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Oct 09
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U.S. Food and Drug Administration (FDA) accepts New Drug Application for elinzanetant

By Advent Life Sciences, KaNDy Therapeutics, Press Release
Press Release.

 

U.S. Food and Drug Administration (FDA) accepts New Drug Application for elinzanetant

  • The New Drug Application (NDA) for elinzanetant, an investigational compound for the treatment of moderate to severe vasomotor symptoms associated with menopause, is based on the positive data from three Phase III studies OASIS 1, 2 and 3
  • Elinzanetant is the first dual neurokinin-1 and 3 (NK-1 and 3) receptor antagonist, in late-stage clinical development for the non-hormonal treatment of moderate to severe VMS associated with menopause, administered orally once daily
BERLIN–(BUSINESS WIRE)–Bayer today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for the investigational compound elinzanetant seeking approval for the treatment of moderate-to-severe vasomotor symptoms (VMS, also known as hot flashes) associated with menopause.

“If approved, elinzanetant will offer a new non-hormonal option to women seeking treatment for moderate to severe vasomotor symptoms and we look forward to the review by the agency.”

Post this

“The NDA acceptance of elinzanetant by the FDA marks a significant milestone in our efforts to advance menopause care for women in the U.S.,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization, Member of the Pharmaceutical Leadership Team at Bayer.“If approved, elinzanetant will offer a new non-hormonal option to women seeking treatment for moderate to severe vasomotor symptoms and we look forward to the review by the agency.”

The NDA application is based on the positive results from the OASIS 1, 2 and 3 Phase III studies evaluating the efficacy and safety of the investigational compound elinzanetant versus placebo. Findings from OASIS 1 and 2 were published in August 2024 in JAMA.1 Detailed results of the Phase III study OASIS 3 providing supporting efficacy and additional long-term safety data were presented at The Menopause Society (TMS) annual meeting in September 2024.

Bayer is continuing to submit applications for marketing authorizations of elinzanetant to further health authorities as well.

About the Elinzanetant clinical development program
The Phase III clinical development program of elinzanetant, OASIS, currently comprises four Phase III studies: OASIS 1, 2, 3 and 4. OASIS 1 and 2 investigated the efficacy and safety of elinzanetant administered orally once daily in women with moderate to severe VMS associated with menopause over 26 weeks and randomized 396 and 400 postmenopausal women between 40 and 65 years across 184 sites in 15 countries. Patients in the elinzanetant arm received a 120 mg dose of elinzanetant once daily for 26 weeks and patients in the control arm received a matching placebo once daily for 12 weeks, followed by elinzanetant 120 mg dose for 14 weeks. OASIS 3 investigated the efficacy and safety of elinzanetant for the treatment of vasomotor symptoms over 52 weeks in postmenopausal women and randomized 628 postmenopausal women between 40 and 65 years across 83 sites in 9 countries. The OASIS 4 study is an expansion of the clinical Phase III program and investigates the efficacy and safety of elinzanetant in women with moderate to severe VMS caused by endocrine therapy for treatment or prevention of breast cancer.

In addition to the OASIS program, Bayer is conducting NIRVANA (NCT06112756), an exploratory Phase II randomized, parallel-group treatment, double-blind study. The primary objective is to explore the efficacy of elinzanetant on sleep disturbances associated with menopause (SDM) as determined by polysomnography (PSG). PSG is a validated method to study sleep and underlying causes of sleep disturbances. Additional objectives include exploring the efficacy of elinzanetant on SDM as determined by patient-reported outcomes and further evaluating the safety of elinzanetant.

About Elinzanetant
Elinzanetant is the first dual neurokinin-1 and 3 (NK-1 and 3) receptor antagonist, in late-stage clinical development for the non-hormonal treatment of moderate to severe VMS associated with menopause, administered orally once daily. Elinzanetant may address moderate to severe VMS by modulating a group of estrogen sensitive neurons in the hypothalamus region of the brain (the KNDy neurons) which, with the decrease of estrogen, become hypertrophic and lead to a hyperactivation of the thermoregulatory pathway, consequently disrupting body heat control mechanisms resulting in VMS. Based on key secondary endpoints of OASIS 1 and 2, Elinzanetant may also decrease sleep disturbances associated with menopause.

About Vasomotor Symptoms
Vasomotor symptoms (VMS; also referred to as hot flashes) result from hyperactivation of the thermoregulatory pathway mediated by hypertrophy of the KNDy neurons. This is due to a decrease of estrogen, which can result from the progressive reduction of ovarian function due to natural menopause or medical intervention by bilateral oophorectomy or endocrine therapy.

VMS are reported by up to 80% of women at some point during the menopausal transition and are one of the leading causes for seeking medical attention during this phase of a woman’s life. Over one-third of menopausal women report severe symptoms, which can last 10 years or more after the last menstrual period, with relevant impact on quality of life.

VMS may also be caused by endocrine therapy, for the treatment or prevention of breast cancer, impacting quality of life and treatment adherence. For these women, there are currently no approved treatment options.

About Menopause
By 2030, the global population of women experiencing menopause is projected to increase to 1.2 billion, with 47 million women entering this phase each year. Menopause is a transitional phase in women’s lives, related to the progressive decline of ovarian function. It usually occurs in women during their 40s or early 50s. It can also be the result of surgical or medical treatment such as breast cancer treatment. The hormonal decline can lead to various symptoms which can substantially affect a woman’s health, quality of life, healthcare utilization and work productivity. The most frequently reported and disruptive symptoms during the menopausal transition are VMS, sleep disturbances and mood changes. Addressing these symptoms is key to maintaining functional ability and quality of life in menopause which is highly relevant from both a healthcare and socio-economic perspective.

About Women’s Healthcare at Bayer
Women’s Health is in Bayer’s DNA. As a global leader in women’s healthcare Bayer has a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. Bayer offers a wide range of effective short- and long-acting birth control methods as well as therapies for menopause management and gynecological diseases. Bayer is also focusing on innovative options to address the unmet medical needs of women worldwide and to broadening treatment choices such as in menopause. Additionally, Bayer intends to provide 100 million women per year in low-and-middle income countries by 2030 with access to family planning by funding multi-stakeholder aid programs for capacity building and by ensuring the supply of affordable modern contraceptives. This is part of the comprehensive sustainability measures and commitments from 2020 onwards and in line with the Sustainable Development Goals of the United Nations.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to www.bayer.com.

Find more information at https://pharma.bayer.com/
Follow us on Facebook: http://www.facebook.com/bayer
Follow us on LinkedIn: Bayer | Pharmaceuticals

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Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conformthem to future events or developments.

_________________________
1 https://jamanetwork.com/journals/jama/fullarticle/2822766

Contacts

Contact for US media inquiries:
Courtney Ambrosi, phone 1 (908) 798-1107
Email: courtney.ambrosi@bayer.com

Contact for global media inquiries:
Katja Wiggers, phone +49 30 221541614
Email: katja.wiggers@bayer.com

Apr 22
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Centessa Pharmaceuticals Announces Open IND for ORX750; Proof-of-Concept Data in Sleep-Deprived Healthy Volunteers Planned for 2H 2024

By Advent Life Sciences, Press Release
Press Release.

 

Centessa Pharmaceuticals Announces Open IND for ORX750; Proof-of-Concept Data in Sleep-Deprived Healthy Volunteers Planned for 2H 2024
April 22, 2024

BOSTON and LONDON, April 22, 2024 (GLOBE NEWSWIRE) — Centessa Pharmaceuticals plc (Nasdaq: CNTA), a clinical-stage pharmaceutical company that aims to discover and develop medicines that are transformational for patients, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug application (IND) to initiate a Phase 1 first-in-human, clinical trial of ORX750 for the treatment of narcolepsy. ORX750 is an investigational, orally administered, highly potent and selective orexin receptor 2 (OX2R) agonist designed to directly target the underlying pathophysiology of orexin neuron loss in narcolepsy type 1 (NT1), with potential applicability to narcolepsy type 2 (NT2), idiopathic hypersomnia (IH), and other sleep-wake disorders with normal orexin levels.

The Phase 1 study will evaluate the safety, tolerability and pharmacokinetics of single-ascending doses (SAD) and multiple-ascending doses (MAD) of ORX750 in healthy adult subjects. In parallel to the SAD, a cross-over pharmacodynamic (PD) assessment will be performed utilizing the Maintenance of Wakefulness Test (MWT) and Karolinska Sleepiness Scale (KSS) in acutely sleep-deprived healthy adult subjects which is intended to provide proof-of-concept data to enable dose selection for NT1, NT2 and IH indications. The study has a maximum exposure limit specified by the FDA which the Company believes significantly exceeds the predicted efficacious doses of ORX750 in indications associated with or without orexin loss; therefore, the Company does not expect this limit to affect any of the planned clinical development activities for ORX750. The Company expects to commence dosing of the Phase 1 study in healthy volunteers imminently, and proof-of-concept data are anticipated in the second half of 2024.

The Phase 1 study design of ORX750 includes SAD combined with PoC cohorts to assess PD effects of ORX750 by measuring sleep latency with the MWT and subjective sleepiness with the KSS in acutely sleep-deprived healthy subjects.

SAD combined with PoC cohorts to assess PD effects of ORX750 by measuring sleep latency with the MWT and KSS in acute sleep-deprived healthy subjects.

“This is a significant milestone for the development of our potential best-in-class OX2R agonist, ORX750, for the treatment of narcolepsy and other sleep-wake disorders,” said Saurabh Saha MD PhD, Chief Executive Officer of Centessa. “We are excited to begin executing what we believe is an elegant, adaptive Phase 1 study aimed at generating early proof-of-concept data for ORX750 in acutely sleep-deprived healthy volunteers in the second half of this year. We expect this study to enable dose selection for planned studies evaluating ORX750 in patients with NT1 and in patient populations with normal orexin levels, including NT2 and IH.”

About ORX750
ORX750 is an investigational, orally administered, highly potent and selective orexin receptor 2 (OX2R) agonist designed to directly target the underlying pathophysiology of orexin neuron loss in narcolepsy type 1 (NT1). ORX750 has been shown to potently activate the OX2R with an in vitro EC50 of 0.11 nM and 9,800-fold selectivity over the human orexin receptor (hOX1R). ORX750 is Centessa’s first orexin product candidate being developed for the treatment of narcolepsy with potential expansion into narcolepsy type 2 (NT2), idiopathic hypersomnia (IH) and other sleep-wake disorders.

About Centessa Pharmaceuticals
Centessa Pharmaceuticals plc is a clinical-stage pharmaceutical company that aims to discover and develop transformational medicines for patients. Our most advanced programs include a hemophilia program, an orexin agonist program for the treatment of narcolepsy and other sleep-wake disorders and an immuno-oncology program focused on our LockBody® technology platform. We operate with the conviction that each of our programs has the potential to change the current treatment paradigm and establish a new standard of care. For more information, visit www.centessa.com, which does not form part of this release.

Forward Looking Statements
This press release contains forward-looking statements. These statements may be identified by words such as “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue,” “ongoing,” “aim,” “seek,” and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements, including statements related to the Company’s ability to discover and develop transformational medicines for patients; the timing of commencement of new studies or clinical trials of ORX750 and other potential orexin agonist candidates; research and clinical development plans and the timing thereof; the Company’s ability to differentiate ORX750 and other potential orexin agonist candidates from other treatment options; the development and therapeutic potential of ORX750 and other potential orexin agonist candidates; predicted efficacious doses of ORX750; the Company’s ability to successfully conduct its clinical development of ORX750 below the maximum exposure limit set by the FDA or, in the event the Company plans to exceed the maximum exposure limit, the Company’s ability to successfully have the maximum exposure limit removed; and other regulatory matters, including the timing and likelihood of success of obtaining authorizations to initiate or continue clinical trials. Any forward-looking statements in this press release are based on our current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, risks related to the safety and tolerability profile of our product candidates; our ability to protect and maintain our intellectual property position; business (including commercial viability), regulatory, economic and competitive risks, uncertainties, contingencies and assumptions about the Company; risks inherent in developing product candidates and technologies; future results from our ongoing and planned clinical trials; our ability to obtain adequate financing, including through our financing facility with Oberland, to fund our planned clinical trials and other expenses; trends in the industry; the legal and regulatory framework for the industry, including the receipt and maintenance of clearances to conduct or continue clinical testing; future expenditures risks related to our asset-centric corporate model; the risk that any one or more of our product candidates will not be successfully developed and/or commercialized; the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies; geo-political risks such as the Russia-Ukraine war and conflicts in the Middle East. These and other risks concerning our programs and operations are described in additional detail in our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and our other reports, which are on file with the U.S. Securities and Exchange Commission (SEC). We explicitly disclaim any obligation to update any forward-looking statements except to the extent required by law.

Contact: 
Kristen K. Sheppard, Esq.
SVP of Investor Relations
investors@centessa.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/b64204a9-7c64-47fd-b834-598ca0e45978

May 26
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Advent Life Sciences Announces Growth of Investment Team with Three Senior Appointments

By Advent Life Sciences, Press Release
Press Release.

 

26 May 2022, London, UK: Advent Life Sciences, a leading transatlantic venture and growth investor focused on building innovative life science companies in the UK, Europe, and the US, announced today that it has appointed three senior members to its team, all sector investment specialists, and adept at building companies and supporting them in translating ideas into transformative medicines. Dominic Schmidt, based in the UK, and Satish Jindal, based in Boston, USA, have been appointed General Partners. Katrine Bosley, based in Boston, USA, joins as Venture Partner.  Advent’s investment team now includes 18 professionals with a track record of nurturing entrepreneurs and companies to deliver innovative new medicines.

Dominic previously spent eight years as a Partner in the investment team of Syncona, where he was involved in the founding, funding, and building of several life science businesses and served on the Boards of Anaveon, Orbit Biomedical, Gyroscope Therapeutics (acquired by Novartis), Purespring Therapeutics and Forcefield Therapeutics. Dominic has a degree in Biochemistry from the Free University of Berlin and the Max Planck Institute for Molecular Genetics, and a PhD from the Department of Oncology at the University of Cambridge. Dominic was a Cancer Research UK scholar, and his award-winning research has been published in Cell, Nature, and Science.

Satish was previously serving as CEO of BioMotiv, an early-stage investment fund. Satish was a co-founder and CEO of NeoGenesis (acquired by Schering-Plough, now Merck), co-founder and President of Verastem (NADAQ: VSTM) and co-founder of Elicio Therapeutics. He also served as Vice President and Site Head at Schering-Plough Research Institute in Cambridge, Massachusetts, and Vice President at Bristol-Myers Squibb. Satish’s PhD in Biochemistry is from Punjab University in India. He did his postdoctoral research at MIT’s Whitehead Institute.

Katrine is an entrepreneur with over 30 years biotech industry experience. She is Chair of the Board of Arrakis Therapeutics, founding CEO of DaCapo Brainscience, and a Board member of Genocea Biosciences. Katrine was CEO of Editas Medicine, the first company established to develop CRISPR-based gene editing therapeutics. Before that she was CEO of Avila Therapeutics, and held various roles at The Broad Institute, Adnexus Therapeutics, Biogen, Highland Capital Partners, and Alkermes. Katrine has been recognized as one of the 100 Most Creative People in Business by Fast Company, as CEO of the Year by Xconomy, as one of 30 Global Game Changers by Forbes, as Entrepreneur of the Year by the New England Venture Capital Association, and as one of the Top Ten Women in Biotech by Fierce Biotech.

Shahzad Malik, General Partner, Advent Life Sciences said:

“I’m delighted to welcome Dominic, Satish, and Katrine. They bring a wealth of expertise to our talented team. Since its launch, Advent Life Sciences has invested at the interface of academic research and commercial drug development with a focus on identifying and backing high-potential innovations that can deliver important new medicines for unmet medical needs. The last few years have reinforced the vital need to translate world class science into the discovery and development of new medicines to tackle devasting diseases.”

Dominic Schmidt, General Partner, Advent Life Sciences said:

“Advent is one Europe’s leading venture capital firms in the life sciences space with a long successful track record resulting in an impressive 14 approved medicines and products to the benefit of patients. I am looking forward to working with such a hands-on and entrepreneurial team supporting Advent’s long-standing successful strategy of backing high-potential life sciences companies.”

Satish Jindal, General Partner, Advent Life Sciences said:

“It’s a great pleasure to join the stellar team at Advent, who have founded over 35 new biotech companies that are focused on translating academic research into the next generation of medicines. This stage of development in life sciences is underserved and we have extensive experience in supporting new companies through the critical early years.”

Katrine Bosley, Venture Partner, Advent Life Sciences said:

“I’m delighted to join the Advent team and provide on-the-ground in-market support in Boston, USA, right at the heart of the world’s biggest cluster of biotech expertise. Venture financing is critical to the development of new medicines, more so than ever in these turbulent public market times, and it will continue to deliver real impact to patients in addition to strong financial returns.”

–    ENDS   –

 

Notes to Editors:

About Advent Life Sciences

Advent Life Sciences founds and invests in early- and mid-stage life sciences companies that have a first- or best-in-class approach to unmet medical needs. The investing team consists of experienced professionals, each with extensive scientific, medical and operational experience, a long-standing record of entrepreneurial and investment success in the US and Europe and is particularly focused on supporting entrepreneurs and founders to take innovative new medical entities from concept to approval. The firm invests in a range of sectors within life sciences, principally drug discovery, enabling technologies and med tech, always with an emphasis on innovative, paradigm-changing approaches. Advent Life Sciences has a presence in the UK, US and France.  For more information, please visit www.Adventls.com

 

Contacts:

Katja Stout, Scius Communications
Daniel Gooch, Scius Communications
katja@sciuscommunications.com
daniel@sciuscommunications.com
+44 (0) 7747 875 479

Mar 17
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Advent Life Sciences’ founded Amphista Therapeutics raises $53M in oversubscribed Series B round to advance next generation targeted protein degradation assets

By Advent Life Sciences, Press Release
Press Release.

 

This investment will fund Amphista Therapeutics’  growing pipeline of potent and selective bifunctional molecules, known as ‘Amphistas’ to the clinic and extend its proprietary platform.

London, UK, 17 March 2021 – Advent Life Sciences (“Advent”) a leading transatlantic venture investor focused on building innovative life science companies in the UK, Europe and the US, today announces that Amphista Therapeutics, an Advent founded biotech and leader in next generation targeted protein degradation (TPD) approaches, has closed a $53 million (£38 million) Series B financing round. Advent Life Sciences, and existing investor BioMotiv, will be joined by a strong syndicate of new investors:  Forbion, Gilde Healthcare, the Novartis Venture Fund and Eli Lilly & Company.

Amphista’s TPD approach offers a greatly improved way of treating disease and modulating drug targets, using synthetic small molecule degraders. Amphista’s next generation bifunctional degraders use a novel set of mechanisms that make use of a wider range of the body’s own innate protein degrading proteins, instead of the very narrow set of ubiquitin E3 ligase-based mechanisms used by most other TPD companies. This proprietary approach offers the potential to overcome many of the limitations seen with current TPD approaches, providing the opportunity to treat a wider range of diseases. Amphista is focused on biological targets with a high level of clinical or genetic validation, allowing the team to focus on the translation of their novel TPD approach for clinical benefit in areas of high unmet need.

Raj Parekh, General Partner, Advent Life Sciences commented:
“Advent over the last 20 years has continued to found and invest in the highest quality life science companies. With its exceptional  academic and medical science base, many of these companies  have originated from the UK. Amphista is another example of Advent’s continuing strategy to identify innovative and differentiated science as the basis of world-leading companies that will address areas of high unmet medical need. The Advent team have worked closely with Professor Alessio Ciulli, the University of Dundee and the Amphista team to found and to grow the company. We are delighted to be joined by this strong syndicate of experienced investors and pharmaceutical companies for the next stage in Amphista’s growth.”

Nicola Thompson, CEO, Amphista Therapeutics commented:

“This financing round, led by an outstanding investor syndicate, is a strong endorsement of our world class team and our novel approach. Amphista will now accelerate its oncology pipeline towards the clinic and extend our portfolio into indications largely inaccessible by traditional TPD approaches, such as diseases of the central nervous system (CNS). This oversubscribed Series B supports our ambition as a world-leading next generation protein degradation company delivering ground-breaking new medicines to patients in areas of high unmet need.”

In addition to Amphista, Advent has founded over 20 new biotech companies. Recent examples include Arrakis Therapeutics that struck an $190 million partnership deal with Roche in the first half of 2020, and KaNDy Therapeutics which was acquired by Bayer Pharmaceuticals for over $875 million also last year. Advent continues to invest at seed, series A and beyond, backing companies to develop new therapeutics and high-potential medical technologies. Advent’s team includes 16 investment professionals with a track record of supporting entrepreneurs to deliver innovative new medicines and products. In the last 15 years, Advent’s portfolio companies have discovered 14 first- or best-in-class medicines and products that have successfully achieved regulatory approval, each for a different and unmet medical need.

The full announcement from Amphista can be found here: Amphista Therapeutics raises $53M

–    Ends   –

Media contacts:

Advent Life Sciences
Laura Lane
+ 44 (0) 7795 469 847
pr@adventls.com

Amphista Therapeutics
CEO Nicola Thompson
+44 (0) 7464 974714
nicki@amphista.com

Scius Communications for Amphista
Katja Stout
+44 (0) 7789 435990
katja@sciuscommunications.com

About Advent Life Sciences
Advent Life Sciences founds and invests in early- and mid-stage life sciences companies that have a first- or best-in-class approach to unmet medical needs. The investing team consists of experienced professionals, each with extensive scientific, medical and operational experience, a long-standing record of entrepreneurial and investment success in the UK, the US and Europe and is particularly focused on supporting entrepreneurs and founders to take innovative new medical entities from concept to approval. The firm invests in a range of sectors within life sciences, principally drug discovery, enabling technologies and med tech, always with an emphasis on innovative, paradigm-changing approaches. Advent Life Sciences has a presence in the UK, US and France.

For more information, refer to: www.adventls.com

About Amphista Therapeutics
Amphista Therapeutics is a biopharmaceutical company creating first-in-class therapeutics that harness the body’s natural processes to selectively and efficiently degrade and remove disease-causing proteins. The company’s pipeline of novel targeted protein degradation (TPD) based medicines is focused on challenging diseases including cancer. Founded by Advent Life Sciences, Amphista is a spin-out of TPD expert Professor Alessio Ciulli’s labs at the University of Dundee. The company has raised approximately £45M to date and is funded by leading life science investors including Forbion, Gilde Healthcare, Novartis Venture Fund, Advent Life Sciences, BioMotiv and Eli Lilly and Company.

For more information, refer to: www.amphista.com

Mar 12
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Advent Life Sciences Becomes Latest Partner of One Nucleus

By Advent Life Sciences, Press Release
Press Release.

 

Cambridge and London UK: 12th March 2021

Advent Life Sciences, one of the sector’s leading Trans-Atlantic venture investors has become the latest Partner to join One Nucleus. The One Nucleus Partner Programme is tailor-made to meet the needs of the Partner and One Nucleus members.

Shahzad Malik, General Partner, Advent Life Sciences commented

“Advent is committed to investing in outstanding, early-stage science and to establish and nurture innovative companies in the UK, Europe and US. We greatly value partnerships in supporting this, as exemplified by the our new Advent-Harrington Impact Fund, in conjunction with the transatlantic not-for-profit drug development group, Harrington Discovery Institute. Joining the Partner Programme brings further opportunities to our multinational portfolio of companies available through One Nucleus membership, and leveraging that ecosystem as they grow.”

Tony Jones, CEO of One Nucleus expands further

“We are delighted to welcome Advent Life Sciences to the One Nucleus Partner Programme. Their track record of funding and nurturing high growth Life Science companies illustrates the value to our members and wider network of engaging them and their portfolio. One Nucleus is entirely focussed on how we bring great innovation, leadership and investment together to enable translation of world class science to patient benefit and returns for all stakeholders. Advent Life Sciences bring immense expertise, connectivity and capacity to help us in that endeavour.”

ENDS

About Advent Life Sciences
Advent Life Sciences founds and invests in early- and mid-stage life sciences companies that have a first- or best-in-class approach to unmet medical needs. The investing team consists of experienced professionals, each with extensive scientific, medical and operational experience, a long-standing record of entrepreneurial and investment success in the US and Europe and is particularly focused on supporting entrepreneurs and founders to take innovative new medical entities from concept to approval. The firm invests in a range of sectors within life sciences, principally drug discovery, enabling technologies and med tech, always with an emphasis on innovative, paradigm-changing approaches. Advent Life Sciences has a presence in the UK, US and France. For more information, please visit www.AdventLS.com

About One Nucleus
Established in 1997, One Nucleus is an award winning not-for-profit Life Sciences & Healthcare membership organisation centred on the Greater London-Cambridge-East of
England corridor. Headquartered in Cambridge, at the heart of Europe’s largest Life Sciences & Healthcare cluster, we support those institutions, companies and individuals undertaking activity in or with the above region.

Through providing the local, UK-wide and international connectivity, One Nucleus seeks to enable our members to maximise their performance. This support helping them achieve, or better still exceed, the goals they have set for themselves. Biomedical and Healthcare R&D have always been impactful in driving social and economic progress. In an increasingly outsourced, collaborative and multi-disciplinary sector, bringing the best people together is key to translating great innovation into great products that markedly improve patient outcomes and drive economic development. Attracting and enabling the best people to engage with is at the heart of the One Nucleus team ethos and what we continually strive to deliver.

For further information, please contact:

Tony Jones, CEO

Email: Tony@onenucleus.com
Tel: +44 (0)1223 896463
Web: www.onenucleus.com

Email: pr@adventls.com
Tel:+44 (0)20 7932 2100
Web: www.adventls.com

Feb 18
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Advent Life Sciences Announces Close of Two New Funds Totalling $215 million

By Advent Life Sciences, Press Release
Press Release.

 

18 February 2021, London, UK: Advent Life Sciences, a leading transatlantic venture investor focused on building innovative life science companies in the UK, Europe and the US, announced today that it has closed two new funds with commitments totalling $215 million.

Advent Life Sciences Fund III is the firm’s third dedicated life sciences venture capital fund raised from new Limited Partners (LPs), including British Patient Capital, as well as existing LPs.

The Advent-Harrington Impact Fund is a new type of fund raised in collaboration with the Harrington Discovery Institute to translate innovative drug discoveries into novel treatments for the benefit of patients and society, otherwise known as ‘impact’ investing.

Investing at seed, series A and beyond, the funds will primarily support companies to develop new therapeutics but will also continue Advent’s successful strategy of backing high-potential medical technology companies.

Since its launch, Advent Life Sciences has invested at the interface of academic research and commercial drug development with a focus on identifying and backing high-impact, high-potential innovations that can deliver important new medicines for unmet medical needs. The partnership with Harrington Discovery Institute expands this paradigm by increasing access to world-class academic science with high medical and commercial promise.

Shahzad Malik, General Partner, Advent Life Sciences said:

“The last year has reinforced the vital need to translate world class science into the discovery and development of new medicines to tackle devasting diseases.  Advent has continued its successful strategy to invest in outstanding, early-stage science and to establish and nurture  innovative companies for patients and investors alike.  We are delighted that British Patient Capital joins as a new cornerstone investor in our third fund.

We are also delighted to have partnered with the transatlantic not-for-profit drug development group, Harrington Discovery Institute to raise the new Advent-Harrington Impact Fund.  This new collaboration will allow us to both broaden the quality of the investment opportunities across the globe and increase the amount of capital available to support them. We believe this translational financing is critical to the development of new medicines, and that it will deliver real impact to patients in addition to strong financial returns.”

Judith Hartley, CEO, British Patient Capital, said:

“Our cornerstone commitment to Advent Life Sciences’ latest fund is a key part of our strategy to invest with fund managers that can leverage the UK’s world leading position in life sciences. Developing new life science technologies from research through to new medicines is crucial. Long-term patient capital can support our high-potential, high growth life science companies to reach their full potential and deliver compelling returns.”

Advent’s portfolio company success stories over the last year include the sale of Advent-founded KaNDy Therapeutics to Bayer Pharmaceuticals for over $875 million bringing a non-hormonal treatment for symptoms of the menopause closer to patients; Advent-founded Arrakis’ $190 million partnership deal with Roche to develop small molecule modulators of RNA; the NASDAQ IPO of Acutus Medical launching a best-in-class mapping technology and future ablation therapies for cardiac arrythmias; and notable follow-on financings including participating in a $60 million round for F2G Therapeutics, that also received Breakthrough Therapy Designation from the FDA for its novel class of anti-fungal treatments that address a very high unmet need.

Advent’s team includes 16 investment professionals with a track record of nurturing entrepreneurs to deliver innovative new medicines. In the last 15 years alone, Advent has supported its portfolio companies in developing 14 new approved medical products.  Advent has founded over 20 new biotech companies that are focused on translating academic research into the next generation of medicines.  This stage of development in life sciences is underserved and Advent’s team has extensive experience in supporting new companies through the critical early years.

–    ENDS   –

Notes to Editors:

About Advent Life Sciences

Advent Life Sciences founds and invests in early- and mid-stage life sciences companies that have a first- or best-in-class approach to unmet medical needs. The investing team consists of experienced professionals, each with extensive scientific, medical and operational experience, a long-standing record of entrepreneurial and investment success in the US and Europe and is particularly focused on supporting entrepreneurs and founders to take innovative new medical entities from concept to approval. The firm invests in a range of sectors within life sciences, principally drug discovery, enabling technologies and med tech, always with an emphasis on innovative, paradigm-changing approaches. Advent Life Sciences has a presence in the UK, US and France.  For more information, please visit www.AdventLS.com

About British Patient Capital
British Patient Capital is the trading name of British Patient Capital Limited, a wholly-owned commercial subsidiary of British Business Bank plc, the UK government’s economic development bank. It forms part of the British Business Bank’s commercial arm.

Its mission is to enable long-term investment in innovative firms led by ambitious entrepreneurs who want to build large scale businesses. Launched in June 2018, British Patient Capital has £2.5bn to invest over 10 years in venture and venture growth capital to support high growth potential innovative UK businesses in accessing the long-term financing they require to scale up. Find out more at britishpatientcapital.co.uk

Contacts:
Katja Stout, Scius Communications
katja@sciuscommunications.com
+44 7789 435990

Laura Lane, Advent Life Sciences
laura@adventls.com
+44 207 932 2159

Aug 11
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Advent Life Sciences announces sale of its portfolio Company KaNDy Therapeutics to Bayer AG for USD 425M upfront plus USD 450M in potential development milestones followed by further potential commercial milestones.

By Advent Life Sciences, Press Release
Press Release.

 

KaNDy’s lead asset NT-814 is a potential novel non-hormonal oral treatment option for women during menopause

11th August, London – Advent Life Sciences, a leading European life sciences venture capital firm, today announced the sale of its portfolio company, KaNDy Therapeutics Ltd, (“KaNDy”), to Bayer AG for an upfront consideration of USD 425 million plus potential milestone payments of up to USD 450 million until launch followed by potential additional triple digit million sales milestone payments.

KaNDy recently completed the Phase IIb with NT-814, a once-daily, oral neurokinin-1,3 receptor antagonist, publishing positive data for the treatment of frequent symptoms of the menopause, hot flashes and night sweats (vasomotor symptoms). The start of Phase III clinical trial is expected to commence in 2021. Once the deal completes, Bayer AG, a global leader in women’s healthcare, will assume full responsibility for completing Phase III studies of NT-814, registration, and marketing and sales.

KaNDy Therapeutics is a spin-out from NeRRe Therapeutics, a Stevenage, UK, based Company, which Advent Life Sciences co-founded with Mike Trower in 2012 based on a portfolio of Neurokinin modulators.  Advent Life Sciences has supported the company since inception and remained the largest shareholder throughout. In 2015, Dr Mary Kerr, then an Operating Partner at Advent Life Sciences, became full time CEO of NeRRe and in 2017 Advent introduced Andrew Kay (previously CEO of Algeta, a realised Advent portfolio company) as Chairman.

Kaasim Mahmood, General Partner at Advent Life Sciences, said:

“KaNDy is another example of our hands-on approach to achieving our twin objectives – to provide strong returns to our Investors while enabling the discovery and development of truly innovative medicines. We hope that NT-814 will fulfil the potential shown in the Phase IIb studies and provide a much-needed non-hormonal treatment for the alleviation of menopause symptoms.”

Mary Kerr, CEO and Co-Founder of KaNDy, said:

“Advent Life Sciences has played a central role in building this company from the very beginning, leveraging its extensive network to introduce new investors and providing strategic guidance to advance this potential novel medicine and become an important non-hormonal treatment option for women suffering debilitating symptoms of the menopause.”

Closing is subject to customary conditions, in particular anti-trust approval, and is expected by September 2020.

ENDS

Contact details:

Katja Stout, Scius Communications
katja@sciuscommunications.com
+447789435990

Kasim Mahmood, Advent Life Sciences
Kaasim.mahmood@adventls.com
+442079322100

About Advent Life Sciences
Advent Life Sciences founds and invests in early- and mid-stage life sciences companies that have a first- or best-in-class approach to unmet medical needs. The investing team consists of experienced professionals, each with extensive scientific, medical and operational experience, a long-standing record of entrepreneurial and investment success in the US and Europe and is particularly focused on supporting entrepreneurs and founders to take innovative new medical entities from concept to approval. The firm invests in a range of sectors within life sciences, principally drug discovery, enabling technologies and med tech, always with an emphasis on innovative, paradigm-changing approaches. Advent Life Sciences has a presence in the UK, US and France.  For more information, please visit www.AdventLS.com

About KaNDy Therapeutics
KaNDy Therapeutics Ltd. is a UK-based private clinical-stage biotech that was founded in 2017 as a spin-off from NeRRe Therapeutics Ltd. It is led by an experienced management team and backed by internationally recognised life sciences investors: Advent Life Sciences, Fountain Healthcare Partners, Forbion Capital Partners, OrbiMed and Longitude Capital. KaNDy Therapeutics is based at the state-of-the-art Stevenage Bioscience Catalyst, a leading location for companies to develop and commercialise cutting edge therapeutics.

About NT-814
NT-814 is a non-hormonal, orally administered, potent and selective small molecule dual antagonist of both the neurokinin-1 and 3 receptors. NT-814 addresses vasomotor symptoms by modulating a group of oestrogen sensitive neurones in the hypothalamus in the brain (the KNDy neurones), that in menopausal women due to the absence of oestrogen, become hyperactive and consequently disrupt body heat control mechanisms resulting in the debilitating vasomotor symptoms of hot flashes and night sweats.

Apr 15
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Advent Life Sciences Continues Support of Innovation in Life Sciences with the Launch of Two New Cancer Companies

By Advent Life Sciences, Press Release
Press Release.

 

  • Leads Recent Financings of PIC Therapeutics and Amphista Therapeutics
  • Portfolio Company Arrakis Therapeutics Partners with Roche

London, UK – 15 April 2020 – Advent Life Sciences (‘Advent’) announces the launch of two exciting new cancer companies, PIC Therapeutics Inc (“PIC”) and Amphista Therapeutics Ltd (“Amphista”), and a major partnership between portfolio company Arrakis Therapeutics Inc (“Arrakis”) and Roche. This continues Advent’s long-running investment and support of early-stage innovative biotechnology companies with a paradigm-shifting approach to the discovery of new medicines. Since 2006, Advent-backed companies have obtained regulatory approvals for 14 innovative medicines and medical products, reflecting the calibre and commitment of the founding scientists, clinicians and entrepreneurs that Advent has supported.  In that time, the Advent portfolio has achieved over 20 exits.

Today it was announced that Advent led the close of a $5M Seed investment round in its portfolio company, Boston-based PIC, which focuses on transforming the treatment of cancer though the selective modulation of oncogene translation. PIC was co-founded by Professor Gerhard Wagner of Harvard University and Dr Richard Peters. The company is led by CEO Sun Altbach and Alan Walts, Executive Chairman and Venture Partner at Advent. Belinda Termeer, PIC Board member, also participated in the financing.

Recently two other companies co-founded by Advent, announced success stories; Massachusetts-based Arrakis, pioneering the discovery of a new class of small molecule medicines that directly target RNA, and Glasgow-based Amphista, creating first-in-class cancer therapeutics that harness the body’s natural processes to degrade and selectively remove disease-causing proteins.

Amphista, which Advent spun out of the lab of Alessio Ciulli at the University of Dundee, closed a $7.5 million Series A round. Amphista discovers and designs small molecules that act in a different way from conventional PROTACs® and the company’s initial focus is to apply its insights to the design of anti-cancer agents.

Arrakis announced a strategic collaboration and license agreement with Roche in which Arrakis received a $190 million upfront cash payment, with the potential to achieve payments totalling up to multiple billions of dollars, for the discovery of RNA-targeted small molecule drugs against a broad set of targets. Advent founded Arrakis in October 2015 with Jennifer Petter, Advent Venture Partner Alan Walts, and the late Henri Termeer.

“Advent has a deep and enduring commitment to founding companies with paradigm-changing approaches. It is a privilege to support the scientists, clinicians and entrepreneurs in our companies as they realise important medical breakthroughs. We look forward to similar success at Amphista, Arrakis and PIC”

said Raj Parekh, General Partner at Advent Life Sciences.

Advent Life Sciences Venture Partner, Arrakis co-founder, and PIC Executive Chairman Alan Walts, commented,

“Since its founding in 2015, Arrakis has established a leadership position in the field of small molecule RNA modulation. We are thrilled to see the recently announced partnership with Roche, which will support Arrakis’ mission of transforming drug discovery. PIC Therapeutics is poised to transform the treatment of cancer and we are excited to partner with the PIC team as a lead investor.”

Advent’s highly experienced and diverse team of 16 investment professionals, all of whom are scientifically or clinically qualified, comprises serial entrepreneurs who have founded numerous companies that have discovered important new medicines for a range of unmet needs. The team takes an active role in both founding and supporting its portfolio companies.

 

–    ENDS  –

Media contacts:

Advent Life Sciences
Laura Lane
+44 7795 469847
pr@adventls.com

Scius Communications
Katja Stout
+44 7789 435990
katja@sciuscommunications.com

About Advent Life Sciences
Advent Life Sciences founds and invests in early- and mid-stage life sciences companies that have a first- or best-in-class approach to unmet medical needs. The investing team consists of experienced professionals, each with extensive scientific, medical and operational experience, a long-standing record of entrepreneurial and investment success in the US and Europe and is particularly focused on supporting entrepreneurs and founders to take innovative new medical entities from concept to approval. The firm invests in a range of sectors within life sciences, principally drug discovery, enabling technologies and med tech, always with an emphasis on innovative, paradigm-changing approaches. Advent Life Sciences has a presence in the UK, US and France.  For more information, please visit www.AdventLS.com

About Arrakis Therapeutics
Arrakis Therapeutics is a biopharmaceutical company pioneering the discovery of a new class of medicines that directly target RNA. Arrakis is building a proprietary pipeline of RNA-targeted small molecule (rSM) medicines focused on cancer and genetically validated targets in other disease areas. The company brings together scientific leaders in RNA structure, chemistry and biology, along with a highly experienced management team and the backing of leading life sciences investors. The company is located in Waltham, Massachusetts. For more information, please visit www.arrakistx.com or engage with them on Twitter @ArrakisTx or on LinkedIn.

About Amphista Therapeutics
Amphista Therapeutics is a biopharmaceutical company creating first-in-class therapeutics that help harness the body’s naturalprocesses to selectively and efficiently degrade and remove disease causing proteins. The company’s pipeline of novel small molecules that cause targeted protein degradation (TPD) is focused on challenging diseases including cancer. Amphista is a spin-out of renowned TPD expert Professor Alessio Ciulli’s labs at the University of Dundee, and is based in BioCity Glasgow, Scotland. The company is funded by leading life science investors including Advent Life Sciences, the European Investment Fund, the Scottish Investment Bank, and BioMotiv. For more information please visit www.amphista.com

About PIC Therapeutics
PIC Therapeutics is a Boston, MA-based biotechnology company focused on fundamentally changing how we treat cancer by developing a new generation of therapeutics based on the modulation of RNA translation. PIC’s therapeutics target the “master switch” of cancer signaling pathways, selectively blocking oncogene protein production by modulating the Pre-Initiation Complex (PIC) that drives their mRNA translation.  PIC Therapeutics’ selective approach has the potential to simultaneously modulate multiple oncogenic drivers leading to a powerful new generation of cancer-treating therapeutics. PIC is guided by a dedication to improving cancer patient outcomes and to realizing the potential of our technology to their benefit. For more information please visit www.pictherapeutics.com

Sep 30
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Advent Life Sciences announces the Appointment of Roy Lobb as Venture Partner

By Advent Life Sciences, Press Release
Press Release.

 

London, UK. September 30 2015

Advent Life Sciences announced today the appointment of Roy Lobb as Venture Partner. Roy brings over 25 years of biotechnology industry experience with an outstanding record as a scientist and company founder. Following a career at Biogen where he led the discovery of a new cell adhesion pathway that became the basis of the development of TysabriTM, Roy co-founded Albor Biologics, Avila Therapeutics and Alvos Therapeutics. Roy received a DPhil from Oxford University, and completed post-doctoral research at Harvard Medical School, where he was a faculty member before joining Biogen. Raj Parekh, General Partner, said

“Roy’s record of innovation and his scientific judgement will be of real value to us as we look to create a new generation of biotech companies – we welcome Roy to the Team.” Roy Lobb commented “The Advent team has consistently focussed on supporting insightful new approaches to medical discovery, and I am excited by the opportunity to work closely with them to found and grow innovative new companies.”

– Ends –

About Advent Life Sciences.
Advent Life Sciences founds and invests in early- and mid-stage life sciences companies that have a first- or best-in-class approach to unmet medical needs. The investing team consists of 16 professionals, each with extensive scientific, medical and operational experience, a long-standing record of entrepreneurial and investment success in the US and Europe, and is particularly focussed on supporting entrepreneurs and founders to take innovative new medical entities from concept to approval. The Firm invests in a range of sectors within life sciences, principally drug discovery, enabling technologies and med tech, always with an emphasis on innovative, paradigm-changing approaches. Advent Life Sciences has a presence in the UK, US and France.
For more information, please visit AdventLS.com

Contact : Advent Life Sciences
Melanie McIntosh
Phone : +44 (0)207 932 2100
email : melanie@adventLS.com

Sep 23
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Advent Life Sciences announces the appointment of Mary Kerr as Operating Partner

By Advent Life Sciences, Press Release
Press Release.

 

London, UK. September 23 2015 

Advent Life Sciences announced today the appointment of Mary Kerr as an Operating Partner. Mary joins from GSK, where she has held a range of senior leadership roles most recently as Senior Vice President and Global franchise Leader for GSK’s Immuno-inflammation and Infectious Diseases portfolio. In conjunction with this appointment, Mary will take the role of CEO of NeRRe Therapeutics, a privately held biotechnology company funded by Advent Life Sciences and Novo A/S.

 

– Ends –

 

About Advent Life Sciences.

Advent Life Sciences founds and invests in early- and mid-stage life sciences companies that have a first- or best-in-class approach to unmet medical needs. The investing team consists of 16 professionals, each with extensive scientific, medical and operational experience, a long-standing record of entrepreneurial and investment success in the US and Europe, and is particularly focussed on supporting entrepreneurs and founders to take innovative new medical entities from concept to approval. The Firm invests in a range of sectors within life sciences, principally drug discovery, enabling technologies and med tech, always with an emphasis on innovative, paradigm-changing approaches. Advent Life Sciences has a presence in the UK, US and France.

For more information, please visit www.AdventLS.com

Contact : Advent Life Sciences
Melanie McIntosh
Phone : +44 (0)207 932 2100
email : melanie@adventLS.com