Step Pharma announces the appointment of Dr Karen Smith as Chief Medical Officer
MWN-AI** Summary
Step Pharma, a leader in CTPS1 inhibition for cancer treatment, has appointed Dr. Karen L. Smith as its new Chief Medical Officer (CMO), effective immediately. With over 25 years of experience in the pharmaceutical and biotech sectors, Dr. Smith brings significant expertise in clinical development and regulatory affairs, having overseen more than 100 clinical trials and facilitated over 20 regulatory approvals in various therapeutic areas such as oncology and neurology.
Her appointment is strategically positioned to enhance Step Pharma's “pipeline in a product” strategy, particularly focused on advancing dencatistat, the company’s first-in-class CTPS1 inhibitor for multiple cancer and blood disorder indications. This move follows the company’s recent €38 million Series C financing, which is expected to further bolster its clinical development plans.
Dr. Smith's extensive background includes senior roles at prestigious companies such as Bristol Myers Squibb, AstraZeneca, and Merck. She has also served on the boards of several biotech firms, contributing to corporate exits totaling nearly $20 billion, including significant acquisitions by AbbVie and Novartis.
Andrew Parker, CEO of Step Pharma, expressed confidence in Dr. Smith's ability to push forward the company’s mission to innovate cancer treatment with CTPS1 inhibition. Dr. Smith herself shared enthusiasm about joining Step Pharma at a critical time and highlighted the potential of dencatistat to provide new treatment avenues for patients.
Founded in 2014, Step Pharma aims to revolutionize cancer treatment through targeted therapies that selectively eliminate cancer cells while sparing healthy ones. This appointment aligns with the company's commitment to transform patient outcomes and solidify its position as a frontrunner in innovative cancer therapies.
MWN-AI** Analysis
Step Pharma's recent appointment of Dr. Karen Smith as Chief Medical Officer (CMO) marks a significant strategic advancement for the company, particularly in light of its innovative therapeutic pipeline centered on CTPS1 inhibition. With her extensive background spanning over 25 years in global pharma and biotech, and a proven track record of facilitating over 20 regulatory approvals, Dr. Smith is poised to enhance Step Pharma's operational capabilities.
Dr. Smith's expertise aligns perfectly with Step Pharma’s objective to expedite the development of dencatistat, a promising first-in-class CTPS1 inhibitor targeting both cancer and blood disorders. This "pipeline in a product" strategy indicates not just a focus on dencatistat but a robust framework capable of enabling multiple indications, optimizing resource allocation, and potentially lowering clinical development costs.
The strategic timing of this appointment, following the successful completion of a €38 million Series C financing, reinforces Step Pharma's position in the oncology landscape, suggesting an eagerness to capitalize on emerging market opportunities. Investors should note that the infusion of capital will likely support accelerated clinical trials under Dr. Smith's leadership, which could lead to quicker market entries and revenue generation.
Given Dr. Smith's previous successes and involvement with numerous biotech firms that successfully exited with substantial valuations, her impact on Step Pharma could be profound. Investors might consider this combination of experienced leadership and financial backing as a green light for potential growth.
In conclusion, while volatility is inherent in biotech investments, the context surrounding Step Pharma—its new leadership, financial support, and innovative strategy—positions the company favorably in the market. Investors looking for exposure in the oncology sector may find Step Pharma a compelling opportunity, particularly as clinical results begin to unfold and contribute to broader therapeutic developments.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
- Karen Smith, MD, PhD, MBA, LLM, joins with over 25 years of global pharma and biotech experience, having contributed to more than 20 regulatory approvals
- Dr Smith's appointment will accelerate Step Pharma's ‘pipeline in a product’ strategy, leveraging her clinical and regulatory expertise to advance dencatistat, a
first-in-class CTPS1 inhibitor across multiple cancer and blood disorder indications - Appointment follows Step Pharma’s recently announced €38 million Series C financing
Saint-Genis-Pouilly, France, 28 October 2025 – Step Pharma (“the Company”), the global leader in CTPS1 inhibition for targeted cancer treatment, today announces the appointment of Karen L. Smith, MD, PhD, MBA, LLM as its Chief Medical Officer (CMO) effective immediately.
Dr Smith brings over 25 years of healthcare industry experience, having held various senior executive positions across global pharmaceutical and biotechnology companies including Bristol Myers Squibb, AstraZeneca and Merck. She brings exceptional expertise in clinical development, regulatory affairs and medical leadership. She has successfully overseen more than 100 clinical trials and 20 regulatory approvals across multiple therapeutic areas including oncology, cardiology, dermatology, rare diseases and neuroscience, leading to global launches of small molecules, biologics and devices.
Dr Smith is currently a board member of several public and private biotech companies including Skye Bioscience (NASDAQ: SKYE), and Context Therapeutics (NASDAQ: CNTX). In her previous board roles, Dr Smith helped deliver significant value through seven corporate exits for pre-clinical, clinical-stage, and commercial businesses totalling almost US $20 billion, including most recently, Capstan Tx (acquired by AbbVie in 2025 for $2.1 billion) and Mariana Oncology (acquired by Novartis in 2024 for $1.75 billion).
She received her MD from the University of Warwick, UK, a PhD in oncology from UCLA/University of Western Australia, as well as an MBA from the University of New England, Australia, and an LLM from the University of Salford, UK.
Andrew Parker, Chief Executive Officer, Step Pharma, commented: “ Karen’s passion for innovative medicine and her experience in leading clinical programmes will help to accelerate our mission to transform cancer and blood disorder treatment through our unique approach to CTPS1 inhibition. Her appointment as Chief Medical Officer, combined with our recently completed Series C financing, leaves us strongly positioned to execute our clinical development plans for dencatistat across multiple indications and ultimately deliver improved outcomes for patients.”
Dr Karen Smith, newly appointed Chief Medical Officer, Step Pharma, added : “I am honoured to join Step Pharma at this point in the Company’s evolution, and excited by the opportunity to advance dencatistat, a first-in-class CTPS1 inhibitor with promising therapeutic potential across multiple indications. Step Pharma's innovative 'pipeline in a product' strategy represents an efficient approach to clinical development that could provide new treatment options to a huge number of patients, and I look forward to applying my clinical development and regulatory experience to help bring this transformative therapy to patients."
-Ends-
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 treatments for both blood cancers and solid tumours.
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 including Kurma Partners, V-Bio Ventures, 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
Media Relations
ICR Healthcare
Amber Fennell, Namrata Taak, Phillip Marriage
Tel. +44 (0) 20 3709 5700
steppharma@icrhealthcare.com
FAQ**
How might Dr. Smith's previous board involvement with Skye Bioscience Inc Com SKYE influence her strategic decisions at Step Pharma in the development of dencatistat?
What specific regulatory strategies does Dr. Smith plan to implement at Step Pharma to expedite the approval of dencatistat, especially given her experience with companies like Skye Bioscience Inc Com SKYE?
Considering Dr. Smith’s background with high-value corporate exits, how could her experience with companies such as Skye Bioscience Inc Com SKYE affect Step Pharma's future acquisition strategies?
How does Dr. Smith envision leveraging her extensive network, including connections from Skye Bioscience Inc Com SKYE, to enhance collaboration opportunities for Step Pharma's innovative pipeline?
**MWN-AI FAQ is based on asking OpenAI questions about Context Therapeutics Inc. (NASDAQ: CNTX).
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