Skip to main content
Category

Press Release

Mar 12
Love0

Advent Life Sciences Becomes Latest Partner of One Nucleus

By Advent Life Sciences, Press Release
Press Release.

 

Cambridge and London UK: 12th March 2021

Advent Life Sciences, one of the sector’s leading Trans-Atlantic venture investors has become the latest Partner to join One Nucleus. The One Nucleus Partner Programme is tailor-made to meet the needs of the Partner and One Nucleus members.

Shahzad Malik, General Partner, Advent Life Sciences commented

“Advent is committed to investing in outstanding, early-stage science and to establish and nurture innovative companies in the UK, Europe and US. We greatly value partnerships in supporting this, as exemplified by the our new Advent-Harrington Impact Fund, in conjunction with the transatlantic not-for-profit drug development group, Harrington Discovery Institute. Joining the Partner Programme brings further opportunities to our multinational portfolio of companies available through One Nucleus membership, and leveraging that ecosystem as they grow.”

Tony Jones, CEO of One Nucleus expands further

“We are delighted to welcome Advent Life Sciences to the One Nucleus Partner Programme. Their track record of funding and nurturing high growth Life Science companies illustrates the value to our members and wider network of engaging them and their portfolio. One Nucleus is entirely focussed on how we bring great innovation, leadership and investment together to enable translation of world class science to patient benefit and returns for all stakeholders. Advent Life Sciences bring immense expertise, connectivity and capacity to help us in that endeavour.”

ENDS

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

About One Nucleus
Established in 1997, One Nucleus is an award winning not-for-profit Life Sciences & Healthcare membership organisation centred on the Greater London-Cambridge-East of
England corridor. Headquartered in Cambridge, at the heart of Europe’s largest Life Sciences & Healthcare cluster, we support those institutions, companies and individuals undertaking activity in or with the above region.

Through providing the local, UK-wide and international connectivity, One Nucleus seeks to enable our members to maximise their performance. This support helping them achieve, or better still exceed, the goals they have set for themselves. Biomedical and Healthcare R&D have always been impactful in driving social and economic progress. In an increasingly outsourced, collaborative and multi-disciplinary sector, bringing the best people together is key to translating great innovation into great products that markedly improve patient outcomes and drive economic development. Attracting and enabling the best people to engage with is at the heart of the One Nucleus team ethos and what we continually strive to deliver.

For further information, please contact:

Tony Jones, CEO

Email: Tony@onenucleus.com
Tel: +44 (0)1223 896463
Web: www.onenucleus.com

Email: pr@adventls.com
Tel:+44 (0)20 7932 2100
Web: www.adventls.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

Feb 18
Love0

Advent Life Sciences Announces Close of Two New Funds Totalling $215 million

By Advent Life Sciences, Press Release
Press Release.

 

18 February 2021, London, UK: Advent Life Sciences, a leading transatlantic venture investor focused on building innovative life science companies in the UK, Europe and the US, announced today that it has closed two new funds with commitments totalling $215 million.

Advent Life Sciences Fund III is the firm’s third dedicated life sciences venture capital fund raised from new Limited Partners (LPs), including British Patient Capital, as well as existing LPs.

The Advent-Harrington Impact Fund is a new type of fund raised in collaboration with the Harrington Discovery Institute to translate innovative drug discoveries into novel treatments for the benefit of patients and society, otherwise known as ‘impact’ investing.

Investing at seed, series A and beyond, the funds will primarily support companies to develop new therapeutics but will also continue Advent’s successful strategy of backing high-potential medical technology companies.

Since its launch, Advent Life Sciences has invested at the interface of academic research and commercial drug development with a focus on identifying and backing high-impact, high-potential innovations that can deliver important new medicines for unmet medical needs. The partnership with Harrington Discovery Institute expands this paradigm by increasing access to world-class academic science with high medical and commercial promise.

Shahzad Malik, General Partner, Advent Life Sciences said:

“The last year has reinforced the vital need to translate world class science into the discovery and development of new medicines to tackle devasting diseases.  Advent has continued its successful strategy to invest in outstanding, early-stage science and to establish and nurture  innovative companies for patients and investors alike.  We are delighted that British Patient Capital joins as a new cornerstone investor in our third fund.

We are also delighted to have partnered with the transatlantic not-for-profit drug development group, Harrington Discovery Institute to raise the new Advent-Harrington Impact Fund.  This new collaboration will allow us to both broaden the quality of the investment opportunities across the globe and increase the amount of capital available to support them. We believe this translational financing is critical to the development of new medicines, and that it will deliver real impact to patients in addition to strong financial returns.”

Judith Hartley, CEO, British Patient Capital, said:

“Our cornerstone commitment to Advent Life Sciences’ latest fund is a key part of our strategy to invest with fund managers that can leverage the UK’s world leading position in life sciences. Developing new life science technologies from research through to new medicines is crucial. Long-term patient capital can support our high-potential, high growth life science companies to reach their full potential and deliver compelling returns.”

Advent’s portfolio company success stories over the last year include the sale of Advent-founded KaNDy Therapeutics to Bayer Pharmaceuticals for over $875 million bringing a non-hormonal treatment for symptoms of the menopause closer to patients; Advent-founded Arrakis’ $190 million partnership deal with Roche to develop small molecule modulators of RNA; the NASDAQ IPO of Acutus Medical launching a best-in-class mapping technology and future ablation therapies for cardiac arrythmias; and notable follow-on financings including participating in a $60 million round for F2G Therapeutics, that also received Breakthrough Therapy Designation from the FDA for its novel class of anti-fungal treatments that address a very high unmet need.

Advent’s team includes 16 investment professionals with a track record of nurturing entrepreneurs to deliver innovative new medicines. In the last 15 years alone, Advent has supported its portfolio companies in developing 14 new approved medical products.  Advent has founded over 20 new biotech companies that are focused on translating academic research into the next generation of medicines.  This stage of development in life sciences is underserved and Advent’s team has extensive experience in supporting new companies through the critical early years.

–    ENDS   –

Notes to Editors:

About Advent Life Sciences

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

About British Patient Capital
British Patient Capital is the trading name of British Patient Capital Limited, a wholly-owned commercial subsidiary of British Business Bank plc, the UK government’s economic development bank. It forms part of the British Business Bank’s commercial arm.

Its mission is to enable long-term investment in innovative firms led by ambitious entrepreneurs who want to build large scale businesses. Launched in June 2018, British Patient Capital has £2.5bn to invest over 10 years in venture and venture growth capital to support high growth potential innovative UK businesses in accessing the long-term financing they require to scale up. Find out more at britishpatientcapital.co.uk

Contacts:
Katja Stout, Scius Communications
katja@sciuscommunications.com
+44 7789 435990

Laura Lane, Advent Life Sciences
laura@adventls.com
+44 207 932 2159

Feb 16
Love0

Centessa Pharmaceuticals Launches with $250 Million Series A Financing and Unveils a New Kind of Pharmaceutical R&D Model

By Centessa Pharmaceuticals, Press Release, Publicly Listed
Press Release.

 

Merger of 10 Privately Held Biotech Companies with Highly Validated Programs Led by Industry Leading Teams to Operate Under Centessa Umbrella

Company Founded by Medicxi with Financing Led by General Atlantic, and Co-led by Vida Ventures and Janus Henderson Investors

Saurabh Saha, M.D., Ph.D., Former Senior Vice President, R&D, and Global Head of Translational Medicine at Bristol Myers Squibb, Appointed as Chief Executive Officer

Moncef Slaoui, Ph.D., Former Chief Scientific Advisor of Operation Warp Speed, Former Chairman of R&D at GlaxoSmithKline, Partner at Medicxi, Appointed as Chief Scientific Officer, Advisor
February 16, 2021 06:30 AM Eastern Standard Time

CAMBRIDGE, Mass. & LONDON–(BUSINESS WIRE)–Centessa Pharmaceuticals (“Centessa”) launched today as a novel asset-centric pharmaceutical company designed and built to advance a portfolio of highly validated programs. Centessa’s asset-centric R&D model applied at scale has assembled best-in-class or first-in-class assets, each of which is led by specialized teams committed to accelerate development and reshape the traditional drug development process. The company was founded by Medicxi and raised $250 million in an oversubscribed Series A financing led by General Atlantic and co-led by Vida Ventures and Janus Henderson Investors. Additional blue-chip investors participated in the financing, including Boxer Capital, Cormorant Asset Management, T. Rowe Price Associates, Inc., Venrock Healthcare Capital Partners, Wellington Management Company, BVF Partners L.P., EcoR1 Capital, Franklin Templeton, Logos Capital, Samsara BioCapital, LifeSci Venture Partners and an undisclosed U.S.-based, healthcare-focused fund.

“This approach encourages an environment where scientific teams are incentivized to maintain an unwavering focus on advancing medicines to key go/no-go inflection points based on data-driven decisions.”

In conjunction with its launch, Centessa has completed the merger of 10 private biotech companies (“Centessa Subsidiaries”) that will each continue to develop its assets with oversight from the Centessa management team. Each Centessa Subsidiary team is asset-focused, in that it prosecutes a single program or biological pathway, with leadership provided by subject matter experts who are given a high degree of autonomy to advance each program. With a singular focus on advancing exceptional science, combined with proprietary capabilities, including structure-based drug discovery and design, the subsidiary teams enable Centessa to potentially develop and deliver impactful medicines to patients.

“The vision of Centessa is to build a pharmaceutical company with a unique operational framework that aims to reduce some of the key R&D inefficiencies that classical pharmaceutical companies face because of structural constraints,”

said Francesco De Rubertis, Ph.D., Co-Founder and Partner at Medicxi and Chairman of the Centessa Pharmaceuticals Board of Directors.

“Our operations will be driven by an asset-centric approach, whereby each Centessa Subsidiary is solely focused on the execution of its programs with oversight from the highly experienced Centessa management team. The ambition of applying asset centricity at scale is to be able to deliver life altering medicines to patients with improved efficiency by boosting R&D productivity.”

Our Approach
Centessa brings together 10 companies from Medicxi’s portfolio with 15 high conviction programs led by experienced teams. Each Centessa Subsidiary is led by industry leaders and subject matter experts with deep experience directly related to key biological pathways that underpin the programs being advanced. These entrepreneurs who have catalyzed the creation of subsidiary companies will continue to advance novel science within the Centessa enterprise.

The Centessa Subsidiaries are comprised of ApcinteX, Capella BioScience, Janpix, LockBody, Morphogen-IX, Orexia Therapeutics, Palladio Biosciences, PearlRiver Bio, Pega-One and Z Factor. The current Centessa Pharmaceuticals portfolio consists of four clinical stage programs, including two that are in late-stage clinical development, and more than 10 additional programs spanning diseases with high unmet need across oncology, hematology, immunology, inflammation, neuroscience and rare diseases.

“With this first-of-its-kind model, we are bringing together programs with robust genetic and biological validation under one new pharmaceutical company that provides centralized resources to enable and empower asset-focused teams to advance highly impactful programs for patients,”

said Saurabh Saha, M.D., Ph.D., Centessa’s Chief Executive Officer.

“This approach encourages an environment where scientific teams are incentivized to maintain an unwavering focus on advancing medicines to key go/no-go inflection points based on data-driven decisions.”

Centessa will have the flexibility to deploy capital by adhering to a “follow-the-data” philosophy and will support each Centessa Subsidiary with centralized capabilities that enable advancement of its respective programs. These include manufacturing, regulatory and operational support to enable and expedite scientific prosecution of programs by subsidiary teams. Each team is uniquely incentivized to expeditiously interrogate key scientific hypotheses.

Moncef Slaoui, Ph.D, Chief Scientific Officer, Advisor of Centessa added,

“In creating Centessa, we have strategically assembled our subsidiary portfolio to include programs with strong biological validation, mechanistic diversification, and teams with proprietary capabilities and insights. This high-quality portfolio aims to deliver enhanced diversification, reduced risk and asymmetric upside with a view to withstanding the inherent low probability of success associated with drug development.”

Meet the Team
The Centessa Pharmaceuticals management team consists of biotech and pharmaceutical industry leaders who oversee decisions related to capital allocation, development plans and strategic transactions in partnership with the Centessa Subsidiaries.

Saurabh Saha, M.D., Ph.D., former Senior Vice President, R&D, and Global Head of Translational Medicine at Bristol Myers Squibb, has been appointed as the company’s Chief Executive Officer and a member of the Board of Directors. In addition, Moncef Slaoui, Ph.D., former Chief Scientific Advisor of Operation Warp Speed, former Chairman of R&D at GlaxoSmithKline, and Partner at Medicxi, has been appointed as Chief Scientific Officer, Advisor.

The Centessa Board of Directors includes Francesco De Rubertis, Ph.D., Medicxi, who will serve as the company’s Chairman; Aaron Kantoff, Medicxi; Brett Zbar, M.D., General Atlantic; and Arjun Goyal, M.D., M.Phil., Vida Ventures.

“We believe Centessa represents a unique opportunity in our sector,”

said Brett Zbar, M.D., Managing Director and Global Head of Life Sciences at General Atlantic.

“The high-quality science and entrepreneurial drive within each of the Centessa Subsidiaries, combined with this deeply experienced leadership team, has the potential to bring important medicines to patients with speed and efficiency.”

“Centessa’s bold vision and unique operating model are supported by compelling clinical programs, strong data and a stellar team,” said Arjun Goyal, M.D., M.Phil., Co-Founder and Managing Director at Vida Ventures. “We believe Centessa’s approach can ultimately lead to impactful medicines that will benefit patients globally.”

ABOUT THE CENTESSA SUBSIDIARIES

ApcinteX
ApcinteX is developing SerpinPC, a specific inhibitor of the anticoagulant protease activated protein C (APC), for the treatment for hemophilia A and hemophilia B, with or without inhibitors.

Capella BioScience
Capella BioScience is developing CBS001, a neutralizing therapeutic monoclonal antibody to the inflammatory membrane form of LIGHT (known as TNFSF14), for the treatment of idiopathic pulmonary fibrosis. Capella BioScience is also developing CBS004, a therapeutic monoclonal antibody to blood dendritic cell antigen 2 (BDCA2), for the treatment of lupus erythematosus (systemic and cutaneous) and systemic sclerosis.

Janpix
Janpix is developing a novel class of selective dual-STAT3/5 small molecule monovalent degraders for the treatment of various hematological malignancies, including leukemias and lymphomas.

LockBody
LockBody is pioneering a platform technology to develop LockBody CD47 (LB1) and LockBody CD3 (LB2) for optimal targeting of solid tumors by the innate immune system.

Morphogen-IX
Morphogen-IX is developing MGX292, a protein-engineered variant of human bone morphogenetic protein-9 (BMP9), for the treatment of pulmonary arterial hypertension.

Orexia Therapeutics
Orexia Therapeutics is developing oral and intranasal orexin receptor agonists using structure-based drug design approaches. These agonists target the treatment of narcolepsy type 1, where they have the potential to directly address the underlying pathology of orexin neuron loss, as well as other neurological disorders characterized by excessive daytime sleepiness.

Palladio Biosciences
Palladio Biosciences is developing lixivaptan, an oral non-peptide, new chemical agent that works by selectively suppressing the activity of the hormone vasopressin at the V2 receptor, as a treatment for autosomal dominant polycystic kidney disease with the goal of slowing the progression of kidney function decline and avoiding the liver safety issues associated with tolvaptan.

PearlRiver Bio
PearlRiver Bio is developing ​potent and selective oral exon20 insertion mutation inhibitors intended to have ​minimal activity on wild-type EGFR and optimal pharmacokinetic properties, ​for the treatment of EGFR exon 20 insertion (with potential to target and treat Her2 exon 20 insertions) non-small cell lung cancer (NSCLC). PearlRiver Bio is also developing oral inhibitors targeting C797S-mutant EGFR and undisclosed next generation EGFR inhibitors for NSCLC.

PegaOne
PegaOne is developing imgatuzumab, a humanized, non-fucosylated, anti-EGFR monoclonal antibody for the treatment of cutaneous squamous cell carcinoma and other solid tumor indications.

Z Factor
Z Factor is developing ZF874, a small molecule chemical chaperone intended to rescue folding of the Z variant of alpha-1-antitrypsin, increasing serum levels of active protein and reducing accumulation in the liver, for the treatment of alpha-1-antitrypsin deficiency.

ABOUT CENTESSA PHARMACEUTICALS

Centessa Pharmaceuticals Limited is a next-generation biopharmaceutical company that aims to reshape the traditional drug development process. The company applies an asset-centric R&D model at scale to advance a portfolio of highly validated programs led by industry leading teams. Each program is developed by an Centessa Subsidiary and supported by a centralized infrastructure and the Centessa management team. The company is headquartered in Cambridge, Mass. For more information, visit www.centessa.com

FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements. Statements we make in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which are usually identified by the use of words such as “estimates,” “expects,” “intends,” “anticipates,” “believes,” “may,” “should,” “will,” “plans,” “projects,” “seeks,” and variations of such words or similar expressions. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements, including statements relating to expectations, plans and prospects regarding the clinical development plans and timing, clinical trial designs, clinical and therapeutic potential, and strategy for any of our programs reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, the success of clinical trials, regulatory filings, and approvals. These forward-looking statements are based upon the current expectations and beliefs of Centessa’s management team as of the date of this release and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Furthermore, Centessa operates in a very competitive and rapidly changing environment in which new risks emerge from time to time. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts

Media:
Dan Budwick, 1AB
dan@1abmedia.com

UK/European media enquiries
Optimum Strategic Communications
Mary Clark, Shabnam Bashir
centessa@optimumcomms.com

Swiss media enquiries
VEITHing Spirit
Marcus Veith
marcus@vspirit.ch
Cellphone: +41 79 20 75 111

Jan 25
Love0

Iterum Therapeutics Announces U.S. FDA Filing Acceptance of New Drug Application for Oral Sulopenem

By Iterum, Press Release, Publicly Listed
Press Release.

 

If approved, First Oral Penem in the U.S. and First New Oral Treatment for uUTIs in Over 20 Years

PDUFA goal date of July 25, 2021

DUBLIN, Ireland and CHICAGO, Jan. 25, 2021 (GLOBE NEWSWIRE) — Iterum Therapeutics plc (Nasdaq: ITRM) (the Company), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today announced that the U.S. Food and Drug Administration (FDA) accepted for review the New Drug Application (NDA) for sulopenem etzadroxil/probenecid (oral sulopenem) for the treatment of uncomplicated urinary tract infections (uUTIs) in patients with a quinolone non-susceptible pathogen. The FDA has designated this application as a priority review and consequently assigned a PDUFA (Prescription Drug User Fee Act) goal date for completion of the review of oral sulopenem of July 25, 2021. The agency currently plans to hold an advisory committee meeting to discuss the NDA.

“The FDA acceptance of our NDA for review is an important milestone for Iterum. If approved, oral sulopenem would be the first penem available orally in the U.S. with the ability to treat multi-drug resistant infections in the community,”

said Corey Fishman, Chief Executive Officer.

“Specifically, this important antibiotic is one step closer to relieving the growing problem of quinolone resistance found in over six million uncomplicated urinary tract infections in the U.S. each year.”

The NDA includes data from the SURE-1, SURE-2 and SURE-3 phase 3 clinical trials, in which oral sulopenem was well tolerated. The SURE-1 clinical trial (uUTIs) demonstrated statistical superiority of oral sulopenem to the widely used comparator, ciprofloxacin, for the primary efficacy endpoint of clinical and microbiologic response at the test-of-cure visit for patients with a quinolone non-susceptible pathogen.

About Iterum Therapeutics plc

Iterum Therapeutics plc is a clinical-stage pharmaceutical company dedicated to developing differentiated anti-infectives aimed at combatting the global crisis of multi-drug resistant pathogens to significantly improve the lives of people affected by serious and life-threatening diseases around the world. Iterum Therapeutics is advancing its first compound, sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation and IV formulation. Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics. Iterum Therapeutics has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications.

Forward-Looking Statements

This press release contains forward-looking statements. These forward-looking statements include, without limitation, statements regarding, among other things, timing of the review of regulatory filings and the market opportunity for, and potential market acceptance of, oral sulopenem for uUTIs, and the Company’s plans, strategies and prospects for its business. In some cases, forward-looking statements can be identified by words such as “may,” “believes,” “intends,” “seeks,” “anticipates,” “plans,” “estimates,” “expects,” “should,” “assumes,” “continues,” “could,” “would,” “will,” “future,” “potential” or the negative of these or similar terms and phrases. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements include all matters that are not historical facts. Actual future results may be materially different from what is expected due to factors largely outside the Company’s control, including the uncertainties inherent in the initiation and conduct of clinical trials,  availability and timing of data from clinical trials, changes in regulatory requirements or decisions of regulatory authorities, the timing of approval of any submission, changes in public policy or legislation, commercialization plans and timelines, if oral sulopenem is approved, the actions of third-party clinical research organizations, suppliers and manufacturers, the accuracy of the Company’s expectations regarding how far into the future the Company’s cash on hand will fund the Company’s ongoing operations, the sufficiency of the Company’s cash resources and the Company’s ability to continue as a going concern, the impact of COVID-19 and related responsive measures thereto, the Company’s ability to maintain listing on the Nasdaq Capital Market, risks and uncertainties concerning the outcome, impact, effects and results of the Company’s evaluation of corporate, organizational, strategic, financial and financing alternatives, including the terms, timing, structure, value, benefits and costs of any corporate, organizational, strategic, financial or financing alternative and the Company’s ability to complete one at all, the price of the Company’s securities and other factors discussed under the caption “Risk Factors” in its most recently filed Quarterly Report on Form 10-Q, and other documents filed with the SEC from time to time. Forward-looking statements represent the Company’s beliefs and assumptions only as of the date of this press release. Except as required by law, the Company assumes no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.

Investor Contact:
Judy Matthews
Chief Financial Officer 312-778-6073
IR@iterumtx.com

Source: Iterum Therapeutics plc

Jan 05
Love0

Aura Biosciences Appoints David Johnson to Its Board of Directors

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

 

CAMBRIDGE, MA –January 5th, 2021– Aura Biosciences, a clinical-stage oncology company developing a novel class of drug conjugate therapies for multiple oncology indications, today announced the appointment of David Johnson to its Board of Directors. Mr. Johnson is a biopharmaceutical business leader with more than 25 years of experience in drug development and currently serves as Chief Executive Officer at VelosBio, a clinical-stage oncology company developing novel antibody-drug-conjugates and bispecific antibodies.

“With David’s impressive track record in oncology and as an accomplished CEO, his engagement and guidance will help Aura drive AU-011 for the treatment of choroidal melanoma to registration and commercialization,”

said George Golumbeski, Ph.D., Chairman of the Board of Aura Biosciences.

“In the last few years, David has led several biopharma transactions, including the acquisition of VelosBio by Merck for $2.75 billion. He has also successfully raised over $500 million in capital for his last two companies. We are really excited to have David’s strategic guidance as we work to accelerate the clinical development of our pipeline of innovative oncology therapies.”

“I am excited to be joining Aura’s Board of Directors during such an important period of growth for the Company,”

said Mr. Johnson.

“I look forward to leveraging my extensive clinical, business development, operational and executive leadership experience in the biotechnology industry to support Aura’s Board of Directors and leadership team in achieving their goal of advancing a new class of oncology drugs for life-threatening cancers.”

Prior to founding VelosBio, Mr. Johnson was the Chief Executive Officer at Acerta Pharma, an oncology-focused pharmaceutical company, where he led the Company through a critical phase of growth from approximately 40 to over 150 employees and from a signal-seeking, first-in-human trial to more than 20 active clinical studies. Under his leadership, Acerta designed and launched three registration-directed trials, including two global Phase 3 trials for acalabrutinib, an irreversible oral Bruton’s tyrosine kinase (BTK) inhibitor initially focused on hematological malignancies. Mr. Johnson and his leadership team ultimately led the acquisition of Acerta by AstraZeneca in a deal valued at up to $7 billion.

Before Acerta, Mr. Johnson held roles with increasing responsibility within commercial, pipeline development, medical affairs, and clinical development organizations at various healthcare companies including Hoffman-La Roche, Immunex (acquired by Amgen), Millennium (acquired by Takeda), Favrille, Gloucester (acquired by Celgene), and Calistoga (acquired by Gilead). He has made significant contributions to drugs ultimately garnering regulatory approvals, including bortezomib (Velcade®), romidepsin (Istodax®), idelalisib (Zydelig®), and acalabrutinib (Calquence®). In addition to Aura’s Board, Mr. Johnson serves on the Board of Directors of Zentalis Pharmaceuticals, a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapeutics targeting fundamental biological pathways of cancers. Mr. Johnson received a Bachelor’s degree from Indiana University.

About Aura Biosciences

Aura Biosciences, Inc. is a clinical-stage biopharmaceutical company developing a new class of oncology therapies based on a novel drug conjugate technology for initial application in ocular and bladder cancers with the potential to treat other cancers. The Company’s proprietary technology platform utilizes virus-like drug conjugates (VDCs) that have a dual mechanism of action with targeted necrosis of cancer cells, followed by a T-cell mediated anti-tumor response. This novel technology platform uses Virus-Like Particles to bind to a novel tumor cell surface target and can deliver hundreds of cytotoxic molecules selectively to tumor cells, while sparing surrounding healthy tissue. 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 for which there are currently no approved therapies. In a Phase 1b/2 study, AU-011 demonstrated compelling efficacy, including high rates of tumor control and vision preservation, along with a favorable safety profile, in patients with choroidal melanoma. Future pipeline applications for Aura’s technology include choroidal metastases and 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

Oct 22
Love0

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

Back