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Saturday, July 3, 2021

Swiss health tech company SOPHiA GENETICS files for a $100 million US IPO

 SOPHiA GENETICS, which provides a data-driven SaaS platform for the healthcare industry, filed on Friday with the SEC to raise up to $100 million.


SOPHiA GENETICS provides a cloud-based software-as-a-service (SaaS) platform capable of analyzing data and generating insights from complex multimodal data sets and different diagnostic modalities. In 2014, the company launched the first application of its platform to analyze NGS data for cancer diagnosis. As of March 31, 2021, it had approximately 240 applications used by healthcare providers, clinical and life sciences research laboratories and biopharmaceutical companies for precision medicine across oncology, rare diseases, infectious diseases, cardiology, neurology, metabolism and other disease areas.

The Saint-Sulpice, Switzerland-based company was founded in 2011 and booked $30 million in sales for the 12 months ended March 31, 2021. It plans to list on the Nasdaq under the symbol SOPH. J.P. Morgan, Morgan Stanley, Cowen, and Credit Suisse are the joint bookrunners on the deal. No pricing terms were disclosed.

Rare disease biotech Rallybio files for a $100 million IPO

 Rallybio, a Phase 1 biotech developing antibodies for rare diseases, filed on Friday with the SEC to raise up to $100 million in an initial public offering.


Rallybio is currently advancing its lead program, RLYB211, in a Phase 1/2 trial for the treatment of fetal and neonatal alloimmune thrombocytopenia, or FNAIT, a potentially life-threatening rare hematological disease affecting fetuses and newborns. RLYB211 is a polyclonal anti-HPA-1a antibody and is expected to report data from its Phase 1/2 trial in July 2021. The company also has four preclinical programs, one of which, RLBY212, is also being developed for the treatment of FNAIT, and two of which are being developed for the treatment of complement dysregulation diseases.

The New Haven, CT-based company was founded in 2018 and plans to list on the Nasdaq under the symbol RLYB. Jefferies, Cowen, and Evercore ISI are the joint bookrunners on the deal. No pricing terms were disclosed.

Cell analysis instruments provider Cytek BioSciences files for a $100 million IPO

 Cytek BioSciences, which provides cell analysis instruments for life science applications, filed on Friday with the SEC to raise up to $100 million in an initial public offering.


Cytek Biosciences' core products are the Aurora and Northern Lights systems, which are full spectrum flow cytometers that deliver high-resolution cell analysis by using the full spectrum of fluorescence signatures from multiple lasers to distinguish fluorescent tags on single cells, also known as full spectrum profiling. As of March 31, 2021, the company has placed over 750 instruments to over 620 companies around the world, including pharmaceutical companies, over 125 biopharma companies, academic research centers, and clinical research organizations. 

The Fremont, CA-based company was founded in 2014 and booked $99 million in sales for the 12 months ended March 31, 2021. It plans to list on the Nasdaq under the symbol CTKB. Cytek BioSciences filed confidentially on April 22, 2021. Morgan Stanley, Goldman Sachs, Piper Sandler, and Cowen are the joint bookrunners on the deal. No pricing terms were disclosed.

Investment firms' SPAC DA32 Life Science Tech Acquisition files for a $200 million IPO

 DA32 Life Science Tech Acquisition, a blank check company formed by Deerfield Management, ARCH Venture Partners, and Section 32, filed on Friday with the SEC to raise up to $200 million.


The New York, NY-based company plans to raise $200 million by offering 20 million shares at $10. The company is not offering units with warrants attached. At the proposed deal size, DA32 Life Science Tech Acquisition would command a market value of $257 million.

Co-sponsored by Deerfield Management, ARCH Venture Partners, and Section 32, DA32 Life Science Tech Acquisition is led by CEO and Director Steve Kafka, a Managing Partner of Section 32. The company plans to leverage management's background and experience to target the life sciences sector.

DA32 Life Science Tech Acquisition was founded in 2021 and plans to list on the Nasdaq under the symbol DALS. The company filed confidentially on May 28, 2021. J.P. Morgan, and Cowen are the joint bookrunners on the deal.

OcugenPartner Bharat Shares Phase 3 Results Demonstrating 77.8% Protection against Overall Disease

 

  • Efficacy analysis demonstrates COVAXIN™ to be 93.4% protective against severe symptomatic COVID-19

  • Efficacy data demonstrates 65.2% protection against the SARS-CoV-2, B.1.617.2 Delta variant

  • Adverse events reported were similar to placebo, with 12.4% of subjects experiencing commonly known side effects and less than 0.5% of subjects feeling serious adverse events

Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19, today announced that its co-development partner, Bharat Biotech, shared positive results of its Phase 3 study of COVAXIN™, a whole virion inactivated COVID-19 vaccine candidate. COVAXIN™ demonstrated a vaccine efficacy in mild, moderate, and severe COVID-19 disease of 77.8% with efficacy against severe COVID-19 disease alone of 93.4%.

“As we brace ourselves for the potential next wave of COVID-19 outbreaks from the Delta variant, reporting of the final efficacy analysis from this Phase 3 study comes at a crucial time. We expect these efficacy and safety outcomes, along with demonstrated efficacy against emerging variants of concern, will support our initiatives to bring COVAXIN™ to the US and Canadian markets,” said Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer and Co-Founder of Ocugen.

“With the Delta variant becoming a dominant strain of COVID-19 in the United States, we believe that the Phase 3 efficacy results reported by Bharat Biotech demonstrate that COVAXIN™ has the potential to become an important option to expand protection against this emerging variant. Combining these data with the only Delta-variant results from a controlled Phase 3 clinical trial, evidence continues to support a favorable benefit-risk profile for COVAXIN™,” said Dr. Bruce Forrest, Acting Chief Medical Officer and a member of the vaccine scientific advisory board of Ocugen.

Friday, July 2, 2021

Lottery-based incentives do not increase COVID-19 vaccination rates: study

 Would you be more willing to get vaccinated against the COVID-19 virus if you could participate in a lottery for cash and prizes? The answer was surprisingly no, according to Boston University School of Medicine (BUSM) researchers who found that Ohio's "Vax-a-Million" lottery-based incentive system, intended to increase COVID-19 vaccination rates, was not associated with an increase in COVD-19 vaccinations.

Prior reports in the media had suggested that the Ohio lottery increased COVID-19 vaccinations, leading other states to use COVID-19 vaccine incentive lotteries in an attempt to increase slowing . "However, prior evaluations of the Ohio vaccine incentive lottery did not account for other changes in COVID-19 vaccination rates in the United States, such as those that may have been due to expansion of vaccination to ages 12-15," explained corresponding author Allan J. Walkey, MD, MSc, professor of medicine at BUSM.

Using data from the U.S. Centers of Disease Control to evaluate trends in vaccination rates among adults 18 and older, the researchers compared vaccination rates before and after the Ohio lottery versus other states in the U.S. that did not yet have vaccine incentive lottery programs. Vaccination rates in other states served as a "control" for vaccination trends measured in Ohio, allowing the researchers to account for factors besides the Ohio lottery (such expanding vaccine eligibility to adolescents) throughout the country.

"Our results suggest that state-based lotteries are of limited value in increasing vaccine uptake. Therefore, the resources devoted to vaccine lotteries may be more successfully invested in programs that target underlying reasons for vaccine hesitancy and low vaccine uptake," said Walkey, a physician at Boston Medical Center.

The researchers believe identifying interventions that can successfully increase COVID-19 vaccination rates is a critical public health issue necessary to curb the pandemic. "It is important to rigorously evaluate strategies designed to increase vaccine uptake, rapidly deploy successful strategies, and phase out those that do not work," Walkey said.

Although Walkey and his colleagues were sorry to see that state  incentives were not associated with an increase COVID-19 vaccinations, they hope their findings will lead to a shift in focus away from ineffective and expensive lotteries, and on to further study of other programs that may more successfully increase  uptake.


Explore further

Almost all U.S. physicians have gotten a COVID vaccine

More information: Allan J. Walkey et al, Lottery-Based Incentive in Ohio and COVID-19 Vaccination Rates, JAMA (2021). DOI: 10.1001/jama.2021.11048
https://medicalxpress.com/news/2021-07-lottery-based-incentives-covid-vaccination.html

Stress can turn hair gray -- and it's reversible

 Legend has it that Marie Antoinette's hair turned gray overnight just before her beheading in 1791.

Though the legend is inaccurate -- hair that has already grown out of the follicle does not change color -- a new study from researchers at Columbia University Vagelos College of Physicians and Surgeons is the first to offer quantitative evidence linking psychological stress to graying hair in people.

And while it may seem intuitive that stress can accelerate graying, the researchers were surprised to discover that hair color can be restored when stress is eliminated, a finding that contrasts with a recent study in mice that suggested that stressed-induced gray hairs are permanent.

The study, published June 22 in eLife, has broader significance than confirming age-old speculation about the effects of stress on hair color, says the study's senior author Martin Picard, PhD(link is external and opens in a new window), associate professor of behavioral medicine (in psychiatry and neurology) at Columbia University Vagelos College of Physicians and Surgeons.

"Understanding the mechanisms that allow 'old' gray hairs to return to their 'young' pigmented states could yield new clues about the malleability of human aging in general and how it is influenced by stress," Picard says.

"Our data add to a growing body of evidence demonstrating that human aging is not a linear, fixed biological process but may, at least in part, be halted or even temporarily reversed."

Studying hair as an avenue to investigate aging

"Just as the rings in a tree trunk hold information about past decades in the life of a tree, our hair contains information about our biological history," Picard says. "When hairs are still under the skin as follicles, they are subject to the influence of stress hormones and other things happening in our mind and body. Once hairs grow out of the scalp, they harden and permanently crystallize these exposures into a stable form."

Though people have long believed that psychological stress can accelerate gray hair, scientists have debated the connection due to the lack of sensitive methods that can precisely correlate times of stress with hair pigmentation at a single-follicle level.

Splitting hairs to document hair pigmentation Ayelet Rosenberg, first author on the study and a student in Picard's laboratory, developed a new method for capturing highly detailed images of tiny slices of human hairs to quantify the extent of pigment loss (graying) in each of those slices. Each slice, about 1/20th of a millimeter wide, represents about an hour of hair growth.

"If you use your eyes to look at a hair, it will seem like it's the same color throughout unless there is a major transition," Picard says. "Under a high-resolution scanner, you see small, subtle variations in color, and that's what we're measuring."

The researchers analyzed individual hairs from 14 volunteers. The results were compared with each volunteer's stress diary, in which individuals were asked to review their calendars and rate each week's level of stress.

The investigators immediately noticed that some gray hairs naturally regain their original color, which had never been quantitatively documented, Picard says.

When hairs were aligned with stress diaries by Shannon Rausser, second author on the paper and a student in Picard's laboratory, striking associations between stress and hair graying were revealed and, in some cases, a reversal of graying with the lifting of stress.

"There was one individual who went on vacation, and five hairs on that person's head reverted back to dark during the vacation, synchronized in time," Picard says.

Blame the mind-mitochondria connection

To better understand how stress causes gray hair, the researchers also measured levels of thousands of proteins in the hairs and how protein levels changed over the length of each hair.

Changes in 300 proteins occurred when hair color changed, and the researchers developed a mathematical model that suggests stress-induced changes in mitochondria may explain how stress turns hair gray.

"We often hear that the mitochondria are the powerhouses of the cell, but that's not the only role they play," Picard says. "Mitochondria are actually like little antennas inside the cell that respond to a number of different signals, including psychological stress."

The mitochondria connection between stress and hair color differs from that discovered in a recent study of mice, which found that stress-induced graying was caused by an irreversible loss of stem cells in the hair follicle.

"Our data show that graying is reversible in people, which implicates a different mechanism," says co-author Ralf Paus, PhD, professor of dermatology at the University of Miami Miller School of Medicine. "Mice have very different hair follicle biology, and this may be an instance where findings in mice don't translate well to people."

Hair re-pigmentation only possible for some

Reducing stress in your life is a good goal, but it won't necessarily turn your hair to a normal color.

"Based on our mathematical modeling, we think hair needs to reach a threshold before it turns gray," Picard says. "In middle age, when the hair is near that threshold because of biological age and other factors, stress will push it over the threshold and it transitions to gray.

"But we don't think that reducing stress in a 70-year-old who's been gray for years will darken their hair or increasing stress in a 10-year-old will be enough to tip their hair over the gray threshold."

More information

The study is titled "Quantitative Mapping of Human Hair Greying and Reversal in Relation to Life Stress."

All contributors (all from Columbia unless noted): Ayelet Rosenberg, Shannon Rausser, Junting Ren, Eugene V. Mosharov, Gabriel Sturm, R. Todd Ogden, Purvi Patel, Rajesh Kumar Soni, Clay Lacefield (New York State Psychiatric Institute), Desmond J. Tobin (University College Dublin), Ralf Paus (University of Miami, University of Manchester, UK, and Monasterium Laboratory, Münster, Germany), and Martin Picard.

The research was funded by grants from the Wharton Fund and the National Institutes of Health (grants GM119793, MH119336, and AG066828).


Story Source:

Materials provided by Columbia University Irving Medical CenterNote: Content may be edited for style and length.


Journal Reference:

  1. Ayelet M Rosenberg, Shannon Rausser, Junting Ren, Eugene V Mosharov, Gabriel Sturm, R Todd Ogden, Purvi Patel, Rajesh Kumar Soni, Clay Lacefield, Desmond J Tobin, Ralf Paus, Martin Picard. Quantitative mapping of human hair greying and reversal in relation to life stresseLife, 2021; 10 DOI: 10.7554/eLife.67437