Step Pharma Presents Encouraging Data on its First-in-Class CTPS1 Inhibitor STP938 at the European Hematology Association Congress

Press release

St. Genis-Pouilly, France, 10 June 2022 – Step Pharma, a world leader in CTPS1 inhibition for the targeted treatment of cancer, announces today that it is presenting encouraging data in three posters for its first-in-class, highly selective, orally bioavailable CTPS1 inhibitor STP938 at the European Hematology Association Congress being held June 9-17, 2022 in Vienna, Austria.

The data presented demonstrate the high specificity of CTPS1 inhibition achieved with STP938, with inhibition of human neoplastic T cell growth shown both in vivo and in vitro. Moreover, inhibition of CTPS1 by STP938 shows anti-proliferative activity in multiple myeloma through the induction of replication stress and demonstrates synergistic activity when combined with ATR inhibition.

These data support Step Pharma’s belief in STP938’s targeted cytotoxic potential in haematological cancers. STP938 displays favourable preclinical safety and pharmacological properties and is due to progress into first in human clinical studies in the second half of 2022.

Philip Beer, Head of Research and Translational Medicine at Step Pharma, commented: “Our promising findings demonstrate the importance of CTPS1 for cancer cell proliferation and the potential of STP938 as a targeted therapy for the treatment of cancers with high unmet clinical need. CTPS1 plays a crucial role in neoplastic cells, where inhibiting its activity could have a significant impact in a number of different cancers, either as monotherapy or in combination with existing or novel cancer drugs. We look forward to progressing this exciting new therapy into the clinic.”

Andrew Parker, Chief Executive Officer of Step Pharma, said: “Our deep understanding of the pathways and CTPS1 biology has led to the development of STP938, a targeted therapy with predicted superior safety and efficacy profiles compared to existing treatments. We believe that this highly selective treatment has the potential to kill cancer cells without affecting immune cell differentiation and therefore could represent a significant step change in the way we treat cancer.”

Full details of the posters are:

Poster Presentation: CTP synthase 1 (CTPS1) is a novel target in T cell cancers, with small molecule inhibition inducing death of neoplastic human T cells in vitro and inhibition of their growth in an in vivo xenotransplant model

Authors: Philip Beer, Hélène Asnagli, Norbert Minet, Eef Hoeben, Andrew Parker, Alain Fischer, Sylvain Latour

Date and Time: Available from June 10, 09:00 CEST and on-demand until Monday, August 15, 2022, on the Congress platform

Session title: Lymphoma Biology & Translational Research

Poster presentation: CTPS1 is a novel therapeutic target in myeloma – selective small molecule inhibition delivers single agent activity and synergises with ATR inhibition

Authors: Christina Pfeiffer, Philip Beer, Hélène Asnagli, Arnold Bolomsky, Alexander Grandits, Anja Schneller, Julia Huber, Niklas Zojer, Martin Schreder, Andrew Parker, Heinz Ludwig

Date and Time: Available from June 10, 09:00 CEST and on-demand until Monday, August 15, 2022, on the Congress platform

Session title: Myeloma and other monoclonal gammopathies – Biology & Translational Research

 

Poster Presentation: Selective small molecule inhibition of CTP synthase 1 (CTPS1) suppresses T cell proliferation and cytokine release, highlighting a novel therapeutic target for graft-versus-host disease

Authors: Philip Beer, Andrew Parker, Hélène Asnagli

Date and Time: Available from June 10, 09:00 CEST and on-demand until Monday, August 15, 2022, on the Congress platform

Session title: Stem cell transplantation – Experimental

-Ends-

About Step Pharma

Step Pharma is focused on the development of a novel class of oral nucleotide synthesis inhibitors targeting CTPS1 for the improved treatment of a range of cancer types. The company has identified several inhibitors of CTPS1, with the most advanced, STP938, being prepared for clinical studies in haematological malignancies.

Step Pharma was founded in June 2014 by Kurma Partners, the Imagine Institute, and Sygnature Discovery based on the scientific discoveries of Dr Sylvain Latour and Prof. Alain Fischer (UMR1163 Inserm unit). Step Pharma is based in Saint-Genis-Pouilly, France, and is supported by a strong investor base led by Kurma Partners and including Bpifrance (Fonds Biothérapies Innovantes et Maladies Rares and InnoBio2 Fund), Pontifax, Hadean Ventures, Sunstone Life Science Ventures, Inserm Transfert Initiative, Idinvest, Sygnature Discovery and the Imagine Institute. More information on the company can be found at www.step-ph.com.

For more information please contact:

Step Pharma
Andrew Parker, Chief Executive Officer
contact@step-ph.com

 

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Step Pharma to Present Promising Data on the Therapeutic Potential of Selective Small Molecule Inhibition of CTPS1 at the European Hematology Association Congress 2022

Press release

St. Genis-Pouilly, France, 30 May  – Step Pharma, a biotech company developing CTPS1 inhibitors for the safe and effective treatment of cancer, announces today that it will be presenting data on its lead candidate STP938 at the European Hematology Association Congress being held from the 9-17 June, 2022 in Vienna, Austria.
Step Pharma will present three posters on STP938, its potent and highly selective small molecule inhibitor of CTPS1 and its potential as a therapeutic for the treatment of T Cell cancers, Multiple Myeloma and Graft-versus-Host Disease (GvHD).

Full details of the posters are:

Poster presentation: CTPS1 is a novel therapeutic target in myeloma – selective small molecule inhibition delivers single agent activity and synergises with ATR inhibition
Authors: Christina Pfeiffer, Philip Beer, Hélène Asnagli, Arnold Bolomsky, Alexander Grandits, Anja Schneller, Julia Huber, Niklas Zojer, Martin Schreder, Andrew Parker, Heinz Ludwig
Date and Time: Available from June 10, 09:00 CEST and on-demand until Monday, August 15, 2022, on the Congress platform
Session title: Myeloma and other monoclonal gammopathies – Biology & Translational Research

Poster Presentation: CTP synthase 1 is a novel target in T cell cancers, with small molecule inhibition inducing death of neoplastic human T cells in vitro and inhibition of their growth in an in vivo xenotransplant model
Authors: Philip Beer, Hélène Asnagli, Norbert Minet, Eef Hoeben, Andrew Parker, Alain Fischer, Sylvain Latour
Date and Time: Available from June 10, 09:00 CEST and on-demand until Monday, August 15, 2022, on the Congress platform
Session title: Lymphoma Biology & Translational Research

Poster Presentation: Selective small molecule inhibition of CTP synthase 1 (CTPS1) suppresses T cell proliferation and cytokine release, highlighting a novel therapeutic target for graft-versus-host disease

Authors: Philip Beer, Andrew Parker, Hélène Asnagli

Date and Time: Available from June 10, 09:00 CEST and on-demand until Monday, August 15, 2022, on the Congress platform
Session title: Stem cell transplantation – Experimental

About Step Pharma

Step Pharma is focused on the development of a novel class of oral nucleotide synthesis inhibitors targeting CTPS1 for the improved treatment of a range of oncology indications. The company has identified several inhibitors of CTPS1, with the most advanced, STP938, being prepared for clinical studies in haematological malignancies.

Step Pharma was founded in June 2014 by Kurma Partners, the Imagine Institute, and Sygnature Discovery based on the scientific discoveries of Dr Sylvain Latour and Prof. Alain Fischer (UMR1163 Inserm unit). Step Pharma is based in St. Genis-Pouilly, France and supported by a strong investor base led by Kurma Partners and including BPI France (Fonds Biothérapies Innovantes et Maladies Rares), Pontifax, Hadean Ventures, Sunstone Life Science Ventures, Inserm Transfert Initiative, Idinvest, Sygnature Discovery and the Imagine Institute. More information on the company can be found at www.step-ph.com.

Contacts:

Media Relations
Consilium Strategic Communications
Amber Fennell, Giulia Lasagni, Stella Lempidaki
steppharma@consilium-comms.com

 

Download the PDF here


Step Pharma Strengthens Clinical Development Team Ahead of First in Human Studies

Press release

St. Genis-Pouilly, France, 10 May  –Step Pharma, a biotech company developing CTPS1 inhibitors for the safe and effective oral treatment of cancer, announces today that it has strengthened its clinical development team with the appointment of Dr. Brian Schwartz as Chief Medical Officer and Dr. Maureen Higgins as Vice President and Head of Clinical Operations, as it continues to advance STP938, its lead CTPS1 inhibitor, towards clinical studies in haematological malignancies.

Dr. Brian Schwartz brings more than 25 years of experience in drug development in the pharmaceutical and biotechnology industries, in areas including oncology, haematology and rare diseases. Dr. Schwartz previously served for twelve years at ArQule, where he was Chief Medical Officer and Head of Research and Development and led clinical development of the BTK inhibitor ARQ 531 before the company’s $2.7 billion acquisition by Merck in 2020. His previous roles also include CMO and Senior Vice President, Clinical and Regulatory Affairs at Ziopharm, where he oversaw the development of new cancer drugs. Earlier in his career, he held leadership roles at Bayer Healthcare and Leo Laboratories. Alongside his role at Step Pharma, Brian will continue to act as a consultant to other biotech companies, and also serve on the boards of Mereo BioPharma, Enlivex, Cyclacel Pharmaceuticals and Infinity Pharmaceuticals.

Dr. Schwartz, who practiced medicine prior to his career in the biopharmaceutical industry, holds a medical degree from the University of Pretoria, South Africa, and completed a fellowship at the University of Toronto, Canada.

Dr. Maureen Higgins has 30 years of experience in clinical research in project management, clinical operations, and business development within both the pharmaceutical and CRO sectors. Dr. Higgins was previously VP for Project Management at Precision for Medicine. Prior to that, she served as Director for Project Management at Chiltern Oncology, overseeing studies and leading project managers in the conduct and delivery of early phase oncology studies, and as Project Director at PRA Health Sciences, UK, where she project-managed early- and late-phase oncology, and neurology studies. She was also Director for Business Development at CroMedica and an Internal Business Consultant at Quintiles, where she also served as Head of Operations in South Africa.

Dr. Higgins holds a B.Sc. in Biology from Bristol Polytechnic, a Ph.D. in Molecular Developmental Genetics from the University of Edinburgh, where she also completed her post-doctoral fellowship in Molecular Biology and an MBA from Strathclyde Graduate Business School.

Andrew Parker, Chief Executive Officer of Step Pharma, commented: “On the eve of Step Pharma progressing into the clinic with STP938, we are delighted to have made such strong clinical operations appointments in Brian and Maureen. Step Pharma are the world leaders in CTPS1 inhibition, a novel approach that we believe could allow us to selectively target cancer cells, not only in our core focus of haematological cancers but in a combination setting in solid tumours as well.”

Dr. Brian Schwartz, Chief Medical Officer, commented: “Researchers have been trying to target pyrimidine synthesis for decades to treat cancer without success, but with Step Pharma’s CTPS1 approach I believe we have the breakthrough. I am delighted to be joining such an experienced team at this pivotal time for the company.”

 Dr. Higgins, VP, Head of Clinical Operations, commented: “Step Pharma is the world leader in CTPS1 research and with its strong scientific heritage, outstanding team and high-quality investors has the clear recipe for success. I am excited to support the company take the next important clinical step in its development.”

About Step Pharma

Step Pharma is focused on the development of a novel class of oral nucleotide synthesis inhibitors targeting CTPS1 for the improved treatment of a range of oncology indications. The company has identified several inhibitors of CTPS1, with the most advanced, STP938, being prepared for clinical studies in haematological malignancies.

Step Pharma was founded in June 2014 by Kurma Partners, the Imagine Institute, and Sygnature Discovery based on the scientific discoveries of Dr Sylvain Latour and Prof. Alain Fischer (UMR1163 Inserm unit). Step Pharma is based in St. Genis-Pouilly, France and supported by a strong investor base led by Kurma Partners and including BPI France (Fonds Biothérapies Innovantes et Maladies Rares), Pontifax, Hadean Ventures, Sunstone Life Science Ventures, Inserm Transfert Initiative, Idinvest, Sygnature Discovery and the Imagine Institute. More information on the company can be found at www.step-ph.com.

Contacts:

Media Relations
Consilium Strategic Communications
Amber Fennell, Giulia Lasagni, Stella Lempidaki
steppharma@consilium-comms.com

 

Download the PDF here


Step Pharma Establishes Clinical Advisory Board

Four Oncology Thought Leaders Will Help Guide Clinical Development

St. Genis-Pouilly, France, 17th Nov 2021 – Step Pharma, a biotech company developing novel drugs for oncology and autoimmune diseases, announced today the formation of its inaugural clinical advisory board (CAB) with the appointment of Steven M. Horwitz, MD (Memorial Sloan Kettering Cancer Center), Stephen M. Ansell, MD, PhD (Mayo Clinic), Jean-Pierre Bizarri, MD and Kapil Dhingra, MD. These world-renowned doctors specialise in oncology research and drug development and commercialization.
“It is an honour to have these four incredible oncology experts come together to form our clinical advisory board. Each have a wealth of expertise and specialist knowledge to bring to Step Pharma as we move STP938, our lead CTPS1 inhibitor, towards clinical studies in haematological malignancies,” said Andrew Parker, CEO of Step Pharma. “We are very much looking forward to the pivotal role this advisory board will play in the future of the company.”

Step Pharma’s Clinical Advisory Board

Steven M. Horwitz, MD is an Attending Physician in the Department of Medicine at Memorial Hospital for Cancer and Allied Diseases and a Member in Memorial Sloan Kettering Cancer Center in New York City. He earned his medical degree at Case Western Reserve University School of Medicine, completed an internship and residency in internal medicine at the University of Rochester/Strong Memorial Hospital, and then completed a fellowship in medical oncology at Stanford University Medical Center. His current research is dedicated to identifying better treatments for individuals with T-cell lymphoma including understanding mechanisms of response and resistance to novel drugs in T-cell lymphoma. Dr. Horwitz participates in several national, and international committees and consortiums dedicated to the understanding and advancement of treatment for T-cell lymphoma.

Stephen M. Ansell, MD, PhD is a consultant in the Division of Hematology, Department of Internal Medicine at Mayo Clinic. He serves as the chair of faculty development and recruitment for the Division of Hematology, and as the chair of the Lymphoma Group in the Division of Hematology. He earned his MB, ChB degree and completed an internal medicine/surgery internship at University of Pretoria in South Africa. He holds specific expertise in T-cell lymphoma and Hodgkin lymphoma and is also an expert in transplantation of lymphoma.

Jean-Pierre Bizzari, MD is a world-renowned oncology expert who served as Executive Vice-President, Group Head, and Clinical Oncology Development (U.S., Europe, and Asia/Japan) at Celgene from 2008 to 2015. He is an active board member in various biotech companies and a member of the Scientific Advisory Board of the French National Cancer Institute (INCa) and European Organization of Research and Treatment of Cancer (EORTC) and Chairman of the New Drug Advisory Committee. Dr Bizzari holds a medical degree specialized in oncology from the University of Nice.

Kapil Dhingra, MD has more than 30 years of experience in oncology clinical research and drug development within the biotechnology and pharmaceutical industries. He previously served as Vice President, Head of the Oncology Disease Biology Leadership Team and Head of Oncology Clinical Development at Hoffmann-La Roche, during which time he led numerous drug approvals. Prior to Roche, he worked in the oncology clinical development group at Eli Lilly and Company. He is now a board member of several successful biotechnology companies. Dr Dhingra obtained his M.B.B.S. degree from the All India Institute of Medical Sciences in New Delhi, India. He completed his residency in internal medicine at Lincoln Medical and Mental Health Center, New York Medical College, and completed his fellowship in hematology and oncology at Emory University School of Medicine.

Targeting CTPS1
Cytidine nucleotide triphosphate (CTP) is a precursor required for DNA synthesis and cell division. Patients deficient in the enzyme CTPS1 have an altered immune cell proliferation response to immune challenge but no other deleterious effects. This same pathway supports the uncontrolled growth of cancerous T and B cells, thus inhibiting CTPS1 represents a novel precision oncology approach to specifically block proliferation and induce killing of cancerous cells in lymphoma and leukaemia.

About Step Pharma
Step Pharma is focused on the development of a novel class of oral nucleotide synthesis inhibitors targeting CTPS1 for the improved treatment of a range of oncology and autoimmune diseases. The company has identified several inhibitors of CTPS1, with the most advanced, STP938, being prepared for clinical studies in haematological malignancies.
Step Pharma was founded in June 2014 by Kurma Partners, the Imagine Institute, and Sygnature Discovery based on the scientific discoveries of Dr Sylvain Latour and Prof. Alain Fischer (UMR1163 Inserm unit). Step Pharma is based in St. Genis-Pouilly, France and supported by a strong investor base led by Kurma Partners and including BPI France (Fonds Biothérapies Innovantes et Maladies Rares), Pontifax, Hadean Ventures, Sunstone Life Science Ventures, Inserm Transfert Initiative, Idinvest, Sygnature Discovery and the Imagine Institute. More information on the company can be found at www.step-ph.com.

20211117_Step Pharma Established Clinical Advisory Board


Step Pharma Appoints Experienced Cancer Drug Developer Adrian Senderowicz to Board of Directors

Archamps, France, October 6, 2021 – Step Pharma, a biotech company developing novel drugs for oncology and autoimmune diseases, announced today the appointment of Dr. Adrian Senderowicz to its Board of Directors. Dr. Senderowicz is a board-certified medical oncologist with 30 years of experience in drug development and commercialization.

“Adrian has phenomenal expertise in cancer drug development having led numerous oncology clinical trials and also brings regulatory agency experience,” said Andrew Parker, CEO of Step Pharma. “We’d like to welcome him to the Board and look forward to working closely with him as we move forward into clinical studies. Our lead program, STP938, will enter clinical studies for the treatment of heamatological malignancies in 2022.”

Dr. Senderowicz was previously Senior Vice President and Chief Medical Officer at Constellation Pharmaceuticals, where he was responsible for the development of a portfolio of compounds leveraging epigenetics. Before Constellation, Dr. Senderowicz was chief medical officer at Cerulean Pharma, where he helped secure fast-track designation for the company’s lead clinical program in two indications. Previously, Dr. Senderowicz held roles of increasing responsibility at Ignyta, Inc, Sanofi Oncology, Tokai Pharmaceuticals and AstraZeneca plc. He began his career as an investigator at the National Cancer Institute before joining the FDA’s CDER. Adrian conducted his Internal Medicine residency training at the Icahn School of Medicine at Mount Sinai and a Clinical Oncology Fellowship at the NCI. He holds an MD from the School of Medicine at the Universidad de Buenos Aires (Argentina). Dr. Senderowicz also sits on the board of Puma Biotechnology.

“Step Pharma’s CTPS1 (cytidine triphosphate synthase 1) platform is extremely promising for cancer indications. I’m looking forward to help guide the company as it moves its first program, STP938, into clinical development for the treatment of haematological malignancies,” Dr. Senderowicz said.

Targeting CTPS1

Cytidine nucleotide triphosphate (CTP) is a precursor required for DNA synthesis and cell division. Patients deficient in the enzyme CTPS1 have an altered immune cell proliferation response to immune challenge but no other deleterious effects. This same pathway supports the uncontrolled growth of cancerous T and B cells, thus inhibiting CTPS1 represents a novel precision oncology approach to specifically block proliferation and induce killing of cancerous cells in lymphoma and leukaemia.

About Step Pharma
Step Pharma is focused on the development of a novel class of oral nucleotide synthesis inhibitors targeting CTPS1 for the improved treatment of a range of oncology and autoimmune diseases. The company has identified several inhibitors of CTPS1, with the most advanced, STP938, being prepared for clinical studies in haematological malignancies.
Step Pharma was founded in June 2014 by Kurma Partners, the Imagine Institute, and Sygnature Discovery based on the scientific discoveries of Dr Sylvain Latour’s laboratory and Prof. Alain Fischer (UMR1163 Inserm unit). Step Pharma is based in Paris, France and supported by a strong investor base led by Kurma Partners and including BPI France (Fonds Biothérapies Innovantes et Maladies Rares), Inserm Transfert Initiative, Idinvest, Pontifax, Sygnature Discovery and the Imagine Institute.

Step Pharma Board Appointment Press Release Final


Step Pharma to present a poster on STP938 at 12th International Congress on AutoImmunity

Paris, France, May 21, 2021 – Step Pharma will present at the 12th International Congress on AutoImmunity. Listen to our poster presentation on Monday 31st May.

Step Pharma awarded ‘First-in-class therapeutic innovation' during the 6th MEET2WIN Oncology Convention

Paris, France, 11 May 2021 – Among eleven pre-selected projects, Step Pharma SAS have been selected by the MATWIN board, based on its relevance from a medical perspective and their future development potential. More on MATWIN, click here

 

Step Pharma Raises EUR35 Million in Series B Financing to Advance First in Class CTPS1 inhibitor into the Clinic in T Cell Malignancies

Archamps, France, 24 March 2021

Step Pharma, a biotech company developing novel drugs for oncology and autoimmune diseases, today announced the successful closing of a EUR35 million Series B financing. New investors Hadean Ventures and Sunstone Life Science Ventures co-led the round, joining existing investors Kurma Partners, Pontifax and Bpifrance, who reinvested through its Innovative Biotherapies and Rare Diseases fund and InnoBio 2 fund. As part of the financing, Jacob L Moresco from Sunstone Life Science Ventures and Walter Stockinger from Hadean Ventures will join the Step Pharma Board of Directors.

The proceeds will be used to advance Step Pharma’s lead proprietary CTPS1 inhibitor, STP938, into clinical development for the treatment of T-cell malignancies. In addition, Step Pharma will use the funding to advance development of CTPS1 inhibitors in other haematological malignancies and solid tumours. CTPS1 (cytidine triphosphate synthase 1) is an enzyme that plays a critical role in DNA synthesis, cell division and proliferation but whose function is highly selective to certain cell types, in particular proliferating T cells, making it an ideal target for drug development.

Roger Franklin, Partner at Hadean Ventures said: “CTPS1 is an elegant target for the development of drugs in the T-cell malignancy space in which there is significant unmet need. The strength of the underlying science, its support from human genetic work as well as the clear commercial opportunity were key factors in our decision to back Step and co-lead this significant financing. We very much look forward to working with the great team at Step as this exciting programme moves into the clinic.”

“Step Pharma is a clear leader in CTPS1 research. They have made significant progress in advancing their 1st in class selective CTPS1 inhibitors toward clinical development and expanding the potential therapeutic applications,” added Jacob L Moresco from Sunstone Life Science Ventures

“The closing of this Series B will enable Step Pharma to transform into a clinical-stage company, enabling us to advance our lead compound into the clinic in Q1 2022,” said Andrew Parker, CEO of Step Pharma. “We’d like to welcome our new investors and thank existing investors for their continued support of the company.”

Targeting CTPS1
Cytidine nucleotide triphosphate (CTP) is a precursor required for DNA synthesis and cell division. Patients deficient in the enzyme CTPS1 have an altered immune cell proliferation response to immune challenge but no other deleterious effects. This same pathway supports the uncontrolled growth of cancerous T and B cells, thus inhibiting CTPS1 represents a novel precision oncology approach to specifically block proliferation and induce killing of cancerous cells in lymphoma and leukemia.

About Step Pharma
Step Pharma is focused on the development of a novel class of oral nucleotide synthesis inhibitors targeting CTPS1 for the improved treatment of a range of oncology and autoimmune diseases. The company has identified several inhibitors of CTPS1, with the most advanced, STP938 being prepared for clinical studies in T-cell malignancies.

Step Pharma was founded in June 2014 by Kurma Partners, the Imagine Institute, and Sygnature Discovery based on the scientific discoveries of Prof. Alain Fischer and Dr Sylvain Latour’s laboratory at the Imagine Institute, Paris. Step Pharma is based in Archamps, France. More information on the company can be found at www.step-ph.com.

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Step Pharma to present a poster on STP938 at American Society of Hematology conference

Paris, France, December 1st 2020 – Step Pharma SAS, in collaboration with Sygnature Discovery, has been selected to present a poster named "STP938, a Novel, Potent and Selective Inhibitor of CTP Synthase 1 (CTPS1) Is a Targeted Therapy Specifically Blocking De Novo Nucleotide Synthesis in Lymphomas and Leukemias" at the American Society of Hematology (ASH) conference starting December 5th.