As of September 19, 2023, Revance Therapeutics Inc. has projected a range of $80 million to $100 million for the non-cash impairment charges incurred due to goodwill and other assets. The company expects all associated undertakings, such as staff downsizing, to be finalized by March 31, 2024.
https://beststocks.com/revance-therapeutics-inc-projects-impairment/
Intends to use court-supervised process to mitigate financial impact and facilitate a fair resolution through an appeals process following the September 14, 2023 decision by a trial court
UpHealth expects to continue operating in the normal course, enabling high quality, affordable and accessible healthcare for all
https://finance.yahoo.com/news/uphealth-subsidiary-uphealth-holdings-files-120000539.html
Following evidence of marked pharmacodynamic activity in first cohort, Cohort 2 has dose reduced while anticipating a similar effect
Indaptus Therapeutics, Inc. (Nasdaq: INDP) (“Indaptus” or the “Company”) announces dosing of the first patient in the second cohort of patients to receive a single dose of Decoy20 in the INDP-D101 trial. This cohort dose is a dose reduction from the previous cohort based on the significant pharmacodynamic effect seen with the first cohort and anticipated optimal Decoy20 safety profile for both weekly dosing and combination approaches.
“This cohort is important to the development of Decoy20 as it may provide sufficient data for us to move Decoy20 to a multi-dosing regimen,” said Dr. Roger Waltzman, Indaptus’ Chief Medical Officer. “To date, we have seen positive signs of an immune response with an anticipated adverse effect profile, and we look forward to seeing whether this lower dose provides similar evidence of increased cytokines that can trigger both innate and adaptive immune responses.”
“We continue to be encouraged by the initial results of the first cohort and look forward to progressing into the multi-dosing regimen as soon as we have enough data,” said Jeffrey Meckler, Chief Executive Officer. The study’s objectives are to assess the safety and tolerability of Decoy20, to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D), as well as to assess Decoy20 pharmacokinetics (PK), pharmacodynamics and clinical activity. More information can be found at www.clinicaltrials.gov.
The Phase 1 study was initiated with a single dose escalation, which is planned to be followed by an expansion with continuous weekly administration of Decoy20. The study is enrolling patients with advanced/metastatic solid tumors, who have exhausted approved treatment options.
About Indaptus Therapeutics
Indaptus Therapeutics has evolved from more than a century of immunotherapy advances. The Company’s novel approach is based on the hypothesis that efficient activation of both innate and adaptive immune cells and pathways and associated anti-tumor and anti-viral immune responses will require a multi-targeted package of immune system-activating signals that can be administered safely intravenously (i.v.). Indaptus’ patented technology is composed of single strains of attenuated and killed, non-pathogenic, Gram-negative bacteria producing a multiple Toll-like receptor (TLR), Nucleotide oligomerization domain (Nod)-like receptor (NLR) and Stimulator of interferon genes (STING) agonist Decoy platform. The products are designed to have reduced i.v. toxicity, but largely uncompromised ability to prime or activate many of the cells and pathways of innate and adaptive immunity. Decoy products represent an antigen-agnostic technology that have produced single-agent activity against metastatic pancreatic and orthotopic colorectal carcinomas, single agent eradication of established antigen-expressing breast carcinoma, as well as combination-mediated eradication of established hepatocellular carcinomas and non-Hodgkin’s lymphomas in standard pre-clinical models, including syngeneic mouse tumors and human tumor xenografts. In pre-clinical studies tumor eradication was observed with Decoy products in combination with anti-PD-1 checkpoint therapy, low-dose chemotherapy, a non-steroidal anti-inflammatory drug, or an approved, targeted antibody. Combination-based tumor eradication in pre-clinical models produced innate and adaptive immunological memory, involved activation of both innate and adaptive immune cells, and was associated with induction of innate and adaptive immune pathways in tumors after only one i.v. dose of Decoy product, with associated “cold” to “hot” tumor inflammation signature transition. IND-enabling, nonclinical toxicology studies demonstrated safe i.v. administration without sustained induction of hallmark biomarkers of cytokine release syndromes, possibly due to passive targeting to liver, spleen, and tumor, followed by rapid elimination of the product. Indaptus’ Decoy products have also produced significant single agent activity against chronic hepatitis B virus (HBV) and chronic human immunodeficiency virus (HIV) infections in pre-clinical models.
https://finance.yahoo.com/news/indaptus-therapeutics-doses-first-patient-120000196.html
Transaction Reflects Increasing Strategic Focus on Proprietary Drug-Eluting Biomatrix Platform –
Elutia Inc. (Nasdaq: ELUT) (“Elutia”), a company pioneering drug-eluting biomatrix products, today announced the divestiture of the Company’s Orthobiologics business unit to Berkeley Biologics LLC, a wholly owned subsidiary of GNI Group Ltd. Elutia will receive cash proceeds of up to $35 million, comprised of an upfront payment at closing of $15 million plus potential earnout payments of up to $20 million over a five-year period. The transaction is expected to close in the fourth quarter of 2023.
This transaction represents a pivotal milestone in Elutia’s progress toward pioneering the drug-eluting biomatrix. The Company continues to make progress towards gaining U.S. Food and Drug Administration clearance for CanGaroo® RM, the Company’s lead drug-eluting product. CanGaroo RM features an advanced biomatrix and the drugs rifampin and minocycline (RM) for extended antibiotic protection for cardiac pacemakers and defibrillators, a $28 billion market. Elutia is targeting the first half of 2024 for the launch of CanGaroo RM. The Company’s pipeline also includes an RM version of its SimpliDerm® biomatrix for use in breast reconstruction procedures.
https://finance.yahoo.com/news/elutia-announces-sale-orthobiologics-business-200800047.html
People in the EU who need access to pre-exposure prophylaxis (PrEP) for HIV could soon have a new option with fewer doses after the European Commission approved ViiV Healthcare’s Apretude.
The long-acting injectable drug, which can be given as few as six times per year, is an alternative to daily oral PrEP with Gilead Sciences’ Truvada (emtricitabine/tenofovir disoproxil fumarate) and Descovy (emtricitabine/tenofovir alafenamide), approved in the EU in 2016 and 2021, respectively.
With approximately 100,000 people newly diagnosed with HIV each year in Europe, expanding HIV prevention options is crucial in reducing HIV transmission, according to ViiV’s majority owner GSK.
Apretude (cabotegravir) has been cleared for use in combination with safer sex practices to reduce the risk of HIV infection in high-risk adults and adolescents (at least 12 years of age), weighing at least 35 kg.
PrEP – used to protect at-risk people such as an HIV-negative individual with an HIV-positive partner – requires high levels of adherence to be effective, and ViiV maintains that the infrequent dosing required with Apretude can make it easier for patients to stay protected.
For some people, compliance with regular dosing can be challenging, particularly if there are confounding issues such as substance use disorders, depression, poverty and efforts to conceal medication from family and friends.
“This authorisation marks a pivotal milestone for people across the EU who could benefit from an innovative, long-acting HIV prevention option that may better suit their personal preferences,” said ViiV’s chief executive Deborah Waterhouse.
“Long-acting PrEP, alongside other HIV prevention strategies, plays an important role in helping to address some of the challenges that people may have with oral PrEP options,” she added.
Apretude has been approved in the US since the end of 2021 and made £41 million in sales in full-year 2022 – all from the US market – rising to £36 million in the first six months of 2023.
It still has a long way to go to challenge Gilead’s PrEP franchise, however, which has raked in billions of dollars since Truvada first reached the market for PrEP in 2012.
It is thought that around two-thirds of Truvada’s peak sales of $3 billion came from PrEP, with the remainder from its use as a treatment for HIV infection, before sales started to fall as generics entered the market. Descovy has been growing to compensate, however – thanks to an improved safety profile – and reached $1.7 billion last year.
Another company looking at entering the PrEP market is MSD – known as Merck & Co in the US – which has been investigating monthly oral and yearly implantable formulations of islatravir for this use. The oral formulation was discontinued last year, however, after a safety signal emerged in clinical trials.
https://pharmaphorum.com/news/viivs-injectable-hiv-prep-drug-apretude-gets-eu-okay
Biophytis SA (Nasdaq CM:BPTS, Euronext Growth Paris:ALBPS), (Biophytis), a clinical-stage biotechnology company specialized in the development of therapeutics that are aimed at slowing the degenerative processes associated with aging and improving functional outcomes for patients suffering from age-related diseases, including severe respiratory failure in patients suffering from COVID-19, today announced that it has received a response from the French National Authority for Health (HAS) to its request for Early Access Authorization in France for patients suffering from severe forms of COVID-19 and provides an update on its strategy in other countries.
After examining the Early Access Authorization request file submitted at the end of May 2023, HAS considered that the Company had not provided sufficient data allowing it to evaluate precisely the benefit vs. risk ratio and to authorize the treatment of patients with severe forms of COVID-19, despite the statistically significant results of the phase 2-3 COVA study. The Company must therefore complete the file by providing in particular certain results of pharmaceutical studies, in progress with its industrial partner Sequens, as well as certain additional data and scientific arguments relating to its phase 2-3 COVA study. On the basis of these various elements, it is planned to resubmit the application to the HAS in the first quarter of 2024, with pharmaceutical partner Intsel Chimos, depending on the progress made in the development plan.
At the same time, Biophytis is taking steps in Brazil to confirm the early access authorization obtained in early 2022 that was interrupted pending publication of the full results of the COVA study. This new authorization is expected by the end of the year.
Finally, the Company is exploring the possibilities of launching early access programs in other key countries in Europe, in order to best respond to the medical need in a pathology that has become endemic.
About BIOPHYTIS
Biophytis SA is a clinical-stage biotechnology company specializing in the development of drug candidates for age-related diseases. Sarconeos (BIO101), our lead drug candidate, is a small molecule in development for age-related neuromuscular (sarcopenia and Duchenne muscular dystrophy) and cardiorespiratory (Covid-19) diseases. Promising clinical results were obtained in the treatment of sarcopenia in an international phase 2 study, enabling the launch of a phase 3 study in this indication (SARA project). The safety and efficacy of Sarconeos (BIO101) in the treatment of severe COVID-19 were studied in a positive international phase 2-3 clinical trial (COVA project). A pediatric formulation of Sarconeos (BIO101) is currently being developed for the treatment of Duchenne Muscular Dystrophy (DMD, MYODA project). The company is based in Paris, France, and Cambridge, Massachusetts. The Company's ordinary shares are listed on Euronext Growth (Ticker: ALBPS -ISIN: FR0012816825) and the ADSs (American Depositary Shares) are listed on Nasdaq Capital Market (Ticker BPTS - ISIN: US09076G1040).
For more information, visit www.biophytis.com
Scientists with the American Society for Microbiology, or ASM, called for standardized practices, greater public transparency and more in a new report on gain-of-function research, studies where microbes are given characteristics that don’t exist in nature and, in some cases, could make them more dangerous.
The report, published Sept. 13, was co-authored by a think tank of scientists from more than a dozen leading research institutions, including Stanford, Johns Hopkins, the University of Pennsylvania, St. Jude Children’s Research Hospital and Harvard. It comes as the White House considers implementing a regulatory framework for gain-of-function research proposed in January by the National Science Advisory Board for Biosecurity or NSABB.
“Our goal here was to present the issues in an unbiased manner, laying out all of the potential risks and benefits that need to be considered when making decisions about these types of experiments,” steering committee chair Michael Imperiale, Ph.D., a microbiologist at the University of Michigan, told Fierce Biotech Research in an email. The report is the product of a workshop conducted by the ASM in May.
Long controversial, gain-of-function research on pathogens has gained new notoriety thanks to the COVID-19 pandemic. Some politicians have asserted that the virus that causes COVID, SARS-CoV-2, is the result of such studies on coronaviruses, which had been conducted prior to the pandemic at the Wuhan Institute of Virology in Wuhan, China, where the virus is believed to have originated from.
Notably, there is little concrete evidence for this claim, popularized in online circles as the lab leak hypothesis. Researchers who have studied the genetics of SARS-CoV-2 believe it came from animals.
Still, the debate has sparked renewed calls from scientists to address transparency, communication and biosecurity around gain-of-function research. At the same time, scientists have also warned not to overstate the risks, as studies on organisms with pandemic potential—which fall under a subtype called “gain-of-function research of concern” and, more specifically, enhanced potential pandemic pathogen research—are essential to heading off emerging disease. They also make up only a fraction of gain-of-function studies. Other applications include cancer treatments, crop preservation and even faster computers, to name a few.
"The controversy about the origins of SARS-CoV-2 have brought the term ‘gain of function’ into the public arena, which emphasizes the need for a science- and fact-based discussion of the topic,” Imperiale said. The researchers at the workshop in May did not, however, discuss the origin of SARS-CoV-2, because “there is no evidence that the virus was the result of a [gain-of-function] experiment,” he wrote.
At a high level, the scientists suggest creating clear definitions of terms like “gain of function” and “enhanced potential pandemic pathogen” as well as establishing international standardized biocontainment practices and frameworks for deciding under what circumstances it’s safe to conduct research on dangerous pathogens. They also called for strengthening reporting systems for lab workers to better track accidents, including whistleblower protections.
The scientists also vouched for more transparent communication with the public about exactly what gain-of-function research entails, including clear language that “recognizes uncertainties,” the report said. Recent high-profile conversations have been dominated by discussions around the risks and dangers of such studies, with much less said about why they’re necessary or the precautions already being taken.
“To help address these concerns, scientists need to acknowledge risks more clearly and candidly and explain and justify why using a perceived risky approach is necessary to answer certain research questions,” the researchers wrote in the report. “A consensus was reached that scientists must do a better job of communicating risks involved in doing science as well as procedures in place to do science safely.”
While no one, including the NSABB, has called for a blanket ban on all studies of potential pandemic-causing pathogens, even supporters of such research recognize that there are some experiments that should not be performed, the report said. Still, it remains to be seen how those decisions should be made and who should make them, which will require further conversations, the scientists wrote.
“Both support for and concern about a number of recommendations have been raised, and it is hoped that the U.S. government will carefully consider these thoughtful opinions,” the researchers wrote.
Coming up with evidence-based policies, forming decision-making frameworks and engaging with stakeholders in a transparent way will be vital not only to responding to the inevitable next pandemic but to strengthening trust in science and maintaining progress.
"Slowing scientific progress has a potential cost to society by making it potentially less prepared for the future...[while] a lack of effective oversight could lead to risks to public health," the scientists said. "Therefore, finding the balance of scientific progress and biorisk mitigation is critical for promoting responsible science."
