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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

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

Mar 17
Love0

Amphista Therapeutics raises $53M in oversubscribed Series B round to advance next generation targeted protein degradation assets

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

 

Financing includes leading life-science investors Gilde Healthcare, Forbion, Novartis Venture Fund and Eli Lilly and Company

 

Glasgow, UK, 17 March 2021 – Amphista Therapeutics, a leader in next generation targeted protein degradation (TPD) approaches, today announced the closing of a $53 million (£38 million) Series B financing round. The round was co-led by Forbion and Gilde Healthcare. Additional investors in this round include Novartis Venture Fund, and Eli Lilly and Company, joining existing investor BioMotiv and founding investor Advent Life Sciences. The proceeds will be used to accelerate the company’s growing pipeline of potent and selective bifunctional molecules, known as ‘Amphistas’ to the clinic and to extend its proprietary TPD platform.

Amphista’s CEO Nicola Thompson said,

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

Rogier Rooswinkel, Partner at co-lead investor, Forbion said,

“We are delighted to have selected Amphista as the first company to invest in from our fifth fund that closed late last year. Amphista combines several attributes we typically look for: a world-class team, innovative science, and a disruptive technology that has the potential to improve treatment options and thus impact many patients’ lives.”

Stefan Luzi, Partner at co-lead investor Gilde, said,

“Amphista emerged as the best-in-class protein degradation company in our comprehensive landscaping effort. We believe this team, who are pioneers in this field, combined with a truly unique platform, will unlock the full therapeutic potential of a broad range of disease targets. Amphista represents a strong fit with Gilde’s longstanding strategy of identifying Europe’s leading science and of engaging with experienced drug developers to build and support high growth (bio)pharma companies.”

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

In association with this financing, Amphista has added the following leading life science executives to the Board: Stefan Luzi, Partner at Gilde Healthcare; Rogier Rooswinkel, Partner at Forbion; and Florian Muellershausen, Managing Director at Novartis Venture Fund.

–    Ends   –

 

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 and Company.

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

About Advent Life Sciences

Advent Life Sciences founds and invests in early- and mid-stage life sciences companies that have a first- or best-in-class approach to unmet medical needs. The investing team consists of experienced professionals, each with extensive scientific, medical and operational experience, a long-standing record of entrepreneurial and investment success in the 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, please visit www.AdventLS.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 wellbeing 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 Gilde Healthcare

Gilde Healthcare is a specialized healthcare investor with $1.8 billion under management across two fund strategies: Venture & Growth and Private Equity. The firm operates out of offices in Utrecht (The Netherlands), Frankfurt (Germany) and Cambridge (United States).

Gilde Healthcare Venture & Growth invests in innovative companies active in (Bio)Pharmaceuticals, HealthTech and MedTech. The portfolio of the Venture & Growth fund is balanced with fast growing life science companies from Europe and North America.

For more information, please visit www.gildehealthcare.com.

About Novartis Venture Fund

Novartis Venture Fund is a financially driven corporate life science venture fund whose purpose is to foster innovation, drive significant patient benefit and generate superior returns by creating and investing in innovative life science companies at various stages of their development.

For more information, please visit www.nvfund.com.

About Eli Lilly and Company

Lilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world. They were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today they remain true to that mission in all their work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism.

For more information, please visit www.lilly.com and www.lilly.com/newsroom.

About BioMotiv

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

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

Mar 02
Love0

Highlight Therapeutics and Pivotal work together on Melanoma therapy and launch a Phase IIa trial to examine BO-112 efficacy and safety

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

 

  • Trial will examine administration of Highlight’s BO-112 in combination with an anti-PD1 in unresectable or metastatic melanoma patients
  • Recruitment has already begun across 19 top-level centers in Spain and France
  • No delays to recruitment despite the persistent challenges encountered during the COVID-19 pandemic

Madrid, Spain, 2 March, 2021 – Highlight Therapeutics, (“Highlight”), a clinical-stage biopharmaceutical company developing RNA-based therapies against cancer, and Pivotal, a Europe-wide full-service CRO, today announced that the first patients have been recruited in a Phase IIa study to assess Highlight’s lead program BO-112 in combination with an anti-PD1 therapy, in patients with unresectable or metastatic melanoma that have previously progressed to checkpoint inhibitors

Melanoma is the most malignant tumor of the skin although it can be seldom found in other organs. Incidences of this tumor are rapidly increasing in western countries and, once disseminated, it has been considered an incurable disease with limited therapeutic options. Recently, immunotherapy with anti-PD1 (checkpoint inhibitors) showed encouraging results with 30-36% patients alive at 5 years. Unfortunately, the median PFS (progression free survival) is less than 12 months, mainly due to primary or acquired resistance to anti-PD1 treatment, and most of those patients will die due to the tumor or its complications.

“This Phase IIa study is an important step forward in our strategy to develop effective cancer therapies which can be used in combination with checkpoint inhibitors. We are looking to produce a better immunological response in anti-PD1 therapy-sensitive patients, and to induce or maintain responses for those patients that progress or are initially treatment-resistant. BO-112 has the potential to be employed from the beginning of disease treatment and we believe it offers patients a resistant status after immunological treatment,”

said Dr. Marisol Quintero, PhD, CEO of Highlight Therapeutics.

“We are encouraged by the effectiveness already seen in previously treated melanoma patients in the phase I study with BO-112 and we are pleased to be working once more with the highly experienced and dedicated team at Pivotal.”

This Phase IIa, open-label clinical study is a non-comparative trial implemented in 19 sites across Spain and France. The protocol will include a minimum of 40 non-resectable melanoma patients. This is the third trial with BO-112, following initiation of the phase I trial in 2016. In 2020, a second trial was initiated in gastrointestinal tumors from which the first cohorts have already been successfully completed, and the recruitment of this phase IIa trial has now been initiated in melanoma despite the obstacles presented due to the COVID-19 pandemic.

The study will evaluate the anti-tumoral activity and systemic exposure of repeated intratumoral injections of BO-112 into a tumoral lesion, in combination with intravenously administered anti-PD1. BO-112 has intrinsic anti-tumoral effects, but interestingly acts on several mechanisms involved in resistance to Checkpoint inhibitors.

“The excellence in clinical research of the clinical investigators´ teams, together with Pivotal’s infrastructure and vast experience in the implementation and performance of innovative early phases clinical trials, will allow us to accelerate the research and to quickly test this new treatment regimen,”

said Dr. Lourdes Huarte, PhD, Senior Vice President of Regulatory and Clinical Operations at Pivotal.

“The challenge of this trial was to swiftly implement the study and activate its recruitment in a period negatively impacted by the COVID-19 pandemic. We are delighted to have diligently achieved our first milestone with the recruitment of the first patients in this trial.”

About Highlight Therapeutic

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; or

Contacts Dr. Marisol Quintero CEO at Highlight Therapeutics     info@highlighttherapeutics.com
Mo PR Advisory    Tel: +44 (0) 7876 444977 / 07860 361746
Mo Noonan/Jonathan Birt

About Pivotal

Pivotal was founded in 2001 by Dr. Ibrahim Farr on the principle that strategic medical advice and support should be the backbone of all clinical trials. After working for over two decades in the pharmaceutical industry, Dr. Farr recognized the need for a medium-sized CRO with a solid internal medical franchise that could act not only as the “doers” but also as the “co-thinkers” for their clients, through its strategic scientific advice. To date, we are the trusted adviser and counsellor for many companies to deliver maximum value in their drug and medical devices development programs. We are a leading privately held European CRO and, since inception, we have experienced a fast and steady organic growth in Europe.
Pivotal´s client portfolio spans major pharmaceutical, biotechnological, medical device and nutrition companies, as well as independent investigators and cooperative groups. We have long-standing relations with over 200 clients. Pivotal has extensive experience across major therapeutic areas and phases I to IV. Our highly customized teams bring to each client a combination of broad industry knowledge and operational excellence, to offer our clients fresh perspectives and breakthrough business insights. Additionally, we have built a strong oncology, innovative therapies, infectious diseases, vaccines, rare diseases and early phases hub that enables us to tackle our customers most difficult challenges, turning recommendations into concrete actions. By remaining true to our core principles and values, our vision is to become our client’s preferred outsourcing solution partner.
For more information, please visit www.pivotalcr.com; or
Contact Ms Natalia Farr at Pivotal natalia.farr@pivotalcr.com

Oct 22
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F2G Receives Second US FDA Breakthrough Therapy Designation for Olorofim

By F2G, Press Release, Private Companies
Press Release.

 

In Phase 2b development for the treatment of life-threatening fungal infections

First antifungal agent to receive Breakthrough Therapy Designation

New second Breakthrough Therapy Designation for CNS Valley Fever (coccidioidomycosis)

MANCHESTER, UK / VIENNA, Austria – October 22, 2020 – F2G Ltd, a UK- and Austria-based biotech company developing novel therapies for life-threatening systemic fungal infections, announced today that the US Food and Drug Administration (FDA) has granted an additional Breakthrough Therapy Designation to its lead first-in-class candidate, olorofim, for the indication of ‘Treatment of Central Nervous System (CNS) coccidioidomycosis refractory or otherwise unable to be treated with standard of care therapy’. This is the second Breakthrough Therapy Designation for olorofim; a designation was granted previously on 11 November 2019 for ‘Treatment of invasive mold infections in patients with limited or no treatment options, including aspergillosis refractory or intolerant to currently available therapy, and infections due to Lomentospora prolificans, Scedosporium, and Scopulariopsis species’. Olorofim (formerly F901318) is the first antifungal agent to be granted Breakthrough Therapy Designation.

Olorofim has orphan drug designation in the United States for coccidioidomycosis, an endemic fungal infection with a geographic distribution focused mainly in the desert Southwest of the United States but also including Mexico, Central America, and South America. Infection begins by inhalation and can spread to any part of the body, even in otherwise healthy individuals. Spread to the brain is particularly feared as it produces a devastating illness that cannot always be controlled with any currently available agent.

Patients with coccidioidomycosis are being studied in an ongoing open-label single-arm Phase 2b study (ClinicalTrials.gov Identifier: NCT03583164) in patients with proven invasive fungal disease (IFD) or probable invasive aspergillosis (IA) and either refractory disease, resistance, or intolerance to available agents. Olorofim has been well tolerated across more than 30 years of cumulative patient dosing days with a median therapy duration of 12 weeks. Preliminary data from this study were provided to the FDA as part of the Breakthrough Therapy Designation submission.

Breakthrough Therapy Designation is an FDA process designed to expedite the development and review of drugs that are intended to treat a serious or life-threatening condition and is granted based on preliminary clinical evidence indicating that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.

Breakthrough Therapy Designation conveys all the features of fast track designation, more intensive FDA guidance on an efficient drug development program, an organisational commitment by FDA to involve senior managers, and eligibility for rolling review and priority review.

Commenting on the news, Ian Nicholson, CEO of F2G Ltd, said:

“The granting of a second FDA Breakthrough Therapy Designation will further support our goal of rapidly developing this novel treatment for patients suffering from serious and life-threatening fungal infections. Olorofim acts via a novel and differentiated mechanism to traditional antifungals, and preliminary data have indicated that it is efficacious in tackling life-threatening invasive fungal infections that cannot be managed with currently approved agents.

“Our Phase 2b programme is on track with over 85 patients recruited in Europe, Asia, and the US. We look forward to working closely with the US FDA to accelerate development of this therapy for patients having limited or no approved treatment options for an invasive mold infection.”

Professor George Thompson, UC Davis and Investigator for the Phase 2b study said:

“This news is very exciting for clinicians caring for patients with Valley Fever (coccidioidomycosis) as spread to the brain is the most-feared complication of infection with this fungus. Unfortunately, available drugs are not curative, must be administered as life-long therapy, and are associated with substantial toxicity. The news that olorofim has encouraging preliminary clinical data that support Breakthrough Therapy Designation brings realistic hope that we can change the paradigm for managing this devastating infection.”

Contact:

F2G Ltd
Ian Nicholson | 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. More than 40 centres are currently open in nine countries (AU, BE, DE, ES, IS, NL, TH, UK, USA) and a further 10 will open in 2020/2021. Olorofim is being developed both as IV and oral formulations.

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 focussing 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. Olorofim is being developed both as IV and oral formulations. www.f2g.com

Oct 13
Love0

Rappta Therapeutics Raises Series A Financing for the Development of Phosphatase 2A drugs

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

 

  • Unique phosphatase technology platform offers a new paradigm in oncology
  • EUR 9M financing, co-led by NVF and Novo Holdings with participation from Advent Life Sciences and a family office
  • To advance lead compounds to clinical candidate stage

Helsinki, Finland, 13 October, 2020:  Rappta Therapeutics (“Rappta”), focused on developing first-in-class anti-cancer drugs activating protein phosphatase 2A (PP2A), announces today the closing of a EUR 9 million Series A financing co-led by Novartis Venture Fund (“NVF”) and Novo Holdings with participation from Advent Life Sciences and a family office. The company also announces it has successfully received funding from Business Finland, the Finnish innovation funding organization.

PP2A is a critical enzyme regulating protein de-phosphorylation and a key tumor suppressor which to date has been very difficult to target pharmaceutically. Rappta has developed proprietary tools and a unique understanding of PP2A which allows it to therapeutically reactivate PP2A. As a result of PP2A’s central role in the regulation of protein de-phosphorylation, Rappta’s PP2A-reactivating technologies offer the potential to develop multiple lead compounds and build a platform for a new class of anti-cancer drugs.

Rappta has assembled a strong scientific, management, and commercial team based in Finland and the US. Rappta’s 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 scientific team has published seminal papers on the structural, functional, and biological mechanisms of PP2A inactivation in human cancer. The team will be supported by the Scientific Advisory Board led by Dr. William Hahn, a Professor of Medicine at the Harvard Medical School and the Chief Scientific Officer of the Dana-Farber Cancer Institute.

Goutham Narla, Rappta’s CSO, board member and co-founder, commented:

“I am thrilled to be working 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 the perfect combination of expertise to translate these discoveries to the clinic.”

Mikko Mannerkoski, Rappta’s CEO, board member and co-founder, commented:

“We are very pleased to attract such a strong syndicate of international investors which validates our approach to developing novel therapies to target the previously undruggable target protein PP2A. This funding will enable us to accelerate the development of our platform and advance the lead compounds towards clinical development.”

Beat Steffen from NVF, Jeroen Bakker from Novo Seeds, and Raj Parekh from Advent Life Sciences, will join Mikko Mannerkoski and Goutham Narla on the Board of Directors with Beat Steffen serving as the chairperson.

For more information please contact:

Rappta Therapeutics
Mikko Mannerkoski, CEO
+358 (0) 40 55 55 268
mikko.mannerkoski@rappta-therapeutics.com

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

About Rappta Therapeutics
Rappta Therapeutics, a private biotech with operations in Finland 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. It is backed by blue-chip investors Advent Life Sciences, Novartis Venture Fund, Novo Seeds 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.

About Novartis Venture Fund
Novartis Venture Fund is a financially driven corporate life science venture fund whose purpose is to foster innovation, drive significant patient benefit and generate superior returns by creating and investing in innovative life science companies at various stages of their development. For more information, go to www.nvfund.com.

About Novo Holdings A/S
Novo Holdings A/S is a private limited liability company wholly owned by the Novo Nordisk Foundation. It is the holding and investment company of the Novo Group, comprising Novo Nordisk A/S and Novozymes A/S, and is responsible for managing the Novo Nordisk Foundation’s assets. Novo Holdings is recognized as a leading international life science investor, with a focus on creating long-term value. As a life science investor, Novo Holdings provides seed and venture capital to development-stage companies and takes significant ownership positions in growth and well-established companies. Novo Holdings also manages a broad portfolio of diversified financial assets. Further information: http://www.novoholdings.dk

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

Sep 02
Love0

Highlight Therapeutics announces first patient dosed in Phase IIa study in liver metastasis

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

 

Second collaboration with MSD to evaluate combination of BO-112 and KEYTRUDA®

•    New research studies may further accelerate delivery of novel treatment strategies for melanoma

Madrid, Spain – September 2, 2020: Highlight Therapeutics (“Highlight”), a clinical-stage biopharmaceutical company developing RNA-based therapies against cancer, announces it has entered into a second Phase II trial collaboration with a subsidiary of Merck & Co., Inc., Kenilworth, New Jersey, U.S.A., known as MSD outside the U.S. and Canada.

The collaboration will focus on the Phase II evaluation of the combination of BO-112, Highlight’s lead program, and KEYTRUDA® (pembrolizumab), MSD’s anti-PD-1 therapy, in patients that have progressed on anti-PD-1-based therapy in refractory advanced malignant melanoma.

The incidence of malignant melanoma is estimated to be 3-5 cases per 100,000 individuals in Europe. Activating therapeutic anti-tumor immunity by the modulation of the host immune system has become a key approach for treating melanoma. Antagonistic monoclonal antibodies (mAb) against immune inhibitory molecules such as CTLA4 (cytotoxic T-lymphocyte associated protein 4) and PD-1 (programmed death receptor-1) have improved the prognosis of patients with malignant melanoma and have been incorporated into oncology treatment guidelines as a standard of care. However, most patients treated in this way do not achieve a clinical response and many of those who do respond eventually develop progressive disease.

The trial, named Spotlight 203, will evaluate the combination of stimulation of the innate immune system by direct intra-tumoral administration of BO-112, combined with systemic administration of pembrolizumab, based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, defined as the percentage of patients achieving a complete response or partial response as primary endpoint.

Spotlight 203 will also seek to further characterize the clinical activity of intra-tumoral BO-112 in combination with pembrolizumab by evaluating disease control rates, duration of response, progression-free and overall survival, as well as safety, tolerability and pharmacokinetics. A total of 40 patients are planned to be enrolled. The sample size for a subsequent randomized portion of the study will be determined based on efficacy results.

Marisol Quintero, CEO of Highlight Therapeutics, commented:

“Spotlight 203 is designed to address the high unmet need of patients with unresectable stage III or IV melanoma who have failed anti-PD-1 therapy. Phase 1 data suggest the potential of BO-112 to sensitize the immune system against the tumor, including enhanced sensitivity to anti-PD-1 treatment. Based on clinical and pre-clinical studies, we believe intra- tumoral BO-112 has the potential to overcome resistance to anti-PD-1 therapy. We are pleased to build on our fruitful collaboration with MSD, whose extensive expertise in immune-oncology makes them the ideal partner.

“This partnership seeks to accelerate the development of therapies for patients with malignant melanoma. We are delighted to commence Spotlight 203 and to be able to combine our capabilities to accelerate the research of medicines in diseases with such a poor prognosis.”

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc., Kenilworth, NJ. A Phase 2 clinical study of intra-tumoral BO-112 in combination with pembrolizumab in patients with liver metastases from colorectal or gastric/gastro-esophageal junction cancer is also currently underway.

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 melanoma
Almost 288,000 new cases of melanoma and more than 60,000 deaths were estimated worldwide in 2018 [Ferlay 2019]. In North America, melanoma is the fifth most common cancer in males and sixth most common cancer in females [Siegel 2018]. In the U.S, it is estimated that more than 100,000 patients will be diagnosed with melanoma in 2020, with almost 7,000 deaths recorded. Advanced or metastatic melanoma (unresectable Stage III, Stage IV) remains a lethal disease with a high proportion of patients resistant to approved therapies. There are currently limited treatment options for patients who progress on targeted therapy or immunotherapy, creating a high unmet need for novel therapies for advanced melanoma patients who have failed existing treatments.

About Highlight Therapeutics
Highlight, formerly known as Bioncotech Therapeutics S.L, is a private, clinical-stage company dedicated to unlocking the full potential of immuno-oncology. Its lead drug candidate BO-112 is a best-in-class RNA-based therapy which has been demonstrated to initiate a powerful immune response, leveraging 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.

Aug 12
Love0

F2G Closes US$60.8 Million Financing to fund late stage development of novel mechanism antifungal agent

By F2G, Press Release, Private Companies
Press Release.

 

Financing round led by Cowen Healthcare Investments with strong support from existing investors Novo Holdings, Morningside Ventures, Brace Pharma Capital and Advent Life Sciences

MANCHESTER, UK / VIENNA, Austria – 12th August 2020 – F2G Ltd, a UK- and Austria-based biotech developing novel therapies for life-threatening systemic fungal infections, announced today that it has secured US $60.8 million in new financing from new and existing investors. The financing round is led by Cowen Healthcare Investments and includes strong participation from existing investors Novo Holdings, Morningside Ventures, Brace Pharma Capital and Advent Life Sciences.

Proceeds from the financing will be used to fund F2G’s late-stage clinical programs for their novel antifungal agent olorofim and organisational scale-up in preparation for commercialisation.

Olorofim (formerly F901318) is F2G’s lead candidate and is in a Phase 2b open-label study focussing on rare and resistant life-threatening invasive fungal infections, such as invasive aspergillosis (including azole-resistant strains), scedosporiosis, lomentosporiosis, fusariosis, scopulariopsosis, and coccidioidomycosis (Valley Fever). Olorofim was granted Breakthrough Therapy designation (BTD) for the indication of ‘Treatment of invasive mold infections in patients with limited or no treatment options, including aspergillosis refractory or intolerant to currently available therapy, and infections due to Lomentospora prolificans, Scedosporium, and Scopulariopsis species’ in November 2019 by the US Food and Drug Administration (FDA), the only antifungal agent ever to have been awarded this status. Olorofim has the potential to be the first truly novel mechanism antifungal therapy for nearly twenty years and represents a very significant market opportunity in an area of high unmet clinical need.

Commenting on the news, Ian Nicholson, CEO of F2G Ltd, said:

“Following a successful year during which F2G has received FDA Breakthrough Therapy designation for olorofim, as well as FDA Orphan Drug Designation for Coccidioidomycosis (Valley Fever), and QIDP designation in multiple fungal infections, today’s announcement is a significant milestone. We are delighted to welcome Cowen Healthcare Investments to F2G, and I would like to thank our existing investors for their continued support. This financing marks the continued commitment of our shareholders and paves the way for the advanced development and potential approval of the first new antifungal treatment in 20 years, offering hope for patients with very limited treatment options and a high medical need.”

Tim Anderson, Managing Director at Cowen Healthcare Investments said:

“The necessity for the discovery and development of treatments to tackle infectious diseases is today more apparent than ever. F2G’s antifungal candidate demonstrates significant promise in terms of safety, tolerability, and efficacy. With our focus on supporting transformational science that can deliver real clinical outcomes, we are pleased to work with this proven management team and group of renowned investors to build on F2G’s significant scientific and commercial potential.”

Joining the F2G Board in conjunction with the financing will be Tim Anderson, Managing Director at CHI, Will West, Investment Advisor at Morningside Ventures and Naveed Siddiqi, Partner at Novo Ventures. Naveed takes over from Martin Edwards who is retiring from the Board.

Ian Nicholson added:

“We welcome Tim Anderson, Will West and Naveed Siddiqi who replaces Martin Edwards as the representative of Novo Holdings on the Board of Directors. On behalf of the Board we would like to thank Martin for his contribution to F2G. His industry expertise and counsel have been instrumental in guiding F2G through recent developmental and financing milestones, and we wish him the very best.”

Contact:

F2G Ltd
Ian Nicholson | 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
Tel: +44 (0) 203 922 0891
Email: F2G@optimumcomms.com

Notes to Editors:

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 target 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 mould infections. Olorofim (formerly, F901318) is F2G’s leading candidate
from this class. www.f2g.com

About Olorofim
Olorofim is currently being investigated in an open-label single-arm Phase 2b study (ClinicalTrials.gov
Identifier: NCT03583164) in patients with proven invasive fungal disease (IFD) or probable invasive
aspergillosis (IA) with limited treatment options (refractory disease, resistance, or intolerance to
available agents). On 7 November 2019, olorofim was granted Breakthrough Therapy designation (BTD)
by the US Food and Drug Administration (FDA), the only antifungal agent ever to have been awarded
this status.

About Cowen Healthcare Investments
Cowen Healthcare Investments invests fiduciary capital in private healthcare companies across the
biopharma, diagnostics and digital health sectors. Cowen Healthcare Investments is a strategy of Cowen
Investment Management, which develops differentiated, actively managed products on behalf of its
clients. Cowen Investment Management is a division of Cowen Inc. Learn more at www.cowen.com

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