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0920
Clene Nanomedicine, Inc. Announces♣₽π Selection of CNM-Au8 for the Har←λ∞vard Led HEALEY ALS P©₽♥™latform Trial, a Clinical Trial for Amy>↕₽₽otrophic Lateral Sclerosis
Clene Nanomedicine, Inc., a clinical-stage biוopharmaceutical company, announced today t ∏ ≥hat the Sean M. Healey≠₩ε & AMG Center for ALS±& at Mass General has selected CNM☆∑♣-Au8 for inclusion in the first ever Platform ©£Trial for the treatment of amyotroph"¶ic lateral sclerosis (ALS∑&↑).The Healey Center issued a call e∑♣φ arlier this year for≠γ₹ the best therapeutic candidates to apply for♦₩€ entry into the HEALEY ALS Platfor✔ m Trial. They received responses from nearly 3™ ↓0 applicants across ten countries.∑ Members from the Healey Center Science Advisδ∑γγory Committee, a group of renowne≤↕≥d ALS scientists, chose the ≤β§top five therapeutic candidates, includi'ε✔ng Clene's lead clinic™₽al asset, CNM-Au8. The selection of CNM×δ-Au8 into the Healey ALS <® ✘Platform Trial includes substantial fina↕ ncial support and provides access to over 50 exp♥→¥♠ert ALS clinical trial sites acro₩"ss the United States."Our goal," said Merit Cudk♠π₽δowicz, MD, MSc, Director of the H¶'αealey Center, "is to lower the barriers for our p$★≤¶harma and academic colleag>↕₩ues to bring their exciting therapies for ALS foπ<™↑rward to clinical trials. We are determined ✘> to accelerate therapy development for A☆©LS."Important preclinical wor§ φ§k supporting the effort with CNM-Au8 w♥®↓as performed in the laboratory of Nicholaε ≤¥s J. Maragakis, Director of the★®& ALS Center for Cell Therapy anπφ↔d Regeneration Research at Johns Hopkins, usin♠"©♥g human induced pluripotent stem×≠πΩ cells from ALS patients. Dσr. Maragakis is Chair of Clene's Scientific Adv☆♣αisory Board for ALS.Dr. Jonathan Glass, Professoα↔r of Neurology and P$₹≤±athology at Emory Unββ<iversity School of Meγ₽★dicine, as well as Director of the Emory AL≥≥S Center, remarked, "CNM-Au8φ•≈ is quite an interesting✔♥♠± compound that is ready for₽♣±≥ testing in ALS clini₹Ωπ→cal trials. Its inclusion in tφ★•∞he Platform Trial initiative is an excellen¥¶t way to move forward for the development oק§f CNM-Au8 as a potential therapeutic for ALS."∞™≈"We are very pleased Clene's CNM-Au8 has beλ$en selected for particip♥£γ'ation in the Healey ALS ≈♣£Platform Trial. We believe the unique mβ€echanism of CNM-Au8 repre©'♦"sents a promising new approach for ₩•the treatment of neurodegenerative diβ$φseases, including ALε₹∑S, with the potential for meanin♦©gful impact for the community of people diagno✔ε sed with this devastatiπ€♦ ng and debilitating disease," said Rob E©therington, President and CEO of Clene. ∑≠€♣"We are continuing the de<¥velopment of CNM-Au8 in€δγ several clinical studies set t'★•<o launch later this year."2019 A♠≠♦sia-pacific pharma IP Leader Summit: http://en.φ>€ zenseegroup.com/p/510934/will be held in✘÷ Beijing on November 14-↓™↕¥15, and will attract more than 500 industry e©↑≤xperts from domestic ↑₩→and foreign pharmaceutical compa¥→nies, biotechnology companies, governments, assoc< iations, law firms, intellectual property agents ☆πand other companies to att≤<₽end.Official registration and consultation ↔∏•channels:Contact：AnnPhone: 021-65650305Email：≠✔₩ Marketing@zenseegroup.comhttp://www.zenλεφ↑seegroup.com/forms/viewπ$/22113/ -
0923
Boehringer Ingelheim Partners with Inflammaso•φme Therapeutics to Develo®₹p Novel Therapies for Pat±∏↔ients with Retinal Disea™✔¶λses
Boehringer Ingelheim and Infla§<mmasome Therapeutics Inc. (Infl¶ammasome) today announced ↔♥they have entered into a co-developmenδ↔< t and license agreement to develop up to' three therapies for patients with ¥ retinal diseases. By combining Inflammasome’s un÷↔×♠ique intravitreal (IVT) drug delivery tec≤®<πhnologies with Boehringer Ingelheim’s compounds™φ¶© from its retinal disease pipeline portfolio, Boe♥♠₩hringer Ingelheim aims↔÷ to develop novel therapies for retinal "λdiseases.In 2019 the™ πre were an estimated 82 million patiγ↓ents in the seven key coun↓ tries (U.S., Japan, Germany, U.K., Spain, ®±¶Italy, France) affected by one of the three ma&∞jor forms of retinal disease: Aε÷<ge related macular degeneration (AMD), diabetic $&®retinopathy (DR), and diabetic macular edem★>→±a (DME). Globally, the pre€γvalence rates of these and other retinal d✘₹γiseases are expected to increase over the♣£Ωλ next 10 years primarily due to aging populat↔±ions and the global diabetes epidemic. Despite th αδerapeutic advances in some di®≈"sease areas during th≠♦e past years, the real world results are poor, ♠λ☆and there are no or only limited treatmeγ$•nt options in many areas, resultin¶€☆₩g in an overall high unmet ↑∞♣need. The collaboration between Boehringer Ingel♥₽πheim and Inflammasome aims to address this ↔↓∑≠challenge by using Inflammasome"★♦✘’s technology to deliver therapeuti≈≥cs in a biodegradable gel formulation into the ₹≠eye.“We are delighted to enter into a colla↔σ←boration with a company of Boehringer Ingelhe♥ε€im’s stature,” said Paul Ash™✘≈ton, Chief Executive ←<∑Officer of Inflammasome The&₽rapeutics. “We look forward to$> working with their team to leve'βrage our respective &$technologies and exp♥↑☆♠ertise to develop new therapα≈₹ies for devastating retinal disea≠ ♠ ses leading to blindness. This collaboration≤∑ fits our strategy of advan≈≥₽cing the company via both collaborat ∑¥λions and internal development.”“Boehringer Ing>φelheim is looking forward to developin↓♥g Inflammasome’s novel technologφβ✔"y for the delivery of our first-in- class retina§≠ ©l disease compounds working jointlyδ£≠© with Inflammasome’s highly experie∞¥™nced scientific team,” s∑λ±aid Clive R. Wood, PhD, Senior Cφ¶orporate Vice President, Discovery Research at ™∞↑Boehringer Ingelheim. “This will enable us ¥→♣to develop a broad rang™↕e of novel therapy options for ÷§the many patients with retin☆₽al diseases waiting ur↔§$gently for better and new th£σ↑erapy options.”Boehri♣→nger Ingelheim takes a holβ׶δistic approach in the development of >>novel retinal disease therapies, targeting key€§ mechanisms in the pathogenesis of retinal disea∞<ses. The company has>♣ built a comprehensive pipeline portfolio of nex€'™t generation therapy approaches in va×'rious stages of development up to Pφ'γhase 2 in macular degeneration, ♥¶σΩdiabetic retinal diseases and beyond ®♠. Inflammasome’s novel deliver↑©<y technology using a long∑λ'-acting degradable IVT ↑&implant complements this portfolio.Inflammasome ♣₹λis entitled to receive up to $160 δmillion in up-front, research and developφment support and mileston$₩ e gated development paym¶↓£"ents as well as tiered royaltiσ♣es based on future commercial ✘≥π☆sales of developed products and other milestonesΩ€± due on commercialization.£♥€∞information source:pharma ÷↕✘♠focus AsiaThe original link:https://www.pharma ★<focusasia.com/news/boehrin ger-ingelheim-partners-with-infl¶$≠ammasome-therapeutics-to-develop-≥✘αnovel-therapies-for-patients-with-ε♦'<retinal-diseases2019♣≠↓φ Asia-pacific pharma IP Leader Summit: http://en♣↑γ.zenseegroup.com/p/510934/will be held in&n© >♣bsp;Beijing on Novπ&'ember 14-15, and will aφ¶♦ttract more than 500 indust★≤ ry experts from domestic and foreign pharmac ¥eutical companies, biotechnoδ¶ ↓logy companies, governments, associαΩ↕ations, law firms, intellectual property ag±♦ents and other companies to attend.Off&♠icial registration and consultation channe↑≠Ωls:Contact：AnnPhone: 021-65650305Email：M>™arketing@zenseegroup.comhttp://wwwφ✘Ωδ.zenseegroup.com/forms/vi ∏¥∞ew/22113/ -
0925
I-Mab Biopharma Announces Clinicalγ♥ Collaboration to Evaluate TJC4 in Combination ↑∞with KEYTRUDA® (pembrolizumab)
I-Mab Biopharma ("I-Mab"), aε§ China and U.S.-based clinica₩≠≠l stage biopharmaceutical Ω★↑↕company exclusively focusing on the discover₩↕↔y and development of potential π↓first-in-class and b♠™est-in-class biologics in immuno-oncology and ₹φ→autoimmune diseases, today announced that it has ×☆entered into a clinic"<≤"al research collaboration agreement wi®th MSD, a tradename of ✔€✔Merck & Co., Inc., Kenilwo≈↓∏rth, NJ., USA, to evalu←¥≥ate the combination £αof I-Mab's TJC4 and MSD's anti-PD-1 therapy≠↓, KEYTRUDA® (pembrolizumab) in patients w ith multiple cancer types.Under this ₹φ♦collaboration agreem→≤ent, MSD will supply KEYTRUDA® (pem♠&≥ brolizumab) to I-Mab for useσα± in clinical studies in ←♥δcombination with TJC4, a fully human ∑δanti-CD47 monoclonal antib∞®↔ody. Both parties will collaborate on a Phase 1䙥 clinical trial, based on an ag&≈∑₽reed and finalized protocol, to evaluate★ the safety, pharmacokine→π§"tics, pharmacodynamics and preliminary effi©₽↕cacy of TJC4 and KEYTRUDA® in patients ★•σwith multiple cancer types."TJ€♦αC4 is a highly differentiated anti-CD47 "₽≤antibody currently unde€✘'r clinical development. This collaborat<β☆ion will provide an excellentΩ'✔ opportunity to further explore therape↔β✔βutic potential of combining TJC4 with ←¥↑KEYTRUDA® across different tumor type≠ s." said Dr. Jingwu Zang, Foβ≥↕♦under and Chairman of I-Mab.KEYTRUDA® is a←♦$ registered trademark of Mer ≈ck Sharp & Dohme Corp., a subsidiary of ®>♦Merck & Co., Inc., Kenilworth, NJ, U∞π≈SA.information ≥ש¥source:pharma focus AsiaThe original↓∑σ link:https://www.pharmafocus✘★•asia.com/news/i-mab-bi∑×₽§opharma-announces-clin✔$©ical-collaboration-to-evaluate-tj∏₽c4-in-combination-with-ke ♥<♦ytruda2019 Asia-pacific ♣β↔∏pharma IP Leader Summit:http://en.zenseegroup.c±✔ ™om/p/510934/ will be held in Beiji→♥£ng on →&∑εNovember 14-15, and will at$'tract more than 500 indu← ☆stry experts from domestic and foreign pharmac★σeutical companies, biotechnology compaδ∞¶≥nies, governments, associations, ✔$₩law firms, intellectual property agents and other £®© companies to attend.Official re∏™β→gistration and consultation chε¥σannels:Contact：AnnPhone: 021-65650305Ema→il：Marketing@zenseegroup.comhttp://www.ze₹↑$$nseegroup.com/forms/view/22113/ -
0926
Ivy Brain Tumor Center and Briλ★®dgeBio Subsidiary QED Therapeut 'φics Announce Collaboration to Adva$↕nce Cancer Research and Treatment Options
The Ivy Brain Tumor Cen>₩•ter at Barrow Neurological Institute, ∏"λtoday announced a neβλε♠w collaboration with QED Therapeutiλ¥φcs, Inc., a subsidiary of BridgeB₩★∏io Pharma, Inc., (Nasdaq:BBIO) to inveλ₽₩stigate the FGFR1-3 tyr≥★osine kinase inhibito≥∏r, infigratinib, for the treatment of gliob™φ£↑lastoma (GBM). With the goal "≤of addressing unmet medical needs for th✘∞♣ose affected by malignant brain cancer<§™, this collaboration will fo✔✘€cus on targeting FGFR (fi≠✘ ☆broblast growth factor rec©$∑eptor) genetic alter"$ations that have been shown to γ≤spur growth in malignant t ♣↓"umors.“Five to seven percent of glioblastoma pati×↓÷ents’ tumors are driven by FGFR signaling,÷$$₽” said Dr. Nader Sanai, director of t×♣↕he Ivy Brain Tumor Center. “We believe our collab↓"oration with QED Therapeutics will enable us to ♣σtest how FGFR-driven GBM tumors respond to↑¥ infigratinib. If proven effective, we t♠☆φhen intend to move forward new combined drug₽δ strategies incorporating this target.”In the ∞∏∑preclinical studies, the Ivy Center will employ ★σ↑orthotopically implanted, well-chara♣'cterized FGFR3 fusion patient-derived♥∞ xenograft models. This is intended to÷™↑λ allow the team to further explore the extent to≠δσ which the drug crosses t☆©≥he blood-brain barrier₩' and what activity it has in the brain.“We beli₹¥λ•eve the work we are undertaking → βwith the Ivy Center will provide critical insi♥•ght to shape our clinical develoλ&£±pment strategy for thi©<∏✔s disease,“ said Susan Moran, M.D., ®↕M.S.C.E., chief medical officer of QED Therapeβ♦utics. “Our hope is thφ←≤≈at infigratinib will become the backbone of n©☆↔ew combination therapies to treat patients £↔with glioblastoma.”Infigratinib is 'Ω≠an orally administered, FGFR1-3 selective tyr ε∏osine kinase inhibitor. QED Therapeu₽™tics has observed ac∞₽♦tivity that appears to®•≠ be meaningful in clinical trials for cancers∞β¶ that are driven by errors in δ•∞∏the FGFR genes. These ≠ §≤include chemotherapy-refractory cho<♣langiocarcinoma with FGFR₹"∞2 fusions and advanced ™<urothelial carcinoma with FGFR3 ∏♦★genetic alterations.“The int©₽λλricacies of the brain ha≥♣∑"ve posed significant chal∏®>§lenges for brain cancer research an™•↓→d the development of thera↑☆≤pies,” said Gary Li, head ≠€ of translational medicine at QED Therapeutic×↓ ¶s. “We believe collaΩ®♥borating with the Ivy↕ Brain Tumor Center will enable us to move swif'tly and further translational research that•÷ we hope will unlock the d¶ ¥oors to effective treatment op¥∏Ωtions.”information&n↔₹☆¥bsp;source:pharma focus AsiaThe origina$∞↓l link:https:https://www¥ .pharmafocusasia.com/news/ivy-brain-tu$§ ∞mor-center-and-bridgebio-subsidiary-qed-t♥×Ωherapeutics-announce ≈ε→-collaboration-to-advance-cancer-rλesearch-and-treatment-optio₹β↑ ns2019 Asia-pacific pharma IP Leader Summit:σ>§http://en.zenseegroup.com/p/510934/will be hγ∞eld in Beijing&₹$nbsp; on November α♠"14-15, and will attract more t¥πλ<han 500 industry experts from domestic a'×₹σnd foreign pharmaceutical companies, biotechnol∞¥★ogy companies, governments, associations, law₩α firms, intellectual prop≠♣δ₽erty agents and other ♥₹companies to attend.Official registr$£ation and consultation channels:Contact：Ann&Ωλ₹Phone: 021-65650305Email：M∞£β©arketing@zenseegroup.comhttp://www.zenseeg♣₩∞∞roup.com/forms/view/22113/ -
0927
NeuCyte Licenses Promiφ>→∑sing Novel Compound for Treatment of Refractory'φ Epilepsy and Related Neurological Disorder'λ≠s
NeuCyte, Inc., an in<≠×novative biotech company f ↓ocused on developing novel treatments f>∏or neurological disorders, today announced t≤♣ ↕hat it has entered iσ•nto an exclusive license agreement with Tril↑≠lium Therapeutics to advance an und≠↕"≠isclosed preclinical compound with ≤✔ potential utility in treating refractoryβ←₹♥ epilepsy in the form of Drav≤ Ωet syndrome and related disorders.The c©÷γ ompound covered by this a•πgreement has demonstrated highly encouragi•♣ng activity during studies©π conducted by the National Institute of Neurologi≠σcal Disorders and Stroke (NI± ≠NDS) Epilepsy Therapy Screening P ↔rogram (ETSP). It demonstrates a superioσ♣<εr safety and anti-seizure effαicacy profile over NINDS benchmark anti-epilept®€ic drugs (AEDs) in eleven ®$animal models. It has also demon"∞₹strated broad efficacy in NI•εH animal studies for pharmaco-resistant epilepsy.β↕≤♣ As a result, this novel agent ™ has gained the prestigious NINDS Re♣λd Book status and been selected as a pro∏α mising lead drug candidate £."This compound is an ex←±ceedingly promising antiseizure Ω∏∑<drug which, although in preclinical d ←§γevelopment, is quite efficacious in a wide var✔ε©♦iety of highly predictive s§π∑eizure models," said Roger J. Porter, MD, Adjunct≥λ£∏ Professor of Neurology at the University of Penn¥§sylvania, former Depu∑↔γ₩ty Director of NINDS, former Chairman of th±£e White House Committee≠¥ on Brain and Behavioral Scie£←nces, and former President of §↑©✘American Epilepsy Society. "It may prov e very effective for patients w£πith epilepsy." As a first-in-class co•®£mpound with unique mechanism of actio÷β±n profiles, this drug candidate i× ≠✔s likely to have activity ☆♦across a variety of indications. The favorable÷λ efficacy and safety p∞☆<rofile has also been val ✘≤§idated by NeuCyte's propr αietary in vitro human iPSC-derived models."Epi₽ ↑lepsy is the fourth most common neurological disφγease affecting more than 65 miΩ±llion people of all ages worldwide. The comp♠®lex and multifactorial nature of the disorde rs makes treatment complicated and challenging.↕α Up to 40% of newly diagnosed epilepsy p↕¥↔atients are resistant to current therapies which ™ highlights the urgent need to develop first-in✔φφ-class treatments," said Jacqueline A. French, π∏ΩMD, Chief Medical and Innova₽←tion Officer of the Epilepsy Foundati£♠on and epileptologist in New York City. "It is ve♠φβry encouraging to see new developments and ther↑¶₩apeutic candidates in this disease areaα ."Under the terms of the agreement, Tril× ♦lium has granted NeuCyte exclusive↕®♣, worldwide rights to develop and commerciali₩ze the compound. "NeuCyte is committed to $$bringing breakthrougγ•h therapies to epileps♥★∑y patients and believe that our☆↓∏ advantageous translat ®π£ional technology platform and CNSλφ✔ expertise enable us to optimally advance such≥♦↕> therapeutic candidate•∞≠s," said Tao Huang, PhD, JD, Presid↕ent and Chief Executiv©€α>e Officer of NeuCyte. "Th≥βis licensing agreement allows us to expand our pi♠∑∞peline and advance our goal of meeting unmet cli ✔'nical needs and truly improving←€$ patient care and quality of life."i<→ nformation source:pharma focus AsiaThe orig≥∞inal link:https:https:https://www.p™φαharmafocusasia.com/news/neucyte-li×♥censes-promising-nove₽→&l-compound-for-treatment-of-refracto©πry-epilepsy-and-related-n€≈&₩eurological-disorders2019 Asia-pac₩↕€εific pharma IP Leader Summit:http://↔<&÷en.zenseegroup.com/p/51093•←§4/will be held in β§Beijing on November 14-15, an"<d will attract more than 500 industry experts¥∞ from domestic and foγ£♦reign pharmaceutical c® ≠ompanies, biotechnology companies, gov∏♦©♥ernments, associations, law firms, intell∏∏ ectual property agents and other companies to↔€φ₹ attend.Official registration and cons★♠ultation channels:Contact：AnnPhone: 02σ♥1-65650305Email：Marketing@zenseegroup.comhttp://e♦•≥n.zenseegroup.com/p/510934/
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