Third Success from Astex Drug Discovery Pharma Collaboration and Licence Agreements as AstraZeneca Receives US Marketing Approval for Cancer Drug Truqap (capivasertib)

AstraZeneca’s TruqapTM (capivasertib) in combination with Faslodex® (fulvestrant) receives US FDA marketing approval for the treatment of adult patients with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer with one or more biomarker alterations (PIK3CA, AKT1 or PTEN).

  • Astex is eligible to receive a milestone payment and royalties on sales of the new drug under its 2005 collaboration and licence agreement with AstraZeneca
  • Truqap, a first in class AKT inhibitor, was discovered by AstraZeneca subsequent to its discovery collaboration with Astex and Astex’s earlier drug discovery collaboration with the Institute of Cancer Research, London
  • Truqap joins Novartis’ Kisqali® and Janssen’s BALVERSA® as the third drug to reach market approval based on collaborations that have utilised Astex’s pioneering fragment-based drug discovery approach

Cambridge, UK, 20 November 2023 – Astex Pharmaceuticals (UK), a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics for oncology and diseases of the central nervous system, announced today that it is in line to receive a milestone payment from AstraZeneca on first commercial sale of the drug in the US and royalties from AstraZeneca on future sales following the US Food and Drug Administration’s (FDA) approval of TruqapTM plus Faslodex® as a treatment for adult patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer with one or more biomarker alterations (PIK3CA, AKT1 or PTEN). Eligible patients will have progressed on at least one endocrine-based regimen in the metastatic setting or experienced recurrence on or within 12 months of completing adjuvant therapy.

This is the third cancer drug in the last five years to reach market approval that has been discovered and developed under, or subsequent to, an Astex drug discovery collaboration. In addition to Truqap, Astex’s other partnered programs that have been highly successful in translating research into new cancer medicines include Novartis’ Kisqali® (ribociclib) and Janssen’s BALVERSA® (erdafitinib).

Truqap is a first-in-class oral targeted inhibitor of the cancer-driving protein AKT, also known as PKB. AKT is an enzyme that plays a key role in the PI3K/AKT tumor cell survival pathway, and dysregulation of this pathway leads to tumor resistance to a number of important anti-cancer medicines. Truqap was discovered by AstraZeneca following an earlier drug discovery research collaboration between Astex, The Institute of Cancer Research, London, and Cancer Research Technology (CRT; now Cancer Research Horizons) that was signed in 2003. As part of that earlier foundational research, Astex and The Institute of Cancer Research (ICR) used the 3D X-ray crystal structure of the AKT protein target to identify small molecule modulators of AKT activity using an approach known as fragment-based drug discovery. In 2005 a series of prototype drug compounds discovered by Astex and the ICR was shown to have very promising activity against a range of human tumors grown in mice and was licensed to AstraZeneca. In 2010, AstraZeneca announced its discovery of Truqap, and began to develop the drug as a potential treatment for various forms of cancer.

Following the marketing approval, Astex is eligible to receive a milestone payment from AstraZeneca on first commercial sale of the drug in the US as well as royalties on future sales.

Harren Jhoti PhD, President and Chief Executive Officer of Astex, UK, said: “We are incredibly proud that another of our drug discovery partnerships has resulted in such a successful outcome. We applaud our valued colleagues at AstraZeneca for their tenacity and exceptional work in the discovery and development of this first-in-class medicine.”

“The early research was a great collaborative effort, and I would like to acknowledge the impressive pioneering research carried out by our colleagues at the ICR, including solving the 3D crystal structure of AKT, which was vital in enabling our initial drug discovery approach. This is also a great example of UK Biotech-Academia-Pharma collaboration and underlines the strength of the UK life sciences ecosystem.”

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About Astex Pharmaceuticals

Astex is a leader in innovative drug discovery and development, committed to the fight against cancer and diseases of the central nervous system. Astex is developing a proprietary pipeline of novel therapies and has a number of partnered products being developed under collaborations with leading pharmaceutical companies. Astex is a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., based in Tokyo, Japan.

For more information about Astex Pharmaceuticals please visit: https://www.astx.com

For more information about Otsuka Pharmaceutical, please visit: https://www.otsuka.co.jp/en/

CONTACTS:

At Astex Pharmaceuticals (UK)

Jeremy Carmichael
SVP Corporate Development
Head of Business Development
Astex Pharmaceuticals
436 Cambridge Science Park
Milton Road, Cambridge
CB4 0QA, UK

Tel: +44 1223 226289
Email: jeremy.carmichael@astx.com

Media Enquiries

Sue Charles
Charles Consultants
Tel: +44 7968 726585
Email: sue@charles-consultants.com

 

Astex CSO David Rees Honoured as a Hero of Chemistry by the American Chemical Society

Cambridge, UK, 13 October 2023, Astex Pharmaceuticals (UK) (“Astex”), a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics for oncology and diseases of the central nervous system, congratulates its Chief Scientific Officer (CSO), David Rees PhD, FMedSci, FRSC on being honoured by the American Chemical Society (ACS) Heroes of Chemistry.

The award recognises researchers and companies for developing products that have led to significant advancements in improving health and the environment. The ceremony to honour these impressive achievements took place yesterday in Alexandria, Virginia.

David is a co-recipient of the award given to Merck & Co. Inc (MSD) for Bridion® (sugammadex). Bridion® is approved in 95+ countries for reversal of the effects of certain neuromuscular blocking agents in adults undergoing surgery. It binds these agents, reducing the amount of active drug available to relax the muscles, resulting in reversal of neuromuscular blockade. David devised the concept of using chemical chelation to reverse anaesthesia and led the team of chemists involved in the early discovery of Bridion® (sugammadex) whilst at Organon Laboratories, Scotland, UK (which became part of MSD in 2009).

Announcing the 2023 awards, ACS President Judith C. Giordan said, “These awards recognize teams of chemists that have worked toward the betterment of humankind. The 2023 ACS Heroes of Chemistry demonstrate the unwavering dedication of chemists to propel us toward healthier lives and a greener tomorrow, and for forging a future where scientists, chemistry and innovation come together to uplift humanity.”

The 2023 winners, which also include scientist teams from AbbVie, Honeywell, Incyte, Vertex and ViiV Healthcare as well as MSD will be inducted into the Heroes of Chemistry scientific hall of fame, which ACS has sponsored annually since 1996.

Astex CSO David Rees said, “I am delighted to receive this award. It is immensely motivating to know that so many patients have benefitted from Bridion® (sugammadex). This is a tribute to the entire team involved in the research and development”.

David joined Astex in 2003 to lead the chemistry team and in 2017 became its CSO. In addition to Bridion®, whilst at Astex, David has been associated with the discovery of two further launched drugs including the anti-cancer agents Kisqali® (ribociclib), discovered under collaboration with Novartis, and Balversa® (erdafitinib) under a collaboration with Janssen.

David is one of the few industrial scientists to have served as President of the Organic Division of the Royal Society of Chemistry (RSC) (2010-2013) and in 2015 was elected to be a Trustee Director of the RSC (2015-2019). He has held visiting professorships at three UK universities and sits on several scientific advisory boards of not-for-profit organisations. In 2020 he was elected to the Fellowship of the Academy of Medical Sciences as well serving on the Board of Directors of The Rosalind Franklin Institute, Parkinson’s Research Ventures, and Ashanti Development. The Heroes of Chemistry honour from the ASC adds to his accolades having been inducted into the RSC Biological and Medicinal Chemistry Sector (BMCS) Hall of Fame in 2020.

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About Astex Pharmaceuticals

Astex is a leader in innovative drug discovery and development, committed to the fight against cancer and diseases of the central nervous system. Astex is developing a proprietary pipeline of novel therapies and has a number of partnered products being developed under collaborations with leading pharmaceutical companies. Astex is a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., based in Tokyo, Japan.

For more information about Astex Pharmaceuticals please visit: https://www.astx.com

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For more information about Otsuka Pharmaceutical, please visit:  https://www.otsuka.co.jp/en/

About The American Chemical Society (ACS)

The ACS is a non-profit organization chartered by the U.S. Congress. ACS’ mission is to advance the broader chemistry enterprise and its practitioners for the benefit of Earth and all its people. The Society is a global leader in promoting excellence in science education and providing access to chemistry-related information and research through its multiple research solutions, peer-reviewed journals, scientific conferences, eBooks and weekly news periodical Chemical & Engineering News. ACS journals are among the most cited, most trusted and most read within the scientific literature; however, ACS itself does not conduct chemical research. As a leader in scientific information solutions, its CAS division partners with global innovators to accelerate breakthroughs by curating, connecting and analyzing the world’s scientific knowledge. ACS’ main offices are in Washington, D.C., and Columbus, Ohio.

For more information about the ACS please visit: http://www.acs.org

 

CONTACTS:

At Astex Pharmaceuticals (UK)

Jeremy Carmichael
SVP Corporate Development
Head of Business Development
Astex Pharmaceuticals
436 Cambridge Science Park
Milton Road, Cambridge
CB4 0QA, UK

Tel: +44 1223 226289
Email: jeremy.carmichael@astx.com

Media Enquiries

Sue Charles
Charles Consultants
Tel: +44 7968 726585
Email: sue@charles-consultants.com

Astex Expands Drug Discovery Collaboration With MSD

Cambridge, UK, 8 August 2023, Astex Pharmaceuticals (UK) (“Astex”), a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics for oncology and diseases of the central nervous system, today announced an exclusive worldwide research collaboration and license agreement with MSD (Merck & Co., Inc., Rahway, N.J., USA).  The goal of the collaboration is to identify small molecule candidates with activity towards a tumour suppressor protein for the treatment of cancer.

“Astex is applying its fragment-based drug discovery capability to design and generate small molecule modulators tailored to a wide range of potentially important therapeutic targets,” said Harren Jhoti, president and CEO of Astex.  “This new alliance builds on our existing productive collaboration and allows us to combine our expertise and assets with MSD’s wide-ranging oncology capabilities.”

Under the terms of the agreement, Astex will apply its fragment-based drug discovery platform to develop compounds targeting multiple forms of the p53 tumour suppressor protein and provide MSD with lead compounds for further optimization and preclinical development.  MSD is granted an exclusive global license to research, develop, and commercialise candidates arising under the collaboration.  Astex will receive an upfront payment of $35 million and is eligible for milestone payments associated with the achievement of preclinical, clinical, regulatory and sales milestones, totalling approximately $500 million per program, as well as tiered royalties on sales of any products arising from the collaboration.  MSD will assume responsibility for funding all future research and development of lead candidates as well as commercialisation of products globally.

“At MSD we are committed to driving innovation with the goal of improving outcomes for patients with cancer,” said George Addona, senior vice president discovery and translational medicine, MSD. “We look forward to building on our collaboration with the Astex team to advance this potentially impactful area of oncology research.”

-ENDS-

About Astex Pharmaceuticals

Astex is a leader in innovative drug discovery and development, committed to the fight against cancer and diseases of the central nervous system. Astex is developing a proprietary pipeline of novel therapies and has a number of partnered products being developed under collaborations with leading pharmaceutical companies. Astex is a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., based in Tokyo, Japan.

For more information about Astex Pharmaceuticals please visit: https://www.astx.com

For more information about Otsuka Pharmaceutical, please visit: https://www.otsuka.co.jp/en/

CONTACTS

At Astex Pharmaceuticals (UK)

Jeremy Carmichael
SVP Corporate Development
Head of Business Development
Astex Pharmaceuticals
436 Cambridge Science Park
Milton Road, Cambridge
CB4 0QA, UK

Tel: +44 1223 226289
Email: jeremy.carmichael@astx.com

Media Enquiries

Sue Charles
Charles Consultants

Tel: +44 7968 726585
Email: sue@charles-consultants.com

Astex and Cardiff University Medicines Discovery Institute Announce New Drug Discovery Collaboration on Neurodegenerative Diseases

Cambridge and Cardiff, UK, 13 February 2023, Astex Pharmaceuticals (UK) (“Astex”), a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics for oncology and diseases of the central nervous system and The Medicines Discovery Institute, Cardiff University (“MDI”) announced today that they have entered into a multi-year, multimillion pound drug discovery research collaboration, aimed to identify new drugs to treat neurodegenerative diseases.

The collaboration brings together the world-leading research expertise of Dr Emyr Lloyd-Evans & Dr Helen Waller-Evans in lysosomal biology, the drug discovery capabilities of the MDI and the fragment-based drug discovery platform at Astex. The combined teams will focus on identifying compounds which modulate lysosomal activity as a way to develop potential new treatments for neurodegenerative diseases with high unmet medical need.  Lysosomes are a subset of organelles that are crucial for cellular function and mutations in the genes encoding lysosomal and associated proteins are linked to a number of neurodegenerative and lysosomal storage diseases for which there are currently no effective treatments.

Under the terms of the agreement, scientists at the MDI and Astex will collaborate to carry out drug discovery research against a chosen lysosomal target with the aim to identify and optimise compounds that modulate its activity.  Cardiff University will receive committed R&D funding and is eligible to receive development and regulatory payments if drug compounds progress and a royalty payment on the sales of any approved products.  Further financial details are not disclosed.

Prof Simon Ward, Director, Medicines Discovery Institute commented “We are excited to be working with Astex in a way that allows each partner to play to its individual strengths and build a combined team which is greater than the sum of its parts. This is a validation of the scientific and translational capabilities we have been building at Cardiff University over the last few years and we look forward to delivering outputs that may ultimately benefit patients for whom current treatment options are so limited. This is an excellent demonstration of the power of academic and industrial teams working together to try to solve currently intractable medical problems.”

Dr David Rees, FMedSci, FRSC, Chief Scientific Officer of Astex commented, “We are very excited about this opportunity to work with Cardiff University, Medicines Discovery Institute. Astex has a long tradition of effective collaborations between academia and industry which we believe is critical for the successful translation of basic science. This partnership aims to support and advance ground-breaking research with the potential to transform the lives of patients with neurodegenerative diseases.”

About Astex Pharmaceuticals

Astex is a leader in innovative drug discovery and development, committed to the fight against cancer and diseases of the central nervous system. Astex is developing a proprietary pipeline of novel therapies and has a number of partnered products being developed under collaborations with leading pharmaceutical companies. Astex is a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., based in Tokyo, Japan.

For more information about Astex Pharmaceuticals please visit:  https://www.astx.com

For more information about Otsuka Pharmaceutical, please visit:  https://www.otsuka.co.jp/en/

About Cardiff University

Cardiff University is recognised in independent government assessments as one of Britain’s leading teaching and research universities and is a member of the Russell Group of the UK’s most research-intensive universities. The 2014 Research Excellence Framework ranked the University 5th in the UK for research excellence. Among its academic staff are two Nobel Laureates, including the winner of the 2007 Nobel Prize for Medicine, Professor Sir Martin Evans. Founded by Royal Charter in 1883, today the University combines impressive modern facilities and a dynamic approach to teaching and research. The University’s breadth of expertise encompasses: the College of Arts, Humanities and Social Sciences; the College of Biomedical and Life Sciences; and the College of Physical Sciences and Engineering, along with a longstanding commitment to lifelong learning. Cardiff’s flagship Research Institutes are offering radical new approaches to pressing global problems.

For more information about Cardiff University, please visit:  www.cardiff.ac.uk

About MDI

The Medicines Discovery Institute is the leading, university-based, CNS drug discovery group in Europe, delivering modern drug discoveries to improve treatments for neurological illnesses. Grounded in the academic & clinical excellence of Cardiff University, the team combines profound insight with industry-standard drug discovery. A robust pipeline of novel drug projects stretches from early drug screening through to human clinical trials, run at Cardiff. The Institute is led by Professors Simon Ward & John Atack.

For more information about Medicines Discovery Institute, please visit:  https://www.cardiff.ac.uk/medicines-discovery 

CONTACTS

At Medicines Discovery Institute

Richard Angell
Commercialisation Lead
Medicines Discovery Institute
Cardiff University
Main Building
Park Place
Cardiff
CF10 3AT
Email: angellr@cardiff.ac.uk

Media Enquiries

Heath Jeffries
Head of Innovation Communication
Cardiff University

Tel: +44 29 2087 70917
Email: jeffrieshv1@cardiff.ac.uk

At Astex Pharmaceuticals (UK)

Jeremy Carmichael
SVP Corporate Development
Head of Business Development
Astex Pharmaceuticals
436 Cambridge Science Park
Milton Road, Cambridge
CB4 0QA, UK

Tel: +44 1223 226289
Email: jeremy.carmichael@astx.com

Media Enquiries

Sue Charles
Charles Consultants

Tel: +44 7968 726585
Email: sue@charles-consultants.com

Astex Co-founder and CEO Harren Jhoti Awarded OBE in the King’s New Year Honours

Cambridge, UK, 31st December 2022, Astex Pharmaceuticals, UK, congratulates Harren Jhoti, PhD, FRS, FMedSci, its co-founder, President and CEO on being honoured in the 2023 King’s New Year Honours list. Dr Jhoti has been made an Officer of the Order of the British Empire (OBE) for services to Cancer Research and Drug Discovery.

Dr. Jhoti co-founded Astex in 1999 to pioneer the development of fragment-based drug discovery (FBDD), a ground-breaking new approach now widely used in the pharmaceutical industry, and which the company has used to help discover two new marketed cancer medicines, Kisqali and Balversa. As a passionate advocate for the UK life sciences sector, Dr. Jhoti has been a prominent figure highlighting the strength of the life sciences ecosystem in Cambridge as well as more widely in the UK and overseas.

Prof. Sir Tom Blundell FRS, an Astex co-founder and Board member, commented, ‘‘This honour is very well deserved. It underlines Harren’s qualities as an innovator, entrepreneur and leader at Astex. Harren has been the main driver of Astex’s success in developing new medicines using structure-guided fragment-based methods for oncology and diseases of the central nervous system. He has proved to be a visionary, not only in the science, but also in managing the team at Astex in a non-hierarchical structure, encouraging innovation by individuals in a multidisciplinary approach to early discovery. He has also successfully developed collaborations with large pharma companies in Europe and USA and the Japanese company Otsuka to ensure success in clinical trials.”

Paying tribute to his colleagues and collaborators, Dr. Jhoti said, “It is a great privilege to receive this honour. This award recognises the contribution that I have made in some small way to the development of Astex, but I share it with all of my colleagues, past and present, and with our collaborators who have helped contribute to the success of our company. As scientists, we hope that our discoveries will make a difference to patients, and as entrepreneurs we strive to build sustainable companies to translate those discoveries into significant new medicines. At Astex we, as a team, are fortunate to have achieved both goals. The company has also greatly benefited from the growth and development of the UK life sciences sector in the last 20 years into a leading international powerhouse.”

-ENDS-

About Harren Jhoti

Harren Jhoti co-founded Astex in 1999 and was Chief Scientific Officer until November 2007 when he was appointed Chief Executive Officer. He was elected a Fellow of the Royal Society in 2018, the Royal Society of Chemistry in 2016, and of the Academy of Medical Sciences in 2015. In January 2018 he was honoured with a Lifetime Achievement Award from the UK BioIndustry Association (BIA). In 2019 he was made a Fellow of Birkbeck College, London his alma mater. He received the Prous Institute-Overton and Meyer Award for New Technologies in Drug Discovery from the European Federation for Medicinal Chemistry in 2012 and was also named by the Royal Society of Chemistry as “Chemistry World Entrepreneur of the Year” for 2007. He was made an Officer of the Order of the British Empire (OBE) for services to Cancer Research and Drug Discovery in December 2022.

Dr. Jhoti has published in Nature and Science, and was featured in Time magazine after Astex was named a Technology Pioneer by the World Economic Forum in 2005. He has served on the board of the BIA, the UK BioIndustry Association and currently consults for life science venture capital firms. Before founding Astex in 1999, he was head of Structural Biology and Bioinformatics at GlaxoWellcome in the United Kingdom (1991-1999). Prior to Glaxo, Dr. Jhoti was a post-doctoral scientist at Oxford University. A British Asian, he was state educated in Swindon and went on to study at the University of London where he received a B.Sc. (Hons) in Biochemistry in 1985 and a Ph.D. in Protein Crystallography in 1989.

Read about his entrepreneur’s journey here, https://bioengineeringcommunity.nature.com/users/333672-harren-jhoti

See his Wikipedia profile here, https://en.wikipedia.org/wiki/Harren_Jhoti

About Astex Pharmaceuticals (UK)

Astex is a leader in innovative drug discovery and development, committed to the fight against cancer and diseases of the central nervous system. Astex is developing a proprietary pipeline of novel therapies and has a number of partnered products being developed under collaborations with leading pharmaceutical companies. Astex is a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., based in Tokyo, Japan.

For more information about Astex Pharmaceuticals, please visit https://stagin.astx.co.uk

For more information about Otsuka Pharmaceutical, please visit http://www.otsuka.co.jp/en/

Contact

At the Company Media Enquiries

Jeremy Carmichael
SVP Corporate Development
Head of Business Development
Astex Pharmaceuticals
436 Cambridge Science Park
Milton Road, Cambridge
CB4 0QA, UK

Tel: +44 (0)1223 226289
Email: jeremy.carmichael@astx.com

Sue Charles
Charles Consultants

Email: sue@charles-consultants.com

British Company Behind Groundbreaking Breast Cancer Treatment

Astex welcomes positive, new data showing breast cancer drug, Kisqali® (ribociclib), cuts risk of death by up to a third when given with hormone therapy

Cambridge, UK, 7 June 2019. A new set of statistically significant overall survival (OS) data unveiled at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract# LBA1008), and published in The New England Journal of Medicine, are being heralded as a major breakthrough forpre- and perimenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancerpremenopausal women with advanced breast cancer.

Kisqali was discovered and developed by the Novartis Institutes for Biomedical Research (NIBR) under a research collaboration entered into with Astex in 2005.  Kisqali is a CDK4/6 inhibitor that slows the progression of cancer by inhibiting two proteins (CDK4 & CDK6) which, when over-activated, can enable cancer cells to grow and divide quickly.

Successful results from the phase III MONALEESA-7 clinical trial resulted in Kisqali receiving marketing approval in the US and EU in 2018 in combination with an endocrine-based therapy for pre- and perimenopausal women with (HR+/HER2-) locally advanced or metastatic breast cancer in combination with an aromatase inhibitor.

The UK’s National Institute for Health and Care Excellence (NICE) recommended Kisqali as a cost-effective treatment option for postmenopausal women within England and Wales with advanced breast cancer in November 2017. Advanced breast cancer in premenopausal women is the leading cause of cancer death in women 20-59 years old [1],[2].

Kisqali is the only CDK4/6 inhibitor to show superior overall survival in a clinical trial (alt. “v. placebo”) in advanced breast cancer (HR=0.712; p=0.00973)[3]. In its announcement at ASCO, Novartis noted that the new data from its MONALEESA-7 trial showed that after a median of 42 months follow-up, survival rate for women was 70.2% for women who received Kisqali combination therapy compared to 46.0% for women who received endocrine therapy alone. The breakthrough data has been widely reported in the world’s press.

Harren Jhoti Ph.D., President and CEO of Astex, UK, said, “It’s fantastic to see such a significant advance in cancer treatment. Ultimately as life science entrepreneurs, our goal is to improve lives through the discovery of new therapies. Kisqali was the first new cancer drug discovered and developed from our collaboration with Novartis to reach marketing approval and was a milestone for the company in 2017.  These new data are a real milestone for patients.”
The paper,Overall Survival with Ribociclib plus Endocrine Therapy in Breast Cancer, was a published in The New England Journal of Medicinetoday and is available online.

See the discovery journey for Kisqali, here: https://stagin.astx.co.uk/research-development/partnered-products-and-programs/kisqali-ribociclib-cdk46-inhibitor-oncology/

-ENDS-

About Astex Pharmaceuticals

Astex is a leader in innovative drug discovery and development, committed to the fight against cancer and diseases of the central nervous system.  Astex is developing a proprietary pipeline of novel therapies and has a number of partnered products being developed under collaborations with leading pharmaceutical companies.  In October 2013 Astex became a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., Tokyo, Japan.  Otsuka Pharmaceutical is a global healthcare company with the corporate philosophy: “Otsuka – people creating new products for better health worldwide.”  Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for the maintenance of everyday health.
For more information about Astex Pharmaceuticals, please visit https://stagin.astx.co.uk
For more information about Otsuka Pharmaceutical, please visit http://www.otsuka.co.jp/en/

References

[1] Benz CC. Impact of aging on the biology of breast cancer. Crit Rev Oncol Hematol. 2008;66:65-74.
[2] World Health Organization. Top cancer per country, estimated age-standardized mortality rates (World) in 2018, females, all ages. 2018. Available at http://gco.iarc.fr/today/home. Accessed May 2019
[3] Hurvitz S, Seock-Ah I, Yen-Shen L et al. Phase III MONALEESA-7 trial of premenopausal patients with HR+/HER2- advanced breast cancer (ABC) treated with endocrine therapy ± ribociclib: Overall survival (OS) results. Presented at the 2019 ASCO Meeting, June 1, 2019, Abstract# LBA 1008.

CONTACT:

At the Company:
Jeremy Carmichael
VP Corporate Development
Head of Business Development
Tel: +44(0)1223 226289
Email: jeremy.carmichael@astx.com

For Media Enquiries:
Sue Charles / Ashley Tapp
Instinctif Partners
Tel: +44 (0)20 7866 7863
Email: astex@instinctif.com

 

Astex Pharmaceuticals Celebrates as Second New Cancer Drug Receives US Marketing Approval

Astex Pharmaceuticals Celebrates as Second New Cancer Drug Receives US Marketing Approval
  • Further Milestone from Janssen on NDA Approval by the US FDA of BALVERSA™ (erdafitinib) for the Treatment of Urothelial Cancer

Cambridge, UK, 12 April 2019. Astex Pharmaceuticals (Astex), a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics for oncology and diseases of the central nervous system, announced today that it has received a milestone payment from Janssen Pharmaceutica N.V. (Janssen). This follows the United States Food and Drug Administration’s (FDA) accelerated review and approval of a Janssen New Drug Application (NDA) for BALVERSA™ (erdafitinib) for the treatment of adults with locally advanced or metastatic urothelial carcinoma (mUC) which has susceptible fibroblast growth factor receptor (FGFR)3 or FGFR2 genetic alterations and who have progressed during or following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.

BALVERSA™ (erdafitinib) is a once-daily, oral pan-FGFR inhibitor that was discovered by Astex and Janssen as part of a 2008 exclusive worldwide collaboration and licence agreement to identify novel, small molecule inhibitors of FGFR kinase, including for the treatment of cancer. Under the ongoing collaboration, Janssen is responsible for the clinical development and commercialisation of all products, including erdafitinib. Astex is eligible to receive further milestone payments on additional regulatory filings and approvals in the US and Europe and for additional indications, as well as tiered double-digit royalty payments on annual sales of erdafitinib.

BALVERSA™ (erdafitinib) received Breakthrough Therapy Designation from the FDA for the treatment of patients with metastatic urothelial cancer in March 2018 and Janssen announced submission of an NDA seeking its approval to the US FDA in September 2018. Urothelial cancer, particularly of the bladder, is the sixth most common type of cancer in the USA.

Before entering into its exclusive worldwide collaboration and licence agreement with Janssen, Astex performed pioneering work on FGFR with the Cancer Research UK Drug Discovery Group at the Newcastle Cancer Centre, Northern Institute for Cancer Research, Newcastle University, UK, underlining the quality of UK science and strengths in academic-biotech collaboration.

Harren Jhoti Ph.D., President and CEO of Astex, UK, said, “‘We are delighted with the approval of BALVERSA™ and congratulate our valued colleagues at Janssen for their determination and excellent work in the discovery and development of this new medicine. We also congratulate our academic collaborators at Newcastle University for their contribution to our pioneering early collaboration on FGFR that aided in its discovery. Astex continues to strive to discover new medicines for cancer patients and is very proud that BALVERSA™ is the second of our Pharma-partnered products to have been approved in the last two years.’

-ENDS

About Astex Pharmaceuticals

Astex is a leader in innovative drug discovery and development, committed to the fight against cancer and diseases of the central nervous system. Astex is developing a proprietary pipeline of novel therapies and has a number of partnered products being developed under collaborations with leading pharmaceutical companies. In October 2013 Astex became a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., Tokyo, Japan. Otsuka Pharmaceutical is a global healthcare company with the corporate philosophy: “Otsuka – people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for the maintenance of everyday health.

For more information about Astex Pharmaceuticals, please visit https://stagin.astx.co.uk

For more information about Otsuka Pharmaceutical, please visit http://www.otsuka.co.jp/en/

BALVERSA is a trademark of Janssen Biotech, Inc.

Contact

At the Company:
Jeremy Carmichael
VP Corporate Development
Head of Business Development

Tel: +44(0)1223 226289
Email: jeremy.carmichael@astx.com

For Media Enquiries:
Sue Charles / Ashley Tapp
Instinctif Partners

Tel: +44 (0)20 7866 7863
Email: astex@instinctif.com

Astex’s Harren Jhoti Made Fellow of the Royal Society

Astex Pharmaceuticals (“Astex”), a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics for oncology and diseases of the central nervous system, announced today that Harren Jhoti Ph.D., co-founder of Astex and President and CEO of Astex Pharmaceuticals (UK) has been elected a Fellow of the Royal Society in recognition of his outstanding contribution to drug discovery research and science in general.

Election to the Fellowship of the Royal Society is the highest accolade in UK science and recognises individuals for their scientific excellence and substantial contributions to research endeavours. At Astex Dr. Jhoti pioneered the development of fragment-based drug discovery, an approach now widely used in pharmaceutical and academic drug discovery centres worldwide.

Astex is one of the UK’s leading biotech companies, employing some 130 staff at its research headquarters in Cambridge UK and over 200 worldwide, and has been highly successful in translating research into new medicines. Notably this includes Kisqali®, a drug co-discovered by Astex under a partnership with Novartis that received marketing approval in the USA and in Europe as a treatment for metastatic breast cancer in 2017.

Dr. Jhoti commented, “I’m delighted and humbled to have been made a Fellow of the Royal Society.  I would like to thank all my scientific colleagues, past and present, who have supported me in my research career. This Fellowship is also a reflection of the excellence of science at Astex created by its many highly talented researchers.”

-ENDS-

Notes to Editors

About Astex Pharmaceuticals

Harren Jhoti co-founded Astex in 1999 and was Chief Scientific Officer until November 2007 when he was appointed Chief Executive Officer.  He was elected a Fellow of the Royal Society in 2018, the Royal Society of Biology in 2017, the Royal Society of Chemistry in 2016, and of the Academy of Medical Sciences in 2015.  In January 2018 he was honoured with a Lifetime Achievement Award from the UK BioIndustry Association (BIA).  He received the Prous Institute-Overton and Meyer Award for New Technologies in Drug Discovery from the European Federation for Medicinal Chemistry in 2012 and was also named by the Royal Society of Chemistry as “Chemistry World Entrepreneur of the Year” for 2007.

He has published widely including in leading journals such as Nature and Science, and has also been featured in TIME magazine after being named by the World Economic Forum a Technology Pioneer in 2005.  He has served on the board of the BIA, the UK BioIndustry Association and currently consults for life science venture capital firms. Before founding Astex in 1999, he was head of Structural Biology and Bioinformatics at GlaxoWellcome in the United Kingdom (1991-1999). Prior to Glaxo, Dr. Jhoti was a post-doctoral scientist at Oxford University. He received a B.Sc. (Hons) in Biochemistry in 1985 and a Ph.D. in Protein Crystallography from the University of London in 1989.

More information on the Royal Society can be found here: https://royalsociety.org/

About Astex Pharmaceuticals

Astex is a leader in innovative drug discovery and development, committed to the fight against cancer and diseases of the central nervous system.  Astex is developing a proprietary pipeline of novel therapies and has a number of partnered products being developed under collaborations with leading pharmaceutical companies.  Astex is a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., Tokyo, Japan; a global healthcare company with the corporate philosophy: “Otsuka – people creating new products for better health worldwide.”  Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for the maintenance of everyday health.

For more information about Astex Pharmaceuticals, please visit https://stagin.astx.co.uk

For more information about Otsuka Pharmaceutical, please visit http://www.otsuka.co.jp/en/

At the Company

Jeremy Carmichael
VP Corporate Development
Head of Business Development
Astex Pharmaceuticals
436 Cambridge Science Park
Milton Road, Cambridge
CB4 0QA, UK

Tel: +44(0)1223 226289
Mobile: +44 (0)7786 738066
Email: jeremy.carmichael@astx.com

 

Astex Continues to Deliver in Oncology as Erdafitinib, a Potential New Treatment for Metastatic Urothelial Cancer, Receives US FDA Breakthrough Therapy Designation

Astex Pharmaceuticals (“Astex”), a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics for oncology and diseases of the central nervous system, announced today that its pharmaceutical collaborator, Janssen Pharmaceutica N.V. (Janssen), has been granted Breakthrough Therapy Designation by the US FDA for erdafitinib in the treatment of metastatic urothelial cancer.

Erdafitinib was discovered by Astex and Janssen as part of a 2008 exclusive worldwide collaboration and licence agreement to identify novel, small molecule inhibitors of Fibroblast Growth Factor Receptor (FGFR) kinase, including for the treatment of cancer.  Janssen is responsible for the clinical development and commercialisation of all products arising from this collaboration.

The FGFR inhibitor programme between Astex and Janssen underlines the UK strengths in academic-biotech collaboration as it originated from pioneering work on FGFR between Astex and the Cancer Research UK Drug Discovery Group at the Newcastle Cancer Centre, Northern Institute for Cancer Research, Newcastle University, UK.

Urothelial cancer, particularly of the bladder, is the sixth most common type of cancer in the USA.  Breakthrough Therapy Designation allows for the expedited development and regulatory review of erdafitinib as a potential new treatment option for patients with metastatic disease.  It was granted based on positive data from a multicenter, open-label Phase 2 clinical trial.

Harren Jhoti Ph.D., President and CEO of Astex, UK, said, “This is a great endorsement of our scientific approach and our team.  Astex is committed to the fight against cancer and so is delighted that erdafitinib has been granted Breakthrough Therapy Designation by the US FDA.  Congratulations to our valued collaborators at Janssen for their excellent work in advancing erdafitinib to this exciting stage in its development.”

-ENDS-

Notes to Editors

About Astex Pharmaceuticals

Astex is a leader in innovative drug discovery and development, committed to the fight against cancer and diseases of the central nervous system.  Astex is developing a proprietary pipeline of novel therapies and has a number of partnered products being developed under collaborations with leading pharmaceutical companies.  In October 2013 Astex became a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., Tokyo, Japan.  Otsuka Pharmaceutical is a global healthcare company with the corporate philosophy: “Otsuka – people creating new products for better health worldwide.”  Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for the maintenance of everyday health.

For more information about Astex Pharmaceuticals, please visit https://stagin.astx.co.uk

For more information about Otsuka Pharmaceutical, please visit http://www.otsuka.co.jp/en/

At the Company

Jeremy Carmichael
VP Corporate Development
Head of Business Development
Astex Pharmaceuticals
436 Cambridge Science Park
Milton Road, Cambridge
CB4 0QA, UK

Tel: +44(0)1223 226289
Mobile: +44 (0)7786 738066
Email: jeremy.carmichael@astx.com

Harren Jhoti Receives Lifetime Achievement Award from the UK BioIndustry Association

Astex Pharmaceuticals (“Astex”), a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics for oncology and diseases of the central nervous system, announced today that Harren Jhoti Ph.D., co-founder of Astex and President and CEO of Astex Pharmaceuticals (UK) has been honoured with a Lifetime Achievement Award from the UK BioIndustry Association (BIA).

The Award was presented to Dr. Jhoti by BIA Chair, Dr. Jane Osbourn, at the BIA Gala Dinner, the BIA’s annual flagship event, which was held last night at The Brewery, in central London.

The BIA Lifetime Achievement Award, the highest accolade awarded by the BIA, recognises outstanding contribution to the life sciences sector in the UK.  The award is made in recognition of Dr. Jhoti’s scientific contributions to the UK life science sector, his entrepreneurial approach and his commitment to scaling and supporting UK biotech.

Dr. Jhoti has steered Astex to become one of the UK’s most successful biotech companies. Employing some 130 staff at its research headquarters in Cambridge UK and over 200 worldwide, including at its clinical development and regulatory headquarters in Pleasanton, California, USA, Astex is today an independent wholly-owned subsidiary of Otsuka Pharmaceutical Co. Ltd., Tokyo, Japan, with a focus on cancer and diseases of the central nervous system.

The Company has applied its leading fragment-based discovery platform and other technologies to the development of an internal pipeline of proprietary novel therapies and several partnered products are being developed under collaborations with leading pharmaceutical companies.  2017 was a pivotal year for the company with Kisqali® (ribociclib, formerly known as LEE011), a drug co-discovered under a partnership with Novartis receiving marketing approval in the USA and Europe as a treatment for advanced (metastatic) breast cancer.

On receiving the Award last night Dr. Jhoti commented, “As scientists we always hope that our discoveries will make a difference and as entrepreneurs we strive to build sustainable companies to translate those discoveries into significant new medicines for patients.  At Astex we have been lucky enough to achieve both of these goals due largely to our highly talented team.  These achievements have been made possible  by playing an active part in the life sciences community in Cambridge and the UK, and I’m delighted and humbled to have received this award from the BIA.

Jane Osbourn, BIA Chairman, said: “Harren’s contribution to the UK biotech sector recognises his combination of scientific and leadership skills, as well as his passion and determination to succeed. He has risen to the challenges of driving innovation, developing productive partnerships, raising investment capital and motivating a team.  He makes an active contribution to initiatives in the UK biotech sector and provides a role-model for today’s entrepreneurs.”

-ENDS-

Notes to Editors

Harren Jhoti co-founded Astex in 1999 and was Chief Scientific Officer until November 2007 when he was appointed Chief Executive Officer.  He also served as President and member of the Board of Directors of Astex Pharmaceuticals Inc., following the merger of Astex with SuperGen Inc., (subsequently renamed Astex Pharmaceuticals Inc.) in July 2011.

Dr. Jhoti was elected a Fellow of Royal Society of Biology in 2017, a Fellow of the Royal Society of Chemistry in 2016, and of the Academy of Medical Sciences in 2015.  He was awarded the Prous Institute-Overton and Meyer Award for New Technologies in Drug Discovery by the European Federation for Medicinal Chemistry in 2012 and was also named by the Royal Society of Chemistry as “Chemistry World Entrepreneur of the Year” for 2007.

He has published widely including in leading journals such as Nature and Science and has also been featured in TIME magazine having been named by the World Economic Forum a Technology Pioneer in 2005.  He has served on the board of the BIA, the UK BioIndustry Association and currently consults for life science venture capital firms.  Before founding Astex in 1999, he was head of Structural Biology and Bioinformatics at GlaxoWellcome in the United Kingdom (1991-1999).  Prior to Glaxo, Dr. Jhoti was a post-doctoral scientist at Oxford University.  He received a B.Sc. (Hons) in Biochemistry in 1985 and a Ph.D. in Protein Crystallography from the University of London in 1989.

About Astex Pharmaceuticals

Astex is a leader in innovative drug discovery and development, committed to the fight against cancer and diseases of the central nervous system.  Astex is developing a proprietary pipeline of novel therapies and has a number of partnered products being developed under collaborations with leading pharmaceutical companies.  Astex is a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., Tokyo, Japan; a global healthcare company with the corporate philosophy: “Otsuka – people creating new products for better health worldwide.”  Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for the maintenance of everyday health.

For more information about Astex Pharmaceuticals, please visit https://stagin.astx.co.uk

For more information about Otsuka Pharmaceutical, please visit http://www.otsuka.co.jp/en/

At the Company

Jeremy Carmichael
VP Corporate Development
Head of Business Development
Astex Pharmaceuticals
436 Cambridge Science Park
Milton Road, Cambridge
CB4 0QA, UK

Tel: +44(0)1223 226289
Mobile: +44 (0)7786 738066
Email: jeremy.carmichael@astx.com