HDP-103 / Heidelberg Pharma, Huadong Medicine - LARVOL DELTA

Antibody Targeted Amanitin Conjugates: A New Payload Provides New Options for Cancer Therapy (PEGS 2023) - "ATACs comprise a new class of antibody-drug conjugates (ADCs) using amanitin as toxic payload. HDP-101 is directed against BCMA for the treatment of relapsed and refractory Multiple Myeloma patients. ATAC introduces a new payload with a new mode of action into oncology therapyPhase I study using ATAC is ongoingHDP’s lead program HDP-101 is targeting BCMA for r/r Multiple Myeloma"

Hematological Malignancies • Multiple Myeloma • Oncology

Heidelberg Pharma Presents New Preclinical Data from its Proprietary ATAC Technology Platform at AACR Annual Meeting 2023 (PharmiWeb) - "Heidelberg Pharma AG...will present data from preclinical studies at this year's American Association for Cancer Research (AACR) annual meeting that provide positive evidence of the efficacy and tolerability of the company's proprietary ATAC technology....At the same time, antitumor efficacy in a xenograft model using human cancer cell lines was comparable after s.c. or i.v. administration. The improved tolerability combined with consistent efficacy resulted in an improved therapeutic index of the candidate HDP-103....ATACs directed against GCC possess high antitumor activity and inhibit tumor growth in preclinical models even at low concentrations after single or multiple dose treatment. The favorable safety profile due to the good tolerability of these ATACs confirms that they may represent a promising new therapeutic option against colorectal cancer."

Preclinical • Colorectal Cancer • Gastrointestinal Cancer • Oncology

Clinical Progress of Antibody Targeted Amanitin Conjugates as New Therapeutic Modalities for Exploring Heidelberg Pharma’s Cancer Therapy (ADC London 2023) - "• ATAC® introduces a new payload with a new mode of action into oncology therapy • Outlining Heidelberg Pharmaceutical’s two ATACs which are in Phase I clinical trials • Outlining Heidelberg Pharmaceutical’s lead program HDP-101 which is targeting BCMA for r/r Multiple Myeloma"

Clinical • Hematological Malignancies • Multiple Myeloma • Oncology

Antibody Targeted Amanitin Conjugates (ATAC): A New Payload Provides New Options for Cancer Therapy (ADC-USA 2022) - "Synopsis Discussing a new payload with a new mode of action providing new options to fight cancer Understanding how the ATAC platform optimized the ADC technology for that payload Reviewing HDP-101 targeting BCMA; the first ATAC which cleared IND and is now in dose escalation in myeloma patients"

Hematological Malignancies • Multiple Myeloma • Oncology

Heidelberg Pharma AG Launches Rights Issue of up to EUR 80 Million (PharmiWeb) - "Heidelberg Pharma AG intends to use the proceeds from the funding mainly to conduct the ongoing Phase I trial with HDP-101, as well as to advance the further development of follow-on projects, HDP-102 and HDP-103, and the proprietary ATAC® technology."

Commercial • Oncology

Antibody Targeted Amanitin Conjugates (ATACs) Provide New Options to Fight Cancer (PEGS 2022) - No abstract available

Oncology

Treatment with antibody-targeted amanitin conjugates induces tolerability in preclinical models without triggering tolerance (AACR 2022) - "ATAC pre-treatment induces tolerability in preclinical animal models without a loss in efficacy. Since this effect of ATAC pre-treatment was observed across different animal species, it likely translates also into humans. Consequently, if reduced liver toxicity and less adverse effects after repeated dosing with ATACs are also observed in the upcoming clinical trials, it might have a significant impact on treatment regimen and clinical success of ATACs."

IO biomarker • Preclinical • Genito-urinary Cancer • Hematological Malignancies • Multiple Myeloma • Oncology • Prostate Cancer • Solid Tumor

Heidelberg Pharma to Present New Data on its Proprietary ATAC(R) Technology Platform at the AACR Annual Meeting 2022 (PharmiWeb) - "Heidelberg Pharma AG...announced today that it will present preclinical data on its proprietary Amanitin-based ATAC(R) technology at the American Association for Cancer Research (AACR) 2022 Annual Meeting. The meeting will take place in New Orleans, Louisiana, USA, from 8th - 13th April 2022."

Preclinical • Oncology

Heidelberg Pharma and Huadong Announce Strategic Partnership, Including Equity Investment (PharmiWeb) - "Heidelberg Pharma has granted Huadong exclusive development and commercialization rights for HDP-101 (BCMA-ATAC) and HDP-103 (PSMA-ATAC) for Asia and is eligible to receive an upfront payment of USD 20 million (EUR 17.5 million) and milestone payments of up to USD 449 million (EUR 400 million), as well as tiered royalties ranging from single to low double digit percentages for each candidate. Heidelberg Pharma has granted Huadong an exclusive option for the pre-IND research candidates HDP-102 (CD37-ATAC) and HDP-104 (undisclosed target) in Asia with a total deal value of up to USD 461 million (EUR 410 million)..."

Licensing / partnership • Oncology

[VIRTUAL] Antibody Targeted Amanitin Conjugates (ATACs) Overcome Resistance Mechanisms to Establish New Treatment Options for Difficult to Treat Cancers (ADC-USA 2021) - "Synopsis Discover how ATACs represent a new class of ADCs using the payload Amanitin, introducing a novel mode of action (inhibition of RNA polymerase II) into oncology therapy Highlighting how the unique MoA facilitates killing of dormant tumor cells (CSCs, TICs) and offers new treatment options for difficult to treat cancers and high-risk patients Reviewing HDP-101, Heidelberg Pharma’s lead ATAC candidate directed against BCMA that is entering Phase I clinical trials in relapsed refractory multiple myeloma patients"

Hematological Malignancies • Movement Disorders • Multiple Myeloma • Oncology

[VIRTUAL] Combination of antibody-targeted amanitin conjugates (ATAC) with immune checkpoint inhibitors shows synergistic therapeutic effect in vitro and in vivo (AACR 2021) - "Antibody-targeted amanitin conjugates (ATACs) induced immunogenic cell death in vitro and resulted in an increased anti-tumor effect in combination with an immune checkpoint inhibitor in a subcutaneous CDX model if human PBMCs were present.Consequently, the data presented provide a rationale to the use of ATACs in combination therapy with immune checkpoint inhibitors."

Checkpoint inhibition • IO biomarker • Preclinical • Breast Cancer • Burkitt Lymphoma • Hematological Malignancies • Lymphoma • Oncology • CALR • HMGB1

[VIRTUAL] Preclinical evaluation of anti-CD37 antibody-targeted amanitin conjugates (ATAC) in B-cell malignancies (AACR 2021) - "Targeted cytotoxic drug delivery to CD37 positive cell lines was achieved by using anti-CD37 ATACs. The mode of action of the payload amanitin led to an efficient anti-tumor potential in vitro and in vivo with good tolerability in non-human primates. Using ADCs in the therapy of B-cell lymphomas, including malignancies that underwent Richter’s transformation, is a promising approach, especially by using a payload whose mode of action differs from other commonly used toxins, like ATACs."

Preclinical • Acute Lymphocytic Leukemia • Burkitt Lymphoma • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Richter's Syndrome

[VIRTUAL] Amanitin-based ADCs targeting PSMA as novel therapeutic modality for prostate cancer therapy (AACR 2021) - "Targeted cytotoxic drug delivery to PSMA positive cell lines was achieved by using anti-PSMA ATACs optimized for the use in solid tumors. The mode of action of the payload amanitin led to an efficient anti-tumor potential in vitro and in vivo with good tolerability in non-human primates. Using ATACs in the therapy of PSMA positive prostate cancer is a promising approach, especially by using a cytotoxic agent whose mode of action differs from other commonly used toxins."

Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • FOLH1

[VIRTUAL] Antibody-Targeted Amanitin Conjugates (ATACs) Overcome Resistance Mechanisms and Provide New Treatment Options for Difficult to Treat Cancers (PEGS 2021) - "Antibody-Targeted Amanitin-Conjugates (ATACs) introduce a new mode of action into oncology therapy. The unique MoA in combination with a demonstrated safety profile and a biomarker for patient selection might pave the way for accelerated development & approval for patient groups with high therapeutic needs. HDP-101 is a BCMA-ATAC entering Phase I trials for Multiple Myeloma in 2021."

IO biomarker • Hematological Malignancies • Movement Disorders • Multiple Myeloma • Oncology