Olivia Vizier

Despite the promise of gene therapies, significant challenges have emerged in the field. Dr Carsten Brunn discusses the current obstacles and opportunities when developing gene therapies.

Valneva has yet to successfully usher its inactivated COVID-19 vaccine across the regulatory finish line, but analysts still see reason to bet on the French vaccine specialist.

The Houston-based preclinical biotech has raised a $15.5 million series A round led by Sporos Bioventures. The funding will go toward bringing Stellanova’s lead antibody into the clinic, building out a discovery platform and growing the team, including leadership hires later this year.

The FDA this week approved Scynexis’ ibrexafungerp tablets, now christened Brexafemme, to treat vaginal yeast infections. The green light marks the first approval in a new class of antifungal drugs in more than 20 years and propels Scynexis into the commercial realm with a potential blockbuster in tow.

But this orphan disease is one of the main reasons the team at Calliditas Therapeutics goes to work every day.

At Fountain, specifically, recent advances in AI have enabled us to spearhead a new unbiased approach to drug discovery and development.  We are using this platform to discover, refine, and advance a pipeline of disease-modifying therapies for age-related diseases, addressing both novel compounds and targets.

“However, the mere presence of antibodies to a virus does not necessarily mean an individual has protective immunity to reinfection,” Ian Chan, CEO of Boston-based biotech developer Abpro, told Healthline.

When Boehringer Ingelheim and OSE Immunotherapeutics teamed up in 2018 to develop OSE’s first-in-class checkpoint inhibitor, it was clear BI had high hopes for the immuno-oncology asset: The closely held German company paid about $18 million upfront but then piled on royalties and milestones, making the deal worth $1.4 billion to OSE.

While vaccines target specific viruses, Dutch start-up Leyden Labs is hunting down commonalities in viral families and working on the delivery of intranasal molecules that can protect humans from both known and future viruses.

Interim blinded data from an ongoing phase 2 clinical trial (NCT04098406) suggest treatment effect of catalytically active nanocrystalline gold (CNM-Au8; Clene Nanomedicine, Salt Lake City, UT) for amyotrophic lateral sclerosis (ALS).

“Candida albicans has been the prominent species causing vaginal yeast infections, however, we are seeing a notable shift in the etiology candidiasis with non-albicans Candida species gaining prominence,” Scynexis Vice President, Clinical Development and Medical Affairs Nkechi Azie, MD, said.

As Celularity makes its most significant clinical progress to date, the company is putting theories born of 20 years of postpartum placental stem cell research into practice. Could the production platform it’s building be the key to accessible, affordable allogeneic cell therapy?

A company called Vaxart is developing a COVID-19 vaccine that comes in the form of a tablet that could be stored at room temperature and even mailed to people at home.

Windtree Therapeutics Chief Executive Officer Craig Fraser called 2020 a transformative and productive year for the Bucks County company focused on the development of life-saving therapeutics for acute cardiovascular and pulmonary disorders.

The company spent roughly three months looking at potential locations for its global headquarters, including Boston and the Washington, D.C., region.

In his 13 years at Genzyme, Michael Wyzga noticed something about East Coast drugmakers. Execs would often jet from Boston or New York to San Francisco to find more assets, and completely miss the work being done in flyover states, like Texas or Wisconsin.

BioSpace recently spoke with Jonathan Rigby, Group CEO of Revolo Biotherapeutics, a biotherapeutic company working to revolutionize the treatment of autoimmune and allergic diseases by achieving superior long-term disease remission through resetting the immune system.

Scynexis announced in October that it submitted a new drug application to the FDA for ibrexafungerp for the treatment of vulvovaginal candidiasis. The target action date is set for June 1, 2021. According to the company’s website, another phase 3 trial investigating the efficacy of ibrexafungerp in preventing recurrent vulvovaginal candidiasis is ongoing.

A similar approach—a broad-spectrum antiviral in the form of a nasal spray—has been taken by Leyden Labs in the Netherlands, who recently struck a deal for a €40M Series A funding round to advance its product.

The next generation of Covid-19 vaccines in development could come as a pill or a nasal spray and be easier to store and transport than the current handful of shots that form the backbone of the world-wide vaccination effort.

Vaxart is among the first to take an oral COVID-19 vaccine into the clinic. “Making the vaccine is only part of the problem,” says CSO and founder Sean Tucker. “The rate-limiting step will be how fast can you put it in people’s arms.”

By measuring the functional MAPK activity of different RAS mutations, researchers have developed a method they believe could help identify patients with RAS-mutated cancers likely to benefit from MEK inhibitors like trametinib (Novartis’ Mekinist).

Imagine a future where such diseases as Multiple Sclerosis, Lou Gehrig’s and Parkinson’s Disease can be controlled or stopped altogether.

The company, Valneva SE, has a vaccine that could be more variant-proof, giving it an edge over other shots in what may be an annual campaign against a disease that’s already killed more than 3 million people. The first participant in its phase three trials will be dosed this week. If successful, that could lead to

Which is why OSE Immunotherapeutics is developing a vaccine that aims to be pan-coronavirus. The formulation for CoVepiT, which focuses on inducing a lasting T cell immune response, is made up of 11 total viral targets. This way, even if one changes, there are still 10 other potentially valid targets.

After raising a monster $152 million in a series B round last month, Pfizer darling Pyxis Oncology is ready to share more details about what it’ll be working on with all that cash.

Thomas Feldborg and Daria Rokina set off nearly every afternoon to explore this city. They leave from their hotel in the Charlestown neighborhood, pushing their baby carriage, some days heading deep into downtown, others choosing a path along the Charles River.