TREND CHART ON INNOVATIVE BIOTHERAPIES

" Landscape in… " Gene Therapy Companies Soon-To-Be Published

BioPharmAnalyses and OctopusyX BioConsulting
are proud to announce the upcoming publication of their next report
on the dynamic and growing landscape of Gene Therapy Companies

This new report provides a deeply scrutinized mapping of
more than 280 companies involved in one of the
fastest-growing businesses in the health sector .

contents

August 2019,29th
*FEATURE STORY* ● Pfizer adds 500MUS$ to gene therapy manufacturing plant GENE THERAPY ● AAV-ie enables safe and efficient gene transfer to inner ear cells. ● Rcent advances in the targeting of systemically administered non-viral gene delivery systems *DISRUPTIVE TECHNOLOGIES* ● Efficient electroporation of neuronal cells using synthetic oligonucleotides -Potential applications of nanoparticles for tumor microenvironment remodeling to ameliorate cancer immunotherapy ● Tumor exosome-based nanoparticles are efficient drug carriers for chemotherapy *INDUSTRIAL LANDSCAPE & AGREEMENTS* ● Sarepta stumbles on FDA rejection of VyonDys53 to treat Duchenne muscular dystrophy ● Zogenix announces acquisition of Modis Therapeutics ● Mustang Bio announces license agreement with CSL Behring for the poduction of MB-107 lentiviral gene therapy *MISCELLANEOUS* ● Circulatory miRNA biomarkers of metabolic syndrome

August 2019,29th

FEATURE STORY

● Pfizer adds 500MUS$ to gene therapy manufacturing plant
GENE THERAPY
● AAV-ie enables safe and efficient gene transfer to inner ear cells.
● Rcent advances in the targeting of systemically administered non-viral gene delivery systems
DISRUPTIVE TECHNOLOGIES
● Efficient electroporation of neuronal cells using synthetic oligonucleotides -Potential applications of nanoparticles for tumor microenvironment remodeling to ameliorate cancer immunotherapy
● Tumor exosome-based nanoparticles are efficient drug carriers for chemotherapy
INDUSTRIAL LANDSCAPE & AGREEMENTS
● Sarepta stumbles on FDA rejection of VyonDys53 to treat Duchenne muscular dystrophy
● Zogenix announces acquisition of Modis Therapeutics
● Mustang Bio announces license agreement with CSL Behring for the poduction of MB-107 lentiviral gene therapy
MISCELLANEOUS
● Circulatory miRNA biomarkers of metabolic syndrome

FEATURE STORY

Pfizer adds 500MUS$ to gene therapy manufacturing plant

Pfizer is investing $500 million to expand a manufacturing facility in Sanford, North Carolina, that plays a central role in its efforts to become a major player in gene therapy, the company said on August 21st. The investment will add additional capacity and capabilities to a facility that makes some of Pfizer’s most closely watched experimental treatments. The Sanford plant manufactures therapies used for the company’s late-stage experimental treatments for Duchenne Muscular Dystrophy (DMD) and hemophilia B therapies, among other gene therapies. It is also responsible for making components for some of Pfizer’s vaccines, such as Prevenar 13, which had nearly $6 billion in sales in 2018. For further information

Related Informations/Publications

-JUL 2019 : RegenxBio and Pfizer Partner on Gene Therapy for Friedreich's Ataxia. Results /Comments : Under the terms of the deal, RegenxBio granted Pfizer a non-exclusive global license, with rights to sublicense, RegenxBio’s NAV AAV9 vector. In return, Pfizer is paying RegenxBio an upfront payment, various milestones and royalties on net sales. No financial details were disclosed. Link: Biospace
-JUL 2019 : Sangamo and Pfizer Announce Updated Phase 1/2 Results for SB-525 Investigational Hemophilia A Gene Therapy Showing Sustained Increased Factor VIII Levels
Results /Comments : The data showed that SB-525 was generally well-tolerated and demonstrated a dose-dependent increase in Factor VIII (FVIII) activity levels.
Link: Press Release
-Int J Mol Sci. 2019 Jun 21;20(12). Molecular Mechanisms and Determinants of Innovative Correction Approaches in Coagulation Factor Deficiencies. Balestra D et al. Department of Life Sciences and Biotechnology, University of Ferrara, 44121 Ferrara, Italy. Link: Abstract
-Orphanet J Rare Dis. 2019 May 9;14(1):102. Priorities when deciding on participation in early-phase gene therapy trials for Duchenne muscular dystrophy: a best-worst scaling experiment in caregivers and adult patients. Paquin RS et al. RTI International, Research Triangle Park, North Carolina, USA Link: Abstract - Full Text
-MAR 2019: Pfizer Secures Exclusive Option to Acquire Gene Therapy Company Vivet Therapeutics
Results / Comments : Pfizer has acquired a 15% equity interest in Vivet and secured an exclusive option to acquire all outstanding shares. Pfizer and Vivet will collaborate on the development of VTX-801, Vivet’s proprietary treatment for Wilson disease.
Link: Press Release

GENE THERAPY

AAV-ie enables safe and efficient gene transfer to inner ear cells.

IHearing loss is the most common sensory disorder. While gene therapy has emerged as a promising treatment of inherited diseases like hearing loss, it is dependent on the identification of gene delivery vectors. Adeno-associated virus (AAV) vector-mediated gene therapy has been approved in the US for treating a rare inherited eye disease but no safe and efficient vectors have been identified that can target the diverse types of inner ear cells. Researchers have recently identified an AAV variant, AAV-inner ear (AAV-ie), for gene delivery in mouse inner ear. Our results show that AAV-ie transduces the cochlear supporting cells (SCs) with high efficiency, representing a vast improvement over conventional AAV serotypes. Furthermore, after AAV-ie-mediated transfer of the Atoh1 gene, we find that many SCs trans-differentiated into new HCs. Our results suggest that AAV-ie is a useful tool for the cochlear gene therapy and for investigating the mechanism of HC regeneration.
The results appeared in August 19th online issue of Nat Comm

Related Informations / Publications

- Mol Ther Methods Clin Dev. 2019 Jan 11;13:197-204. Targeted Gene Delivery into the Mammalian Inner Ear Using Synthetic Serotypes of Adeno-Associated Virus Vectors. Kim MA et al. Kyungpook National University, Daegu 41566, Republic of Korea
Results/Comments: The recombinant DJ serotype most effectively transduced a range of cell types at a high rate. The findings provide a basis for improving treatment of hereditary hearing loss using targeted AAV-mediated gene therapy
Link: Abstract - Full Text
-Methods Mol Biol. 2019;1950:271-282. AAV-Mediated Gene Delivery to the Inner Ear. Akil O et al. University of California San Francisco, San Francisco, CA, USA
Results/Comments: The efficacy of this surgical technique will be demonstrated by the restoration of hearing to the VGLUT3 knockout mice (a mouse model of congenital deafness) after delivery of VGLUT3 gene to the inner ear using an adeno-associated virus as a vector.
Link: Abstract

Recent advances in the targeting of systemically administered non-viral gene delivery systems

Systemically administered non-viral gene delivery systems face multiple biological barriers that decrease their efficiency. These systems are rapidly cleared from the circulation and sufficient concentrations do not accumulate in diseased tissues. A number of targeting strategies can be used to provide for sufficient accumulation in the desired tissues to achieve a therapeutic effect. In a recent review, researchers discuss recent advances in the targeting of non-viral gene delivery systems to different tissues after systemic administration. They have compared passive and active targeting applied for tumor delivery and propose some strategies that can be used to overcome the drawbacks of each case. They also discuss targeting the liver and lungs as two particularly important organs in gene therapy. There is currently no optimum non-viral gene delivery system for targeting genes to specific tissues. The dose delivered to tumor tissues using passive targeting is low and shows a high patient variation. Although active targeting can enhance binding to specific cells, only a few reports are available to support its value in vivo. The design of smart nanocarriers for promoting active targeting is urgently needed and targeting the endothelium is a promising strategy for gene delivery to tumors as well as other organs.
The review appeared in August 21st online issue of Exp Opin Drug Deliv

Related Informations / Publications

-AAPS J. 2019 Aug 6;21(5):98. Cellular Uptake and Distribution of Gemini Surfactant Nanoparticles Used as Gene Delivery Agents. Jin W et al. University of Saskatchewan, 107 Wiggins Road, Saskatoon, Saskatchewan, S7N 5E5, Canada
Link: Abstract
-Brain Res Bull. 2019 Aug;150:216-230. Challenges of gene delivery to the central nervous system and the growing use of biomaterial vectors. Puhl Dl et al. Rensselaer Polytechnic Institute, 110 8th Street, Troy, New York, 12180, USA
Results/Comments: This review discusses the challenges of delivering various forms of genetic material to the CNS, the use and limitations of current viral vector delivery systems, and the use of non-viral, biomaterial vectors for CNS applications.
Link: Abstract
-Polymers (Basel). 2019 Apr 25;11(4). Polymeric Nanoparticles in Gene Therapy: New Avenues of Design and Optimization for Delivery Applications. Rai R et al. University of Saskatchewan, Saskatoon, SK S7N 5E5, Canada
Results/Comments: The overview of the properties, challenges, and functionalization approaches and, finally, the applications of the polymeric delivery systems in gene therapy marks this review as a unique one-stop summary of developments in this field Link: Abstract - Full Text
-J Gene Med. 2019 Jul;21(7):e3092. Non-viral gene delivery for cancer immunotherapy. Wang W et al. School of Pharmacy, Nantong University, Nantong, China
Results/Comments: Nanoparticle-based non-viral gene delivery strategies have great potential to be implemented in the clinic for cancer immunotherapy
Link: Abstract

DISRUPTIVE TECHNOLOGIes

Efficient electroporation of neuronal cells using synthetic oligonucleotides

Oligonucleotide drugs are experiencing greater success in the clinic, encouraging the initiation of new projects. Resources are insufficient to develop every potentially important project, and persuasive experimental data using cell lines close to disease target tissue is needed to prioritize candidates. Friedreich's ataxia (FRDA) is a devastating and currently incurable disease caused by insufficient expression of the enzyme frataxin (FXN). The researchers have previously shown that synthetic nucleic acids can activate FXN expression in human patient-derived fibroblast cells. Researchers (in collaboration with MaxCyte and Ionis Pharmaceuticals now chose to further test these compounds in induced pluripotent stem cell-derived neuronal progenitor cells (iPSC-NPCs). They recently described methods to deliver oligonucleotides and duplex RNAs into iPSC-NPCs using electroporation. Activation of FXN expression is potent, easily reproducible, and potencies parallel those determined using patient-derived fibroblast cells. A duplex RNA and several antisense oligonucleotides (ASOs) with different combinations of 2'-methoxyethyl (2'-MOE), 2'-fluoro (2'-F), and constrained ethyl (cEt) were active, providing multiple starting points for further development and highlighting improved potency as an important goal for preclinical development.
The results will appear in the September issue of RNA

Related Informations / Publications

-Bioorg Med Chem Lett. 2018 Sep 15;28(17):2850-2855. Activating frataxin expression by single-stranded siRNAs targeting the GAA repeat expansion. Shen X et al. UT Southwestern Medical Center at Dallas, Dallas, TX 75390, USA
Results/Comments: Single-stranded siRNAs (ss-siRNAs) that combine the strengths of dsRNA and ASO approaches had nanomolar potencies. ss-siRNAs provide an additional option for developing nucleic acid therapeutics to treat FRDA
Link: Abstract
-Nucleic Acid Ther. 2018 Feb;28(1):23-33. Activation of Frataxin Protein Expression by Antisense Oligonucleotides Targeting the Mutant Expanded Repeat. Li L et al. UT Southwestern Medical Center at Dallas , Dallas, Texas, USA
Link: Abstract - Full Text

Potential applications of nanoparticles for tumor microenvironment remodeling to ameliorate cancer immunotherapy

In recent years, researchers have made significant innovations in the field of tumor immunotherapy based on the knowledge of biology, oncology, and immunology. Tumor immunotherapy involves the use of immune checkpoint inhibitors and CAR (chimeric antigen receptor)-T cell therapy. As compared with conventional chemotherapy, immunotherapy is a potential approach to induce a more powerful immune response against tumor in the patient suffering from the advanced stage malignancy. Regardless of the developments made, a large number of clinical studies have confirmed that a substantial number of cancer patients still demonstrate non-responsiveness to immunotherapy, mainly due to the immunomodulating interactions of tumor cells with the immunosuppressive tumor microenvironment (iTME). It leads to immune tolerance of tumors and influences the efficacy of immunotherapy. This immune failure could be attributed to a complex immunosuppressive network comprising stromal and inflammatory cells, vessel system, ECM (extracellular matrix) and the cytokines released in tumor microenvironment (TME). The antitumor immune activity can be enhanced at different stages of tumor development by selective suppression of inhibitory pathways in the TME. This specific task can be achieved by using nano-sized drug delivery tools which are specific in their action and biocompatible in nature. The results appeared in August 22nd online issue of Int J Pharm

Related Informations / Publications

-Biomaterials. 2019 Oct;219:119401. Non-viral nano-immunotherapeutics targeting tumor microenvironmental immune cells. Yong SB et al. Hanyang University, 133-791, Seoul, Republic of Korea
Results/Comments: Recent studies on dendritic cell-targeted mRNA vaccination are discussed and the future perspectives of nano-immunotherapeutic for next-generation of cancer immunotherapy is emphasized . Link : Abstract
-World J Stem Cells. 2019 Jul 26;11(7):398-420. Targeting cancer stem cells in drug discovery: Current state and future perspectives. Du FL et al. Shenyang Pharmaceutical University, Shenyang 110016, Liaoning Province, China Link : Abstract
-Adv Drug Deliv Rev. 2019 Jul 19. pii: S0169-409X(19)30119-X. Optimizing Advances in Nanoparticle Delivery for Cancer Immunotherapy. Caster JM et al. University of Iowa Carver College of Medicine, Iowa City, IA, USA
Results/Comments: Advanced nanomedicines can be precisely engineered to overcome many of the current limitations and appear well-poised to enable the clinical translation of promising cancer immunotherapies. Link : Abstract

Tumor exosome-based nanoparticles are efficient drug carriers for chemotherapy

Developing biomimetic nanoparticles without loss of the integrity of proteins remains a major challenge in cancer chemotherapy. Researchers have developped a biocompatible tumor-cell-exocytosed exosome-biomimetic porous silicon nanoparticles (PSiNPs) as drug carrier for targeted cancer chemotherapy. Exosome-sheathed doxorubicin-loaded PSiNPs (DOX@E-PSiNPs), generated by exocytosis of the endocytosed DOX-loaded PSiNPs from tumor cells, exhibit enhanced tumor accumulation, extravasation from blood vessels and penetration into deep tumor parenchyma following intravenous administration. In addition, DOX@E-PSiNPs, regardless of their origin, possess significant cellular uptake and cytotoxicity in both bulk cancer cells and cancer stem cells (CSCs).
The results appeared in August 23th online issue of Nat Comm

Related Informations / Publications

-Biomacromolecules. 2019 Aug 26. doi: 10.1021/acs.biomac.9b0092. Ligand-Functionalized Poly(ethylene glycol) Particles for Tumor Targeting and Intracellular Uptake. Cui J et al. Shandong University , Jinan , Shandong 250100 , China
Results/Comments: The targeted PEG particles represent a platform for developing particles aimed at balancing nonspecific and specific interactions in biological systems Link Abstract
-Semin Cancer Biol. 2019 Aug 22. pii: S1044-579X(19)30187-7. Implications of nanotechnology for the treatment of cancer: Recent advances. Klochkov SG et al. Russian Academy of Sciences, Chernogolovka, 142432, Russia
Link: Abstract
-Molecules. 2019 Aug 15;24(16). pii: E2961. pH-Responsive Polypeptide-Based Smart Nano-Carriers for Theranostic Applications. Augustine R et al. Pusan National University, Geumjeong-gu, Busan 46241, Korea
Link: Abstract - Full Text

INDUSTRIAL LANDSCAPE
& AGREEMENTS

Sarepta stumbles on FDA rejection of VyonDys53 to treat Duchenne muscular dystrophy

Sarepta Therapeutics was dealt a surprising setback on August 19th when the Food and Drug Administration rejected its marketing application for a second drug that aimed to treat children with Duchenne muscular dystrophy. In a statement, Sarepta said the FDA denied the approval of its drug, called Vyondys 53 (golodirsen), due to the risk of infections related to intravenous infusion ports and kidney toxicity seen in animal experiments. The FDA did not issue its own statement explaining its negative decision, but the rejection of Vyondys 53 is an uncommon instance where the agency pushed back against a company seeking fast approval for a rare-disease drug based on an early biomarker — and before substantial evidence of patient benefit was obtained. Fast approvals for rare-disease drugs have skyrocketed and become almost routine in recent years as the FDA established expansive rules meant to speed the development of medicines for unmet medical needs. The decision to reject Vyondys 53, therefore, might represent a new and more restrictive regulatory policy at FDA, which could affect all companies developing drugs for rare diseases. For further information, see Statnews

Related Informations / Publications

-AUG 2019: Sarepta Therapeutics Receives Complete Response Letter from the US Food and Drug Administration for Golodirsen New Drug Application
Link: Press Release
-Medicine (Baltimore). 2019 Jun;98(26):e15858. Long-term treatment with eteplirsen in nonambulatory patients with Duchenne muscular dystrophy. Aflano NL et al. Pediatrics, Center for Gene Therapy, Nationwide Children's Hospital, Columbus, OH, USA
Results/Comments: Dystrophin production was confirmed following eteplirsen treatment.Despite the loss of ambulation, other markers of disease progression remained relatively stable in the eteplirsen-treated twin patients and were similar to those of the ambulatory patients
Link: Abstract - Full Text
-PLoS One. 2019 Jun 25;14(6):e0218683. Long-term natural history data in Duchenne muscular dystrophy ambulant patients with mutations amenable to skip exons 44, 45, 51 and 53. Brogna C et al. Child Health Area, Università Cattolica del Sacro Cuore, Rome, Italy
Link: Abstract - Full Text

Zogenix announces acquisition of Modis Therapeutics

Zogenix announces acquisition of Modis Therapeutics, a privately held biopharmaceutical company focused on developing novel therapies for rare genetic diseases with high unmet medical need. Modis’s lead product candidate, MT1621, an investigational deoxynucleoside substrate enhancement therapy, is in late-stage development for the treatment of Thymidine Kinase 2 deficiency (TK2d), an inherited mitochondrial DNA depletion disorder that predominantly affects children and is often fatal. A pivotal Phase 2 retrospective treatment study (called RETRO) of MT1621 substrate enhancement therapy in patients with TK2d was recently completed, with results demonstrating a substantial treatment benefit for patients. Thirty-eight patients from eight clinical sites in three countries (U.S., Spain and Israel) were enrolled in RETRO and received MT1621 treatment for up to seven years.
For further information, see Zogenix

Related Informations / Publications

-JUL 2019: Zogenix Completes Enrollment in Phase 3 Trial of Fintepla® in Lennox-Gastaut Syndrome. Link: Press Release
-FEB 2019: Modis Therapeutics Announces that MT1621 Receives Breakthrough Therapy Designation from FDA for the Treatment of TK2 Deficiency.
Link: Press Release
-Epilepsia. 2018 Oct;59(10):1881-1888. A pilot, open-label study of the effectiveness and tolerability of low-dose ZX008 (fenfluramine HCl) in Lennox-Gastaut syndrome. Lagae L et al. Division of Pediatric Neurology, University of Leuven, Leuven, Belgium Results/Comments: ZX008 provided clinically meaningful reduction (≥50%) in CS frequency in the majority of patients with LGS in this pilot study and was generally well tolerated. A phase 3, randomized, controlled study is ongoing. Link: Abstract
-Clin Ther. 2018 Aug;40(8):1338-1346. The Lack of Effect of Food on the Pharmacokinetics of ZX008 (Fenfluramine Oral Solution): Results of a Single-dose, Two-period Crossover Study. Gammaitoni A et al. Zogenix, Inc., Emeryville, California, USA Link: Abstract

Mustang Bio announces license agreement with CSL Behring for the Production of MB-107 lentiviral gene therapy

Mustang Bio, a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, announced on August 28th that it has entered into a license agreement with CSL Behring for the Cytegrity™ stable producer cell line developed and used by St. Jude Children’s Research Hospital. Cytegrity™ stable producer cell line will be used to produce the viral vector for Mustang Bio’s MB-107 lentiviral gene therapy program for the treatment of X-linked severe combined immunodeficiency (XSCID). Mustang licensed MB-107 from St. Jude in August 2018. MB-107 is currently being assessed in two Phase 1/2 clinical trials for XSCID: the first in newly-diagnosed infants under the age of two (NCT01512888) and the second in patients over the age of two who have received prior hematopoietic stem cell transplantation (NCT01306019). Positive Phase 1/2 clinical data from the trial for infants under the age of two were published in the New England Journal of Medicine in April. The FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to MB-107 for the treatment of XSCID earlier this month.
For further information, see Mustang Bio

Related Informations / Publications

-AUG 2019: Mustang Bio and St. Jude Children’s Research Hospital announce MB-107 lentiviral gene therapy for X-linked Severe Combined Immunodeficiency (XSCID) granted regenerative medicine advanced therapy (RMAT) designation from FDA
Results/Comments: Under the terms of the RMAT designation, the FDA will help facilitate the program’s expedited development and review and provide guidance on generating the evidence needed to support the approval of MB-107 for XSCID. RMAT designation was granted to MB-107 based on positive Phase 1/2 clinical data for infants with XSCID under the age of 2. Link: Press Release
-AUG 2019: Mustang Bio Announces $9.28 Million Grant to Fund Phase 1 Trial of CAR T Therapy MB-103 in HER2-Positive Breast Cancer with Brain Metastases
Link: Press Release
-AUG 2019: FDA Clears IND for Mustang Bio’s MB-102 (CD123 CAR T) Results / Comments : MB-102 is a CAR T cell therapy that is produced by engineering patient T cells to recognize and eliminate CD123-expressing tumors. CD123 is widely expressed on bone marrow cells of patients with myelodysplastic syndrome and hematologic malignancies, including in 75-89% of AML patients and over 90% in BPDCN patients Link: Press Release

miscellaneous

Circulatory miRNA biomarkers of metabolic syndrome

Circulatory microRNAs (c-miRNAs) exert important roles in the molecular dysregulation of cardio-metabolic diseases. However, little is known whether dysregulated miRNA expression occurs when risk factors are elevated, as in the metabolic syndrome (MetS). This study quantified c-miRNA expression in individuals with MetS compared to healthy, further examining the relationship of gene pathways with the underlying pathogenesis. Regression model adjusted for age and sex identified miR-15a-5p, miR-17-5p, miR-370-3p and miR-375 as important predictors of MetS presence. Analysis of predictive miRNAs in the validation cohort strengthened the relationship with miR-15a-5p and miR-17-5p expression. These miRNAs share genes involved in the regulation of metabolic pathways including insulin, wnt, fatty acid metabolism and AMPK. miR-15a-5p and miR-17-5p were identified as predictive biomarkers of MetS, irrespective of sexes, further demonstrating the relationship of c-miRNAs to known pathways of metabolic disturbances present in cardio-metabolic diseases.
The review appeared in August 21st online issue of Acta Diabetol

Related Informations / Publications

- J Cell Physiol. 2019 Aug;234(10):16971-16986. Long noncoding RNAs biomarker-based cancer assessment. Sarfi M et al. Teheran University of Medical Sciences, Teheran, Iran
Results/Comments: This review summarizes the most significant and up-to-date findings of research on lncRNAs involvement in different cancers, focusing on the potential of cancer-related lncRNAs as biomarkers for diagnosis, prognosis, and therapy Link: Abstract
-Cancers (Basel). 2019 Jun 27;11(7). Circulating microRNAs as Promising Biomarkers in Colorectal Cancer. Rapado-González Ó et al. University of Santiago de Compostela, 15782 Santiago de Compostela, Spain
Results/Comments: In this review researchers focus on the clinical potential of blood circulating miRNAs as emerging biomarkers with high value to improve the clinical management of CRC patients, providing a deep and complete perspective of the realities and challenges to translate these biomarkers to the clinical context
Link: Abstract - Full Text
-EBioMedicine. 2019 May;43:307-316. Development and validation of plasma miRNA biomarker signature panel for the detection of early HIV-1 infection. Biswas et al. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, USA
Results/Comments: Accurate laboratory diagnosis of HIV is essential to reduce the risk of HIV-positive individuals transmitting HIV-1 infection. The goal of this study was to identify and assess a panel of host derived plasma miRNAs that could to serve as a prognostic and predictive biomarker to detect early/acute HIV-1 infection
Link: Abstract - Full Text

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