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0917
Akari Therapeutics’ Nomacopan Granted U.©≤♣"S. Orphan Drug Designation©≠∞☆ for Bullous Pemphigoid
Akari Therapeutics, Plc, a≈★ biopharmaceutical company focused on i'↕nnovative therapeutics β<βto treat orphan autoimmune and inflammat↑→ory diseases where the complement (C&¥5) and/or leukotriene•×£÷ (LTB4) systems are implicated, today announced<"π that the U.S. Food anΩ£↑✔d Drug Administration (FDA) has grante♥∞ <d orphan drug designation for nomac± ★opan for the treatment of bullo€☆us pemphigoid (BP).“BP, a severe ÷'blistering skin condition with no approved treaε☆tments, is an exciting therapeutic targ★•♣×et for our lead drug candida↔≠<₹te, nomacopan. It is also a disease¶♠↓ of increasing preval♥γ↔§ence due to an aging population anπd improving diagnosis,” said Clive Richardson, ♥♦ Chief Executive Officer of Akari Therapeu←←tics. “Orphan drug designation for nδ↑$omacopan is a major step forward for the ∞☆program, positioning nomacopan fo§r eligibility for an additional seven years of marketing exclusivity in BP if nomacopa±&↕n is approved by the FDA. This news is ±↕≠in addition to the recent orphan drug design✘&★€ation received for our ♥€±HSCT-TMA program.”The Company plans to release n →¥ew safety and efficacy data fr₩β₽om an ongoing Phase II t±→↔rial with nomacopan in paε®tients with BP at an oral presentation by Dr. •≠Christian Sadik at the 28th European Academy o±₩f Dermatology and Venereology (EADV) Congres&'s on October 10, 2019. In August, the Company an>® ₩nounced new data demonstratingδ< the synergistic benefits of nomacopan’s dual C5 ↓and LTB4 inhibitory activity in p §∏emphigoid disease, generated by Dr. Christia'∞★$n Sadik’s group at University of Lubeck, $☆ ∏Germany, and published in the August ©÷↔2019 edition of JCI Insight [link].Or♠™±phan drug designation by the FDA is granted Ω"®to promote the development of drugs that tar∏>¶get conditions affecting 200,000 or fewe ✘r U.S. patients annually aπ≥nd that are expected to provide signifi£≥cant therapeutic advantage over e↔∑λxisting treatments. Orphan designation qual↕ ×£ifies Akari for vario↕φ us benefits, including seven years of market eβ✘xclusivity following ♦ ✔∏marketing approval, tax credits oγ₩≠n U.S. clinical trials, eligibil♥₽↓ity for orphan drug grants, and aσσ waiver of certain adminis÷™φtrative fees.2019 Asia-pa≥cific pharma IP Leader Summit:http://≤$≠en.zenseegroup.com/p/510934/will b₽×↕e held in Beijing&nbs₹♠p; on November 14-15, and will att♣←←ract more than 500 indust↑★↔ry experts from domestic and foreign ✔£↕pharmaceutical companies, b¶§δ♣iotechnology companies,≠✔ ♦ governments, associations, law firm≠φ≤s, intellectual property agents and oth✘∏er companies to attend.Official registrat©σion and consultation₩σ channels:Contact：AnnPhone: 021-65650305Email：≥'Marketing@zenseegrou₽ π>p.comhttp://en.zenseegroup.com/p/510934/ -
0918
Hansoh Pharma and Atomw♣ε"ise start strategic collaboration on AI σ'εdrug discovery for multiple therapeutic a®≥↑reas
Major Chinese biopharmaceuticγα™←al company Hansoh Pharmaceutical Group Comp★∑↓"any Limited (Hanmori Pharmaceutical Gr→•<♣oup Co., Ltd., Hanso Pharmaceutical) a§"♣≤nd AI ) Atomwise, Inc., a leader in the field, anπ€nounced the collaboration. The purpose of the✘₽λ collaboration is to des ¶ign and discover potential drug ca←✔ndidates for a total of 11 private ¥ target proteins in multiple th≥÷erapeutic areas.Atomwiseδ☆λ and Hansoh Pharma scienti™π×Ωfic teams work closely togeth ≠ er in each program. The combi✔×™nation of complementary expertise and technolo×≠gy has the potential to dramatically in±•$§crease success rates and shorten schedules< in drug discovery and clinical de×£velopment.Dr. Aifeng Lyu, President of J₩∑iangsu Hansoh Pharmaceutical Group Co., Ltd."β™σ, a subsidiary of Hansoh Pharma, said:απ≠ “Atomwise is the bes¥γt partner for Hansoh £Pharma to use AI technology to innov♠γate and create diverse smal<σl molecule pipelines in oncology and other the'±™rapeutic areas. I am very impresse→↔∏d with the team and I b¥αelieve that working together will prα∞ovide a special opportuni§ty to develop first-in-class an$✔d best-in-class therapeutics. "Dr. Abraham He✘'πifets, CEO of Atomwise, said: “It ♦βis a great pleasure for ££∑us to partner with Chinese biopha'≠ "rmaceutical giant Hansoh Pharma. Hansoh Pharma →★>αshares our strong com↔←<<mitment to innovation a→ nd our mission to influence patient healtε↑ h globally.”Atomwise's world-c₹₩€•lass AI platform for structure-based d± ★φrug design leads the way in &ε♦>finding hit compounds, $™selecting lead compound ®♣s from hit compounds, and ≈βoptimizing lead compounds. Hansoh Pha∑Ω ≤rma will contribute in its capacity in b× iological assays and medicinal •φchemistry, and will lead the ÷γ∞subsequent preclinical and clinical dev&>elopment.Subject to the terms of the collaborλ©ation, Atomwise will r÷₽αeceive revenue based on p±₹rivate technology fees, ≠¥∏option exercise fees, royalties, and sublicenses"β&± and sales of assets created und¥δ♣er the collaboration.σ≥& Based on historical average sales of small molec→×πδule drugs, the overall potential value of thi♠★₽☆s transaction for Atomwise may ex 'ceed the potential v™£↕alue of a hit drug if all pα§rojects succeed. Hansoh Pharma receives de☆→velopment and commercialization rights in all∑ε fields and regions.2019 Asia-pacific pha§ rma IP Leader Summit: http"≤://en.zenseegroup.com/p/510934/will be held in&nb✘φ<δsp;Beijing on November 14-15, andπ∞ will attract more than 500 industry experts f¥☆•≠rom domestic and fore♠σ♥πign pharmaceutical com¥≠panies, biotechnology companies, g™εδ©overnments, associations,α₹₽✔ law firms, intellectua§✔πl property agents and other ₽π♣↓companies to attend.Offici© ∞al registration and consu∏≠≥ltation channels:Con<λε≤tact：AnnPhone: 021-65650305Email：Maλ'rketing@zenseegroup.comh♠↔©ttp://en.zenseegroup.com/p/510934/ -
0919
IBio’s Collaboration with South Af↔♦rica’s AzarGen Biotechnologies Adv ♦♣ances to Next Stage
iBio, Inc. today announced that it σ₩∏has entered into the initial Statement of♣ε Work (“SOW1”) under its Memorandum¥★∏ of Understanding (“MOU”>♥¶) with AzarGen Biotechnologies (Pty.) &∞ Ltd. (“AzarGen”).Following iBio’s successful use→>× of its technologies and manufactε∞ uring capabilities to advance the develop εment of AzarGen’s surfactant protein therapeutic ∞§through an initial assessm≥™ent of production feasibiσ✘lity, in May 2017, the two companiesφ₹ expanded their collaboration by initiating t∏he development of a plant-made r©'ituximab for the South African mark☆βet under the MOU.Pursuant to the SOW1, iBio✔♣¥ will manufacture research quantities of a plant->♥δmade rituximab for A≥ ∑zarGen using iBio’s proprietary FastPharming™ S♠•₹ystem. Following batch producti♣£Ωon, the drug product can↓★¥didate will undergo testing via iBio CDMO’s ≠ Ωbioanalytical services.“After demons ★trating the success of our pla£φtform through our opening project wi∞✔♠₩th AzarGen, we are now advancing to t→≠¥he next stage of the two compan™π∑↓ies’ collaboration,” ≤πcommented Robert B. Kay, iBio<↓©’s Chairman and CEO. Ω<λα“We look forward to helping AzarGen develop ∏←a plant-based, bio-similar rituximab prodδ<βuct for the South African≤•£™ market.”“The early suc✔±>cess in combining iB ≤io’s and AzarGen's advanced genetic engineering≠γε± and synthetic biology techniques↔'© in plants really empowere♠∞↑•d us to evolve our business plans and produc←φφt priorities to initiate dev♠'♥βelopment of a biosimilar versiπ<£on of rituximab,” saidε♠ Dr. Mauritz Venter, CEO of AzarGen. “As w♣≈e continue to move toward the✘π initiation of advanced pre-clinical activitiesλΩ ₹, we are confident that iBio CDMO is i'×≤λdeally suited to provide us with the requγ &isite long-term process devΩ✘elopment and cGMP manufa£✘Ω✔cturing support. We are excite¥♦♠"d to take this important ste♦∑p forward in advancing this program. Focusi↑γ₩ng on accessibility and affordability of δ≤biological medicine for the≤γ African continent, we look forwar♥>d to initiating additional projects with iBio a♣₽♥¥s we progress.”Rituximab was first πγapproved by the U.S. Food and Drugβ×₩ Administration in 1997 for treatment of c ↓₽ertain B cell non-Hodgk±÷→in lymphomas. Since that time,∑φ§ its clinical uses have expanded to encompass♣<¥ treatment of chroniσ c lymphocytic leukemia,∏♦Ω as well as a range of auλ✘ε©toimmune diseases, including∞☆₽ certain types of rheumatoid aπ→βrthritis. Rituximab has been placed on the World↔✔≥ Health Organization’s List of Essenti©™β≈al Medicines and it was ranked ↑☆as one of the world’s top-10 sell±∏φing pharmaceuticals in 2018.2019 Asia-pa>∑cific pharma IP Leader Summit: http:©♠☆//en.zenseegroup.com/p/404716/ ≤•will be held in ®€∑'Beijing on November 14-15>←✘♥, and will attract more tha≈✘n 500 industry experts from domestic and forei>✘gn pharmaceutical companies, bi$♥ otechnology companies, governments, as •sociations, law firms, i✘™ntellectual property agents and other¥ companies to attend.Official registration an™★<d consultation channels:Contact：A∏§λ±nnPhone: 021-65650305♣¶→Email：Marketing@zenseegroup.comhttp://www.zensλ¥£eegroup.com/forms/view/22113/ -
0920
Clene Nanomedicine, Inc. Announces Selection ↕'§of CNM-Au8 for the Harvard Led HEALEY ALS∞∏≥ Platform Trial, a Clinical Trial fo£¥ ↑r Amyotrophic Lateral Sclerosisφα
Clene Nanomedicine, Inc. >, a clinical-stage biopharγ∞♠≠maceutical company, a¥¶&nnounced today that the Sean M. Healey & AMG &'♣Center for ALS at Mass General has₽→ selected CNM-Au8 for inclusion in the first €'§ever Platform Trial for the treatment of amyotrop→φhic lateral sclerosis (ALS).The ↓π Healey Center issued a call earlier this year δ&↓>for the best therapeutic candidates& to apply for entry into ✔"δthe HEALEY ALS Platform Trial. They receiv±λ±₽ed responses from nearly 30 applicants a↓₩♥cross ten countries. Membβ♣πers from the Healey Center Science Advisory α©Committee, a group of ren±₹®owned ALS scientists, chose the top fiv™★≈e therapeutic candidat✔'es, including Clene's lead clinical asset₽ ₹ , CNM-Au8. The selection ←↕of CNM-Au8 into the Healey ALS Platform Trial÷" includes substantial financial$•♣ support and provides access to ov &₽er 50 expert ALS clinical tri•÷γ★al sites across the United States."Our goal," ≥↑ ✘said Merit Cudkowicz, MD, MSc, €✘Director of the Healey✔δ Center, "is to lower the barriers •×for our pharma and academic colleagues to •☆bring their exciting therapies ≈★&for ALS forward to clinical trials. We are dete<γ£rmined to accelerate therapy development ☆∑σσfor ALS."Important preclinical wor φ'₹k supporting the effort with CNM-A★$u8 was performed in the laboratory ofβ β♣ Nicholas J. Maragakis, Director of the™γ ALS Center for Cell Therapy and Regeneration Res βΩearch at Johns Hopkins, using •♠∏×human induced pluripotent stem≥♣ cells from ALS patien&>ts. Dr. Maragakis is Chai©∏<r of Clene's Scientific Advis¶♥ory Board for ALS.Dr. Jonathan Glass, Profess₽αor of Neurology and Pa→&®thology at Emory Universitγ¶y School of Medicine, as well✔ as Director of the Em↔δ✔ory ALS Center, remarked, "CNM-Au©∞8 is quite an interesting comp→αound that is ready for testing in AL∏ ©S clinical trials. Its ↓≥inclusion in the Platform Trial initiative♣♣♦♥ is an excellent way to move €λforward for the development of CNM-Au8 as ∞≠ a potential therapeutic for ALS.""We are very pl→≥§eased Clene's CNM-Au8 has been₽↔↕ selected for participat &φ∑ion in the Healey ALS Platform Trialγπ☆±. We believe the unique m∞&≈★echanism of CNM-Au8 represents a promising new π©approach for the treatment of neurodegenerative d÷δiseases, including AL←∏∑≥S, with the potential for mea§>ningful impact for the ✔ ↓φcommunity of people diagnosed with this de"₽®vastating and debilitating disease," said Ro™φ≠≤b Etherington, President and C'♦©∞EO of Clene. "We are c∏©¶ontinuing the development o®✔↓f CNM-Au8 in several clinical studiβ>↔↔es set to launch later this year."2019 Asia-pacif∑'"ic pharma IP Leader Summit: http://en.z&÷enseegroup.com/p/510934/will be held in&nb<♦sp;Beijing on No>&vember 14-15, and will attα'γ∏ract more than 500 indust •÷ry experts from domestic a×φnd foreign pharmaceutical companies, biγ±<≠otechnology companies, government∑↑s, associations, law firms, inte¥™llectual property agents and other≠✘≈ companies to attend.Offici← δ₹al registration and consultatio₽<≥ n channels:Contact：AnnPhone: 021-65650•$≈305Email：Marketing@zenseegrou♦γ€p.comhttp://www.zenseegroup.com®¶</forms/view/22113/ -
0923
Boehringer Ingelheim Partners with In€→ Ωflammasome Therapeuti♥>↑γcs to Develop Novel >₹Therapies for Patients with Retinal Diseases¶π♥
Boehringer Ingelheim and In★ε☆←flammasome Therapeutics←£ Inc. (Inflammasome) ↔±≥today announced they have entered into a co-dev±€σelopment and license agreement¥&€ to develop up to threβ¥≠e therapies for patientsε€™ with retinal diseases. By combi ♣∞ning Inflammasome’s unique int∑§¥Ωravitreal (IVT) drug delivery technσ®φologies with Boehringer Ingelheim’s ✘compounds from its retinal disease p←≤↓₽ipeline portfolio, Boehringe★ ✘©r Ingelheim aims to develop nove§§'l therapies for retinal disea♦✘ses.In 2019 there were an estimated 82 mill♥ ♠ion patients in the seven key count€σ←ries (U.S., Japan, Germany, U.K.,Ω©↕γ Spain, Italy, France) affect©λed by one of the three major forms of r×δ©♣etinal disease: Age related macular degeδ ✘★neration (AMD), diabetic retinop✘→αathy (DR), and diabetic ≥∏₩macular edema (DME). Globally, the prev↑>÷alence rates of these and othe§★r retinal diseases are♠≥ expected to increase over the nexφ₩∑t 10 years primarily due to aging pop≥₩' ulations and the glob∏♦¥al diabetes epidemic. Despi≥¶te therapeutic advances$↓≈ in some disease areas during thδ&e past years, the real world ♣©πresults are poor, and there are no or only lim☆™&πited treatment options in many areas,•∞ resulting in an overall high unmet need. The✘₽¶ collaboration between Boehringer In>₩₹£gelheim and Inflammasome aims•✘§¥ to address this challenge by using Inflammasome'± ’s technology to deliver therapeutics in a biodegβ™±radable gel formulationβ∑ into the eye.“We are delighted to enter into a cεπ©ollaboration with a company of Boehr←×≈→inger Ingelheim’s stature,” said Pau±∞✔γl Ashton, Chief Executive O÷↑∏©fficer of Inflammasome ± ↕Therapeutics. “We lo↕♥ok forward to working with their team to₹♦ ₹ leverage our respective technologies and e≈¥'xpertise to develop new therapies for↕ • devastating retinal diseas✘ ♠es leading to blindness. This c↑ ollaboration fits our strategy of advanc§∏ing the company via both coll↓✘★"aborations and internal development.£×♣”“Boehringer Ingelheim is lo≥$★oking forward to develop≤εing Inflammasome’s novel technoloε₽✔♦gy for the delivery of our first-in- class§™ retinal disease compounds worδε¶πking jointly with Inflammasome→∏’s highly experienced scienti♠↑fic team,” said Clive R. Wood, PhD, Senior Cor€€≤porate Vice President, Discovery Resea✘&✘÷rch at Boehringer Inσ©gelheim. “This will enable♣← us to develop a broad range of nove䧩πl therapy options for the many patients with r ®¥φetinal diseases waiting ©<urgently for better and new→<γ♠ therapy options.”Boehringer Ingelheim takes a¥€© holistic approach in the development of no™™♥vel retinal disease therapies, targeting§♣ key mechanisms in the paα₩thogenesis of retinal diseases. The compaλ↓>ny has built a comprehensive ♥λΩ₹pipeline portfolio of next generation theΩ∏✔♦rapy approaches in various stages of developm≠λ®αent up to Phase 2 in macular degeneration, diabet✔×ic retinal diseases and'"←★ beyond. Inflammasome’s novel delivery$© technology using a lon<≥g-acting degradable IVT↑γ implant complements this portfoσ≤lio.Inflammasome is entitled$÷ ← to receive up to $160 million in up-fπו✔ront, research and development support aαλnd milestone gated development payments as $Ωλwell as tiered royalties based on future commeγ♣↔rcial sales of develop πed products and other milestones due on comme→↕®rcialization.information source:pharm↕<a focus AsiaThe original link:h↓"ttps://www.pharmafocusas®φ♣ia.com/news/boehringer-ingelheim-partn♥ ≠'ers-with-inflammasome-therapeutics-to-de♠≤Ωvelop-novel-therapies-for-patients-w¥"ith-retinal-diseases2019 Asia"↓®-pacific pharma IP Leader Su✘≤ mmit: http://en.zenseegroup.com/p/510©∑π934/will be held in Be•®ijing on November 14-15 >>, and will attract more than 50'Ω≥0 industry experts from domestic and foreα✔ign pharmaceutical companies, biotechnology αλ≈companies, governments, associati¥♥φons, law firms, intelle•₹ctual property agents and other companies÷ to attend.Official registration and c™∞&onsultation channels:Contact：AnnPhone: 02→¥1-65650305Email：Marketing@zenseegroup.comht✔βtp:/for©×♦↕ms/view/22113/
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