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Dec 02
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AviadoBio™ Raises $80 million in Series A Financing to Advance Neurodegenerative Gene Therapy Platform

By AviadoBio, Press Release, Private Companies
Press Release.

 

  • Series A led by New Enterprise Associates (NEA) and co-led by Monograph Capital follows seeding by Advent Life Sciences, Dementia Discovery Fund (DDF), F-Prime Capital, Johnson & Johnson Innovation – JJDC, Inc. (JJDC), and LifeArc
  • AviadoBio’s unique platform combines next-generation gene therapy design with deep neuroscience expertise and a novel neuroanatomy-led approach to drug delivery
  • Co-founded by leading neurologist and neuroscientist Professor Christopher Shaw, molecular neurobiologist Dr Youn Bok Lee and vector biologist Dr Do Young Lee from King’s College London and the UK Dementia Research Institute
  • Lisa Deschamps appointed Chief Executive Officer, bringing 25 years of industry and extensive gene therapy experience

London, UK, December 2, 2021 — AviadoBio Ltd, a pioneering gene therapy company focused on developing and delivering transformative medicines for people living with neurodegenerative disorders, announced today the successful completion of an $80 million (£58.6 million) Series A financing round, following an initial $16.5 million (£12 million) seed financing. The funds will be used to advance AviadoBio’s lead program in frontotemporal dementia (FTD) into the clinic, progress its preclinical assets, including for amyotrophic lateral sclerosis (ALS), whilst continuing to expand its industry-leading team.

The financing was led by New Enterprise Associates (NEA) and co-led by Monograph Capital, with participation from LSP, as well as seed investors Advent Life Sciences, Dementia Discovery Fund (DDF), F-Prime Capital, JJDCand medical research charity LifeArc.

AviadoBio’s technology was developed in the laboratory of Christopher Shaw, Professor of Neurology and Neurogenetics at King’s College London’s Institute of Psychiatry, Psychology & Neuroscience, with the support of the UK Dementia Research Institute, the My Name’5 Doddie Foundation and the Van Geest Foundation and, incubated by F-Prime Capital and JJDC.

“Whilst neurodegenerative conditions are focal at onset, the pathology eventually spreads throughout the nervous system. We have seen that modifying gene expression can be curative, but achieving widespread distribution is the greatest challenge. We have shown that precision micro dosing to neural networks will deliver broad CNS expression, providing safe and effective treatments,”

said Prof. Christopher Shaw, Co-founder and Chief Scientific and Clinical Advisor of AviadoBio.

“We are directly exploiting insights into the causes of diseases to design therapies that have the potential to cure patients for whom there are no effective treatments. I believe that AviadoBio has the potential to move neurodegeneration from palliation to prevention.”

Shaw added:

“AviadoBio’s unique platform combines next-generation gene therapy design with deep neuroscience expertise and a novel neuroanatomy-led approach to drug delivery. Precision micro dosing achieves extensive gene expression throughout the nervous system, maximizing the therapeutic potential for patients living with devastating neurological diseases.”

The Company is led by recently appointed Chief Executive Officer and Board member Lisa Deschamps, former Senior Vice President and Chief Business Officer at Novartis Gene Therapies. Lisa brings more than 25 years of biopharma experience including leading the global neuroscience business of Novartis and the worldwide commercialization of its gene therapy for spinal muscular atrophy.

“I am excited about the promise we can bring to people living with neurodegenerative disease, where a significant unmet medical need remains with only symptomatic therapies currently available. Our differentiated approach has the potential to transform the treatment landscape and we have the opportunity with our group of experienced investors, our advisors and founders, to change the lives of people living with these debilitating conditions,”

said Lisa Deschamps, Chief Executive Officer.

“The expansion of our team and investor syndicate, positions AviadoBio to make this mission a reality while advancing the field.”

As part of the Series A financing, Matt McAviney, Partner at NEA and Tim Funnell, Partner at Monograph Capital have been appointed to the Company’s Board of Directors. They are joined by Amber Salzman and Prof. Philip Scheltens as an independent Board Director and a Board Observer for LSP, respectively. Amber has been a pioneering entrepreneur in leading companies and not-for-profit organizations focused on gene therapies and rare diseases for more than 20 years, while Prof. Sheltens is a world-renowned dementia scientist and thought leader.

“Traditionally, there have been very few options to combat the devastating course of neurodegenerative disorders,”

said Matt McAviney, Partner, NEA and AviadoBio Board member.

“AviadoBio’s gene therapy platform introduces a revolutionary approach, supported by world-renowned neuroscience expertise and strong preclinical data. The Company is poised to make a meaningful impact, and we are thrilled to partner with the team to introduce a new portfolio of treatments to patients suffering from a range of debilitating diseases.”

ABOUT AVIADOBIO

At AviadoBio our mission is to transform the lives of people living with neurodegenerative disorders by developing and delivering transformative gene therapies for diseases including frontotemporal dementia (FTD) and amyotrophic lateral sclerosis (ALS). The Company’s technology is based on pioneering research from King’s College London and the UK Dementia Research Institute, co-founded by Prof. Christopher Shaw, Dr. Youn Bok Lee and Dr. Do Young Lee, with support from leading life science investors and Dr. Jonathan Jones and Dr. Graeme Fielder, as the Company’s founding management team. AviadoBio is building world-class capabilities to discover, develop, manufacture and commercialize gene therapy products.

For more information, please visit www.aviadobio.com and follow us at Twitter @AviadoBio and LinkedIn AviadoBio.
LEARN MORE ABOUT US

CONTACT
For media enquiries:

Consilium Strategic Communications
Chris Gardner, Angela Gray, Isabelle Abdou
+44 (0) 20 3709 5700
AviadoBio@consilium-comms.com

Nov 12
Love0

Highlight Therapeutics announces positive preliminary results from Phase 2b study of BO-112 + anti-PD1 in confirmed anti-PD1 progressor melanoma patients at SITC

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

 

Highlight Therapeutics announces positive preliminary results from Phase 2b study of BO-112 + anti-PD1 in confirmed anti-PD1 progressor melanoma patients at SITC

Breakthrough cancer treatment shows best-in-class potential to open up 2nd-line immunotherapy market to anti-PD1 resistant patients

  • BO-112 demonstrates potential as best-in-class therapy to overcome anti-PD1 resistance in melanoma patients whose disease has progressed on prior anti-PD-1 treatment
  • Primary endpoint met with a 27% Overall Response Rate (ORR), 8% Complete Responses (CR) & 65% Disease Control Rate (DCR) substantially exceeding current standard of care; further improvements anticipated over one year follow up
  • Hard-to-treat mucosal melanoma patients achieved 66% ORR and 100% DCR
  • Durable responses and manageable safety profile, with no patients discontinuing due to adverse events
  • Preparation for pivotal trial based on FDA guidance underway; potential for use in multiple solid cancers resistant to anti-PD1 inhibitors, and with different anti-PD1 combinations

Madrid, Spain, 12 November, 2021 – Highlight Therapeutics, (“Highlight”), a clinical-stage biopharmaceutical company developing RNA-based therapies against cancer, today announced positive preliminary results of a Phase 2 study of intratumoral administration of BO-112 with pembrolizumab in patients with advanced melanoma whose disease had progressed on first-line anti-PD1-based therapy. BO-112 is a dsRNA agonist targeting anti-PD1 resistance, which has been successfully tested in several previous Phase 1b studies.

Initial results of the study were presented today (12th November) in a late-breaking session at The Society for Immunotherapy of Cancer (SITC) 36th Annual Meeting in Washington DC, Nov. 10–14, 2021. (LBA Poster Abstract (961): Preliminary results of a phase 2 study of intratumoral administration of BO-112 with pembrolizumab in patients with advanced melanoma that have progressive disease on anti-PD-1-based therapy, presented in the Poster Hall in Washington, D.C. and the virtual ePoster Hall beginning Friday, Nov. 12 at 7 a.m. EST).

“These are potentially game-changing results showing that BO-112 can rescue melanoma patients who have failed first-line immune-therapy with anti-PD1,”

said Dr Carlos Paya, Executive Chairman of Highlight Therapeutics.

“Anti-PD1 based immunotherapy has revolutionized oncology treatments, but only a fraction of patients initially respond and many of these patients progress thereafter. These initial Phase 2 results show that BO-112 combined with a leading PD1 inhibitor rescue around 65% of anti-PD1 failing patients, making many of them respond to the combined treatment. These much-anticipated outcomes demonstrate BO-112’s potential as a best-in-class therapy for melanoma patients whose disease has progressed on prior anti-PD1 treatment, and we now look forward to further clinical studies, not only in melanoma but in other major tumor types in which anti-PD1 resistance is also an issue.”

Anti-PD1 therapies are valued at approximately $24 billion1 and are used across most solid tumors but currently fewer than 20% of all cancer patients benefit from first-line anti-PD1 treatment. BO-112 in combination with anti-PD1 therapy is designed to resensitize tumors to anti-PD1 treatment through improved antigen presentation, enhanced T-cell infiltration and increased MHC-1 and PDL1 expression by the tumor itself.

“This initial data is very encouraging and has the potential to change medical practice,”

said Dr. Marisol Quintero, CEO of Highlight Therapeutics.

“The preliminary ORR of 27%, including 8% Complete Responses, already exceeds current standard of care, such as the use of anti-CTLA-4. Based on the mode of action and experience from previous BO-112 Phase 1 studies, additional follow-up of these patients is expected to deliver further improvements in ORR. We are also encouraged by the excellent safety profile, with no patients discontinuing the study due to adverse events. Highlight Therapeutics is in the planning stage of a pivotal Phase 3 trial, due to begin in 2022, and we look forward to opening discussions with potential partners to explore combinations with anti-PD1s.”

Highlight Therapeutics and Merck, known as MSD outside the United States and Canada, conducted an open-label, single arm study to evaluate the efficacy & safety of intra-tumoral administration of BO-112 + pembrolizumab in mucosal, acral and cutaneous melanoma patients whose disease had progressed, confirmed by two consecutive CT scans. The study recruited 42 patients in France and Spain, with recruitment completed by August 24, 2021. Patients included those with high LDH levels, which are often associated with poor response rates and have been excluded from comparable clinical trials.

The preliminary analysis shows:

  • Primary endpoint (ORR by independent reviewer) has been met
  • With a median follow up of three months, there is a clear clinical benefit in patients with confirmed anti-PD1-resistant melanoma, with a 27% ORR and a 65% DCR, superior to 2nd line Standard of Care in stage III/IV melanoma of ~8% (continuing with anti-PD1 Ab) or 13% (second line ipilimumab).
  • Three hard-to-treat mucosal melanoma patients have achieved an ORR of 66% and DCR of 100%
  • High baseline LDH levels (>3xULN) predict progressive disease
  • Responses and SD are durable
  • Study treatment has a manageable safety profile, with no patients discontinuing due to adverse events

Next steps in the development of BO-112 include:

  • Initiation of a pivotal Phase 3 study in 2nd-line melanoma is planned in 2022 following discussions with regulatory agencies in the US and Europe
  • Highlight Therapeutics has initiated strategic partnerships discussions with anti-PD1 companies interested in enhancing their anti-PD1 market potential
  • Initial data from a sponsor-initiated Phase 1B trial by UCLA evaluating BO-112 + pembrolizumab in anti-PD1 resistant hepatocellular carcinoma currently recruiting patients is expected in 2022

1. IQVIA Global Oncology Report 2020

For more information, please contact:

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

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

Consilium Strategic Communications     Tel: +44 7921 697654
Chris Gardner                                            cgardner@consilium-comms.com

Notes to editors

About Highlight Therapeutics

Highlight Therapeutics, formerly known as Bioncotech Therapeutics, is a private, clinical-stage company dedicated to unlocking the full potential of immuno-oncology. Our lead drug candidate 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. In addition to in-house research, Highlight Therapeutics has a number of external collaborators, including Merck & Co and UCLA.

For more information, please visit www.highlighttherapeutics.com

Nov 01
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Amphista Therapeutics Appoints CBO, Beverley Carr

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

 

Amphista Therapeutics Appoints CBO, Beverley Carr

Cambridge, England, 1 November 2021 – Amphista Therapeutics, a leader in next generation targeted protein degradation (TPD) approaches, today announced the appointment of a Chief Business Officer (CBO), Beverley Carr.

Amphista’s CEO Dr Nicola Thompson said,

“On behalf of the Amphista team, I am thrilled to welcome Beverley as our CBO.  Beverley brings a wealth of business development expertise from an impressive career as a business leader, spanning both global Pharma and Biotech. Beverley’s leadership of this strategically important function will be key to ensuring that the full potential of our proprietary next generation TPD technology is captured across therapy areas in order to bring transformative medicines to patients.”

Amphista’s new CBO, Beverley Carr, commented on her appointment,

“I’m delighted to join Amphista’s world class team. Amphista is founded on transformational science and I’m looking forward to driving the Company’s business development strategy as we execute our mission of building the leading TPD company.”

Beverley joins Amphista from Achilles Therapeutics plc (NASDAQ: ACHL), a clinical-stage biopharmaceutical company, where she was CBO. Previously Beverley was Vice President Business Development for the Immunoinflammation Therapy Area at GSK, where she led over twenty transactions for the immune-inflammation therapy area. Beverley has negotiated and closed major deals across all stages of drug discovery and development. She is a scientist by training with an MA and DPhil in chemistry from Oxford University and has an MBA from Cambridge University.

– Ends –

Media contacts:

Amphista Therapeutics
CEO NicolaThompson
+447464974714
nicki@amphista.com

Scius Communications
Katja Stout
+447789435990
katja@sciuscommunications.com

About Amphista Therapeutics

Amphista Therapeutics is focused on transforming the lives of patients with severe diseases including cancer. The company is applying its proprietary Amphista degrader platform to advance new approaches in targeted protein degradation (TPD), which address the challenges faced by the field and to realise the full therapeutic potential of this transformational approach. Founded by Advent Life Sciences, Amphista is a spin-out of TPD expert Professor Alessio Ciulli’s labs at the University of Dundee. The company has raised over $60M to date and is funded by leading life science investors including Forbion, Gilde Healthcare, Novartis Venture Fund, Advent Life Sciences, BioMotiv and Eli Lilly & Company.
For more information, please visit: http://www.amphista.com/

Sep 21
Love0

Amphista Therapeutics Appoints New Chairman, Joshua T. Brumm

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

 

Glasgow, UK, 21 September 2021 – Amphista Therapeutics, a leader in next generation targeted protein degradation (TPD) approaches, today announced the appointment of Joshua T. Brumm as its new Independent Chairman, succeeding Satish Jindal.

Amphista’s CEO Dr Nicola Thompson said,

“On behalf of the Amphista team I am thrilled to welcome someone of Josh’s calibre to the Board. I look forward to working with Josh as we rapidly develop our pipeline of TPD therapeutics in oncology and beyond and unlock the full therapeutic potential of this exciting new modality. I would also like to thank our outgoing Chairman, Satish Jindal, who has tirelessly given his support as we have successfully advanced Amphista to this next stage of growth.”

Josh Brumm, Amphista’s new Chairman, commented on his appointment,

“I am delighted to join Amphista as its Chairman. The company, founded by leading pioneers in the field, has a unique, truly differentiated approach to targeted protein degradation and the opportunity to develop transformational therapies for patients. The potential of the technology is extremely exciting and together with Amphista’s world class team, I’m looking forward to executing on our mission of building the leading TPD company.”

Founding investor Raj Parekh, General Partner, Advent Life Sciences added,

“I am excited to welcome Josh as Amphista’s new Chairman. He brings a wealth of experience that will compliment the work that Nicki and the team have achieved and will support Amphista’s ambitious strategy”.

Josh Brumm is the president and CEO of Dyne Therapeutics, Inc. (NASDAQ: DYN), a leading muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. Before joining Dyne, he served as COO and CFO of Kaleido Biosciences, leading the company’s IPO, and helped bring the lead program into Phase 2 development.  Prior to this he was COO and CFO at Versartis, where he oversaw the company’s financial strategy including the successful completion of its IPO. Brumm has also held senior positions at Pharmacyclics, ZELTIQ Aesthetics and Proteolix, Inc as well as investment banking positions at Citigroup Global Markets, Inc. and Morgan Stanley. Over the course of his career, he has raised nearly $2 billion in capital. He holds a B.A. in business administration from the University of Notre Dame.

– Ends –

Media contacts:

Amphista Therapeutics
CEO NicolaThompson
+447464974714
nicki@amphista.com

Scius Communications
Katja Stout
+447789435990
katja@sciuscommunications.com

About Amphista Therapeutics

Amphista Therapeutics is focused on transforming the lives of patients with severe diseases including cancer. The company is applying its proprietary Amphista degrader platform to advance new approaches in targeted protein degradation (TPD), which address the challenges faced by the field and to realise the full therapeutic potential of this transformational approach. Founded by Advent Life Sciences, Amphista is a spin-out of TPD expert Professor Alessio Ciulli’s labs at the University of Dundee. The company has raised over $60M to date and is funded by leading life science investors including Forbion, Gilde Healthcare, Novartis Venture Fund, Advent Life Sciences, BioMotiv and Eli Lilly & Company.

For more information, please visit: http://www.amphista.com

Sep 15
Love0

Rappta Therapeutics Appoints Sunjeet Sawhney as Chief Executive Officer

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

 

  • Experienced industry leader with successful track-record in oncology to lead Rappta through its next stages of growth
  • Rappta’s industry-leading phosphatase technology platform offers a new paradigm in oncology
  • Lead compounds on track to enter IND/CTA-enabling studies in the first half of 2022

Helsinki, Finland and London, UK, 15 September, 2021: Rappta Therapeutics (“Rappta”), which is focused on developing first-in-class anti-cancer drugs reactivating protein phosphatase 2A (PP2A), announces today the appointment of Sunjeet Sawhney as Chief Executive Officer (CEO) with immediate effect. Rappta’s Co-founder and Founding CEO Mikko Mannerkoski will move to be Chief Financial Officer (CFO) as planned.

With over 20 years of experience in the industry, Sunjeet joins Rappta from Ipsen where he has most recently been the Global Head of the Oncology Franchise. Prior to this Sunjeet led businesses across a range of geographies both in biotech and major pharmaceutical companies. Sunjeet holds a MSc in Immunology from the University of London and will be based in London, UK.

In October 2020, Rappta raised its first round of financing from blue-chip investors Advent Life Sciences, Novartis Bioventures, Novo Holdings, and a family office. Under the scientific leadership of Dr. Goutham Narla, Rappta’s Co-Founder and Chief Scientific Officer, the Company is developing first-in-class anti-cancer drugs reactivating PP2A – a critical enzyme regulating protein de-phosphorylation and a key tumor suppressor which to date has been very difficult to target pharmaceutically. Rappta’s strengthened leadership team is well-positioned to take its first-in-class program of PP2A-reactivating anti-cancer molecules to IND/CTA-enabling studies in the first half of 2022.

Sunjeet Sawhney, CEO of Rappta Therapeutics, commented:

“I am honored to have been given the opportunity to lead Rappta. The Company’s robust first-in-class program of anti-cancer drugs that reactivate PP2A represents an exciting clinical and commercial opportunity, much like kinase inhibitors did more than two decades ago. I am particularly impressed with the rigorous science and the swift progress that the team has made in moving the program forward from discovery towards development. I look forward to working together with the Rappta team in progressing our lead compounds while continuing to leverage our proprietary tools and unique understanding of PP2A to build a platform of a new class of anti-cancer drugs.”

Mikko Mannerkoski, CFO and Co-Founder of Rappta Therapeutics, commented:

“I look forward to working with Sunjeet, an experienced industry leader, to guide the Company through the next important stages of growth. As an entrepreneur and co-founder, it gives me great pride that Rappta has in a very short period of time built a robust drug development program that is ready to enter IND/CTA-enabling studies and subsequent first-in-human clinical trials, which has the potential to offer real benefit to patients while creating value for our shareholders.”

Goutham Narla, Rappta’s CSO and Co-Founder, commented:

“I am thrilled to work with Sunjeet on this opportunity to build a new platform and a novel class of pharmaceuticals to treat cancer. We have a unique team whose deep understanding of the PP2A biochemistry, structural biology, biogenesis, medicinal chemistry, and drug development represent a great combination of expertise to translate these discoveries into meaningful outcomes for patients. Sunjeet’s vast industry experience will add a new dimension to our competencies and accelerate the growth of the Company.”

ENDS

 

For more information please contact:

Rappta Therapeutics
Sunjeet Sawhney, CEO
+44 74 7244 6005
sunjeet.sawhney@rappta-therapeutics.com

Optimum Strategic Communications
Mary Clark, Manel Mateus, Vici Rabbetts
+44 (0) 20 3922 1906
rappta@optimumcomms.com

About Rappta Therapeutics

Rappta Therapeutics, a private biotech with operations in Finland, UK and the US, is developing first-in-class anti-cancer drugs activating protein phosphatase 2A (PP2A). It has developed proprietary tools and a unique understanding of PP2A which allows it to therapeutically reactivate PP2A, a critical enzyme regulating protein de-phosphorylation and tumor growth, with the potential to create a new class of anti-cancer drugs. Rappta has a strong scientific, management and commercial team. Its scientific team, led by CSO and co-founder, Professor Goutham Narla, Division Chief of Genetic Medicine at the University of Michigan, represents world-leading expertise in PP2A. The team is supported by a Scientific Advisory Board led by Dr. William Hahn, Professor of Medicine at the Harvard Medical School and the Chief Operating Officer of the Dana-Farber Cancer Institute and a Clinical Advisory Board lead by Dr. Mathew Galsky, Professor of Medicine and Director of Genitourinary Medical Oncology at the Icahn School of Medicine at Mount Sinai. The Company is backed by blue-chip investors Advent Life Sciences, Novartis Bioventures, Novo Holdings and a family office. For more information, go to www.rappta-therapeutics.com.

About PP2A

Reversible phosphorylation is a fundamental mechanism controlling all cell signaling and communication and this process is regulated through the opposing actions of phosphatases (which remove phosphate groups from proteins) and kinases (which add phosphate groups to proteins). Altered cellular signaling as a result of protein hyperphosphorylation, results in the sustained growth of malignant cells and is a hallmark of human cancer development and progression.

Protein Phosphatase 2A (PP2A) is a serine/threonine phosphatase that functions as a tumor suppressor by negatively regulating multiple oncogenic signaling pathways responsible for driving cancer progression. PP2A is made up of three subunits, that form a complete and active enzyme when bound together. The active enzyme is comprised of a scaffolding subunit (A), serving as the structural platform for the assembly of the catalytic (C) subunit and one substrate directing regulatory (B) subunit. In cancer, the tumor-suppressive activity of PP2A is often disrupted as a result of the inability of the three subunits to bind together correctly, rendering the PP2A enzyme inactive. This inactivation of PP2A, leads to increased oncogenic signaling, driving cancer progression and growth. Therefore, the reactivation of PP2A affords a unique therapeutic strategy to restore PP2A activity and cellular homeostasis, that can be used for the treatment of cancer and a broad range of other diseases.

Sep 02
Love0

Orphalan announces FDA acceptance for filing of New Drug Application (NDA) for trientine tetrahydrochloride (TETA 4HCl) for the treatment of Wilson’s Disease

By Orphalan, Press Release, Private Companies
Press Release.

 

  • NDA supported by positive data from Phase 3 CHELATE clinical trial
  • TETA 4-HCl previously granted Orphan Drug Designation for first-line treatment of Wilson’s Disease

Paris, France – 02 September 2021 – Orphalan SA, a Company that identifies, develops and delivers worldwide therapies for orphan diseases, today announces that the US Food and Drug Administration (FDA) has accepted for review the Company’s New Drug Application (NDA) for trientine tetrahydrochloride (TETA 4HCl) for the first-line treatment of Wilson’s Disease.

Wilson’s Disease is a rare inherited disorder of copper transport primarily affecting the liver and brain, affecting about 1 in every 30,000 people worldwide. For the last 70 years d- Penicillamine has been the only approved first-line treatment of Wilson’s Disease and to which about a third of patients develop intolerance.

TETA 4HCl is proposed as an alternative copper chelating agent to d-Penicillamine as a first line treatment. The Company’s NDA submission follows its previous Orphan Drug Designation by the FDA. The filing is based upon positive data from the CHELATE Phase 3 clinical trial that met its primary efficacy endpoint by demonstrating that TETA 4HCl was non-inferior to d-Penicillamine as measured by copper speciation evaluation of nonceruloplasmin copper (NCC).

Treatment with TETA 4HCl is supported by Orphalan’s novel NCC assay, for which the Company plans to file for FDA approval as a companion diagnostic. The in vitro NCC assay has the potential to provide an important additional tool to support physicians in identifying patients and monitoring their treatment with TETA 4HCl.

Dr Naseem Amin, Chief Executive Officer at Orphalan, commented:

“The FDA’s acceptance of the NDA brings us one step closer to providing first-line treatment to patients with Wilson’s Disease, who currently do not benefit from alternative methods of treatment, beyond D-Penicillamine”.

Notes to Editors

About the CHELATE Study

CHELATE was a Phase 3, multicentre, randomised, open label, active-controlled, noninferiority study conducted in 9 countries at 15 centres designed to evaluate efficacy and safety of trientine tetrahydrochloride compared to d-Penicillamine in patients with stable Wilson’s Disease. Fifty-three adult Wilson’s Disease patients with clinically stable disease for over one year and who met specific inclusion criteria, including laboratory measures of serum non-ceruloplasmin copper (NCC), 24-hour urinary copper excretion (UCE) and liver function tests, were followed for a baseline period for 12 weeks before being randomised 1:1 to either trientine tetrahydrochloride or d-Penicillamine twice daily. The study’s primary endpoint was serum NCC as measured using Orphalan’s proprietary method using copper speciation at 24-weeks post-randomisation. A secondary composite efficacy endpoint was NCC and 24-hour UCE.

Additional secondary endpoints included were: clinical Global Impression of Change (CGIC) score; serum copper and ceruloplasmin levels; the unified Wilson’s Disease Rating Scale (UWDRS); modified Nazer score; cognitive assessments and standard safety assessments. In addition, an independent adjudication committee blinded to the allocated treatment, and study centres assessed key efficacy and safety parameters to determine clinical stability of the patient. Trientine tetrahydrochloride was well tolerated and during treatment, more patients achieved the pre-specified composite endpoint of NCC and 24-hour Urinary Copper Excretion (UCE) within therapeutic target ranges, compared to patients treated with d- Penicillamine, 50% versus 24%. Data from the trial was presented during an oral presentation at EASL’s The International Liver Congress™ 2021.

About Orphalan

At Orphalan, our mission is clear: we are pioneers in orphan diseases. Orphalan identifies, develops and delivers worldwide innovative therapies for people living with Orphan diseases. Orphalan was founded in 2011 and has launched Cuprior™ across Europe with its own commercial organisation. For more information get in touch or follow us on LinkedIn.

For more information, please contact:

Orphalan
Tel: +33 (0)1 42 49 82 64
Email: info@orphalan.health

Consilium Strategic Communications:
Mary-Jane Elliott, Allison Connolly, Genevieve Wilson
Tel: +44 (0) 203 709 5700
Email: orphalan@consilium-comms.com

Jul 13
Love0

Artax Biopharma Granted MHRA Clinical Trial Authorization for AX-158

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

 

Authorization Represents Start of Clinical Program for Company’s
Global Platform of T Cell-Mediated Diseases

Phase 1 Clinical Trial Expected to Start in Second Half of this Year

Cambridge, Mass., July 13, 2021 – Artax Biopharma, Inc., a biotechnology company focused on transforming the treatment of T Cell-mediated diseases, today announced that the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted clinical trial authorization to evaluate AX-158 in a Phase 1 clinical trial for the treatment of T Cell-Mediated Diseases.

The MHRA authorization marks the start of Artax’s clinical trial program for its global platform of T Cell-mediated diseases. The AX-158 Phase 1 clinical trial is expected to start in the second half of this year.

Artax’s lead compound AX-158 is a first-in-class, oral small molecule immunomodulating agent for the treatment of T Cell-mediated diseases. AX-158 employs a novel mechanism of action that selectively modulates, or adjusts, T cell responses that play a critical role in immune system function. In preclinical studies, AX-158 decreased key cytokines including INFγ, TNFα and IL-2. Based on this activity, Artax is planning future clinical development in autoimmune diseases, T cell malignancies and other related T cell pathologies.

“This authorization to study the tremendous science behind AX-158 is fantastic news for the immunology field,”

said Dr. Lawrence Steinman, Stanford University Zimmerman Professor of Neurology and Neurosciences, Pediatrics, and Genetics and Artax Scientific Advisory Board member.

“Artax Biopharma’s Nck inhibitor AX-158 has shown impressive experimental biologic and mechanistic impact on T Cell modulation – managing autoimmune disease without inducing the profound immunosuppression associated with current conventional or biological therapies.”

“There is a great need for oral therapeutics that offer efficacy with fewer side effects for the many patients suffering from debilitating and life-threatening T Cell-mediated diseases including autoimmune diseases and T cell malignancies”

Artax Biopharma Chief Executive Officer Joseph Lobacki stated.

“The MHRA approval and opportunity to initiate clinical trials for AX-158 is a significant milestone, and we look forward to bringing this first-in-class treatment option to the clinic.”

About Artax Science and Immunomodulation
A healthy immune system eliminates harmful foreign pathogens, while being tolerant of self-tissues and organs. The T Cell Receptor (TCR) is central to healthy T Cell function and a well-functioning immune system. When TCR signaling becomes dysregulated, T Cells behave abnormally. This behavior results in T Cell-driven conditions including autoimmune diseases, T Cell malignancies (lymphomas), and induced T Cell pathologies in which medical treatments result in immune reactions (such as stem cell transplants resulting in acute graft-versus-host-disease or immune-oncology treatments resulting in immune related-adverse events). Artax believes immunomodulation – during which our medicines assist the immune system to maintain healthy control and eliminate a direct cause of T Cell-mediated diseases while not impacting patients’ ability to properly fight foreign pathogens – holds great potential.

About Artax-158
AX-158 is a first-in-class, oral small molecule immunomodulating agent in development for the treatment of T Cell-mediated diseases. AX-158 employs a novel mechanism of action that selectively modulates, or adjusts, T Cell responses that play a critical role in immune system function. Nck is a protein that naturally amplifies T Cell signaling directly at the TCR, contributing to pathogenic responses. AX-158 is a Nck SH3.1 domain inhibitor which selectively counteracts the role of Nck in T Cells. This process of immunomodulation eliminates a direct factor in T Cell-mediated diseases. Importantly, data suggest AX-158 is not immunosuppressive and does not impact the immune system’s ability to mount a strong response to foreign pathogens and infections.

About Artax Biopharma
Artax Biopharma is a biotechnology company transforming T Cell-mediated disease treatment by developing innovative small molecules that modulate the immune system. Artax science holds broad potential to treat T Cell-mediated diseases such as autoimmune diseases, induced T cell pathologies (such as acute graft versus host disease and immune-oncology treatment-related adverse events) and T Cell malignancies (lymphomas), while simultaneously allowing the body to fight foreign pathogens. For more information, please visit www.artaxbiopharma.com.

Contacts:
Karen LaRochelle
Chief Business Officer
Artax Biopharma
klarochelle@artaxbiopharma.com

Media:
Linda Phelan Dyson
+1 973-986-5873
ldyson@artaxbiopharma.com

Jul 07
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NeRRe Therapeutics raises £20 million in a Series B2 financing round

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

 

  • New funds to evaluate orvepitant as a treatment for the disabling chronic cough associated with idiopathic pulmonary fibrosis (IPF).
  • New investor Columbus Venture Partners joins existing investors Advent Life Sciences, Fountain Healthcare Partners, Forbion Capital Partners, OrbiMed, and the UK Government’s Future Fund.

Stevenage, UK, 7 July 2021 – NeRRe Therapeutics, a clinical-stage company developing orvepitant, its wholly-owned neurokinin-1 (NK-1) antagonist, as a first in class treatment for disabling chronic cough caused by reflex hypersensitivity disorders, today announces it has raised an additional £20 million in a Series B2 financing round.

Having demonstrated proof of efficacy in patients with refractory or unexplained chronic cough , NeRRe will now continue the clinical development of orvepitant in chronic cough caused by IPF, a rare type of interstitial lung disease . A dominant symptom of this severe progressive fibrotic pulmonary disease, in a high proportion of these terminally ill patients, is an uncontrolled, persistent, and disabling cough. The chronic cough can markedly reduce quality of life, is often refractory to medical therapy and there are no approved treatments for it . Idiopathic pulmonary fibrosis is recognised as an orphan disease in both Europe and the US.

The financing round involved a syndicate of leading transatlantic life sciences investors led by new investor Columbus Venture Partners and existing investors Advent Life Sciences, Fountain Healthcare Partners, Forbion Capital Partners, OrbiMed and the UK Government’s Future Fund. The proceeds from the financing round will primarily be used to fund the Phase 2 clinical development of orvepitant as a treatment for chronic cough associated with IPF. Preparation for the start of the Phase 2 trial is underway.

Dr. Mary Kerr, CEO of NeRRe Therapeutics, said:

“After demonstrating that orvepitant reduces the burden of chronic cough in one population, we are delighted to have received the financial support to further advance this promising asset for patients suffering from chronic cough associated with IPF. I am also pleased to welcome Columbus Venture Partners to the syndicate and would like to thank our existing investors for their continued support of the NeRRe team, and this exciting first in class asset.”

Toby Maher Professor of Medicine and Director of Interstitial Lung Disease at Keck School of Medicine, University of Southern California, Los Angeles said:

“IPF is a rare, progressive, and fatal form of interstitial lung disease in which cough can be a dominant and distressing feature. A treatment that improves this chronic cough would substantially improve the quality of life of many IPF patients.”

Javier Garcia, General Partner and Founder of Columbus Venture Partners, said:

“We have been impressed by NeRRe’s clear strategy and focus on chronic cough associated with IPF, a condition of high unmet medical need and we look forward to supporting the company as it fully uncovers the multiple benefits that orvepitant can provide to these patients.”

Notes to Editors

About NeRRe Therapeutics (www.nerretherapeutics.com)
NeRRe Therapeutics is a clinical-stage company developing orvepitant, a neurokinin(NK)-1 receptor antagonist, as a first in class, once daily breakthrough treatment for cough hypersensitivity disorders. Having demonstrated proof of efficacy in patients with refractory or unexplained cough, NeRRe will now continue development in chronic cough caused by the rare and terminal lung disease idiopathic pulmonary fibrosis (IPF). A dominant feature of this severe progressive respiratory disease in a high proportion of patients is an uncontrolled and persistent cough which is disabling for these terminally ill patients. The cough is often refractory to medical therapy and there are no approved treatments for it. IPF has been designated an orphan disease in both Europe and the USA. Preparations for the start of the Phase 2 trial to evaluate orvepitant as a treatment for disabling chronic cough associated with IPF are currently underway.

About Columbus
Columbus Venture Partners is a Spanish independent venture capital that brings a unique approach for investing in outstanding early-stage and high growth opportunities in the life science industry of Spain. Columbus has $275M under management through three funds. Our team includes solid and internationally experienced investment professionals with a deep scientific, medical and business development background combined with a proven experience in building and investing in companies to accelerate their commercialization. The combination of industry possibilities and investment experience will provide Limited Partner investors in the Fund a level of professionality and deep expertise that is essential for success in this field.

For more information, refer to www.columbusvp.com

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

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

About Fountain Healthcare Partners
Fountain Healthcare Partners is a life science focused venture capital fund with EUR 300 million (USD 354 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. fh-partners.com

About Forbion
Forbion is a dedicated life sciences venture capital firm with offices in The Netherlands, Germany and Singapore. Forbion invests in life sciences companies that are active in the (bio-) pharmaceutical space. Forbion manages well over EUR 1.7 billion across multiple fund strategies that cover all stages of (bio)pharmaceutical drug development. Forbion’s current team consists of 20 life sciences investment professionals that have built an impressive performance track record since the late nineties with successful investments in over 69 companies. The firm is a signatory to the United Nations Principles for Responsible Investment. Besides financial objectives, Forbion selects investments that will positively affect the health and well-being of patients. Its investors include the EIF, through its European Recovery Programme (ERP), LfA, Dutch Venture Initiative (DVI), AMUF and EFSI facilities and KfW Capital through the Programme, “ERP – Venture Capital Fonds investments”. Forbion operates a joint venture with BGV, the manager of seed and early-stage funds, especially focused on Benelux and Germany.

For more information, please visit: www.forbion.com

About OrbiMed
OrbiMed is a leading healthcare investment firm, with approximately $19 billion in assets under management. OrbiMed invests globally across the healthcare industry through a range of private equity funds, public equity funds, and royalty/credit funds. OrbiMed’s team of over 100 professionals is based in New York City, San Francisco, Shanghai, Hong Kong, Mumbai, Herzliya and other key global markets.

For more information, please visit: www.OrbiMed.com

About the Future Fund
The Future Fund was established to support the UK’s innovative businesses currently affected by Covid-19. These businesses have been unable to access other government business support programmes, such as CBILS, because they are either pre-revenue or pre-profit and typically rely on equity investment. The Future Fund provided eligible companies with convertible loans, on the condition that private investors at least match the government’s commitment. The convertible loans are designed to convert into equity at the next qualifying funding round. The Future Fund is developed by the government and delivered by the British Business Bank.

For more information, please contact:

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

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

Jun 28
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Amphista Therapeutics Expands Research Team by Appointing Martin O’Rourke as Head of Drug Discovery and James Osborne as Director of Chemistry

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

 

Glasgow, Scotland, 28 June 2021 – Amphista Therapeutics, a Targeted Protein Degradation (TPD) biopharmaceutical company creating first-in-class cancer therapeutics that harness the body’s natural processes to remove disease-causing proteins selectively and efficiently, today announced the addition to their world class team of Martin O’Rourke as Head of Drug Discovery and James Osborne as Director of Chemistry.

Amphista’s CSO and TPD pioneer Dr Ian Churcher said,

“I am delighted to welcome Martin and James to the team. They both bring a wealth of expertise in drug discovery that will be invaluable to further strengthen our team as we progress our TPD pipeline to the clinic following our successful $53M Series B financing round. The funding is also helping us open whole new areas for exploration beyond Amphista’s cancer focus into areas largely inaccessible to the TPD field, such as CNS, with our approach that provides the best of both worlds: great drug like properties and a broad target and tissue scope.”

Amphista’s Head of Drug Discovery, Martin O’Rourke, commented on his appointment,

“I’ve always been interested in progressing drug discovery projects in the oncology space. Working at Amphista excites me particularly due to the company’s unique, proprietary approach which builds on the huge promise of TPD while addressing the limitations with current methods. I am looking forward to exploring the opportunities Amphista’s platform provides, working alongside a world class team.”

Most recently, Martin has been a Director in the Oncology Bioscience group at AstraZeneca. As a member of the leadership team there he contributed to oncology strategy, new target selection and project leadership on early-stage projects. Prior to this Martin worked in a global position at Charles River contributing to a wide range of drug discovery projects. Additionally, whilst working in Professor Tracy Robson’s lab at Queen University Belfast, Martin co-invented a peptide therapeutic and, via his role at Almac Discovery, led the biology team to produce data enabling Phase 1 clinical trials. Martin holds a BSc in Applied Biochemical Science and a PhD from the University of Ulster.

James has significant experience in leading projects to delivery of development candidates for both oncology and CNS disorders. In James’s most recent position he led the Discovery function at GW Pharmaceuticals where he was responsible for the delivery of several novel development candidates in the CNS space. James started his career at the Institute of Cancer Research where he was a key contributor to the delivery of the CHK1 clinical candidate SRA737. Since then he has successfully taken project and medicinal chemistry leadership roles at Astex Pharmaceuticals and Charles River Labs, where he worked across several different target classes and therapeutic areas. James holds an MSci in Chemistry and a PhD in organic synthesis, from Nottingham University and completed his postdoctoral studies at the University of Oxford.

Amphista has developed a proprietary broad technology platform with the potential to generate first-in-class small molecules (called ‘Amphistas’) that harness the body’s own protein degradation mechanisms to deliver highly potent pharmacology. Amphista’s unique approach offers the potential to overcome many of the limitations seen with current TPD technologies, providing greater opportunity to treat a wider range of diseases. Amphista is focused on biological targets in oncology and other therapy areas, focusing on the translation of their novel TPD approach for clinical benefit in areas of high unmet need.

Media contacts:

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

For more information, please visit: http://www.amphista.com/

Jun 23
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Aleta Biotherapeutics and Cancer Research UK collaborate to advance blood cancer therapy into the clinic

By Aleta Biotherapeutics, Press Release, Private Companies
Press Release.

 

NATICK, Mass., June 23, 2021 – Aleta Biotherapeutics (‘Aleta’) and Cancer Research UK today announced a collaboration to advance the early phase clinical development of Aleta’s CAR-T cell engager candidate, ALETA-001.

Aleta is a privately held immuno-oncology company focused on transforming cellular therapeutics to allow a broad spectrum of cancer indications to be targeted, and Cancer Research UK is the world’s leading cancer charity dedicated to saving lives.

Under the terms of the clinical development partnership, Cancer Research UK’s Centre for Drug Development will fund, sponsor and conduct the first-in-human Phase 1/2a clinical trial of ALETA-001, which will be led by Dr Amit Patel’s Cellular and CAR-T therapies team at The Christie NHS Foundation Trust in Manchester, UK.

ALETA-001 has been developed to benefit people with B-cell lymphoma and leukemia whose disease has progressed after receiving CD19 CAR-T cell therapy, and it is hoped that ALETA-001 will offer a new therapy for these patients who have limited treatment options.

CAR-T cell therapy works by targeting the T cell response against cancer through the engineering of T cells to recognize CD19 proteins on the surface of lymphoma and leukemia cells*. CAR-T cell therapy is showing promising results in treating people with blood cancers who are no longer responding to current lines of treatment.

However, over half of the patients treated with CD19 CAR-T cell therapy relapse, mostly due to reduction or loss of CD19 expression. Through binding CD20 present on the surface of cancer cells, ALETA-001 reactivates the CD19 CAR-T cells by effectively ‘recoating’ the cancer cell with the target CD19 proteins** and restoring the CAR-T cells ability to recognise and engage the cancer cell.

In the Cancer Research UK-sponsored Phase 1/2a trial, patients with B-cell lymphoma/leukemia who have received CD19 CAR-T cell therapy but did not achieve a complete response or who relapsed from a complete response will be enrolled. After the recommended Phase 2 dose of ALETA-001 has been determined, Aleta will initiate a multi-center, single arm, pivotal Phase 2 trial in the United States focused on diffuse large B-cell lymphoma (DLBCL) patients. This clinical trial will be designed to support potential accelerated approval of ALETA-001.

Aleta retain the rights to further develop and commercialize ALETA-001 and will receive a licence to the results of the clinical trial from Cancer Research UK in return for undisclosed success-based milestone and royalty payments.

Paul Rennert, President, Co-Founder and Chief Scientific Officer, Aleta Biotherapeutics, said:

“We are deeply honored to be partnering with Cancer Research UK to rapidly advance our lead drug candidate, ALETA-001, into the clinic. There is an urgent need to develop new therapies that can help people with B-cell cancers, such as lymphoma and leukemia, whose cancer has progressed after treatment with CD19 CAR-T cell therapy. Our collaboration with Cancer Research UK is a strong endorsement of the potential of our scientific platform to address the critical issues of CAR-T cell persistence, tumour antigen loss leading to patient relapse, and tumour antigen heterogeneity. We look forward to working with Cancer Research UK’s exceptional network of experienced clinical trial investigators and researchers to conduct the trial.”

Nigel Blackburn, Cancer Research UK’s Director of Drug Development, said:

“CAR-T cell therapy has been transformative in treating patients with hard-to-treat blood cancers, but many will see their cancer return and treatment options begin to run out. ALETA-001 uses a simple yet elegant method to redirect a patient’s circulating CD19 CAR-T cells against cancer cells expressing CD20, and we hope this could be a new treatment avenue for blood cancer.  This is a landmark collaboration for Cancer Research UK as it’s the first-in-human trial for a new drug that reboots CAR-T cell therapy, and we look forward to progress its early clinical development with Aleta.”

Notes to editor

* CAR T cell therapy consists of T cells that have been taken from a patient and are reprogrammed in the lab to recognize cancer cells so they can target and kill them more effectively. T cells are taken from a patient and are engineered in the lab to carry a specific CD19 receptor on their surface, which will allow them to target and kill the cancer cells through binding the CD19 antigen present on B cell leukemia and lymphoma cells. The CAR-T cells are then given back to the patient to mount an immune response directed at cancer cells. CAR-T therapy is thus a patient specific personalized anti-cancer treatment.

** In order to replace and increase CD19 antigen expression on the cancer cell surface, ALETA-001 binds to CD20 on the tumour cell leading to the presentation of the CD19 extracellular domain which is recognised and engaged by circulating CD19 CAR-T cells leading to cancer cell killing. CD20 is another type of receptor found expressed on cancer cells, but it appears to be more stable than CD19 and its expression is rarely lost.

About Aleta Biotherapeutics

Aleta Biotherapeutics is an immuno-oncology company focused on transforming cellular therapeutics to allow a broad spectrum of cancer indications to be targeted, including currently intractable solid tumors. The company was founded by Paul Rennert and Roy Lobb, who bring extensive scientific and leadership experience in immunology, oncology, and drug development to this new enterprise. Aleta has created a unique portfolio of multi-antigen targeting solutions for cell therapy, designed to address the critical issues of CAR-T persistence, tumor antigen loss leading to patient relapse, and tumor antigen heterogeneity. http://www.aletabio.com/

About Cancer Research UK’s Centre for Drug Development

Cancer Research UK has an impressive record of developing novel treatments for cancer. The Cancer Research UK Centre for Drug Development has been pioneering the development of new cancer treatments for 25 years, taking over 140 potential new anti-cancer agents into clinical trials in patients. It currently has a portfolio of 21 new anti-cancer agents in preclinical development, Phase I or early Phase II clinical trials. Six of these new agents have made it to market including temozolomide for brain cancer, abiraterone for prostate cancer and rucaparib for ovarian cancer. Two other drugs are in late development Phase III trials. www.cruk.org.uk/cdd

Media Contact:
Nick Chang
MacDougall
781-235-3060
nchang@macbiocom.com