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contents

December 2019, 3rd
*FEATURE STORY* ● Artificial intelligence approach to create AAV capsids for gene therapies *DISRUPTIVE TECHNOLOGIES* ● Nanoparticles as carriers for drug delivery of macromolecules across the blood-brain barrier CLINICAL TRIALS - DATA ● Libella gene therapeutics to run a patient paid trial of telomerase gene therapy *M&A - AGREEMENTS* ● Novartis to acquire The Medicines Company for USD 9.7bn, adding inclisiran -● ● ● INVESTMENTS - FUNDRAISING ● Ferring and Blackstone Life Sciences invest over $570 Million USD in novel gene therapy for bladder cancer patients ● Two Chinese companies invest in Vigeneron, a German firm developing ophthalmological gene therapy programs ● Vertex is planning a major expansion in the Seaport ● Thermo Fisher Scientific unveils $6 Million expansion at viral vector manufacturing facility Miscellaneous ● $50M cell and viral vector manufacturing operation backed by Harvard *MISCELLANEOUS* ● FDA issues guidance for industry on adaptive designs for clinical trials of drugs and biologics

December 2019, 3rd

FEATURE STORY

● Artificial intelligence approach to create AAV capsids for gene therapies

DISRUPTIVE TECHNOLOGIES

● Nanoparticles as carriers for drug delivery of macromolecules across the blood-brain barrier

CLINICAL TRIALS - DATA

● Libella gene therapeutics to run a patient paid trial of telomerase gene therapy

M&A - AGREEMENTS
● Novartis to acquire The Medicines Company for USD 9.7bn, adding inclisiran -● ● ●

INVESTMENTS - FUNDRAISING

● Ferring and Blackstone Life Sciences invest over $570 Million USD in novel gene therapy for bladder cancer patients

● Two Chinese companies invest in Vigeneron, a German firm developing ophthalmological gene therapy programs

● Vertex is planning a major expansion in the Seaport

● Thermo Fisher Scientific unveils $6 Million expansion at viral vector manufacturing facility Miscellaneous

● $50M cell and viral vector manufacturing operation backed by Harvard

MISCELLANEOUS

● FDA issues guidance for industry on adaptive designs for clinical trials of drugs and biologics

FEATURE STORY

Artificial intelligence approach to create AAV capsids for gene therapies

Adeno-associated viruses (AAVs) have become the go-to vehicle for delivering therapeutic gene cargo to target tissues for the recent wave of gene therapies that are in development in academic and biotechnology laboratories (1). However, natural AAVs do not specifically target diseased cells and tissues, and they can be recognized by the immune system in ways that limit therapeutic success. Synthetic biologists from Dyno Therapeutics, a biotech company pioneering use of artificial intelligence in gene therapy and scientists at Harvard's Wyss Institute for Biologically Inspired Engineering and Harvard Medical School (HMS) have been taking a "directed evolution" approach to overcome the limitations of current capsids. They have developed new machine-guided technologies to rapidly and systematically engineer a suite of new, improved capsids for widespread therapeutic use. In this machine-guided approach, they randomly mutate specific amino acid building blocks of the capsid proteins that form the shell of the virus and directly contact target cells and evaluate which changes can route the virus to target tissues and successively layering mutations on top of each other in an arduous iterative process.
The results appeared in November 27th issue of Science.

(1) Our recent report “Gene Therapy Products in Development” (Nov 2019) indicates that AAV-based products make up over 27% of gene therapy products in development in biotech and pharmaceutical companies.
Click here to download freely sample pages. Order before December 15th and Save 10 % (Order form)

Related Informations/Publications

-Nat Neurosci. 2019 Nov; 22(11):1761-1770. A deep learning framework for neuroscience. Richard BA et al. Mila, Montréal, Quebec, Canada.
Link: Abstract
-Clin Transl Med. 2019 Oct 21;8(1):27. From fiction to science: clinical potentials and regulatory considerations of gene editing. Schacker M et al. Biopharma Excellence GmbH, Agnes-Pockels-Bogen 1, 80992, Munich, Germany
Results/Comments: This article reviews ongoing preclinical and clinical studies and discusses how gene editing technologies are altering the gene therapy landscape. In addition, it focusses on the regulatory challenges associated with such therapies and how they can be tackled during the drug development process
Link: Abstract - Full Text

DISRUPTIVE TECHNOLOGIES

Nanoparticles as carriers for drug delivery of macromolecules across the blood-brain barrier

Current therapies of neurodegenerative or neurometabolic diseases are, to a large extent, hampered by the inability of drugs to cross the blood-brain barrier (BBB). This very tight barrier severely restricts the entrance of molecules from blood into the brain, especially macromolecular substances (i.e. neurotrophic factors, enzymes, proteins, as well as genetic materials). Due to their size, physicochemical properties, and instability, the delivery of these materials is particularly difficult. Recent research showed that biocompatible and biodegradable nanoparticles possessing tailored surface properties can enable a delivery of drugs and specifically of macromolecules across the BBB by using carrier systems of the brain capillary endothelium (Trojan Horse strategy). In the present review, the state-of-art of nanoparticle-mediated drug delivery of different macromolecular substances into the brain following intravenous injection is summarized, Different nanomedicines that are used to enable the transport of neurotrophic factors and enzymes across the BBB into the CNS are critically analysed. Brain delivery of macromolecules by intravenous application using nanomedicines is now a growing area of interest which could be really translated into clinical application if dedicated effort will be given to industrial scale-up production.
The review appeared in November 27th online issue of Exp Opin Drug Deliv

Related Informations / Publications

-Semin Cancer Biol. 2019 Nov 5. Nanoparticles-based drug delivery and gene therapy for breast cancer: Recent advancements and future challenges. Mirza Z et al. Faculty of Applied Medical Sciences, King Abdulaziz University, Jeddah, Saudi Arabia Results/Comments: Researchers discuss the mechanism of nanoparticles targeted drug delivery, recent advancement of therapeutic strategies of nanoparticles based carriers for small interfering RNA, and microRNA, and gene augmentation therapies in BC
Link: Abstract
-Proc Natl Acad Sci U S A. 2019 Oct 15;116(42):21150-21159. Lipid nanoparticle-targeted mRNA therapy as a treatment for the inherited metabolic liver disorder arginase deficiency. Truong B et al. David Geffen School of Medicine at UCLA, Los Angeles, CA 90095, USA
Link: Abstract
-Sci Rep. 2019 Aug 7;9(1):11457. Sleeping Beauty Transposon-Mediated Asparaginase Gene Delivery by a Nanoparticle Platform. Chang JH et al. Department of Chemistry, National Taiwan University, Taipei, 106, Taiwan
Results/Comments: This work demonstrates that silica-based nanoparticles have great potential in gene delivery for therapeutic purposes
Link: Abstract - Full Text

CLINICAL TRIALS/DATAS

Libella gene therapeutics to run a patient paid trial of telomerase gene therapy

Libella Gene Therapeutics recently announced that an institutional review board (IRB)-approved pay-to-play clinical trial in Colombia (South America) using gene therapy that aims to treat and ultimately cure aging. This could lead to Libella offering the world's only treatment to cure and reverse aging by 20 years. Under Libella's pay-to-play model, trial participants will be enrolled in their country of origin after paying $1 million. Participants will travel to Colombia to sign their informed consent and to receive the Libella gene therapy under a strictly controlled hospital environment. The team has developed a gene therapy that aims to lengthen telomeres. Dr. Andrew's gene therapy delivery system has been demonstrated as safe with minimal adverse reactions in about 200 clinical trials. Dr. Andrews led the research at Geron 20 years ago that initially discovered human telomerase and was part of the team that led the initial experiments related to telomerase induction and cancer. Telomerase gene therapy in mice delays aging and increases longevity. Libella's clinical trial involves a new gene-therapy using a proprietary AAV Reverse (hTERT) Transcriptase enzyme and aims to lengthen telomeres. Libella believes that lengthening telomeres is the key to treating and possibly curing aging.
For further information.

Related Informations / Publicationss

-Environ Res. 2019 Nov 5:108900. A possible relationship between telomere length and markers of neurodegeneration in rat brain after welding fume inhalation exposure. Shoeb M et al. National Institute for Occupational Safety and Health, Morgantown, WV 26505, USA. Link: Abstract
-Adv Exp Med Biol. 2019;1192:521-544. Interventions Addressing the Telomere-Telomerase System. Muneer A. Riphah International University, 274 Peshawar Road, Rawalpindi, Pakistan. Link: Abstract
-Nat Commun. 2019 Oct 17;10(1):4723. Mice with hyper-long telomeres show less metabolic aging and longer lifespans. Muñoz-Lorente MA et al. Spanish National Cancer Centre (CNIO), Melchor Fernández Almagro 3, Madrid, 28029, Spain
Results/Comments: The findings demonstrate that longer telomeres than normal in a given species are not deleterious but instead, show beneficial effects
Link: Abstract - Full Text

M&A - AGREEMENTS

Novartis to acquire The Medicines Company for USD 9.7bn, adding inclisiran

Novartis announced on November 24th that it has entered into an agreement and plan of merger with The Medicines Company to acquire the US-based biopharmaceutical company for USD 85.00 per share in cash, valuing the company at approximately USD 9.7 billion on a fully diluted equity basis. The offer price represents a premium of approximately 41% over The Medicines Company’s 30-day (to November 22, 2019) volume weighted average price of USD 60.33 and approximately 24% premium over The Medicines Company’s closing share price of USD 68.55 on November 22, 2019 which represented a fully diluted equity value of approximately USD 7.7 billion when including the impact of outstanding stock options and convertible debt. The transaction has been unanimously approved by the Boards of Directors of both companies. The Medicines Company recently announced data from its comprehensive clinical program consisting of three Phase III trials (ORION-9, 10 and 11) for inclisiran involving over 3,600 high-risk patients with ASCVD and FH. In all trials, inclisiran demonstrated potent and durable LDL-C reduction with an excellent safety and tolerability profile. Furthermre, inclisiran’s potentially first-in-class, twice-yearly dosing schedule allows administration during patients’ routine visits to their healthcare professionals and will likely contribute to improved patient adherence and sustained, lower LDL-C levels. The Medicines Company expects to file regulatory submissions in the U.S. in the fourth quarter of 219 and in Europe in the first quarter of 2020. An ongoing clinical trial (ORION-4) will evaluate the cardiovascular morbidity and mortality benefits of inclisiran. For further information

Related Informations / Publications

-NOV 2019: The Medicines Company Announces that the ORION-9 Study of Inclisiran in HeFH Patients Showed Durable and Potent LDL-C Lowering with Twice-Yearly Dosing Results/Comments: Inclisiran achieved 50% LDL-C lowering with time-adjusted reductions of 45% sustained over 18 months of treatment in patients with heterozygous familial hypercholesterolemia (HeFH). Link: Press Release
-NOV 2019: The Medicines Company to Present Inclisiran Data from ORION-9 and ORION-10 Pivotal Phase 3 Clinical Studies at American Heart Association Scientific Sessions 2019 Link: Press Release
-Mayo Clin Proc. 2019 Oct 17. Effects of Renal Impairment on the Pharmacokinetics, Efficacy, and Safety of Inclisiran: An Analysis of the ORION-7 and ORION-1 Studies. pii: S0025-6196(19)30756-6. Wright RS et al. Mayo Clinic, Rochester, MN, USA Results/Comments: The pharmacodynamic effects and safety profile of inclisiran were similar in study participants with normal and impaired renal function. Dose adjustments of inclisiran are not required in these patients. Link: Abstract

INVESTMENTS-FUNDRAISINGS

Ferring and Blackstone Life Sciences invest over US$570 Million in novel gene therapy for bladder cancer patients

Ferring Pharmaceuticals and Blackstone Life Sciences announced on November 25th the joint investment of over US$570 million in nadofaragene firadenovec (Instiladrin®, rAd-IFN/Syn3), an investigational novel gene therapy in late stage development for patients with high-grade, Bacillus Calmette-Guérin (BCG) unresponsive, non-muscle invasive bladder cancer (NMIBC). FerGene, a new gene therapy company and Ferring subsidiary, has been created to potentially commercialize nadofaragene firadenovec in the US and to advance the global clinical development. FerGene’s goal is to bring this promising therapy to a patient population which has seen little improvement in their standard of care over the past twenty years. Blackstone will invest US$400 million and Ferring will invest up to US$170 million in FerGene. Ferring will also potentially launch and commercialize nadofaragene firadenovec outside of the US. Nadofaragene firadenovec, currently in late Phase 3 development, has been granted Breakthrough Therapy designation and had its Biologics License Application (BLA) accepted for filing and granted Priority Review by the FDA. Phase 3 clinical trial results will be presented at the Society of Urologic Oncology (SUO) 20th Annual Meeting in Washington, DC on December 5, 2019 by Dr. Colin Dinney, Professor and Chairman of the Department of Urology at the University of Texas MD Anderson Cancer Center (MDACC) and a founder and past president of the Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC). Dr Dinney pioneered the development of nadofaragene firadenovec and co-heads the development program alongside Dr. Nigel Parker6 of FKD Therapies Oy (FKD). Upon the potential FDA approval, FerGene will hold the marketing authorization of nadofaragene firadenovec. For further information, see Blackstone Life Sciences or Fiercebiotech

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Related Informations / Publications

-Curr Urol Rep. 2018 Oct 24;19(12):101. Current Clinical Trials in Non-muscle Invasive Bladder Cancer. Nykopp TK et al. Institute of Clinical Medicine, University of Eastern Finland, Kuopio, Finland
Results/Comments: After many years of relative stagnation, multiple new therapies currently under investigation in well-designed clinical trials appear poised for routine clinical implementation in the near future
Link: Abstract
-World J Urol. 2019 Oct;37(10):2041-2049. The development of interferon-based gene therapy for BCG unresponsive bladder cancer: from bench to bedside. Duplisea JJ et al. The University of Texas MD Anderson Cancer Center, 1220 Holcombe Blvd Floor 7, Houston, TX, 77030, USA
Results/Comments: A comprehensive review was performed of all studies pertaining to IFN-based gene therapy for non-muscle invasive bladder cancer from 2003 to 2018
Link: Abstract

Two Chinese companies invest in Vigeneron, a German firm developing ophthalmological gene therapy programs

The German gene therapy company Vigeneron has closed a series A financing round led by WuXi AppTec, a Chinese provider of R&D and manufacturing services and Sequoia Capital China, a venture capital firm based in Beijing. The proceeds will enable ViGeneron to accelerate its proprietary viral vector-based gene therapy platforms and drive product development in its two lead ophthalmic gene therapy programs. ViGeneron’s pipeline in gene therapy addresses ophthalmic diseases with high unmet medical need, including two programs in development for undisclosed indications where no approved treatment options are currently available. The company’s pipeline is built on two novel next-generation gene therapy platforms addressing the limitations of existing adeno-associated virus (AAV)-based gene therapies. The vgAAV vector platform allows superior transduction efficiency and intravitreal, less invasive treatment administration. The second, REVeRT vector platform, targets diseases caused by mutations in larger genes (>5Kb). ViGeneron is a spin-off of the Ludwig-Maximilians-University in Munich. The company’s founding team includes highly experienced executives and internationally renowned experts with track records in developing retinal gene therapy programs from discovery to clinical stage.
For further information, see Marketscreener

Related Informations / Publications

-J Pharm Sci. 2019 Oct 19. pii: S0022-3549(19)30668-9. Intrinsic Differential Scanning Fluorimetry for Fast and Easy Identification of Adeno-Associated Virus Serotypes. Rieser R et al. Ludwig-Maximilians-Universität München, Munich, Germany
Link: Abstract
-Hum Gene Ther Clin Dev. 2019 Jun;30(2):50-56. Safety and Toxicology of Ocular Gene Therapy with Recombinant AAV Vector rAAV.hCNGA3 in Nonhuman Primates. Tobias P et al. University of Tübingen, Tübingen, Germany
Results/Comments: Treatment-related adverse effects were not found, and parameter changes were mostly related to the surgical procedure. The treatment of achromatopsia with rAAV.hCNGA3 is therefore deemed safe to apply to humans
Link: Abstract
-J Clin Invest. 2018 Dec 3;128(12):5663-5675. Accessory heterozygous mutations in cone photoreceptor CNGA3 exacerbate CNG channel-associated retinopathy. Burkard M et al. University of Tübingen, Tübingen, Germany
Link: Abstract - Full Text

Vertex is planning a major expansion in the Seaport

Vertex Pharmaceuticals preparing to grow even bigger—another 256,000 square feet bigger. The drugmaker is in advanced talks to lease a building in Innovation Square, a research campus in Boston’s Raymond Flynn Marine Industrial Park, The Boston Globe reported. The target is the entire second phase of the new R&D hub that developer Related Beal is building on the South Boston waterfront. It’s close to Vertex’s existing 1.1 million-square-feet Fan Pier headquarters and would serve as a research and manufacturing facility for gene and cell therapies, according to the newspaper. n June, Vertex put down $245 million upfront to acquire Exonics and its gene editing technology, which uses CRISPR to repair dystrophin, the protein missing in patients with Duchenne muscular dystrophy (DMD). At the same time, it shelled out $175 million upfront to deepen its ties with CRISPR Therapeutics, also for using CRISPR-Cas9 to develop DMD and myotonic dystrophy Type 1 therapies. The first project coming out of the CRISPR-Vertex partnership has just shown promise. CTX001, a CRISPR-based therapy for severe blood disorders marked by abnormal hemoglobin, helped a beta thalassemia patient live without transfusions for nine months, and a sickle cell patient was free of the painful vaso-occlusive crises after four months, the pair unveiled last week. Vertex also agreed to pay $950 million to snatch up Semma Therapeutics and its stem cell treatment for Type 1 diabetes. For further information, see FiercePharma or The Boston Globe

Related Informations / Publications

-SEP 2019 : Vertex to Acquire Semma Therapeutics With a Goal of Developing Curative Cell-Based Treatments for Type 1 Diabetes
Results/Comments: Under the terms of the acquisition, Vertex will acquire all outstanding shares of Semma for $950 million in cash, and Semma will become a separate operating subsidiary of Vertex. Dr. Sanna will join Vertex as President of Semma. Also, Dr. Melton will continue in his role as Chair of Semma’s Scientific Advisory Board and provide oversight and guidance on the research and development of the programs
Link: Press Release
-JUN 2019: Vertex Expands into New Disease Areas and Enhances Gene Editing Capabilities Through Expanded Collaboration with CRISPR Therapeutics and Acquisition of Exonics Therapeutics Results/Comments: Under the terms of this strategic collaboration and license agreement, Vertex will pay $175 million upfront for the exclusive worldwide rights to CRISPR Therapeutics’ existing and future intellectual property including foundational CRISPR/Cas9 technology, novel endonucleases, single and double cut guide RNAs, and AAV vectors for DMD and DM1 gene editing products. Link: Press Release

Thermo Fisher Scientific unveils $6 Million expansion at viral vector manufacturing facility

Thermo Fisher Scientific, a world leader in serving science, unveiled on November 22nd the $6 million expansion of its gene therapy and viral vector services site in Alachua, Florida. The investment doubles the site’s laboratory and warehousing capacity for upstream process development and quality control testing of gene therapy products. The expansion at the Alachua facility is part of Thermo Fisher’s $270 million investment this year to expand its capabilities, capacity and talent globally to enable its customers to develop and deliver high quality medicines to patients around the world. This investment follows the company’s recent acquisition of Brammer Bio, a leader in viral vector manufacturing. Thermo Fisher Scientific Inc. is a world leader in serving science, with revenues of more than $24 billion and approximately 70,000 employees globally. Through its premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – the Company offers a combination of innovative technologies, purchasing convenience and comprehensive services.
For further information, see Thermo Fischer

Related Informations / Publications

-NOV 2019: Thermo Fisher Scientific to Invest $24 Million to Increase Global Bioproduction Capabilities . Link: Press Release
-MAR 2019: Thermo Fisher to Acquire Brammer Bio for $1.7B, Expanding Gene Therapy Presence
Results/Comments: Headquartered in Cambridge, MA, Brammer Bio employs nearly 600 people at primary locations in Massachusetts and Florida. Brammer Bio is projected to generate $250 million in revenue this year, and expects to continue to exceed the projected market growth rate of 25% over the mid-term, according to the companies.
Link: Genetic Engineering and Biotechnology News

US$50M cell and viral vector manufacturing operation backed by Harvard

CDMOs are building cell and viral vector manufacturing facilities left and right, but Harvard says it just isn’t enough, at least to serve the Boston biotech hub. That is why a host of public and private players is working on a $50 million clinical supply manufacturing facility.Board members will come from Fujifilm Diosynth Biotechnologies, GE Healthcare Life Sciences and Alexandria Real Estate Equities as well as Harvard and the Massachusetts Institute of Technology. Contributing members include the state, a list of hospitals and MilliporeSigma. This project comes even as drugmakers are getting gene therapies approved and contractors are moving fast to buy or boost capacity to serve the growing viral vector and gene therapy fields. Earlier this year, Catalent dropped $1.2 billion to grab viral vector and gene therapy manufacturer Paragon Bioservices, and Thermo Fisher shelled out $1.7 billion to get viral vector producer Brammer Bio. Thermo Fisher now has a facility in Massachusetts, along with others, while Catalent got one in Baltimore. Other contractors are adding or expanding facilities in the U.S., Europe and Asia.
For further information, see FiercePharma

Related Informations / Publications

-NOV 2019: Cell and gene therapy boom creates CDMO capacity bottleneck
Link: BioPharma Reporter
-NOV 2019 : Facing bottlenecks in manufacturing cell therapies, Boston leaders plan to build their own
Link: Statnews

MISCELLANEOUS

FDA issues guidance for industry on adaptive designs for clinical trials of drugs and biologics

The FDA issued on November 29th a final guidance for industry entitled, “Adaptive Designs for Clinical Trials of Drugs and Biologics.” Adaptive design clinical trials allow for prospectively planned modifications to one or more aspects of the design based on accumulating data from subjects in the trial. The guidance provides information to sponsors submitting investigational new drug applications (INDs), new drug applications (NDAs), biologics licensing applications (BLAs), or supplemental applications on the appropriate use of adaptive designs for clinical trials to provide evidence of the effectiveness and safety of a drug or biologic. The guidance also advises sponsors on the types of information to submit to facilitate FDA evaluation of clinical trials with adaptive designs, including Bayesian adaptive and complex trials that rely on computer simulations for their design. The Adaptive Design guidance is a revision of the 2018 draft guidance entitled “Adaptive Design Clinical Trials for Drugs and Biologics.” The final guidance contains revisions to the Bayesian subsection of the guidance, provides clarifications on the prespecification principle for adaptive design, and cross-references advice from the newly published draft guidance on Interacting with the FDA on Complex Innovative Trial Designs.
For further information, see FDA

Related Informations / Publications

-SEP 2019: Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products. Link: FDA
-JUN 2019: Cellular & Gene Therapy Products. Link: FDA
-JUL 2018: Human Gene Therapy for Rare Diseases. Link: FDA
-Yale J Biol Med. 2017 Dec 19;90(4):683-693. Regulatory Considerations for Gene Therapy Products in the US, EU, and Japan. Halioua-Haubold CL et al. Department of Paediatrics, University of Oxford, Oxford, UK
Results/Comments: Understanding the regulatory requirements for seeking GTP market approval in these major jurisdictions is crucial for an effective and expedient path to market. The novel challenges facing GTP developers is highlighted by a case study of alipogene tiparvovec (Glybera®)
Link: Abstract - Full Text

BioPharmAnalyses and Octopusyx BioConsulting will publish by mid-December
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