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Data in Multiple Cancers at ESMO 2020
Merck Advances Oncology Portfolio and Pipeline

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Merckabstracts today announced more than 30 abstracts will be presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 from September 19-21. The abstracts span the Company’s clinical program in oncology across several innovative modalities and mechanisms that have the potential to advance treatment across a range of tumor types including biliary tract, lung and urothelial (bladder) cancers.

“Our oncology ambition is to discover innovative therapies with transformative results. The data being presented in urothelial cancer demonstrate this approach in action, where we are seeing promising results for a new first-line maintenance therapeutic option with BAVENCIO® in this form of cancer,” said Luciano Rossetti, Global Head of Research & Development for the Biopharma business of Merck. “In addition, long-term follow up data in advanced lung cancer from two of our in-house developed mechanisms—our oral MET inhibitor, tepotinib, and our first-in-class bifunctional fusion protein immunotherapy targeting TGF-β/PD-L1, bintrafusp alfa—continue to show sustained impact in one of the leading causes of cancer mortality.”

(Presentations #699O; 704MO; 745P). Primary results from the JAVELIN Bladder 100 study demonstrated an overall survival (OS) benefit for BAVENCIO vs. best supportive care in the first-line maintenance treatment of advanced urothelial carcinoma, making BAVENCIO the first and only immunotherapy to significantly prolong OS in this setting. Three new abstracts from the JAVELIN Bladder 100 study will be presented at ESMO:

  • An oral presentation during the Proffered Paper 1 – GU, non-prostate session scheduled on September 19, 2020 at 5:28pm–5:40pm CEST/11:28am-11:40am EDT, will highlight associations between clinical outcomes and exploratory biomarkers (Presentation #699O)
  • Two other abstracts provide more information on prespecified subgroup analyses, as well as patient-reported outcomes.

(Presentation #910O). Primary results from this Phase III study will be presented. The study is a demonstration of our commitment to develop options for patients with squamous cell carcinoma of the head and neck, and the results increase understanding in the field of the role of immunotherapy.

(Presentations: #1283P; 1286P; 1347P). Three posters from the largest study in patients with non-small cell lung cancer (NSCLC) harboring METex14 skipping treated with tepotinib—an oral, once-daily, highly selective MET inhibitor. Data presented will highlight:

  • Durable clinical activity that has been consistent across clinically relevant subgroups both in treatment-naïve and in previously treated patients as well as in patients with brain metastases as assessed by liquid biopsy or tissue biopsy (Poster #1283P)
  • Health-related quality of life (HRQoL) has been shown to be maintained, with clinically meaningful delays in the time to deterioration of cough, dyspnea, and chest pain (Poster #1286P)
  • A safety profile consisting of mostly mild to moderate adverse events with few treatment discontinuations.

The INSIGHT 2 study assessing the combination of osimertinib and tepotinib in patients with EGFR-mutant NSCLC that has developed resistance to first-line osimertinib treatment due to MET amplification is ongoing and actively recruiting patients (Poster #1415TiP).

Data from the INTR@PID clinical trial program for first in-class bintrafusp alfa, an investigational bifunctional fusion protein, targeting both TGF-β and PD-L1 pathways, shows promising and durable responses across multiple tumor types including NSCLC and biliary tract cancer (BTC) with a manageable safety profile in Phase I expansion cohorts.

Two long-term follow-up studies assessing efficacy and safety from the INTR@PID clinical trial program will be presented as posters at ESMO 2020:

In addition, preliminary analysis will be presented in a mini-oral presentation (#616MO) from a trial conducted by the National Cancer Institute (NCI), the Quick Efficacy Seeking Trial (QuEST) investigating a triple combination therapy (BN-brachyury [BVax] + bintrafusp alfa + N-803) in castration-resistant prostate cancer. Available on demand from September 18 at www.ESMO.org.

For the Company’s first biology-driven leader ERBITUX, a number of investigator-sponsored studies (ISS), including in combination with BAVENCIO (avelumab), continue to demonstrate its steady role across the continuum of care in metastatic colorectal cancer, and backbone of treatment of squamous cell carcinoma of the head and neck. Data demonstrating the role of ERBITUX as a promising combination partner include an oral presentation investigating avelumab plus cetuximab in pre-treated RAS wild type metastatic colorectal cancer patients as rechallenge strategy: the Phase II CAVE (cetuximab-avelumab) mCRC study. This will be presented during the Proffered Paper GI – colorectal session scheduled on September 19, 2:49pm-3:01pm CEST/8:49am-9:01am EDT (Presentation #397O)

*BAVENCIO is under clinical investigation for the first-line maintenance treatment of advanced UC and not yet approved in any markets outside of the US.

Tepotinib is the International Nonproprietary Name (INN) for the MET kinase inhibitor MSC2156119J. Tepotinib is currently under clinical investigation in NSCLC and not yet approved in any markets outside of Japan.

Bintrafusp alfa is currently under clinical investigation and not approved for any use anywhere in the world.

BAVENCIO is a human anti-programmed death ligand-1 (PD-L1) antibody. BAVENCIO has been shown in preclinical models to engage both the adaptive and innate immune functions. By blocking the interaction of PD-L1 with PD-1 receptors, BAVENCIO has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models. In November 2014, Merck and Pfizer announced a strategic alliance to co-develop and co-commercialize BAVENCIO.

The European Commission has authorized the use of BAVENCIO in combination with axitinib for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). In September 2017, the European Commission granted conditional marketing authorization for BAVENCIO as a monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC).

In the US, BAVENCIO® (avelumab) is indicated for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. BAVENCIO is also indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

BAVENCIO in combination with axitinib is indicated in the US for the first-line treatment of patients with advanced renal cell carcinoma (RCC). Additionally, the US Food and Drug Administration (FDA) granted accelerated approval for avelumab (BAVENCIO®) for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

BAVENCIO is currently approved for patients with MCC in 50 countries globally, with the majority of these approvals in a broad indication that is not limited to a specific line of treatment.

The special warnings and precautions for use for BAVENCIO monotherapy include infusion-related reactions, as well as immune-related adverse reactions that include pneumonitis and hepatitis (including fatal cases), colitis, pancreatitis (including fatal cases), myocarditis (including fatal cases), endocrinopathies, nephritis and renal dysfunction, and other immune-related adverse reactions. The special warnings and precautions for use for BAVENCIO in combination with axitinib include hepatotoxicity.

The SmPC list of the most common adverse reactions with BAVENCIO monotherapy in patients with solid tumors includes fatigue, nausea, diarrhea, decreased appetite, constipation, infusion-related reactions, weight decreased and vomiting. The list of most common adverse reactions with BAVENCIO in combination with axitinib includes diarrhea, hypertension, fatigue, nausea, dysphonia, decreased appetite, hypothyroidism, cough, headache, dyspnea, and arthralgia.

Pharmaceuticals

First online edition
Arab Pharma Manufacturers’ Expo 2020

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During the pandemic situation, healthcare manufacturing has remained a top priority all around the world in terms of continuous investments and expansions at the pharma manufacturing facilities across the world.

The frist online edition of the 3rd ARAB PHARMA MANUFACTURERS’ EXPO 2020 – an international exhibition on complete pharma manufacturing focusing Arabic countries in Middle East & North Africa (MENA) region has drawn attention of buyers and trade professionals attended from more than 20 countries to virtually meet the exhibiting companies for business networking and to attend the Technology Presentations.

Keeping in mind the health advisories by the Government due to the pandemic, the online Exhibition integrated all the basic essential features to the exhibiting companies to generate optimum output in terms of display and communication while participation in a highly cost effective manner.

More than 45 live Technology Presentations addressing the latest trends and current practices of pharma manufacturing technologies by the exhibiting companies spanning over 6 days as concurrent event alongside the online exhibition had remained highly resourceful for pharma manufacturing fraternity to acquire the technology based information.

Overall, the exhibitors have well appreciated the novel concept of the online exhibition, as it applies all the latest technical aspects to offer the optimum business networking domain bypassing all the limitations.

Outstanding benefits of the exhibition are the acceleration of an instant business connectivity, global exposure without any geographical barriers, ease of accessibilities and business networking through mobile, laptop or computer, longer exhibit hours, live chat to engage with prospective suppliers, live technology presentations, real-time experience with negligible investment, options of affordable packages for cost effective participation, and, most importantly, bypass of several other associated costs and time.

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Fight against COVID-19
Technology for gene-based vaccines

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The COVID-19 pandemic has prompted a breakthrough in gene-based vaccines. Currently, the only established process for transporting mRNA vaccines into the human cell is encapsulation by means of lipid nanoparticles (LNP). Without this protection, the mRNA with the blueprint for stimulating the immune system could not reach the right site of action in the body. Within seconds it would degrade in the bloodstream and make the vaccine ineffective.

“Coping with the pandemic depends largely on the availability of effective vaccines,” says Christian Kullmann, chairman of Evonik’s executive board. “The fact that the supply of vaccines is imminent is an outstanding achievement of the pharmaceutical and biotech industry, which we support with highly specialized applications from formulation development to production”. The innovation growth field Healthcare Solutions in the life-science division Nutrition & Care has been growing strongly ever since its formation. For decades, the company has been a leader in the field of drug delivery technologies, which includes lipid nanoparticles. “We are now consistently expanding this position as a solutions provider and integrated development partner.”

Evonik believes that its drug delivery technologies and services have great potential for above-average growth in vaccines as well as cell and gene therapies. Gene therapies, including those involving mRNA active ingredients and the use of lipid nanoparticles, open up the potential for the Health Care business line to generate revenues in the clear triple-digit millions within the next years.

The COVID-19 pandemic has now greatly accelerated the growth of innovative therapeutic approaches. In addition to the vaccines against COVID-19, which are close to approval, the head of Evonik’s Health Care business line, Thomas Riermeier, sees numerous other areas of application on the verge of breakthrough, and Evonik is helping to develop them. “Innovative vaccines against influenza, malaria or HIV are just as conceivable as promising approaches for cancer immunotherapy, the treatment of hereditary diseases or defective genes.” A major step in gene editing is expected within the next five years.

Evonik has supported various COVID-19 vaccine projects, from development to the production of clinical samples. As one of the integrated development partners for gene-based therapies, Evonik has been involved in over 100 projects in the past years, within various application fields.

“The higher efficacy as well as the significantly shorter development times are advantages of gene-based drug products that are currently becoming particularly apparent. The dynamics of the market show a paradigm shift in the way the industry will develop and produce drugs in the future,” says Riermeier. Evonik intends to further expand its position as an integrated solutions provider in this market. This includes the marketing of special pharmaceutical excipients such as lipids, the development of formulations, i.e. the combination of excipients and active ingredients, as well as the production of clinical test samples, and the production of commercial quantities. The expansion of clinical production capacities is also being planned, as is the expansion of manufacturing capacities for commercial quantities.

Evonik recognized the potential of gene-based therapeutic approaches early on. For customers worldwide, the specialty chemicals company develops and formulates lipid nanoparticles in Burnaby (BC, Canada) and operates a plant for the production of commercial quantities in Birmingham (AL, USA).

“With the acquisition of Burnaby-based Transferra Nanosciences, we deliberately invested in this promising technology in 2016,” explains Riermeier. With the acquisition of Wilshire Technologies, a US manufacturer of natural excipients for the pharmaceutical industry, the portfolio was further expanded in early 2020.

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Acquiration of LACTEL Polymers
Evonik expands portfolio

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Evonik has signed an agreement to acquire the LACTEL® business of biodegradable polymers from DURECT Corporation for USD 15m. The transaction is expected to close by Q1 2021 pending the satisfaction of certain customary closing conditions. An offer will be extended to each of the 15 employees of DURECT located in Birmingham, Alabama, which are associated with the LACTEL® business to transition to the Evonik. 

“The acquisition of the Lactel® business will strengthen both our innovation growth field Healthcare Solutions and Evonik’s position as a globally leading CDMO for drug delivery solutions”, says Johann-Caspar Gammelin, Head of the Nutrition & Care Division of Evonik. The acquisition marks a consequential step in the growth agenda of the life-science division Nutrition & Care. The LACTEL® business will benefit from fast-growing markets such as advanced drug delivery, biomaterials for tissue engineering, and the 3D printing of implantable medical devices.

“It has been a pleasure working with the highly motivated and talented LACTEL® team. We have confidence that Evonik will apply its resources and commitment to excellence to enable the product line and supporting team members to thrive,” says James E. Brown, President and Chief Executive Officer of DURECT Corporation. With Evonik’s global reach, existing and new customers will benefit from tapping into Health Care’s twelve global laboratories staffed with formulation, application and regulatory experts to assist in bringing their products faster to the market.

“The integration of the LACTEL® business into Evonik’s market-leading portfolio of functional excipients, biomaterials and integrated CDMO services will strengthen our position as a preferred development partner and solutions provider for pharmaceutical and medical device customers,” says Thomas Riermeier, Head of the Health Care business line. “By welcoming LACTEL® and members of their team into the Evonik family, we look forward to providing customers with even greater platform versatility as well as other value-adding services.”

Poly(lactide-co-glycolide) polymers are widely used as a functional excipient to control the release of parenteral drug products. They are also utilized to control the biodegradation of implantable medical devices across various orthopedic, cardiovascular, wound healing and other applications.

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