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Sep 02
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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
Love0

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
Love0

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
Love0

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

Jun 17
Love0

Aura Biosciences Assembles New Bladder Cancer Focused Scientific Advisory Board

By Aura Biosciences, Press Release, Publicly Listed
Press Release.

 

Prominent, Multi-Disciplinary Clinicians and Scientists Bring Extensive Strategic Expertise in Urologic Oncology Across All Stages of Research and Development

CAMBRIDGE, Mass.–(BUSINESS WIRE)– Aura Biosciences, a clinical-stage oncology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, today announced the formation of a new, urologic oncology focused Scientific Advisory Board (SAB). The new SAB will work closely with Aura’s senior management team to advance the Company’s novel VDC technology for the treatment of non-muscle invasive bladder cancer (NMIBC).

The new SAB will be comprised of seven members: John T. Schiller, PhD, Deputy Chief and Head of the Neoplastic Disease Section, Laboratory of Cellular Oncology at the National Cancer Institute (NCI), National Institutes of Health (NIH); Piyush K. Agarwal, MD, Director, Bladder Cancer Program, University of Chicago; Trinity J. Bivalacqua, MD, PhD, Director, Urologic Oncology, Johns Hopkins Medicine; Isaac Kim, MD, PhD, MBA, Chief, Urologic Oncology, Rutgers Cancer Institute of New Jersey; Seth P. Lerner, MD, Beth and Dave Swaim Chair in Urologic Oncology, Baylor College of Medicine; and Andrea B. Apolo, MD, Head, Bladder Cancer Section, Genitourinary Malignancies Branch, NCI, NIH. This newly formed SAB builds upon Aura’s existing ocular oncology focused SAB that has helped advance the Company’s lead development candidate belzupacap sarotalocan (AU-011) into a Phase 3 ready asset for the treatment of choroidal melanoma.

“The creation of this Scientific Advisory Board is an important step for our continued growth as a leading innovative oncology company,”

said Cadmus Rich, MD, MBA Chief Medical Officer and Head of R&D of Aura Biosciences.

“We are both excited and fortunate to have brought together such an esteemed group of prominent oncology advisors as we advance our VDC platform for the treatment of bladder cancer. These newly assembled members of the SAB bring complementary areas of urologic oncology, drug development and strategic expertise and will be invaluable as we reach the next phase of growth at Aura.”

“On behalf of all of the members of the new SAB, we look forward to working together with the Aura senior leadership team to draw on our complementary expertise and insights to support a shared vision for Aura and drive innovation for patients with bladder cancer,”

said Dr. Agarwal.

The following is more detail about the Aura SAB members:

John T. Schiller, PhD – Dr. Schiller is Deputy Chief and Head of the Neoplastic Disease Section, Laboratory of Cellular Oncology at the National Cancer Institute, NIH, and an NIH Distinguished Investigator. He has received numerous awards for his contributions to papillomavirus virus molecular biology and HPV vaccine development, including the Lasker DeBakey Award in 2017, the American Society for Microbiology’s Joseph Public Health Award in 2014, and National Medal of Technology and Innovation in 2014. Dr. Schiller graduated from the University of Wisconsin-Madison with a B.S. in molecular biology and received a Ph.D. from the Department of Microbiology of the University of Washington in Seattle.

Piyush K. Agarwal, MD – Dr. Agarwal is a highly respected urologic surgeon who specializes in the multidisciplinary management of bladder cancer as Director of both the Bladder Cancer Program and the Urologic Oncology Fellowship. He is also an expert in all urologic cancers and was the previous Head of the Bladder Cancer Section in the Center for Cancer Research of the National Cancer Institute. He has conducted several investigator-initiated clinical trials and has served on the U.S. Food and Drug Administration’s oncologic drug advisory committee.Dr. Agarwal earned his MD degree from Weill Cornell College of Medicine in New York, completed his residency in Urology at University Hospital Cleveland Medical Center in Cleveland and his Urologic Oncology fellowship at MD Anderson Medical Center in Houston.

Andrea Apolo, MD – Dr. Apolo is an internationally recognized expert in bladder cancer research who is a Lasker Clinical Research Scholar in the Genitourinary Malignancies Branch of the Cancer Research Center at the NCI, NIH. She is Head of the Bladder Cancer Section and the Director of the Bladder Cancer and Genitourinary Tumors Multidisciplinary Clinic. She holds an MD degree from Albert Einstein College of Medicine, completed her internal medicine residency at New York-Presbyterian Hospital/Weill Cornell Medical Center and a medical oncology fellowship at Memorial Sloan Kettering, all in New York.

Trinity J. Bivalacqua, MD, PhD – Dr. Bivalacqua is the R. Christian B. Evensen Professor of Urology and Oncology and Director of Urologic Oncology at the James Buchanan Brady Urologic Institute. As a member of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Dr. Bivalacqua participates in multidisciplinary approaches to the treatment of a variety of genitourinary cancers. He has a special interest in cancers of the prostate and bladder. His research laboratory focuses on the tumor immune microenvironment and mechanisms of BCG-resistance namely T-cell signaling and macrophage polarization. He holds graduate and medical degrees from Tulane University, completed his general surgery and urology training at Johns Hopkins Hospital in Baltimore and completed an American Urological Association (AUA) Foundation post-doctoral fellowship from the AUA Care Foundation in Linthicum.

Isaac Kim, MD, PhD, MBA – Dr. Kim is a board certified urologist who serves as the Chief and Associate Professor of the Division of Urology at Rutgers Robert Wood Johnson Medical School and Chief of the Section of Urologic Oncology and director of the Prostate Cancer Center at the Rutgers Cancer Institute of New Jersey. He runs a thriving clinical practice and has established a robust research program focused on the biology of castration-resistant prostate cancer. He holds a PhD and MD from Northwestern University, completed a urology residency at Baylor College of Medicine in Houston, a research fellowship in Urologic Oncology at the National Cancer Institute in Bethesda and clinical fellowship in endourology, laparoscopy and robotics at the University of California in Irvine.

Seth P. Lerner, MD – Dr. Lerner is Professor of Urology and holds the Beth and Dave Swalm Chair in Urologic Oncology, in the Scott Department of Urology, Baylor College of Medicine. He is Director of Urologic Oncology and the Multidisciplinary Bladder Cancer Program and Vice-chair for Faculty Affairs for Urology. His clinical practice, education, and research activities are devoted to urologic oncology and particularly lower and upper tract urothelial cancer. He holds an MD from Baylor College of Medicine in Houston and completed a two-year fellowship at the University of Southern California in urologic oncology and reconstructive surgery in Los Angeles.

About Aura Biosciences

Aura Biosciences, Inc. is a clinical-stage oncology company developing a novel technology platform based on virus-like drug conjugates (VDCs) to target and destroy cancer cells selectively while activating the immune system to create long lasting anti-tumor immunity. The VDC technology platform is based on the discoveries of NIH Distinguished Investigator Dr. John Schiller of the Center for Cancer Research at the National Cancer Institute (NCI). The company has the goal of developing this technology in multiple cancer indications with an initial focus in ocular oncology, a group of rare diseases for which there are no approved drugs. Aura’s lead product candidate belzupacap sarotalocan (AU-011) is currently in Phase 2 development for the first line treatment of choroidal melanoma, a vision and life-threatening form of eye cancer where standard of care radioactive treatments leave patients with major vision loss and severe comorbidities. Aura has demonstrated the efficacy and safety of AU-011 in a Phase 1b/2 trial, including high rates of tumor control and vision preservation. Future pipeline applications for Aura’s technology include additional ocular oncology indications like choroidal metastases and solid tumor indications like non-muscle invasive bladder cancer. Aura is headquartered in Cambridge, MA. For more information, visit www.aurabiosciences.com or follow us on Twitter.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210617005134/en/

Contacts
Investor and Media Contact:
Joseph Rayne
Argot Partners
617.340.6075 | joseph@argotpartners.com

Jun 08
Love0

Aura Biosciences Appoints Sapna Srivastava, Ph.D., to its Board of Directors

By Aura Biosciences, Press Release, Publicly Listed
Press Release.

 

June 08, 2021 07:00 AM Eastern Daylight Time

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Aura Biosciences, a clinical-stage oncology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, today announced the appointment of Sapna Srivastava, Ph.D., to its Board of Directors.

“Sapna is a recognized leader in the biopharmaceutical industry with over two decades of broad experience in corporate and financial strategy,”

said David Johnson, Chairman of the Board of Aura Biosciences.

“We welcome Sapna to the Board and look forward to her contributions as we look to further build our position as a leader in ocular oncology and expand the research of our VDC technology into additional cancers in need of better treatments to improve patient outcomes.”

“I believe that Aura’s novel approach to treat ocular cancers while preserving vision can transform the treatment paradigm for patients with these life-threatening diseases,”

said Dr. Srivastava.

“It is a privilege to be joining Aura’s Board of Directors as the Company advances into a pivotal program for the early treatment of choroidal melanoma and prepares for this next phase of growth.”

Dr. Srivastava is currently the Chief Financial and Strategy Officer at eGenesis. Prior to eGenesis, she held similar roles as the Chief Financial and Strategy Officer at Abide Therapeutics (acquired by Lundbeck) and at Intellia Therapeutics. In these positions, she has played a key role in equity financings including a successful initial public offering, strategic alliances, mergers and acquisitions, and shaping the strategic direction of the company. Before Intellia, Dr. Srivastava spent more than a decade on Wall Street as a senior biotechnology analyst for Goldman Sachs, Morgan Stanley and ThinkEquity Partners. She began her career as a research associate at J.P. Morgan. Dr. Srivastava received her Ph.D. in neuroscience from the New York University School of Medicine and her B.S. in biology from St. Xavier’s College at the University of Mumbai.

About Aura Biosciences

Aura Biosciences, Inc. is a clinical-stage oncology company developing a novel technology platform based on virus-like drug conjugates (VDCs) to target and destroy cancer cells selectively while activating the immune system to create long lasting anti-tumor immunity. The VDC technology platform is based on the discoveries of NIH Distinguished Investigator Dr. John Schiller of the Center for Cancer Research at the National Cancer Institute (NCI). The company has the goal of developing this technology in multiple cancer indications with an initial focus in ocular oncology, a group of rare diseases for which there are no approved drugs. Aura’s lead product candidate belzupacap sarotalocan (AU-011) is currently in Phase 2 development for the first line treatment of choroidal melanoma, a vision and life-threatening form of eye cancer where standard of care radioactive treatments leave patients with major vision loss and severe comorbidities. Aura has demonstrated the efficacy and safety of AU-011 in a Phase 1b/2 trial, including high rates of tumor control and vision preservation. Future pipeline applications for Aura’s technology include additional ocular oncology indications like choroidal metastases and solid tumor indications like non-muscle invasive bladder cancer. Aura is headquartered in Cambridge, MA. For more information, visit www.aurabiosciences.com or follow us on Twitter.

Contacts

Investor and Media Contact:
Joseph Rayne
Argot Partners
617.340.6075 | joseph@argotpartners.co

Apr 14
Love0

Aura Biosciences Announces Publication of Data in Cancer Immunology Research Supporting the Immune Mediated Mechanism of Action of the Virus-Like Drug Conjugate (VDC) Technology Platform with Broad Application in Cancer Treatment

By Aura Biosciences, Press Release, Publicly Listed
Press Release.

 

  • Results Support VDCs induction of Pro Immunogenic Cell Death and the Generation of Long Lasting Adaptive Anti-Tumor Immunity –
  • Combination of VDCs with Checkpoint Inhibitors Achieves a High Complete Response Rate and Prevents Long Term Tumor Recurrence

CAMBRIDGE, MA – April 14, 2021 – Aura Biosciences, a clinical-stage oncology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, today announced the online publication of data in the peer-reviewed medical journal Cancer Immunology Research, a journal of the American Association for Cancer Research, that supports the broad application of the Company’s proprietary VDC technology platform for treating cancer. The manuscript, titled, “Virus-like Particle-drug Conjugates Induce Protective, Long-lasting Adaptive Anti-Tumor Immunity in the Absence of Specifically Targeted Tumor Antigens,” describes promising long term anti-tumor activity of AU-011, the Company’s lead VDC candidate, as a monotherapy and in combination with checkpoint inhibitor antibodies in preclinical studies conducted in collaboration with the Center for Cancer Research at the National Cancer Institute of the National Institutes of Health.

“Collectively, these promising results confirm treatment of AU-011 resulted in targeted tumor cytotoxicity with hallmarks of immunogenic cell death that may promote a durable anti-tumor immune response,”

said Cadmus C. Rich, MD, MBA, Chief Medical Officer and Head of R&D for Aura.

“Additionally, the additive activity of AU-011 in combination with checkpoint inhibitors has shown a high level of durable complete responses and prevention of tumor recurrence, warranting continued research into its potential clinical utility to effectively treat multiple types of tumors like non-muscle invasive bladder cancer as a primary treatment and further prevent metastatic disease.”

Key findings from the manuscript include:

  • In vitro and in vivo studies in immunocompetent murine tumor models demonstrated a dose-dependent cytotoxic response of AU-011 with an upregulation of the markers of immunogenic cell death like caspase-1 and calreticulin surface expression demonstrating that AU-011 mediated cell death was able to generate potent immune stimulatory conditions within the tumor microenvironment.
  • A single in vivo dose administration of AU-011 caused rapid cell death leading to long term complete responses in 50% of all animals.  Combination with immune checkpoint inhibitor antibodies improved therapeutic efficacy resulting in 70-100% complete response rate that was durable 100 days post-treatment with 50-80% of those animals displaying protection from secondary tumor re-challenge.
  • Depletion studies of CD4+ or CD8+ T-cells at the time of AU-011 treatment or tumor re-challenge confirmed the involvement of both cell populations in the mechanism of action of AU-011 and the promotion of long-lasting anti-tumor protection.

“These promising findings further reinforce the therapeutic advantages of VDCs in treating cancer compared to other available treatments, which include the broad tumor selectivity and multivalent binding of the virus-like particles compared to antibodies, the ability to deliver hundreds of cytotoxic molecules and the generation of long-lasting anti-tumor immunity,”

said Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura.

“While our initial clinical focus has been in ocular oncology, our VDC approach has wide application as a single agent and as a combination therapy in a variety of solid tumors, including non-muscle invasive bladder cancer, which is expected to enter the clinic in 2022 We remain focused on advancing our novel VDC approach to transform the treatment of tumors and improve outcomes for patients with cancer.”

About AU-011 (belzupacap sarotalocan)
AU-011 is a first-in-class virus-like drug conjugate (VDC) therapy in development for the first line treatment of choroidal melanoma. The virus-like component of the VDC selectively binds unique heparan sulphate proteoglycans (HSPGs) that are modified and overexpressed on the tumor cell surface of choroidal melanoma (and other tumor types) and delivers a potent cytotoxic drug that is activated with infrared light. Upon activation with an ophthalmic laser, the cytotoxic drug rapidly and specifically disrupts the cell membrane of malignant melanoma cells with a pro-immunogenic cell death that can activate the immune system generating long term anti-tumor immunity. The unique specificity of tumor binding by the VDC enables the preservation of key eye structures, which may allow for the potential of preserving patients’ vision and reducing other long-term complications of radiation treatment. The possibility of early treatment intervention and the activation of the immune system could lead to a reduction in the metastases rate for patients with this life-threatening disease. AU-011 can be delivered using equipment commonly found in an ophthalmologist’s office and does not require a surgical procedure, pointing to a potentially less invasive, more convenient therapy for patients and physicians. AU-011 for the treatment of choroidal melanoma has been granted Orphan Drug and Fast Track designations by the U.S. Food and Drug Administration and is currently in Phase 2 clinical development.

About Aura Biosciences

Aura Biosciences, Inc. is a clinical-stage oncology company developing a novel technology platform based on virus-like drug conjugates (VDCs) to target and destroy cancer cells selectively while activating the immune system to create long lasting anti-tumor immunity. The VDC technology platform is based on the discoveries of NIH Distinguished Investigator Dr. John Schiller of the Center for Cancer Research at the National Cancer Institute (NCI). The company has the goal of developing this technology in multiple cancer indications with an initial focus in ocular oncology, a group of rare diseases for which there are no approved drugs. Aura’s lead product candidate belzupacap sarotalocan (AU-011) is currently in Phase 2 development for the first line treatment of choroidal melanoma, a vision and life-threatening form of eye cancer where standard of care radioactive treatments leave patients with major vision loss and severe comorbidities. Aura has demonstrated the efficacy and safety of AU-011 in a Phase 1b/2 trial, including high rates of tumor control and vision preservation. Future pipeline applications for Aura’s technology include additional ocular oncology indications like choroidal metastases and solid tumor indications like non-muscle invasive bladder cancer.  Aura is headquartered in Cambridge, MA. For more information, visit www.aurabiosciences.com or follow us on Twitter.

Investor and Media Contact:
Joseph Rayne
Argot Partners
617.340.6075 | joseph@argotpartners.com 

Apr 14
Love0

Highlight Therapeutics to present data from Phase 2 immunotherapy studies of liver metastases and melanoma data at AACR Virtual Annual Meeting 202

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

 

Madrid, Spain, 14 April, 2021 – Highlight Therapeutics, (“Highlight”), a clinical-stage biopharmaceutical company developing RNA-based therapies against cancer, today announced that data from Phase 2 studies of its RNA-based immunotherapy BO-112 will be presented as posters at the American Association for Cancer Research (AACR) Virtual Annual Meeting 2021, April 10-15 and May 17-21.

The e-poster presentations, which are available for browsing on from April 10, 2021, through June 21, 2021, are entitled:

  • Phase IIa open-label clinical study of intratumoral administration of BO-112 in combination with pembrolizumab in subjects with liver metastasis from colorectal cancer or gastric/gastro-oesophageal junction cancer (Abstract number 5289)
  • Phase 2 clinical study to evaluate the efficacy and safety of intratumoral BO-112 in combination with pembrolizumab in patients with advanced melanoma that have progressive disease on anti-PD-1-based therapy (Abstract number 4936)
  • BO-112 as a modifier of the tumor microenvironment for liver metastases (Abstract number 994)
  • A phase I study of intratumoral BO-112 and nivolumab for resectable soft tissue sarcoma (Abstract number 5273)

Marisol Quintero, CEO of Highlight Therapeutics, commented:

“Data to be presented at AACR include promising results from one of our Phase 2 studies testing the combination of BO-112 + pembrolizumab in colorectal cancer microsatellite stable patients with liver metastases. The data demonstrates that BO-112 can be injected directly into liver metastases, triggering a potent change in the tumor micro-environment, characterized by increased numbers of CD8-T cells and increased expression of PDL-1.”

Highlight Therapeutics aims to use this approach to modify the suppressive environment of liver tumors that limits the activity of immunotherapy. (Abstracts 5289 and 994).

Highlight Therapeutics is also presenting data from its Phase 2 trial for patients that have progressed to anti-PD-1-based therapy in refractory advanced malignant melanoma.

Marisol Quintero added:

“Results from Phase 1 studies showed a clear signal in the melanoma resistant population, prompting us to develop this trial with a higher dose of BO-112 and a more frequent injection scheme designed to maximize the possibility of seeing responses in this setting. Our aim is to demonstrate how BO-112 can extend the benefit of immunotherapy in patients that have progressed to anti-PD1-based therapies. This concept could be later on applied to other indications.” (Abstract 4936).

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

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-inclass
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

Apr 12
Love0

Francesco Maria Lavino appointed Chief Executive Officer of F2G Ltd

By F2G, Press Release, Private Companies
Press Release.

 

  • Brings substantial pharmaceutical expertise to lead the development and commercialization of olorofim in the USA
  • Ian Nicholson stepping down to pursue non-executive roles

MANCHESTER, UK / VIENNA, AUSTRIA, April 12, 2021 — F2G Limited (“F2G”), a clinical-stage biopharmaceutical company focused on life threatening fungal diseases, announces that Francesco Maria Lavino has been appointed Chief Executive Officer (CEO) and member of the Board of F2G. Mr. Lavino brings substantial specialty pharmaceutical leadership and expertise in the antifungal arena, including most notably, serving as AVP, Global Brand Leader, Anti-infectives portfolio at Merck & Co. and as Chief Commercial Officer of Nabriva Therapeutics, Inc. (NASDAQ: NBRV). Ian Nicholson is stepping down as CEO following eight years of dedicated service to F2G to pursue non-executive roles and will provide support to ensure an effective transition.

Mr. Lavino is based in Princeton, New Jersey, USA, and will lead the development and commercialization of olorofim for the treatment of patients who have limited treatment options for difficult-to-treat invasive fungal mold infections such as azole-resistant aspergillosis, coccidioidomycosis, scedosporiosis, lomentosporiosis, and other rare mold infections.

“We are delighted to welcome Francesco Lavino to F2G. He is a highly experienced leader with a proven track record of working to create significant value for shareholders. We believe we have a strong team in place to lead F2G into its next phase of growth. The team will focus on the US and worldwide opportunities to help patients with serious fungal infections in need of additional treatment options,”

said Patrick Vink, Chairman of F2G Ltd.

“I would like to thank Ian Nicholson for his dedicated leadership in transforming F2G from a preclinical company into the strong Company it is today with two FDA Breakthrough Therapy designations for its lead compound olorofim, and an NDA filing expected in 2022. Ian has successfully raised significant capital, most recently a $60 million round in 2020, which has enabled the generation of excellent data supporting the strong efficacy and safety profile of olorofim in rare fungal infections. I am pleased he will continue to support the transition to ensure the further success of F2G.”

Francesco Maria Lavino, CEO of F2G Ltd, commented:

“This is a transformational time to join F2G and I am very excited to lead the Company through its next phase of growth and to maximize the full potential of olorofim, a first-in-class, oral agent for the treatment of severe fungal infections including invasive pulmonary aspergillosis and Valley Fever. The fact that olorofim is the only anti-fungal agent ever to have been granted FDA Breakthrough Therapy designation underscores its potential to positively impact the treatment of patients with these life-threatening diseases.”

Francesco has over twenty years of pharma and biotech experience in strategic and operational roles in US, Europe and Emerging Markets. He served as Chief Commercial Officer at Nabriva Therapeutics from July 2017 where he led the US commercial organization buildout and the launch of Xenleta, a first-in-class new antibiotic treatment. Prior to Nabriva, he spent almost 15 years at Merck and Cubist Pharmaceuticals in different commercial roles and therapeutic areas at global, regional and country level. He held the position of Global Brand Leader for the Anti-Infective Portfolio (2015-2017) and was the commercial lead of the Merck Antifungal Portfolio in EMEAC (2009-2010) and Globally (2011-2013). Francesco began his career in pharmaceutical sales in Italy and holds a BS in Pharmacy from Federico II University of Naples, Italy and a MBA from SDA Bocconi School of Management in Milan, Italy.

Contact:

F2G Ltd
Francesco Maria Lavino | Chief Executive Officer
Ralf Schmid | Chief Financial Officer
Tel: +44 (0)161 785 1271 (UK) / +43 (0)1 997 4267 (A)

Optimum Strategic Communications
Mary Clark / Supriya Mathur / Charlotte Hepburne-Scott
Email: F2G@optimumcomms.com
Tel: +44 (0) 203 950 9144

Notes to Editors:

About Olorofim / Clinical trial
The Phase 2b study for olorofim (ClinicalTrials.gov Identifier: NCT03583164) is a global open-label study in patients who have limited treatment options for difficult-to-treat invasive fungal mold infections such as azole-resistant aspergillosis, scedosporiosis, lomentosporiosis, and other rare mold infections.

About F2G
F2G is a world-leading UK- and Austria-based biotech company (F2G Ltd and F2G Biotech GmbH) focused on the discovery and development of novel therapies to treat life-threatening invasive fungal infections. F2G has discovered and developed a completely new class of antifungal agents called the orotomides. The orotomides selectively target fungal dihydroorotate dehydrogenase (DHODH), a key enzyme in the de novo pyrimidine biosynthesis pathway. This is a completely different mechanism from that of the currently marketed antifungal agents and gives the orotomides fungicidal activity against a broad range of rare and resistant fungal mold infections. Olorofim (formerly, F901318) is F2G’s leading candidate from this class and is in a Phase 2b open-label study focusing on rare and resistant invasive fungal infections such as aspergillosis (including azole-resistant strains), scedosporiosis (including lomentosporiosis). Olorofim has received orphan drug status from the European Medicines Agency for the treatment of invasive aspergillosis and invasive scedosporiosis. Olorofim has received orphan drug status from the US FDA for the treatment of coccidioidomycosis, lomentosporiosis/scedosporiosis, and invasive aspergillosis. Olorofim has been granted Qualified Infectious Disease Product (QIDP) designation Invasive for aspergillosis, invasive scedosporiosis, invasive lomentosporiosis, coccidioidomycosis, invasive disease due to Scopulariopsis species, and invasive fusariosis. www.f2g.com