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Apr 17
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Highlight Therapeutics appoints Dr. Carlos Paya as Executive Chairman

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

 

Dr Ralph Weichselbaum, Dr.Antoni Ribas & Michael Docherty appointed to SAB

Company renamed to Highlight Therapeutics

Madrid,  Spain –April  17, 2020: Highlight Therapeutics (“Highlight”), a clinical-stagebio pharmaceutical company developing RNA-based therapies against cancer,announces the appointment of Carlos Paya, MD, PhD,as Executive Chairman with immediate effect.The Company has also significantly expanded its Advisory Board with a number of internationally-renowned scientific and industry leaders.  In line with these changes, the  Company has  been  renamed from Bioncotech Therapeutics  to  Highlight Therapeutics – see separate press release.

Marisol  Quintero, CEO of Highlight, said:

“Dr Paya’s impressive industry experience,  his  track  record  of guiding biotech companies through product development to global launch and his extensive reach with both scientists and investors will all be of great assistance to Highlight at this important point in our development. In  addition,  we have significantly expanded our Advisory  Board with distinguished scientists and  industry specialists of the highest caliber. These key appointments provide Highlight with the broad range of skills and know how to drive our ambition to unlock thepotential of immunotherapy for many more patients.”

Dr. Paya has a distinguished track record of leadership in large-cap pharma and mid-cap biotech and start-up companies, with a focus on strategic execution, pipeline growth, product life cycle management and global product launches, as well as a number of successful public and private fundraises.

He is a director of Mallinckrodt Pharmaceuticals and of Fluidigm Corporation. Previously, he was president, chief executive officer and board member of Immune Design Corp., a late-stage immunotherapy company, from  May  2011  until  its  acquisition  by  Merck  &  Co.,  Inc.  in  April  2019.He held  leadership  roles  at Elan Pharmaceuticals and Eli Lilly and Co. in discovery research and clinical development. Prior to  his  industry roles, Dr.  Paya spent  nearly  a  decade  at  the  Mayo  Clinic-Rochester, including as professor of medicine, immunology and pathology and vice dean of the clinical investigation program.

Dr Paya received his medical and doctorate degrees from the Universidad Complutense of Madrid Medical School, and completed his specialty training in Internal Medicine, Infectious Diseases and Immunology at the Mayo Graduate  School of  Medicine.  He was a research scientist in a  post-doctoral  position at Institute Pasteur in Paris and completed the advanced management program at the University of Chicago’s Booth School of Business.

The Company’s Scientific Advisory Board has expanded and now comprises:

Ralph R. Weichselbaum MD

  • Professor of Radiation & Cellular OncologyChair, Department of Radiation & Cellular Oncology, University of Chicago
  • Made discoveries in basic signal transduction after ionizing radiation exposure &, in separate studies, discovered that mechanisms of radiation resistance/sensitivity are mediated by cytokine activation in tumors
  • Currently investigating the relationship between radiotherapy & immunotherapy

Antoni Ribas MD, PhD

  • Professor of Medicine, Professor of Surgery & Professor of Molecular & Medical Pharmacology at UCLA
  • Director of Tumor Immunology Program at Jonsson Comprehensive Cancer Center
  • Director of Parker Institute for Cancer Immunotherapy Center, UCLA
  • Chair of SWOG Melanoma Committee; member of American Society of Clinical Investigation
  • Recipient of AACR Richard & Hinda Rosenthal Award & NCI Outstanding Investigator Award

Michael Doherty

  • Led Global Regulatory Affairs function at Roche & launched first oncology portfolio with a franchise of monoclonal antibodies and targeted medicines
  • Member of the Roche portfolio committee from 2002 to 2016
  • Prior positions: Global Head, Pharma Regulatory Affairs
  • Hoffmann La-Roche Ltd., Basel/Genentech, San Francisco
  • Head Product Development Foundation Medicine

For more information, please contact:

Highlight Therapeutics, Marisol Quintero, CEO info@highlight.com

Mo PR Advisory, Mo Noonan / Jonathan Birt Tel: +44 (0) 7876 444977/ 07860 361746

 

Notes to Editors

About Highlight Therapeutics

Highlight, formerly known as Bioncotech Therapeutics S.L, is a private, clinical-stage company dedicated to unlocking the full potential of immuno-oncology. Itslead drug candidate BO-112 is a best-in-class RNA-based therapy which has been demonstrated to initiate a powerful immune response, leveraging aunique multi-target approach to turn ‘cold’ tumors ‘hot’ and therefore visible to theimmune system. It has the potential to rescue patients who are resistantto current checkpoint inhibitor therapy, a very large market opportunity. BO-112 is currently being investigated in a range of clinical trials as a monotherapy and in combination with checkpoint  inhibitors.  In  addition  to  in-house  research,  Highlight  Therapeutics  has  a  numberof  external collaborators, including Merck & Co and UCLA

Apr 17
Love0

Highlight Therapeutics announces name change from Bioncotech and launch of new website

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

 

Madrid,  Spain –April 17,  2020:Highlight Therapeutics, a  clinical-stagebio pharmaceutical  company developing RNA-based therapies against cancer, announces that  it has changed its name  from Bioncotech with immediate effect. The company has launched a new corporate website, www.highlighttherapeutics.com, and related rebranding.

Highlight  Therapeutics  also announced  that  clinical  trials  of  its  lead  product  candidate  BO-112  will  be classified numerically under the umbrella name Spotlight for ease of identification.

BO-112 is a best-in-class RNA-based therapy which has been demonstrated to initiate  a powerful immune response, leveraging a unique multi-target approach to turn ‘cold’ tumors ‘hot’ and therefore visible to the immune  system.It  has  the  potential  to  rescue  patients  who are resistant to current  checkpoint  inhibitor therapy, a very large market opportunity. BO-112 is currently being investigated in a range of clinical trials as  a  monotherapy and  in  combination with  checkpoint  inhibitors by Highlight Therapeutics  and  external collaborators including MSD, a subsidiary of Merck & Co., Inc, and UCLA.

Marisol Quintero, CEO of Highlight Therapeutics, commented:

“BO-112 highlights tumor cells,making them visible to the immune system.Our new identity as Highlight Therapeutics, and the branding of our expanding clinical  trial  program under  the Spotlight banner,  are  a clear representation  of  our  focus  and  the  unique approach we are taking to unlock the potential of checkpoint inhibitors in immunotherapy.

“Highlight Therapeutics has developed an extensive preclinical  package  differentiating BO-112 from other innate immune activators.  We are launching our new name at amajor inflection point in the development of  our  portfolio  as  we  work  to expand  on our initial  findings  and  apply  intratumoral  immunotherapy  to indications where we believe it has the potential to benefit many more patients, including liver metastases and melanoma.”

For more information, please contact:

Highlight Therapeutics S.L- Marisol Quintero, CEO info@highlight.com

Mo PR Advisory – Mo Noonan / Jonathan Birt Tel: +44 (0) 7876 444977/ 07860 361746

Notes to Editors

About Highlight Therapeutics

Highlight, formerly known as Bioncotech Therapeutics S.L, is a private, clinical-stage company dedicated to unlocking the full potential of immuno-oncology. Its lead drug candidate BO-112 is a best-in-class RNA-based therapy which has been demonstrated to initiate a powerful immune response, leveraging aunique multi-target approach to turn ‘cold’ tumors ‘hot’ and therefore visible to the immune system. It has the potential to rescue patients who are resistant to current checkpoint inhibitor therapy, a very large market opportunity. BO-112 is currently being investigated in a range of clinical trials as a monotherapy and in combination with checkpoint  inhibitors.  In addition to in-house  research,  Highlight  Therapeutics  has  a  numberof  external collaborators, including Merck & Co and UCLA.

Apr 15
Love0

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

Apr 15
Love0

PIC Therapeutics Raises $5 Million to Advance Development of Small Molecules That Selectively Modulate eIF4E

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

 

Series Seed Equity Round led by Advent Life Sciences

BOSTON–(BUSINESS WIRE)–PIC Therapeutics (“PIC”), a biotechnology company focused on transforming the treatment of cancer though the selective
modulation of oncogene translation, closed a $5M Series Seed round of preferred equity funding.

The oversubscribed round was led by Advent Life Sciences (“Advent”), and included participation by Belinda Termeer, widow of legendary Genzyme CEO Henri Termeer, as well as several biopharmaceutical industry executives and other individual investors.

PIC Therapeutics was founded based on the extensive research of scientific founder Professor Gerhard Wagner of Harvard University and is led by founding CEO Sun Altbach, a 20+ year life sciences veteran and by Dr. Alan Walts, Executive Chairman and Venture Partner at Advent Life Sciences.PIC is supported by a world-renowned Scientific Advisory Board and Board of Directors.

PIC targets the “master switch” of cancer signaling pathways, blocking oncogene protein production by selectively modulating the Pre-Initiation Complex (PIC), specifically eIF4E – a convergence point driving oncogene RNA translation. PIC Therapeutics’ targeted approach has the potential to simultaneously impact multiple oncogenic drivers leading to a powerful new generation of cancer-treating therapeutics that address drug resistance and tumor heterogeneity, issues that plague many existing treatments.

Sun Altbach, CEO commented,

“This is an important step for PIC as we seek to transform how cancer is treated and therefore make a significant difference in patients’ lives. With this funding in hand we can accelerate our program focusing on allosteric regulation of eIF4E via an innovative drug development platform designed to produce early proof of concept in advance of the clinic.”

Alan Walts, Executive Chairman and Venture Partner at Advent added,

“PIC is a leader in the rapidly advancing field of translational modulation of oncogenes. PIC has developed a best in class portfolio of proprietary small molecule modulators of eIF4E and a comprehensive platform to validate human tumor activity. We are pleased to support their efforts to develop a new class of cancer therapies.”

PIC’s Board of Directors consists of:

  • Alan Walts, PhD, Executive Chairman of the Board; Venture Partner, Advent Life Sciences
  • Sun Altbach, MBA, CEO and President, PIC Therapeutics
  • Richard Peters, MD, PhD, Co-Founder, PIC Therapeutics; CEO Yumanity Therapeutics
  • Belinda Termeer, Termeer Foundation
  • Gerhard Wagner, PhD, Co-Founder, PIC Therapeutics; Elkan Rogers Blout Professor of Biological Chemistry and Molecular Pharmacology, Harvard Medical School

PIC’s Scientific and Corporate Advisory Board consists of:

  • Keith Flaherty, MD, Director of Clinical Research at the Cancer Center at MGH
  • Jennifer Petter, PhD, Founder and Chief Scientific Officer of Arrakis Therapeutics
  • Nahum Sonenberg, PhD, Biochemistry Professor and Gilman Cheney Chair, McGill University
  • Yat Sun Or, PhD, Chief Scientific Officer, Enanta Pharmaceuticals
  • Jan Van Heek, MBA, Board Member, Amarin Corporation and Minerva Neuroscience
  • Gerhard Wagner, PhD, Co-Founder, PIC Therapeutics; Elkan Rogers Blout Professor of Biological Chemistry and Molecular Pharmacology, Harvard Medical School

 

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.

www.pictherapeutics.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.

Contacts
PIC Therapeutics
Sun Altbach, CEO and President
info@pictherapeutics.com
+1 617-637-378

Apr 08
Love0

Arrakis Therapeutics Enters Strategic Collaboration and License Agreement with Roche for Multi-Target Program Utilizing RNA-Targeted Small Molecule Drug Discovery Platform

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

 

Arrakis Therapeutics Enters Strategic Collaboration and License Agreement with Roche for Multi-Target Program Utilizing RNA-Targeted Small Molecule Drug Discovery Platform

Arrakis Receives $190 Million Upfront Cash Payment with Potential for Multi-Billion Dollar Future Payments

Waltham, MA – April 8, 2020 – Arrakis Therapeutics, a biopharmaceutical company pioneering the discovery of a new class of small molecule medicines that directly target RNA, today announced a strategic collaboration and license agreement with Roche (SIX: RO, ROG; OTCQX: RHHBY) for the discovery of RNA-targeted small molecule (rSM) drugs against a broad set of targets across all of Roche’s research and development areas. Under the terms of the agreement, Arrakis will lead discovery and research activities for each target to a defined point, at which time Roche will have the right to exclusively pursue further preclinical and clinical development. Arrakis will receive an upfront payment of $190 million in cash and may also receive preclinical, clinical, commercial and sales milestone payments and royalties for any resulting products. The aggregate potential value of future payments to Arrakis exceeds several billion dollars, subject to regulatory approvals and other conditions being met.

“We are excited to partner with Roche’s strong research and development teams. Together, we share a common vision of accessing new drug targets at the RNA level and thereby discovering novel medicines to treat diseases with high unmet medical need. The collaboration will increase the number of new treatments for patients arising from our proprietary rSM discovery platform,”

said Michael Gilman, Ph.D., Chief Executive Officer of Arrakis.

“In addition to the Roche collaboration, we are further building our capabilities and advancing our wholly-owned rSM programs for diseases unaddressed by today’s medicines.”

“Through our pioneering work in RNA biology, we have built a platform for creating and adapting drug discovery tools that allow us to predict and validate the structure of RNA targets, locate druggable pockets, identify drug-like hits, and conduct medicinal chemistry programs to discover a new class of RNA-targeted medicines optimized for potency, selectivity, and safety. This agreement with Roche underscores the value inherent in our rSM platform and will enable us to continue to make leading discoveries and further scientific contributions in the field,”

said Jennifer C. Petter, Ph.D., Founder and Chief Scientific Officer of Arrakis.

Arrakis is taking a broad approach, targeting multiple mechanisms across the lifecycle of RNA to establish a new paradigm for small-molecule drug discovery. The company’s discovery platform integrates leading-edge RNA bioinformatic and structural tools, curated chemical libraries, RNA-specific assays, and RNA-guided medicinal chemistry. In addition to collaborating with partners, Arrakis is developing an internal pipeline of rSMs to treat a range of serious illnesses including cancers and other diseases where strongly validated targets and drivers of disease have been identified but have proven challenging with other drug approaches and modalities.

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 and engage with us on Twitter @ArrakisTx or on LinkedIn.

###

Investor Contact:
Will O’Connor
212-362-1200
will.oconnor@sternir.com

Media Contact:
Kathryn Morris
914-204-6412
kathryn@theyatesnetwork.com

Apr 07
Love0

Amphista Therapeutics raises $7.5m Series A round to advance targeted protein degradation assets in cancer

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

 

April 7, 2020

  • Amphista’s potent bifunctional small molecules augment targeted protein degradation
  • Investors include Advent Life Sciences, the Scottish Investment Bank, the European Investment Fund and US-based BioMotiv

Glasgow, Scotland, 7 April 2020 – Amphista Therapeutics, a biopharmaceutical company creating first-in-class cancer therapeutics that harness the body’s natural processes to selectively and efficiently degrade and remove disease causing proteins, today announced the closing of a USD $7.5m Series A round, led by Advent Life Sciences. Seed round funders the Scottish Investment Bank, with backing from the Scottish Growth Scheme, and the European Investment Fund joined the round, along with new investor, US-based life sciences BioMotiv.

Amphista’s CEO Nicola Thompson said,

“This international financing provides Amphista with a firm foundation to underpin a Series B round to progress our oncology pipeline to the clinic. Our vision is to create a leading protein degradation company on the global stage that delivers ground-breaking new medicines to patients in areas of high unmet need.”

Raj Parekh, General Partner at lead investor Advent Life Sciences said,

“We are excited to support Amphista in its next stage of development. The Company has a potentially unique approach to targeted protein degradation when compared with traditional proteolysis targeting chimera (PROTAC®) platforms. We believe that Amphista has great potential with its differentiated proprietary technology to address traditionally undruggable targets.”

Satish Jindal, CEO of BioMotiv, and newly appointed Amphista Chairman, commented,

“We are a mission-driven accelerator, and we are excited by Amphista’s focus to rapidly produce potent bifunctional small molecules to augment the body’s own processes to remove disease-associated proteins. We see huge potential to accelerate Amphista’s breakthrough technology platform into medicines.”

Amphista’s scientific founder, Professor Alessio Ciulli, based at the University of Dundee, is an internationally renowned expert in the field of targeted protein degradation (TPD).

“Highly specific TPD is a transformative new modality for tackling previously undruggable targets with high therapeutic value.”

said Ciulli.

Amphista’s TPD small molecules instruct the cell to degrade the target directly rather than activating or inhibiting the target protein function. As protein-protein interactions are involved in disease progression, removing the target protein provides a clear therapeutic advantage over simple inhibition. Specifically, Amphista’s platform is independent of traditional E3 ubiquitin ligases used by the field, potentially expanding the available target scope of TPD approaches and should overcome recently identified PROTAC® resistance mechanisms.

Media contacts:

Amphista Therapeutics
CEO NicolaThompson
+447464974714
nicki@amphista.com

Scius Communications
Katja Stout
+447789435990
katja@sciuscommunications.com

About Amphista Therapeutics
Amphista Therapeutics is a biopharmaceutical company creating first-in-class therapeutics that help harness the body’s natural processes 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 spinout 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, visit http://www.amphista.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 the Scottish Investment Bank
The Scottish Investment Bank (SIB) is the investment arm of Scotland’s national economic development agency, Scottish Enterprise, operating Scotland-wide in partnership with Highlands and Islands Enterprise (HIE).

SIB’s activities support Scotland’s SME funding market to ensure businesses with growth and export potential have adequate access to growth capital and loan funding. It helps ambitious Scottish companies get the right level of funding from the right sources at the right time, through building relationships with both domestic and international investors.

SIB manages a suite of co-investment funds including the Scottish Co-Investment Fund, the Scottish Venture Fund and the Energy Investment Fund on behalf of the Scottish Government. SIB is also an investor in Epidarex Capital’s Life Sciences Fund and administers the Scottish Loan Scheme, with funding secured from the Scottish Government’s Scottish Growth Scheme.

Furthermore, SIB provides funding into LendingCrowd, Scotland’s marketplace lender providing loans to SMEs, and Maven’s Regional Buyout Fund (MBO) that offers financial support for management buyouts (MBOs) and helps existing management teams acquire businesses from their owners so they can continue to flourish.

SIB’s team of financial readiness specialists help companies prepare for new investment and access appropriate finance.

About BioMotiv
https://www.biomotiv.com
BioMotiv is a mission-driven accelerator associated with The Harrington Project for Discovery & Development, a $340 million initiative focused on advancing early stage breakthrough discoveries from research institutions into medicines. Led by a highly accomplished and passionate team of veteran biopharma experts, BioMotiv’s innovative model efficiently aligns resources and capital to select, fund, manage and advance a portfolio of drug development programs.

Feb 18
Love0

New company takes aim at treatments for multiple sclerosis

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

 

Novel treatments that may reverse the effects of multiple sclerosis (MS) will be investigated by a new drug-discovery company spun out from the University of Edinburgh.

Backed by Series A funding of £5 million over its first three years, Pheno Therapeutics will search for new drugs that aim to repair damage to the nervous system and significantly improve patients’ debilitating symptoms.

Building on original research by Professors Siddharthan Chandran and Neil Carragher of the University of Edinburgh, the company aims to develop new therapies for MS by identifying novel molecules that cause the body to repair or replace the damaged myelin sheath surrounding nerve cells.

This so-called remyelination process has the potential to slow or arrest the progressive disability caused by MS.

Pheno Therapeutics is supported by Advent Life Sciences, the London-based venture capital firm; the Scottish Investment Bank, with backing from the Scottish Government through the Scottish Growth Scheme; and independent medical research charity LifeArc. Together they have committed to invest £5 million over three years, subject to the company meeting certain milestone conditions.

Pheno Therapeutics co-founder Professor Siddharthan Chandran said:

“There are no interventions for people with later stage multiple sclerosis, which is a devastating and debilitating condition. The opportunity for this company is to bring new and repurposed therapeutics to clinical trials and, by doing so, meet an urgent and currently unmet need.”

Key to the company’s potential impact in MS treatments is the University’s advanced cell based technology platform, which enables the screening of large compound libraries on novel human cellular platforms, in addition to the founders’ and investors’ combination of clinical and drug discovery expertise.

Pheno Therapeutics intends to optimise the leads emerging from its cutting edge phenotypic screens via medicinal chemistry to deliver new candidate compounds that will progress through pre-clinical tests then proof-of-concept clinical trials.

MS affects more than 100,000 people in the UK and 2.5 million worldwide. Targeting the nervous system, including the brain and spinal cord, the disease occurs when the body’s immune system attacks the protective layer surrounding nerve cells called the myelin sheath, slowing or disrupting the electrical signals travelling along the nerves.

It causes a wide range of symptoms including problems with movement, vision, sensation and balance.

Current treatments mainly focus on the immune system aspects of the disease and reduce the severity and frequency of relapses. There is a significant medical need for novel neuroprotective agents that halt the disease progression and prevent long-term disability.

Pheno Therapeutics is a spinout company from the University of Edinburgh founded by Professors Chandran and Carragher, Advent Life Sciences and Dr Jon Moore, Operating Partner at Advent Life Sciences.

The formation of Pheno Therapeutics has been supported by Edinburgh Innovations, the University’s commercialisation service, which helped bring together the scientific and clinical expertise in partnership with Advent Life Sciences to launch the company.

Dr George Baxter, CEO of Edinburgh Innovations, said:

“I’m delighted to see this company launch with the support of such credible investors.

“Everyone involved is focused on driving the science forward, and we look forward to supporting the team as momentum continues to build, ultimately offering the promise of new treatments.”

Dr David Holbrook, head of LifeArc’s Seed Fund, said:

“At the Seed Fund, we look to use our translational expertise to invest in enterprises with a sound scientific concept and the potential to lead to new interventions that address patient needs.

“In the founders of Pheno Therapeutics and their research to induce myelin repair, we saw an appealing opportunity, particularly given the existing clinical needs in progressive MS. We are delighted to have reached an agreement to support Pheno Therapeutics translate their discoveries.”

ENDS

Notes
Image shows Professor Siddharthan Chandran of the University of Edinburgh, co-founder of Pheno Therapeutics.

Contact:
Gareth Overton
Communications Manager
Edinburgh Innovations
The University of Edinburgh
+44 (0)131 651 3426
+44 (0)7772 396 552
garethoverton@ei.ed.ac.uk

About Pheno Therapeutics
Pheno Therapeutics is an early stage biotechnology company focussed on the identification of novel neuroprotective therapies for multiple sclerosis. The company builds on the University of Edinburgh’s world-class research in phenotypic screening, stem cell biology and myelin biology. We will apply cutting edge drug discovery approaches to probe the pathways that can impact remyelination, selecting leads that will be developed into drugs and tested in early stage clinical trials.
https://www.phenotherapeutics.com/

About LifeArc
LifeArc is a self-funded medical research charity. Our mission is to advance translation of early science into health care treatments or diagnostics that can be taken through to full development and made available to patients. We have been doing this for more than 25 years and our work has resulted in a diagnostic for antibiotic resistance and four licensed medicines. Our success allows us to explore new approaches to stimulate and fund translation. We have our own drug discovery and diagnostics development facilities, supported by experts in technology transfer and intellectual property who also provide services to other organisations. Our model is built on collaboration, and we partner with a broad range of groups including medical research charities, research organisations, industry and academic scientists. We are motivated by patient need and scientific opportunity. Two funds help us to invest in external projects for the benefit of patients: our Philanthropic Fund provides grants to support medical research projects focused on the translation of rare diseases research and our Seed Fund is aimed at start-up companies focussed on developing new therapeutics and biological modalities.
Find out more about our work on www.lifearc.org or follow us on LinkedIn or Twitter.

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 Edinburgh Innovations
Edinburgh Innovations is the University of Edinburgh’s commercialisation service. EI leads the University’s activities in industry engagement and business development, enterprise support for students and staff, and the identification, management and commercialisation of University intellectual property. EI also manages Old College Capital, the University’s venture fund.
https://edinburgh-innovations.ed.ac.uk

About the Scottish Investment Bank
The Scottish Investment Bank (SIB) is the investment arm of Scotland’s national economic development agency, Scottish Enterprise, operating Scotland-wide in partnership with Highlands and Islands Enterprise (HIE).

SIB’s activities support Scotland’s SME funding market to ensure businesses with growth and export potential have adequate access to growth capital and loan funding. It helps ambitious Scottish companies get the right level of funding from the right sources at the right time, through building relationships with both domestic and international investors.

SIB manages a suite of co-investment funds including the Scottish Co-Investment Fund, the Scottish Venture Fund and the Energy Investment Fund on behalf of the Scottish Government. SIB is also an investor in Epidarex Capital’s Life Sciences Fund and administers the Scottish Loan Scheme, with funding secured from the Scottish Government’s Scottish Growth Scheme.

Furthermore, SIB provides funding into LendingCrowd, Scotland’s marketplace lender providing loans to SMEs, and Maven’s Regional Buyout Fund (MBO) that offers financial support for management buyouts (MBOs) and helps existing management teams acquire businesses from their owners so they can continue to flourish.

SIB’s team of financial readiness specialists help companies prepare for new investment and access appropriate finance.

Jan 13
Love0

KaNDy Therapeutics Announces Positive Phase 2b Data in Post-Menopausal Women with its Lead Non-Hormonal Product NT-814

By KaNDy Therapeutics, Press Release
Press Release.

 

  • Phase 2b dose range finding study showed rapid and highly significant reductions in the frequency of hot flashes (primary endpoint) for the full 12-week treatment period~
  • Reduction in hot flashes was associated with statistically significant improvements in quality of life, mood and sleep – all key secondary endpoints~
  • All doses of NT-814 were well tolerated during the study, demonstrating a safety profile that supports progression to Phase 3

Stevenage, UK, 13 January 2020 – KaNDy Therapeutics, a UK clinical-stage biotech company, today announces positive data from the Phase 2b “SWITCH-1” clinical trial with its lead non-hormonal drug candidate, NT-814, for the treatment of symptoms of the menopause.

Following on from the clear benefits NT-814 demonstrated in the Phase 2a RELENT-1 study, the SWITCH-1 trial provides further compelling evidence that NT-814, a first in class, once-daily, oral neurokinin-1,3 receptor antagonist, can produce a rapid and marked reduction in the most troublesome and frequent symptoms of the menopause, hot flashes and night sweats (vasomotor symptoms). The clinical relevance of the marked improvements shown on the vasomotor symptom endpoints was supported by highly statistically significant improvements across patient reported assessments of quality of life, mood and sleep.

The SWITCH-1 study was a randomised, double-blind, placebo-controlled trial conducted in the US, UK and Canada.  One hundred and ninety-nine women experiencing at least 7 moderate or severe hot flashes/flushes (HF) per day were recruited into the study and randomised to receive one of four doses of NT-814 or placebo. Treatment with NT-814 once daily for 12 weeks at the most effective dose evaluated resulted in:

•    Statistically significant reductions compared to placebo in average hot flash frequency (primary endpoint), starting during the first week of treatment and continuing throughout the 12-week treatment period. Least squares mean reductions in average hot flash frequency were -6.7 for NT-814 vs -2.7 for placebo at week 4, and -7.8 vs -4.7 at Week 12 (p<0.0001 and p=0.0092, respectively).

•    Marked improvements in all key secondary endpoints: improved quality of life was shown by highly    significant improvements over placebo in the MenQoL menopause-specific quality of life scores, benefits on mood were demonstrated by significant improvements in the Beck Depression Inventory (II), and improved quality of sleep  was shown by statistically significant improvements compared to placebo in the Pittsburgh Sleep Quality Index scores.

•    NT-814 was well tolerated across the dose range with a safety profile that supports progression to Phase 3.

Dr. James A. Simon, Clinical Professor of Reproductive Endocrinology & Infertility at George Washington University, and the study’s Lead Investigator, commented:

“These top-line results of the SWITCH-1 study are very exciting. They demonstrate that NT-814, a truly novel therapy, offers a rapidly effective, non-hormonal approach to treating menopausal hot flashes and night sweats, debilitating symptoms of menopause. Unique to this trial, patients also reported improvements in quality of life, mood and sleep with NT-814.”

Dr Mary Kerr, Co-Founder and CEO KaNDy Therapeutics, said:

“The SWITCH-1 study started in November 2018, and so we are excited to share such positive results on schedule. The data confirms and validates Phase 2a observations, providing more evidence that neurokinins are fundamental to sex hormone biology and the pathophysiology of the menopause, resulting in almost immediate symptom relief. The Company looks forward to presenting these data at future scientific meetings and discussing it with regulatory agencies in advance of progressing the compound into pivotal registration studies.”

For more information, please contact:

KaNDy Therapeutics
Email: info@kandytherapeutics.com

Consilium Strategic Communications
Mary-Jane Elliott/ Lindsey Neville/ Carina Jurs
Tel: +44 (0) 20 3709 5700
KaNDyTherapeutics@consilium-comms.com

About the SWITCH-1 Study: The Phase 2b SWITCH-1 study was a randomised, double-blind, placebo-controlled study conducted at 25 sites in the UK, US and Canada.  It included an adaptive randomisation design that enabled the randomisation ratio to be modified to focus on doses of greatest interest based on emerging data. The study was initiated in November 2018 and completed, ahead of schedule, at the end of 2019.  A total of 199 post-menopausal women experiencing at least 7 moderate or severe HFs per week were recruited into the study and randomized to receive one of four doses of NT-814 or placebo. Study drug was taken once daily in the evening for 12 weeks. Subjects completed electronic diaries twice daily for the two weeks before and throughout treatment and underwent routine safety assessments periodically throughout the trial. Patient reported assessments of sleep, quality of life and mood were also completed periodically during study visits. Further information on the study design can be found on www.clinicaltrials.gov and full results of the study will be published at scientific congresses and in peer-reviewed journals over the coming months.

NT-814 is an orally administered, potent and selective small molecule dual antagonist of both the neurokinin-1 and 3 receptors under development by KaNDy as a therapy for a range of Women’s Health conditions. 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.

KaNDy Therapeutics is a clinical-stage company focused on optimizing the potential of NT-814 in the treatment of common, chronic debilitating female sex-hormone related conditions. These conditions, such as post-menopausal vasomotor symptoms, are debilitating for women often over many years and associated with significant healthcare and economic costs. NT-814 is wholly owned by KaNDy.

Dec 10
Love0

Bioncotech Therapeutics Announces Oncology Clinical Trial Collaboration with MSD Phase II Trial

By Press Release
Press Release.

 

Madrid, Spain – December 10, 2019: Bioncotech Therapeutics (“Bioncotech”), a clinical-stage biopharmaceutical company developing RNA-based therapies against cancer, announces it has entered into a Phase II clinical trial collaboration with a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey, U.S.A., known as MSD outside the U.S. and Canada.

The collaboration will focus on the Phase II clinical evaluation of the combination of BO-112, Bioncotech’s lead program, and KEYTRUDA® (pembrolizumab), MSD’s anti-PD-1 therapy, in patients with select advanced stage solid tumors with liver metastases. The trial will evaluate if the combination of stimulation of the innate immune system by direct intra-tumoral administration of BO-112, combined with systemic administration of pembrolizumab, shows safety and efficacy in patients with tumors that are poorly or only moderately responsive to monotherapy with an anti-PD1 agent.

“This collaboration is an important next step in the clinical development of BO-112 and the potential of the innate immune system and intra-tumoral route of administration to provide improved outcomes for cancer patients,”

said Marisol Quintero, CEO of Bioncotech.

“We consider MSD, with its extensive expertise in immune-oncology, as the ideal partner for Bioncotech to complete this study.”

“Early clinical data suggest BO-112 induces immunological changes in the tumor microenvironment and beyond, which may render previously anti-PD1 refractory tumors susceptible to checkpoint inhibition,”

added Dominique Tersago, CMO of Bioncotech.

“Cancers that have metastasized to the liver present a significant therapeutic challenge. By targeting the metastatic liver lesions as the site for intra-tumoral injection we aim to reduce organ-related variability of the injection site, and also evaluate if BO-112 has potential to break through the generally immune tolerant hepatic environment and trigger or improve responsiveness to anti-PD1 therapy.”

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc., Kenilworth, NJ, U.S.A.

For more information, please contact:

Bioncotech Therapeutics S.L
info@bioncotech.com
Marisol Quintero, CEO
Mo PR Advisory
Tel: +44 (0) 7876 444977 / 07860 361746
Mo Noonan / Jonathan Birt

Notes to Editors

About Bioncotech
Bioncotech is a Spanish biopharmaceutical company focusing on the development of RNA-based therapies against validated and novel targets in cancer and immune cells.

About BO-112
Bioncotech’s lead candidate, BO-112, is a formulated non-coding double stranded RNA (dsRNA) that acts as an agonist to toll-like receptor 3 (TLR-3), and the cytosolic helicases melanoma differentiationassociated gene 5 (MDA5) and retinoic acid-inducible gene I (RIG-I). It is a stimulator of the innate immune system, activates dendritic cells and induces interferons (IFNs), and also has been shown to trigger apoptosis and cause immunogenic cell death in tumor cells. BO-112 is being evaluated in combination with anti-PD1 treatment in a Phase I clinical trial. For information on clinical trials, please visit www.clinicaltrials.gov.

Nov 14
Love0

Axonics® Announces U.S. Food & Drug Administration Approval for its Sacral Neuromodulation System for Urinary Clinical Indications

By Axonics, Press Release
Press Release.

 

IRVINE, Calif.–(BUSINESS WIRE)– Axonics Modulation Technologies, Inc. (NASDAQ: AXNX), a medical technology company that has developed and is commercializing novel implantable rechargeable sacral neuromodulation (“SNM”) devices for the treatment of bladder and bowel dysfunction, today announced the approval of the Axonics r-SNM® System by the United States Food & Drug Administration (“FDA”) for the clinical indications of overactive bladder (“OAB”) and urinary retention.

The FDA premarket approval (“PMA”) grants Axonics the right to market its product in the United States for the clinical indications of OAB (urinary urge incontinence and urinary urge frequency) as well as urinary retention, representing the largest segment of the market for SNM devices. The FDA approval follows the Company’s September approval for the clinical indication of fecal incontinence, which, according to published clinical studies, is a co-morbidity reported by as many as a third of patients presenting with urinary urge incontinence.

The FDA approval was supported by the results of a detailed review of technical data and the positive results of the Axonics ARTISAN-SNM 129-patient pivotal clinical study that met all primary and secondary endpoints and demonstrated 90% efficacy for all implanted urinary incontinence patients at six months, as well as published clinical literature.

The Axonics r-SNM System is the first rechargeable SNM system approved for sale in the U.S., Europe, Canada and Australia. It is also the only SNM device approved for patients to undergo full-body MRI scan without the necessity of having the device explanted. The FDA approval includes the claim of a 15-year functional life, which is in contrast to the incumbent company’s legacy device which requires replacement on average every four years. In addition to many other differentiating attributes, the system includes a patented tined lead, user-friendly accessories, such as a wireless charging system optimized for infrequent charging, a small easy-to-use key-fob patient remote control and an intuitive clinician programmer that facilitates lead placement and stimulation programming. The long-lived miniaturized neurostimulator is approximately the size of a USB stick.

“If we consider the millions of women who have tried and discontinued OAB pharmaceuticals, the market opportunity for Axonics goes well beyond the approximate $700 million of revenue that is currently being generated by the incumbent’s non-rechargeable SNM device,“

said Raymond W. Cohen, CEO of Axonics.

”Based on feedback from U.S. physicians, we believe the SNM market is poised to dramatically expand over the next few years given our fuss-free, highly efficacious, long-lived, full-body MRI compatible device. Our U.S. commercial team of 146 territory managers, clinical support specialists and sales managers rivals the size of the incumbent’s field staff, and is focused on calling on the top 1,000 urologists, urogynecologists and colorectal surgeons who account for approximately 80% of the SNM implants in the U.S.”

As previously announced, Axonics is hosting a conference call with the investment community today, Thursday, November 14, 2019, at 4:30 p.m. Eastern Time to discuss 2019 third quarter financial results and recent business developments.

Interested parties may access the live call via telephone by dialing (866) 687-5771 (U.S.) or (409) 217-8725 (International) and using passcode 4373989. A live webcast of the call may be accessed by visiting the Events & Presentations page of the investors section of the Company’s website at ir.axonicsmodulation.com.

ARTISAN-SNM pivotal study and the PMA approval process with the U.S. FDA

ARTISAN-SNM was conducted at 14 centers in the U.S. and five centers in Western Europe. The study met all primary and secondary endpoints and demonstrated that implanted patients received clinically meaningful and statistically significant improvements in urinary incontinence symptoms and quality of life. At the study endpoint of six months post-implant, 90% of all 129 implanted patients were therapy responders. At one year, the efficacy remained consistent with an 89% responder rate. The vast majority of implanted patients experienced a significant reduction in urgency incontinence episodes and approximately one third were completely dry. No serious device-related adverse events were reported.

After the initial filing in December 2018, the Company filed a number of amendments, including complete test data to support full-body MRI labeling for the implantable components of the Axonics r-SNM System and the full six-month data set from its pivotal study. The FDA conducted two detailed PMA audits of the Axonics quality system and manufacturing during the review period. The audits were completed without any negative observations.

About Axonics Modulation Technologies, Inc. and Sacral Neuromodulation

Axonics, based in Irvine, Calif., has developed and is commercializing novel implantable SNM devices for patients with urinary and bowel dysfunction. These conditions are caused by a miscommunication between the bladder and the brain and significantly impacts quality of life. Overactive bladder affects an estimated 87 million adults in the U.S. and Europe. Another estimated 40 million adults are reported to suffer from fecal incontinence/accidental bowel leakage. SNM therapy has been employed to reduce symptoms and restore pelvic floor function for the past two decades. Reimbursement coverage is well established in the U.S. and Europe. The Axonics System is the first rechargeable SNM system approved for sale in the world, and the first to gain full-body MRI conditional labeling. For more information, visit the Company’s website at www.axonics.com.

Forward-Looking Statements

Statements made in this press release that relate to future plans, events, prospects or performance are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. Words such as “planned,” “expects,” “believes,” “anticipates,” “designed,” and similar words are intended to identify forward-looking statements. While these forward-looking statements are based on the current expectations and beliefs of management, such forward-looking statements are subject to a number of risks, uncertainties, assumptions and other factors that could cause actual results to differ materially from the expectations expressed in this press release, including the risks and uncertainties disclosed in Axonics filings with the Securities and Exchange Commission, all of which are available online at www.sec.gov. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, Axonics undertakes no obligation to update or revise any forward-looking statements to reflect new information, changed circumstances or unanticipated events.

View source version on businesswire.com: https://www.businesswire.com/news/home/20191114005205/en/

Contacts

Axonics’ Contact
Axonics Modulation Technologies, Inc.
Dan Dearen, +1-949-396-6320
President & Chief Financial Officer
ir@axonics.com

Investor & Media Contact
W2Opure
Matt Clawson, +1-949-370-8500
mclawson@w2ogroup.com

Source: Axonics Modulation Technologies, Inc.