The biotech world is still preoccupied with finding the most effective, safe, and widely available treatment for Covid-19. Although the vaccination progress across the world is gradually advancing, a large portion of the most breaking biotech news has to do with Covid-19 treatment candidates. Today, we will share details on the oral antiviral for Covid-19, plant-based Covid-19 vaccine, and the skepticism towards the Chinese experimental Covid-19 treatment that shows an unbelievable 92% reduction in mortality. Apart from Covid-19 treatments, we will also discuss Eli Lily’s advancements on tackling type 2 diabetes, nasal swabs detecting lung cancer, new findings on melanoma, and FDA urging gene therapy developers to be more consistent, as several possible treatments are delayed due to inadequacies discovered during the FDA submission.
Veracyte announced that later this year, their nasal swab testing for lung cancer will be ready for launch.
The Percepta genomic test was clinically tested on almost 250 patients with no lung nodule uncovered by a CT scan. After a year of the initial swab, the test showed great efficiency in assigning a low risk for cancer
Its Percepta genomic test aims to separate current and former smokers into groups with higher or lower risks for lung cancer, allowing those whose nodules are most likely benign to avoid additional procedures, while expediting the course of those who may need care sooner.
In a blinded study, researchers collected nasal swabs from nearly 250 patients who had a lung nodule uncovered by a CT scan.
“Lung nodules are often the first sign of lung cancer and cannot be ignored, yet most of them are benign,” said study investigator Carla Lamb, an interventional pulmonologist at Lahey Hospital & Medical Center.
“Today, physicians have limited objective tools to determine which patients with lung nodules found on CT scans have cancer and which don’t,” Lamb said. “Our findings showed that the nasal swab test can determine, with a high level of accuracy, which patients are at low risk of cancer and can avoid invasive procedures.”
The test explores the genomic changes in the lining of the respiratory tract, looking for active cancer cells.
“These findings suggest that the Percepta Nasal Swab test will be able to objectively and accurately stratify approximately half of the patients with lung nodules found on CT scans to low or high risk, while those not classified will remain a candidate for the current standard of care,” said Giulia Kennedy, Veracyte’s chief scientific officer and chief medical officer.
Today, it was announced that after the 4th clinical trial by Eli Lily, Tirzepatide has resulted in outstanding A1C and body weight reductions after three doses given to adults with type 2 diabetes and increased cardiovascular tirk, as compared to titrated insulin glarine.
The highest dose of tirzepatide led to an A1C reduction of 2.58 percent and reduced body weight by 11.7 kg compared to results for those treated with insulin glargine.
“Tirzepatide delivered impressive results in this study, providing superior A1C reductions compared to insulin glargine – as well as the addition of significant weight loss – in people with type 2 diabetes who have increased cardiovascular risk,” said John Doupis, M.D., Ph.D., Director, Diabetes Division and Clinical Research Center, Iatriko Paleou Falirou Medical Center, Athens, Greece and Senior Investigator for SURPASS-4. “Type 2 diabetes is a complex condition that requires personalized approaches to treatment, and results from SURPASS-4 demonstrate the potential of tirzepatide to be an important option to help reduce A1C and weight for people with type 2 diabetes on one or up to three oral medicines.”
Yesterday, the ML biotech company PostEra and the independent medical charity LifeArc have revealed they will partner in developing a potential antiviral treatment for Covid-19. For this purpose, PostEra was granted a £100 000 grant by LifeArc. The aim is to develop the oral antiviral that will be ready for clinical trials within 3 months.
PostEra will lead the Covid-19 Moonshot initiative together with expert researchers from
Diamond Light Source, Oxford University, Weizmann Institute, Memorial Sloan Kettering Cancer Center, and MedChemica.
“LifeArc’s support will enable us to reach an important milestone, delivering a molecule ready for preclinical studies,” said Alpha Lee, Chief Scientific Officer of PostEra. “Our open science model has enabled us to make rapid progress by establishing a wide net of collaborators. We look forward to working with visionary medical charities like LifeArc as our lead compound moves towards the clinic.”
“LifeArc plays a vital role in advancing medical research through funding, advice and scientific expertise to translate early discoveries into patient benefit,” Dr Andy Merritt, Head of Chemistry at LifeArc said. “Since the beginning of the pandemic, LifeArc has contributed £27m to research projects to address the healthcare challenges of COVID-19 and we have been considering more ways in which we could apply our knowledge and expertise in this area. Our collaboration with the Moonshot consortium enables us to do this, as we seek to advance a potential antiviral candidate to first in patient trials and support the development of a framework for a response to future pandemics.”
Melanoma is among the most dangerous form of skin cancer. Although it has been known that CRTC proteins are involved in pigmentation and melanoma, no specifics about the proteins were discovered until now. However, recently, the scientists from the Salk Institute reported their new findings of one of the proteins in the CRTC family – CRTC3. The findings may result in new melanoma treatments.
Scientists have discovered a “genetic switch” that appears to be instrumental for melanoma development. Their full findings have been published in he journal Cell Reports in a paper titled, “Transcriptional co-activator regulates melanocyte differentiation and oncogenesis by integrating cAMP and MAPK/ERK pathways.”
“We’ve been able to correlate the activity of this genetic switch to melanin production and cancer,” explained corresponding study author Marc Montminy, MD, Ph.D., a professor in the Clayton Foundation Laboratories for Peptide Biology.
“This is a really interesting situation where different behaviors of these proteins, or genetic switches, can actually give us specificity when we start thinking about therapies down the road,” said first author Jelena Ostojic, a former Salk staff scientist and now a principal scientist at DermTech.
FDA Urges Gene Therapy Developers To More Consistency
On Wednesday, one of the top officials of The Food and Drug Administration (FDA) called for more consistency among cell and gene therapy developers. The official said that develops a need to measure the characteristics of highly complex products better.
In the last months, we have seen several drug developers delay the launch of their products due to a number of issues pointed out by the FDA.
“Just like manufacturers like consistency, FDA likes consistency in product,” said Peter Marks, head of the regulator’s biologic drugs division, at the World Medical Innovation Forum’s virtual meeting.
Marks believes that the cell and gene therapy makers are not always detailed enough in constructing the tests early enough which would allow for adequate measurement of the products in the process from early testing to clinical trials and eventually, FDA.
“It sounds almost sing-songy,” he added. “But many times developers get very excited about the fact that their product produces an important effect that they don’t worry as much about reproducibly making that product.”
“Pick something. Pick some quality of the cell. Pick something that you think might correlate and measure that,” he said. “We’ll take any offers that are reasonable.”
The experimental Covid-19 drug developed by the Chinese biotech, Kintor Pharmaceutical Limited, announced it has completed its first enrollment and dosing of the Covid-19 treatment, in a late-stage U.S. clinical trials.
While the announcement was made at the end of April, the progress of the drug, Proxalutamide, is a cause for skepticism among researchers.
Although companies are not obliged to release information about their clinical trials, in terms of the leading scientists and research institution in charge of patient safety. However, most pharmaceutical companies routinely choose to do so. In the case of Kintor, there has been a lot of confusion, false information, and a lack of transparency. Moreover, there have been several issues and inconsistencies in the company’s statements.
Moreover, Kintor has frequently referred to a Brazilian study of its drudge, Proxalutamide, which has found a 92% reduction in mortality risk among Covid-19 patients that are hospitalized. Pharmaceutical specialists say this is highly unlikely and would border on a miracle, raising another red flag about the drug.
Covid-19 Treatment: Medicago And GlaxoSmithKline Show Promising Data On A Plant-Based Covid-19 Vaccine
Medicago and GlaxoSmithKline have announced the phase 2 data on their plant-based Covid-19 vaccine. The results show a clear difference between this candidate and other vaccines that have successfully undergone clinical trials.
As the plant-based vaccine’s structure is different than the other vaccines, its triggers a mixed cellular response. Medicago’s and GlaxoSmithKline’s vaccine consists of self-assembling viruslike particles (VLPs) that display trimers of recombinant S protein from SARS-CoV-2.
However, Medicago showed that the vaccine is safe, tolerable, and does trigger an immune response.