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INNOVATIVE BIOTHERAPies

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January 2020, 15th
*FEATURE STORY* ● The National Gene Vector Biorepository. Eleven years of providing resources to the gene therapy community GENE THERAPY ● Recommendations for the development of cell-based anti-viral vector neutralizing antibody assays DISRUPTIVE TECHNOLOGIES ● A small molecule-controlled Cas9 repressible system ● CRISPR/Cas9: targeted genome editing for the treatment of hereditary hearing loss CLINICAL TRIALS - DATA ● AGTC reports positive six-month data from its ongoing Phase I/II clinical trial in X-Linked Retinitis Pigmentosa *INDUSTRIAL LANDSCAPE & AGREEMENTS* ● Empirico scores $660M deal with Ionis and lands series A-2 financing ● MiNA Therapeutics announces research collaboration with AstraZeneca in metabolic diseases ● Avacta and Daewoong Pharmaceutical form immunotherapy focused joint-venture ● EQRx launches to create innovative medicines at dramatically lower prices for people, healthcare systems and society *MISCELLANEOUS* ● ICER posts draft scoping document for the assessment of treatments for beta-thalassemia

January 2020, 15th

FEATURE STORY

● The National Gene Vector Biorepository. Eleven years of providing resources to the gene therapy community

GENE THERAPY

● Recommendations for the development of cell-based anti-viral vector neutralizing antibody assays

DISRUPTIVE TECHNOLOGIES
● A small molecule-controlled Cas9 repressible system
● CRISPR/Cas9: targeted genome editing for the treatment of hereditary hearing loss
CLINICAL TRIALS - DATA

● AGTC reports positive six-month data from its ongoing Phase I/II clinical trial in X-Linked Retinitis Pigmentosa

INDUSTRIAL LANDSCAPE & AGREEMENTS
● Empirico scores $660M deal with Ionis and lands series A-2 financing

● MiNA Therapeutics announces research collaboration with AstraZeneca in metabolic diseases

● Avacta and Daewoong Pharmaceutical form immunotherapy focused joint-venture

● EQRx launches to create innovative medicines at dramatically lower prices for people, healthcare systems and society

MISCELLANEOUS

● ICER posts draft scoping document for the assessment of treatments for beta-thalassemia

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FEATURE STORY

The National Gene Vector Biorepository. Eleven years of providing resources to the gene therapy community

The National Gene Vector Biorepository (NGVB) program has been highly accessed by gene therapy investigators. The Reagent Repository has distributed over 1,000 reagents to 397 investigators. The Pharmacology/Toxicology Archive contains over 36,000 specimens from a variety of AAV, Adenoviral and other Pharmacology/Toxicology studies. NGVB also maintains a searchable database of Gene Therapy Pharmacology/Toxicology studies to promote data sharing. NGVB has provided FDA mandated replication competent virus testing for over 70 clinical trials. From 2008 through 2018, there have been 114 publications acknowledging the NGVB. It is unlikely that any other NIH funded program has served as many gene therapy investigators as the NGVB.
The review appeared in January 07th online issue of Hum Gene Ther

Related Informations/Publications

-Mol Ther Methods Clin Dev. 2018 Aug 17;10:371-378. Screening Clinical Cell Products for Replication Competent Retrovirus: The National Gene Vector Biorepository Expérience. Cornetta K et al. Indiana University School of Medicine, Indianapolis, IN 46202, USA
Results/Comments: The majority of vector products used in the clinical trials were generated in the PG13 packaging cell line. The findings suggest that screening of the retroviral vector product generated in PG13 cell line may be sufficient and that further screening of transduced cells does not provide added value
Link: Abstract – Full Text

Gene Therapy

Recommendations for the development of cell-based anti-viral vector neutralizing antibody assays

Viral vector-based gene therapies (GTx) have received significant attention in the recent years and the number of ongoing GTx clinical trials is increasing. A platform of choice for many of these studies is adeno-associated virus (AAV). All humans may be exposed to natural AAV infections and could mount an immune response against the virus. Consequently, there can be a high prevalence of pre-existing anti-AAV immunity. This presents a potential limitation for AAV-based GTx due to the potential for AAV-specific antibodies to reduce the efficacy of the GTx. Therefore, appropriate assessment of potential subjects enrolled in these studies should include evaluation for the presence and degree of anti-AAV immunity, including anti-AAV neutralizing antibodies (NAb). Recommendations for the development and validation of cell-based anti-AAV NAb detection methods, including considerations related to selection of appropriate cell line, surrogate vector/reporter gene, assay matrix and controls, and methodologies for calculating assay cut-point are discussed herein. General recommendations for the key assay validation parameters are provided as well as considerations for the development of NAb diagnostic tests. This manuscript is produced by a group of scientists involved in GTx therapeutic development representing various companies. The review appeared in January 06th online issue of AAPS J.

Related Informations / Publicationss

-Adv Exp Med Biol. 2019;1185:165-168. Innate Immune Response Following AAV Administration. Dauletbekov DL. University Hospital Tübingen, Tübingen, Germany Results/Comments: The understanding of innate immune responses to AAV can potentially improve safety and therapeutic efficiency of AAV. This article provides an overview of innate immune responses to AAV vectors
Link: Abstract
-Curr Opin Biotechnol. 2019 Dec;60:99-103. Engineering the AAV capsid to evade immune responses. Barnes C et al. University of California, Berkeley, CA, USA Results/Comments: This review summarizes recent advances in understanding the immune response to AAV as well as highlights engineering methods that enhance AAV's potential as a gene therapy vector
Link: Abstract
-Viruses. 2019 Jan 25;11(2). Adeno-associated Virus (AAV) versus Immune Response. Rabinowitz J et al. Pfizer Inc., 7030 Kit Creek Road, Morrisville, NC 27560, USA
Link: Abstract – Full Text

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DISRUPTIVE TECHNOLOGIES

A small molecule-controlled Cas9 repressible system

CRISPR-Cas9 has been developed into a powerful molecular tool for genome engineering, and has revolutionized the field of biomedical research. Despite the tremendous potential of CRISPR-Cas9 in biomedical research, precise control of CRISPR-Cas9 over the dose and exposure time is important to expand its applications. In a recent study, American researchers fused Cas9 with a peptide termed small molecule-assisted shut-off (SMASh) consisting of a protease domain and a degron domain derived from hepatitis C virus (HCV). The presence of SMASh allows tight control of the Cas9 stability via a clinically approved HCV protease inhibitor asunaprevir (ASV). They have shown that the engineered Cas9 responded to ASV administration and rapidly degraded in a dose- and time-dependent manner. Cas9 degradation was reversible upon ASV removal that restored the gene editing activity. They also showed that limiting the level of Cas9 in cells increased the specificity of gene editing. The SMASh tag therefore provides an effective tool to control Cas9 stability, allowing an improvement in the accuracy, safety and versatility of the CRISPR-Cas9 system for genome editing and gene regulation studies.
The results appeared in January 09th online issue of Mol Ther Nuc Acids

Related Informations / Publications

-Biochem Soc Trans. 2020 Jan 10. pii: BST20190119. Characterization and applications of Type I CRISPR-Cas systems. Hidalgo-Cantabrana C et al. North Carolina State University, Raleigh, NC, USA
Results/Comments: This review provides a framework for expanding the CRISPR toolbox, and repurposing the most abundant CRISPR-Cas systems for a wide range of applications. Link: Abstract
-Trends Pharmacol Sci. 2020 Jan;41(1):55-65. Strategies for the CRISPR-Based Therapeutics. Li B et al. The First Affiliated Hospital of Southern University of Science and Technology, Shenzhen 518020, China
Results/Comments: In this review, researchers focus on representative strategies for regulation and delivery of the CRISPR-Cas system, and outline current therapeutic applications in their clinical translation. Link: Abstract
-J Genet Genomics. 2019 Nov 22. pii: S1673-8527(19)30175-4. Advances in detecting and reducing off-target effects generated by CRISPR-mediated genome editing. Li J et al. The First Affiliated Hospital of Fujian Medical University, Fuzhou, 350005, China Results/Comments: In this review researchers outline the different versions of CRISPR systems and off-target detection strategies, discuss the merits and limitations of off-target detection methods, and provide potential implications for further gene editing research. Link: Abstract
-J Genet Genomics. 2019 Nov 23. pii: S1673-8527(19)30176-6. Engineering guide RNA to reduce the off-target effects of CRISPR. Wu J et al. Wuhan University, China Results/Comments: The modalities of gRNA engineering can be applied across CRISPR systems. In conjunction with CRISPR protein effectors, the engineered gRNA enables efficient and precise genome editing. Link: Abstract

CRISPR/Cas9: targeted genome editing for the treatment of hereditary hearing loss

Hereditary hearing loss (HHL) is a neurosensory disorder that affects every 1/500 newborns worldwide and nearly 1/3 people over the age of 65. Congenital deafness is inherited as monogenetic or polygenic disorder. The delicacy, tissue heterogeneity, deep location of the inner ear down the brainstem, and minute quantity of cells present in cochlea are the major challenges for current therapeutic approaches to cure deafness. Targeted genome editing is considered a suitable approach to treat HHL since it can target defective molecular components of auditory transduction to restore normal cochlear function. With the advent of CRISPR/Cas9 technique, targeted genome editing and biomedical research have been revolutionized. The robustness and simplicity of this technology lie in its design and delivery methods. It can directly deliver a complex of Cas9 endonuclease and single guide RNA (sgRNA) into zygote using either vector-mediated stable transfection or transient delivery of ribonucleoproteins complexes. This strategy induces DNA double strand breaks (DSBs) at target site followed by endogenous DNA repairing mechanisms of the cell. CRISPR/Cas9 has been successfully used in model animals to edit hearing genes like calcium and integrin-binding protein 2, myosin VIIA, Xin-actin binding repeat containing 2, leucine-zipper and sterile-alpha motif kinase Zak, epiphycan, transmembrane channel-like protein 1, and cadherin 23. This review discusses the utility of lipid-mediated transient delivery of Cas9/sgRNA complexes, an efficient way to restore hearing in humans, suffering from HHL.
The review appeared in January 07th online issue of J Appl Genet.

Related Informations / Publications

-Front Cell Neurosci. 2019 Jul 16;13:323. Gene Therapy for Human Sensorineural Hearing Loss. Ren Y et al. Harvard Medical School, Boston, MA, United States Results/Comments: Recently, there has been tremendous progress in the development of gene therapy vectors to treat sensorineural hearing loss (SNHL) in animal models in vivo. Nevertheless, significant hurdles remain before such technologies can be translated toward clinical use. Link: Abstract – Full Text
-Hum Mol Genet. 2019 Oct 1;28(R1):R65-R79. Gene therapy for hearing loss. Omichi R et al. Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama 700-8558, Japan
Results/Comments: Researchers here discuss delivery methods, techniques and viral vectors employed for inner ear gene therapy and the advancements in this field that are paving the way for basic science research discoveries to transition to clinical trials
Link: Abstract
-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
Link: Abstract

CLINICAL TRIALS

AGTC reports positive six-month data from its ongoing Phase I/II clinical trial in X-Linked Retinitis Pigmentosa

Applied Genetic Technologies Corporation (AGTC), a biotechnology company conducting human clinical trials of adeno-associated virus (AAV)-based gene therapies for the treatment of rare diseases, reported on January 09th positive interim six-month data from its ongoing Phase 1/2 clinical program in X-linked retinitis pigmentosa (XLRP). The results show that patients treated centrally with its product candidate demonstrated durable improvement in visual function six months after dosing. These data reinforce the promising efficacy and safety results reported in September 2019 and will help to design the XLRP pivotal trial that is currently being planned to initiate by the end of 2020. The company also remains on track to report interim six-month data from the dose escalation cohorts of both of its ongoing trials in achromatopsia later this month. For further information

Related Informations / Publications

-Genes (Basel). 2019 Sep 4;10(9). Molecular Strategies for RPGR Gene Therapy. Cehajic Kapetanovic J et al. University of Oxford, Oxford OX3 9DU, UK
Results/Comments: Researchers here discuss the structure of three current phase I/II clinical trials based on three AAV vectors and RPGR sequences and link the rationale behind the use of the different vectors back to the bench research that led to their development
Link: Abstract – Full Text
-OCT 2019: AGTC Presents Data Demonstrating Efficiency of its AAV Vectors for Ocular Gene Therapy Even in the Presence of Anti-AAV Antibodies. Link: Press Release
-Pharm Res. 2019 Jan 7;36(2):34. Adeno-Associated Viral Gene Therapy for Inherited Retinal Disease. Ong T et al. Nightstar Therapeutics, 203 Crescent Street, Suite 303, Waltham, Massachusetts, 02453, USA Link: Abstract
-Expert Opin Orphan Drugs. 2018 Feb 27;6(3):167-177. Gene therapy for the treatment of X-linked retinitis pigmentosa. Martinez-Fernandez De La Camara C et al. Department of Clinical Neurosciences, John Radcliffe Hospital, Oxford, UK
Results/Comments: X-linked retinitis pigmentosa is an amenable disease to be treated by gene therapy. Codon optimisation has overcome the challenge of designing an RPGR vector without mutations, and with a therapeutic effect in different animal models
Link: Abstract – Full Text

INUSTRIAL LANDSCAPE & AGREEMENTS

Empirico scores $660M deal with Ionis and lands series A-2 financing

Empirico Therapeutics announced on January 09th that it has entered into a strategic collaboration with Ionis Pharmaceuticals. During the three-year collaboration, Empirico will utilize its Precision Insights Platform, which incorporates huge biological data sets, human genetics and advanced algorithmic approaches, to identify therapeutic targets for indications and tissues that are amenable to Ionis’ industry-leading antisense technology. Under the terms of the agreement, Ionis can advance up to ten targets identified by Empirico and assume responsibility for all preclinical and clinical development activities. Empirico and Ionis will also work together to incorporate human genetics evidence into ongoing efforts with existing Ionis programs, including work on target validation, indication and biomarker selection, and patient stratification. As part of this new collaboration, Ionis has made a $10 million equity investment in Empirico, with additional near-term commitments of up to $30 million based on operational and preclinical milestones. Empirico will be eligible to receive in excess of $620 million for the achievement of clinical development, regulatory and commercial milestones, and royalties on net sales. Empirico also has the option to license, develop, and commercialize an Ionis development candidate directed toward a collaboration target for which Ionis will receive milestone payments and royalties on net sales. In connection with this new collaboration, Empirico also announced the closing of its $17 million Series A-2 financing, led by Ionis and with participation by DCVC Bio and Neotribe Ventures. This was a follow-on round to Empirico’s $12.5 million Series A financing, co-led by DCVC Bio and Neotribe Ventures and completed In November 2018.
For further information

Related Informations / Publications

-Empirico has active preclinical development programs across several immune, dermatological, cardiometabolic, and ophthalmic indications based on targets identified with the Precision Insights Platform. Empirico is headquartered in San Diego, Calif. with laboratories in Madison, Wis, USA
Link: Businesswire

MiNA Therapeutics announces research collaboration with AstraZeneca
in metabolic diseases

MiNA Therapeutics announced on January 07th the initiation of a research collaboration with AstraZeneca to evaluate small activating RNA ("saRNA") molecules in metabolic diseases. The collaboration combines MiNA's leading expertise in the discovery and development of saRNA therapeutics with AstraZeneca's experience in identifying and bringing breakthrough treatments to patients with metabolic diseases. Under the terms of the agreement MiNA and AstraZeneca will conduct in vitro and in vivo studies that may enable the future development of saRNA therapeutics to treat metabolic diseases through biological pathways not addressable by conventional treatment strategies. Upon completion of these studies, AstraZeneca will have the option to negotiate a license agreement to further develop saRNA molecules that activate an undisclosed gene target identified by AstraZeneca. No further details about the collaboration have been disclosed.
For further information

Related Informations / Publications

-Mol Ther Nucleic Acids. 2019 Dec 6;18:142-154. Targeted Delivery of C/EBPα-saRNA by RNA Aptamers Shows Anti-tumor Effects in a Mouse Model of Advanced PDAC. Yoon S et al. Beckman Research Institute of City of Hope, Duarte, CA 91010, USA
Link: Abstract – Full Text
-NOV 2019 Novartis to acquire The Medicines Company for 9.7bnUS$
Results/Comments: The Medicine Company’s inclisiran is first-in-class siRNA inhibitor targeting PCSK9, currently being evaluated in P-III (ORION-9, 10 and 11) studies for patients with atherosclerotic cardiovascular disease (ASCVD) or familial hypercholesterolemia (FH), demonstrating potent and durable LDL-C reduction with its expected regulatory submission in the US in Q4’19 and in the EU in Q1’20. Link: Pharmashots
-SEP 2019 MiNA Therapeutics Presents Clinical and Pre-Clinical Data at ESMO Supporting MTL-CEBPA as Immunological Combination Treatment
Results/Comments: MiNA Therapeutics announced final Phase 1 clinical data of MTL-CEBPA as a single agent in patients with advanced liver cancer as well as pre-clinical data demonstrating synergistic immunological and anti-tumour activity of MTL-CEBPA in combination with anti-PD1 checkpoint inhibition. Link: Press Release
-Mol Ther. 2019 May 8;27(5):999-1016. Anti-inflammatory Activity of MTL-CEBPA, a Small Activating RNA Drug, in LPS-Stimulated Monocytes and Humanized Mice.Zhou J et al. Beckman Research Institute, City of Hope, Duarte, CA 91010, USA
Results/Comments: The data support further investigation of MTL-CEBPA in acute and chronic inflammatory diseases where this mechanism has pathogenic importance
Link: Abstract

Avacta and Daewoong Pharmaceutical form immunotherapy focused joint-venture

Avacta Group, a developer of Affimer® biotherapeutics and reagents, and Daewoong Pharmaceutical announced on January 08th that they have agreed to establish a joint venture in South Korea, and to enter a collaboration and license agreement for the joint venture to develop the next generation of cell and gene therapies incorporating Affimer proteins to enhance the immune-modulatory effects. Mesenchymal stem cells (MSCs) are promising agents for the treatment of autoimmune and inflammatory diseases. The joint venture will develop a new class of MSCs that are primed to produce Affimer proteins, which are designed to enhance the immune-modulatory effect when administered to patients, by reducing inflammatory or autoimmune responses. Daewoong will provide the joint venture with access to its proprietary technology for generating allogeneic MSCs from a single donor to treat a large number of patients. This proprietary technology facilitates developing cell therapies as "off-the-shelf" products. Avacta will develop Affimer proteins against several undisclosed targets which will be transferred to the joint venture to be incorporated into MSCs. The resulting engineered MSCs will have broad ranging therapeutic utility, depending on the Affimer proteins' intended therapeutic purposes.
For further information

Related Informations / Publications

-Biotechniques. 2019 Dec;67(6):261-269. Affimers as anti-idiotypic affinity reagents for pharmacokinetic analysis of biotherapeutics. Adamson H et al. University of Leeds, Leeds, LS2 9JT, UK Results/Comments: Affimer proteins therefore represent promising anti-idiotypic reagents that are simple to select and manufacture, and that offer the sensitivity, specificity and consistency required for pharmacokinetic assays
Link: Abstract – Full Text
-NOV 2019 : LG Chem Life Sciences Expands Partnership with Avacta
Results/Comments: The multi-target therapeutics development agreement with LG Chem was signed in December 2018 and provided upfront and near-term development milestone payments, plus longer-term clinical development milestones. Avacta will also receive royalties on any future product sales and LG Chem is covering all Avacta’s costs of research and development associated with the collaboration Link: Press Release
-OCT 2019 : Collaboration and Option Agreement with ADC Therapeutics
Results/Comments: As part of the multi-target collaboration Avacta will generate and optimise Affimer® binders against three undisclosed cancer targets and provide these to ADC Therapeutics to target its proprietary cytotoxic warheads (PBDs) to the site of the tumour. ADC Therapeutics will carry out pre-clinical research and development programmes to evaluate each of the Affimer-drug conjugates with a view to generating clinical candidates.
Link: Press Release

EQRx launches to create innovative medicines at dramatically lower prices for people, healthcare systems and society

EQRx announced on January 12th that it is launching to create novel, patent-protected medicines at prices that are more affordable for people and sustainable for healthcare systems. EQRx, a first of its kind biotechnology company, is focused on re-engineering the process from drug discovery to patient delivery with the goal of offering a market-based solution for the rising cost of medicines. Leveraging advances in science and technology to bring treatments for life threatening and chronic diseases to people more efficiently and cost-effectively, EQRx intends to offer its therapies at dramatically lower prices compared to today’s innovative medicines. EQRx is launching with $200 million in Series A financing led by GV, ARCH Venture Partners, Andreessen Horowitz, and Casdin Capital, Section 32, Nextech and Arboretum Ventures, among others. The bold mission of EQRx to deliver better medicines at lower prices is one that can redefine the therapeutics landscape. The company’s business model will deliver a sustainable approach for creating, reinvesting in, and rewarding therapeutics innovation, while ensuring these new medicines are broadly accessible to people and healthcare systems through dramatically lower pricing.
For further information

MISCELLANEOUS

ICER posts draft scoping document for the assessment of treatments for beta-thalassemia

The Institute for Clinical and Economic Review (ICER) has posted on January 06th a document outlining a planned review of the comparative clinical effectiveness and value treatments for LentiGlobin (Bluebird Bio) and luspatercept-aamt (Reblozyl®, Acceleron Pharma and BMS/Celgene) for the treatment of beta thalassemia. LentiGlobin is an investigational gene therapy currently marketed in Europe under the brand name Zynteglo®; an FDA decision regarding potential US approval is expected by late 2020. Luspatercept-aamt was approved by the FDA in November 2019.
For further information

Related Informations / Publications

-JAN 2020 : ICER to Assess Gene Therapy for Hemophilia A . Link: Press Release
-NOV 2019 : FDA approves luspatercept-aamt for anemia in patients with beta thalassemia.
Link: FDA
-NOV 2019 : American Society for Clinical Pharmacology and Therapeutics. Regulators' Advice Can Make a Difference: European Medicines Agency Approval of Zynteglo for Beta Thalassemia. Schuessler‐Lenz et al. European Medicines Agency (EMA) Committee for Advanced Therapies, Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen, Germany . Link: Full Text
-JUN 2019 : bluebird bio Announces EU Conditional Marketing Authorization for ZYNTEGLO™ (autologous CD34+ cells encoding βA-T87Q-globin gene) Gene Therapy for Patients 12 Years and Older with Transfusion-Dependent β-Thalassemia Who Do Not Have β0/β0 Genotype
Link: Full Text

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