CLINSQUARE: CLINICAL RESEARCH COURSES
Monday, December 23, 2024
CLINSQUARE: Clinical Rsearch Courses by LIFEPRONOW
Home Blog Page 11

New ARASENS data reinforce strong tolerability profile of darolutamide plus ADT and docetaxel for mHSPC

admin
-
0
New ARASENS data reinforce strong tolerability profile of darolutamide plus ADT and docetaxel for mHSPC

September11,2022: “New results from the Phase III ARASENS trial evaluating quality of life (QoL) and patient-relevant endpoints for darolutamide plus androgen deprivation therapy (ADT) and docetaxel in patients with metastatic hormone-sensitive prostate cancer (mHSPC) show that, in addition to extending overall survival (OS), darolutamide has a strong tolerability profile and ability to maintain patient QoL with control of disease-related physical symptoms and pain.

The full results were presented during the ESMO Congress 2022.

“For those diagnosed with advanced prostate cancer, it is crucial to find a treatment that is not only effective but allows them to safely preserve their quality of life,” said Bertrand Tombal, M.D., Ph.D., Professor of Urology, Université catholique de Louvain (UCL), Cliniques universitaires, Saint-Luc, Brussels, Belgium.

“These additional findings from the ARASENS trial further reinforce darolutamide’s potential for patients with mHSPC in this critical phase of their life.”

Additionally, treatment with darolutamide plus ADT and docetaxel showed a trend toward delaying time to worsening of disease-related physical symptoms and pain in patients with moderate or severe baseline pain and improvement across patient-relevant endpoints compared to ADT plus docetaxel, supporting early treatment intensification with addition of darolutamide.

Results from the Phase III ARASENS trial have demonstrated a 32.5% reduction in risk of death and improvement across all patient-relevant endpoints for patients with early treatment intensification compared to ADT plus docetaxel.

At baseline, most patients in Phase III ARASENS trial had high QoL scores, and no pain or only mild pain (81%).

Data from the study showed that darolutamide in combination with ADT and docetaxel maintained QoL with similar time to worsening (TTW) of disease-related physical symptoms and pain as ADT and docetaxel.

Treatment with darolutamide in combination with ADT and docetaxel also led to fewer all-cause deaths (35.1% versus 46.8%) and prostate cancer-related deaths (26.1% versus 36.0%) compared to ADT and docetaxel.

Overall incidence of adverse events (AEs) was similar between treatment arms, despite longer treatment exposure for those treated with darolutamide (median 41.0 versus 16.7 months). Incidence of AEs of special interest was generally low and similar across both arms.

Bayer recently received U.S. Food and Drug Administration (FDA) approval for darolutamide in combination with docetaxel in mHSPC patients and has submitted applications in mHSPC to the European Medicine Agency (EMA), the Ministry of Health, Labour and Welfare (MHLW) in Japan, and China’s Center of Drug Evaluation (CDE).

Darolutamide is developed jointly by Bayer and Orion Corporation, a globally operating Finnish Pharmaceutical company.

About the ARASENS Trial

The ARASENS trial is the only randomized, Phase III, multi-center, double-blind, trial which was prospectively designed to compare the use of a second-generation oral androgen receptor inhibitor (ARi) darolutamide plus androgen deprivation therapy (ADT) and chemotherapy docetaxel to ADT plus docetaxel (a guideline recommended standard-of-care) in metastatic hormone-sensitive prostate cancer (mHSPC).

A total of 1,306 newly diagnosed patients were randomized in a 1:1 ratio to receive 600 mg of darolutamide twice a day or matching placebo, plus ADT and docetaxel.

The primary endpoint of this trial was overall survival (OS). Secondary endpoints included time to castration-resistant prostate cancer (CRPC), time to pain progression, time to first symptomatic skeletal event (SSE), time to initiation of subsequent anticancer therapy, all evaluated at 12‐week intervals, as well as adverse events (AEs) as a measure of safety and tolerability.

Results from this trial were published in the New England Journal of Medicine.

The ARASENS trial demonstrated that darolutamide plus ADT and docetaxel significantly reduced the risk of death by 32.5% compared to ADT plus docetaxel.

Improvements in the secondary endpoints supported the OS benefit observed in the trial’s primary endpoint.

About Metastatic Hormone-Sensitive Prostate Cancer

Prostate cancer is the second most commonly diagnosed malignancy in men worldwide. In 2020, an estimated 1.4 million men were diagnosed with prostate cancer, and about 375,000 died from the disease worldwide.

At the time of diagnosis, most men have localized prostate cancer, meaning their cancer is confined to the prostate gland and can be treated with curative surgery or radiotherapy.

Upon relapse, when the disease will metastasize or spread, the disease is hormone-sensitive and androgen deprivation therapy (ADT) is the cornerstone of treatment. Current treatment options for men with metastatic hormone-sensitive prostate cancer (mHSPC) include hormone therapy, such as ADT, androgen receptor pathway inhibitors plus ADT or a combination of the docetaxel chemotherapy and ADT.

Despite these treatments, a large proportion of men with mHSPC will eventually progress to metastatic castration-resistant prostate cancer (mCRPC), a condition with high morbidity and limited survival.

About Nubeqa™ (darolutamide)

Darolutamide is an oral androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells.

The low potential for blood-brain barrier penetration for darolutamide is supported by preclinical models and neuroimaging data in healthy humans.

This is supported by the overall low incidence of central nervous system (CNS)-related adverse events (AEs) compared to placebo as seen in the ARAMIS Phase III trial and the improved verbal learning and memory observed in the darolutamide arm of the Phase II ODENZA trial.

The product is approved under the brand name Nubeqa™ in more than 70 markets around the world, including the U.S., EU, Japan, China, for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease.

For the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC), the product has recently been granted U.S. Food and Drug Administration (FDA) approval and is currently being reviewed by other health authorities around the globe with further filings underway.

Darolutamide is also being investigated in further studies across various stages of prostate cancer, including in the Phase III ARANOTE trial evaluating darolutamide plus androgen deprivation therapy (ADT) versus ADT alone for mHSPC, ARASEC trial (darolutamide plus ADT) in the U.S. for mHSPC, as well as the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) led international Phase III co-operative group DASL-HiCaP (ANZUP1801) trial evaluating darolutamide as an adjuvant treatment for localized prostate cancer with very high risk of recurrence.”

https://www.bayer.com/media/en-us/new-arasens-data-reinforce-strong-tolerability-profile-of-darolutamide-plus-adt-and-docetaxel-without-compromising-quality-of-life-for-patients-with-mhspc/

U.S. confirmed as country with circulating vaccine-derived poliovirus

admin
-
0
U.S. confirmed as country with circulating vaccine-derived poliovirus

September 13, 2022: “CDC announced that polioviruses found in New York, both from the case of paralytic polio in an unvaccinated adult in Rockland County and in several wastewater samples from communities near the patient’s residence, meet the WHO’s criteria for circulating vaccine-derived poliovirus (cVDPV) – meaning that poliovirus continues to be transmitted in Rockland County, NY, and surrounding areas.

CDC is working closely with WHO, the Pan American Health Organization (PAHO), and other international public health partner organizations.

As previously reported, the virus’ genetic sequences from the patient from Rockland County, NY, and wastewater specimens collected in New York have been linked to wastewater samples in Jerusalem, Israel, and London, UK, indicating community transmission. 

The viral sequences from the patient and from three wastewater specimens had enough genetic changes to meet the definition of a vaccine-derived poliovirus (VDPV).

These two things – one individual with VDPV and at least one detection of a related VDPV in an environmental sample – meet WHO’s definition of cVDPV, and CDC submitted this data to WHO for inclusion on its list of countries with cVDPV.

There are global recommendations for countries with cVDPV2 outbreaks to protect people from polio, and the United States is taking all appropriate actions to prevent new cases of paralysis.

The United States now joins a list of about 30 other countries where cVDPVs have been identified. Circulating vaccine-derived poliovirus occurs when local immunity to poliovirus is low enough to allow prolonged transmission of the original weakened virus in the oral polio vaccine.

As the virus circulates and more genetic changes occur, the virus can regain its ability to infect the central nervous system and cause paralysis.

It’s important to note that cVDPVs are not caused by a child receiving the polio vaccine. Oral polio vaccine has not been used or licensed in the U.S. since 2000 but continues to be used in some countries.

“Polio vaccination is the safest and best way to fight this debilitating disease and it is imperative that people in these communities who are unvaccinated get up to date on polio vaccination right away,” said Dr. José R. Romero, Director of CDC’s National Center for Immunization and Respiratory Diseases.

“We cannot emphasize enough that polio is a dangerous disease for which there is no cure.”

It’s important to note that no additional cases of polio have been reported in the United States at this time, and today’s update does not impact the current CDC recommendations for polio vaccination for children or adults.

CDC continues to support New York State Department of Health’s investigation through ongoing testing of wastewater to better understand the possible spread of the virus and through supporting vaccination efforts in the affected communities.

Last week, the New York State Governor issued an Executive Order declaring a State Disaster Emergency. While no additional polio cases have been found, this action helps the state expand vaccination efforts and surveillance.

Improving vaccination coverage is the key to preventing additional cases of paralytic polio in the United States.”

https://www.cdc.gov/media/releases/2022/s0913-polio.html

WHO launches guide to safely unlock benefits of the life sciences

admin
-
0
WHO launches guide to safely unlock benefits of the life sciences

September 13, 2022: “WHO issued the Global guidance framework for the responsible use of the life sciences.

The Framework calls on leaders and other stakeholders to mitigate biorisks and safely govern dual-use research, which has a clear benefit but can be misused to harm humans, other animals, agriculture and the environment.

This is the first global, technical and normative framework for informing the development of national frameworks and approaches for mitigating biorisks and governing dual-use research.

It aims to safely unlock the great promise for new and improved ways to improve global health offered by life sciences and related technologies.

The Framework addresses the decades-long challenges of preventing the accidental and deliberate misuse of biology and other life sciences, as well as how to manage governance and oversight to both accelerate and spread innovation, while mitigating negative impacts.

The life sciences are increasingly crossing over with other fields, such as chemistry, artificial intelligence and nanotechnology, which changes the landscape of risks, with those that span multiple sectors and disciplines more likely to be missed.

“Life sciences and technologies offer many opportunities to improve our health, our societies and our environment” said Dr Soumya Swaminathan, WHO Chief Scientist.

“However, developments and advances in life sciences and associated technologies could pose risks caused by accidents during experiments, inadvertent and deliberate misuse.”

Looking at how to manage the increasing pace of advances in the life sciences, the Framework outlines the need for anticipatory and responsive governance mechanisms, including foresight approaches, which are participatory and multi-disciplinary ways of exploring trends, emerging changes, systemic impacts and alternative futures.

To help manage risks, it covers issues such as preventing misinformation and disinformation, as well as managing large health data sets.

Other topics include: increasing awareness and capacities for biorisk management, navigating the particular challenges around research on infectious diseases and preventing the misuse of research and technologies through collaboration among different actors and sectors.

The Framework is intended as the go-to starting point for the development and strengthening of biorisk management, which relies on three core pillars: biosafety, laboratory biosecurity and the oversight of dual-use research.

Accounting for different contexts, resources and priorities, the Framework is designed to be adapted by Member States and other stakeholders, depending on their needs and perspectives.

Ministries of health are called upon to work with other ministries, including of science and technology, education, agriculture, environment and defense, along with other key stakeholders, to assess the risks posed by life sciences locally and nationally, and identify appropriate risk mitigation measures to strengthen governance for biorisks and dual-use research.

The document aims to raise awareness about the importance of biorisk management in the context of the One Health approach to optimize the health of people, animals and ecosystems; provide a set of values and principles to guide decision-making; and identify tools and mechanisms for biorisk management.

Practically focused, it also sets out a six-step approach for implementation; checklists for various stakeholders; and scenarios and case studies to illustrate issues and options in the governance of biorisks and dual-use research. 

Recognising that awareness and resources will be limited in low- and middle-income countries (LMICs), the Framework calls for providing these countries with technical and financial support and empowering their scientists through opportunities to pursue and govern life sciences.

It also highlights the importance of developing more context-specific materials for awareness raising, education, capacity-building and training.

The life sciences include all sciences that deal with living organisms, including humans, nonhuman animals, plants and agriculture, and the environment, or products of living organisms or that incorporate components derived directly or synthetically from living organisms; the life sciences include but are not limited to biology, biotechnology, genomics, proteomics, bioinformatics, pharmaceutical and biomedical research and technologies.

WHO activities to support the Framework’s worldwide implementation include:

  • Leveraging existing efforts and initiatives, including those on laboratory biosafety, biosecurity and ethics;
  • Maintaining different stakeholders and local champions to monitor and evaluate the measures developed and implemented at local, national, regional and global levels;
  • Conducting awareness-raising activities, including regional and global dialogues, to support the sharing of experiences, lessons learned and best practices;
  • Developing trainings and tools to evaluate progress.

While governance of biorisks cannot be under the sole responsibility of one international body, WHO, through its leadership, aims to harness the developments of the life sciences to improve global health while anticipating and mitigating risks posed by such developments.

Implementing the Framework will be done at country and local levels, with efforts supported by WHO regional offices and other partners.”

https://www.who.int/news/item/13-09-2022-who-launches-guide-to-safely-unlock-benefits-of-the-life-sciences

Novartis invests in early technical development capabilities for next-generation biotherapeutics

admin
-
0
Novartis invests in early technical development capabilities for next-generation biotherapeutics

 Sept 12, 2022: “Novartis announced it is investing in next-generation biotherapeutics with the creation of a fully integrated, dedicated USD 300m scientific environment that will bolster its capacity and capabilities for early technical development of biologics.

Spanning both drug substance and drug product development, the multi-year investment will be implemented across existing Novartis locations in Switzerland, Slovenia and Austria, strengthening Novartis ability to deliver on the increasing growth and diversity of its early-stage biotherapeutics portfolio.

“Across the industry, biotherapeutics account for almost one-half of all recent new drug approvals and have enormous potential to address unmet need across a wide range of diseases,” said Reto Fischer, Head of Technical Research Division, Global Drug Development (GDD), Novartis.

“We are building the scientific environment necessary to bring these complex biologic compounds from the bench through development in an integrated, seamless, and rapid fashion. In doing so, we are supporting our broader ambition to enable faster development and focused prioritization across our global portfolio.”

The Novartis early-stage biologics portfolio has grown significantly in the last 15 years.

It has also expanded beyond conventional monoclonal antibodies into a wide range of novel development candidates with potential to be first-in-class, best-in-class, or both, including antibody-drug conjugates and therapeutic proteins.

This investment is intended to position Novartis at the forefront of biotherapeutic development, by supporting the company’s increasingly sophisticated pipeline with the most advanced technical infrastructure, alongside the highest level of capabilities.

It will create seamless, end-to-end development and manufacturing environments by embedding biologics development within existing Novartis commercial manufacturing facilities in Slovenia and Austria as well as by establishing a biologic’s hub on the Basel St. Johann Campus in Switzerland alongside the NIBR biologics center fostering scientific innovation, technology leadership and talent attraction.

Collectively these commitments will enhance development processes targeting faster transition times from pre-clinical to first in human studies.

Specifically, the investment will:

  • Strengthen the Novartis St. Johann campus in Basel by investing USD 100M to establish a biologics hub to complement the existing NIBR Biologics Center; 
  • Create a biocampus in Mengeš, Slovenia with an investment of USD 110M in clinical manufacturing capabilities (non cGMP and cGMP) and technical development capabilities in proximity of development operations; and
  • Amplify synergies and strategic proximity at the Schaftenau campus in Austria with a USD 60M USD investment in development manufacturing capacity and capabilities.

“The science of developing biologics is increasingly sophisticated, and we are excited to meet its challenges head-on,” said Jonathan Novak, Global Head for Biologics, Technical Research Division, GDD at Novartis.

“We look forward to amplifying the knowledge and experience of our associates to ensure that biologics development is an exhilarating and rewarding process for our current and future colleagues – and that is ultimately a source of profoundly innovative new therapies for patients worldwide.”

https://www.novartis.com/news/media-releases/novartis-invests-early-technical-development-capabilities-next-generation-biotherapeutics

Imfinzi plus chemotherapy improved survival benefit in advanced biliary tract cancer

admin
-
0
Imfinzi plus chemotherapy improved survival benefit in advanced biliary tract cancer

 September 12, 2022: “Updated results from the TOPAZ-1 Phase III trial showed AstraZeneca’s Imfinzi (durvalumab), in combination with standard-of-care chemotherapy demonstrated a clinically meaningful and durable overall survival (OS) benefit as a treatment for patients with advanced biliary tract cancer (BTC).

These results from TOPAZ-1, the first Phase III trial to show improved OS with an immunotherapy combination in this setting, will be presented today at the European Society for Medical Oncology (ESMO) Congress 2022 in Paris (abstract #56P).

The updated results for Imfinzi plus chemotherapy (gemcitabine plus cisplatin) showed enhanced clinical efficacy after an additional 6.5 months of follow-up, demonstrating a 24% reduction in the risk of death versus chemotherapy alone (based on a hazard ratio [HR] of 0.76; 95% confidence interval [CI], 0.64–0.91).

Updated median OS was 12.9 months versus 11.3 with chemotherapy. More than two times as many patients were estimated to be alive at two years versus chemotherapy alone (23.6% versus 11.5%). Results were seen across all prespecified subgroups, regardless of disease status, tumour location or PD-L1 expression.

In addition, OS benefit was observed in patients whose tumours stayed the same size (stable disease) as well as in patients whose tumours got smaller or disappeared (responders).

The safety profile of Imfinzi plus chemotherapy continued to be well-tolerated, with no new safety signals observed with longer follow-up.

Grade 3 or 4 treatment-related AEs were experienced by 60.9% of patients treated with Imfinzi and chemotherapy, and by 63.5% of patients receiving chemotherapy alone. 

Imfinzi plus chemotherapy did not increase the discontinuation rate due to adverse events (AEs) compared to chemotherapy alone (8.9% for the Imfinzi combination versus 11.4% for chemotherapy).  

Do-Youn Oh, MD, PhD, Professor, Division of Medical Oncology, Department of Internal Medicine at Seoul National University Hospital and Seoul National University College of Medicine, and principal investigator in the TOPAZ-1 Phase III trial, said: “It’s exciting to see the improved overall survival delivered by durvalumab plus chemotherapy over the current standard of care for patients with advanced biliary tract cancer after a median follow-up of nearly two years.

With limited treatment advances over the past decade, these patients have long faced a dismal prognosis. For the first time, an immunotherapy-based combination has shown the ability to alter the course of treatment for this disease and should become the new standard of care.”

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “These longer-term data reinforce the survival benefit and well-tolerated safety profile of Imfinzi added to standard-of-care chemotherapy for patients with advanced biliary tract cancer.

With these results, the exploratory data from the HIMALAYA trial and the recent FDA approval based on the TOPAZ-1 trial, we are continuing to advance our commitment to extend survival for patients with gastrointestinal tumours who desperately need new treatment options.”

Summary of updated results: TOPAZ-1

Imfinzi + chemotherapy (N=341)Chemotherapy (n=344)
OSi,ii  
Median OS (95% CI) (in months)12.911.3
HR (95% CI)iii0.76 (0.64, 0.91)
OS rate at 12 months (95% CI) (%)iv54.347.1
OS rate at 24 months (95% CI) (%)23.611.5
OS by BoRv,vi  
Median OS (95% CI), responders, months19.515.7
HR (95% CI) respondersiii0.69 (0.46, 1.04)
Median OS (95% CI), stable disease (SD), months13.611.5
HR (95% CI) SDiii0.77 (0.62, 0.96)
12-month OS rate in responders (95% CI) (%)iv75.875.0
12-month OS rate in SD (95% CI) (%)iv57.548.0
24-month OS rate in responders (95% CI) (%)iv40.620.5
24-month OS rate in SD (95% CI) (%)iv20.710.6

OS, overall survival; HR, hazard ratio; CI, confidence interval; BoR, best overall response; SD, stable disease

  i.    6.5 months of additional follow-up (data cut-off: 25 February 2022) after the primary analysis, with 76.9% overall OS event maturity

 ii.   At data cut-off for this analysis, median (95% CI) follow-up time (calculated using the inverse Kaplan-Meier techniques with the censoring indicator of OS reversed) was 23.4 (20.6–25.2) months for Imfinzi plus chemotherapy and 22.4 (21.4–23.8) months for chemotherapy

iii.    HRs were calculated using a Cox proportional hazards model

iv.   OS rates calculated using Kaplan-Meier techniques

 v.    To avoid immortal time bias, only participants surviving ≥ 3 months were included in this OS by best objective response analysis

vi.   BoR was assessed by the investigator per Response Evaluation Criteria In Solid Tumours (RECIST) v1.1 in all randomised participants with measurable disease at baseline and defined as response (complete response or partial response), SD or progressive disease (PD); BoR was determined based on the IA data cut-off (11 August 2021)

Earlier this month, Imfinzi in combination with chemotherapy was granted approval in the US as a treatment for adults with locally advanced or metastatic BTC based on results from TOPAZ-1. Regulatory applications are also currently under review in Europe, Japan and several other countries based on the TOPAZ-1 results.

In October 2021, the TOPAZ-1 trial met the OS primary endpoint at a predefined interim analysis, reducing the risk of death by 20% versus chemotherapy (based on a HR of 0.80; 95% CI, 0.66-0.97; 2-sided p=0.021).

HIMALAYA Phase III trial exploratory analysis by aetiology in unresectable hepatocellular carcinoma at ESMO
Also at ESMO, an exploratory analysis from the HIMALAYA Phase III trial evaluated the impact of disease causes on outcomes for patients with unresectable hepatocellular carcinoma (abstract #714P).

Data from HIMALAYA suggest a trend for OS benefit over sorafenib with the STRIDE regimen regardless of the underlying disease cause (hepatitis B virus [HBV], hepatitis C virus [HCV] or nonviral). Similar trends were observed with Imfinzi versus sorafenib across subsets.

In 2021, positive results from the HIMALAYA Phase III trial showed a single priming dose of tremelimumab, an anti-CTLA4 antibody, added to Imfinzi (STRIDE regimen) demonstrated a statistically significant and clinically meaningful improvement in OS versus sorafenib as a 1st-line treatment for patients with unresectable hepatocellular carcinoma (HCC) who had not received prior systemic therapy and were not eligible for localised treatment.

Patients treated with the STRIDE regimen experienced a 22% reduction in the risk of death versus sorafenib (based on a HR of 0.78, 96.02% CI 0.65-0.93; p=0.0035). Nearly one in three (31%) patients were still alive at three years versus one in five (20%) for sorafenib.

When subsets were adjusted for prognostic factor imbalances, patients with HBV treated with the STRIDE regimen experienced a 36% reduction in the risk of death versus sorafenib (based on a HR of 0.64, 95% CI 0.47-0.86).

Median duration of response was 25.69 months versus 17.00 months for sorafenib. Patients with HCV treated with the STRIDE regimen experienced an 11% reduction in the risk of death versus sorafenib (based on a HR of 0.89; 95% CI 0.63-1.25). Median duration of response was 13.5 months versus 15.7 months for sorafenib.

Nonviral patients treated with the STRIDE regimen experienced a 23% reduction in the risk of death versus sorafenib (based on a HR of 0.77; 95% CI 0.59-1.00). Median duration of response was 13.21 months versus 6.01 months for sorafenib.

The safety profiles of STRIDE and durvalumab were consistent across aetiology subgroups.

In the past, viral HCC (disease associated with cirrhosis related to chronic hepatitis B or hepatitis C) has been the primary aetiology of the disease.

Over the last two decades, the prevalence of non-viral HCC (disease associated with non-viral factors including liver disease, obesity and diabetes) has significantly increased.

HIMALAYA is the only Phase III trial to demonstrate a survival benefit for immunotherapy in participants with non-viral HCC.

The STRIDE regimen is under review by global regulatory authorities in unresectable HCC based on the results of the HIMALAYA trial.”

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2022/imfinzi-plus-chemotherapy-further-improved-overall-survival-benefit-in-advanced-biliary-tract-cancer-in-the-topaz-1-phase-iii-trial.html

Novartis invests in early technical development capabilities for next-generation biotherapeutics

admin
-
0
Novartis invests in early technical development capabilities for next-generation biotherapeutics

Sept 12, 2022: “Novartis announced it is investing in next-generation biotherapeutics with the creation of a fully integrated, dedicated USD 300m scientific environment that will bolster its capacity and capabilities for early technical development of biologics.

Spanning both drug substance and drug product development, the multi-year investment will be implemented across existing Novartis locations in Switzerland, Slovenia and Austria, strengthening Novartis ability to deliver on the increasing growth and diversity of its early-stage biotherapeutics portfolio.

“Across the industry, biotherapeutics account for almost one-half of all recent new drug approvals and have enormous potential to address unmet need across a wide range of diseases,” said Reto Fischer, Head of Technical Research Division, Global Drug Development (GDD), Novartis.

“We are building the scientific environment necessary to bring these complex biologic compounds from the bench through development in an integrated, seamless, and rapid fashion.

In doing so, we are supporting our broader ambition to enable faster development and focused prioritization across our global portfolio.”

The Novartis early-stage biologics portfolio has grown significantly in the last 15 years.

It has also expanded beyond conventional monoclonal antibodies into a wide range of novel development candidates with potential to be first-in-class, best-in-class, or both, including antibody-drug conjugates and therapeutic proteins.

This investment is intended to position Novartis at the forefront of biotherapeutic development, by supporting the company’s increasingly sophisticated pipeline with the most advanced technical infrastructure, alongside the highest level of capabilities.

It will create seamless, end-to-end development and manufacturing environments by embedding biologics development within existing Novartis commercial manufacturing facilities in Slovenia and Austria as well as by establishing a biologic’s hub on the Basel St. Johann Campus in Switzerland alongside the NIBR biologics center fostering scientific innovation, technology leadership and talent attraction.

Collectively these commitments will enhance development processes targeting faster transition times from pre-clinical to first in human studies.

Specifically, the investment will:

  • Strengthen the Novartis St. Johann campus in Basel by investing USD 100M to establish a biologics hub to complement the existing NIBR Biologics Center; 
  • Create a biocampus in Mengeš, Slovenia with an investment of USD 110M in clinical manufacturing capabilities (non cGMP and cGMP) and technical development capabilities in proximity of development operations; and
  • Amplify synergies and strategic proximity at the Schaftenau campus in Austria with a USD 60M USD investment in development manufacturing capacity and capabilities.

“The science of developing biologics is increasingly sophisticated, and we are excited to meet its challenges head-on,” said Jonathan Novak, Global Head for Biologics, Technical Research Division, GDD at Novartis.

“We look forward to amplifying the knowledge and experience of our associates to ensure that biologics development is an exhilarating and rewarding process for our current and future colleagues – and that is ultimately a source of profoundly innovative new therapies for patients worldwide.”

https://www.novartis.com/news/media-releases/novartis-invests-early-technical-development-capabilities-next-generation-biotherapeutics

FDA Issues Safety Alert for Squamous Cell Carcinoma and Various Lymphomas in Scar Tissue around Breast Implants

admin
-
0
FDA Issues Safety Alert for Squamous Cell Carcinoma and Various Lymphomas in Scar Tissue around Breast Implants

September 08, 2022: “The U.S. Food and Drug Administration issued a safety communication informing patients and providers about reports of squamous cell carcinoma (SCC) and various lymphomas located in the capsule or scar tissue around breast implants.

After an initial extensive review, we currently believe that the risk of SCC and other lymphomas occurring in the tissue around breast implants is rare.

However, in this case, and when safety risks with medical devices are identified, we wanted to provide clear and understandable information to the public as quickly as possible. 

In some reported cases, patients were diagnosed years after having breast implants and presented with findings such as swelling, pain, lumps or skin changes.

These emerging reports of lymphoma in scar tissue are different from Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), which the FDA began communicating about as a potential risk more than a decade ago.   

The FDA’s work in the area of patient-centered risk communication for these devices has accelerated in recent years, including convening stakeholders to share perspectives that have informed the FDA’s regulatory oversight and implementation of new requirements for manufacturers.

We continue to engage top cancer experts and are consulting with our Oncology Center of Excellence to ensure a coordinated approach informed by leaders in the field.

Additionally, the agency continues to closely monitor various data sources, such as the scientific literature, adverse event reports submitted to the agency and is soliciting information from manufacturers regarding any reports they may have regarding SCC and other lymphomas related to the tissue around an implant. 

We know that breast implants are not lifetime devices, and that the longer a patient has breast implants, the more likely they will need to be removed or replaced.

We also understand that information regarding breast implant risks can be overwhelming for a patient.

For this reason, we encourage review of our website with attention to patient labeling, which has easy to understand information in the patient brochure. 

Right now, we do not have enough information to say whether breast implants cause these cancers or if some implants pose higher risk than others. For this reason, instances of SCC, lymphoma and any cancer located in the scar tissue around breast implants should be reported to the FDA.

Our collective understanding has advanced significantly because of the efforts to study, communicate and act when needed.

As the agency moves further into adopting modernized approaches to our regulatory responsibilities to promote faster science-based decision-making, accurate data is crucial. 

If a patient with breast implants is experiencing a problem, or there is a case of SCC, lymphoma or any other cancer of the breast implant capsule identified, the FDA strongly encourages reporting this through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

Reporting strengthens our ability to work with manufacturers and others to improve safety.

Today’s safety communication underscores our commitment to sharing the information that we regularly gather and analyze so that patients may fully consider and thoughtfully discuss implant risks with their doctors.

We will continue to collaborate with other regulatory authorities, clinical and scientific experts, breast implant registries and patients as a part of our commitment to educate and enhance evidence generation on these potential new risks.

Looking ahead, the FDA will soon complete a thorough literature review and continue our partnershipExternal Link Disclaimer with the American Society of Plastic Surgeons as we work to identify ways to collect more detailed information regarding patient cases where cancer in the breast implant capsule has been reported.

As we learn more about these cases, we hope to better understand the patient risk and communicate findings to the public.  

The safety signal issued today is an emerging issue that will require steadfast, ongoing evaluation and communication with patients, healthcare providers and manufacturers.

We remain committed to informing the public of important and emerging medical device safety risks and appropriately take action on behalf of patients and public health. “

https://www.fda.gov/news-events/press-announcements/fda-issues-safety-alert-squamous-cell-carcinoma-and-various-lymphomas-scar-tissue-around-breast

Novartis Kisqali® adds one more year of survival benefit for broadest set of patients

admin
-
0
Novartis Kisqali® adds one more year of survival benefit for broadest set of patients

September 9, 2022: “Novartis today announced results from a new pooled exploratory analysis across the entire MONALEESA Phase III program, confirming nearly one year of additional overall survival (OS) benefit in a subgroup of patients with aggressive forms of hormone receptor-positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer (aBC).

This subgroup analysis found that patients with visceral metastases—including liver metastases and multiple metastatic sites, which are typically associated with a poor prognosis—who were treated with Kisqali® (ribociclib) plus endocrine therapy in the first-line setting, achieved a median OS of 62.7 months compared to 52.1 months for those treated with endocrine therapy alone (HR=0.79; 95% CI: 0.65-0.97).

Data from this analysis will be presented at the European Society of Medical Oncology (ESMO) Congress in Paris, France.

“Patients who have visceral metastases typically have a worse prognosis and often demonstrate resistance to treatment, so as a clinician it is encouraging to see significant survival benefit with ribociclib in the first-line setting in patients with more aggressive disease,” said Denise A. Yardley, MD, Senior Investigator, Breast Cancer Research Program, Sarah Cannon Research Institute at Tennessee Oncology, USA.

“Ribociclib is the only CDK4/6 inhibitor to show a consistent overall survival benefit in combination with endocrine therapy, while also maintaining quality of life across the Phase III program.”

Those with liver metastases on Kisqali plus endocrine therapy in the first-line achieved 44.2 months median OS compared to 38.1 months for those on endocrine therapy alone (HR=0.77; 95% CI: 0.55-1.07).

For patients with visceral metastases in three or more organs, first-line
treatment with Kisqali-endocrine therapy achieved 57.7 months median OS compared to 49.3 months for those on endocrine therapy alone (HR=0.81; 95% CI: 0.63-1.03).

“The goal for advanced breast cancer treatment is to help people live longer, and we are proud that Kisqali continues to deliver a significant survival benefit while also maintaining quality of life, even for those with harder-to-treat disease,” said Jeff Legos, Executive Vice President, Global Head of Oncology and Hematology at Novartis.

“We are committed to demonstrating what makes Kisqali a unique CDK4/6 inhibitor, thus providing patients and oncologists confidence in this therapeutic option.”

HARMONIA head-to-head CDK4/6 inhibitor trial design
Also at ESMO, the trial design will be presented for HARMONIA, the first prospective, head-to-head Phase III trial of CDK4/6 inhibitors being conducted in collaboration with SOLTI Innovative Cancer Research, to evaluate Kisqali vs. Ibrance®* (palbociclib) for patients with advanced HR+/HER2-, HER2-enriched subtype, ultimately exploring what makes Kisqali unique at a molecular level.

HARMONIA seeks to test if Kisqali improves the course of HR+/HER2- aBC by changing tumor biology to enable a better response to endocrine therapy as compared to Ibrance*, and could further substantiate differences seen among these CDK4/6 inhibitors.

HER2-enriched is an intrinsic subtype associated with a very poor prognosis and endocrine-resistance, as compared to luminal disease.

The global, multicenter, randomized, open-label, Phase III study has a primary outcome of progression-free survival (PFS), and secondary outcomes include OS and PFS2. HARMONIA is currently ongoing with an anticipated enrollment of 456 patients.

About Kisqali® (ribociclib)
Kisqali is the only CDK4/6 inhibitor with proven overall survival benefit across all its three pivotal Phase III advanced breast cancer trials, and is recognized by the National Comprehensive Cancer Network (NCCN) guidelines as the only CDK4/6 inhibitor with overall survival benefit in first-line HR+/HER2- advanced breast cancer.

Additionally, Kisqali has the highest rating of any CDK4/6 inhibitor on the ESMO Magnitude of Clinical Benefit Scale, achieving a score of five out of five for first-line premenopausal patients with HR+/HER2- advanced breast cancer.

Further, Kisqali in combination with either letrozole or fulvestrant has uniquely, among other CDK4/6i, received a score of four out of five for postmenopausal patients with HR+/HER2- advanced breast cancer treated in the first line16.

Kisqali has been approved in more than 95 countries worldwide, including by the United States Food and Drug Administration (FDA) and the European Commission, for the treatment of women with HR+/HER2- advanced or metastatic breast cancer in combination either with an aromatase inhibitor or with fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy.

Kisqali in combination with fulvestrant is approved as initial endocrine-based therapy or following disease progression on endocrine therapy in men by the FDA.

Novartis is committed to continuing to study Kisqali in breast cancer.

NATALEE is a large Phase III clinical trial of Kisqali with endocrine therapy in the adjuvant treatment of HR+/HER2- early breast cancer being conducted in collaboration with Translational Research In Oncology (TRIO).

Additionally, Novartis is collaborating with the Akershus University Hospital in Norway on the NEOLETRIB trial, a neoadjuvant Phase II trial studying the effects of Kisqali in HR+/HER2- early breast cancer and to discover the potentially unique underlying mechanism of action.

Kisqali was developed by the Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex Pharmaceuticals.”

https://www.novartis.com/news/media-releases/novartis-kisqali-adds-one-more-year-survival-benefit-broadest-set-patients-including-those-aggressive-hrher2-advanced-breast-cancer

Pfizer Invites Public to View and Listen to Webcast of Pfizer Discussion at Healthcare Conference

admin
-
0
Pfizer Invites Public to View and Listen to Webcast of Pfizer Discussion at Healthcare Conference

September 06, 2022: “Pfizer Inc. invites investors and the general public to view and listen to a webcast of a discussion with William Pao, Chief Development Officer, Executive Vice President, and Aamir Malik, Chief Business Innovation Officer, Executive Vice President, at the Morgan Stanley 20th Annual Global Healthcare Conference on Monday, September 12, 2022 at 1:40 p.m. EDT.

To view and listen to the webcast, visit our web site at www.pfizer.com/investors. Information on accessing and registering for the webcast will be available at www.pfizer.com/investors beginning today.

The transcript and webcast replay of the discussion will be made available on our web site at www.pfizer.com/investors within 24 hours after the end of the live discussion and will be accessible for at least 90 days.

About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives.

We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines.

Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time.

Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us.”

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-invites-public-view-and-listen-webcast-pfizer-11

New Dupixent data at EADV 2022 adds to body of evidence across multiple inflammatory skin diseases

admin
-
0
New Dupixent data at EADV 2022 adds to body of evidence across multiple inflammatory skin diseases

 September 6, 2022: “Twenty-five scientific abstracts evaluating Dupixent® (dupilumab) in moderate-to-severe atopic dermatitis from infancy to adulthood, prurigo nodularis and chronic spontaneous urticaria will be presented at the European Academy of Dermatology and Venereology (EADV) 2022 Congress from September 7 to 10.

The data add to a growing body of clinical and real-world evidence illustrating the potential benefit of Dupixent in targeting IL-4 and IL-13, key and central drivers of the type 2 inflammation that plays a role in these inflammatory skin diseases.

New analyses from the pivotal trial in children aged 6 months to 5 years with moderate-to-severe atopic dermatitis will be shared across eight posters.

Data presentations will show dupilumab plus low-potency topical corticosteroids significantly improved quality of life and sleep quality for both children and their caregivers.

Presentations will also show that children aged 6 months to 5 years treated with dupilumab experienced improvement in skin pain and that dupilumab treatment was associated with lower overall infections and non-herpetic skin infections in this age group.

The safety results of this pivotal trial were generally consistent with the known safety profile of dupilumab in atopic dermatitis.

Data in patients with moderate-to-severe atopic dermatitis aged 6 years and older will also be presented. Presentations of analyses from an open-label trial evaluating skin barrier function (BALISTAD) in patients 12 years and older will show Dupixent normalized skin barrier function for many patients and was associated with improvements in disease signs and symptoms and quality of life.

In a separate Phase 4 randomized, placebo-controlled trial in adults assessing the effect of Dupixent on sleep (DUPISTAD), analyses will be presented showing that Dupixent treatment improved sleep quality, daytime sleepiness, symptoms of anxiety and depression, health-related quality of life measures and itch, including in patients who switched to Dupixent from placebo.

The safety results of this pivotal trial were generally consistent with the known safety profile of Dupixent in atopic dermatitis.

Late-breaking results from a Phase 3 dupilumab trial showing improvement in signs and symptoms in adults with prurigo nodularis will also be presented.

The potential uses of dupilumab in prurigo nodularis, chronic spontaneous urticaria and bullous pemphigoid are currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority.

Data to be presented at the EADV 2022 Congress

Investigation of Dupilumab in Prurigo Nodularis

  • Late-breaking oral presentation (4:45-5:00 pm CEST):
    • #3583: Dupilumab Significantly Improves Itch and Skin Lesions in Patients with Prurigo Nodularis: Results from a 2nd Phase 3 Trial (LIBERTY-PN PRIME), Gil Yosipovitch

Investigation of Dupilumab in Chronic Spontaneous Urticaria

  • Poster #P1754: Dupilumab Significantly Reduces Itch and Hives in Patients With Chronic Spontaneous Urticaria Irrespective of Baseline IgE Level: Results From a Phase 3 Trial (LIBERTY-CSU CUPID Study A), Marcus Maurer

Study Design for Dupilumab in Bullous Pemphigoid

  • Poster #P0404: The Study Design of a Trial of Dupilumab in Adult Patients With Bullous Pemphigoid: LIBERTY-BP ADEPT, Dedee Murrell

Clinical Efficacy and Safety of Dupilumab in Infants and Young Children with Atopic Dermatitis

  • Poster #P0322: Dupilumab Treatment Improves Health-Related Quality of Life in Children Aged 6 Months to 5 Years with Moderate-to-Severe Atopic Dermatitis and Their Caregivers, Amy Paller
  • Poster #P0321: Dupilumab Treatment Improves Sleep Quality in Children Aged 6 Months to 5 Years With Moderate-to-Severe Atopic Dermatitis and Their Caregivers, Amy Paller
  • Poster #P0297: Dupilumab Treatment Is Not Associated With an Increased Overall Risk of Infections in Patients Aged 6 Months to 5 Years With Moderate-to-Severe Atopic Dermatitis, Michael Cork
  • Poster #P0320: Dupilumab Treatment Reduces Skin Pain in Infants and Young Children With Moderate-to-Severe Atopic Dermatitis Aged 6 Months to 5 Years, Amy Paller
  • Poster #P0290: Dupilumab Treatment Shows Rapid and Consistent Improvement in Atopic Dermatitis in All Anatomical Regions in Patients Aged 6 Months to 5 Years, Andreas Wollenberg
  • Poster #P0356: Laboratory Safety From a 16-Week Phase 3 Study of Dupilumab in Patients Aged 6 Months to 5 Years With Moderate-to-Severe Atopic Dermatitis, Amy Paller
  • Poster #P0354: Clinically Meaningful Within-Patient Change Threshold for the Children’s Dermatology Life Quality Index and Infants’ Dermatitis Quality of Life Index Instruments in Patients Aged 6 Months to <6 Years With Atopic Dermatitis, Amy Paller
  • Poster #P0199 Meaningful Change Threshold for the Dermatitis Family Impact (DFI) Questionnaire for Parents/Caregivers of Children Aged 6 Months to <6 Years With Atopic Dermatitis (AD), Amy Paller

BALISTAD Skin Barrier Trial of Dupilumab in Atopic Dermatitis

  • Poster #P0319: Dupilumab Treatment Normalizes Skin Barrier Structure and Function and Improves Quality of Life in Adult and Adolescent Patients With Moderate-to-Severe Atopic Dermatitis, Robert Bissonnette
  • Poster #P0317: Dupilumab Treatment Normalizes Skin Barrier Function and Improves Clinical Outcomes in Patients With Atopic Dermatitis, Robert Bissonnette

DUPISTAD Sleep Trial of Dupilumab in Atopic Dermatitis

  • Poster #P0328: Dupilumab ameliorates sleep disturbance and relieves itch in adults with moderate-to-severe atopic dermatitis over 24 weeks, Joseph Merola
  • Poster #P0331: Improvement in sleep quality anxiety and depression in adults with moderate-to-severe atopic dermatitis with dupilumab treatment, Joseph Merola
  • Poster #P0332: Improvement in symptoms of atopic dermatitis (AD) and AD-related quality of life with dupilumab treatment in adults: 24-week results of the DUPISTAD study, Joseph Merola

Clinical and Real-World Efficacy and Safety of Dupilumab in Atopic Dermatitis

  • Oral Presentation (September 8, 10:45-10:55 am CEST):
    • #FC02.04: Real-world treatment outcomes for up to 2 years in patients aged less than 12 years with inadequately controlled moderate-to-severe atopic dermatitis, Amy Paller
  • Poster #P0323: Dupilumab 16-Week Efficacy and Safety Is Robust and Consistent in Adults Over 60 Years of Age With Moderate-to-Severe Atopic Dermatitis, Johnathan Silverberg
  • Poster #P0312: Dupilumab Treatment Leads to Rapid, Progressive, and Sustained Reduction in Lichenification in Children, Adolescents, and Adults With Atopic Dermatitis, Emma Guttman-Yassky
  • Poster #P0313: Dupilumab Treatment Leads to Rapid, Progressive and Sustained Reduction in Lichenification in White, African American/Black and Asian Patients With Atopic Dermatitis, Emma Guttman-Yassky.”

https://www.sanofi.com/en/media-room/press-releases/2022/2022-09-06-05-00-00-2509982

Forxiga approved in China for the treatment of chronic kidney disease

admin
-
0
Forxiga approved in China for the treatment of chronic kidney disease

September 05, 2022: “AstraZeneca’s Forxiga (dapagliflozin), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, has been approved in China to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease (ESKD), cardiovascular (CV) death and hospitalisation for heart failure (hHF) in adults with chronic kidney disease (CKD) at risk of progression with and without type-2 diabetes (T2D).

The approval by China’s National Medical Products Administration (NMPA) is based on positive results from the DAPA-CKD Phase III trial.

CKD is a serious, progressive condition defined by decreased kidney function and is often associated with an increased risk of heart disease or stroke.

The condition affects 850 million people worldwide. However, diagnosis rates remain low and up to 90% of patients are unaware they have the disease.

Member of the DAPA-CKD Executive Committee, Fan Fan Hou, Southern Medical University, Guangzhou, China, said: “With unprecedented results of DAPA-CKD, dapagliflozin becomes the first SGLT2 inhibitor approved in China for the treatment of chronic kidney disease.

This transformational milestone brings great hope to the 120 million subjects suffering from chronic kidney disease in China.”

Sir Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca said: “In addition to AstraZeneca’s commitment to drive increased awareness, prevention and earlier diagnoses, this approval marks another important step forward in our ambition to stop, reverse and ultimately cure chronic kidney disease globally.

We are thrilled at the opportunity to bring Forxiga to millions of patients across the country and improve patient outcomes.”

The DAPA-CKD Phase III trial demonstrated that Forxiga, on top of standard-of-care (SoC) treatment with an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker, reduced the relative risk of worsening of renal function, onset of ESKD, or risk of CV or renal death by 39%, the primary composite endpoint, compared to placebo (absolute risk reduction [ARR]=5.3%, p<0.0001) in patients with CKD Stages 2-4 and elevated urinary albumin excretion. Forxiga also significantly reduced the relative risk of death from any cause by 31% (ARR=2.1%, p=0.0035) compared to placebo.

The safety and tolerability of Forxiga were consistent with the well-established safety profile of the medicine.

Forxiga (known as Farxiga in the US) is now approved in 100 countries around the world including the US, the European Union and Japan for the treatment of CKD in adults with and without T2D.

Notes

CKD
CKD is a serious, progressive condition defined by decreased kidney function (shown by reduced estimated glomerular filtration rate (eGFR) or markers of kidney damage, or both, for at least three months). 

The most common causes of CKD are diabetes, hypertension and glomerulonephritis. CKD is associated with significant patient morbidity and an increased risk of CV events, such as heart failure (HF) and premature death.

In its most severe form, known as ESKD, kidney damage and deterioration of kidney function have progressed to the point where dialysis or kidney transplantation are required. 

The majority of patients with CKD will die from CV causes before reaching ESKD. Currently in China, up to 120 million people are living with CKD.

DAPA-CKD
DAPA-CKD was an international, multi-centre, randomised, double-blinded Phase III trial in 4,304 patients designed to evaluate the efficacy of Forxiga 10mg, compared with placebo, in patients with CKD Stage 2-4 and elevated urinary albumin excretion, with and without T2D. 

Forxiga was given once daily in addition to SoC. The primary composite endpoint was worsening of renal function or risk of death (defined as a composite of an eGFR decline ≥50%, onset of ESKD or death from CV or renal cause).

The secondary endpoints included the time to first occurrence of the renal composite (sustained ≥50% eGFR decline, ESKD or renal death), the composite of CV death or hospitalisation for HF (hHF), and death from any cause.

The trial was conducted in 21 countries.”

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2022/forxiga-approved-in-china-for-ckd.html

Manus Bio receives additional funding to fight malaria

admin
-
0
Manus Bio receives additional funding to fight malaria

August 31, 2022: “Manus Bio, the leading biomanufacturer of natural products, has received a fourth award from the Bill & Melinda Gates Foundation to develop a scalable production route for the potential antimalarial drug, artemisinin. 

The $2 million award will enable Manus Bio to begin scaling up the unique biological process it has developed towards the key chemical intermediate, dihydroartemisinic acid.

Economical and scalable access to this compound will enable process simplification for large-scale, commercial manufacturing of artemisinin.

“We are grateful for the longstanding support from the Bill & Melinda Gates Foundation on developing a sustainable and low-cost manufacturing route for artemisinin,” says Dr. Christine Santos, Chief Technology Officer at Manus Bio.

“Ready access to this life-saving drug is such an important tool in the global fight against malaria.

The additional funding we have received will enable us to translate a robust technology built with our BioAssemblyLineTM cell factory engineering platform into a fully scaled process.”

A key time to beat malaria…

Malaria remains one of the world’s biggest public health issues, with rising numbers of both cases and deaths globally in the last couple years, thought to be attributable to disruption from the COVID-19 pandemic.

However, it is a preventable and curable disease with sufficient access to key antimalarial medicines.

Artemisinin is an effective compound in malaria treatments. The World Health Organization (WHO) recommends artemisinin or one of its derivatives formulated in combination therapies as frontline treatments for all cases of malaria.

It has traditionally been extracted from the Artemisia annua plant – or “sweet wormwood”. However, availability of the plant is subject to agricultural instabilities and vulnerabilities.

The artemisinin precursor, dihydroartemisinic acid, can be produced using fermentation, which provides a more stable and sustainable source for making artemisinin than through agricultural extraction.

…using robust biotechnology-based solutions

Manus Bio has already made significant progress in applying its pioneering BioAssemblyLine™ cell engineering platform to develop a fermentation-based approach for artemisinin production through the support of the foundation.

“Our aim is to complete the development process within a significantly accelerated timeframe by leveraging our experience, know-how, and track record in scaling next-generation biotechnology solutions,” adds Dr. Santos.

https://www.manusbio.com/manus-bio-receives-additional-funding-to-fight-malaria-through-biotechnology/

1...101112...156Page 11 of 156

EDITOR PICKS

POPULAR POSTS

POPULAR CATEGORY

ABOUT US

LifeProNow provides guidance and high quality contents to help job seekers to get their dream Job. All the contents are written by experienced folks and peer reviewed by experts.

Contact us: [email protected]

FOLLOW US

© LifeProNow | All Rights Reserved