AcuraBio (formerly Luina Bio), a leading Australian biopharmaceutical CDMO, has been acquired by biotech investor Dr. Glenn Haifer and Ampersand Capital Partners, a global healthcare private equity firm.
With more than two decades of experience, AcuraBio is a globally focussed organization bringing innovative therapeutics to market for customers in the biotech, pharmaceutical, and animal health industries. AcuraBio provides recombinant proteins and vaccines, and complex live biotherapeutic products to customers on the leading edge in emerging therapeutics.
The rebranding of the company signifies an innovative new growth phase for AcuraBio. As part of the transaction, Dr. Haifer and Ampersand are bringing significant investment to the company, with a focus on expanding the organization to better serve customers. To fuel additional growth, AcuraBio is planning to increase production facility capacity, and is actively evaluating expansion into new service offerings and technological capabilities.
Dr. Haifer brings a wealth of experience to AcuraBio, as the former company Chairman and investor behind Australian biotech successes such as Agilex Biolabs and Avance Clinical. “We are very excited to be reinventing a company with such deep scientific experience,” said Dr. Haifer. “With our deep expertise and commitment to further investment, AcuraBio will be a leader in the APAC region for international biopharma clients attracted by the technology, scientific excellence, and innovation we will bring to the platform. I am excited to leverage Ampersand’s industry expertise as we take AcuraBio to the next level.”
Based in the US and with more than $3 billion of assets under management, Ampersand is exclusively focused on growth-oriented investments in the healthcare sector. Ampersand has previously partnered with leading CDMOs such as Brammer Bio, ArrantaBio, Vibalogics, and Genezen, and the firm is a highly experienced investor in the emerging therapeutics CDMO industry. David Anderson, General Partner at Ampersand, said “AcuraBio is strategically positioned in Australia to support international biopharma drug development. Australia has a strong reputation for clinical and scientific excellence which is the foundation to success for a company like AcuraBio. We are extremely pleased to be working with Dr. Haifer, who is a proven biotech investor and growth strategist with a real focus on client-centric service innovations.”
About AcuraBio
AcuraBio Pty Ltd is one of Australia’s most experienced biopharmaceutical CDMOs, offering trusted, client-focused services to both domestic and international clients for the past 20 years. AcuraBio offers significant quality, cost, and IP assurances for biopharma companies around the world. World-class researchers and proven facilities, a streamlined regulatory framework, generous tax incentives, and government funding make Australia a prime location for biotech research. AcuraBio has the following operating licenses: TGA (Australian FDA equivalent) license for the manufacture of human therapeutic APIs from biological and synthetic sources, APVMA (veterinary equivalent of the TGA) license for manufacture of sterile immunobiological products, OGTR license to produce products from genetically modified organisms, and a DAF facility license for import and use of biologic materials. Additional information about AcuraBio is available at www.acurabio.com.
About Ampersand Capital Partners
Founded in 1988, Ampersand is a middle market private equity firm with more than $3 billion of assets under management dedicated to growth-oriented investments in the healthcare sector. With offices in Boston and Amsterdam, Ampersand leverages its unique blend of private equity and operating experience in seeking to build value and drive strong long-term performance alongside its portfolio company management teams. Ampersand has helped build numerous market-leading companies across each of the firm’s core healthcare sectors. Additional information about Ampersand is available at www.ampersandcapital.com.
Category: Clinical Trials
Avance Clinical Sponsors Biotech Company of the Year Awards at Informa Pharma Intelligence Awards 2022
Avance Clinical, the leading Australian CRO for international biotechs, is sponsoring two awards – Biotech Company of the Year Private and Public – at the Informa Pharma Intelligence Awards 2022 and is also a finalist for the Best Contract Research Organization in APAC.
The Biotech Company of the Year awards recognize achievements including “moving the business from an early stage to a more mature company, signing a transformative deal, taking its first or a major new product towards the market, or raising significant new funds”.
CEO Yvonne Lungershausen and Chief Strategy Officer Ben Edwards are attending the awards night and hosting a table for biotech clients in Japan next week.
Avance Clinical, which is backed by global private equity firm The Riverside Company, is in the process of regional and international expansion plans.
Along with Avance Clinical, the finalists for the Best Contract Research Organization APAC are:
- Calyx
- CMIC Group
- EPS
- ICON
- Parexel
- Syneos Health
Avance Clinical’s CEO Yvonne Lungershausen said: “Avance Clinical is extremely pleased to be sponsoring these biotech awards. We are the CRO for international biotechs and this collaboration with Informa Pharma Intelligence shows our ongoing support and investment for the biotech industry.”
The finalists for Biotech Company of the Year – Private:
- ARTham Therapeutics
- Chordia Therapeutics
- Cuorips
- Heartseed
- Prism BioLab
- Rebirthel
- ReboRNA Biosciences
- TMS
The finalists for Biotech Company of the Year – Public:
- NanoCarrier
- Rakuten Medical (Rakuten Group Inc.’s equity accounted affiliate)
- Sosei Heptares
- Stella Pharma
- StemCell Institute
“In addition, we are extremely honored to be selected as a finalist for the prestigious award Best Contract Research Organization in APAC. It is a credit to our customer-focused team for delivering world-leading CRO services for biotechs which has been recognized by the Informa Pharma Intelligence award judges. Avance Clinical has a global reputation for agile clinical solutions to support accelerated clinical development for our international biotech clients. We are very proud of our growth and success in recent years.”
According to Informa Pharma Intelligence, this Award is to recognize CROs that provide full or specialist services to their clients and which have an office in either in Japan or the Asia region including Australia. Judging considers the quality of services and relationships built with clients and pays particular attention to the innovative patient recruitment strategies the CRO has brought to the table. The award is based on achievements in the 2021 calendar year.
Core areas judged include:
- The particular capabilities and strengths the CRO offers
- How the company has delivered results that exceed sponsor expectations
- Innovations in patient recruitment strategy has the CRO brought to its partner
- How it has improved its performance, for example, in its quality of data, timelines and transparency
- The steps the company is taking towards streamlining data collection and reporting
To find out more please visit: https://pharmaintelligence.informa.com/events/awards/japan-awards-2022/shortlist-2022
Avance Clinical is the Australian-owned CRO that provides global regulatory standard clinical research services across all phases to the local and international biopharma industry. The company is also accredited as a gene technology CRO under the Office of the Gene Technology Regulator (OGTR) which has allowed it to expand into clinical trials for vaccines and GMO therapies.
“We have shown, with our high growth and industry-leading repeat business rates that our focus on gold standard technology paired with solution-orientated clinical experts is the mix our biopharma clients require in this fast-moving, competitive and high-stakes sector,” said Lungershausen.
Avance Clinical has been recognised for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award.
Find out more:
– Learn about the Australian Advantage here https://www.avancecro.com/the-australian-advantage/
– Read more about Avance Clinical’s cell and gene therapy capabilities here www.avancecro.com/avance-clinical-featured-in-endpoints-news-on-cell-gene-therapy-capabilities/
– For more information about the benefits of running your next study with Avance Clinical contact us: enquiries@avancecro.com
About Avance Clinical
Avance Clinical is the largest premium full-service Australian CRO delivering quality clinical trials, with globally accepted data, in Australia and New Zealand for international biotechs. The company’s clients are biotechs in their early phases of drug development that need fast, agile, and adaptive solution-oriented clinical research services.
Frost & Sullivan Awards
Avance Clinical, a Frost & Sullivan Asia-Pacific CRO Market Leadership Award recipient for the past two years, has been providing CRO services in the region for more than 24 years.
Pre-clinical through to Phase 1 and 2
Avance Clinical offers pre-clinical services with their experienced ClinicReady team right through to Phase 1 and 2 clinical services leveraging significant Government incentive rebates of up to 43.5% and rapid start-up regulatory processes. With experience across more than 110 indications, the CRO can deliver world-class results and high-quality internationally accepted data for FDA and EMA review.
Technology
Avance Clinical uses state-of-the-art technology and gold standard systems across all functional areas to provide clients with the most effective processes. Medidata, Oracle, IBM Watson and Medrio are just some of the technology partners.
Media Contacts:
Avance Clinical
Chris Thompson
media@avancecro.com
Legend Capital Portfolio: China-leading CRO Enterprise R&G Pharmastudies Listed on the ChiNext Market Successfully
On August 2, 2022, R&G Pharmastudies Co., Ltd. (SHE: 301333), a China-leading CRO enterprise invested by Legend Capital, was successfully listed on the ChiNext of Shenzhen Stock Exchange. R&G Pharmastudies publicly issued 15,000,000 shares at a price of RMB78.88 per share, and the total amount of funds raised is expected to be RMB1.18 billion.
R&G PharmaStudies is a large-scale professional clinical trial outsourcing service supplier in China. It has established a complete set of pharmaceutical R&D outsourcing service systems covering the whole chain of clinical trials. R&G PharmaStudies provides integrated services throughout the entire process of clinical trials with its comprehensive drug R&D service system; the main services offered by the company cover clinical trial operation services, clinical trial site management services, biological sample testing services, data management, and statistical analysis services, clinical trial consulting services, clinical pharmacology services, etc. R&G PharmaStudies is committed to providing high-quality and efficient clinical research services in line with international standards. With a broad and high-quality customer base, it has provided professional services for about 750 Chinese and foreign pharmaceutical companies.
Legend Capital invested in the Series A round of R&G PharmaStudies in the second half of 2017 and has kept on supporting the development of R&G PharmaStudies. Jafar Wang, the Co-Chief Investment Officer of Legend Capital, said, “Congratulations on the successful listing of R&G PharmaStudies! R&G PharmaStudies is a veteran of China’s pharmaceutical clinical CRO industry and has long provided full-chain clinical CRO services for Chinese and foreign innovative pharmaceutical enterprises. The successful listing will be the starting point of the new long run of R&G PharmaStudies; with its global vision, well-known expert team, and high-quality service system, we are optimistic about the long-term development potential of R&G PharmaStudies, and look forward to the continuous growth of the company.”
Legend Capital has a systematic layout in CRO/CDMO. In addition to R&G PharmaStudies, Legend Capital has invested in plenty of other new-drug R&D CRO/CDMO companies, such as WuXi Apptec, WuXi Biologics, Pharmaron, Bellen, ClinChoice, SAFE Pharmaceutical, dMed Biopharmaceutical, XiHua Scientific, BirdoTech, Intellective Biologics, Biortus, and Simoon Record.
About Legend Capital
Founded in 2001, Legend Capital is a leading VC&PE investor focusing on the early-stage and growth-stage opportunities in China, with offices across Beijing, Shanghai, Shenzhen, Hong Kong, and Seoul, Korea.
It currently manages USD and RMB funds of over US$10 billion in commitments and has invested in around 600 companies, covering technology, healthcare, consumer, enterprise service and intelligent manufacturing sectors. Rooted in China, Legend Capital participated in the rise of many world-leading companies through solid investment coverage and systematic post-investment value-add. Over the years, Legend Capital has also become a widely recognized name in bridging key resources in China and overseas through cross-border activities, and a valuable partner to Chinese and overseas investors.
Legend Capital values long-term sustainable investment and incorporates ESG into its long-term development strategy. As a UNPRI signatory since November 2019, Legend Capital is among the first group of top VC/PE firms in China to join the initiative.
For more information, please visit www.legendcapital.com.cn/index_en.aspx and follow us on LinkedIn @Legend Capital (https://www.linkedin.com/company/legend-capital).
Virios Therapeutics: The ‘Virus Hypothesis’ That Stands to Change the Lives of 10M Americans
Company’s September Phase 2b trial results could be transformative for fibromyalgia patients
PCG Digital — Life may change for the better for the 10 million Americans suffering from fibromyalgia. The development-stage biotech Virios Therapeutics, Inc. (Nasdaq:VIRI) is anticipating the reporting of phase 2b treatment results for its lead fibromyalgia treatment candidate this September and continues to add value through its research and development of compelling clinical assets for multiple categories of viruses.
Humans and viral pathogens have co-existed for millennia. Some human viruses are gone as quickly as they came, while others – such as the herpes virus – are able to co-exist with a human’s immune system, leaving genetic material permanently in the host’s cells.
Nearly four billion people around the world are infected with herpes viruses. Most of us don’t even know if we are infected and the virus may remain dormant in the body for months or years before reactivating in response to stress.
Dr. William Pridgen, the founder of Virios Therapeutics, Inc. has observed the effects of virus reactivation firsthand. In 2002, he noted recurring functional gastrointestinal disorder symptoms (“FGIDs”) in his surgical patients that waxed and waned, worsening in times of stress. He observed that his treatment protocol for these patients – a combination of antiviral drugs – not only improved his patient’s FGIDs, but also alleviated symptoms including pain, fatigue, depression and fibromyalgia (FM).
We spoke with Dr. Pridgen to learn more about the virus hypothesis and why he thinks Virios Therapeutics’ lead candidate could potentially be life-changing for the 10 million Americans living with FM.
Q: Can you tell us about FM and how IMC-1, Virios Therapeutics’ lead product candidate, could potentially be an effective treatment?
FM is a chronic pain disorder characterized by severe fatigue, gastrointestinal and sleep disturbances and increased levels of depression and anxiety. It can be difficult to diagnose – on average, patients wait five years for a diagnosis, due to the lack of widely-accepted medical testing – and the disorder can be even harder to treat. There are currently three FDA approved drugs available to FM patients, each of which treat the symptoms of FM, rather than targeting a potential underlying cause of the disease. All three approved medications work to control pain, but often induce side-effects which can limit their utility when used chronically, as is required to manage FM. As a result, patients are largely dissatisfied with available treatments.
In a recent phase 2a double-blind randomized controlled trial, FM patients who took IMC-1 reported statistically significant improvements in pain, fatigue, anxiety and depression compared with patients treated with placebo. Notably, IMC-1 was better tolerated than placebo in this proof-of-concept trial. A follow-on phase 2b trial of IMC-1, called FORTRESS (Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of HSV-1), is fully recruited, with results expected to be reported in September 2022.
Q: How does IMC-1 work?
It is my belief that viral outbreaks of herpes resident in the central nervous system, where the brain amplifies the aberrant pain processes that the research community believes is causing FM. Our lead development candidate, oral IMC-1, offers the exciting potential to treat a potential root cause of fibromyalgia – not just management of select symptoms – but by suppressing viral activity and improving FM patients symptoms and functioning.
IMC-1 is a fixed-dose combination of two medications, famciclovir and celecoxib, that work together to inhibit replication of activated herpes viruses and convert activated herpes back into a dormant state. Famciclovir inhibits viral DNA polymerase, a key enzyme that the virus uses to make DNA and replicate. Meanwhile, celecoxib inhibits a different enzyme, cyclooxygenase-2, which is upregulated during herpes virus replication. By targeting two enzymes important for viral replication, this combination treatment has to-date proven to effectively treat FM, and because of the novelty of the approach, has garnered the first-ever FDA “fast track” review designation.
Q: Based on your real-world experience, can you tell us more about how IMC-1 has the potential to change lives?
Living with FM can be debilitating and isolating. Affected patients carry a three times greater risk for committing suicide. Patients fight for a diagnosis for years, and when they get their diagnosis, they are often unsatisfied with their prescribed treatment. In my practice, and in research carried out with my colleague, virologist Dr. Carol Duffy, we have seen marked increase in the presence of actively replicating herpes simplex virus type 1 in gastric mucosal tissue from patient groups with functional gastrointestinal disorders and with FM, as compared to control patients.
In my experience, IMC-1 treats the potential root cause of several somatic syndrome disorders, and we’ve demonstrated that the two antivirals together do something that individually the components failed to achieve, notably, reducing the symptoms associated with a FM diagnosis. By targeting the potential viral trigger of FM, we hope to not only treat acute FM symptom “flare-ups”, but also delay future FM “flare-ups” by keeping the herpes virus in a dormant state through chronic administration of IMC-1.
Q: Virios has been working through rigorous clinical trials to establish the safety and efficacy of IMC-1. What can we expect to see next from the company?
A: Virios announced in April that it had completed enrollment in its 425 patient Phase 2b FORTRESS clinical trial, which is a testament to the interest and motivation that clinicians, investigators and patients have shown about being involved in the study. The study will build on the statistically significant results from Virios’ previous clinical study, which evaluated 143 FM patients, and demonstrated that IMC-1 improved FM patient pain, fatigue, anxiety and depression, as well as improved their overall functioning. Importantly in the context of current patient dissatisfaction with FDA approved medications, IMC-1 was statistically better tolerated than placebo. If IMC-1 proves to be as effective and well tolerated in the ongoing Phase 2b trial as it was in the completed Phase 2a trial, we think we have a potential game changing therapy for FM patients worldwide.
Virios expects to report top line results for its phase 2b FORTRESS clinical trial in September 2022. At the same time, the company is completing chronic toxicology studies in preparation for future FM Phase 3 program discussions with FDA. It is an exciting time for Virios and its shareholders but more than that, it has the potential to completely change the lives of FM patients.
Forward-Looking Statements
Statements in this press release contain “forward-looking statements,” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “suggest,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Virios Therapeutics’ current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including risks related to the success, cost and timing of Virios Therapeutics’ preclinical studies and clinical trials; its ability to obtain regulatory approval for IMC-1, IMC-2 and any future product candidates; the company’s need for additional funding; and Virios Therapeutics’ ability to develop and, if approved, commercialize its product candidates. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in the Annual Report on Form 10-K for the year ended December 31, 2021, filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Virios Therapeutics, Inc. (VIRI) undertakes no duty to update such information except as required under applicable law.
Disclaimer
This communication was produced by PCG Digital Holdings, LLC, an affiliate of PCG Advisory Inc., (together “PCG”). PCG is not a registered or licensed broker-dealer nor investment adviser. No information contained in this communication constitutes an offer to sell, a solicitation of an offer to buy, or a recommendation of any security. PCG may be compensated by respective clients for publicizing information relating to its client’s securities. See www.pcgadvisory.com/disclosures.
PCG Digital
info@pcgadvisory.com
646-863-6341
Novotech’s Flexible Work Policy is Finalist in Best Workplace Flexibility Program “Excellence Award 2022”
Novotech, the leading Asia Pacific biotech specialist CRO with expanded services in the US, has been recognised for its innovative approach to workplace flexibility.
Novotech CEO Dr. John Moller said: “Our flexible workplace design, information technology infrastructure, and flexible resourcing of projects are consistently delivering successful outcomes for our team members, clients, and all stakeholders. We are extremely pleased our workplace flexibility efforts are recognised by the Best Workplace Flexibility Program which has selected Novotech as an Excellence Awardee in 2022.”
Novotech Chief People Officer Angela Edwardson said that “over the last 12 months, Novotech has re-imagined what flexible working looks like for teams, clients, and the business. This renewed way of working incorporates flexible, remote, and in-office working options and aims to create a dynamic business environment and trusted culture. Team members can determine and apply the most effective way to work, unlocking the maximum value of their talent to benefit all stakeholders.”
Some of the new flexible working policies include:
- FlexLocation: Work from home, office or other suitable location.
- FlexTime: Flexible start/finish times
- FlexBreak:Bbreaks during the day for wellbeing or other commitments.
- FlexHours: An adjustment to contracted hours, either permanently or temporarily (ie: full-time to part-time).
- FlexPlace: The option to work at other Novotech offices or cities/countries without a Novotech office temporarily.
- FlexStudy: A combination of Flex options and/or leave to meet study commitments.
- FlexHolidays: The option to select alternate dates in lieu of allocated celebration/public holidays.
- FlexLeave: Leave can be taken by the hour and in combination with other leave types and flexible options.
- FlexTimeout: Extended unpaid leave to pursue and interest, relax or attend to caring responsibilities
- FlexPersonal: A combination of day-to-day and/or planned options.
“Already 17 team members have used or are planning to use FlexPlace in 2022,” said Edwardson. “Novotech has a large cohort of expatriate workers, and our new addition of FlexPlace supports them to re-connect with their families and friends or travel while still meeting their working requirements.”
Novotech’s Asia-Pacific and US teams support cost-effective expedited clinical research with world-class data and the most advanced technology including solutions that enable acceleration of clinical trials across the regions.
Novotech now has a workforce of ~2,500 clinical trial professionals across Australia, South Korea, Greater China, Southeast Asia, India, South Africa and the US.
Asia-Pacific offers a compelling solution for expedited clinical trials especially in oncology with its vast patient populations, less competitive clinical trial landscape, and world-class KOLs, in addition regulatory reforms, such as those in China, have accelerated approval processes.
The expansion into the US provides US-based expertise and infrastructure for our US clients wanting trials in APAC and the US, and for our APAC clients wanting US clinical programs.
About Novotech
Novotech is the leading Asia-Pacific biotech specialist CRO. Novotech has integrated labs and phase I facilities and provides drug development consulting and clinical development services across all phases. It has been instrumental in the success of approximately 4,000 clinical trials across a broad range of therapeutic areas. Novotech is well-positioned to serve biopharma clients conducting clinical trials in Asia-Pacific and the US. For more information visit https://novotech-cro.com/contact
Media Contact
David James
E: communications@novotech-cro.com
AU: +61 2 8218 2144
USA: +1 415 951 3228
Asia: +65 3159 3427
TrialWire Technology Platform Rolls Out World First SMS/Text Patient Contact System Across all Studies Globally
TrialWire(TM) Technology Platform, the most secure and rapid digital patient recruitment Platform for trial rescue, today announced the rollout of the proprietary SMS/Text patient contact system across all studies globally.
The SMS/Text patient contact system is a world first in speed, security, and compliance for study coordinators contacting patients to discuss their study application and site bookings.
It is primarily designed to speed up the contact process which is typically delayed using phone or email. Up to 50% of patients can be lost due to contact failure because they often don’t answer an unknown number call from a site. In addition, study coordinators often can’t afford the time to call more than 3-4 times in the hope of connecting with the patient.
TrialWire has found from patient responses that 92% want to be contacted by SMS/Text so this was a driving force behind the development and rollout of the service. This includes studies for older people.
The SMS/Text system can support all languages and keeps a record in the study coordinator’s Dashboard of all conversations.
Most study coordinators are using the contact system to arrange then confirm times for screening calls, or site screening visits.
TrialWire recruitment can start in under 24-hours because the Platform doesn’t require approvals.
The TrialWire Technology Platform includes:
- Dedicated secure dashboards for each Study Coordinator where they can review patient details and medical information
- Multiple dashboards per site so all Study Coordinators can see real-time progress
- Dashboards for sponsors and CROs where they can see de-identified referral status information
- Secure SMS system inside their dashboards for instant communications with the patient
- book calls and screening visits
- Automated AI-Match and algorithm-driven “find and screen” patients process
- Minute-by-minute metrics for Study Coordinators showing numbers referred, contacted, screened, and enrolled at their site
- Minute-by-minute metrics for sponsors and CROs showing numbers referred, contacted, screened, and enrolled – across all sites on a study
- HIPAA compliance and all patient privacy security
- Built on the Salesforce Health Cloud
- Unlimited number of sites globally
- Available in all languages
With more than 80% of clinical trials failing to recruit patients on time, and 30% of research sites not able to meet enrollment goals – 10% of sites don’t enroll any patients – TrialWire offers peace of mind for sponsors and their CROs.
TrialWire is ideal for sponsors and CROs wanting to avoid extended recruitment delays.
Request more information here – starts in 24 hours https://trial-wire.com/contact/
Learn more here https://www.trial-wire.com/
About TrialWire www.trial-wire.com
TrialWire is a privately held technology company that leverages 25 years of experience in the clinical trial patient recruitment sector. TrialWire, which is solving the most serious problem in the drug development sector, has a recent valuation of USD$27m.
Its mission is to end the patient recruitment crisis delaying the development of new therapies which is costing drug companies billions of dollars a day due to problems finding the right people quickly and enrolling them at the site level.
The TrialWire Platform is the most secure service (powered by Salesforce Health Cloud) that uses advanced algorithms to find the right people who are online that might be suitable for studies available on the Platform. They are invited into the Platform and taken through the AI-Match screener to determine an exact match to a study – site-based or remote/virtual. No account sign-up is required to find and apply for a study. The Platform ingests study data from approved trial registries like ClinicalTrials.Gov. It uses advanced online algorithms to find patient/trial matches based on detailed demographic and location profiles.
Key to the TrialWire success is that it finds motivated people who are actively online trying to find out more about their conditions. They can be connected to a site in under 2 minutes. These people have high retention rates. Unlike all other digital recruitment firms, TrialWire does NOT keep patient details once a study is completed – no databases so no potential privacy breaches. Sponsors are not paying for database building where patients are sent to other studies.
Therapeutic Goods Administration Grants Provisional Approval for Moderna’s COVID-19 Vaccine in Children Aged Six Months to Five Years
- Announcement follows recent authorization of the Company’s mRNA COVID-19 vaccine in Argentina, Canada, Israel, the US, and Taiwan for active immunization to prevent COVID-19 caused by SARS-CoV-2 in children aged 6 months to five years
Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the Therapeutic Goods Administration (TGA) in Australia has granted provisional registration for the use of Moderna’s mRNA COVID-19 vaccine, Spikevax, in a two-dose series of 25 ug per dose for active immunization to prevent COVID-19 caused by SARS-CoV-2 in children aged 6 months to 5 years. Until now, children under six were the only age group not eligible for vaccination against COVID-19 in Australia.
“We are pleased that our vaccine for children under six years of age has received provisional approval by the TGA,” said Michael Azrak, General Manager of Moderna for Australia and New Zealand. “The continued evolution of COVID-19 represents an emergent threat to global public health, including young children. Since the onset of the pandemic, we have worked with a deep sense of responsibility to deliver on the promise of mRNA science to all Australians. The approval from TGA helps extend an opportunity to all parents and caregivers in Australia to protect their young children against SARS-COV-2.”
Positive interim results from the Phase 2/3 KidCOVE study, announced on March 23, 2022, showed a robust neutralizing antibody response in the 6-month to 5 years of age group after a two-dose primary series of mRNA-1273, along with a favorable safety profile. The antibody titers in the pre-specified 6 month to 23 month and 2 years to 5 years of age sub-groups met the statistical criteria for similarity to the adults in the COVE study, which satisfied the primary objective of the study. Preliminary efficacy analysis on PCR-confirmed cases collected during the Omicron wave showed similar efficacy estimates against Omicron in the 6-month to 5 years of age group to those in adults after two doses of mRNA-1273.
The KidCOVE study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services. The ClinicalTrials.gov identifier is NCT04796896.
Moderna is committed to supporting the Australian Government on the COVID-19 program implementation in children aged 6 months to five years upon receiving a recommendation from the Australian Technical Advisory Group on Immunisation (ATAGI).
The TGA previously approved the use of Moderna’s mRNA COVID-19 vaccine, Spikevax (elasomeran mRNA vaccine), for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals aged six years or over.
Authorized Use
Therapeutic Goods Administration has provisionally approved the use of Moderna’s mRNA COVID-19 vaccine, Spikevax (elasomeran mRNA vaccine), for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older.
About Moderna
In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both ground-breaking science and rapid scaling of manufacturing. Most recently, Moderna’s capabilities have come together to allow the authorized use and approval of one of the earliest and most-effective vaccines against the COVID-19 pandemic.
Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.
Forward Looking Statements
This post contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding: the development of the Company’s COVID-19 Vaccine (mRNA-1273, or Spikevax); the approval of the vaccine in children ages 6 months to 5 years by the Therapeutic Goods Administration; and the safety, efficacy, and tolerability of the vaccine in children ages 6 months to 5 years of age. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include those other risks and uncertainties described under the heading “Risk Factors” in Moderna’s most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this post in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna’s current expectations and speak only as of the date hereof.
Moderna Contacts
Media:
Luke Mircea-Willats
Director, Media Relations & Communications
Luke.mirceawillats@modernatx.com
Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
617-209-5834
Lavina.Talukdar@modernatx.com
SOURCE: Moderna, Inc.
Novotech and Endpoints Present “Evolution of Cell & Gene Therapy in China: The Case for Universal CAR-T”
Novotech, the leading Asia Pacific biotech specialist CRO with expanded services in the US, is pleased to present an Endpoints webinar on CAR-T therapy in China – the current landscape and future opportunities.
China now represents 60% of clinical development in CAR-T therapy development globally. This webinar will cover learnings to date and future opportunities.
Specific areas covered include:
- The current landscape for biotech CAR-T therapy research in China
- CAR-T clinical development in China: key areas of focus
- Potential opportunities related to universal CAR-T cell therapy development
- The challenges of allogeneic CAR-T cell therapy
Register here: https://webinars.endpts.com/evolution-of-cell-gene-therapy-in-china-the-case-for-universal-car-t/
Webinar Date:
- July 19, 2022
- 1:00 pm – 2:00 pm EDT
Moderator:
- Arsalan Arif, Founder and Publisher Endpoints News
Presenters:
- Dr. Jie Cheng, Chief Medical Officer Bioheng
- Dr. Vivian Gu, Vice President, Clinical Development & Regulatory, CMO, Novotech China
- Dr Kai Xue, Associate Professor, Department of Haematology, Ruijin Hospital, Shanghai, China
According to Global Data: “Over the last five years more than 70,000 new clinical trials were registered in the APAC region, the US, and the EU5. The APAC region was the largest contributor, with more than 50% of the trials followed by the US (29%) and the EU5 (17%). The APAC region has become the preferred destination for conducting clinical trials due to its large patient population, ease of regulatory compliance, lower cost of conducting studies, high-quality standards and the presence of top clinical sites.”
Novotech CEO Dr. John Moller said: “The Asia-Pacific is the fastest-growing clinical trial destination for biotechs, with China being the leading location for new trials followed by the US. Novotech, which has a reputation for delivering full-service, high-quality expedited clinical trials in Asia-Pacific, also offers its biotech clients clinical services in the US to support later phase global studies. Novotech’s service delivery model is tailored to the needs of biotech clients. Our local teams have exceptional site and investigator access, our project management approach emphasises problem-solving, ownership and flexibility, and our investments in data and technology ensure clients have real-time access to trial performance.”
Novotech has recently been benchmarked as a top 10 CRO among the world’s leading CROs, and has signed 45 Leading Site Partnership agreements over the last 3 years.
About Novotech
Novotech is the leading Asia-Pacific and US biotech specialist CRO. Novotech has integrated labs and phase I facilities and provides drug development consulting and clinical development services across all phases. It has been instrumental in the success of approximately 4,000 clinical trials across a broad range of therapeutic areas. Novotech is well-positioned to serve biopharma clients conducting clinical trials in Asia-Pacific and the US. For more information visit https://novotech-cro.com/contact
Media Contact
David James
E: communications@novotech-cro.com
AU: +61 2 8218 2144
USA: +1 415 951 3228
Asia: +65 3159 3427
TrialWire Technology Platform Announces Success-based Patient Recruitment Plan
TrialWire(TM) Technology Platform, the fastest and most secure digital patient recruitment Platform for trial rescue powered by Salesforce Health Cloud, today announced the launch of its success-based recruitment plan.
With clinical budgets and investment funds tightening globally, TrialWire is supporting the biotech drug development sector with a success-based patient recruitment solution.
Designed to help manage budgets, the Success-based Plan means sponsors only pay when a person is actually enrolled in a study.
In addition, recruitment can start in under 24-hours because the Platform isn’t subject to the normal lengthy approval processes.
The Success-based Plan includes all the normal benefits from the TrialWire(TM) Technology Platform:
- Dedicated secure dashboards for each Study Coordinator where they can review patient details and medical information
- Multiple dashboards per site so all Study Coordinators can see real-time progress
- Dashboards for sponsors and CROs where they can see de-identified referral status information
- Secure SMS system inside their dashboards for instant communications with the patient – book calls and screening visit
- Automated AI-Match and algorithm-driven “find and screen” patients process
- Minute-by-minute metrics for Study Coordinators showing numbers referred, contacted, screened, and enrolled at their site
- Minute-by-minute metrics for sponsors and CROs showing numbers referred, contacted, screened, and enrolled – across all sites on a study
- HIPAA compliance and all patient privacy security
- Built on the Salesforce Health Cloud
- Unlimited number of sites globally
- Available in all languages
With more than 80% of clinical trials failing to recruit patients on time, and 30% of research sites not able to meet enrollment goals – 10% of sites don’t enroll any patients – TrialWire(TM) offers peace of mind for sponsors and their CROs.
TrialWire(TM) is ideal for sponsors and CROs wanting to avoid extended recruitment delays.
Request more information here https://trial-wire.com/contact/
Learn more here https://www.trial-wire.com/
About TrialWire(TM) www.trial-wire.com
TrialWire(TM) is a privately held technology company that leverages 25 years of experience in the clinical trial patient recruitment sector. TrialWire(TM), which is solving the most serious problem in the drug development sector, has a recent valuation of USD$27m.
Its mission is to end the patient recruitment crisis delaying the development of new therapies which is costing drug companies billions of dollars a day due to problems finding the right people quickly and enrolling them at the site level.
The TrialWire(TM) Platform is the most secure service (powered by Salesforce Health Cloud) that uses advanced algorithms to find the right people who are online that might be suitable for studies available on the Platform. They are invited into the Platform and taken through the AI-Match screener to determine an exact match to a study – site-based or remote/virtual. No account sign-up is required to find and apply for a study. The Platform ingests study data from approved trial registries like ClinicalTrials.Gov. It uses advanced online algorithms to find patient/trial matches based on detailed demographic and location profiles.
Key to the TrialWire(TM) success is that it finds motivated people who are actively online trying to find out more about their conditions. They can be connected to a site in under 2 minutes. These people have high retention rates. Unlike all other digital recruitment firms, TrialWire(TM) does NOT keep patient details once a study is completed – no databases so no potential privacy breaches. Sponsors are not paying for database building where patients are sent to other studies.
Novotech Client SK bioscience Achieves SKYCovione(TM) COVID-19 Vaccine Approval in Korea
Novotech, the leading Asia Pacific biotech specialist CRO which has recently expanded its services to the US, congratulates its client SK bioscience on the recent COVID-19 vaccine licence approval.
SK bioscience and GSK recently announced the successful authorization:
SK bioscience announced that ‘SKYCovione(TM),’ South Korea’s first COVID-19 vaccine candidate adjuvanted with GSK’s pandemic adjuvant has been authorized by the Korean Ministry of Food and Drug Safety (KMFDS). South Korea has become one of the few countries in the world to have both a domestically developed COVID-19 vaccine and a treatment.
SKYCovione(TM) is a self-assembled nanoparticle vaccine targeting the receptor binding domain of the SARS-CoV-2 Spike protein for the parental SARS-Cov-2, jointly developed with the Institute for Protein Design (IPD) at the University of Washington School of Medicine with combination of GSK’s pandemic adjuvant. The development of SKYCovione(TM) has been supported by funding from the Bill & Melinda Gates Foundation and Coalition for Epidemic Preparedness Innovations (CEPI).
The results of the Phase III clinical trial, collected in 4,037 adults over 18-year-old, showed that SKYCovione(TM) induced neutralizing antibody responses, against the SARS-CoV-2 parental strain. The neutralizing antibody titres increased about 33 times compared to before the injection and were 3 times that of AstraZeneca’s Vaxzevria(TM), the control vaccine used in the study, 2 weeks after the second dose.
The clinical trial was conducted in cooperation with 16 institutions, including Korea University Guro Hospital and IVI (International Vaccine Institute), a non-profit international organization.
SK bioscience will apply for authorizations at other selected regulatory agencies for distribution of SKYCovione(TM), including through the COVAX Facility and for emergency use listing (EUL) to the World Health Organization (WHO).
SKYCovione(TM) is based on recombinant protein vaccine technology which has been used for development of current vaccines including influenza, hepatitis B, and HPV. SKYCovione(TM) can be stored in normal refrigeration conditions from 2 to 8 degrees Celsius, so it is particularly suitable for use in low-income settings without the need for ultra-cold chain facilities.
The market expects that SKYCovione(TM) will accelerate securing of Korea’s vaccine sovereignty and reducing dependence on vaccine imports.
Jaeyong Ahn, CEO of SK bioscience said, “The development of Korea’s first COVID-19 vaccine was achieved based on the efforts of the government and members who have been working hard all day and night. We will continue to work with various global organizations based on our own research and manufacturing technologies to preemptively respond to new pandemics.”
See full press release here https://www.skbioscience.co.kr/en/news/news_01_01?mode=view&id=132&
Dr. John Moller, CEO Novotech said, “As the lead CRO managing the Phase lll study in six APAC countries, the entire team at Novotech congratulates SK bioscience for such an outstanding clinical success and subsequent licence approval. Licence approval is the ultimate goal in clinical research and drug development and we are honoured to be part of the process of bringing new life-saving therapies to market. We look forward to working with SK bioscience on further vaccine developments in the near future.”
About Novotech
Novotech is the leading Asia-Pacific biotech specialist CRO. Novotech has integrated labs and phase I facilities and provides drug development consulting and clinical development services across all phases. It has been instrumental in the success of approximately 4,000 clinical trials across a broad range of therapeutic areas. Novotech is well-positioned to serve biopharma clients conducting clinical trials in Asia-Pacific and the US. For more information visit https://novotech-cro.com/contact
Media Contact
David James
E: communications@novotech-cro.com
AU: +61 2 8218 2144
USA: +1 415 951 3228
Asia: +65 3159 3427