Olivia Vizier

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.

The company Richman leads, Gain Therapeutics, went public in March through an IPO. Regardless, he still thinks that going public through a SPAC is a trend that’s sustainable, even saying Gain Therapeutics considered it.

A third of those American adults now refusing to get vaccinated would get vaccinated if they could take a pill instead of getting the vaccine shot, according to a poll conducted by Quadrant Strategies and commissioned by biotechnology company Vaxart, Inc. A pill vaccine is expected to overcome vaccine resistance of millions of Americans.

“Differences in heavy chain polypeptides allow these immunoglobulins to function in different types of immune responses and at particular stages of the immune response. The polypeptide protein sequences responsible for these differences are found primarily in the Fc fragment,” explained Dr. Patrick Soon-Shiong, world-class bioscientist and executive chairman of ImmunityBio

BioSpace recently spoke with Norman Sussman, chief medical officer at DURECT, a company committed to transforming the treatment of acute organ injury and chronic liver diseases by advancing novel and lifesaving therapies based on its endogenous epigenetic regulator program.

BioSpace spoke with Paula Ragan, CEO and President of X4 Pharmaceuticals, a company focused on restoring healthy immune system function in people with rare diseases. X4’s lead product candidate, mavorixafor (X4P-001), is a potential first-in-class inhibitor of CXCR4.

While the since renamed company Sio Gene Therapies in-licensed one program in Parkinson’s disease, it also in-licensed a pair of gene therapy programs from the University of Massachusetts in GM1 gangliosidosis and Tay-Sachs/Sandhoff disease with the GM1 program being Sio’s lead candidate.

US biotech firm Celularity is a leader in cell therapy development, and is focused on harnessing the therapeutic potential of cells contained in the postpartum placenta. Having raised over $350 million since spinning out from pharma giant Celgene, today the company has multiple cell therapy candidates in both pre-clinical and clinical development, with indications including chronic degenerative

CUE Biopharma CEO Dan Passeri, J.D. joins us for a discussion on the development of the company’s Immuno-STAT platform for the selective targeting and alteration of T cells. Passeri shares the rationale behind his belief in the company’s immunotherapeutic approach, and how the CUE-100 series of candidates in its pipeline are being developed to address

According to FasterCures, which is tracking 326 COVID-19 treatments and 252 vaccines, five companies are developing oral vaccines, and two — ImmunityBio and Vaxart — have progressed to Phase 1 clinical trials.

AltruBio would like to reintroduce itself. After shifting from oncology to immunology, swapping out the board and completing a name change, the biotech is relaunching with a $63 million series A funding round.

A French study has demonstrated that the novel agonist anti-human ChemR23 monoclonal antibody (MAb) designated OSE-230 accelerated recovery from acute inflammation and triggered resolution of chronic inflammation in mice chronic colitis models, preventing fibrosis and reducing tumor development.

Nevan Charles Elam, JD founded Rezolute Bio ten years ago on the heels of a complex career intersecting law, high tech, and life sciences. On this episode of the Business of Biotech, Elam shares the company’s rationale for pursuing congenital hyperinsulinism and diabetic macular edema therapeutics by leveraging monoclonal antibodies and discusses the company’s approach

How does one decide who makes an “under 40” list? After the last nominations come in from staff and readers, we’re left to sort through hundreds of names, with no obvious guideposts for how to do so. Do we want the basic scientist behind a major discovery, or the executive working to translate it into

PsyBio Therapeutics, where Jones is chairman of the scientific advisory board, is commercializing the process. Jones and his team invented a one-pot method of bioprocessing with E. coli to make tryptamines. Starting with 4-hydroxyindole, the process developed by Jones produces psilocybin. He says that this technique provides three key advantages—cheaper, faster, and greener than other methods.

Rain Therapeutics catapulted itself toward pivotal development in September when it picked up a cancer drug from Daiichi Sankyo. Now, the California biotech aims to raise up to $100 million in its Wall Street debut, which will fuel a phase 3 study for the asset in liposarcoma, a cancer that occurs in the body’s fat

It’s been a nice month for Pyxis Oncology: After penning a major licensing deal with Pfizer, the startup now has $152 million extra in the bank to help it push on with its expanded pipeline.

Evan Levine, Co-Founder and CEO, PsyBio Therapeutics is pursuing a paradigm shift in the treatment of mental illness and other neurological disorders by using psychedelics and hallucinogenics. PsyBio biosynthesizes psilocybin and other psychoactive drugs from different plants  and fungi from genetically-modified bacteria. Under the influence of an anxiogenic molecule in a controlled setting, early clinical