Loci Orthopaedics Closes €12.8 Million Series A Financing

Posted on by

Company developing its innovative InDx Implant System for thumb base joint arthritis
Focused on a painful and disabling condition with increasing prevalence in patient population
Funds to support clinical programs, regulatory submissions and future commercialisation

GALWAY, Ireland–(BUSINESS WIRE)–Loci Orthopaedics Ltd, an orthopaedic medical device company, today announced the successful closing of an oversubscribed €12.8 million Series A financing. The financing round was led by new investors Seroba, Johnson & Johnson Innovation, JJDC, Inc., (JJDC) and the European Innovation Council (EIC) Fund.

Loci Orthopaedics develops novel technologies that target major unmet clinical needs in orthopaedics extremities. The company’s primary device, its patented InDx Implant System, is an innovative, evidence-based implant for thumb base joint arthritis. Thumb base joint arthritis is a highly and increasingly prevalent condition which is estimated to actively affect up to 5% of the US and EU population and 100 million people worldwide¹. The InDx implant replicates the functional biomechanics of the thumb base joint, with the aim of restoring natural motion for those affected by this painful and disabling condition. InDx’s novel design could address the limitations of current thumb implants which are often unsuccessful and are prone to both dislocation and movement post implantation.

The Series A financing will enable the company to augment the initial clinical investigation, which indicates positive preliminary results, and develop additional clinical data to support regulatory approval applications and future commercialisation in different geographies.

In October 2023, Loci Orthopaedics successfully completed enrolment of a 15-patient clinical study for its InDx Implant System. The Thumb Hemi-Arthroplasty with Natural Kinematics study is designed to evaluate the surgical implantation of the device as well as improvements in pain, grip, and quality of life for those affected by thumb base joint arthritis. Results from the clinical study are expected to be published later this year.

Dr Brendan Boland, Co-Founder and Executive Chairperson, commented: “Thumb base joint arthritis is a painful and disabling condition with a significant unmet clinical need for an effective, evidence-based, surgical solution. With a growing patient population, our InDx Implant System has the potential to provide surgeons and patients with a less invasive and more effective treatment for this condition. This funding will enable us to expand our clinical programs, submit regulatory approval applications in the US and EU and accelerate our efforts towards future commercialisation.”

Barry Russell, CEO, added: “The company is excited to work with three very experienced and well-respected investment groups to help the company bring a promising new solution to market to help the many currently underserved patients and their surgeons with a joint sparing treatment option.”

Maud Lazare, Head of Investor Relations at Seroba, commented: “Orthopaedics extremities is one of the fastest growing areas in orthopaedics, so it is great to work with a company whose innovative solutions may positively disrupt the future treatment landscape for one of the most frequently performed surgeries in this space.”

Svetoslava Georgieva, Chair of the EIC Fund Board, commented: “We are very happy to participate in this funding round. Loci Orthopaedics is disrupting the treatment landscape for one of the most frequently performed surgeries in orthopaedics extremities. The EIC’s unique financing approach, combining grants and equity, provides Europe’s most promising companies with means to develop and scale up their businesses in Europe.”

¹	Zhang Y, Niu J, Kelly-Hayes M, Chaisson CE, Aliabadi P, Felson DT. Prevalence of symptomatic hand osteoarthritis and its impact on functional status among the elderly: The Framingham Study. Am J Epidemiol. 2002 Dec 1;156(11):1021-7. doi: 10.1093/aje/kwf141. PMID: 12446258.Y

About Thumb Base Joint Arthritis

Most activities that involve grasping or pinching are possible because of the thumb’s remarkable range of motion. Dexterity, however, comes at a price – an increased risk of osteoarthritis (OA) in the first carpometacarpal (CMC) joint, where the thumb meets the trapezium bone in the wrist. Thumb arthritis is common with aging and occurs when cartilage wears away from the ends of the bones that form the joint at the base of the thumb.

Thumb arthritis can cause severe pain, swelling, and decreased strength and range of motion, making it difficult to do simple tasks, such as turning doorknobs and opening jars. Treatment generally involves a combination of medication and splints. Severe thumb arthritis might require surgery. It is estimated that 5% of the population have symptomatic thumb base joint arthritis which causes significant hand pain and has a major negative impact on quality of life¹.

About Loci Orthopaedics

Loci Orthopaedics was founded by Mr Gerry Clarke and Dr Brendan Boland as a concurrent spin-out from the University of Galway (Ireland), University College Cork (Ireland) and KU Leuven (Belgium). The company develops orthopaedic technologies to meet major unmet clinical needs with a primary focus on the orthopaedics extremities market. The company focuses on evidence-based design to ensure that its technologies are physiologically optimal to restore natural movement for superior clinical outcomes. Following the Series A financing, to date the company has raised over €22 million in grant and equity financing. See more information at www.lociorthopaedics.com.

About Seroba

Seroba is a European life sciences venture capital firm based in Dublin, Paris and Milan, investing from its fourth Fund. We focus on value creation through backing cutting-edge Biotech and MedTech innovation that will transform the treatment of unmet medical needs. Our team has deep industry and operational experience and an extensive global network. We like to work with entrepreneurs who share our passion for success and for investors who share the same goal of improving human health while driving financial returns. Follow our story at www.serobavc.com.

About EIC Fund

The European Innovation Council Fund from the European Commission is an agnostic Fund: it invests across all technologies and verticals, and all EU countries and countries associated to Horizon Europe. It provides the investment component of the EIC Accelerator blended finance. The European Investment Bank acts as investment adviser to the EIC Fund. The EIC Fund aims to fill a critical financing gap and its main purpose is to support companies in the development and commercialisation of disruptive technologies, bridging with and crowding in market players, and further sharing risk by building a large network of capital providers and strategic partners suitable for co-investments and follow-on funding. The Fund pays particular attention to the empowerment and support of female founders as well as the ambition to reduce the innovation divide among EU countries.

Contacts

For additional information, please contact Dr Brendan Boland.

T: +353 91 863 775

E: brendan@lociorthopaedics.com

Media Contacts

FTI Consulting

Paddy Berkery / Rugile Nenortaite

T: +353 86 602 5988 / +353 86 277 9905

E: LociOrthopaedics@fticonsulting.com

Epsilogen announces CTA approval for Phase Ib trial of MOv18 IgE in platinum-resistant ovarian cancer

Posted on by

Phase Ib study expected to initiate in H2 2024

Previously reported Phase I results showed MOv18 IgE to be safe and well tolerated, with evidence of anti-tumour activity

LONDON–(BUSINESS WIRE)–Epsilogen, a global leader in the development of immunoglobulin E (IgE) antibodies to treat cancer, today announces that the Clinical Trial Application for the Phase Ib trial of MOv18 IgE has been approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA).

The Phase Ib study is expected to initiate later in 2024 and will evaluate the efficacy of MOv18 IgE in patients with platinum-resistant ovarian cancer (PROC).

Dr Tim Wilson, Chief Executive Officer of Epsilogen, said: “This CTA is another significant milestone for Epsilogen and the clinical development of MOv18 IgE. We look forward to progressing MOv18 IgE into a Phase Ib efficacy study later this year as we continue to demonstrate the potential of IgE antibodies as a new, differentiated class of cancer treatments.”

About MOv18 IgE

MOv18 IgE is an immunoglobulin E (IgE) antibody targeting the folate receptor alpha (FR alpha) antigen. FR alpha is present on a variety of cancers including ovarian, endometrial, lung and triple negative breast cancer. Epsilogen has successfully completed a Phase I safety study of MOv18 IgE in PROC patients. The results of the study, published in Nature Communications, found MOv18 IgE to be safe and well tolerated, with evidence of anti-tumour activity observed. Epsilogen, alongside its partner Lonza, also announced the successful completion of large-scale Good Manufacturing Practice (GMP) manufacturing of MOv18 IgE earlier this year.

About the Phase Ib study

The Phase Ib study is designed to confirm the safety and tolerability of MOv18 IgE and demonstrate efficacy in PROC. Following the dose escalation, an expansion cohort will be recruited to make a preliminary assessment of the anti-tumour activity of MOv18 IgE at a selected dose. In addition, delay to disease progression will be assessed along with a number of translational elements to generate further understanding of MOv18 IgE in the study population.

About Epsilogen Ltd

Epsilogen is a global leader in the development of immunoglobulin E (IgE) antibodies to treat cancer. IgE’s natural function is to provide immunological defence against certain parasites. This functionality makes it an ideal treatment of solid tumours due to its strong potency, enhanced tumour access and long tissue half-life.

Epsilogen’s lead product candidate, MOv18 IgE, is the first therapeutic IgE antibody to enter the clinic and encouraging data from a completed Phase I trial demonstrated MOv18 IgE to be safe and well tolerated with early signs of clinical activity. Epsilogen has recently successfully completed large scale GMP manufacture of MOv18 IgE (the first time this has been achieved for an IgE antibody) and will initiate a Phase Ib trial in platinum-resistant ovarian cancer patients later this year. The company is also developing a pipeline of IgE therapies in oncology as well as proprietary platforms including IgE bispecifics and unique IgE/IgG combination antibody molecules (IgEGs) with enhanced functionality.

Epsilogen began operations in 2017 as a spin-out of King’s College London and has attracted venture capital financing from Epidarex Capital, Novartis Venture Fund, 3B Future Health, British Patient Capital, ALSA Ventures and Schroders Capital amongst others. Find out more at epsilogen.com.

Contacts

Communications advisor to Epsilogen Ltd:

Simon Conway

Senior Managing Director

FTI Consulting

epsilogen@fticonsulting.com
+44 (0)20 3727 1000

GSK and CureVac to Restructure Collaboration into New Licensing Agreement

Posted on by

GSK acquires full rights to develop, manufacture and commercialize globally mRNA candidate vaccines for influenza and COVID-19, including combinations
CureVac receives €400 million upfront and up to an additional €1.05 billion in development, regulatory and sales milestone payments as well as tiered royalties; all previous financial considerations from the prior collaboration agreement replaced

London UK; TÜBINGEN, Germany/BOSTON, MA, USA – July 3, 2024 – GSK plc (LSE/NYSE: GSK) and CureVac N.V. (Nasdaq: CVAC) today announced they have restructured their existing collaboration into a new licensing agreement, allowing each company to prioritize investment and focus their respective mRNA development activities.

Since 2020, GSK and CureVac have worked together to develop mRNA vaccines for infectious diseases. Through this collaboration, GSK and CureVac currently have vaccine candidates for seasonal influenza and COVID-19 in Phase 2 and avian influenza in Phase 1 clinical development. All candidates are based on CureVac’s proprietary second-generation mRNA backbone. Data generated to date for these candidate vaccines are promising and demonstrate their potential to be best-in-class new vaccines.

Under the terms of the new agreement, GSK will assume full control of developing and manufacturing these candidate vaccines. GSK will have worldwide rights to commercialise the candidate vaccines. The agreement represents the latest step in GSK’s ongoing investment in vaccine platform technologies, matching the best platform to each pathogen to develop best-in-class vaccines. mRNA is an adaptable vaccine technology with demonstrated application in emerging and constantly changing viral pathogens due to its ability to support rapid strain change. GSK continues to develop and optimize its mRNA capabilities through investments and partnerships, including in AI/ML-based sequence optimisation, nanoparticle design and manufacturing.

CureVac will receive an upfront payment of €400 million and up to an additional €1.05 billion in development, regulatory and sales milestones and tiered royalties in the high single to low teens range. The new agreement replaces all previous financial considerations from the prior collaboration agreement between GSK and CureVac. CureVac further retains exclusive rights to the additional undisclosed and preclinically validated infectious disease targets from the prior collaboration together with the freedom to independently develop and partner mRNA vaccines in any other infectious disease or other indication. CureVac’s ongoing patent litigation against Pfizer/BioNTech is unaffected by the new agreement.

Tony Wood, Chief Scientific Officer, GSK said: “We are excited about our flu/COVID-19 programs and the opportunity to develop best-in-class mRNA vaccines to change the standard of care. With this new agreement, we will apply GSK’s capabilities, partnerships and intellectual property to CureVac’s technology, to deliver these promising vaccines at pace.”

Alexander Zehnder, Chief Executive Officer, CureVac said: “The collaboration with GSK has been instrumental in developing promising, late clinical-stage vaccine candidates, leveraging our proprietary mRNA platform. This new licensing agreement puts us in a strong financial position and enables us to focus on efforts in building a strong R&D pipeline.”

Completion of the new agreement remains subject to certain antitrust and regulatory approvals and customary closing conditions.

About GSK
GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.

About CureVac
CureVac (Nasdaq: CVAC) is a pioneering multinational biotech company founded in 2000 to advance the field of messenger RNA (mRNA) technology for application in human medicine. In more than two decades of developing, optimizing, and manufacturing this versatile biological molecule for medical purposes, CureVac has introduced and refined key underlying technologies that were essential to the production of mRNA vaccines against COVID-19, and is currently laying the groundwork for application of mRNA in new therapeutic areas of major unmet need. CureVac is leveraging mRNA technology, combined with advanced omics and computational tools, to design and develop off-the-shelf and personalized cancer vaccine product candidates. It also develops programs in prophylactic vaccines and in treatments that enable the human body to produce its own therapeutic proteins. Headquartered in Tübingen, Germany, CureVac also operates sites in the Netherlands, Belgium, Switzerland, and the U.S. Further information can be found at www.curevac.com.

CureVac Media Contact
Patrick Perez, Junior Manager Public Relations
CureVac, Tübingen, Germany
T: +49 7071 9883-1831
patrick.perez@curevac.com

CureVac Investor Relations Contact
Dr. Sarah Fakih, Vice President Corporate Communications and Investor Relations
CureVac, Tübingen, Germany
T: +49 7071 9883-1298
M: +49 160 90 496949
sarah.fakih@curevac.com

Macomics Announces Appointment of Simon Dew as New Chief Business Officer

Posted on by

Macomics continues to expand its leadership team to accelerate the development of first-in-class macrophage-targeted therapies
Simon Dew brings over 25 years of experience in pharmaceutical business development to advance partnerships for Macomics’ macrophage ENIGMAC™ platform

EDINBURGH, United Kingdom and CAMBRIDGE, United Kingdom, June 10, 2024 (GLOBE NEWSWIRE) — Macomics Ltd, a leader in macrophage drug discovery has announced the appointment of Simon Dew in the newly created position of Chief Business Officer (CBO). He will be instrumental in advancing Macomics’ mission to develop first-in-class medicines targeting macrophage-driven diseases of high unmet medical need, in oncology and chronic inflammatory diseases.

With an extensive background in pharmaceutical business development, corporate strategy, Simon will play a pivotal role in maximizing the potential of Macomics’ proprietary macrophage ENIGMAC™ drug discovery platform through strategic partnerships and collaborations.

Simon brings over 25 years of experience in the pharmaceutical industry, having held senior leadership roles in Pharma and Biotech. He is currently on the Business Development Board of Sunstone Capital, a Danish Venture Capital Company and, most recently served as CBO at ReNeuron Group. His career also includes significant roles at Gyroscope Therapeutics, Astellas Pharmaceuticals, IQVIA, Parexel, Phytopharm plc, and GSK/SB, where he demonstrated exceptional expertise in business development, corporate strategy, and operational leadership. He has a BSc in Pharmacy and has completed the INSEAD Managing Partnerships and Strategic Alliances and M&A Executive Program.

Dr Stephen Myatt, CEO of Macomics said, “I am delighted to welcome Simon to the company. Business development is a critical role to our leadership team and Simon’s extensive experience and successful track record in the biotech and pharmaceutical industry will be invaluable as we continue to advance our macrophage-targeted therapies and expand our strategic partnerships. Macrophages are key to multiple diseases of high unmet medical need, including as key mediators of solid tumour immunosuppression and pathological inflammation in chronic inflammatory disorders.”

Simon Dew, new CBO of Macomics said, “The potential of the ENIGMAC platform to discover and develop novel macrophage-targeted therapies is unique, and I look forward to working with the talented team at Macomics to deliver on strategic partnerships that will accelerate the development of transformative medicines for patients with high unmet medical needs.”

Image: Simon Dew, Chief Business Officer, Macomics

About Macomics – www.macomics.com

Macomics Ltd is a macrophage drug discovery company with a world-leading macrophage drug discovery platform, developing first-in-class medicines to deliver transformational impact for patients with macrophage-driven diseases: Macrophages are key to multiple diseases of high unmet medical need, including as key mediators of solid tumour immunosuppression and pathological inflammation in chronic inflammatory disorders.

The company is progressing a diversified portfolio of therapies targeting disease specific macrophages towards the clinic. Its ENIGMAC macrophage drug discovery platform enables identification and validation of novel macrophage therapeutic targets and provides a translationally relevant path to clinic through the development of more physiologically relevant human macrophage models combined with proprietary gene editing technology.

The company was co-founded in 2020 by Prof. Jeffrey Pollard and Dr. Luca Cassetta, University of Edinburgh, internationally recognised leaders in macrophage biology. It has R&D and office facilities in Edinburgh and Cambridge, UK. The company’s financing was led by Epidarex Capital and the company is backed by Scottish Enterprise, LifeLink Ventures and Caribou Property Limited.

For further information please contact:

Macomics

At the Company – Steve Myatt, CEO, Macomics E: myatt@macomics.com

Media enquiries (for Macomics) – Sue Charles, Charles Consultants T: +44 (0)7968 726585 E: sue@charles-consultants.com

Engitix Announces Appointment of Matthew Edwards Ph.D., as SVP Discovery and Emma Huang Ph.D., as VP Data Sciences

Posted on by

LONDON, May 21, 2024 (GLOBE NEWSWIRE) — Engitix Ltd (‘Engitix’), a biotechnology company with a portfolio of drug discovery programmes in fibrosis and solid tumours using its proprietary human extracellular matrix (ECM) platform, today announces the appointment of Matthew Edwards, Ph.D., as Senior Vice President of Discovery Sciences, and Emma Huang, Ph.D., as Vice President of Data Sciences.

Dr. Edwards is a seasoned drug discovery leader with extensive industry experience. He has developed six clinically-enabled novel therapeutics and has deep immunology and oncology domain expertise. He joins Engitix from Johnson & Johnson, where he was the Global Head of Discovery and Translational Sciences for Interventional Oncology. In this role, he developed a portfolio of immuno-oncology assets primarily designed to be delivered intra-tumourally, which included low molecular weight drugs, therapeutic antibodies and RNA therapeutics. Prior to this, further industrial drug discovery experience included leadership positions at Novartis, and GSK in the respiratory and immunology therapeutics areas.

At Engitix, he will be responsible for leading the company’s internal drug discovery scientific strategy.

Dr. Huang brings to Engitix a strong track record of identifying and executing on transformative opportunities harnessing data science to accelerate the development of novel therapies and solutions for patients. She joins Engitix from Johnson & Johnson, where she served as Head of Data Sciences for Interventional Oncology. In this role, she shaped and built key data science capabilities including the data, analytics, platforms, and partnerships necessary to support discovery and translational biomarker efforts.

With over 40 peer reviewed papers, and a career spanning academia, government, and industry, Emma has consistently demonstrated her commitment to scientific advancement and collaboration through roles such as Deputy Chair of the MRC Population & Systems Medicine Board. She holds a Ph.D. in Biostatistics from the University of North Carolina-Chapel Hill, and a B.S. in Mathematics from Caltech.

At Engitix, she will be responsible for leading the company’s data and analytics strategy supporting platform development, internal drug discovery pipeline, and external partnerships.

Dr. Christopher Stevenson, CSO at Engitix, said, “I am delighted to welcome Matt and Emma to Engitix. We have created the roles of SVP Discovery and VP Data Sciences to expand our leadership team and capabilities. The expertise Matt and Emma bring will galvanise the team’s focus on translating the insights gained from Engitix’ proprietary platform technologies into transformational therapies for patients.”

Dr. Matthew Edwards, SVP Discovery Sciences of Engitix, said, “Engitix is undoubtedly a company with world leading disease ECM analysis capability providing a unique opportunity for novel target identification. I’m excited to take on this critical role and help build and prosecute our internal drug discovery pipeline and expedite bringing novel therapeutics to patients with high unmet medical need.”

Dr. Emma Huang, VP Data Sciences of Engitix, said, “What attracted me to Engitix, was its innovative ECM platform generating high-quality, disease-relevant datasets to drive drug discovery. It’s an incredibly exciting opportunity to combine these novel data with cutting-edge analytics to help develop therapeutics addressing a broad range of medical needs.”

Notes to Editors:

About Engitix Ltd

Engitix is progressing a portfolio of internal and partnered drug discovery programmes in fibrosis and solid tumours using its pioneering human extracellular matrix (ECM) platform. Engitix patient-centric ECM platform is underpinned by an extensive bioarchive, one of the world’s largest ECM databases, and best-in-class, human in vitro 3-D cell culture bioassays. Together, these unique capabilities transform its ability to identify new targets and biomarkers, investigate novel mechanisms of action, and more accurately predict the efficacy of therapeutic candidates. It has a strategic drug discovery partnership with Dompé farmaceutici where Engitix’s internal drug development programmes are being accelerated by leveraging Dompé’s AI-enabled high performance computing platform, Exscalate, and drug discovery and development collaborations with Takeda in advanced fibrotic liver diseases, including non-alcoholic steatohepatitis (NASH), and in fibrostenotic Inflammatory Bowel Disease (IBD), including Crohn’s disease and ulcerative colitis.

Established to commercialise cutting-edge research from the Institute for Liver and Digestive Health, Division of Medicine, University College London (UCL), Engitix is headquartered in Westworks, White City Place, London, UK. It has raised more than $60m in equity from investors including Netherton Investments (a fund investing on behalf of Mike Platt) and Dompé farmaceutici S.P.A.

For more information, please visit www.engitix.com

For more information:

At the Company

Giuseppe Mazza, CEO
E: giuseppe.mazza@engitix.com

Media enquiries (for Engitix)

Sue Charles, Charles Consultants
T: +44 7986 726585
E: sue@charles-consultants.com

Theolytics successfully closes latest financing raising total of £19M ($24.5M) and welcomes Sound Bioventures as new investor

Posted on by

Oxford, UK April 17th, 2024. Theolytics, a biotechnology company developing next-generation oncolytic viral therapies, today announced it has successfully closed its latest financing round, raising a total of £19M ($24.5M) with the addition of Sound Bioventures as a new investor. Sound Bioventures joins a strong international syndicate of existing investors participating in the round that includes M Ventures, Taiho Ventures, Epidarex Capital, Oxford Science Enterprises and the University of Oxford.

The proceeds from this financing round further strengthen the company’s position as it advances its lead oncolytic adenovirus – THEO-260 – into clinical trials in ovarian cancer. The first trials are planned for this year and will aim to demonstrate safe, effective administration, and provide insight to the candidate’s dual cancer/cancer-associated fibroblast-killing and immunomodulatory mechanism of action when administered by intravenous or intraperitoneal routes in platinum-resistant ovarian cancer patients.

Following this investment, Thomas Tan, Principal at Sound Bioventures, will join Theolytics’ Board of Directors.

Charlotte Casebourne Stock, Chief Executive Officer of Theolytics, said; “We’re on the brink of a potential step-change for the oncolytic adenovirus field. Our lead asset THEO-260 will be entering the clinic this year, and at this key juncture we are pleased to complete this significant financing and welcome Sound Bioventures as a new investor alongside our existing investors. Sound Bioventures’ extensive oncology experience, network, operational expertise and collaborative approach will bring important benefits to Theolytics and I am delighted to welcome Thomas Tan to our Board.”

Thomas Tan, Principal at Sound Bioventures, added; “The oncolytic virus modality is rapidly evolving, and we believe that Theolytics is well positioned at the forefront of this exciting therapy area. With THEO-260 about to enter the clinic, we see a significant opportunity to help bring an important and potentially practice-changing therapy to the many women suffering from this fatal disease. I look forward to working with the Board and management team bringing our hands-on approach to support the company’s unwavering fight against cancer.”

“THEO-260 has the potential to bring a much-needed new therapy to ovarian cancer patients and their families that are impacted by this devastating disease,” said Mike Grey, Executive Chair of the Board. “Theolytics is at a pivotal point as it approaches its first clinical trial and we are delighted to welcome Sound Bioventures, a highly knowledgeable and experienced investor with extensive oncology and company building expertise, to our group of leading international investors.”

About Ovarian Cancer (OC)

It is estimated that around 7,500 women in the UK and 20,000 women in the US will be diagnosed with ovarian cancer in 2024. More than 75% of cases will be diagnosed at an advanced stage (grade-III/IV) with less than 25% of patients expected to survive for more than five years.

Standard-of-care, first-line treatments combine cytoreductive-surgery, platinum-based chemotherapies, and paclitaxel. Although initially effective, more than 70% of patients relapse within three years and become resistant to platinum-based therapies. There are no effective treatments for platinum-resistant OC and at this point patients have a life-expectancy of less than 12 months.

About THEO-260

THEO-260 is a next-generation oncolytic adenovirus for the treatment of (platinum-resistant) ovarian cancer. It is highly efficacious in killing cancer cells and cancer-associated fibroblasts in ovarian cancer patient tumour samples. The destruction of cancer-associated fibroblasts, in addition to cancer cells, is a potentially differentiating feature of THEO-260 as cancer-associated fibroblasts in stromal-rich tumours are a barrier to the effectiveness of many cancer treatments. THEO-260 is being explored as a therapeutic for intravenous and intraperitoneal delivery.

About Theolytics

Theolytics is working to develop next-generation oncolytic viral therapies. The company has pioneered a new approach to develop efficacious, targeted candidates suitable for systemic intravenous delivery.

The company is focused on the advancement of its lead program THEO-260 into the clinic with the ambition of providing better outcomes for patients with ovarian cancer, for whom current treatment options are limited. Additional pipeline programmes in preclinical development include novel candidates developed for colorectal cancer and hematological malignancies where there remains significant unmet need.

Theolytics, which was founded in 2017 and is headquartered in Oxford, UK, is backed by international life sciences investors M Ventures, Taiho Ventures, Epidarex Capital, Oxford Science Enterprises, Sound Bioventures and the University of Oxford.

www.theolytics.com

About our Investors

For more information on our investors please see the following websites:
M Ventures
Taiho Ventures
Epidarex Capital
Oxford Science Enterprises
Sound Bioventures
The University of Oxford

Contacts

Theolytics
enquiries@theolytics.com

Laverock Therapeutics announces appointment of Ali Elsley as Finance Director and expansion of team

Posted on by

STEVENAGE, United Kingdom, March 26, 2024 (GLOBE NEWSWIRE) — Laverock Therapeutics, a gene-silencing company with a uniquely powerful technology for the development of programmable advanced therapies to tackle major diseases, today announces the appointment of Ali Elsley as Finance Director.

Ali has extensive experience in the biotechnology and pharma sector working with both private and public companies. She joins from Acacia Pharma Group plc, an early commercial-stage listed pharma company, where she was Group Financial Controller and Company Secretary and focused on equity fundraising, M&A activity and all aspects of financial operations. Prior to this, she spent 10 years as an auditor with PwC LLP in Cambridge, with a focus on early-stage biotech and pharma companies, together with advisory IPO work. She is a fellow of the Institute of Chartered Accountants in England and Wales and holds a degree in Archaeology and Anthropology from the University of Cambridge.

In addition to Ali’s appointment, Laverock has significantly grown its team to 24 people, representing growth of 50% over the past year, and expanded its R&D facilities in the Stevenage Bioscience Catalyst as it continues to build its capabilities following its £13.5m expanded seed round announced in September last year, the second highest seed investment by a UK company in 2023.

David Venables, CEO of Laverock, said: “Ali has an exceptional track record working with innovative biotechnology and pharma companies. I very much look forward to working closely with her and the rest of our fast-growing team as we continue to apply our uniquely powerful gene-silencing technology to the development of a new generation of programmable advanced therapies to tackle major diseases.”

Ali Elsley, FD of Laverock, said: “Laverock’s technology has the potential to create a step-change in advanced therapies and I have been hugely impressed with the pace of progress since joining the company. The management team and Board are exceptionally strong, and I believe we have a very solid foundation from which to deliver on the promise.”

For further information please contact:

Laverock Therapeutics:

E: contact@laverocktx.com

Media Enquiries :

Charles Consultants
Sue Charles – Sue@charles-consultants.com +44 (0)7968 726585
Chris Gardner – Chris@CGComms.onmicrosoft.com +44 (0)7956 031077

About Laverock Therapeutics

Laverock Therapeutics is a gene-silencing company with a uniquely powerful technology which harnesses the cell’s natural gene regulatory mechanisms to develop a new generation of programmable advanced therapies to tackle major diseases. Laverock’s truly innovative technology re-directs naturally-occurring micro RNAs (miRNAs) to conditionally silence genes in a way which is programmable, tunable, stable and specific. This opens a path to more effective, safer and accessible advanced therapies. Laverock is applying its technology through its own pipeline – targeting regenerative medicine and oncology – and through partnerships.

Laverock has a highly experienced leadership team with proven track records in biotechnology, pharma and academia, and an exceptionally strong Board. Laverock completed a £13.5m seed round in September 2023. Its high-calibre investors include Calculus Capital, Eli Lilly and Company, Mercia Ventures, Maven Capital Partners, Eos, UK Innovation & Science Seed Fund and Tekfen Ventures.

For more information, please visit www.laverocktx.com and follow us on LinkedIn.

MiNA Therapeutics Presents Late-Breaking Positive Phase 1b Data for MTL-CEBPA in Combination with an Anti-PD1 Checkpoint Inhibitor at the Annual American Association of Cancer Research (AACR) Meeting

Posted on by

MiNA Therapeutics Presents Late-Breaking Positive Phase 1b Data for MTL-CEBPA in Combination with an Anti-PD1 Checkpoint Inhibitor at the Annual American Association of Cancer Research (AACR) Meeting

MiNA Therapeutics Presents Late-Breaking Positive Phase 1b Data for MTL-CEBPA in Combination with an Anti-PD1 Checkpoint Inhibitor at the Annual American Association of Cancer Research (AACR) Meeting

Findings validate clinical proof of mechanism of MTL-CEBPA as a combination therapy in solid tumor cancers

Company to initiate out-licensing activities of its immuno-oncology portfolio, including MTL-CEBPA

LONDON–(BUSINESS WIRE)–MiNA Therapeutics Limited, the pioneer in small activating RNA (RNAa) therapeutics, will present positive updated biomarker data from its Phase 1a/b TIMEPOINT study of MTL-CEBPA in combination with the anti-PD1 checkpoint inhibitor, pembrolizumab, in adults with advanced solid tumors at the annual meeting of the American Association of Cancer Research (AACR) in Orlando, Florida. Findings from the Phase 1b portion of the study validate the clinical proof of mechanism of MTL-CEBPA as a combination treatment and identify a novel predictive biomarker of clinical response. The data will be presented on Tuesday, April 18, during a late-breaking research session beginning at 9:00 am EDT.

MTL‑CEBPA is the first therapy that specifically up-regulates CCAAT/enhancer binding protein alpha (C/EBP-α), a transcription factor that acts as a master regulator of myeloid cells. Dysregulated myeloid cells are implicated in several diseases including solid tumor cancers. MTL-CEBPA is designed to improve the effectiveness of checkpoint inhibitors and other immunotherapies by enhancing the body’s immune response and ability to attack the cancerous cells. Interim data from an open-label, multi-center study demonstrated the safety, tolerability, immunological and clinical activity of MTL-CEBPA in combination with pembrolizumab.

“Anti-PD1 checkpoint inhibition has significantly advanced the treatment of cancer, but many patients are resistant to treatment and present with tumors that resemble an ‘immune-desert’,” said Robert Habib, CEO of MiNA Therapeutics. “The updated analysis of TIMEPOINT shows that MTL-CEBPA used in combination with anti-PD1 checkpoint inhibitors profoundly reprograms the tumor microenvironment, reducing resistance and enabling infiltration of disease-fighting T-cells.”

The TIMEPOINT study also identified a novel predictive biomarker of clinical response to the combination treatment, presenting an opportunity for further evaluation as a potential companion diagnostic. The novel biomarker predicted clinical response across multiple tumor types.

MiNA plans to explore out-licensing opportunities for its immuno-oncology portfolio, which uniquely combines the capability to specifically restore or boost any dysregulated gene target with clinically validated in vivo delivery to myeloid immune cells.

MiNA’s immuno-oncology portfolio includes the following programs:

MTL‑CEBPA, which has been cleared for evaluation in a global Phase 2 clinical trial in combination with the tyrosine kinase inhibitor, sorafenib, in advanced hepatocellular carcinoma (HCC or liver cancer) and in a Phase 1 clinical trial in pediatric patients with MPS1 Hurler Syndrome
MTL-STING currently in pre-clinical development
Additional programs currently in discovery

About TIMEPOINT

TIMEPOINT is a global Phase 1a/b clinical study in patients with solid tumor malignancies to assess the safety and tolerability of MTL‑CEBPA in combination with pembrolizumab in patients who are ineligible or resistant to standard therapies. The study has received clearance from the U.S. Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). To learn more about the TIMEPOINT clinical study, visit ClinicalTrials.gov (NCT04105335).

The poster presentation at AACR entitled, “MTL-CEBPA in combination with pembrolizumab converts an immune desert to an inflamed TME in solid tumors resistant to checkpoint blockade,” will be available on MiNA’s website in the Publications section under “RNA Activation”.

About MTL-CEBPA

MTL-CEBPA is the first therapy that specifically up-regulates CCAAT/enhancer binding protein alpha (C/EBP-α), a transcription factor that acts as a master regulator of myeloid cell lineage determination and differentiation. Dysregulated myeloid cells have been implicated in several diseases, and in solid tumor cancers these cells have been identified as a critical barrier to induction of clinical response for many therapies. In pre-clinical studies, MTL-CEBPA has been shown to improve the anti-tumor activity of cancer therapies by targeting dysregulated myeloid cells and reducing or eliminating their suppressive effect on immune response and therapies in the tumor microenvironment.

About MiNA Therapeutics

MiNA Therapeutics is the global leader in small activating RNA therapeutics or RNAa. Harnessing innate mechanisms of gene activation, RNAa therapeutics are a revolutionary new class of medicines that can restore or boost normal function of genes and thereby protein-modulated pathways in patients’ cells. We are advancing a proprietary pipeline of new medicines with an initial focus on genetic medicine, while collaborating with leading pharmaceutical companies to apply our technology platform across a broad range of other therapeutic areas. Based on our unique know-how in RNA activation, we are expanding the possibilities of RNA-based medicine for patients. www.minatx.com

Contacts

MiNA Therapeutics

Peter Bains, CBO

+44 208 811 6700

bd@minatx.com

Media:
Mike Beyer

Sam Brown, Inc.

mikebeyer@sambrown.com
+1 312-961-2502