372 gene therapy clinical trials are underway, 25 gene therapy drugs are coming soon May 22, 2019 Source: Arterial Network The Regenerative Medicine Alliance (ARM) released the first quarter of 2019 quarterly regenerative medicine global data report showing that the number of clinical trials involved in gene therapy has increased. As of the end of the first quarter, there were 372 clinical trials of gene therapy in progress worldwide. Among them, most of the clinical trials in the second phase, there are 217, accounting for 58%; followed by 123 in the first phase, accounting for 33%; 32 clinical trials in the phase III, accounting for 9%. Compared with the data at the end of 2018, the number of clinical trials of gene therapy increased by 10, compared with 319 trials in the same period of 2018, an increase of 17%. Also heating up is the speed of acquisitions in the field of gene therapy. On April 15, Catalent said it has agreed to acquire Paragon Bioservices for $1.2 billion in an attempt to expand gene therapy. Once Thermo Fisher Scientific plans to complete its $1.7 billion acquisition of the viral vector CDMO Brammer Bio at the end of the second quarter, it will expand its presence in this area. In February of this year, when Roche said that it planned to acquire Spark Therapeutics for $4.8 billion, this year's largest gene therapy M&A transaction has arrived. However, the resistance from Spark shareholders and the reasons for the regulatory review forced Roche to extend its tender offer period three times, making the transaction difficult. Two drug candidates considered to be close to approval appear on this list. One is Zynteglo (formerly known as LentiGlobin) from Bluebird Bio, a gene therapy for thalassemia and sickle cell disease, which has been approved by the European Medicines Agency (EMA) Human Medicine Products Council (CHMP). Comments, it is recommended to conditionally approve gene therapy Zynteglo, which is usually a reliable final approval indicator for the European Commission EC. The EC will usually follow the CHMP recommendations and will make a final review decision in approximately 2 months. The other is Zolgensma (formerly known as AVXS-101) from Novartis AveXis. Zolgensma is a gene therapy for spinal muscular atrophy, and it is expected that the multi-million dollar treatment price will be more news-focused than its positive phase III trial data. The genengnews website collects data from ARM, as well as ClinicalTrials.gov and company announcements, listing a total of 25 "emerging" gene therapy drugs including Zynteglo and Zolgensma, each by name, business, indications, mechanism , test registration number and recent developments. Axalimogene filolisbac (AXAL, ADXS11-001) and ADXS-DUAL Enterprise: Advaxis Indications: metastatic cervical cancer Mechanism: Targeted immunotherapy based on platform technology, which uses live attenuated Listeria monocytogenes (Lm) bioengineering to generate and deliver tumor antigen/adjuvant fusion proteins in antigen presenting cells, producing Strong T cell-mediated immunity. ADXS-DUAL is the second generation of axalimogene filolisbac. Clinical Trial (Registration No.): ADXS11-001 in high-risk locally advanced cervical cancer (AIM2CERV, NCT02853604, III), ADXS 11-001 robotic pre-operative vaccination, HPV-positive oropharyngeal cancer (NCT02002182, Phase II) ) Recent developments: On May 15, the FDA undertook partial clinical control of AIM2CERV, which appears to be related to Advaxis's proposed revision of the test analysis program and various chemical, manufacturing, and control (CMC) issues. Advaxis's axalimogene filolisbac was also tested in combination with Merckon Keytruda (pembrolizumab), Bristol-Myers Squibb's Opdivo (nivolumab) and AstraZeneca's Imfinzi (durvalumab). AMT-061 Enterprise: uniQure Indications: hemophilia B Mechanism: AMT-061 consists of an AAV5 vector carrying the Padua variant (FIX-Padua) gene encoding FIX. Test (registration number): NCT03569891 (HOPE-B, Phase III); NCT03489291 (stage IIb) Recent developments: On May 10th, uniQure provided clinical data on the latest developments. It was shown that in all three patients, factor IX (FIX) activity was significantly increased 6 months after a single administration of AMT-061. The FIX activity of the first patient reached 51% of the normal value, the second patient reached 33% of the normal value, and the third patient reached 57% of the normal value. Fidanacogene elaparvovec (formerly SPK-9001 and PF-06838435) Enterprise: Pfizer Indications: hemophilia B Mechanism: Bioengineered adeno-associated virus (AAV) capsid (protein shell) and highly active human factor IX gene. Clinical trial (registration number): NCT03587116 (phase III) The latest development: Spark Therapeutics' SPK-9001 has become Pfizer's Fidanacogene elaparvovec. In July 2018, the two companies launched a phase III program to evaluate the efficacy and safety of experimental gene therapy fidanacogene elaparvovec as a preventive replacement therapy for factor IX in hemophilia B. Generx (alferminogene tadenovec, Ad5FGF-4) Enterprise: Angionetics, Winbond Life Health (China Exclusive Distribution and License Agreement) Indications: refractory angina (stage III), heart syndrome X (stage I/II), bloody heart failure (stage I/II), Moyamoya disease (induction of IND), cerebral ischemia (candidate selection) Mechanism of action: Generx is composed of human fibroblast growth factor-4 (FGF-4) gene, CMV promoter sequence and signal peptide, and is encapsulated in human serum type 5 adenovirus. Generx uses Angionetic-optimized cardiac catheterization to deliver to the heart, binds to cardiac cells via the Coxsackie adenovirus receptor, and transfects cells with the FGF-4 gene. Clinical trial (registration number): NCT02928094 (AFFIRM, Phase III) The latest development: NCT02928094 is expected to begin on June 1, 2019, the main completion date is June 1, 2021. Angionetics is a subsidiary of Gene Biotherapeutics (formerly Taxus Cardium Pharmaceuticals Group) but operates independently. Last year, Angionetics said it plans to provide external financing for the clinical development and commercialization of Generx, which may include achieving an IPO in 2019. GS010 Enterprise: GenSight Biologics Indications: Leber hereditary optic neuropathy (LHON) caused by mutations in the ND4 gene Mechanism: AAV2 gene therapy vector, encoding human wild-type ND4 protein Clinical trial (registration number): NCT02652780 (REVERSE, Phase III), NCT02652767 ((RESCUE, Phase III), NCT03293524 (REFLECT, Phase III). Recent developments: On May 15, GenSight received positive 96-week results from the REVERSE trial, which showed that GS010 remained effective two years after the injection. At week 96, GS010 treated eyes showed an average improvement of -0.308 LogMAR compared to baseline. The company announced a positive result of 72 weeks on May 6. Instiladrin (n adofaragene firadenovec/Sny3; rAd-IFN/Syn3) Company: FKD Therapies, Ferring Pharmaceuticals Indications: non-muscle invasive bladder cancer that does not respond to BCG Mechanism: Instiladrin is an adeno-associated virus 5 (Ad5) that does not replicate autonomously. Instiladrin carries a gene encoding interferon alpha-2b (IFNα2b) in combination with the adjuvant Syn3 (rAD-IFN/Syn3). It is capable of infecting nearby tumor cells and activating the expression of the ifnα-2b gene in the cells. Clinical Trial (Registration No.): NCT02773849 (Phase III) Recent developments: Ferring Pharmaceuticals purchased Nadofaragene firadenovec/Syn3 from FKD Therapies in 2018 for global commercialization rights. On May 5, 2019, Dr. Colin Dinney of the MD Anderson Cancer Center presented the latest phase III data from patients with non-muscle invasive bladder cancer who did not respond to Instiladrin BCG. In a follow-up study of 34 male patients, 24 patients survived 3 years after treatment. Of the other 10 cases, 3 died of bladder cancer and 7 died of other causes. Lenti-D Enterprise: Blue Bird Creature Indications: brain adrenal white matter malnutrition (CALD) Mechanism: Transplant the patient's own stem cells and modify the ABCD1 gene, which encodes a functional adrenal leukotriosis protein (ALDP). Clinical Trial (Registration No.): NCT03852498 (ALD-104, Phase III); NCT01896102 (Starbeam or ALD-102, Phase II/III); NCT02698579 (long-term follow-up) Recent developments: On May 2, 2019, Bluebird Bio announced that the first patient treatment was performed in April in the ALD-104 clinical trial. The end of the experiment was that the patient continued to survive within 24 months and there were no missing features in the six major functions. LYS-SAF302 Enterprise: Lysogene, Regenxbio, Sarepta Therapeutics Indications: Type IIIA mucopolysaccharidosis (MPS IIIA), also known as type A Sanfilippo syndrome Mechanism: Injection of the AAVrh10 virus containing the healthy N-sulfosylglucosyl hydrolase (SGSH) gene into the brain stimulates the production of enzymes that break down heparan sulfate, slowing or preventing the progression of the disease. Clinical trial: NCT03612869 (AAVance, Phase II/III); NCT02746341 (SAMOS, Natural History Research) Recent developments: Lysogene said on April 29, 2019 that they expect to complete AAVance patient recruitment in the first half of 2020. The first patient was enrolled in the group in December 2018 and received treatment two months later. In October 2018, Sarepta Therapeutics acquired the commercialization of LYS-SAF302 in the US and other European regions, which resulted in more than $125 million in revenue for Lysogene. It is worth mentioning that LYS-SAF302 uses Regenxbio's NAV AAVrh10 vector. Nexagon Company: Eyevance Pharmaceuticals, OcuNexus Therapeutics Indications: persistent corneal epithelial defects (PED) that do not respond to current standard treatment Mechanism: The expression of connexin Cx43 was down-regulated by a native, unmodified oligonucleotide (30-mer). The Nexagon can be placed on contact lenses or amniotic membranes to ensure contact with the cornea or conjunctiva, ensuring enough time for active drugs to enter the cell. Clinical Trial (Registration No.): Unknown, Nexagon is the subject of eight early studies, five of which have been completed, two have been terminated and the other has been withdrawn. Recent developments: Eyevance purchased Nexagon's global rights from OcuNexus in October 2018 at an undisclosed price. It is said that Eyevance is funding a key trial that is expected to begin in 2019. Eyevance's CSO Dr. Mark Jasek said in the November 5, 2018 Eye Innovation Summit that they will evaluate the potential treatment of Nexagon for PED caused by burns or chemical burns in a Phase IIb study. NSR-REP1 Enterprise: Nightstar Therapeutics Indications: no choroidal disease Mechanism: AAV2 vector was loaded with recombinant human complementary DNA (cDNA) to produce REP1 in the eye. During the operation, NSR-REP1 will be injected under the iris by injection. Clinical Trial (Registration No.): NCT03496012 (STAR, Phase III); NCT03507686 (GEMINI, Phase II); NCT03584165 (SOLSTICE, Long-Term Follow-up) The latest development: On March 4, 2019, Nightstar announced that it was acquired by Biogen for approximately $877 million. Biogen aims to supplement its ophthalmic drug pipeline with NSR-REP1. On May 8, Nightstar shareholders approved the acquisition and the transaction is expected to be completed on June 7. The data for NCT03496012 is expected to be disclosed in the second half of 2020. OTL-101 Enterprise: Orchard Therapeutics, Ormond Street Hospital Children's NHS Foundation Indications: adenosine deaminase severe combined immunodeficiency (ADA-SCID) Mechanism: Based on autologous and ex vivo hematopoietic stem cell gene therapy. Clinical trial (registration number): NCT03765632 (I/II period) Recent Developments: On February 22, 2019, Orchard announced a two-year positive follow-up trial of the OTL-101 New Formula Registration Trial, which included a total of 20 patients. In the 24 months, 88% and 56% of the two groups of OTL-101 treated patients, the overall survival rate was 100%, and the event-free survival rate was 100%. Dr. Orchard CMO Andrea Spezzi said the company plans to submit a BLA application by 2020. OTL-103 (formerly GSK2696275) Enterprise: Orchard Therapeutics, Ospedale (Hospital) San Raffaele-Telethon Institute for Gene Therapy (OSR-TIGET) Indications: Wiskott Aldrich Syndrome (WAS) Mechanism: Genetically modified autologous hematopoietic stem cells. Hematopoietic stem cells are harvested from bone marrow or peripheral blood and transduced with the ability to encode WAS via a lentiviral vector. Clinical trial (registration number): NCT01515462 (TIGET-WAS, Phase II); NCT03837483 (phase II) Recent developments: Orchard acquired OTL-103 from GlaxoSmithKline last year. Orchard said on March 21 that they published three-year follow-up data for eight patients enrolled in NCT01515462 and began to register for NCT03837483. OTL-200 (formerly GSK2696274) Enterprise: Orchard Therapeutics, Ospedale (Hospital) San Raffaele-TelethonInstitute for Gene Therapy (OSR-TIGET) Indications: metachromatic leukodystrophy (MLD) Mechanism: autodifferentiation cluster 34+ (CD34+) cells transduced with a lentiviral vector carrying human arylsulfatase A (ARSA) cDNA Clinical trial (registration number): NCT03392987 (phase III) Recent developments: Orchard acquired OTL-200 from GlaxoSmithKline in 2018. On March 26, 2019, Orchard submitted registration data for Phase I/II trials (NCT01560182): late infant patients at 2 and 3 years after treatment Motor function scores increased by 65% ​​and 72%, respectively, while early adolescents showed a 40% increase. Orchard intends to submit regulatory documents in 2020 as previously planned. OXB-301 (TroVax, MVA-5T4) Company: Oxford BioMedica, University College London, Cancer Research UK Indications: ovarian cancer, colorectal cancer Mechanism: A cancer vaccine consisting mainly of attenuated vaccinia virus Ankara (MVA). OXB-301 is designed to deliver the 5T4 carcinoembryonic antigen gene, designed to disrupt cancer cells by stimulating the immune system. Clinical Trial (Registration No.): NCT01556841 (TRIOC, Phase II) The latest development: NCT01556841 was completed on May 9, 2018. In September 2018, Oncoimmunology announced the results of the second SKOPOS trial (NCT01569919). The results showed that 95.6% of patients developed a cellular or humoral immune response to 5T4, reaching the primary end point of the study (over 64%). Disease control was observed in 87% of patients (including 69.6% showing stable disease and 17.4% partial response). Pexa-Vec (Pexastimogene devacirepvec, JX-594) Companies: SillaJen, Transgene, Beijing Shenyuan Pharmaceutical Group, Lee's Pharmaceutical, GC Pharma Indications: Hepatocellular carcinoma Mechanism: Wyeth strain vaccinia virus can be modified to directly lyse tumor cells and stimulate anti-tumor immunity Clinical trial (registration number): NCT02562755 (PHOCUS, III), NCT03071094 (I/II) The latest development: SillaJen said on March 20 that it will issue 110 billion won (about 97.3 million US dollars) of convertible bonds for the clinical trial of Pexa-Vec. Clinical studies will assess the role of Pexa-Vec in liver and breast cancer, head and neck cancer, and neuroendocrine tumors. Transgene said preliminary data from PHOCUS (intermediate data for NCT03071094) is expected to be released later this year. Transgene owns the European commercial rights of Pexa-Vec. ProstAtak (aglatimagene besadenovec, AdV-tk) Enterprise: Advantagene (d/b/a Candel Therapeutics) Indications: prostate cancer, hepatocellular carcinoma, pancreatic cancer, non-small cell lung cancer Mechanism: ProstAtak is based on Advantagene's gene-mediated cytotoxic immunotherapy (GMCI) technology platform, consisting of aglatimagene besadenovec and valacyclovir. Aglatimagene besadenovec (AdV-tk) is an adenovirus-derived gene vector engineered to deliver a thymidine kinase (tk) gene derived from herpes simplex virus to target cells. In clinical practice, AdV-tk needs to be delivered by injection at the tumor site of the patient, and the target tissue and cells will be stimulated to produce TK protein. Clinical Trial (Registration No.): NCT01436968 (PrTK03, Phase III); NCT02768363 (ULYSSES, Phase II/III); NCT03313596 (LT-03, Phase III); NCT03576612 (Phase I) Recent Developments: On April 1st, Advantagene (operating as “Candel Pharmaceuticalsâ€) announced a $22.5 million C financing led by Northpond Ventures. In addition, on March 21, Candel said that the first batch of NCT03576612 high-grade glioma patients have been recruited. RT-100 (AC6 Gene Transfer) Enterprise: Renova Therapeutics Indications: Heart failure and reduced ejection fraction (HFrEF) Mechanism: RT-100 is directly infused into the arteries of the heart by cardiac catheterization, and the gene encoding the human AC6 protein is delivered to the body by the modified adenoviral vector, which can enter the cell but cannot reproduce itself ( Ad5.hAC6). Clinical Trial (Registration No.): NCT03360448 (FLOURISH, Phase III) Recent developments: As of December 18, 2018, according to the latest developments published on ClinicalTrials.gov, the clinical trial NCT03360448 has not yet begun recruiting patients. SPK-8011 Enterprise: Spark Therapeutics (acquired by Roche) Indications: Hemophilia A Mechanism of action: The AAV-LK03 capsid is activated using a bioengineered adeno-associated virus (AAV) vector. Clinical trial (registration number): NCT03003533 (stage I/II), NCT03432520 (long-term follow-up study), NCT03876301 (forward-looking, observational study) Recent Developments: In 2018, Spark advanced SPK-8011 to Phase III clinical trials, which began with a six-month observational run-in study. In December 2018, Spark published preliminary, up-to-date data on ongoing I/II trials from 12 participants. The results showed that from 4 weeks after vehicle infusion, all three doses of patients had a 94% reduction in bleeding and a 95% reduction in FVIII infusion. Toca 511 (vocimagene amiretrorepvec) and Toca FC Company: Tocagen, ApolloBio Indications: Recurrent high-grade glioma (stage II/III), metastatic solid tumors, including colorectal cancer, renal cell carcinoma, melanoma, pancreatic cancer, lung cancer, and breast cancer (stage I), newly diagnosed High grade glioma (preclinical) Mechanism of action: This is a two-part cancer immunotherapy. Among them, Toca 511 is an injectable retroviral replication vector (RRV) capable of encoding the prodrug activating enzyme cytosine deaminase (CD); Toca FC is a prodrug 5-fluorocytosine (5-FC) An oral sustained release preparation, when it encounters a CD, will be converted to 5-fluorouracil (5-FU). Clinical Trial (Registration No.): NCT02414165 (Toca 5, II/III), NCT02576665 (Toca 6, Phase I), NCT02598011 (Toca 7, Phase I) Recent developments: In April 2019, Tocagen published preclinical data on the therapy, and the results showed that Toca 511 / Toca FC combined with temozolomide or cyclophosphamide improved survival. Tocagen noted that the results were sufficient to support the planned phase II/III NRG-BN006 trial, which was designed to assess the standard treatment level of Toca 511/Toca FC for newly diagnosed glioblastoma patients. It is expected that NRG-BN006 will begin registration in the second half of 2019. Valoctocogene Roxaparvovec (formerly BMN 270) Company: BioMarin Pharmaceuticals Indications: Hemophilia A Mechanism of action: AAV-factor VIII vector Test: NCT03370913 (BMN270-301 or GENEr8-1, Phase III); NCT03392974 (BMN270-302, also known as GENEr8-2; Phase III) Recent developments: On April 25, BioMarin said it expects to be registered in the full clinical trial NCT03370913 in the third quarter of 2019. In addition, BioMarin has registered some of the documents needed to speed up approvals based on the FDA's 2018 draft guidelines for hemophilia gene therapy products. VB-111 (ofranergene obadenovec) Enterprise: VBL Therapeutics (Vascular Biogenics), NanoCarrier (Japanese Commercialization Authority) Indications: solid tumors, including recurrent platinum-resistant ovarian cancer (stage III) Mechanism: Biological agents that target anti-oncogenes are administered intravenously once every two months. VB-111 was developed based on the VBL-based Vascular Targeting System (VTSTM). VBL indicates that VB-111 binds to two anti-tumor mechanisms, namely, blocking tumor angiogenesis and anti-tumor immune response. Clinical Trial (Registration No.): NCT03398655 (OVAL, Phase III) Recent clinical advances: On March 28th, Vascular Biogenics stated that OVAL will continue to recruit patients and is expected to undergo an interim efficacy assessment by the end of the year. In the second half of this year, the company is also expected to launch a phase III trial with the National Cancer Institute: VB-111 in combination with checkpoint inhibitors to explore its efficacy against colon cancer. VGX-3100 Company: Inovio Pharmaceuticals, ApolloBio Indications: HPV-16 and HPV-18-infected cervical high-grade squamous intraepithelial lesions (HSIL) (stage III); vulvar and anal precancerous lesions (stage II). Mechanism: VGX-3100 is the first immunotherapeutic agent for the treatment of precancerous lesions of the cervix caused by HPV. Using ASPIRE (antigen-specific immune response) technology, VGX-3100's DNA plasmid can target E6 and E7 proteins on HPV 16 and HPV18 surfaces. The VGX-3100 achieves intramuscular transmission through the electroporation technology of Cellectra® 5PSP. Clinical trial (registration number): NCT03185013 (REVEAL 1, III); NCT03721978 (REVEAL 2, III) latest progress:  Inovio joined QIAGEN on May 16 and announced that they will jointly develop diagnostic tests to identify patients most likely to respond to the VGX-3100. On March 4, Inovio said that REVEAL 2 has been launched and plans to submit a BLA application in 2021 as the first immunotherapy for women with cervical dysplasia. Later this year, Inovio anticipates the interim Phase II results of NCT03603808 and NCT03499795 and NCT03180684. VM202 Company: ViroMed, Beijing Northlandi Biotechnology, Reyon Pharmaceutical Indications: Painful diabetic peripheral neuropathy (US and Korea), chronic non-healing ischemic foot ulcer (US), severe limb ischemia (China), amyotrophic lateral sclerosis (US), acute myocardial infarction (Korea) Mechanism: Gene therapy drug VM202 can express two kinds of HGF (hepatocyte growth factor), namely HGF728 and HGF723 Clinical trial (registration number): NCT02563522 (VMNHU-003, III), NCT02427464 (VMDN-003, III), NCT03363165 (HI-PAD, Phase II), NCT03404024 (VMCAD-002, Phase II) The latest development: On March 29, ViroMed CEO Sunyoung Kim, DPhil wrote to investors in a letter that VM202 will receive three indications for a pipeline in the preclinical drug pipeline, or be supplemented by others. Substituting drugs, these drug pipelines will reach phase III in 2025. On February 1, Kim said that ViroMed will receive the results of Phase III trial of VM202 for PDPN this summer. Zolgensma (formerly AVXS-101) Enterprise: Novartis subsidiary AveXis Indications: Spinal muscular atrophy (SMA) Mechanism: A non-replicating recombinant adenoviral capsid delivers a functional copy of the human gene SMN to the nucleus of the patient's own cells. This gene fragment helps cells increase the secretion of SMN protein to normal levels. Clinical Trial (Registration No.): NCT03505099 (SPR1NT, Phase III), NCT03461289 (STRIVE-EU, Phase III), NCT03306277 (STR1VE, Phase III) Recent developments: On May 5, 2019, AveXis announced a number of high-profile Zollensma clinical trial data. Among them, the SPR1NT Phase III clinical trial results have a milestone, and the patients who have received symptoms before the onset of symptoms have significant differences in exercise abilities. Zynteglo (formerly LentiGlobin, BB30) Enterprise: Blue Bird Creature Indications: blood transfusion-dependent beta thalassemia (TDT) Mechanism: The gene expressing the normal hemoglobin β subunit (βA-T87Q-globin gene) is implanted in vitro into hematopoietic stem cells taken out from the patient by a lentiviral vector, and these cells are returned to the patient. Clinical trial (registration number): NCT02906202 (Northstar-2 or HGB-207, Phase III), NCT03207009 (Northstar-3 or HGB-212, Phase III) Recent developments: Bluebird Bio received a positive recommendation from the European Medicines Agency for a conditional marketing license for Zynteglo on March 29, 2019. Bluebird Bio said it expects to submit a BLA application to FDA by the end of 2019.
4G Mini Camera Structural components
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The main structures and components of the camera can be listed from the working principle of the camera:
1. LENS
Lens structure, consisting of several lenses, including plastic lens or glass lens
2. Image sensor
It can be divided into two categories:
CCD (charge couple device): charge coupled device
CMOS (complementary metal oxide semiconductor): complementary metal oxide semiconductor
3. Digital signal processing chip (DSP)
There are many DSP manufacturers, such as VIMICRO 301P/L, SONIX 102/120/128, ST (Logitech LOGITECH's DSP provider), SUNPLUS (SUN+focuses on the development of CIF and VGA for single chip, but the image quality is average), PIXART (original phase), PAC207, SQ930C, etc.
4. Power supply
Two working voltages are required inside the camera: 3.3V and 2.5V. The latest process chip can use 1.8V.
Some cameras also use video transmission lines for synchronous power supply without external power lines.
372 gene therapy clinical trials are underway, 25 gene therapy drugs are coming soon
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