate cancer or gastrointestinal tumors such as colorectal cancer.

Heidelberg Pharma AG is based in Ladenburg, Germany, and is listed on the Frankfurt Stock Exchange: ISIN DE000A11QVV0 / WKN A11QVV / Symbol HPHA. More information is available at www.heidelberg-pharma.com.

ATAC^® is a registered trademark of Heidelberg Pharma Research GmbH in the EU and the USA.

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