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Arrakis Therapeutics Announces $38M Series A Financing To Target RNA with Small-Molecule Medicines And Names Michael Gilman Chairman and CEO

By Arrakis Therapeutics, Press Release, Private Companies
Press Release.

 

Veteran management team to re-architect small molecule drug discovery to pursue new RNA targets within vast human transcriptome

Waltham, Mass., February 27, 2017Arrakis Therapeutics, a pioneering biopharmaceutical company, has completed a $38 million Series A financing led by Canaan Partners with participation by Advent Life Sciences, Pfizer Inc., Celgene Corporation, Osage University Partners, and biotech industry leader Henri Termeer.  The company has also named serial entrepreneur and biotech leader Michael Gilman, Ph.D., as Chairman and Chief Executive Officer of Arrakis.

The proceeds from the Series A financing will be used to advance Arrakis’ proprietary discovery platforms, comprised of a high-throughput, comprehensive system of bioinformatics tools, assays and chemical libraries that can identify new ribonucleic acid (RNA) targets and create new small-molecule drugs. Using its TRYST™ and PEARL-seq™ platforms, Arrakis is developing an internal product pipeline of RNA-targeted small molecules focused on neurology, oncology, and rare genetic disorders. The basis of Arrakis’ unique approach is a proprietary chemical biology technology that interrogates structures of folded RNAs in their native state, within cells, to enable discovery and rational design of potent, selective small-molecule inhibitors of RNA function.

“RNA is the locus of most human biology, yet our current pharmacopeia is largely limited to protein targets,”

said Dr. Gilman.

“Arrakis intends to re-architect small molecule drug discovery by redirecting, modifying, and creating tools that enable medicinal chemistry to directly address therapeutically-important RNA molecules. Our substantial intellectual property, financial resources, and the extensive experience of our team in discovering and developing novel drugs will enable us to build a pipeline of new small-molecule therapeutics for patients not helped by today’s medicines.”

Targeting RNA with Small Molecules

The transcriptome encompasses all of the RNA transcribed from our genetic blueprint, including coding RNAs, which are translated into proteins, and noncoding RNAs, which regulate the fate and function of both coding RNAs and proteins. There are over 200,000 RNA transcripts in the human transcriptome – a vast pool of potential therapeutic targets. Yet today’s small-molecule medicines address approximately 500 protein targets in a small number of structural classes. Accessing the biology embodied by the rest of the transcriptome has required the development of new therapeutic modalities, such as oligonucleotide drugs and gene therapies, which are at the early stages of their clinical evolution. Arrakis intends to open RNA biology to medicines with the attractive and predictable pharmaceutical properties of small-molecule drugs, including oral bioavailability, broad biodistribution, and efficient cell penetration.

“The importance of targeting RNA in disease is well recognized,”

said Russell C. Petter, Ph.D., founder and CSO of Arrakis Therapeutics.

“But until now, targeting RNA with small-molecule compounds has been thought to be too challenging. Nevertheless, there are a number of precedents for conventional small molecules that bind and modulate RNA, including several approved drugs. These molecules were all discovered in functional screens, and only later did we learn that they acted on RNA. Our goal is to intentionally discover RNA-modulating small-molecule medicines. We believe that new developments in informatics, structural biology, and biophysical tools now make that possible.”

Colleen Cuffaro, Ph.D., principal at Canaan, who is joining the Arrakis board said,

“Arrakis is pursuing a fundamentally different approach to RNA targets. For decades, the pharmaceutical industry has invested billions of dollars to develop tools and techniques to create drugs for protein targets. Arrakis is building on this toolkit to create a platform to discover RNA-targeted drugs. In doing so, I believe Arrakis has the potential to create an entirely new class of medicines for patients with unmet need.”

Industry-leading Experts on Management Team and Board

Arrakis has assembled an executive team and board of directors comprised of industry veterans with established records of building successful biopharmaceutical companies.

The Arrakis senior management team is comprised of the following:

  • Michael Gilman, Ph.D., CEO and chairman of Arrakis; former founding CEO of Padlock Therapeutics and Stromedix, as well as executive roles at Biogen and ARIAD Pharmaceuticals
  • Russell C. Petter, Ph.D., founder and chief scientific officer of Arrakis; former executive roles at Celgene, Avila, Mersana, Biogen, and Sandoz/Novartis
  • Daniel Koerwer, chief business officer of Arrakis; former executive roles at BIND and Biogen
  • James Barsoum, Ph.D., senior vice president of biology of Arrakis; former executive roles at RANA, Synta, and Biogen

Raj Parekh, Ph.D., founder of Arrakis and general partner at Advent Life Sciences said, “Our investor syndicate is a collaborative team committed to supporting Arrakis’ pioneering approach, and providing the company theresources needed to bring transformative new drugs to patients.”

The Arrakis board of directors is comprised of the following:

  • Michael Gilman, Ph.D., CEO and chairman of Arrakis Therapeutics
  • Colleen Cuffaro, Ph.D., principal at Canaan Partners
  • Carolyn Green, executive director of strategic investments, External R&D Innovation, Pfizer Worldwide Research & Development
  • Raj Parekh, Ph.D., founder of Arrakis Therapeutics and general partner at Advent Life Sciences
  • Alan Walts, Ph.D., founder of Arrakis Therapeutics and venture partner at Advent Life Sciences

Observers on the Arrakis board of directors are Tim Shannon, M.D., general partner at Canaan Partners; Elaine Jones, Ph.D., VP of Pfizer Ventures; Peter Worland, Ph.D., VP Integrative Research Development at Celgene; and Matthew Cohen, Ph.D., principal at Osage University Partners.

About Arrakis Therapeutics

Arrakis Therapeutics is a biopharmaceutical company pioneering the discovery of a new class of medicines that directly target RNA. The company’s TRYST™ and PEARL-seq™ platforms identify new RNA targets and drug candidates to treat diseases unaddressed by today’s medicines. Arrakis is developing a proprietary pipeline of RNA-targeted small molecules focused on neurologic diseases, cancer, and rare genetic diseases.

Arrakis was founded in 2015 by Russell Petter, Ph.D., Alan Walts, Ph.D., Henri Termeer and Raj Parekh, Ph.D. with a vision to create a proprietary, transformational discovery platform that identifies small-molecule drugs that act directly on disease-causing RNA.  The company was established with seed funding provided by Advent Life Sciences and Henri Termeer.  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, Mass.  Please visit www.arrakistx.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 AdventLS.com.

About Canaan Partners

Canaan Partners is an early stage venture capital firm that invests in entrepreneurs with visionary ideas.  With $4.2 billion under management, a diversified fund and 190 exits to date, Canaan has invested in some of the world’s leading technology and health care companies over the past 30 years. Canaan’s focus areas include fin tech, enterprise/SaaS, marketplace, e-commerce, biopharma, digital health and medtech.  To learn more about our people and our portfolio, please visit canaan.com.

About Pfizer Inc.

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. For more information, please visit us at www.pfizer.com.

About Celgene Corporation

Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through next-generation solutions in protein homeostasis, immuno-oncology, epigenetics, immunology and neuro-inflammation. For more information, please visit www.celgene.com.

About Osage University Partners

Osage University Partners is a venture capital firm focused on investing in startups that are commercializing pioneering university technologies. Osage partners with top research universities to invest in their most innovative startups, and Osage shares its investment profit with its partner institutions. The firm invests in software, hardware, and life science companies at all stages of company development. Osage has partnered with over 80 universities, including 36 of the top 50 U.S. institutions by research expenditures, and has invested in over 60 of their spinouts. Osage University Partners is part of a family of investment funds within Osage Partners, which is based in Philadelphia, PA and manages in excess of $500 million. For more information, visit www.osageuniversitypartners.com.

Contact:
Kathryn Morris
The Yates Network
Tel:  845-635-9828
kathryn@theyatesnetwork.com

NeRRe Therapeutics raises £23 million in oversubscribed Series B financing round

By NeRRe Therapeutics, Press Release, Private Companies
Press Release.

 

New funds to advance unique neurokinin receptor antagonist pipeline towards late-stage clinical development in common, chronic and debilitating respiratory and women’s health conditions.

New investors Fountain Healthcare Partners, Forbion Capital Partners and OrbiMed join existing investors Advent Life Sciences and Novo A/S

Stevenage, UK, 5th January 2017 – NeRRe Therapeutics (‘NeRRe’), a clinical-stage company developing a unique portfolio of neurokinin (NK) receptor antagonists for the treatment of common, chronic and debilitating conditions caused by neuronal hypersensitivity, announced it has raised £23 million in an oversubscribed Series B financing round.

The funds will be used by NeRRe to generate Phase 2 data on orvepitant, its lead oral NK-1 antagonist candidate as a potential new treatment for a common, chronic respiratory condition; and to advance NT-814, a dual NK-1,3 antagonist, into Phase 2 trials as a potential non-hormonal treatment of distressing post-menopausal vasomotor symptoms.

The financing round involved a syndicate of leading transatlantic life sciences investors led by new investor Fountain Healthcare Partners, and co-led by Forbion Capital Partners and OrbiMed. Existing investors, Advent Life Sciences and Novo A/S also participated.

Dr Ena Prosser, Partner at Fountain Healthcare Partners; Geert-Jan Mulder MD, General Partner at Forbion Capital Partners; and Dr Iain Dukes, Venture Partner at OrbiMed will join Dr Kaasim Mahmood, General Partner at Advent Life Sciences (Chairman), Dr Mary Kerr, NeRRe’s CEO and Jo Craig, Vice-President GSK (Board Observer) on the NeRRe Board of Directors.

OrbiMed’s Iain Dukes, formerly Senior Vice President, Business Development & Licensing at Merck & Co., said:

“We have been impressed by NeRRe’s clear strategy, and are pleased to be involved in funding the company to deliver important Phase 2 clinical data on both of these exciting candidates. We look forward to supporting the company in achieving these aims.”

Mary Kerr, NeRRe’s CEO, said:

“NeRRe is delighted to have attracted such a substantial investment from these high profile life sciences investors. Now that we are fully funded to execute the next phase of development, everyone at the company is focused on moving orvepitant and NT-814 closer to the market for the alleviation of these common, chronic and debilitating conditions.”

*Biographies of the Board of Directors can be found at www.nerretherapeutics.com

Notes to Editors

About NeRRe Therapeutics (www.nerretherapeutics.com)

NeRRe Therapeutics is a private, UK-based clinical-stage company focused on the development of its unique portfolio of NK receptor antagonists for the treatment of common, chronic and debilitating conditions caused by neuronal hypersensitivity.

NeRRe Therapeutics was founded in 2012 as a spin out from GSK, which transferred its NK antagonist portfolio, including clinical data, toxicity, safety and formulation packages, and all associated IP to NeRRe. NeRRe is led by an experienced management team including Dr Mary Kerr (CEO), formerly SVP and Global Franchise lead at GSK and Dr Mike Trower (Co-founder, CSO/COO), formerly VP & Head of the External Drug Discovery Group in the Neurosciences CEDD at GSK.

NeRRe Therapeutics is backed by leading international life sciences investors: Advent Life Sciences, Fountain Healthcare Partners, Forbion Capital Partners, OrbiMed, and Novo A/S.

NeRRe is based at the state-of-the-art Stevenage Bioscience Catalyst (www.stevenagecatalyst.com), the UK’s first open innovation bioscience campus.

About Fountain Healthcare Partners
Fountain Healthcare Partners is a life science focused venture capital fund with €176 million ($200 million) under management. Within the life science sector, specific areas of interest to Fountain include specialty pharma, medical devices, biotechnology and diagnostics. The firm deploys the majority of its capital in Europe, with the balance in the United States. Fountain’s main office is in Dublin, Ireland, with a second office in New York. www.fh-partners.com

About Forbion Capital Partners
Forbion Capital Partners is a dedicated life sciences venture capital firm with offices in The Netherlands and Germany. Forbion invests in life sciences companies in the pharmaceutical, as well as the medical device space. Forbion’s investment team has built an impressive performance track record since the late nineties with successful investments in multiple companies. With the new FCFIII fund, Forbion manages well over EUR 700M across six funds, including the new fund FCF III. Its investors include the EIF through its European Recovery Programme (ERP), LfA and Dutch Venture Initiative (DVI) facilities and the KFW through the ERP – Venture Capital Fondsfinanzierung facility. Forbion also operates a joint venture with BioGeneration Ventures, who manages two separate seed and early stage funds focused on Benelux. For further information please visit www.forbion.com.

About OrbiMed
OrbiMed is a leading investment firm dedicated exclusively to the healthcare sector, with over $14 billion in assets under management. OrbiMed invests globally across the spectrum of healthcare companies, from venture capital start-ups to large multinational companies utilizing a range of private equity funds, public equity funds, royalty/debt funds and other investment vehicles. OrbiMed maintains its headquarters in New York City, with additional offices in San Francisco, Shanghai, Mumbai and Herzliya. www.OrbiMed.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 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 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

For more information, please contact:

Mary Kerr, CEO of NeRRe Therapeutics
Tel:  +44 1438 906960
Email: info@nerretherapeutics.com 

Katja Stout/Mark Swallow, Citigate Dewe Rogerson
Tel: +44 20 7282 1066/2948
Email: NeRRe@citigatedr.co.uk

F2G Ltd Announces $60 Million Financing to Progress Development of Novel Antifungal Agents

By F2G, Press Release, Private Companies
Press Release.

 

Funding to Take Lead Compound Through to Product Approval and Development of Pipeline Assets

MANCHESTER, UK – 20 June 2016 – F2G Ltd, the UK-based antifungal drug discovery and development company, today announced that it has raised $60 million in financing to develop its pipeline of novel therapies to treat life threatening invasive fungal infections. The round was led by Sectoral Asset Management, with participation from Novo A/S, Aisling Capital and Brace Pharma Capital. Existing investors Advent Life Sciences LLP, Novartis Venture Fund, Sunstone Capital and Merifin Capital each participated in the round.

F2G has discovered and developed a completely new class of antifungal agents called the orotomides. The orotomides are active against Aspergillus and other rare and resistant moulds and act via a completely different mechanism than currently marketed antifungal agents. Existing antifungal therapies have known safety limitations and between 10-30% of patients cannot tolerate any initial given therapy. Due to their new mechanism of action, orotomides are active against infections resistant to current therapies, a growing problem globally.
F2G plans to advance its lead compound, F901318, a novel clinical stage candidate for the treatment of invasive aspergillosis and other serious rare mould infections, to completion of a pivotal registration study, and to further develop earlier stage assets in its pipeline. Aspergillosis is a serious pulmonary infection caused by Aspergillus, a common fungus that affects people with weakened immune systems or lung diseases.

Ian Nicholson, Chief Executive Officer, F2G Ltd commented:

“F2G has made significant progress in the last 12 months and this financing, achieved in a tough funding environment, demonstrates investor confidence in our novel class of therapies and outstanding team. We welcome our new investors to the company and thank our existing investors for their continuing support and confidence in our team and strategy. We are now well positioned to achieve our goal of product approval in an area with significant unmet medical need and look forward to conducting our pivotal registration study.”

Dr Maha Katabi, Private Equity Partner, Sectoral Asset Management added:

“We look forward to working with the F2G team and a high quality venture capital syndicate to bring an important medicine to patients with life-threatening fungal infections. We have been impressed by the progress that F2G has made to date and are pleased to support its next phase of growth.”

Dr Maha Katabi, Private Equity Partner at Sectoral Asset Management and Dr Martin Edwards, Senior Partner at Novo A/S will join the F2G Board of Directors.

About F2G Ltd: F2G is a world leading UK biotech company focused on the discovery and development of novel therapies to treat life threatening invasive fungal infections, with experienced management & board. F2G has discovered and developed a completely new class of antifungal agents called the orotomides. The orotomides are active against Aspergillus and other rare and resistant moulds and act via a completely different mechanism than currently marketed antifungal agents. Due to their new mechanism of action, orotomides are active against fungal infections resistant to current therapies, a growing problem globally. A small PK Phase 2 clinical trial for F901318 is planned for 2H 2016 with pivotal registration trials in Invasive Aspergillosis planned for 1H 2017 based on an accelerated regulatory pathway agreed with the relevant agencies. F901318 is being developed both as IV and oral formulations and promises to have a safe and well-tolerated profile.

Contact:
F2G Ltd
Ian Nicholson | Chief Executive Officer
inicholson@f2g.com | +44 (0)161 785 1271 | www.f2g.com

Hume Brophy
Mary Clark, Supriya Mathur
f2g@humebrophy.com | +44 (0)207 862 6475

Artax Biopharma Funded to Clinically Develop Breakthrough Oral Therapies for Autoimmune Diseases

By Artax Biopharma, Press Release, Private Companies
Press Release.

 

Raises $10M Series B to fund Phase Ib-IIa clinical trials for AX-024, a novel oral treatment; and to further develop its pipeline of preclinical candidates

September 22, 2015 08:05 AM Eastern Daylight Time

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Artax Biopharma, a clinical stage biotechnology company developing first-in-class highly selective oral therapies for the treatment of autoimmune diseases, has secured a $10M Series B round of funding. The financing was led by Henri Termeer, former CEO of Genzyme, and Advent Life Sciences; with participation from A.M. Pappas and existing investors. In conjunction with the financing, Henri Termeer and Raj Parekh, General Partner at Advent Life Sciences, will join Artax’s Board of Directors.

Artax’s lead compound, AX-024, is a highly selective immunomodulator of T-cell Receptor (TCR) signaling in autoimmune T-cells. The new funding will be used to advance AX-024 through Phase Ib and IIa clinical trials for the treatment of autoimmune diseases, and to further develop selective Nck inhibitors in partnership with Dr. Balbino Alarcon. Dr. Alarcon’s lab discovered Nck’s role in T-cell activation at the Spanish National Council (CSIC). Nck is a member of the SH2/SH3 family of cytoplasmic adapter proteins involved in transducing signals from receptor tyrosine kinases to downstream effectors, which play a key role in T-cell activation.

“The selective inhibition of Nck is an area of tremendous therapeutic potential for treating autoimmune diseases and one where Artax leads the world’s research efforts. As our AX-024 program advances in the clinic, we continue developing additional Nck-specific compounds,”

said Damia Tormo, founder and CEO of Artax Biopharma.

“We are thrilled with the confidence the new investors have in Artax and its technology. They will help us realize the full potential of our products and enable us to bring them to patients in need.”

“Artax is pursuing breakthrough science: a targeted immunomodulatory approach for autoimmune diseases that does not compromise the protective function of T-cells to external threats,”

said Henri Termeer.

“Artax has the potential to treat a range of autoimmune conditions in which current therapies are not optimal and may result in serious side effects.”

“Artax’s compounds could have clinical utility in virtually any pathogenic T-cell mediated diseases,”

said Raj Parekh, General Partner at Advent Life Sciences.

“We are excited about the potential of this novel science and its broad clinical applications.”

Clinical Phase 1 Study: Excellent Safety and PK/PD Profile

In Phase I studies, orally dosed AX-024 was well tolerated in healthy volunteers even at very high doses. Experiments carried out ex vivo showed that treatment with AX-024 in humans has a significant immunomodulatory effect on T-cells, with dose-dependent behavior, measured either by inhibition of T-cell proliferation or by Th17, Th2 and Th1 cell cytokine secretion. Artax has validated the target and mechanism of action, and demonstrated preclinical proof of concept of AX-024 in various preclinical autoimmune disease (MS, Psoriasis, IBD, Type I diabetes) and GVHD models.

About Artax Biopharma

Artax Biopharma is a clinical stage biopharmaceutical company developing breakthrough therapies for autoimmune diseases. Its pipeline of drugs is based on novel science that targets the interaction between T-cell receptors (TCR) and Nck, a key protein involved in T-cell activation. Based in Cambridge, Massachusetts, more information on Artax Biopharma can be found at www.artaxbiopharma.com.

About Advent Life Sciences

Advent Life Sciences is one of Europe’s leading venture teams investing in life sciences businesses in the UK, Europe and US. The team consists of professionals with extensive scientific, medical and operational experience, and a long-standing track record of entrepreneurial and investment success across the UK, Europe and the US. The firm invests in a range of sectors within life sciences, principally in new drug discovery, enabling technologies and med tech. Realizations in the last three years include Algeta, Avila, CN Creative, EUSA and Micromet. Current investments include Acutus, Aura Biosciences, Biocartis, Cellnovo, f2G, GMP-Orphan, NeRRe, and Versartis. For more information, please visit www.adventls.com.

Contacts

 

For Artax Biopharma

Matt Burke, +1 603-315-0618

mattdavidburke@gmail.com

First Clinical Trial for NeRRe Therapeutics

By F2G, Press Release, Private Companies
Press Release.

 

First Clinical Trial for NeRRe Therapeutics

Press Release:

Start of Phase II study of neurokinin-1 receptor antagonist orvepitant for intense pruritus induced by epidermal growth factor receptor inhibitors

First Clinical Trial for NeRRe Therapeutics

Stevenage, UK, 23 January 2014. NeRRe Therapeutics Ltd, which is focused on the development of neurokinin (NK) receptor antagonists for a range of indications, is pleased to announce the start of a Phase II study of the novel NK-1 receptor antagonist orvepitant. The proof-of-concept study, results of which are expected in 2015, is investigating orvepitant’s effectiveness as a treatment for the intense pruritus (itch) associated with epidermal growth factor receptor inhibitor (EGFRi) anticancer therapies. The itch intensity experienced by patients can be so severe that their EGFRi dose must be reduced or the treatment withdrawn; also pruritus along with rash has a significant effect on quality of life1.

The RELIEVE-1 trial is a randomised, double-blind, placebo-controlled study to evaluate the safety, tolerability and efficacy of two daily dose levels of oral orvepitant on EGFRi-induced intense pruritus in oncology subjects. Its primary endpoint is the difference between orvepitant and placebo in reducing the intensity of pruritus over 4 weeks, as measured on a subject-recorded numerical rating scale. RELIEVE-1 is being undertaken in 15 clinical sites in Italy, with Dr Bruno Vincenzi from Università Campus Bio-Medico di Roma as lead investigator. Dr Vincenzi and his colleagues at the centre have pioneered the use NK-1 antagonists as anti-pruritics in this setting2. Chemistry, manufacturing and control support for RELIEVE-1 is being provided by Aptuit (Verona) Srl, with clinical operations assistance from the CRO Cromsource.

Dermatologic adverse events such as pruritus are a common feature of targeted anti-cancer therapies, with incidence of this symptom induced by EGFRia drugs in clinical trials ranging from 14.6% to 54.9% depending on the specific agent3. Open-label studies in patients suffering from refractory chronic pruritus have indicated that NK-1 receptor antagonism can provide rapid and highly effective relief as well as significantly improving quality of life.2,4,5,6

Dr Mike Trower, Co-founder & Chief Operating Officer of NeRRe Therapeutics said:  ‘We are very pleased to announce the start of RELIEVE-1, NeRRe’s first clinical trial, in this important area of unmet medical need. There is a strong rationale and a growing body of clinical evidence supporting the potential of orvepitant as an anti-pruritic for this devastating symptom commonly associated with EGFRis. Given its known effects on mood and sleep, orvepitant may also provide additional benefits for patient well-being.’

Dr Emiliangelo Ratti, NeRRe Therapeutics Co-founder added: ‘The intense pruritus induced by EGFRis can lead to significant suffering and poor quality of life, and we believe that a treatment for this troubling side effect would be welcomed by cancer patients and supportive care doctors alike. A successful study of orvepitant in this indication would provide further evidence of the broad therapeutic potential of the NK-1 receptor antagonist mechanism which NeRRe is exploiting in its pipeline.’

–ENDS–

a This includes monoclonal antibodies that target the extracellular domain of EFGR, small molecule tyrosine kinase (TK) inhibitors, and small molecule dual TK inhibitors.

For more information about NeRRe Therapeutics, please contact:
Dr Mike Trower, Chief Operating Officer
Tel: +44 (0) 1438 906960
Email:  info@nerretherapeutics.com

About NeRRe Therapeutics
NeRRe Therapeutics was formed in December 2012 and is focussed on the development of a portfolio of NK receptor antagonists acquired from GlaxoSmithKline (GSK), which have therapeutic potential in a broad range of indications. NeRRe Therapeutics was co-founded by Drs Emiliangelo Ratti and Mike Trower, both of whom are both former senior leaders of neurosciences drug discovery at GSK with intimate knowledge of the transferred assets and the neurokinin receptor system field. In 2012 NeRRe Therapeutics raised £11.5 million ($18.4 million) in Series A financing from two leading European financial institutions, Novo A/S (www.novo.dk/ventures) and Advent Life Sciences (www.adventventures.com), who are represented by Dr Martin Edwards (Chairman) and Dr Kaasim Mahmood respectively on the company’s Board.

NeRRe (www.nerretherapeutics.com) is based at the state-of-the-art Stevenage Bioscience Catalyst (www.stevenagecatalyst.com), the UK’s first open innovation bioscience campus.

About Orvepitant
Orvepitant is a ‘novel generation’ brain penetrant, selective and potent, small molecule NK-1 receptor antagonist7 that features high receptor occupancy and full and long lasting (≥24hrs) central NK-1 receptor occupancy8. It has previously completed extensive safety and toxicology studies to support its clinical development; and it has already demonstrated a positive antidepressant effect in a Phase II clinical study together with beneficial effects on sleep8.

References:
1.    Rosen AC et al. Am J Clin Dermatol. (2013), 14(4):327-33
2.    Santini D et al. Lancet Oncol. (2012), 13(10):1020-4
3.    Ensslin CJ et al. J Am Acad Dermatol. (2013), 69(5):708-20
4.    Duval A, Dubertret L. N Engl J Med. (2009), 1;361(14):1415-6
5.    Ständer S et al. PLoS One. (2010), 5(6):e10968
6.    Torres T et al. J Am Acad Dermatol. (2012), 66(1):e14-5
7.    Di Fabio R et al. Bioorg Med Chem. (2013), 21(21):6264-73
8.    Ratti E et al. J Psychopharmacol. (2013), 27(5):424-34

NeRRe Therapeutics Press Release here:

First Clinical Trial for NeRRe Therapeutics

By NeRRe Therapeutics, Press Release, Private Companies
Press Release.

 

Start of Phase II study of neurokinin-1 receptor antagonist orvepitant for intense pruritus induced by epidermal growth factor receptor inhibitors

First Clinical Trial for NeRRe Therapeutics

Stevenage, UK, 23 January 2014. NeRRe Therapeutics Ltd, which is focused on the development of neurokinin (NK) receptor antagonists for a range of indications, is pleased to announce the start of a Phase II study of the novel NK-1 receptor antagonist orvepitant. The proof-of-concept study, results of which are expected in 2015, is investigating orvepitant’s effectiveness as a treatment for the intense pruritus (itch) associated with epidermal growth factor receptor inhibitor (EGFRi) anticancer therapies. The itch intensity experienced by patients can be so severe that their EGFRi dose must be reduced or the treatment withdrawn; also pruritus along with rash has a significant effect on quality of life1.

The RELIEVE-1 trial is a randomised, double-blind, placebo-controlled study to evaluate the safety, tolerability and efficacy of two daily dose levels of oral orvepitant on EGFRi-induced intense pruritus in oncology subjects. Its primary endpoint is the difference between orvepitant and placebo in reducing the intensity of pruritus over 4 weeks, as measured on a subject-recorded numerical rating scale. RELIEVE-1 is being undertaken in 15 clinical sites in Italy, with Dr Bruno Vincenzi from Università Campus Bio-Medico di Roma as lead investigator. Dr Vincenzi and his colleagues at the centre have pioneered the use NK-1 antagonists as anti-pruritics in this setting2. Chemistry, manufacturing and control support for RELIEVE-1 is being provided by Aptuit (Verona) Srl, with clinical operations assistance from the CRO Cromsource.

Dermatologic adverse events such as pruritus are a common feature of targeted anti-cancer therapies, with incidence of this symptom induced by EGFRia drugs in clinical trials ranging from 14.6% to 54.9% depending on the specific agent3. Open-label studies in patients suffering from refractory chronic pruritus have indicated that NK-1 receptor antagonism can provide rapid and highly effective relief as well as significantly improving quality of life.2,4,5,6

Dr Mike Trower, Co-founder & Chief Operating Officer of NeRRe Therapeutics said:  ‘We are very pleased to announce the start of RELIEVE-1, NeRRe’s first clinical trial, in this important area of unmet medical need. There is a strong rationale and a growing body of clinical evidence supporting the potential of orvepitant as an anti-pruritic for this devastating symptom commonly associated with EGFRis. Given its known effects on mood and sleep, orvepitant may also provide additional benefits for patient well-being.’

Dr Emiliangelo Ratti, NeRRe Therapeutics Co-founder added:

‘The intense pruritus induced by EGFRis can lead to significant suffering and poor quality of life, and we believe that a treatment for this troubling side effect would be welcomed by cancer patients and supportive care doctors alike. A successful study of orvepitant in this indication would provide further evidence of the broad therapeutic potential of the NK-1 receptor antagonist mechanism which NeRRe is exploiting in its pipeline.’

–ENDS–

a This includes monoclonal antibodies that target the extracellular domain of EFGR, small molecule tyrosine kinase (TK) inhibitors, and small molecule dual TK inhibitors.

For more information about NeRRe Therapeutics, please contact:
Dr Mike Trower, Chief Operating Officer
Tel: +44 (0) 1438 906960
Email:  info@nerretherapeutics.com

About NeRRe Therapeutics
NeRRe Therapeutics was formed in December 2012 and is focussed on the development of a portfolio of NK receptor antagonists acquired from GlaxoSmithKline (GSK), which have therapeutic potential in a broad range of indications. NeRRe Therapeutics was co-founded by Drs Emiliangelo Ratti and Mike Trower, both of whom are both former senior leaders of neurosciences drug discovery at GSK with intimate knowledge of the transferred assets and the neurokinin receptor system field. In 2012 NeRRe Therapeutics raised £11.5 million ($18.4 million) in Series A financing from two leading European financial institutions, Novo A/S (www.novo.dk/ventures) and Advent Life Sciences (www.adventventures.com), who are represented by Dr Martin Edwards (Chairman) and Dr Kaasim Mahmood respectively on the company’s Board.

NeRRe (www.nerretherapeutics.com) is based at the state-of-the-art Stevenage Bioscience Catalyst (www.stevenagecatalyst.com), the UK’s first open innovation bioscience campus.

About Orvepitant
Orvepitant is a ‘novel generation’ brain penetrant, selective and potent, small molecule NK-1 receptor antagonist7 that features high receptor occupancy and full and long lasting (≥24hrs) central NK-1 receptor occupancy8. It has previously completed extensive safety and toxicology studies to support its clinical development; and it has already demonstrated a positive antidepressant effect in a Phase II clinical study together with beneficial effects on sleep8.

References:
1.    Rosen AC et al. Am J Clin Dermatol. (2013), 14(4):327-33
2.    Santini D et al. Lancet Oncol. (2012), 13(10):1020-4
3.    Ensslin CJ et al. J Am Acad Dermatol. (2013), 69(5):708-20
4.    Duval A, Dubertret L. N Engl J Med. (2009), 1;361(14):1415-6
5.    Ständer S et al. PLoS One. (2010), 5(6):e10968
6.    Torres T et al. J Am Acad Dermatol. (2012), 66(1):e14-5
7.    Di Fabio R et al. Bioorg Med Chem. (2013), 21(21):6264-73
8.    Ratti E et al. J Psychopharmacol. (2013), 27(5):424-34

NeRRe Therapeutics Press Release here:

F2G Ltd. Appoints Ian Nicholson as Chief Executive Officer Manchester

By F2G, Press Release, Private Companies
Press Release.

 

March 11th 2013

F2G Ltd. Appoints Ian Nicholson as Chief Executive Officer Manchester

F2G Ltd, the UK-based antifungal drug discovery and development company, today announced the appointment of Ian Nicholson to the position of CEO and to the Board of Directors . Ian has over 25 years of international experience in management and transactions within the life sciences sector. He is currently, and will remain, an Operating Partner of London-based Advent Life Sciences LLP. Previously he spent eight years as CEO of the privately held Oncology R&D company, Chroma Therapeutics Limited. Before that he was senior vice president for business development at UK biotechnology company Celltech Group, and has worked extensively in licensing, M&A, and market development in the UK, Europe and the US. Ian holds a BSc (Hons) from University College London and an MBA from Boston University.

Dr Richard White, Executive Chairman of F2G, commented

‘We are delighted to welcome such an experienced executive to lead the company, and I look forward to working closely with him.’

Dr. White will revert to his former role of Non-Executive Chairman. Ian Nicholson added

‘I am excited to join F2G at this critical stage and lead the company in the successful development of an important first-in-class drug to treat Aspergillosis, an area of high unmet medical need.’

About F2G Ltd: Based in Manchester, UK, F2G Ltd is dedicated to the discovery and development of new and clinically superior drug classes to treat life-threatening systemic fungal infections in at-risk patient populations. This is a growing health risk for which there are currently limited treatment options and for which demand is increasing globally Market growth is expected to increase with the emergence of new clinical indications in allergies and asthma. For more information visit www.f2g.com

F2G Ltd Completes $30 Million Financing Round to Fund Pre-clinical and Clinical Development of Novel Anti-fungal Compounds

By F2G, Press Release, Private Companies
Press Release.

 

Manchester, UK, Sept 5th 2012 – F2G Limited, an antifungal drug discovery and development company, today announced the completion of a $30 million equity financing round in which two new investors (Advent Life Sciences and Novartis Bioventures) joined the existing syndicate (Sunstone Capital, Merifin Capital, K Nominees, and Astellas Venture Fund). These funds will be used to select a clinical candidate from the F3 series of advanced preclinical analogs and proceed to first in man studies. The F3 series represents a proprietary group of compounds with highly potent and selective activity against Aspergillus species and other moulds, which act via a totally novel mechanism. Aspergillus infections are a serious threat in immune-compromised patient populations and result in a high rate of mortality even with the most effective treatment currently available. Dr Richard White, chairman of F2G, commented,

“We are delighted to welcome two top tier investors into F2G. We now have a first class international syndicate, including the venture arms of two major pharmaceutical companies”.

Shane Kelly, previously the CEO, is leaving the company to pursue another opportunity. Dr White will assume the expanded role of Executive Chairman and noted

“We would all like to thank Shane for his tireless and steadfast management of the company over the last 10 years and for bringing us to this successful juncture. We wish him well in his new venture”

Dr Raj Parekh of Advent and Dr Anja König of Novartis Venture Funds will both be joining the Board of F2G. Raj Parekh, General Partner at Advent said, “The F2G molecules show a compelling and novel profile and have the genuine potential to be first- and best- in-class agents for the treatment of invasive aspergillosis, which remains a serious unmet medical need. We look forward to working with Richard and the team to bring these molecules to an early clinical evaluation.”

About F2G Ltd:

Based in Manchester, UK, F2G Ltd is dedicated to the discovery and development of new and clinically superior drug classes to treat life-threatening systemic fungal infections in at-risk patient populations. The antifungal market is currently estimated at over 6 billion dollars annually and is growing steadily year on year. Market growth is expected to increase with the emergence of new clinical indications in allergies and asthma. The company has impressive internal capabilities, employing a core team of scientists with a unique understanding of the antifungal arena, supported by an experienced management team. For more information visit www.f2g.com