Eckert & Ziegler Receives Green Light for Phase III Study with PENTIXAFOR

Würzburg / Berlin (Germany), November 25th, 2022 

PentixaPharm GmbH, a 100% subsidiary of Eckert & Ziegler AG (ISIN DE0005659700, SDAX), received green light from the European Medicines Agency (EMA) to conduct a phase III registration study in patients suffering from various forms of Non-Hodgkin-Lymphomas. Following several rounds of scientific advice, the EMA Committee for Medicinal Products for Human Use (CHMP) endorsed a study design presented by PENTIXAPHARM’s management, which envisions treating up to 500 lymphoma patients with the Gallium-68 based radiotracer PENTIXAFOR in about 30 participating European clinics. In its endorsement the CHMP adopted the advice given by the EMA Scientific Advice Working Party, a multidisciplinary group, which comprises delegates from several national European Health Agencies, members of the Committee for Orphan Medicinal Products, the Paediatric Committee, the Committee for Advanced Therapies, and the Pharmacovigilance Risk Assessment Committee. The first treatments with PENTIXAFOR are expected to start in the first half of 2023, subject to approval by national health authorities.

The Executive Board expects to have completed the clinical trials and approval of PENTIXAFOR by the end of 2025 and estimates development costs of EUR 50 million, which will initially be capitalized in the balance sheet and thus not be recognized in the income statement. In addition to the diagnostic agent, Eckert & Ziegler is also developing radiotherapeutics for several hematological indications based on CXCR4 peptides. The Group acquired the global property rights to the CXCR4 receptor addressing agents from the patent licensing office of the Technical University of Munich.

Contacts

Anne Lobach, Executive Assistant, PentixaPharm GmbH

anne.lobach@pentixapharm.com

First CNS Lymphoma Patient Imaged with PentixaFor in Phase II Trial

(Only Available in English)

Treatment with PentixaFor

Berlin (Germany)/ Aalborg (Denmark), October 27th, 2022 – The University Hospital Aalborg (Denmark) yesterday has imaged the first patient with Eckert and Ziegler’s Gallium (68Ga) boclatixafortide (PENTIXAFOR) in an international phase II trial. Code named PTF202, the clinical examination tries to measure the predictive potential of the CXCR4 receptor targeting radiotracer for the treatment of central nervous system lymphoma (CNSL). If successful, PENTIXAFOR could change the way that chemotherapy in the future will be prescribed. Among others, it could save CNSL patients who do not respond to treatment from unnecessary hardship.

CNSL are severe tumors with a poor prognosis. They force oncologists to retort to aggressive chemotherapy regimens, which not only have strong side effects, but often fail to even stop tumor growth. In this situation, knowing quickly whether a lymphoma responds to treatment is very valuable. This can be achieved by looking for CXCR4 receptors, which central nervous system tumors often express while progressing. PENTIXAFOR detects such receptors. The information from the innovative radiotracer hence has the potential to significantly increase the options for an improved response and risk assessment and for the optimization of CNSL patient’s therapeutic needs.

“We are very excited to enrol the first patient into the trial." stated Jakob Madsen, MD, Head of the Department for Hematology at the University Hospital Aalborg and principal investigator of the trial. Helle Zacho, MD, Professor at the Nuclear Medicine Department at the University Hospital Aalborg added, "The overall aim of the study is to prospectively and systematically investigate whether PENTIXAFOR can be used for response assessment in CNSL and in addition, can serve as a prognostic marker.”

The PTF202 phase II trial, which includes 50 patients from up to eight clinics in Europe and the United States, is expected to be finished by the first quarter of 2025. It is only a part of Eckert & Ziegler’s broader drive to develop the CXCR4 compound. The European Medicine Agency (EMA) is currently reviewing a study design from Eckert & Ziegler for an even larger phase III trial with PENTIXAFOR which aims at patients suffering from various other forms of lymphoma. It may include up to 500 participants and could be finished as early as 2025. A decision of the EMA for the go-ahead of this diagnostic radiotracer is expected still within this year.

Further, Eckert & Ziegler is preparing an application for a phase I clinical trial in which a modified version of PENTIXAFOR is used to directly attack tumor cells that express the CXCR4 receptor. This modified version of the radiopharmaceutical, Yttrium (90Y) anditixafortide (PENTIXATHER), would hopefully show therapeutic effects. The clinical development of the therapeutic, however, is still at the beginning.

Dr. Hakim Bouterfa, Managing Director of Eckert & Ziegler’s subsidiary PentixaPharm, which conducts and sponsors the study, explains: “We are very optimistic about the prospects of radiopharmaceuticals using the CXCR4 receptor. The target has already shown its usefulness in a broad array of academic studies, under compassionate-use, and in investigator-initiated study settings. Scans with radiopharmaceuticals targeting the CXCR4 receptor have been summarized in over 70 publications which include more than 1100 patients. PTF202 is our first step in clinically exploring the potential of this compound."

Contacts

Anne Lobach, Executive Assistant, PentixaPharm GmbH

anne.lobach@pentixapharm.com

Radboud University Medical Center Netherlands to Image First Patient with PENTIXAFOR

Berlin (Germany), April 8th, 2022 – Radboud University Medical Center (RUMC) in Nijmegen, one of the largest centres of excellence in the Netherlands for adrenal diseases, treated the first patient with primary aldosteronism with the Ga-68-based diagnostic PENTIXAFOR as part of the CASTUS study.

Developed by PentixaPharm, PENTIXAFOR is an innovative imaging PET tracer that targets the chemokine-4 receptor (CXCR4) and is used to diagnose various oncological and inflammatory diseases. The Ga-68-based PET radiodiagnostic is expected to have the potential to significantly improve the diagnosis of these disorders and to direct patients to the appropriate therapy.

Primary aldosteronism (PA), also known as Conn's disease, is an abnormality of the adrenal gland characterised by either a unilateral aldosterone-producing adenoma (APA) or bilateral adrenal hyperplasia (BAH). Regardless of the location of the pathological tissue, adrenal tumours cause hypersecretion of aldosterone, which leads to hypertension and is therefore closely associated with high vascular morbidity. The prevalence of PA in patients with hypertension, about 20 million patients in Germany, is about 5.9 %. The number of unreported cases is even higher due to the complicated and invasive standard diagnosis by adrenal vein sampling (AVS).

The CASTUS study is a clinical research programme aiming to evaluate the accuracy of PENTIXAFOR in the diagnosis of primary aldosteronism. The Ga-68-based PET radiodiagnostic will be used to detect the unilateral or bilateral nature of aldosterone hypersecretion in primary aldosteronism. This distinguishing feature determines patient management and medical therapy. Compared to the previous diagnostic procedure, in which hormone levels are measured on the adrenal gland using a complex invasive catheterisation procedure, PENTIXAFOR is a non-invasive diagnostic method. In order to investigate the potential of PENTIXAFOR, the RUMC is recruiting up to 300 patients.

RUMC has started imaging the first patient with PENTIXAFOR with great success. High-resolution images show the potential of the non-invasive PET radiodiagnostic PENTIXAFOR. One of the investigators of the CASTUS study, Professor J. F. Langenhuijsen explained: "The high sensitivity of PENTIXAFOR allows us to determine the location of the adrenal tumour much more accurately and may replace the previous, invasive gold standard AVS for diagnosis in the future. Further studies are needed to determine the promising prognostic value of PENTIXAFOR at baseline or during treatment evaluation."

"The fact that one of the leading centres in the Netherlands, such as RUMC, has decided to work on PENTIXAFOR itself shows the great interest in finding a new diagnostic for adrenal disease and could pave the way for additional therapeutic alternatives. The CASTUS trial provides PentixaPharm with the opportunity to enter another therapeutic area in addition to its core development strategy in oncology," commented Dr Hakim Bouterfa, founder and managing director of PentixaPharm GmbH. "We are pleased to have Professor J. F. Langenhuijsen, Professor J. Deinum and Professor M. Gotthardt as principal investigators for this study."

Eckert & Ziegler (ISIN DE0005659700, TecDAX), the owner of the rights to the underlying [68Ga]Ga-PentixaFor PET compound, is supporting the RUMC team by providing PENTIXAFOR. In return, Eckert & Ziegler receives access to the study results. PENTIXAFOR is being developed by Eckert & Ziegler subsidiary PentixaPharm GmbH as a highly sensitive diagnostic for a portfolio of haemato-oncological malignancies, including myeloma and lymphoma.

In 2021, the European Medicines Agency (EMA) gave Eckert & Ziegler the green light to jump directly into a phase III clinical trial for PENTIXAFOR, allowing the company to save a number of time-consuming evaluation steps. Since end of December, the Phase III study design has been submitted for review in Amsterdam. However, the EMA recently had to postpone the start of the review, which was scheduled for March 7, 2022, by two months because an "exceptionally high number of applications" faced a pool of reviewers decimated by Corona and its processing capacities were insufficient. The phase III clinical trial is expected to start approximately 5 months after the start of the review and will include about 500 patients in a PAN cancer trial with European participation.

The CASTUS study is sponsored by ZonMW, the Dutch national organisation for health research and innovation in healthcare.

Contacts

Anne Lobach, Executive Assistant, PentixaPharm GmbH

anne.lobach@pentixapharm.com

Nantes University Hospital Doses First Patients with Eckert & Ziegler's Novel Ga-68 Imaging Agent PENTIXAFOR

Treatment with PentixaFor

Berlin (Germany), September 27th, 2021 – The Centre Hospitalier Universitaire de Nantes (CHU), the French university hospital serving the greater Nantes/Saint-Nazaire metropolitan area, has started to dose first patients with PENTIXAFOR, an innovative imaging compound for the initial staging of cancer patients with symptomatic multiple myelomas. The Ga-68 based radio-diagnostic promises to significantly improve the patient management for early forms of the disease by identifying the optimal therapeutic alternative.

To investigate the potential of PENTIXAFOR the CHU will recruit, on its own account, up to 45 patients in a so-called investigator-initiated study (ISS). Eckert & Ziegler (ISIN DE0005659700, TecDAX), the owner of the rights to the underlying chemokine 4 receptor (CXCR4), supports the CHU team under Professor Caroline Bodet-Milin by providing the compound in exchange for access to certain data.

PENTIXAFOR is being developed by Eckert & Ziegler's subsidiary PentixaPharm GmbH also on its own as a superiorly sensitive diagnostic for a portfolio of rare blood cancers, among them myelomas and lymphoma. In spring 2021 the European Medicine Agency gave Eckert & Ziegler green light to leapfrog into a phase III clinical examination, thereby allowing her to cut a range of time-consuming evaluation steps. The clinical tests are scheduled to start next year and will involve about 500 patients worldwide.

Given the potential of PENTIXAFOR for improved patient stratification, academic groups like CHU have decided to move ahead on their own and to test PENTIXAFOR right away. To speed up the PENTIXAFOR marketing authorization, Eckert & Ziegler closely cooperates with such initiatives and supports them where feasible.

Multiple myeloma is a form of blood cancer that affects the bone marrow. It is caused by the malignant proliferation of plasma cells in the bone marrow. Globally, multiple myelomas annually affect about half a million people and result in about 100,000 deaths.

Principal Investigator Professor Caroline Bodet-Milin for the PENTIMYELO study stated, "The PENTIXAFOR-PET may improve sensitivity and specificity of PET imaging in symptomatic Multiple Myeloma patients, as compared with FDG-PET. An improved sensitivity of PENTIXAFOR may allow visualization of bone marrow lesions and extra-medullary disease not detected by FDG commonly generating a significant number of false negative results. Moreover, PentixaFor may allow to determine new prognostic value at baseline or during therapy evaluation."

"The fact that one of the leading centers in France like the CHU has decided to work on the PENTIXAFOR on its own indicates the immense interest among haematologists in the potential of PENTIXAFOR," comments Dr. Jens Kaufmann, co-founder and general manager of Pentixapharm. "We are delighted to have Professor Françoise Kraeber-Bodéré and Professor Caroline Bodet-Milin of the nuclear medicine department as the principal investigators in these tests."

Professor Françoise Kraeber-Bodéré is Head of the department of Nuclear Medicine at the University Hospital in Nantes, France and an expert of the Oncology committee of the French Society of Nuclear Medicine (SFMN) as well as of the Oncology and Therapy committee of the European Association of Nuclear Medicine. She is on the scientific board of the French Lymphoma research group LYSA and expert for PET in lymphoma and myeloma.

Professor Caroline Bodet-Milin is senior physician in the department of Nuclear Medicine at the University Hospital in Nantes, France and an eminent expert on PET lymphoma and myeloma.

This project is supported by several cancer research associations, among them Siric ILIAD and IRON Labex.

Contacts

Anne Lobach, Executive Assistant, PentixaPharm GmbH

anne.lobach@pentixapharm.com

Eckert & Ziegler Strahlen- und Medizintechnik AG Acquires Direct Majority Stake in Drug Developer PENTIXAPHARM

Major Change in Shareholding Structure

Würzburg (Germany), April 19th, 2021 – Eckert & Ziegler Strahlen- und Medizintechnik AG has acquired several share packages from the founders of PentixaPharm GmbH. Together with another internal share transfer, Eckert & Ziegler AG will directly hold a total of about 83% of the shares in the company as of closing of the transactions. The total cost for the three share packages amount to approximately EUR 30 million. About a quarter of the purchase price payments will be made in cash, the remainder in shares of Eckert & Ziegler AG, which the seller has committed to hold at least until the date at which an advanced clinical trial approval is expected. The management of PentixaPharm, which holds the remaining 17% of PENTIXAPHARM shares, has been granted additional options to sell its remaining shares.

About PentixaFor / PentixaTher

This theranostic pair specifically targets the CXCR4-CXCR12 axis, which is significantly involved in the interaction and proliferation of hematologic and solid tumors and their protective environment. The Gallium-68 based PET agent PentixaFor has demonstrated advanced imaging not only for several different hematologic indications – including leukaemia, lymphoma, and multiple myeloma – but also for other solid tumors like adrenocortical carcinoma, and small cell lung cancer. In addition, other disease conditions, such as atherosclerosis, myocardial infarction, splenosis and stroke and can be targeted with this tracer. The therapeutic counterpart PentixaTher, labeled with α- or β-emitters, offers new treatment options for individualised medicine in terms of endoradiotherapy.

About PentixaPharm

PentixaPharm, founded in 2019, is a radiopharmaceutical development company committed to developing the innovative theranostic pair PentixaFor and PentixaTher. PentixaFor and PentixaTher are two-small peptide-based radiopharmaceuticals, which specifically target the CXCR4-receptor.

Contacts

Dr. Hakim Bouterfa, CEO PentixaPharm

+49 931 991360-73

hakim.bouterfa@pentixapharm.com

PENTIXAPHARM receives confirmation from EMA that its Lead Candidate PENTIXAFOR is ready for Phase III Study

(Only Available in English)

Würzburg (Germany), February 10th, 2021 – PentixaPharm, a radiopharmaceutical development company, received confirmation from the European Medicines Agency (EMA) last week that its lead candidate PentixaFor may be advanced directly in a phase III development program. The positive assessment of the authority was given in an Initial Scientific Advice Meeting, which addressed non-clinical, clinical, and CMC aspects. EMA followed the reasoning of PentixaPharm that there is sufficient safety data available to initiate a phase III program for the [68Ga]Gallium based PET agent and responded positively to the proposed development design. PentixaPharm will now start the operational preparations for a Phase III Study, including a follow-up Scientific Advice with EMA. In addition, PentixaPharm will begin its Series B fundraising process.

Interviews:

“We are delighted that EMA shared our view that PentixaFor is ready for a Phase III study and opens the possibility to develop the lead compound PentixaFor effectively to the next level. With the Initial Scientific Advice, we have a good understanding which non-clinical, clinical and CMC subjects have to be addressed”, says Dr. Hakim Bouterfa, Managing Director of PentixaPharm.

“The regulatory feedback is an important milestone for our clinical as well as our CMC development strategy and accelerates our commitment to make our PET tracer PentixaFor widely available to patients across Europe in a state of the art ready to use kit-design”, adds Dr. Jens Kaufmann, Managing Director of PentixaPharm.”

About PentixaFor

PentixaFor specifically targets the CXCR4-CXCR12 axis, which is significantly involved in the interaction and proliferation of hematologic and solid tumors and their protective environment. The [68Ga]Gallium based PET agent PentixaFor has demonstrated advanced imaging not only for several different hematologic indications – including leukemia, lymphoma, and multiple myeloma – but also for solid tumors like adrenocortical carcinoma and small cell lung cancer. In addition, other disease conditions, such as atherosclerosis, myocardial infarction, splenosis and stroke can be visualised with this tracer.

About PentixaPharm

PentixaPharm, founded in 2019, is a radiopharmaceutical development company committed to developing the innovative theranostic pair PentixaFor and PentixaTher. PentixaFor and PentixaTher are two-small peptide-based radiopharmaceuticals, which specifically target the CXCR4-receptor.

Contacts

Anne Lobach, Executive Assistant, PentixaPharm GmbH

anne.lobach@pentixapharm.com

PENTIXAPHARM Secures € 15 Million Series A Financing to Develop CXCR4-Targeted Theranostics

(Only Available in English)

Funding will be used for phase I / phase II trials of the lead program PentixaTher/ PentixaFor

Würzburg (Germany), February 6th, 2020 – PentixaPharm announced today to have secured € 15 million in a series A financing round led by ELSA Eckert Life Science Accelerator.

PentixaPharm GmbH, a joint venture of Scintomics GmbH and 1717 Life Science Ventures GmbH, is committed to develop PentixaFor and PentixaTher as a theranostic radiopharmaceutical pair, specifically targeting the CXCR4-receptor expressed in most fast progressing diseases, particularly malignant cancers. Funding is dedicated for a phase II trial of the imaging compound PentixaFor and for a phase I trial of the therapeutic compound PentixaTher in Central Nervous System (CNS) Lymphoma while supporting proof-of-concept studies in various other indications.

Interviews:
"With the renowned expertise of the PentixaPharm team, the company is well positioned to bring the lead-compounds PentixaFor and PentixaTher with an effective clinical development program to the next level. We are thrilled to accompany this venture.”, says Phillip Eckert, Responsible Programme Manager and Partner at ELSA.

“Scintomics is very excited about this new partnership marking another important milestone towards a strong positioning of PentixaPharm as radiopharmaceutical development specialist”, comments Saskia Kropf, CEO of Scintomics.  Prof. Hans-Jürgen Wester, founder of Scintomics, adds: “We are enthusiastic by this round A financing to advance the CXCR4 program. Preclinical and clinical data so far have demonstrated encouraging evidence and good potential for targeted cancer therapies. Now with the experienced development team of PentixaPharm, we are sure to quickly establish this theranostic approach towards meaningful clinical trials.”

“We are delighted that in ELSA we have found a strong financing partner with an outstanding expertise in the radiopharmaceutical field. The proceeds of the series A financing will enable us to bring a new treatment for CNS Lymphoma, up to today a disease with limited treatment options, a little closer to patients in need”, adds Anna Steeger, Co-founder of 1717 LSV GmbH and CEO of PentixaPharm.

About PentixaFor / PentixaTher
This theranostic pair specifically targets the CXCR4-CXCR12 axis, which is significantly involved in the interaction and proliferation of hematologic and solid tumors and their protective environment. The [68Ga]Gallium based PET agent PentixaFor has demonstrated advanced imaging not only for several different hematologic indications – including leukemia, lymphoma, and multiple myeloma – but also for solid tumors like adrenocortical carcinoma and small cell lung cancer. In addition, other disease conditions, such as atherosclerosis, myocardial infarction, splenosis and stroke can be visualised with this tracer. The therapeutic counterpart PentixaTher, labeled with α- or β-emitters, offers new treatment options for individualised medicine in terms of endoradiotherapy.

About ELSA Eckert Life Science Accelerator
ELSA, a subsidiary of Eckert Wagniskapital und Frühphasenfinanzierung, is a Berlin-based life science incubator with over two decades of experience in the venture capital industry. ELSA invests primarily in start-up companies, which are in need of first-round venture capital financing and actively supports them during the transformation process from start-ups into mature companies.

About Scintomics GmbH
Scintomics, based in Fuerstenfeldbruck/Munich, is a privately held company for innovative-targeted theranostics and corresponding radiopharmaceutical technologies with a strong commitment towards personalised cancer care with an exceptional pipeline of functional diagnostics and radiotherapeutics.

About 1717 LSV GmbH
1717 LSV, based in Berlin, is a privately held company with expertise in the development of precision radiopharmaceuticals for the targeted diagnosis and treatment of malignant oncological diseases. By enabling novel radiopharmaceutical therapies to traverse early stages of manufacturing and clinical development, 1717 LSV brings innovative drug candidates to patients with unmet medical needs.

Contacts

Anne Lobach, Executive Assistant, PentixaPharm GmbH

anne.lobach@pentixapharm.com

Scintomics and 1717 Life Science Ventures team up in the joint venture PENTIXAPHARM to develop CXCR4-targeted theranostics

(Only Available in English)

Scintomics and 1717 LSV to collaborate in the development of novel cancer diagnostics and treatment

Würzburg, Berlin, Munich (Germany), May 15th, 2019 – Scintomics GmbH and 1717 Life Science Ventures GmbH announced today to have signed an agreement to collaborate in the development of the theranostic pair PentixaFor / PentixaTher.

PentixaPharm GmbH, based in Würzburg, is committed to develop PentixaFor and PentixaTher as a theranostic radiopharmaceutical pair, specifically targeting the CXCR4-receptor expressed in most fast progressing diseases, particularly malignant cancers.

Interviews:
“We are delighted that in 1717 LSV we have found a strong partner with an outstanding expertise in the clinical development of precision oncologics. Taking the various recent and successful proof-of-concept studies with PentixaFor and PentixaTher in men into account, this joint venture creates optimal conditions for the effective and swift clinical development of this unrivalled and unique pair of theranostic drugs”, said Prof. Hans-Jürgen Wester, PhD, Founder of Scintomics and Chair for Pharmaceutical Radiochemistry at the Technical University of Munich (TUM), Germany.

“The introduction of 68Ga-PentixaFor may be regarded as a milestone for clinical PET imaging of CXCR4 expressing malignancies”, added Dr. Hakim Bouterfa Co-founder of 1717 LSV GmbH and CEO of PentixaPharm. “Now we will focus on the next major step to provide CXCR4-directed endoradiotherapy in prospective clinical trials.”

About PentixaFor / PentixaTher
This theranostic pair specifically targets the CXCR4-CXCR12 axis, which is significantly involved in the interaction and proliferation of hematologic and solid tumors and their protective environment. The Gallium-68 based PET agent PentixaFor has demonstrated advanced imaging not only for several different hematologic indications – including leukaemia, lymphoma, and multiple myeloma – but also for other solid tumors like adrenocortical carcinoma, and small cell lung cancer. In addition, other disease conditions, such as atherosclerosis, myocardial infarction, splenosis and stroke and can be targeted with this tracer. The therapeutic counterpart PentixaTher, labeled with α- or β-emitters, offers new treatment options for individualised medicine in terms of endoradiotherapy.

About Scintomics GmbH
Scintomics, based in Fuerstenfeldbruck/Munich, is a privately held company for innovative-targeted theranostics and corresponding radiopharmaceutical technologies with a strong commitment towards personalized cancer care with an exceptional pipeline of functional diagnostics and radiotherapeutics. Scintomics considers the joint venture partnership with 1717 LSV as another important milestone towards a strong positioning as radiopharmaceutical development specialist.

About 1717 LSV GmbH
1717 LSV, based in Berlin, is a privately held company with expertise in the development of targeted precision radiopharmaceuticals for the targeted diagnosis and treatment of malignant oncological diseases. By enabling novel radiopharmaceutical therapies to traverse early stages of manufacturing and clinical development, 1717 LSV brings innovative drug candidates to patients with unmet medical needs.

Contacts

Anne Lobach, Executive Assistant, PentixaPharm GmbH

anne.lobach@pentixapharm.com