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1024
PDS Biotechnology Completes₽βε≠ Manufacturing of Clinical Batches of PDS01<©£≤01
PDS Biotechnology Com≈φpletes Manufacturing of Clinical Batches of PD&Ω¶S0101WEDNESDAY, OCTOBER 23, 2019PDS Biotechnol×↑•→ogy Corporation, a clinical-stage i←¶∞mmuno-oncology company pioneering de™velopment of multi-functional novel immunothe¶♥rapies, today announ®¥Ωced that it has completed manufacturing>↓≠₹ of clinical batches of PDS₩'★0101 with its partner BSP Pharmaceutic™als S.p.A, a leading man↑≠ ufacturer of anticancer drugs.The clinical batchε☆ ♦es of PDS0101 will be used in the Compa>φny’s two upcoming Phase 2 studies, whic×←♦≈h are expected to start in the first ★ ★♣quarter of 2020. The tri ↔als include a combination study with ΩσMerck to evaluate PDS0101 in combinati→§✘φon with KEYTRUDA® in first-line treatment of he±≈ad and neck cancer and a study to evaluat∑∞e PDS0101 in combination with two•↔ novel clinical-stage i∑∞βmmunotherapies in advanced HP↓∏V associated cancers with the National Ca₽∞€ncer Institute.“We are pleγ§ased to have completed the ma¶←÷₽nufacturing of the clinical batcσ₩∏hes of PDS0101 with our partner BSP Pharma≈★ceuticals and are honored to be collaborating wit "h two leaders in the fielσ✘•d of immuno-oncology,” said D✘'¶r. Frank Bedu-Addo, CEO of PDS. “Based on $β♦our recently announced Phase 1 clinical outco♥ ®™me data which demonstrated PD≠←"φS0101’s unique ability to promote the ≈∏in-vivo induction of high le•∑λ≠vels of HPV-specific CD8+ killer T-cells as >≤€well as the regression of pre-"cancerous lesions in↑☆ 60% of patients, we™☆Ω← believe that PDS0101 could ex™≈pand the clinical efficacy of checkpoint in∏∏≠₹hibitors such as KEYTRU ₹DA®. We are now working d☆"→♦iligently to qualify clinical si∞λπtes for our combination trial with ∑∏₽KEYTRUDA® in first line treatment of head andα neck cancer and look foΩεrward to initiating both our planned comε∏↕¶bination trials by the first quarter of 2020.” ε&☆information sourc✔ e:pharma focus AsiaThe original link:https://ww¥↕₽w.pharmafocusasia.co'≥✔×m/news/pds-biotechno↓§logy-completes-manufactu☆ ↑φring-of-clinical-batches-of-pds01012019 Asia-☆↑•pacific pharma IP Leader Summit: http://en.z≈ε♠enseegroup.com/p/404716/ will be held in ε≈© Beijing on November 14-15, δεand will attract more than 500 indu₽stry experts from domestic and foreign pharmac®Ωeutical companies, biotechnology companies₹→, governments, associations, law fir✘βms, intellectual property agents and other ± companies to attend.Official registr☆←&<ation and consultation channels:Contact：AnnPho'σ↓ne: 021-65650305Email：Marketing@ze€β¥≈nseegroup.comhttp://en.zenseegroup.com/p/5αα10934 -
1025
Pliant Therapeutics Announ™✘λces Strategic Collaboration t<∞¥o Develop Novel Therapies for NASH and Fibrotic £πΩDiseases
Pliant Therapeutics Announα×ces Strategic Collaboration to Develop No↔εvel Therapies for NASH anΩ'd Fibrotic DiseasesTHURSDAY, OCTOBφ £₩ER 24, 2019Pliant Therapeutics, Inc.,&Ωγ× a clinical stage biopharmaceutical co≥₹€♥mpany focused on discovering and develop ≠≈>ing novel therapies fo©ε£βr the treatment of fibrosis, tod≈♣ay announced it has e®™&ntered into a strategic collabor' ation and license agreement wi♦©•§th Novartis covering the develo₩∑♣✘pment and commercialπ•ization of Pliant's preclinical proπ∞duct candidate, PLN-1474 and↔♣↔ up to three additional integrin targets. PLN- ♣1474 is an internally discovered small§ molecule selective inγ★hibitor of integrin αVβ1, currently be✔&≈∞ing developed for the ₩$treatment of liver fibrosis associated with nona™≈≤lcoholic steatohepatitis (NASH)."Our research c>±ontinues to generate compel↓×ling preclinical evidence thεδ©at supports the advancement of PLN-1474 aλ₹s a clinical candidate an₽׶d validates our approach of evalσ≈♥uating αVβ1 integrin inhibi§®∏tion to treat advanced liver fπ>ibrosis associated with NASH,₹✔ " said Bernard Coulie, M.D., Ph.D., president and chief executiv∏φe officer of Pliant Therapeutics. "Pairin$♣≈×g Pliant's leading inteσ≠γgrin biology and drug di♥§ scovery capabilities withΩ★" Novartis, a world-leader with oneλα ✘ of the broadest pipelines investigating mono an$≥d combination therapies f₩ε₽or liver diseases including NASH, will suppσλαort our goal of developing novel™↑γ therapies for fibrotic diseases and potenti'♥®ally bring meaningful treatment options to pat↕λ ients."Pliant will initially receive $80 million ∞ from Novartis, includin≤♠≥g an upfront payment in connection with th βe collaboration agreement as wel∏" l as equity investment commitments. The↓¶♥₹ collaboration agreement is f ↓γor a worldwide exclusive license to PLN-∞÷1474 and up to three additional ∞♥ product candidates generated under the collabor®♥ation. In addition, Novartis will fund Plian£≥∑t's research and development≈™ activities under the collab★ oration. Pliant will be resp$onsible for development of PLN-1474 through₹↓ Phase 1 after which Novart¶"is will assume responsibility for all future↕<÷ development, manufac∑☆≤↕turing and commercialization. Pliant i¥ ≠s eligible to earn milestone ★®payments, contingent upon the achievemε↑★ent of specified development,₽γ©₹ regulatory and commercial miles∑Ωtones. The agreement also provideσ$s for tiered royalties payab€ε≤le to Pliant ranging from the mid-single×✔★€ digits to low double "×digits on product sales upon commercializatio★₩∞n. The transaction is subject to customary¶• closing conditions, including c ¶learance under the Hart-Scott-Rodino Antitr<™¥ust Improvements Act.NASH associated ↔≈ cirrhosis is the fastest growing indication for ✔<liver transplantation in the United<®¥ States. Many patients with NASH develop as÷≥πsociated liver fibrosis, which can le §ad to complications such as ci÷δrrhosis and ultimately liver failure. W✔ γhile several investigational agents targ•¶et mechanisms that impact the earlier stages o±∞✔f the NASH continuum, δ₩ Pliant is targeting αvβ1, an integrin that act"✔≈ivates TGF-β, a putative mast&↑er regulator of hepati™>≠c fibrosis. PLN-1474 has sh≠↑own significant inhibition±® of fibrosis in live human tissue mode∏✔£ls. Pliant expects to submit an investiga®∞₹♥tional new drug (IND₹∏↓) application to the U.S. Food ↓↔←©and Drug Administration before the end →♣↔of 2019.information source:pharm≥®δεa focus AsiaThe original link:https://www.p→♥harmafocusasia.com/news/pliant≥≥-therapeutics-announces-<★strategic-collaboration-to-develop-novel-theraφ£pies-for-nash-and-fibrotic-diseases201≤≤☆σ9 Asia-pacific pharma IP Le±<≤ader Summit: http://en.zenseegroup.cΩ σ←om/p/510934/ willε✘$ be held in Beijing ∞≈ on November 14-15, and wil"₩>l attract more than 500 industry experts f¶≠♦ rom domestic and foreign ph≠£∞armaceutical companies, biotechnology companies&♦, governments, associations,ε' law firms, intellectual pro≠≠≠perty agents and other compan×♥₽ies to attend.Official reg£>♥istration and consultation channels:Contac↕£ ∑t：AnnPhone: 021-65650305Email：✔₩€Marketing@zenseegroup.comhttp:/>∞/en.zenseegroup.com/p/5109σ♥34 -
1026
AZTherapies Strengthens Neu¶←λroinflammation-Targeted α Pipeline Through Acquisition of Smith Therapeu•tics
FRIDAY, OCTOBER 25, 2019AZTherapies, Inc., a bio≤☆♦pharmaceutical company developing ther§☆apeutics to extend brain heal₽ ♠th, today announced the acquisition of Smith ☆×≠Therapeutics, a private biopharmaceu ↓ε'tical company with a shared goα§≥al of targeting neuroinflammation to treat ₹→¥neurodegenerative disease. Smith ≥↓Therapeutics’ Founder and ₹ Chief Executive Officer Philip Ashton-Rickar$Ωπ♣dt, Ph.D., has joined the senior leadership t→←γ✔eam at AZTherapies as Senior Vice Preside↑♦₹&nt of Immunology. Financial ter→>∑ms of the acquisition were not disclo☆β☆sed.Smith Therapeutics’ proprietary research×♣£ platform focuses on the use of₹ modified T cells to restore a healthy balanc∑★e of inflammatory an&→₽γd regulatory cells in the brai↔π∞Ωn. To date, Smith has successfully engineσ₩βered immunosuppressive T regulatory (Treg) cel♠☆ls with Chimeric Antigen Reλ≈ceptors (CARs) targeting braiα≤n glial cells. Previous research has dem↑∏∞onstrated the ability of Tregs to dampen microgli £al activity and redu∏★ce neuroinflammation i↑₹♥n models of neurodegeneration, sugges±€♥ting their potential uΩφ☆tility in the treatment of disea↑♣Ωses including Progres¶∞sive Supranuclear Palsy (PSP), Alzheimer’s di¶αΩ★sease, Parkinson’s disease, Huntington’s d↕Ωαisease, Amyotrophic Lateral®♣ Sclerosis (ALS), and other↔≈εs.“This acquisition represents a meaning λful step forward for us as we continue >to strengthen our lea÷φ™dership position in the development of therapγ÷"ies targeting neuroinflammatio←§'αn to stop or slow the progression Ω€→of neurodegenerative diseases,” said ↔ε¶David R. Elmaleh, Ph.D., Founder, CEO☆ ≈∞, and Chairman of AZTherapies. ↓“We are excited to be work§∞ing with Philip as we add this cutt←¶ing-edge technology to our portfolio of innovati&§ve programs. An esteem>£ed immunologist and inventor of the technology, ≠™λPhilip brings unparall×πeled expertise to the company and we÷£≠ε look forward to advancing this CA ∏R-Treg program further into IND-enabling st∑σudies and into clinical development"∑σφ as rapidly as possi ₽πble.”Dr. Ashton-Rickardt ±€commented on the acquisit®αion and his appointment: “Our shared ratio£≠nale of targeting neuroinflammation as th£←™e root cause of neurodegenerative disease ma•€☆$kes this acquisition a great★↕ strategic fit for us. With AZTherapie ©←>s’ expertise in drug development and ←>clinical trial execution, we believe that ∑↔together, we are well positione姥$d to advance our CAR- ✘↑Treg technology and fundamentall≠y change neurodegenerative disease progressio'n.”Prior to launching Smith Thγ≠♠erapeutics in 2017, Dr. Ashton-Rickardt was¶ ε Chair in Immunology at Imperial Collπ ≤ege London, Visiting Professor, Brigham and Wome≥™n’s Hospital, Harvard Medical School, and Assoc↑•γiate Professor in the Departme•σ©nt of Pathology at th✔↔ε e University of Chicago. €φ₹His work has been recognized by his peers throuφ↕gh the award of tenure from The Universφ αity of Chicago and by his fellow cit$>izens as a recipient of α♦™the Early Career Award for Scienti→'§sts and Engineers frα>♦€om President Bill Clinton. Hαδ&±e has published more than 65 peer-reviewed 'φ↑papers in more than 30 academic journals (includi∞✘ng Cell, Science, Immunity, and N≤©≤✔ature Immunology), has served as an edi£λtor for several academic jouα↔rnals, and has been a member of grant review boarπ ₹ds globally. Dr. Ashton-Rickardt§ received a B.Sc. in Biochemistry from the Univ★φ∏ersity of London, King’s College wi∑Ωth honors, a Ph.D. in Mol÷×→∞ecular Biology from the Univerβ£'φsity of Edinburgh, and φπcompleted post-doctoral work at the Unive≠σrsity of Edinburgh and the MassachusΩ←'etts Institute of Technology in Molecular ≤ λ∞Biology and Molecular Immunology,®↓ respectively.information source:pharma ☆↑✔focus AsiaThe original link:h✔φ♥ttps:https://www.pharmafocusasia.com/news/a&λztherapies-strengthens-neuroinflammation-taεγrgeted-pipeline-through-acqui'✔₹Ωsition-of-smith-therapeutics2019 Asia-ε♠π↓pacific pharma IP Leader Summit: http://en¥♥.zenseegroup.com/p/510↓→∞ 934/will be held in Beijing on&nδ®♣→bsp;November 14-15, and will attra♦€↔ct more than 500 industry expeφεφ∞rts from domestic and foreign pharmaceutica×∞l companies, biotechnology compani es, governments, associations, law firms, i>α♥∑ntellectual property age"✔nts and other companie✘s to attend.Official£♠ registration and consultation cha₽ ≈ nnels:Contact：AnnPhone: 021✘₹-65650305Email：Marketin×★∑✘g@zenseegroup.comhttp://e×α<εn.zenseegroup.com/p/510934 -
1028
AVROBIO Receives Orphan-Drug Designation from theβ✔ U.S. FDA for AVR‑RD‑02∞← for the Treatment of Gauc←±φ÷her Disease
AVROBIO Receives Orphan-Drug Designation'₹₽ from the U.S. FDA for AVR‑RD‑02 forβ$✔ the Treatment of Gaucher DiseaseFRIDAYα≠ ×, OCTOBER 25, 2019AVROBIO, Inc., to≈♣&day announced that the U≈✘¥.S. Food and Drug Admi→ nistration (FDA) has grantedβ' orphan-drug designation for t≠•☆he Company’s investigati ≤↑★onal gene therapy, AVR-RD-02, for the tre§★€atment of Gaucher disease. AVR-RD-02 consists of↔↑'✔ the patient’s own hematopoietic st §"em cells, genetically modif→→δied to express glucocereb♣<rosidase (GCase), the enzyme tΩ hat is deficient in Gaucher disease. The C ₩→≤ompany is actively recruiting in ≥Canada for its Phase 1/2 clinica&≠l trial of AVR-RD-02♣↑<, which seeks to evaluate the safety and effi©<♥cacy of the therapy in patients♠ with Type 1 Gaucher disease.“Under thσ₹€✘e existing standard of care,∏εα patients with Gaucher disease are bound¶© ↔ to a lifelong infusion ♠₽£schedule of enzyme replacement t₩ε✘ herapies, and still exp™₹₽erience painful and progressive symptoms such as σ←αdebilitating musculoskeletal pain and faδ™₹tigue,” said Birgitte Volck, MD, PhD, Preside¶&nt of Research and Development at AVROBIO. “Orph' ÷an-drug designation ♥♦recognizes the unmet need of populat>¥ions with rare diseases like Gaucher where AVROB€♥IO strives to transform lives by ad←♣dressing the underlying cause of t•♦∞he disease with a single dose of geδ♠ne therapy.”Orphan-drug desig¥★nation is granted by the FDA to drugs and biolo™₩≤gics which are intended for the safe a®←αεnd effective treatment, diagnosi♦✔s or prevention of r↓÷€are diseases or conditions that affect feσ∑wer than 200,000 people in the United Statδπ"es. Orphan-drug designation provides certa←βin incentives, which may includeΩ®δ♦ tax credits towards the co₩≠≤st of clinical trials and prescriptio≤£n drug user fee waivers.information ↓∏&source:pharma focus AsiaT←∞§he original link:https:https://www.pharmafo♣cusasia.com/news/avrobio-receives-or≠σ≤∏phan-drug-designatio$★n-from-the-us-fda-for-avrrd02-for-¥'the-treatment-of-gaucher-disea↕₽se2019 Asia-pacific pharma IP Leader Summit: htt'≥©p://en.zenseegroup.com/p/510934/will be h≥♥eld in Beijing &nbs♥φ'p;on November 14-15, and will attract mo>γπre than 500 industry experts from domestic and ∞ δforeign pharmaceutical φ¥≈companies, biotechnology companie ∑ s, governments, assoε ♥→ciations, law firms, intellectual property€☆→λ agents and other companies π<to attend.Official registration and consultation<>≤ channels:Contact：AnnPhone: 02∏↔α1-65650305Email：Marketing@zenseegroup.π≥comhttp://en.zenseegroup.com/p/510934 -
1029
HistoIndex Announces Global Partnerships To E↕≤σxpand AI-Based Digital Pathol↔Ωσogy Platform
HistoIndex Announces Glo®×÷bal Partnerships To Expand AI-Based•≤α↔ Digital Pathology PlatformMONDAY,∞ OCTOBER 28, 2019HistoIndex announces the expansi"π♥on of its AI-based di₽™δgital pathology platform towards α±Ω≠large-scale NASH preclinical progra≥§ms for pharmaceutical and biotech c€<✔ompanies to achieve quantifiable a§¶nd reproducible data on t♣∞herapeutic responses in NASH ←"≤≤animal models, and to α$aid CROs as well as research agencies in ♣÷validating new models ♥©<mimicking the NASH disea¶βεse.Published preclinical studiesσ have demonstrated the use of HistoIndex's fully≠ ₹∞ quantifiable Second Harmon&∏×ic Generation (SHG) ↑♣☆technology as a high♣ly accurate stain-free met♠₽σβhod that can monitor the efficacy of various t©<herapeutic agents, by quant×£<∏ifying more than 450 NASH-associated para≥→meters in fibrosis, inflammation, balloonin≤∑™αg and steatosis. The information of these NASH-σ≈associated parameters gathered fro♦γ↕m the entire liver tissue, provides ∑φ£§comprehensive insights on the mechanism of acti•§€on of the therapeutic agent. As a drug d₹ ♠iscovery tool, HistoIndex's SHG-enabl•≠£ed digital pathology platforλλm will allow pharmaceutical and b∞∑✔iotech companies to sele¥<✔ct promising lead candidates for fu↑>♣rther optimization and make inf£>≈±ormed decisions in the manag©$®ement of their NASH drug developme ∞nt pipeline.In addition to ongoin∑↔g NASH clinical trials, HistoI→• ndex is currently involved ¥±✘in multiple preclinical studies, ≤♥ most of which are conducted γ<by major pharmaceuti∑>¶cal and biotech companie€'↓↕s, medical universities, CROs and research agenc♥εα ies. Notably, HistoIndex has recently entere'♠d into a collaboration✘∑ with the A*STAR's Genome I ↔nstitute of Singapore (GIS) >♣§to validate their in vivo and in vitro NA'™SH models based on Asian-centric cl£ inical data. Says Professor Patrick Tan, ≤∞ Executive Director of the Genome Insti☆>♣tute of Singapore (GIS), "At G↔≠✘IS, we conduct our preclinical st©₩£udies on fatty liver involving ↔&data from animal models based on patie"γ®∑nt-derived transcriptomic data. This has a high♣¶♦δ translational potential→© as it helps us to pinpoint ne↕↕w therapeutic target>↓ ↔s and their validation. Therefore, using a ful♣✔€ly quantitative, reliable and objective patho∑↑≤logical evaluation such a₹₽ $s HistoIndex's AI-based digital pat§$→hology platform is essential to th♦¶e success of our efforts in therapeuti♦ε♠₽c target discovery."HistoIndex is al↕&εso a partner with globβ✘←±ally-renowned CRO, WuXi Apptec, in advancing thei¶$$r NASH preclinical programs∞≥¶> with advanced R&D and sma±↔rt imaging analysis capabilities. Published st↑✔udy data will be available for discu↕©↓≠ssions during networking opportunities th± ↕roughout AASLD's The Liver Meeting® in Novβ ember 2019. "We are very excσΩ$βited to extend our AI-bas₽ed SHG platform to preclinical stu₽∑dies to help companies ↔'with drug discovery →programs select promising lead canφ←Ωdidates for further optimizatioΩ₩n and subsequent clinical development," say'♣♣s Dr Poon Thong Yuen,€§ Chief Executive Officer of Hisφ¶toIndex. "Our SHG image analysφ$is platform has alrea↔ dy been used to analyze the efficacy of• $ a series of promisi✔ε✘∑ng drug candidates for NASH within various an≠€→¶imal models commonly-useδ✘αd by the industry, a↓¥nd we believe these preclinical pa<'rtnerships will help drive tβ∏♦≤he adoption of our platform significantly.γ←"information source:pharma focusα♦÷✘ AsiaThe original link:https:https://www.pharmaf¶★ocusasia.com/news/histoindex-announces-€♠≥§global-partnerships-to-expand-ai-base∞₽Ω↕d-digital-pathology-platform2019 Asia-§®≈σpacific pharma IP Leader Summit: http://en.ze₩"§nseegroup.com/p/510934/will be held in€€ Beijing on Novemb∏€π☆er 14-15, and will attract moreπ than 500 industry ex→§λγperts from domestic and f★©♦oreign pharmaceutical companies, biotechnolog₩§¥y companies, governments, associations, la←εαw firms, intellectual property agents and otσ☆her companies to atten'>ε d.Official registration and consultaΩ×φtion channels:Contact：AnnPh→$one: 021-65650305Email：Marketing@zenseegroup.com http://en.zenseegroup.com/p/51∞ ÷0934
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