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Step Pharma
In Press Release

Step Pharma Appoints Dr Philip Beer as Chief Scientific Officer

Press Release

St. Genis-Pouilly, France, 04 January 2023

Step Pharma, the world leader in CTPS1 inhibition for the targeted treatment of cancer, today announces the appointment of Dr Philip Beer as Chief Scientific Officer.

Philip is a board-certified haematologist with over 16 years of frontline healthcare experience as well as biopharmaceutical industry experience, particularly in translational medicine, drug development, and biomarker discovery.

He joined Step Pharma in June 2021 as Vice President, Head of Research & Translation Medicine and has led the Company’s research strategy and execution on the run up to Step Pharma’s lead asset, the targeted CTP synthase 1 (CTPS1) inhibitor STP938, entering the clinic in both the UK and US with compelling preclinical data in support.
Philip is being promoted to Chief Scientific Officer from Vice President, Head of Research & Translational Medicine at Step Pharma. In his new role, he will lead the Company’s research activities with a focus on further development of STP938, a first-in-class, highly selective, orally bioavailable inhibitor of CTPS1 currently being evaluated for safety and efficacy in T cell and B cell lymphomas.

Prior to joining Step Pharma, Philip held senior leadership roles in biotech and biopharma companies, overseeing oncology drug development and biomarker discovery programmes. He is a cofounder of Gabriel Precision Oncology, a clinical software company also focussed on improving outcomes for those living with cancer.

Andrew Parker, Chief Executive Officer of Step Pharma said:

“It has been a privilege working with Philip and advancing STP938 to the clinic with a strong pre-clinical data package built under his stewardship. As Chief Scientific Officer and with his extensive experience in leading oncology drug discovery and development programmes, he will continue his invaluable work to progress our pipeline of a novel class of oral drugs that specifically inhibit CTPS1, with the potential to yield highly selective, safe and effective treatments for both blood cancers and solid tumours..”

Dr Philip Beer, Chief Scientific Officer of Step Pharma, commented:

“I am honoured to be working with such a driven leadership team and thrilled to be promoted to the role of Chief Scientific Officer. Step Pharma is a highly innovative, research driven company with high quality science which has the potential to transform how we treat cancer.  I remain committed to bringing Step Pharma’s targeted therapies to the clinic and to continue to develop life-saving treatments for patients.”

Philip is a Member of the Royal College of Physicians, UK, and a Fellow of the Royal College of Pathologists, UK. He holds a PhD in molecular cancer biology from the University of Cambridge, UK. Following this he conducted post-doctoral research studies at the BC Cancer Agency, Vancouver, Canada, and has more than 100 peer-reviewed publications. Philip is an Honorary Professor of Translational Medical at the Hull York Medical School, UK.

Contacts

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

Media Relations
Consilium Strategic Communications
Amber Fennell, Namrata Taak, Stella Lempidaki
T. +44 (0) 20 3709 5700
steppharma@consilium-comms.com

+ DOWNLOAD PDF

About Step Pharma

Step Pharma’s goal is to bring about a step change in how cancer is treated with targeted therapies that kill cancer cells and leave healthy cells unharmed. The Company is the world leader in CTPS1 inhibition, a new approach with the potential to yield highly selective, safe and effective cancer treatments for both blood cancers and solid tumours.

The Company’s lead product STP938 has received both IND and CTA clearance to proceed into first in human trials in the US and UK for the treatment of T cell and B cell lymphomas. Clinical trials in lymphoma commenced in September 2022. STP938 has the potential to be the backbone of a multitude of cancer therapies as well as a potent monotherapy for hard-to-treat blood cancers.

Step Pharma was founded in 2014 by Kurma Partners, the Imagine Institute and Sygnature Discovery, based on the scientific discoveries of Prof. Alain Fischer and Dr Sylvain Latour. Step Pharma is based in Saint-Genis-Pouilly, France, and is supported by a strong syndicate of investors 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.

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About STP938

STP938 is a first-in-class, highly selective, orally bioavailable inhibitor of CTP synthase 1 (CTPS1), a key component of the pyrimidine synthesis pathway. CTPS1 inhibition inhibits the proliferation of neoplastic lymphoid cells and results in cell death. All cancers appear to be addicted to CTPS1 for DNA synthesis. STP938 entered clinical development in September 2022 for the treatment of T cell and B cell lymphoma.

Step Pharma
In Press Release

Step Pharma Announces Promising Data on the Therapeutic Potential of Selective Small Molecule Inhibition of CTPS1 Presented at the 64th American Society of Hematology Annual Meeting

Press Release

St. Genis-Pouilly, France, 12 December 2022

  • STP938 shows strong anti-tumour effect in preclinical models of mantle cell lymphoma and multiple myeloma
  • STP938 shows synergistic anti-tumour activity in preclinical models when combined with selective inhibitors of other pathways

St. Genis-Pouilly, France and London, UK, 12 December 2022 – Step Pharma, the world leader in CTPS1 inhibition for the targeted treatment of cancer, today announces that encouraging pre-clinical data on its first-in-class, highly selective, orally bioavailable CTPS1 inhibitor, STP938, were presented at the 64th American Society of Hematology (ASH) Annual Meeting held from the 10-13 December, 2022 in New Orleans, Louisiana and virtually.

The data presented by Step Pharma collaborators demonstrates the potential of STP938, a highly selective CTPS1 inhibitor, as a therapeutic for the treatment of mantle cell lymphoma and multiple myeloma both as a single agent and in combination with other targeted inhibitors.

In pre-clinical models of mantle cell lymphoma, STP938 showed strong anti-tumour effects, which were further enhanced by combined administration with venetoclax, a selective BCL-2 inhibitor currently in clinical development for treatment of this lymphoma type.

Single agent STP938 also showed activity in preclinical models of multiple myeloma and demonstrated strong synergy when combined with an inhibitor of the DNA damage response pathway (ATR, CHEK1 or WEE1).

“We are encouraged by the promising pre-clinical data produced by our collaborators showing the anti-tumour effects of STP938 in mantle cell lymphoma and multiple myeloma models”,

said Andrew Parker, Chief Executive Officer of Step Pharma.

“These data reinforce our conviction that by inhibiting CTPS1, a key component of the pyrimidine synthesis pathway to which all cancers are addicted, STP938 has broad therapeutic potential. We have commenced clinical trials to test the safety and efficacy of STP938 in T cell and B cell lymphomas to bring this potentially lifesaving therapy to patients in our efforts to drive a step change in the way we treat cancer.”

Full details of the poster presentations, which were both presented on Sunday, December 11, 2022 at 6:00 PM-8:00 PM EST in Hall D (Ernest N. Morial Convention Center), are:

Authors: David Chiron, PhD, Emmanuelle Menoret, PhD, Charlotte Kervoelen, PhD, Sophie Maïga, Celine Bellanger, Benoit Tessoulin, MD, Cyrille Touzeau, Hélène Asnagli, PhD, Andy Parker, PhD, Philip Beer, MD, PhD and Catherine Pellat-Deceunynck, PhD

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

Step Pharma also recently entered clinical development with STP938 in a Phase I/II trial for T cell and B cell lymphomas. An abstract outlining the study design was published by ASH in the journal Blood. Full details are:

Authors: Philip Beer, Maureen Higgins, Hélène Asnagli, Eef Hoeben, Michael Hubank, Andrew Parker, Brian Schwartz

Contacts

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

Media Relations
Consilium Strategic Communications
Amber Fennell, Namrata Taak, Stella Lempidaki
T. +44 (0) 20 3709 5700
steppharma@consilium-comms.com

+ DOWNLOAD PDF

About Step Pharma

Step Pharma’s goal is to bring about a step change in how cancer is treated with targeted therapies that kill cancer cells and leave healthy cells unharmed. The Company is the world leader in CTPS1 inhibition, a new approach with the potential to yield highly selective, safe and effective cancer treatments for both blood cancers and solid tumours.

The Company’s lead product STP938 has received both IND and CTA clearance to proceed into first in human trials in the US and UK for the treatment of T cell and B cell lymphomas. Clinical trials in lymphoma commenced in the second half of 2022. STP938 has the potential to be the backbone of a multitude of cancer therapies as well as a potent monotherapy for hard-to-treat blood cancers.

Step Pharma was founded in 2014 by Kurma Partners, the Imagine Institute and Sygnature Discovery, based on the scientific discoveries of Prof. Alain Fischer and Dr Sylvain Latour. Step Pharma is based in Saint-Genis-Pouilly, France, and is supported by a strong syndicate of investors 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.

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About STP938

STP938 is a first-in-class, highly selective, orally bioavailable inhibitor of CTP synthase 1 (CTPS1), a key component of the pyrimidine synthesis pathway. CTPS1 inhibition inhibits the proliferation of neoplastic lymphoid cells and results in cell death. All cancers appear to be addicted to CTPS1 for DNA synthesis. STP938 entered clinical development in September 2022 for the treatment of T cell and B cell lymphoma.

Step Pharma
In Press Release

Step Pharma and Concr announce partnership to advance CTPS1 inhibition in cancer treatment

Press Release

St. Genis-Pouilly, France, 3 November 2022

Concr’s proprietary statistical modelling, which uses cosmology methods, will identify biomarkers to help select patients most likely to respond to Step Pharma compounds targeting cytidine triphosphate synthase 1 (CTPS1).

St. Genis-Pouilly, France and London, UK, 07 December 2022 – Step Pharma, the world leader in CTPS1 inhibition for the targeted treatment of cancer, and Concr, a techbio company with a statistical learning-powered biomarker prediction engine, today announced a partnership to identify biomarkers to improve therapeutic response to inhibitors of cytidine triphosphate synthase 1 (CTPS1), an enzyme to which all cancers appear to be addicted.

Concr’s proprietary data modelling will be used to identify biomarkers for Step Pharma’s cancer drug assets, which includes its first-in-class, highly selective, orally bioavailable CTPS1 inhibitor, STP938, by effectively integrating diverse experimental data with patient and tumour-centric datasets. Concr adopts cosmology methods to effectively combine diverse data types into a single holistic tumour model with superior predictive power. The biological insights generated will be utilised by Step Pharma in its pre-clinical and clinical development programmes, with the overall aim of improving patient response and outcomes.

Andrew Parker, Chief Executive Officer of Step Pharma, commented:

“We are committed to bringing our targeted treatments, including STP938, to patients as fast as possible. To this end, we are excited to partner with Concr and employ its integrated analysis of complex datasets to explore the potential to accelerate the development of our targeted cancer therapy assets and maximise their utility. Our collaboration with Concr is aimed at deepening our understanding of CTPS1 biology and identifying patients most likely to respond to CTPS1 inhibition.”

Matt Foster, Chief Executive Officer of Concr, added:

“There is a significant need for novel targeted therapies across a range of cancer types. However, only with successful application of biomarkers can such cutting edge therapeutic developments be optimally applied in a clinical setting. Concr is excited to be enabling this to happen with Step Pharma – utilising our approach to ensure inhibitors of CTPS1 have the greatest chance of translational success by being applied to patients who will truly benefit.”

Step Pharma recently entered clinical development with its first in class CTPS1 inhibitor STP938 in a Phase I/II trial for T cell and B cell lymphomas and is the latest company to utilise the potential of data and predictive modelling for translational research. By inhibiting the enzyme CTPS1, Step Pharma can selectively target the de novo pyrimidine synthesis pathway in cancer cells, enabling highly selective treatment of both blood cancers and solid tumours. Concr’s existing partnerships are investigating biomarkers of response in multiple cancer types, including breast cancer and cancer of unknown primary.

Contacts

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

Concr
Matt Foster, Chief Executive Officer
info@concr.co

Media Relations
Consilium Strategic Communications
Amber Fennell, Namrata Taak, Stella Lempidaki
T. +44 (0) 20 3709 5700
steppharma@consilium-comms.com

+ DOWNLOAD PDF

About Step Pharma

Step Pharma’s goal is to bring about a step change in how cancer is treated with targeted therapies that kill cancer cells and leave healthy cells unharmed. The Company is the world leader in CTPS1 inhibition, a new approach with the potential to yield highly selective, safe and effective cancer treatments for both blood cancers and solid tumours.

The Company’s lead product STP938 has received both IND and CTA clearance to proceed into first in human trials in the US and UK for the treatment of T cell and B cell lymphomas. Clinical trials in lymphoma commenced in the second half of 2022. STP938 has the potential to be the backbone of a multitude of cancer therapies as well as a potent monotherapy for hard-to-treat blood cancers.

Step Pharma was founded in 2014 by Kurma Partners, the Imagine Institute and Sygnature Discovery, based on the scientific discoveries of Prof. Alain Fischer and Dr Sylvain Latour. Step Pharma is based in Saint-Genis-Pouilly, France, and is supported by a strong syndicate of investors 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.

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About Concr

Concr is a mission-driven techbio company that answers essential questions in oncology through solving data. By adopting astrophysics methods used to study the universe, Concr unlocked the ability to effectively integrate diverse and incomplete datasets to help scientists identify and develop biomarkers for their drugs with 300x less pre-clinical and 7x less clinical data. Using Concr’s online platform – Nightingale – researchers can make advanced predictions about biomarkers and model patient response by leveraging Concr’s unique technology, as well as perform standard bioinformatics analyses directly.
The company is headquartered in London, UK, with a wholly-owned subsidiary in Brisbane, Australia. The company is a venture capital-backed enterprise, with investors including the University of Cambridge Enterprise, Cambridge Angels, R42 and Deep Science Ventures.

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About STP938

STP938 is a first-in-class, highly selective, orally bioavailable inhibitor of CTP synthase 1 (CTPS1), a key component of the pyrimidine synthesis pathway. CTPS1 inhibition inhibits the proliferation of neoplastic lymphoid cells and results in cell death. All cancers appear to be addicted to CTPS1 for DNA synthesis. STP938 entered clinical development in September 2022 for the treatment of T cell and B cell lymphoma.

Step Pharma
In Press Release

Step Pharma to Present Promising Data on the Therapeutic Potential of Selective Small Molecule Inhibition of CTPS1 at the 64th American Society of Hematology Annual Meeting

Press Release

St. Genis-Pouilly, France, 3 November 2022

Step Pharma, the world leader in CTPS1 inhibition for the targeted treatment of cancer, today announces that it will be presenting pre-clinical data on its lead candidate STP938 at the 64th American Society of Hematology Annual Meeting being held from the 10-13 December, 2022 in New Orleans, Louisiana and virtually.

Step Pharma and collaborators will present two posters on STP938, its potent and highly selective small molecule inhibitor of CTPS1, reporting its potential as a targeted therapeutic for the treatment of Mantle Cell Lymphoma and Multiple Myeloma.

Full details of the posters are:

Poster presentation: CTPS1 is a Novel Therapeutic Target in Multiple Myeloma that Synergizes with Inhibition of ATR, CHEK1 or WEE1

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

Date and Time: Available online from November 3, 09:00 EDT on the Congress platform

Poster Presentation: STP938, a Selective CTPS1 Inhibitor, Shows Single Agent Activity and Synergy with BCL2 Inhibition in Preclinical Models of Mantle Cell Lymphoma

Authors: David Chiron, PhD, Emmanuelle Menoret, PhD, Charlotte Kervoelen, PhD, Sophie Maïga, Celine Bellanger, Benoit Tessoulin, MD, Cyrille Touzeau, Hélène Asnagli, PhD, Andy Parker, PhD, Philip Beer, MD, PhD and Catherine Pellat-Deceunynck, PhD

Date and Time: Available online from November 3, 09:00 EDT on the Congress platform

Contacts

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

Media Relations
Consilium Strategic Communications
Amber Fennell, Namrata Taak, Stella Lempidaki
T. +44 (0) 20 3709 5700
steppharma@consilium-comms.com

+ DOWNLOAD PDF

About Step Pharma

Step Pharma’s goal is to bring about a step change in how cancer is treated with targeted therapies that kill cancer cells and leave healthy cells unharmed. The Company is the world leader in CTPS1 inhibition, a new approach with the potential to yield highly selective, safe and effective cancer treatments for both blood cancers and solid tumours.

The Company’s lead product STP938 has received both IND and CTA clearance to proceed into first in human trials in the US and UK for the treatment of T cell and B cell lymphomas. Clinical trials in lymphoma commenced in the second half of 2022. STP938 has the potential to be the backbone of a multitude of cancer therapies as well as a potent monotherapy for hard-to-treat blood cancers.

Step Pharma was founded in 2014 by Kurma Partners, the Imagine Institute and Sygnature Discovery, based on the scientific discoveries of Prof. Alain Fischer and Dr Sylvain Latour. Step Pharma is based in Saint-Genis-Pouilly, France, and is supported by a strong syndicate of investors 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.

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Step Pharma
In Press Release

Step Pharma Announces First Patient Dosed with STP938, the World’s Most Advanced CTPS1 Inhibitor, in a Phase 1/2 Trial for T cell and B cell lymphomas

Press Release

St. Genis-Pouilly, France, 24 October 2022

Potential first-in-class targeted treatment for relapsed/refractory T cell and B cell lymphomas

Step Pharma, the world leader in CTPS1 inhibition for the targeted treatment of cancer, announces today that the first patient has been successfully dosed with STP938, in a Phase 1/2 trial in adult subjects with relapsed/refractory B cell and T cell lymphomas.

The dose-escalation part of the open label, non-randomised Phase 1/2 trial comprises multiple cohorts dosed with STP938, administered as an oral monotherapy, ascending in a stepwise manner. The primary objective in Phase I is to assess the safety and tolerability of STP938.

Brian Schwartz, Chief Medical Officer of Step Pharma, commented:

“We are developing STP938, a highly selective, first-in-class treatment based on ground-breaking genetics. The dosing of the first patient into our Phase 1/2 trial is an important step to identify an optimal dose to take forward into further clinical development for relapsed/ refractory T cell and B cell lymphomas.”

STP938 is a first-in-class oral cancer therapeutic that specifically inhibits nucleotide synthesis and the enzyme cytidine triphosphate synthase 1 (CTPS1) in particular, originally identified as an essential gene for lymphocyte proliferation. By targeting CTPS1, Step Pharma has unlocked the ability to selectively target the de novo pyrimidine synthesis pathway in cancer cells. This ground-breaking approach should enable the highly selective treatment of both blood cancers and solid tumours.

Further details of the study can be found on clinicaltrials.gov under the identifier NCT05463263.
Contacts

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


Media Relations
Consilium Strategic Communications
Amber Fennell, Namrata Taak, Stella Lempidaki
Tel: +44 (0) 20 3709 5700
steppharma@consilium-comms.com

+ DOWNLOAD PDF

About Step Pharma

Step Pharma’s goal is to bring about a step change in how cancer is treated with targeted therapies that kill cancer cells and leave healthy cells unharmed. The Company is the world leader in CTPS1 inhibition, a new approach with the potential to yield highly selective, safe and effective cancer treatments for both blood cancers and solid tumours.

The Company’s lead product STP938 has received both IND and CTA clearance to proceed into first in human trials in the US and UK for the treatment of T cell and B cell lymphomas. Clinical trials in lymphoma commenced in the second half of 2022. STP938 has the potential to be the backbone of a multitude of cancer therapies as well as a potent monotherapy for hard-to-treat blood cancers.

Step Pharma was founded in 2014 by Kurma Partners, the Imagine Institute and Sygnature Discovery, based on the scientific discoveries of Prof. Alain Fischer and Dr Sylvain Latour. Step Pharma is based in Saint-Genis-Pouilly, France, and is supported by a strong syndicate of investors 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.

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Step Pharma
In Press Release

Step Pharma Progresses into Oncology Clinical Trials with STP938, the World’s Most Advanced CTPS1 Inhibitor

Press Release

St. Genis-Pouilly, France, 28 July 2022

  • Clearance of IND and CTA applications in the US and UK for STP938 for the treatment of T cell and B cell lymphomas

  • First-in-class targeted therapy with potential applications in multiple cancer indications

  • Novel mechanism of action with high selectivity has the potential to yield an oral treatment with minimal side effects

Step Pharma, a world leader in CTPS1 inhibition for the targeted treatment of cancer, announces today that its lead asset STP938 has cleared both an Investigational New Drug (IND) application by the Food and Drug Administration (FDA), and a clinical trial application (CTA) by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), enabling Step Pharma to progress STP938, its first-in-class, selective CTPS1 inhibitor into the clinic in the US and UK.

STP938 has now entered an open label, first-in-human, Phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of STP938 in adult subjects with relapsed/refractory B cell and T cell lymphomas. Further details of the study can be found on clinicaltrials.gov under the identifier NCT05463263. Patients with such cancers currently face high relapse rates from existing treatments.

Step Pharma is pioneering a novel class of oral drugs that specifically inhibits nucleotide synthesis and the enzyme cytidine triphosphate synthase 1 (CTPS1) in particular, originally identified as an essential gene for lymphocyte proliferation. By targeting CTPS1, Step Pharma has unlocked the ability to selectively target the de novo pyrimidine synthesis pathway in cancer cells. This ground-breaking approach should enable the highly selective treatment of both blood cancers and solid tumours.

Andrew Parker, Chief Executive Officer of Step Pharma, said:

“Our unique approach to cancer treatment has the potential to yield a novel targeted cancer therapy that can form the backbone of both blood and solid tumour cancer treatment regimens. We are delighted to have moved STP938 into the clinic for hard-to-treat lymphomas with the ultimate goal of improving the lives of millions of cancer patients.”

Dr. Brian Schwartz, Chief Medical Officer, commented:

“The clinical trial approvals by both the US FDA and UK MHRA are a significant milestone for Step Pharma and our highly differentiated lead candidate STP938, as we become a clinical-stage company and move at speed to bring this first-in-class treatment to cancer patients with high unmet medical needs.”

Step Pharma will initially investigate STP938 in blood cancers, with a focus on T cell lymphomas, where there has been no improvement in five-year survival rates for over 20 years. However, as studies have shown that all cancer cells require CTPS1 for DNA synthesis, STP938 could be a key component of a multitude of cancer treatment regimens.

Contacts:

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


Media Relations
Consilium Strategic Communications
Amber Fennell, Namrata Taak, Stella Lempidaki
Tel: +44 (0) 20 3709 5700
steppharma@consilium-comms.com

+ DOWNLOAD PDF

About Step Pharma

Step Pharma’s goal is to bring about a step change in how cancer is treated with targeted therapies that kill cancer cells and leave healthy cells unharmed. The Company is the world leader in CTPS1 inhibition, a new approach with the potential to yield highly selective, safe and effective cancer treatments for both blood cancers and solid tumours.

The Company’s lead product STP938 has received both IND and CTA clearance to proceed into first in human trials in the US and UK for the treatment of T cell and B cell lymphomas. Clinical trials in lymphoma commenced in the second half of 2022. STP938 has the potential to be the backbone of a multitude of cancer therapies as well as a potent monotherapy for hard-to-treat blood cancers.

Step Pharma was founded in 2014 by Kurma Partners, the Imagine Institute and Sygnature Discovery, based on the scientific discoveries of Prof. Alain Fischer and Dr Sylvain Latour. Step Pharma is based in Saint-Genis-Pouilly, France, and is supported by a strong syndicate of investors 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.

+ LEARN MORE
Step Pharma
In Press Release, Events

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-

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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.

For more information please contact

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

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Step Pharma
In Press Release, Events

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.ciation Congress being held June 9-17, 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

 

Contacts:

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

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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.

For more information please contact

Step Pharma
contact@step-ph.com

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Step Pharma
In Press Release

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.”

 

Contacts:

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

+ DOWNLOAD PDF

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.

For more information please contact

Step Pharma
contact@step-ph.com

+ LEARN MORE
Step Pharma
In Press Release, Events

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

Press Release

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.

+ DOWNLOAD PDF

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.

For more information please contact

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

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