Drug Discovery and Development Archives - Page 125 of 158

Carlyle to invest nearly $70M in Inova

Investment firm Carlyle and Inova today announced a long-term funding partnership to accelerate growth, product innovation and M&A activities.

Lyon, France-based Inova develops software platforms dedicated to life sciences to enable pharmaceutical and biotech companies to collaborate on workstreams across organizations.

Inova touts its flagship product, “Inova Enterprise,” as a collaborative tool used to manage all processes related to outsourced innovation for laboratories and biotechs, enabling lead sourcing, transaction execution, alliance management and virtual events.

Carlyle’s investment aims to support Inova as it enters its next phase of growth, with the investment thesis centered around accelerating Inova’s internal expansion, including the strengthening of its presence in China. Other goals include investing in Inova’s product suite and differentiated platform, as well as helping with strategic acquisitions. Read more

CureVac aims to rebound after announcing disappointing COVID-19 results

Some two week after announcing that its COVID-19 vaccine had an interim efficacy of 47% in a Phase 2b/3 trial, CureVac (NSDQ:CVAC) appears to be regaining its footing.

While its stock is trading well below its Feb. 5 peak of $120.43, CVAC shares have risen 30% in the past five days to $75.95 in mid-day trading today.

The company is installing a new chief operating officer, Dr. Malte Greune, who will begin work on July 1, 2021.

Greune will work to bolster CureVac’s board and clinical and manufacturing capabilities.

Greune joins CureVac from Sanofi where he worked in an executive business development role. Gruene has held various leadership positions at pharma companies in the past decade.

Earlier this month, CureVac cofounder Ingmar Hoerr withdrew his candidacy for nomination to the company’s board. Hoerr also served as the company’s CEO from March to August 2020

CureVac has also charged another co-founder, Florian von der…

Zuranolone shows promise in treating postpartum depression

Sage Therapeutics’ (NSDQ:SAGE) and Biogen’s (NSDQ:BIIB) experimental depression drug zuranolone fared well in a Phase 3 clinical trial comparing it to placebo in the treatment of postpartum depression.

The investigational drug demonstrated meaningful improvements in terms of the baseline 17-item Hamilton Rating Scale for Depression (HAMD-17) score, the most common clinician-administered depression assessment scoring system.

After a 15-day treatment period, the zuranolone group had a mean change in HAM-D score of −17.8, resulting in a final mean score of 11.0, which is the normal range. Meanwhile, the −13.6 change in the placebo group results in a final mean score of 14.8, indicating mild-to-moderate depression.

For context, in the HAM-D system, a score of 10–13 indicates mild depression. The range of 14–17 represents mild to moderate depression. A score higher than 17 indicates severe depression.

[Related: Biogen bets $1.5B on Sage Therapeutics’ n…

Biliary cancer drug candidate wins orphan drug designation from FDA

Cranbury, N.J.–based Rafael Pharmaceuticals has announced that its lead pipeline drug CPI-613 (devimistat) now has orphan drug status for biliary cancer.

The orphan designation extends the orphan drug status for devimistat, including pancreatic cancer, acute myeloid leukemia, myelodysplastic syndrome, Burkitt’s lymphoma, peripheral T-cell lymphomas, and soft tissue sarcoma.

The Europe Medicines Agency has granted orphan drug designation to devimistat for pancreatic cancer and acute myeloid leukemia.

“Biliary cancer is often identified as an advanced stage cancer and considered aggressive with only modest response to existing treatment options for patients,” said Dr. Vaibhav Sahai, an associate professor of medical oncology at The University of Michigan Medicine in a statement. “The orphan drug designation for devimistat showcases the importance of discovering these new treatment options,” added Sahai, who was the principal investigator in the Phase 1b/2 …

Moderna’s COVID-19 vaccine holds its own against Delta variant in study

A small study indicated that Moderna’s messenger RNA COVID-19 vaccine was effective against the Delta variant.

Using serum samples from eight Phase 1 participants drawn one week after administering the second dose of the vaccine, the analysis found a 2.1-fold reduction in neutralizing titers against the Delta (B.1.617.2) variant relative to the ancestral strain of the virus.

The World Health Organization has urged the public — including the fully vaccinated — to continue wearing masks and practice social distancing to reduce the spread of the Delta variant.

In related news, Moderna’s COVID-19 also won emergency use authorization in India, where scientists first identified the Delta variant.

The variant is gaining traction in the U.S. and will likely gain dominance in the coming weeks.

The vaccine appears to also offer protection against the Beta (B.1.351), Gamma (P.1), Kappa (B.1.617.1) and Eta (B.1.525) variants, although the reduction in…

Charles River Laboratories completes $292.5M Vigene acquisition

Charles River Laboratories (NYSE:CRL) announced that it completed a $292.5 million acquisition of Vigene Biosciences.

Rockville, Md.-based Vigene, a gene therapy contract development and manufacturing organization (CDMO), develops viral vector-based gene delivery systems, with a primary area of expertise in CGMP viral vector manufacturing for gene therapies and gene-modified cell therapies.

Get the full story at our sister site, Drug Delivery Business News.

Pfizer-AstraZeneca COVID-19 vaccine combinations are effective, study suggests

Doses of the COVID-19 vaccine at Walter Reed National Military Medical Center, Bethesda, Md. DoD photo by Lisa Ferdinando.

British researchers report that using distinct COVID-19 vaccine types for the first and second doses appears to be effective, according to a preprint study in The Lancet.

As global health authorities seek to vaccinate as many people as possible, a potential hurdle is the need to use identical vaccines for the prime and boost stages. Using a so-called heterologous prime-boost vaccination would enable more rapid vaccination, but data about the efficacy of such a strategy have been scarce.

In the recent study, researchers randomized 830 adults 50 and older into eight groups to receive the varying combinations of the AstraZeneca and BioNTech-Pfizer vaccines.

To get a sense of the efficacy of the various combinations, the researchers used a geometric mean ratio (GMR) and geometr…

Boston Children’s Hospital, ElevateBio enter 5-year cell, gene therapy collaboration

Boston Children’s Hospital announced today that it partnered with ElevateBio for a five-year cell and gene therapy advancement program.

The collaborative agreement will seek to advance cell and gene therapy programs originating out of Boston Children’s Hospital with an introduction to Boston Children’s translational research capabilities.

Get the full story at our sister site, Drug Delivery Business News.

Sanofi to spend nearly half a billion dollars a year on mRNA vaccine research

Sanofi (NYSE:SNY) announced today that it plans to invest approximately $476.3 million (€400 million) per year on mRNA vaccine development.

Paris-based Sanofi’s intends for its annual investment to go toward a first-of-its-kind vaccines “mRNA Center of Excellence,” where work will be conducted to accelerate the development and delivery of next-generation vaccines.

Approximately 400 employees will integrate end-to-end mRNA vaccine capabilities with dedicated R&D, digital and chemistry, manufacturing and controls (CMC) teams at sites in Cambridge, Mass., and Marcy l’Etoile, Lyon, France, according to a news release. The center will seek to accelerate the mRNA portfolio developed by Sanofi in collaboration with Translate Bio, the company said.

“During the COVID-19 pandemic, mRNA technologies demonstrated potential to deliver new vaccines faster than ever before,” Sanofi Pasteur global head of R&D Jean-Francois Toussaint…

Essent Biologics debuts stem cell offerings for biopharma and cell therapy research

AlloSource (Centennial, Colo.), a central U.S. provider of allograft providers, has founded a separate nonprofit known as Essent Biologics to provide human-derived biomaterials for research. Essent has recently launched a human mesenchymal stem cells (hMSCs) offering for a range of research applications.

“The mission for the nonprofit is to maximize that gift of donation,” said Derek Mathers, head of business development at Essent Biologics.

Each vial of hMSCs contains more than one million cells after thawing. They have a passage level of P0 or P1 to ensure potency.

The company offers stem cells produced under current Good Manufacturing Practices (cGMP) and in accordance with International Society for Cell & Gene Therapy (ISCT) guidelines.

The company’s scientists have discovered a method for isolating cells and scaffold materials from tissue donation. The resulting cells are the first human-derived cell product that doesn’t use animal pro…

San Diego company aiming to target glioblastoma with nanotechnology-based approach

Intermediate magnification micrograph of a glioblastoma. HPS stain image courtesy of Wikimedia.

The emerging biopharmaceutical company Global Cancer Technology (GCT; San Diego) is developing a novel x-ray activated therapy to treat glioblastoma, which remains stubbornly difficult to treat.

GCT has a licensing agreement with the University of California, San Diego (UCSD) for a drug delivery platform that unites a nanocrystal to a prodrug that can be activated using radiosurgery. GCT has also acquired two patents for investigational drugs that can cross the blood-brain barrier. One is an inhibitor of phosphatidylinositol 3-kinase (PI3K), a type of enzyme involved in several cellular functions that facilitates rapid growth in glioblastoma. The other compound targets Vps34, a phosphatidylinositol 3-kinase. Both compounds modulate autophagy, a regenerative cellular process. According to UCSD researchers, autophag…

The pandemic and cumulative disease burden are ‘existential’ threats, experts argue

Image courtesy of Pixabay

While the pandemic has highlighted the prowess of the pharmaceutical industry, it should also “serve as a major wake-up call,” said Dr. George Yancopoulos, co-founder, president and CSO of Regeneron (NSDQ:REGN), at a panel at the virtual USA India Chamber of Commerce meeting. COVID-19 has underscored the importance of preparing for infectious pandemics and addressing the burden of all diseases, Yancopoulos added.

Society needs new strategies for addressing the disease burden. “By the year 2050, there will be 10 to 20 million Americans with Alzheimer’s disease with no treatment,” Yancopoulos said. While Biogen’s (NSDQ:BIIB) recently-approved aducanumab could be the first disease-modifying therapy, it remains unclear if the drug is effective.

Added to the disease burden are growing rates of obesity, diabetes, cancer and heart disease — “not to mention the potential of seeing th…