Philadelphia, January 4, 2022Aberrant splicing of messenger RNAs encoding surface antigen CD22 leads to downregulation of this protein in pediatric B-lymphoblastic leukemia (B-ALL), rendering malignant cells resistant to the effects of CD22-directed immunotherapies, according to a recent study by researchers at Childrens Hospital of Philadelphia (CHOP). The findings could allow oncologists to screen new patients to see if their leukemic cells contain alternatively spliced CD22 mRNA variants, which could reveal which patients might not respond to anti-CD22 therapies and would need alternative treatment plans. The study was published inBlood Cancer Discovery, a journal of the American Association for Cancer Research.

Cancer cells often evade immunotherapy through so-called antigen escape, where the targets on cancer cells are no longer visible to the immune system, even if the latter is modified to maximize potency, said co-senior authorAndrei Thomas-Tikhonenko, PhD, Chief of theDivision of Cancer Pathobiology at CHOPand Professor ofPathology and Laboratory Medicine at the University of Pennsylvania School of Medicine. As more of these cutting-edge approaches are becoming frontline therapies, it is of the utmost importance to identify cancer patients at diagnosis who might fail to respond or develop resistance over time. One way to achieve this is by paying close attention to aberrant RNA splicing events, like those described in our study.

Adoptive immunotherapy, in which a patients own immune system is used to kill cancer cells, has been a breakthrough in the treatment of B-ALL. Particularly effective are chimeric antigen receptor (CAR)-based therapies such as tisagenlecleucel and axicabtagene ciloleucel. These therapies are directed against CD19, a protein found in abundance on the surface of B cells. However, despite the success of these treatments, close to half of patients with B-ALL treated with anti-CD19 CAR T cell immunotherapy relapse because CD19 vanishes from the cell surface.

As a last resort, these patients are often treated with immunotherapies directed against CD22, another surface protein unique to both normal and malignant B cells. Increasingly, these CD22-directed immunotherapies, such as the antibody-drug conjugate inotuzumab ozogamicin, are also being used as frontline therapies to treat B-ALL. However, a significant fraction of patients treated with either inotuzumab or anti-CD22 CAR T cells relapse over time as well. As with CD19, the loss of target antigen appears to play an important role, but the mechanisms responsible for CD22 disappearance are still poorly understood.

Knowing that the decrease in CD22 protein occurred despite continued production of CD22 mRNA, the researchers suspected that alternative splicing events might be at play,as had been the case for CD19-negative relapses. Alternative splicing allows a gene to code for multiple proteins by cutting the RNA sequences at different points and including or skipping distinct exons, the coding portions of RNA. Although earlier studies had shown that CD22 undergoes alternative splicing, the role of these CD22 isoforms in the context of immunotherapy had not been characterized.

Using RNA sequencing, former CHOP pediatric hematology-oncology fellow Sisi Zheng, MD, and her colleagues identified splicing variations within the CD22 transcript that are prevalent in B-ALL by comparing data from more than 200 B-ALL samples with data from multiple healthy bone marrow donors. They identified numerous splicing variations in the B-ALL samples, including a novel isoform that involves skipping ofCD22exons 5 and 6 and several variants involving skipping of exon 2.

The cross-disciplinary research team then characterized these variants potential roles in immunotherapy resistance. They discovered that although the CD22 variant that splices out exons 5 and 6 is still able to localize to the surface of B cells and maintain a functional intracellular domain, the skipping of these exons results in the loss of part of the protein to which several antibodies and CARs attach. As anticipated, this reduced the efficacy of certain immunotherapies that had shown some promise in preclinical models.

In addition, the researchers found that exon 2 skipping markedly decreased expression of all CD22 protein isoforms and hindered recognition by all antibodies, irrespective of their binding sites. As a result, it led to inferiorin vitroleukemia cell killing by inotuzumab. They then extended this observation to the study of relapsed B-ALL samples from children treated with inotuzumab in the Childrens Oncology GroupAALL1621phase 2 clinical trial. The researchers observed that the CD22 isoform skipping exons 2 through 6 was prevalent in this patient population. In one case, it was the only CD22 isoform, and predictably that patient did not respond to treatment with inotuzumab. In another patient, skipping of CD22 exons was moderate at the beginning of treatment, but went up sharply as the disease progressed.

Inotuzumab is an important drug in our ALL immunotherapy armamentarium for children and adolscents with relapsed leukemia and is now under evaluation in newly-diagnosed patients via frontline clinical trials, said co-senior authorSarah K. Tasian, MD, Chief of the Hematologic Malignancies Program at CHOP and Associate Professor of Pediatrics at the University of Pennsylvania School of Medicine. The CD22 variants identified in our study may be predictive biomarkers of inotuzumab treatment response versus failure, as well as provide rationale for investigation of alternative antibody-based and cellular immunotherapeutic strategies.

Zheng et al. Modulation of CD22 protein expression in childhood leukemia by pervasive splicing aberrations: implications for CD22-directed immunotherapies, Blood Cancer Discovery, online November 15, 2021, DOI: 10.1158/2643-3230.BCD-21-0087

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About Childrens Hospital of Philadelphia:Childrens Hospital of Philadelphia was founded in 1855 as the nations first pediatric hospital. Through its long-standing commitment to providing exceptional patient care, training new generations of pediatric healthcare professionals, and pioneering major research initiatives, Childrens Hospital has fostered many discoveries that have benefited children worldwide. Its pediatric research program is among the largest in the country. In addition, its unique family-centered care and public service programs have brought the 595-bed hospital recognition as a leading advocate for children and adolescents. For more information, visithttp://www.chop.edu

Blood Cancer Discovery

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Aberrant splicing of CD22 in acute lymphoblastic leukemia underlies resistance to immunotherapy - EurekAlert

The new drug application for dovitinib as a third-line treatment for patients with renal cell carcinoma is supported by a pre-marketing approval for companion diagnostic, Dovitinib-DRP.

A new drug application has been submitted to the FDA for marketing approval of dovitinib as third-line therapy in in patients with renal cell carcinoma (RCC), according to a press release from developer Allarity Therapeutics.1

The application is supported by a previous pre-marketing approval submission for Dovitinib-DRP, a companion diagnostic for the agent that can select patients with RCC who are eligible and likely to respond to treatment with dovitinib.

This [new drug application] submission for dovitinib, in connection with the Dovitinib-DRP companion diagnostic, is a historic milestone for our company and an important step for late-stage renal cell carcinoma patients awaiting new treatment options. Over the past decade, we have worked diligently to advance our novel oncology therapeutics pipeline together with our unique DRP diagnostic technology to realize the promise of personalized cancer care for patients. We greatly look forward to the approval of dovitinib and to introducing the clinical value of DRP companion diagnostics to oncologists and their patients, Steve Carchedi, chief executive officer at Allarity Therapeutics, said in a press release.

The small molecule pantyrosine kinase inhibitor has previously demonstrated efficacy across a number of tumor types, including RCC, gastrointestinal stromal tumors, endometrial cancer, metastatic breast cancer, and hepatocellular carcinoma.

One phase 3 trial (NCT01223027) compared the use of dovitinib with sorafenib (Nexavar) as a third-line treatment for patients with metastatic RCC.2 In total, 284 patients received the experimental agent and 286 were randomized to the control arm. After a median follow-up of 11.3 months, investigators reported a median progression-free survival of 3.7 months (95% CI, 3.5-3.9) vs 3.6 months in the control arm (95% CI, 3.5-3.7; HR, 0.86; 95% CI, 0.72-1.04; one-sided P = .063).

Common grade 3/4 adverse effects (AE) in the dovitinib cohort included hypertriglyceridemia (14%), fatigue (10%), hypertension (8%), and diarrhea (7%). Additionally, 6% of those in the experimental arm had a serious AE of dyspnea compared with 5% in the sorafenib arm.

As a clinical oncologist looking for new therapies for my [patients with] RCC, I am enthusiastic about Allaritys [new drug application] filing together with its Dovitinib-DRP companion diagnostic, Professor Roberto Pili, MD, associate dean for Cancer Research and Integrative Oncology at the University at Buffalo Jacobs School of Medicine and Biomedical Sciences, said in a statement. These patients, and their treating oncologists, are greatly in need of new precision medicines, coupled with validated companion diagnostics, to help select and treat the most likely responders. I look forward to working with Allarity to advance this new personalized cancer care approach for RCC patients.

Link:
New Drug Application Submitted to FDA for Dovitinib in Third-Line RCC - Cancer Network

By Dr Nitesh Rohatgi

The year 2021 will be remembered in the history of mankind when healthcare failed as well as succeeded, both at the same time.

While the Covid-19 pandemic was at the epicentre, its actually how individual teams reacted to treat patients that are the stories that will be long told.

Oncology, the art of cancer medicine, was no different. But 2021 also saw some big leaps in technology and science of oncology despite everything and these are my top picks.

Cancer disparities are affecting outcomes in a big way including diagnosis, treatment and research. In August 2020, ASCO published its Cancer Disparities and Health Equity Policy Statement that highlighted this and gave direction that can help solve this crisis.

Molecular profiling in gastro-intestinal cancers including esophageal, stomach pancreas, gallbladder and colo-rectal cancers set a new standard of care in early and advanced diseases where the role of both Immunotherapy and targeted therapy was consolidated and benchmark set for future research.

Aspirin usage was linked to long-term reduction in cancer risk in patients with hereditary cancer predisposition.

Immunotherapy before surgery in early stage triple negative breast cancer, the most virulent type, was established for the first time.

Similarly the role of a new class of drugs the CDK 4/6 and PARPi was established in reducing the risk of recurrence in high risk post-operative breast cancer patients.

Patients with lung cancer also saw benefits of post-surgical administration of targeted therapy with Osimertinib. Hepatocellular carcinoma saw new treatment options after almost a decade with a combination of immunotherapy using atezolizumab and targeted therapy with bevacizumab.

CAR T cell treatment improved survival for the majority of patients with relapsed or refractory mantle cell lymphomas.

We also saw huge developments in integration of Artificial Intelligence (AI) and Deep Learning in cancer research.

The fact of the matter is that obesity reduction is probably the most important action to reduce incidence of cancer.

Covid-19 will be a catalyst in research with a positive impact on oncology outcomes. This is the result of decentralisation and global acceptance of virtual collaborations.

Going forward, new trail designs focusing on timeliness and optimisation will be the key. (IANS)

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Covid-19 will be a catalyst in future oncology research - India New England

PLYMOUTH MEETING, PA [January 4, 2022] Today, the National Comprehensive Cancer Network (NCCN) published significant updates to the expert consensus recommendations on vaccination and pre-exposure prophylaxis of COVID-19 in people with cancer. The NCCN Advisory Committee on COVID-19 Vaccination and Pre-exposure Prophylaxis meets frequently to review all available research and provide evidence-based best practices for keeping people with cancer as safe as possible during the COVID-19 pandemic. The updated guidanceavailable at NCCN.org/covid-19includes information on the preventive use of human monoclonal antibodies in addition to the following principals:

All of us are called to do everything we can to save as many lives as possible during the ongoing pandemic, said Robert W. Carlson, MD, Chief Executive Officer, NCCN. Vaccination is our most effective approach for avoiding serious COVID-19 complications, including hospitalization and death. However, research shows many immunocompromised people develop inadequate immune responses from vaccines. Thankfully, we now have additional tools to help people in active treatment for cancer, solid organ transplant recipients, engineered cellular therapy (e.g. CAR T-cell) or stem cell transplant recipients (a.k.a. hematopoietic stem cells), and those with other immunodeficiency-causing conditions (such as HIV, DiGeorge syndrome, or Wiskott-Aldrich syndrome).

The Food and Drug Administration (FDA) has issued an emergency use authorization for the monoclonal antibody combination of tixagevimab plus cilgavimab for pre-exposure protection from COVID-19 in adults and children starting at age 12 (weighing at least 40 kg) who have moderate to severe immune compromise and may not be responsive to vaccination. Patients with blood cancers (including those receiving stem cell transplantation or engineered cellular therapy) are more likely to have inadequate responses to COVID-19 vaccination and are at highest risk of major COVID-19 complications. The committee states that it is reasonable to prioritize these patients for tixagevimab plus cilgavimab before patients with solid tumor cancers in the event of limited supply.

We have new agents to prevent and treat COVID-19 that will benefit patients with cancer, said Brahm Segal, MD, Roswell Park Comprehensive Cancer Center, Co-Leader of the NCCN Advisory Committee on COVID-19 Vaccination and Pre-exposure Prophylaxis. An important challenge on a national level is to ensure drug availability to patients with cancer and others at high risk for COVID-19. The revised recommendations from the NCCN Advisory Committee on COVID-19 Vaccination and Pre-exposure Prophylaxis will provide guidance on the use of these agents for patients with cancer, including prioritization when supplies are limited.

The committee also supports recommendations from the Centers for Disease Control (CDC), American Society of Transplantation and Cellular Therapy (ASTCT), and the American Society of Hematology (ASH) that previously vaccinated patients completing stem cell transplantation or engineered cellular therapy should receive a repeat vaccination series starting at three months post-treatment.

The medical and scientific communitys response to the COVID-19 crisis continues to be extremely encouraging, even in the face of setbacks like new variants and surging infection rates, said Dr. Carlson. Rapid research, thoughtful analyses, and tireless care delivery is allowing us to save so many more people than we could have a year ago. We hope by sharing this simplified guidance highlighting the latest research and approvals, we can help make sure the very latest in evidence-based care reaches as many patients and providers as possible.

The NCCN Advisory Committee on COVID-19 Vaccination and Pre-exposure Prophylaxis is comprised of leading multidisciplinary physicians from across NCCN Member Institutions, with particular expertise in infectious diseases, vaccine development and delivery, cancer management, and medical ethics. NCCN will continue to update recommendations to adapt to changing circumstances, including the growing body of evidence.

All of NCCNs recommendations for cancer care during the pandemic can be found at NCCN.org/covid-19. A patient and caregiver guide to vaccinations is also available at NCCN.org/patientguidelines.

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About the National Comprehensive Cancer Network

The National Comprehensive Cancer Network (NCCN) is a not-for-profit alliance of leading cancer centers devoted to patient care, research, and education. NCCN is dedicated to improving and facilitating quality, effective, equitable, and accessible cancer care so all patients can live better lives. The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) provide transparent, evidence-based, expert consensus recommendations for cancer treatment, prevention, and supportive services; they are the recognized standard for clinical direction and policy in cancer management and the most thorough and frequently-updated clinical practice guidelines available in any area of medicine. The NCCN Guidelines for Patients provide expert cancer treatment information to inform and empower patients and caregivers, through support from the NCCN Foundation. NCCN also advances continuing education, global initiatives, policy, and research collaboration and publication in oncology. Visit NCCN.org for more information and follow NCCN on Facebook @NCCNorg, Instagram @NCCNorg, and Twitter @NCCN.

Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert system.

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Protecting people with cancer from COVID-19: - EurekAlert

By Nancy Lapid

Jan 3 (Reuters) - The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review.

Coronavirus leaves survivors with self-attacking antibodies

Months after recovering from SARS-CoV-2 infection, survivors have elevated levels of antibodies that can mistakenly attack their own organs and tissues, even if they had not been severely ill, according to new findings.

Among 177 healthcare workers who had recovered from confirmed coronavirus infections contracted before the availability of vaccines, all had persistent autoantibodies, including ones that can cause chronic inflammation and injury of the joints, skin and nervous system. "We would not normally expect to see such a diverse array of autoantibodies elevated in these individuals or stay elevated for as long six months after full clinical recovery," said Susan Cheng of the Cedars-Sinai Smidt Heart Institute in Los Angeles. Patterns of elevated autoantibodies varied between men and women, the researchers reported on Thursday in the Journal of Translational Medicine https://translational-medicine.biomedcentral.com/articles/10.1186/s12967-021-03184-8.

"We don't yet know how much longer, beyond six months, the antibodies will stay elevated and/or lead to any important clinical symptoms," Cheng said. "It will be essential to monitor individuals moving forward." Her team is investigating whether autoantibody elevations are linked with persistent symptoms in people with long COVID and planning to study autoantibody levels after infections with newer variants of the virus.

B cells' effects weakened but not defeated by Omicron

The effects of antibodies produced by the immune system's "memory B cells" against the Omicron variant of the coronavirus, while weakened, could still be significant, researchers believe.

Story continues

Once the body learns to recognize SARS-CoV-2, either after infection or vaccination, B cells generate fresh antibodies against the virus if there are not already enough antibodies circulating in the blood that can neutralize it. In a study reported on bioRxiv https://www.biorxiv.org/content/10.1101/2021.12.21.473528v1 ahead of peer review, researchers analyzed the strength of more than 300 antibodies produced by memory B cells obtained from vaccinated volunteers, including some who had a prior SARS-CoV-2 infection.

"Omicron seemed to evade a very large share of the memory B cells pool," researchers said, adding that it "seems to still be efficiently recognized by 30% of total antibodies and close to 10% of all potent neutralizing antibodies," said Matthieu Mahevas and Pascal Chappert of Universite de Paris in a joint email. Memory B cells' robust ability to proliferate and produce antibodies might compensate "in less than two days" for those antibodies' reduced effectiveness, they speculate.

In combination with other immune system components, particularly T cells, the effects of B cells likely help to explain why most vaccinated individuals who become infected do not become sick enough to require hospitalization, they said.

Virus variants' activity in cells makes them more effective

Along with spike mutations that help the coronavirus break into cells, mutations that change how the virus behaves inside the cells are a big factor in why some variants have been more transmissible, researchers have discovered.

The findings, published in Nature https://www.nature.com/articles/s41586-021-04352-y, show that scientists "have to start looking at mutations outside the spike," which has so far been the main focus of vaccines and antibody drugs, said Nevan Krogan of the University of California, San Francisco. Studying the Alpha variant, his team found a mutation at a non-spike site that causes infected cells to ramp up their production of a protein called Orf9B. Orf9b in turn disables a protein called TOM70 that cells use to send signals to the immune system. With higher levels of Orf9B disabling TOM70, the immune system does not respond as well and the virus can better evade detection, the researchers said.

Referring to the increase in Orf9B, Krogan said, "It's rare that mutations 'turn up' a protein. It's a very sneaky thing for this virus to do." The same mutation was identified on Delta, "and sure enough, almost the same mutation is on Omicron," he said, which suggests they may have similar effects on the immune system. The new information could spur development of drugs that target the interaction of Orf9b and TOM70.

Click for a Reuters graphic https://tmsnrt.rs/3c7R3Bl on vaccines in development.

(Reporting by Nancy Lapid; Editing by Bill Berkrot)

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COVID SCIENCE-Virus leaves antibodies that may attack healthy tissues; B cell antibodies weakened, not defeated by Omicron - Yahoo Finance

DALLAS Jan. 03, 2022 A first-in-kind immune-modulating drug that arose from decades of basic research at UTSouthwestern Medical Center has received approval from the U.S. Food and Drug Administration as a new treatment for adults with a form of myasthenia gravis. This rare and chronic autoimmune disease is characterized by debilitating and potentially life-threatening muscle weakness.

E. Sally Ward, Ph.D., at UT Southwestern in 2004

The new drug, efgartigimod alfa-fcab, is an engineered fragment of a human antibody that binds to a cell surface receptor known as the neonatal Fc receptor, or FcRn. Between 1990 and 2015, former UTSW Professor of Immunology E. Sally Ward, Ph.D., led work that characterized this receptors role in regulating the levels and persistence of immunoglobulin G (IgG) antibodies. In 2005, her laboratory described an approach to lower antibody levels by blocking FcRn activity, and subsequently demonstrated preclinical proof-of-concept to treat antibody-mediated autoimmune disease. The global immunology company argenx has licensed exclusive patent rights related to this drug from UTSW.

The development of this FcRn inhibitor came out of the fundamental work on FcRn biology that my group had worked on during the decades that I was on the UTSW faculty, said Dr. Ward, now a Professor of Molecular Immunology and Director of Translational Immunology at the University of Southampton in England. Working out the molecular and cell biological processes involved in FcRn biology and its regulation and transport of antibody molecules was a major focus of our work at UTSW over more than two decades, starting when I was an assistant professor there.

Clinical trials that led to the recent FDA approval found that 68% percent of patients with anti-acetylcholine receptor antibody positive myasthenia gravis responded to efgartigimod, compared to 30% of those taking a placebo. The company is exploring possible uses for the agent in other conditions mediated by IgG.

Efgartigimod represents Dr. Wards second commercial success based on fundamental research conducted at UTSW. That work also led to technology that can extend the half-life of therapeutic antibodies and currently is used in the FDA-approved drug ravulizumab and two antibody therapies against COVID-19, as well as another antibody in development to treat respiratory syncytial virus (RSV).

It is also the second first-in-kind drug developed from basic research at UTSW to be approved by the FDA in the past year. Less than six months ago, belzutifan, a HIF-2 inhibitor, received approval as a treatment for familial kidney cancer.

Considered together, these approvals mark UTSW as one of the major sources of breakthrough medicines for previously untreatable diseases. We are indeed a center for biotechnology, said Michael Brown, M.D., Professor of Molecular Genetics and Internal Medicine and joint recipient of the 1985 Nobel Prize in Physiology or Medicine with research partner UTSW colleague Joseph Goldstein, M.D.Dr. Brown helped recruit Dr. Ward to UTSW in 1990.

UTSouthwestern receives financial compensation from argenx for the newly approved drugs foundational intellectual property. Dr. Ward also receives compensation related to the licensing of the technology and research funding from the company.

Both Drs. Goldstein and Brown are Regental Professors.

Dr. Brown holds The W. A. (Monty) Moncrief Distinguished Chair in Cholesterol and Arteriosclerosis Research and the Paul J. Thomas Chair in Medicine.

Dr. Goldstein holds the Julie and Louis A. Beecherl, Jr. Distinguished Chair in Biomedical Research and the Paul J. Thomas Chair in Medicine.

About UTSouthwestern Medical Center

UTSouthwestern, one of the nations premier academic medical centers, integrates pioneering biomedical research with exceptional clinical care and education. The institutions faculty has received six Nobel Prizes and includes 25 members of the National Academy of Sciences, 16 members of the National Academy of Medicine, and 14 Howard Hughes Medical Institute Investigators. The full-time faculty of more than 2,800 is responsible for groundbreaking medical advances and is committed to translating science-driven research quickly to new clinical treatments. UTSouthwestern physicians provide care in about 80 specialties to more than 117,000 hospitalized patients, more than 360,000 emergency room cases, and oversee nearly 3 million outpatient visits a year.

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More than two decades of UTSW research paves way for first-in-kind drug - UT Southwestern

LA JOLLA, Calif.--(BUSINESS WIRE)--Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders with high unmet medical need, today announced publication of a manuscript featured on the front cover of the Journal of Clinical Investigation (www.jci.org), confirming the role of T cells activated by the CD6-ALCAM pathway in the development of lupus nephritis (LN). The newly published data supports Equilliums research of itolizumab, a first-in-class anti-CD6 monoclonal antibody that targets the CD6-ALCAM signaling pathway to selectively inhibit pathogenic T effector cells. Equillium is currently evaluating itolizumab in LN patients in the EQUALISE study (NCTT04128579).

The Journal of Clinical Investigation is the premier venue for discoveries in basic and clinical biomedical science that will advance the practice of medicine. The publication, titled The CD6-ALCAM pathway promotes lupus nephritis via T cell mediated responses, was the result of a collaborative study between investigators from The Accelerated Medicines Partnership (AMP), Chaim Putterman, M.D., (Albert Einstein College of Medicine), Chandra Mohan, M.D., Ph.D., (University of Houston) and Equillium. The work demonstrates the association of soluble urinary ALCAM (uALCAM) with human disease and how modulating the CD6-ALCAM pathway in animal models significantly reduces disease pathology.

More targeted therapies are urgently needed to effectively treat LN, as well as other T cell mediated diseases, said Dr. Putterman. This study, using urine biomarkers, tissue biopsy data and animal models, conclusively demonstrates that the CD6-ALCAM pathway is important in the pathogenesis of this disease, and supports the targeting of this pathway using itolizumab in the EQUALISE study.

Building on work first reported by Professor Chandra Mohan, this study examined uALCAM in an extended cross-sectional cohort of 1038 patients of different ethnicities with LN and systemic lupus erythematosus (SLE). These results validate uALCAM as a biomarker that can discern active renal involvement in SLE vs. inactive, or no renal involvement. Notably, in all ethnicities, the uALCAM level correlated with renal SLE disease activity index (SLEDAI), a clinical measure of LN disease severity, linking this protein more closely with renal disease progression. AMP helped this collaboration leverage single cell RNA sequencing data from kidney tissues of LN patients versus normal subjects that indicated an increase in CD6+ T cells and ALCAM on infiltrating leukocytes and resident kidney cells. To establish the role of the CD6-ALCAM pathway in disease pathogenesis, the effect of CD6 blockade in animal models of SLE/LN was investigated. Blockade of CD6 demonstrated the pathways ability to prolong survival, decrease infiltrating immune cells, lower cytokine levels, and reduce renal pathology in a manner comparable to mycophenolate mofetil and cyclophosphamide, both potent immunosuppressors used in the treatment of LN. Targeting of CD6 on T cells resulted in decreasing activity of T cells as well as other immune cells, including inflammatory macrophages and neutrophils. Combined, these data further support uALCAM as a biomarker that distinguishes active lupus nephritis and validates targeting the CD6-ALCAM pathway to treat SLE and LN.

Pathogenic T cells are thought to be instrumental in the development and progression of both SLE and LN and this data strengthens our belief that blocking the CD6-ALCAM pathway could prove to be an ideal approach for new therapeutic intervention in these diseases, said Stephen Connelly, Ph.D., chief scientific officer of Equillium. In the Type A portion of the EQUALISE clinical study, itolizumab, our anti-CD6 monoclonal antibody, has demonstrated encouraging results in SLE patients without LN that had elevated urine protein/creatinine and albumin/creatinine ratios, where we saw a decrease in proteinuria.

Beatrice Goilav, M.D., associate professor of pediatrics, Albert Einstein College of Medicine added, Itolizumab utilizes a unique mechanism of action that allows it to target an established pathway in the human kidney. This specific approach is informed by actual lupus nephritis patients and preserves T regulatory cells that protect against autoimmune disease. I believe this is a tremendous step forward in precision medicine because this approach was developed not only based on pre-clinical models, but also strong support from mechanisms already demonstrated to be operative in human disease.

About Lupus and Lupus Nephritis

Lupus or systemic lupus erythematosus (SLE) is a chronic, complex autoimmune disease that affects hundreds of thousands of people worldwide. In lupus, the immune system, which is designed to protect against infection, creates antibodies that can attack any part of the body including the kidneys, brain, heart, lungs, blood, skin, and joints. Kidney damage due to attacks by immune cells (lupus nephritis) is one of the most common complications of lupus, affecting as many as half of adults with lupus. When the kidneys become inflamed, they cant effectively get rid of waste products and other toxins from the body. This may lead to blood in the urine, protein in the urine, high blood pressure, impaired kidney function or even kidney failure.

About Itolizumab

Itolizumab is a clinical-stage, first-in-class anti-CD6 monoclonal antibody that selectively targets the CD6-ALCAM pathway. This pathway plays a central role in modulating the activity and trafficking of T cells that drive a number of immuno-inflammatory diseases. Equillium acquired rights to itolizumab through an exclusive partnership with Biocon Limited.

About Equillium

Equillium is a clinical-stage biotechnology company leveraging deep understanding of immunobiology to develop novel products to treat severe autoimmune and inflammatory disorders with high unmet medical need. Equillium is developing itolizumab for multiple severe immuno-inflammatory diseases, including acute graft-versus-host-disease (aGVHD), lupus/lupus nephritis and uncontrolled asthma.

For more information, visit http://www.equilliumbio.com.

Forward Looking Statements

Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as "anticipate", "believe", could, continue, "expect", "estimate", may, "plan", "outlook", future and "project" and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Because such statements are subject to risks and uncertainties, many of which are outside of the Companys control, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to statements regarding the potential benefit of treating patients with aGVHD, uncontrolled asthma, or lupus/lupus nephritis with itolizumab, Equilliums plans and expected timing for developing itolizumab including the expected timing of initiating, completing and announcing further results from the EQUATE, EQUIP, and EQUALISE studies, the potential for any of Equilliums ongoing or planned clinical studies to show safety or efficacy, statements regarding the impact of new leadership team members, Equilliums anticipated timing of regulatory review and feedback, Equilliums cash runway, and Equilliums plans and expected timing for developing itolizumab and potential benefits of itolizumab. Risks that contribute to the uncertain nature of the forward-looking statements include: uncertainties related to the abilities of the leadership team to perform as expected; Equilliums ability to execute its plans and strategies; risks related to performing clinical studies; the risk that interim results of a clinical study do not necessarily predict final results and that one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data become available; potential delays in the commencement, enrollment and completion of clinical studies and the reporting of data therefrom; the risk that studies will not be completed as planned; Equilliums plans and product development, including the initiation and completion of clinical studies and the reporting of data therefrom; whether the results from clinical studies will validate and support the safety and efficacy of itolizumab; changes in the competitive landscape; uncertainties related to Equilliums capital requirements; and having to use cash in ways or on timing other than expected and the impact of market volatility on cash reserves. These and other risks and uncertainties are described more fully under the caption "Risk Factors" and elsewhere in Equillium's filings and reports with the SEC. Investors should take such risks into account and should not rely on forward-looking statements when making investment decisions. All forward-looking statements contained in this press release speak only as of the date on which they were made. Equillium undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

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Equillium Announces Publication of Data in the Journal of Clinical Investigation Highlighting the Importance of the CD6-ALCAM Pathway in the...

Overview

Sirona Biochem Inc. (TSXV:SBM) is a biotechnology company with an innovative platform for developing safer, more effective cosmetic and pharmaceutical active ingredients. The technology is based on proprietary fluorination chemistry developed by the companys wholly-owned French subsidiary, research and development (R&D) laboratory TFChem. Sirona Biochems business model centers on leveraging its technology platform and chemistry expertise to build strategic R&D partnerships with leading global companies through contract services, licensing and royalty agreements as well as joint ventures.

TFChem has developed a fluorination chemistry that can improve the safety and efficacy of carbohydrate-based molecules. Carbohydrate-based molecules are valuable in that they have broad application potential for the development of pharmaceuticals and cosmeceuticals. Examples of commercially available carbohydrate-based drugs include viral neuraminidase inhibitor Tamiflu, and Johnson & Johnsons (NYSE:JNJ) SGLT2 inhibitor Invokana. However, carbohydrate-based molecules are extremely challenging to develop due to their inherent instability. Sirona Biochems proprietary chemistry technique overcomes that challenge by stabilizing carbohydrates, allowing the company to explore commercial opportunities for these valuable molecules.

Sirona Biochems product pipeline includes an SGLT2 inhibitor for the treatment of type 2 diabetes as well as cosmeceuticals such as compound libraries for safe and effective skin lighteners and anti-aging compounds. The company has completed two successful licensing agreements. The first, for its SGLT2 inhibitor to Wanbang/Fosun Pharmaceutical in China, which is now in advanced Phase I clinical trials. The second was a non-exclusive license to Rodan + Fields, the leading skin care brand in the United States, for Sironas skin lightening compound TFC-1067. The compound has proven safe and effective in clinical trials.

Sirona Biochem is led by a highly experienced team of finance and biotechnology professionals. The companys Chief Scientific Officer Dr. Graldine Deliencourt-Godefroy is an award-winning synthetic chemist and the founder of the French biotechnology company TFChem. Her scientific research in carbohydrate chemistry has led to the discovery of new drug families and the development of drug candidates for diabetes and obesity, cosmetic ingredients and biological adjuvants. She is the recipient of the acclaimed Francinov Research and Innovation Medal, the French Ministry of Research Award and the French Senate Award.

Sirona Biochems technology platform is based on a fluorination chemistry that stabilizes carbohydrate-based molecules to improve their cosmeceutical and pharmaceutical qualities. Carbohydrate molecules play a central role in cell to cell communication and have the ability to interact with proteins, hormones, viruses, toxins and bacteria. In this way, carbohydrates perform a variety of essential biological functions in the human body, making them valuable components for the development of therapeutics and cosmeceuticals.

While they have broad application potential, carbohydrates are extremely challenging to develop due to their inherent instability. Using chemistry techniques originally developed by TFChem, Sirona has overcome the challenge of stabilizing carbohydrates to develop safer, more effective cosmetic and pharmaceutical active ingredients. This proprietary chemistry method involves strengthening the bond of a carbohydrate molecule by strategically placing fluorine atoms with the molecule. The result is enhanced stability and bioavailability of carbohydrate-based molecules.

Sirona Biochems fluorination platform has multiple applications, including improving the properties of drugs in development or discontinued drugs that may have been shelved for stability reasons as well as for the development of new products for cosmetics and biological manufacturing.

Sirona Biochem is exploring multiple commercial opportunities and partnerships for its fluorination technology platform and currently has three high-value programs in development. Each program was chosen for its high market potential and attractive development timeline.

The three most advanced products on this platform include diabetes therapeutics, cosmetic skin lighteners and anti-aging cream.

Sirona Biochems diabetes drug TFC-039 is a sodium-glucose co-transporter SGLT2 Inhibitor compound developed using the companys proprietary fluorination technology. SGLT2 Inhibitors act in the kidneys to reduce the reabsorption of glucose into the bloodstream. TFC-039 has achieved positive results in head-to-head preclinical studies, performing better than Johnson & Johnsons canagliflozin (Invokana), which was given US FDA market approval in March 2013 and in European market approval in November 2013.

Globally, diabetes caused 4.2 million deaths in 2019 and at least US$760 billion in health expenditures. The number of adults living with diabetes in 2019 totaled approximately 463 million, and that figure is projected to rise to 700 million by 2045.

In 2014, Sirona licensed SGLT2 Inhibitor TFC-039 to Wanbang Biopharmaceuticals for development and commercialization exclusively in the Peoples Republic of China, the largest population of diabetes patients in the world. In exchange for this license, Wanbang Biopharma has provided an upfront payment and will give milestone payments of up to US$9.5 million in addition to royalty payments for product sales. Wanbang is currently in Phase I clinical studies with SGLT2 Inhibitor TFC-039.

Sirona Biochem has a library of skin lightening compounds and is in partnership discussions for compound TFC-1067. The French government awarded a C$1.9 million innovation grant to the companys subsidiary TFChem in 2011 to develop its cosmetic skin lightener program to the commercial-ready stage. The product has indications for treating various skin conditions including hyperpigmentation, melasma, vitiligo and rosacea. The most common skin lightening agent today is hydroquinone, however, this compound has been linked to cancer and has been banned in Europe since 2001.

Sirona Biochem is working to meet the demand for a safer and more effective skin lightening cream. In 2019, the company conducted safety and efficacy trials for the depigmenting agents in its TFC-1067 product. In April of 2019, the company announced that during a US-based clinical trial the product was shown to perform better than the gold standard 2 percent hydroquinone in improving irregular or patchy discoloration to create an even skin tone. In January of 2020, Sirona Biochem announced the product demonstrated 100 percent safety in a final toxicology test for the increased dose (0.4 percent) of TFC-1067. Clinical trials of the product are expected to begin later in 2020.

The global market for skin lightening products is witnessing increasing demand with the largest growth in Asia, while North America and Europe are also epicenters of demand growth.

In September 2019, Sirona signed a definitive non-exclusive agreement with Rodan + Fields for the licensing and commercial sales of novel ingredient TFC-1067 to brighten and even skin tone. Under the terms of the agreement, Sirona will receive upfront and milestone payments as well as ongoing revenue in return for the manufacturing and supply of TFC-1067.

Anti-aging cream

Sirona Biochem is also developing an anti-aging compound library based on the naturally occurring antifreeze glycoproteins found in Antarctic fish and the companys proprietary chemistry technology. Sironas studies have shown that these glycoproteins can protect against environmental stressors such as UV light, oxidation and nutrient deprivation. The company is working to prove its anti-aging products can potentially protect peoples skin cells against many of the stresses associated with natural aging and environmental effects. The global market for anti-aging products reached US$20.25 billion in 2018 and is projected to experience a CAGR of 5.7 percent from 2019 to 2025.

Dr. Howard J. Verrico, MD CEO and Chairman of the Board

Dr. Howard Verrico obtained his medical degree from the University of Toronto in 1985 and has been a member of the College of Physicians and Surgeons of British Columbia since July 1986. Dr. Verrico is currently a practicing emergency room physician. In addition, Dr. Verrico has extensive experience as a venture capitalist in the junior capital markets.

Graldine Deliencourt-Godefroy, PhD Chief Scientific Officer

Dr. Graldine Deliencourt-Godefroy is an award-winning synthetic chemist and the founder of French-based biotechnology company TFChem. Since the acquisition of TFChem by Sirona Biochem in March 2011, Dr. Deliencourt-Godefroy has assumed the role of Chief Scientific Officer. Her scientific research in carbohydrate chemistry has led to the discovery of new drug families and the development of drug candidates for diabetes and obesity, cosmetic ingredients and biological adjuvants. Previous to founding TFChem, Dr. Deliencourt-Godefroy was a scientific leader at INSA (National Institute of Applied Sciences) in Rouen, France, where she developed a new technology on stabilized carbohydrates. Previous roles also include a post-doctoral position at the University College London and doctoral research at the Research Institute of Fine Organic Chemistry in Rouen, France. Dr. Deliencourt-Godefroy received a PhD and Masters in Organic Chemistry as well as her business degree from the University of France. She is the author of several publications and patents and is also the recipient of the acclaimed Francinov Research and Innovation Medal, French Ministry of Research Award and the French Senate Award.

Christopher Hopton, CGA Chief Financial Officer

Christopher Hopton brings 25 years of expertise in financial management and operations. His extensive experience covers areas of financial planning, accounting policy and business process improvement. As a business investment and finance consultant, Hopton has worked with several public and privately-held companies. Most recently, Hopton was the Chief Financial Officer of Central Resources Corp., a junior mineral exploration company. Formerly, he held the position of Division Controller at Canadian Airlines where he was responsible for an annual operating budget of $200M. Hopton was also involved in the restructuring of 360 Networks, a network communications company, which led to a buyout by Bell Canada. Hopton earned his Bachelor of Business Administration from Simon Fraser University in British Columbia, Canada and received his professional designation as a Certified General Accountant.

Michelle Seltenrich, MBA Vice President, Operations

Michelle Seltenrich brings 19 years of expertise in public biotech companies. Her experience ranges from both academic and industry R&D lab management to corporate mergers and acquisitions. Seltenrich was previously the Manager of Business Development at Forbes MediTech and was responsible for international business development, in-licensing and M&A. She played a key role in the successful acquisition of a U.S. based biotech company. Seltenrich holds a BSc from the University of British Columbia and an MBA in Technology Management from Simon Fraser University.

Dr. Alex Sandro Marazzi, MD Director

Dr. Alex Marazzi is a family physician with certification in both Family and Emergency Medicine. He has been in family practice in Mission, British Columbia since 1997. He is also a part owner of a well established walk-in-clinic. Most recently he served as the Chief of the Emergency Department at Mission Memorial Hospital. Prior to practicing medicine in British Columbia, Dr. Marazzi was an Emergency Room physician for 7 years in Midland, Ontario. Dr. Marazzi earned his Bachelor of Pharmaceutical Sciences at UBC in 1985. While studying medicine he worked as a Hospital Pharmacist at Langley Memorial Hospital. He earned his Doctor of Medicine at UBC in 1989 and pursued an internship at Toronto East General Hospital.

Jason Tian Director

Jason Tian has been providing legal services to international clients since 2007 and has worked in top firms in China such as Beijing Zhonglun, Beijing Zhongyin, Beijing Dacheng and is now a Senior Partner of Shanghai Landing Law Offices. He also worked as senior legal translator in UK-based firm, Clifford Chance LLP, before starting his legal career. Shanghai Landing Law Offices is a full-service law firm with headquarters in Shanghai, China. Lawyers at Landing provide full-service to clients in industries such as healthcare and pharmaceuticals as well as consumer retail in China. Landing has several domestic branches and overseas branches in the United States, India, Singapore, Indonesia, Bangladesh, Philippines and Cambodia.

Dr. Denis Richard, PH.D. Scientific Advisory Board Member

Dr. Denis Richard earned his Ph.D. in Physiology at Laval University and received further postdoctoral training in nutrition and physiology at the Dunn Nutrition Unit at the University of Cambridge, Cambridge, England. Dr. Richard is a full professor at the Department of Medicine at Universit Laval. Together with serving as director of the Research Centre of the Institut de Cardiologie et de Pneumologie de Qubec, and director of the Groupe Interdisciplinaire de Recherche sur lObsit de lUniversit Laval, he is the recipient of the Merck Frosst / CIHR Research Chair in Obesity, the first Chair devoted to obesity research in Canada. He is active with several societies and associations and is a member of: The Canadian Obesity Network, The American Physiological Society, The Society for Neuroscience, The Endocrine Society, and The Society for the Study of Ingestive Behavior. Dr. Richard is a well-established scientist with regard to the study of (i) neurosystems involved in the control and regulation of food intake, thermogenesis, and energy balance, (ii) the mechanisms whereby the gastrointestinal hormones influence energy balance regulation, (iii) the relationship between stress and obesity, (iv) the role of the sympathetic nervous system in controlling uncoupling protein 1 in brown adipose tissue, and (v) the role of uncoupling protein 2 in energy metabolism, oxidative stress and neuroprotection. He lists over 200 publications in his career.

Dr. Bruce Verchere, PH.D. Scientific Advisory Board Member

Dr. Bruce Verchere is a Professor in the Departments of Surgery and Pathology & Laboratory Medicine at the University of British Columbia (UBC). He is also head of the Diabetes Research Program at the Child & Family Research Institute, and holds the Irving K Barber Chair in Diabetes Research. Dr. Vercheres research aims to understand the function of pancreatic islet beta cells and their relevance in both type 1 and type 2 diabetes, with a goal of developing therapeutic approaches for enhancing beta cell survival and function. He has published more than 90 manuscripts in the field of islet biology and diabetes and has been invited to present his research worldwide. Dr. Verchere was a Senior Scholar of the Michael Smith Foundation for Health Research (MSFHR) and was awarded the UBC Outstanding Young Alumnus award in 2000 and the Canadian Diabetes Association Young Scientist award in 2006. He is currently chair of the CIHR Diabetes Obesity Lipid and Lipoprotein Disorders panel, Chair of the National Research Council of the Canadian Diabetes Association, and Chair of the MSFHR Research Advisory Council. He currently sits on the editorial board of the publications Diabetes and Canadian Journal of Diabetes.

Dr. Michael Walker, PH.D. Scientific Advisory Board Member

Dr. Michael Walker has been a director and CEO of Verona Pharma since September 2006. He is an Emeritus Professor at the Department of Anesthesiology, Pharmacology & Therapeutics, University of British Columbia, Canada and has founded and managed various biotech companies in Canada and the UK. His research interests are wide including many aspects of general pharmacology (from basic to clinical studies), marine toxins and respiratory and cardiac pharmacology. Dr. Walker was the founder of Rhythm Search Developments (RSD) Ltd., which company evolved into Nortran Pharmaceuticals Inc. and subsequently Cardiome Pharma Corp. (TSX:COM, NASDAQ: CRME) whose drug, RSD1235, for the acute termination of atrial fibrillation (a disorder of heart beating), is currently the subject of a New Drug Application filed with the US Food and Drug Administration.

Dr. Caigan Du Scientific Advisory Board Member

Dr. Caigan Du is a scientist at the Vancouver Coastal Health Research Institute and an Associate Professor in the Department of Urologic Sciences at the University of British Columbia. He received a Ph.D. degree in Biochemistry in the UK and postdoctoral training in Immunology in the USA. He is interested in the pathogenesis of kidney ischemia-reperfusion injury and transplant rejection, and molecular control of urinary malignancies. He has been studying the impact of kidney donor-derived factors on renal allograft rejection, and the molecular pathways of kidney injury and regeneration in experimental models. He is also interested in developing medical solutions including drugs made from natural compounds for all kinds of health problems, including immune disorders, organ preservation, kidney failure and urinary cancer. He is the PI of many grant supports from the Kidney Foundation of Canada and the Canadian Institutes of Health Research.

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Global Immune Repertoire Sequencing Market: Introduction

Immune repertoire is the sum of T cell receptors and B cell receptors that make an organism's adaptive immune system.It is extensively used in biomarker discovery to improve the success rate and cost-effectiveness of rational drug development. Advancements in next generation sequencing (NGS) have facilitated the development of a prevailing new technology known as immune repertoire sequencing for probing the complimentary determining region of these receptors. Immune repertoire sequencing targets T and B-lymphocytes and utilizes the 5 Rapid Amplification of cDNA Ends (RACE) Technology.

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Global Immune Repertoire Sequencing Market: Trends, Drivers, Restraints

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North America to Dominate Global Immune Repertoire Sequencing Market

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As the very infectious Omicron variant of COVID-19 surges around the country, you need to know what kind of tests to take to protect yourself and your community.

Emily Landon, infectious disease expert and executive medical director for infection prevention and control at University of Chicago Medicine, answers common questions about COVID-19 tests.

These include when to get a COVID-19 test, what kind you should use, what to do if you cant get one at all, and why its still important to get vaccinated and boosted.

Q: When should I get a COVID-19 test?

Isolate and get a COVID-19 test if you have any symptoms of COVID-19, even if theyre mild and even if youre fully vaccinated and/or boosted. Symptoms may include sniffles, congestion or a cough, and might resemble a mild cold, especially in fully vaccinated and boosted people.

Even if you have minor symptoms, you are still contagious. People who are unvaccinated or immunocompromised may still get severe disease. Stay isolated if you have any symptoms, even if you cannot quickly get a COVID-19 test.

Q: How are rapid antigen tests different from PCR tests? Is one better than another?

Rapid antigen tests, which you can buy in most pharmacies, are great in specific circumstances and less good in others. Rapid antigen tests detect COVID-19 when people have a higher amount of virus particles in their system and are more contagious. But a negative antigen test doesnt necessarily mean you arent contagious. If someone has COVID-19, but hasnt yet reached the tests threshold of viral particles, they may still test negative with an antigen test but positive on a PCR test. Thats why I tell people they should trust a positive antigen test, but be more skeptical about a negative one.

PCR tests, which are still mostly done at hospitals and other testing facilities rather than at home, are far more sensitive than antigen tests. Theyre able to detect smaller quantities of the virus and detect them sooner (and for more time) than antigen tests.

While theyre considered the gold standard for a COVID-19 diagnosis, PCR tests are unnecessary for those who have already tested positive on an antigen test. Thats important to know as wait times for PCR tests grow due to increased demand.

In short: any positive test counts as a positive, but a negative antigen test needs to be confirmed with a PCR test.

Q: When should I use an at-home test?

A rapid, at-home antigen test is a useful tool to have in your COVID-19 arsenal. But you need to know when and how to use these tests.

If you have symptoms:

If you have COVID-19 symptoms and test positive on an at-home test, you have COVID-19. You dont need to get another test to confirm the results.

But if you have symptoms and you test negative, you should not rule out COVID-19 just yet. In this case, we recommend getting a more sensitive PCR test. If you cant get in for a PCR test quickly, its recommended to repeat the antigen test the following day, being sure to isolate until you get your PCR test and results. If you cant get a PCR test at all, isolate for 10 days.

If you dont have symptoms:

For those without COVID-19 symptoms, using these tests before a gathering will reduce (but not eliminate) the risk that someone attending has COVID-19. Remember: antigen test results can change quickly, and a negative result is really only trustworthy for eight to 12 hours.

In other words, you shouldnt rely on a negative test in the morning if you want to get together in the evening with friends or family. Make sure everyone whos attending an event uses an at-home test as close as possible to the time theyre gathering and understands that a negative test doesnt guarantee safety or completely prevent exposure.

If youve had a known COVID-19 exposure, no test is going to make it safe for you to gather unmasked with high-risk individuals. Stay home.

Q: How do I interpret at-home tests?

If youre taking an at-home COVID-19 test, consider any positive result to mean you have COVID-19. You dont need to confirm with a PCR test. (Even if its an extremely faint line, you should consider yourself infected and isolate.) If youre unclear about what your test result says, isolate and repeat the test in six to 12 hours. Youll likely see a clearer line on the test strip next time.

Dont forget: a negative at-home test is only reliable for eight to 12 hours and still doesnt guarantee youre COVID-free. You should get a PCR test if you have symptoms.

Q: What should I do if I cant get a COVID-19 test?

Given the widespread transmission of the Omicron variant, if you have symptoms, you should assume you are infected with COVID-19, regardless of your vaccination status. Isolate for the amount of time thats recommended by the health department.

Q: What should I do if Ive been exposed?

If youve been exposed, but have no symptoms and you are fully vaccinated and boosted, you dont need to quarantine. But you should get a test on Day 4, 5, or 6 following your exposure. (For example, if you were exposed on Monday, you should get tested on Thursday, Friday or Saturday.) If you develop symptoms, assume youre infected and begin isolation.

If youve been exposed and are vaccinated but not boosted, you need to quarantine for five days after an exposure and wear masks for another five days after that. You are still at high risk of infection, especially from the quickly spreading Omicron variant. You should wear a mask around other people, and get tested four to six days after the exposure and anytime you develop symptoms. Avoid gatherings and do your best to limit contact with people who are immunocompromised or who are unvaccinated.

If youve been exposed, have no symptoms, but are NOT vaccinated, stay home and quarantine for five days. Youll need to wear a mask for another five days after that.

Q: Im vaccinated and boosted. Why did I still get COVID-19?

COVID-19 vaccines and boosters are hugely valuable. In addition to providing protection from the virus, vaccines and boosters reduce the chances of serious illness, hospitalization and death. But people can still get infected when theyre fully vaccinated and boosted. This may be because the vaccines protection has decreased over time or because a new variant (like the Omicron variant) is better at getting around the vaccines protective properties.

COVID-19 infections in fully vaccinated people are called breakthrough infections, which usually result in milder symptoms versus infections in the unvaccinated. Your bodys memory B cells and T cells, which developed after your vaccine, respond quickly to stop the infection and prevent severe damage. Immunocompromised people may not have strong B cell- and T cell-immunity even after vaccination, so they remain at higher risk. If you are immunocompromised and have a breakthrough infection, you should contact your doctor even if you only have mild symptoms.

Unvaccinated people dont have existing antibodies or memory B cells or T cells waiting to fight off COVID-19, so they have to start their immune response from scratch if they become infected. Infections typically cause more damage to their organs and tissues, which can lead to complications like having low oxygen levels, as well as problems with the lungs, kidney and heart. Unvaccinated individuals are also much more likely to need intensive care support or have lingering symptoms known as long COVID-19.

Q: If I have a breakthrough infection after my COVID-19 vaccine, will I still be contagious for the same amount of time?

Theres a good amount of evidence showing most fully vaccinated and boosted people with breakthrough infections are both less contagious, and contagious for a shorter time. Theyre also more likely to get mild infections.

Q: Can I report my positive at-home test results to public health officials?

At-home antigen test results are not typically reported to public health agencies, nor are they usually included in official case tallies. This means statistics are significantly under-reported. In some communities, local health departments are setting up portals for people to self-report at-home results, but youll need to check to see whats available in your area.

The most important thing to do is stay home and isolate. If you have certain health conditions especially if youre immunocompromised contact your doctor ASAP so they are aware of your diagnosis.

Q: When can I get the new medicine thats received emergency use authorization to fight or prevent COVID-19?

The good news is that new antiviral medication and a preventative monoclonal antibody treatment have received emergency use authorization from the U.S. Food & Drug Administration. Theyll be very important resources for doctors and high-risk patients. Even so, these treatments will be extremely limited at first. They will first be distributed by public health agencies and will only be available to the highest-risk patients.

If you are a transplant recipient, have a primary immunodeficiency, take immunosuppressive medication, or are undergoing active chemotherapy, and you test positive for COVID-19, you should contact your doctor right away to see if any of these treatments are available to you.

Q: Do COVID-19 booster shots offer added protection against the Omicron variant?

A: Boosters offer the best protection from catching Covid, but they arent perfect. Scientists are still gathering data on the effectiveness of vaccines against Omicron, but existing data show people who are vaccinated and boosted have additional protection and are less likely to be hospitalized than those who are unvaccinated. Read more about booster shots and third doses here: What to know about booster shots and third doses of the COVID-19 vaccine.

Adapted from an article published by UChicago Medicine.

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When should I use a rapid COVID test, and how accurate are they? - UChicago News