News and Resources from the WTWH Media Life Science Network - Page 214 of 968

Science 37, Crinetics and Gritstone Bio announce inducement grants to boost talent acquisition

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Science 37 Holdings (Nasdaq:SNCE), Crinetics Pharmaceuticals (Nasdaq: CRNX) and Gritstone Bio (Nasdaq:GRTS) have announced recent inducement grants to attract new non-executive employees under Nasdaq Listing Rule 5635(c)(4). This move showcases the companies’ focus on talent acquisition and retention in the competitive pharmaceutical and biotechnology markets.

A clinical trial research organization based in Durham, North Carolina, Science 37 announced today that its compensation committee signed off on inducement equity awards. In all, the company granted options to purchase an aggregate of 110,800 shares of its common stock at an exercise price of $0.29 per share to three new employees. The options have a 10-year term and a four-year vesting schedule.

Grants for Critics and Gritstone

The clinical-stage pharma firm Crinetics Pharmaceuticals specializing in rare endocrine disease…

Three strikes in pharma: Exploring recent drug withdrawals and clinical trial challenges

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Pharmaceutical companies face a long list of regulatory challenges ranging from patent expiry to bioequivalence and international harmonization. It’s not uncommon for drug makers to withdraw or discontinue drugs after failing to meet clinical requirements or endpoints, resulting in drug withdrawals. On average, life science companies pull roughly 4,500 drugs and devices from the market, many of which are widely used. In recent years, drug companies, for instance, have pulled a growing number of products for nitrosamine contamination. While the FDA can identify safety concerns, it often falls upon the manufacturer to initiate and execute a recall.

Here, we round up three recent examples of recent drug withdrawals where pharma companies either pulled drugs from the market or gave up on developing a drug for a given indication.

Covis Pharma withdraws Makena

The Zug, Switzerland–base…

Verana Health launches Qdata anti-VEGF market tracker for in-depth market analysis

Digital health company Verana Health (San Francisco) has unveiled the Qdata anti-VEGF market tracker. It is their first market tracking Data as a Service (DaaS) product.

Excessive amounts of vascular endothelial growth factor (VEGF) can cause abnormal blood vessel growth in the eyes, which, when untreated, can result in vision loss in patients with retinal diseases. Consequently, anti-VEGF therapies help preserve eyesight for patients with conditions such as age-related macular degeneration and diabetic retinopathy.

Qdata anti-VEGF market tracker supports brand-level analysis

The Qdata anti-VEGF market tracker enables comprehensive brand-level analysis. It also provides direct access to real-world data, according to Sujay Jadhav, Verana Health’s CEO. The service offers accurate and timely insights into product performance and market dynamics.

Sujay Jadhav

Real-world data is drawn from the Ameri…

Behind the scenes: Dr. Andy Beck, PathAI CEO, talks PathExplore

A selected region of a digitized H&E-stained slide [Image courtesy of PathAI]

In a recent conversation with Dr. Andy Beck, co-founder and CEO of PathAI, we had the opportunity to discuss PathExplore, an AI-driven platform that aims to transform the way tumor microenvironment (TME) analysis is conducted. Traditional methods such as manual pathology, multiplex immunofluorescence and single-cell omics often face limitations, including high costs or tissue consumption. PathExplore addresses these challenges by using AI to analyze digitized H&E slides, which are widely available and don’t necessitate advanced assays or equipment.

In the following interview, Dr. Beck highlights the advantages of PathExplore, such as its ability to bridge the gap between H&E and high-resolution modalities such as multiplex and single-cell RNA sequencing and its potential for rapidly scaling biomarkers. Additionally, t…

QRL-201, a novel therapy targeting STMN2 expression, enters phase 1 ALS trial

Cambridge, Massachusetts-based QurAlis has dosed the first patient with the biotherapeutic QRL-201 in a Phase 1 clinical trial (ANQUR) in Canada. QRL-201 is a novel therapy targeting the restoration of STATHMIN-2 (STMN2) expression in amyotrophic lateral sclerosis (ALS) patients. QurAlis believes ANQUR the first study to evaluate such a treatment.

Stathmin-2 (STMN2), also known as superior cervical ganglia neural specific 10 (SCG10), belongs to the stathmin protein family involved in the regulation and dynamics of microtubules. Predominantly expressed in neurons, STMN2 serves key functions in neuronal development, axonal growth and regeneration.

Recent research has revealed the significance of STMN2 in neurodegenerative diseases, especially ALS and frontotemporal dementia (FTD). Researchers have linked the pathogenesis of those conditions to the loss of STMN2 function.

“In mice, STMN2 deletion causes axonal degeneration and loss of muscle innervation, w…

BioTheryX’s Prodegy platform takes center stage in cancer research partnership with Incyte

BioTheryX, a privately-held company, and Incyte (Nasdaq:INCY) have formed a research collaboration and license agreement. Their focus is on discovering and developing molecular glue targeted protein degraders for oncology targets.

Several other privately-held companies also focus on protein degradation. Examples include Kymera Therapeutics (Cambridge, Massachusetts), Arvinas (New Haven, Connecticut), Nurix Therapeutics (San Francisco), Cullgen (San Diego) and Vividion Therapeutics (La Jolla, California).

BioTheryX’s Prodegy platform serves as the partnership’s centerpiece. It aims to identify and develop molecular glue degraders for multiple historically undruggable oncology targets. “Our platform enables flexible degrader approaches, allowing us to tailor the molecular approach to a given target,” said Philippe Drouet, CEO of Biotheryx, over email.

Conventional small molecule inhibitors often insufficiently drug many targets considered druggable. …

Understanding cellular heterogeneity and its implications for disease diagnosis and treatment

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Cellular heterogeneity enables cells in the body to perform an array of functions, but it also plays a role in diseases like cancer as well. In oncology, this fact influences molecular therapy targets, tumor evolution as well as drug sensitivity and resistance. Cellular heterogeneity is also a consideration in areas such as immunotherapy, neuroscience, stem cell research and infectious diseases. By probing cellular heterogeneity in diseased tissues, drug developers can help uncover potential molecular targets for treatment, highlight varying drug sensitivities and unravel the mechanisms responsible for treatment resistance.

To learn more about the importance of cellular heterogeneity, we recently conducted an email interview with two executives at Bio-Rad Laboratories, Mina Zeinali, single cell field application specialist and Joby Chesnick, senior segment manager, single cell technologies …

FDA authorization of vilobelimab signals new opportunities for drug developers in inflammatory diseases

The FDA has granted InflaRx (Nasdaq:IFRX) emergency use authorization (EUA) for the monoclonal antibody Gohibic (vilobelimab) to treat critically-ill COVID-19 patients. The company’s shares were up yesterday almost 84% to $3.77. Today, its shares jumped an additional 62% to $6.10.

The EUA represents a significant advance for the Jena, Germany–based company, which on March 31, 2022, encountered a setback related to the antibody. At that time, the company announced that vilobelimab failed a topline readout for critically ill intubated patients suffering from COVID-induced pneumonia in the phase 2/3 PANAMO study. Later, however, InflaRx reported in a predefined analysis without site-stratification that vilobelimab significantly decreased all-cause mortality at 28 days. While the initial protocol did not require site-stratification, the company amended the protocol based on regulators’ recommendations.

Regulatory nod for vilobelimab could spark new developments …

The psychedelic neuroplasticity and safety conundrum: Reaping the rewards of neuroplasticity with caution

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Evidence continues to build that serotonergic psychedelics such as psilocybin, DMT, and LSD promote neuroplasticity. Cortical atrophy is involved in the development of a broad swathe of neuropsychiatric conditions ranging from depression to substance use disorder. But it remains unclear how psychedelics may potentially treat mood disorders and other conditions. Despite their therapeutic potential, these compounds continue to remain unpopular in some quarters and could be contraindicated for many individuals even if they ultimately win regulatory approval.

Drug developers, such as Boston-based Delix Therapeutics and Onsero Therapeutics, aim to develop compounds that trigger neuroplasticity in what they deem to be a safer and more accessible therapeutic option than classic psychedelics.

Meanwhile, players such as Compass Pathways (Nasdaq:CMPS) and Small Pharma (CVE:DMT), are wo…

The ‘Iron man suit’ for QA Managers: Quality management software taps power of ChatGPT

Gone are the days when Microsoft’s animated paperclip, Clippy, popped up on your screen with helpful — and sometimes annoying — tips and tricks for your Word document. Now, the Israeli eQMS compliance provider Dot Compliance has launched what it hails as an industry-first electronic Quality Management System (eQMS) for life sciences with a prominent generative AI-enhanced digital assistant that could take intelligent assistance to new heights. “It’s not just ChatGPT. It’s many other algorithms that are evolving,” said Doron Sitbon, founder and CEO of the company.

Transforming quality assurance with AI-driven quality management software

Rather than Clippy, Sitbon uses another metaphor to illustrate the company’s ChatGPT-enhanced “Dottie” capabilities for its QMS Xpress quality management software. “I think of it as an Iron Man suit for a [quality assurance] manager,” Sitbon quipped. The Dottie digital assistan…

The new National Cancer Plan launches with goal of cutting cancer death rate by half in 25 years

[Image courtesy of National Institutes of Health]

Today, the U.S. Department of Health and Human Services (HHS) debuted the National Cancer Plan with an ambitious albeit vague quest to “end cancer as we know it.”

Specifically, the initiative will serves as a guideline to support President Biden’s Cancer Moonshot objectives, which aims to reduce the cancer mortality rate by 50% over a 25-year period.

NCI will lead the National Cancer Plan and Cancer Moonshot program

HHS will put the National Institutes of Health’s (NIH) National Cancer Institute (NCI) in charge of the program, which supports the Cancer Moonshot initiative from President and First Lady Biden.

The President’s Cancer Moonshot has galvanized the goal of advancing the fight against cancer,” said Dr. Monica M. Bertagnolli, National Cancer Institute director, in a press release.

Despite Biden’s focus on ramping up oncology res…

An overview of the RSV vaccine candidate landscape in early 2023

[RSV image from NIAID]

Respiratory syncytial virus (RSV) remains a prominent global health concern. Each year, the virus is to blame for 2.1 million outpatient visits for children under 5 years old, according to CDC. Other vulnerable populations, including older adults and immunocompromised individuals, are also at risk.

Nevertheless, RSV has long been a research focus. Scientists first identified RSV in 1956. A year later, the pediatrician and virologist Robert M. Chanock linked RSV to respiratory infections in children. Attempts to develop a vaccine for the virus soon followed.

Despite numerous attempts beginning in the 1960s, an FDA-approved RSV vaccine has remained elusive until recently. Out front is GSK’s (NYSE:GSK) RSV vaccine for adults aged 60 and older, which has won the backing of an FDA advisory panel. Close behind is Pfizer’s (NYSE:PFE) single-dose vaccine for the same a…