Noveome Biotherapeutics, Inc.

Merck said Friday morning that its HIF-2α inhibitor Welireg met the co-primary endpoint of progression-free survival in a Phase III trial for patients with advanced forms of renal cell carcinoma, but it did not meet the other co-primary endpoint of overall survival. The topline data come from a head-to-head Phase III trial with everolimus, also known as Novartis’ Afinitor, testing Welireg in pre-treated patients with advanced forms of renal cell carcinoma. You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

DUBLIN--( BUSINESS WIRE )--The "Diabetic Retinopathy - Pipeline Insight, 2022" clinical trials has been added to ResearchAndMarkets.com's offering. This "Diabetic Retinopathy - Pipeline Insight, 2022" report provides comprehensive insights about 60+ companies and 60+ pipeline drugs in Diabetic Retinopathy pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. Geography Covered Global coverage Diabetic Retinopathy Understanding Diabetic Retinopathy: Overview Diabetic Retinopathy Emerging Drugs Chapters This segment of the Diabetic Retinopathy report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases. Diabetic Retinopathy Emerging Drugs KSI-301: Kodiak Sciences The Therapeutic candidate KSI-301, currently in clinical development, is a novel anti-VEGF biologic designed to have an extended ocular half-life. Ischemia due to vein occlusion results in secretion of vascular endothelial growth factor (VEGF) that causes further vascular leakage and edema. Anti-VEGF agents have become a very common treatment to improve the clinical outcomes in patients with diabetic retinopathy. As in wet AMD, an intensive treatment frequency is required to achieve optimal outcomes with currently-approved anti-VEGFs agents. However, many patients are lost to follow up due to the frequent injections and real-world outcomes in diabetic retinopathy do not meet the promise shown in clinical trials. By extending on mechanism treatment interval, KSI-301 may relieve the high treatment burden for patients, their family members, and physicians. KSI-301 is being developed in Phase III stage of development towards a once every four to six-month treatment regimen - a possible gamechanger that may provide the opportunity for real prevention. Brolucizumab: Novartis Brolucizumab (RTH258) is a humanized single-chain antibody fragment (scFv) and the most clinically advanced, humanized single-chain antibody fragment to reach this stage of development. Single-chain antibody fragments are highly sought after in drug development due to their small size, enhanced tissue penetration, rapid clearance from systemic circulation and drug delivery characteristics. The proprietary innovative structure results in a small molecule (26 kDa) with potent inhibition of, and high affinity to, all VEGF-A isoforms. In preclinical studies, brolucizumab inhibited activation of VEGF receptors through prevention of the ligand-receptor interaction. Increased signaling through the VEGF pathway is associated with pathologic ocular angiogenesis and retinal edema. Inhibition of the VEGF pathway has been shown to inhibit the growth of neovascular lesions, resolve retinal edema and improve vision in patients with chorioretinal vascular diseases. Currently, it is in Phase III stage of development to treat Diabetic Retinopathy. RGX 314: Regenxbio Inc. RGX-314 is being developed as a novel, one-time subretinal treatment that includes the NAV AAV8 vector containing a gene encoding for a monoclonal antibody fragment. The expressed protein is designed to neutralize vascular endothelial growth factor (VEGF) activity, modifying the pathway for formation of new leaky blood vessels and retinal fluid accumulation. The company is currently enrolling patients in ALTITUDETM, a Phase II trial for the treatment of diabetic retinopathy using suprachoroidal delivery of RGX-314. Diabetic Retinopathy: Therapeutic Assessment This segment of the report provides insights about the different Diabetic Retinopathy drugs segregated based on following parameters that define the scope of the report, such as: Major Players in Diabetic Retinopathy There are approx. 60+ key companies which are developing the therapies for Diabetic Retinopathy. The companies which have their Diabetic Retinopathy drug candidates in the mid to advanced stage, i.e. Phase III include, Kodiak Sciences Phases The report covers around 60+ products under different phases of clinical development like Late-stage products (Phase III ) Mid-Stage products (Phase II) Early-stage products ( Phase I) along with the details of Pre-clinical and Discovery stage candidates Discontinued & Inactive candidates ^- Route of Administration Diabetic Retinopathy pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as Intravenous Oral Molecule Type Products have been categorized under various Molecule types such as Small molecules Peptide Antibiotics Product Type Drugs have been categorized under various product types like Mono, Combination and Mono/Combination. Diabetic Retinopathy: Pipeline Development Activities The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Diabetic Retinopathy therapeutic drugs key players involved in developing key drugs. Pipeline Development Activities The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Diabetic Retinopathy drugs. Report Highlights The companies and academics are working to assess challenges and seek opportunities that could influence Diabetic Retinopathy R&D. The therapies under development are focused on novel approaches to treat/improve Diabetic Retinopathy. Diabetic Retinopathy Report Insights Diabetic Retinopathy Pipeline Analysis Therapeutic Assessment Unmet Needs Impact of Drugs Diabetic Retinopathy Report Assessment Pipeline Product Profiles Therapeutic Assessment Pipeline Assessment Inactive drugs assessment Unmet Needs Key Questions Answered Current Treatment Scenario and Emerging Therapies: How many companies are developing Diabetic Retinopathy drugs? How many Diabetic Retinopathy drugs are developed by each company? How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Diabetic Retinopathy? What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Diabetic Retinopathy therapeutics? What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies? What are the clinical studies going on for Diabetic Retinopathy and their status? What are the key designations that have been granted to the emerging drugs? Key Products KSI-301 Brolucizumab Runcaciguat RC 28 E AKB-9778 RG7774 RGX-314 APX3330 ADVM-022 THR-687 OCX 063 BI 764524 MS-553 A selection of companies mentioned in this report includes Ascentage Pharma AptaBio BONAC corporation CCRP Therapeutics Curacle Co Ltd Emerald Bioscience, Inc. EnnovaBio Everglades Biopharma LUYE PHARMA MIRAE CELL BIO Novelty Nobility Inc Noveome Biotherapeutics, Inc. Palatin Technologies Inc PharmAbcine Inc PYC Therapeutics Retinset SL RIBOMIC Shanghai Henlius Biotech OccuRx Kodiak Sciences Novartis Bayer RemeGen Aerpio Therapeutics Hoffman-La-Roche Regenxbio Inc. Ocuphire Pharma, Inc. Adverum Biotechnologies Oxurion MingSight Relin Pharmaceuticals Boehringer Ingelheim NovaGo Therapeutics HanAll Biopharma For more information about this clinical trials report visit https://www.researchandmarkets.com/r/vy3xvo About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Pablo Cagnoni → We led off Peer Review two weeks ago with what remains of Rubius Therapeutics — and it’s not much. But ex-CEO Pablo Cagnoni has quickly rebounded at another Flagship biotech, taking control at a place where he’s been a board member for the last year. Cagnoni is succeeding interim CEO John Mendlein at Endless RNA (eRNA) biotech Laronde , which had the exceptionally lofty ambition of developing 100 drugs by 2031 upon its May 2021 launch and then raised $440 million in a Series B to put the wheels in motion. Disappointing AACR data and two significant rounds of layoffs spelled the end of Cagnoni’s tenure at Rubius, a company he still chairs but is now led by former COO Dannielle Appelhans . Ex- Vividion chief Diego Miralles stepped down as Laronde’s CEO in August and is currently an advisor for Flagship. Michael Shi → In a “strategic shift in focus” that was announced this week, Hutchmed is deprioritizing early-stage candidates, redirecting its attention to the top of the pipeline. Fruquintinib owns the spotlight after a Monday data drop showed that the drug hit a primary endpoint of progression-free survival but fell short of statistical significance in overall survival in a Phase III trial of gastric cancer patients in China. To coincide with this decision, Hutchmed’s R&D chief and CMO in China, Michael Shi , will now take charge of global clinical development, while managing director and international CMO Marek Kania has been shown the door. A 15-year Novartis vet, Shi was Transcenta ’s global head of R&D and CMO before heading over to Hutchmed this year. Dipal Patel → It’s been tough on the Covid front for Valneva — with the company recently announcing plans to downsize its workforce by 20% to 25% — but that isn’t stopping the company from bringing in some new firepower, as it’s racing to have the first chikungunya vaccine approval, securing Dipal Patel as chief commercial officer in the process. Patel had an 18-year career at GSK in a variety of roles, including as global commercial head of the pharma giant’s shingles vaccine Shingrix . Ben Halladay → Ex- Pfizer financial analyst Ben Halladay has made a rapid rise at Esperion , earning a promotion to CFO at the Michigan biotech that was plagued by commercial obstacles when its cholesterol drug Nexletol was approved on the eve of the Covid-19 pandemic. About 170 employees lost their jobs in the aftermath. Halladay started as a finance manager at Esperion in January 2020 and had been senior director, financial planning and analysis since August. → Perhaps it’s no surprise that Instil Bio would see some turnover after it put up barricades on clinical trial enrollment in late October because of manufacturing issues with its TIL candidate ITIL-168 . As the Dallas biotech looks into potential avenues for resolution, CMO Zachary Roberts resigned on Nov. 11, while Instil Bio has plugged in Robert Hawkins as its new R&D chief. Hawkins founded and was CEO of Immetacyte before it was sold to Instil Bio in March 2020, becoming chief strategy advisor shortly thereafter. Alex Tracy → Taking the non-viral approach with its type 1 diabetes and Duchenne muscular dystrophy candidates, Takeda rare disease partner Code Biotherapeutics has tapped Alex Tracy as chief technical officer. Tracy, the one-time global head of manufacturing science & technology at Novartis Vaccines & Diagnostics , is coming off a yearlong stint as chief technical officer for BridgeBio Gene Therapy and has also held the same title at Istari Oncology . With former GSK exec Brian McVeigh at the controls, Code Bio need not worry about cash for now, after pulling together a $75 million Series A in June that will help bankroll its gene therapy programs. Ryan Kruger → Boston-based Anagenex — a biotech where machine learning and DNA libraries commingle for drug discovery — has enlisted Ryan Kruger as CSO, five months removed from its $30 million Series A . Kruger had a nearly 16-year career with GSK that ended as head of the cancer epigenetics research unit, oncology R&D, and since March 2021 he had been the head of biology at Foghorn Therapeutics , where a clinical hold continues for its blood cancer drug FHD-286 . → In December 2021, Dave Weiner replaced Arnon Aharona as interim CMO of Chemomab , and nearly a year later, Matthew Frankel has taken over as permanent CMO and VP of drug development. Frankel moves on from Boehringer Ingelheim , where he was VP, clinical development and medical affairs, specialty pharma, and he’s also held leadership positions at Novartis and Sandoz . Phase II trials are ongoing with Chemomab’s lead program CM-101 for primary sclerosing cholangitis and liver fibrosis, but that’s not all for the drug: The Israeli biotech is also hoping to launch a Phase II study in patients with systemic sclerosis in due course. Chemomab CEO Dale Pfost said in a statement that Weiner will continue as a senior advisor. David DiGiusto → Garuda Therapeutics , an off-the-shelf stem cell therapy player that took the tarp off a $72 million Series A in September 2021, has welcomed David DiGiusto as chief technology officer. DiGiusto comes from one of Garuda’s backers, Resilience , where he was chief technology officer and SVP, stem cells and regenerative medicine. He’s also been chief technical officer of Semma Therapeutics , and after the $950 million buyout in 2019 , DiGiusto kept going at Vertex as SVP, cell & gene therapies, preclinical & clinical manufacturing — CMC. David Clark → Ottorino Respighi’s masterwork “ Fountains of Rome ” features a dazzling orchestral portrait of the Trevi Fountain — and its biotech namesake, Trevi Therapeutics , has cued the trumpet fanfares for David Clark as CMO. Clark has held this post before with NormOxys , Wilson Therapeutics , Aldeyra Therapeutics and, for the last two years, Allena Pharmaceuticals . Trevi unveiled Phase II results for Haduvio in IPF patients with chronic cough, and like so many biotechs before it, pulled off its own positive-data-to-public-offering double in September. Linda Neuman → Feeling the pinch with a corporate restructuring that has shrunk the workforce and prompted a change at the top, Aeglea BioTherapeutics has promoted Linda Neuman to CMO. Neuman was introduced as VP, clinical development in April 2021 and was elevated to SVP in January; in recent years, she’s been a clinical exec with Catalyst Biosciences and the interim medical chief for Adverum Biotechnologies . Anglea’s pegzilarginase hit with a thud in Phase III last year and had an RTF thrown at it to boot, so for Neuman, the focus now shifts to a Phase I/II trial for Aeglea’s homocystinuria drug pegtarviliase . Vanya Sagar → Vanya Sagar has been named chief people officer of OrbiMed -backed Sionna Therapeutics , a cystic fibrosis player that secured a $111 million Series B haul this past spring. After three years in talent acquisition and HR at Biogen , Sagar joined Flagship ’s Sigilon Therapeutics in 2018 and would earn a promotion to chief human resources officer in 2020. She then became chief people officer of Affinivax last year. Competing with CF giant Vertex is a tall order, but Sionna thinks it’s cornered a market by going after a CFTR mutation that is present in 86% of CF patients. “Up until this point, nobody has been able to drug this target,” CEO Mike Cloonan told Lei Lei Wu . → Wedged into a corporate update that outlined its emphasis on TCR-T therapies, BioNTech partner Medigene has pegged James Cornicelli as head of corporate development and strategy. Cornicelli just completed a four-year run as VP, global business development with Pharming , and he also brings BD experience from his days at UCB and Salix Pharmaceuticals . Julia Gaebler → Here’s Lucy: Julia Gaebler has taken the CBO job at mitochondria biotech Lucy Therapeutics , which is going after CNS diseases like Parkinson’s and Rett syndrome. A Roche alum, Gaebler was senior director of global medical outcomes strategy at Biogen during the Tecfidera launch, and from March 2021 until this past September, she served as VP of commercial strategy and portfolio planning with Milestone Pharmaceuticals . → Calgary-based XORTX Therapeutics has recruited Pfizer vet Stacy Evans as CBO. XORTX is shopping for a partner to develop and commercialize its autosomal dominant polycystic kidney disease candidate XRx-008 , and it will be up to Evans to find one. He has filled this position before with Avillion and AxeroVision , and he was new product development lead as well as search & evaluation lead in ophthalmology during his 12 years with Pfizer. Christiane Bardroff → German CDMO Rentschler Biopharma has promoted Christiane Bardroff to COO. Bardroff held a number of posts in her nine years with Roche — including senior manager, upstream processing — before jumping to Teva Biotech , where she rose to senior director of operations. She started at Rentschler Biopharma nine months ago as SVP, client program management. → Freedom Biosciences is waving in David Hough as CMO. For nearly 17 years, Hough has been working away at Janssen Research and Development , holding a number of roles, including leading the Spravato compound development team. Ann Tomlin → Myovant Sciences initially rebuffed a buyout offer from majority owner Sumitomo Pharma , but the second time was the charm in a $2.9 billion deal . Several weeks later, Myovant has selected Ann Tomlin from AbbVie as SVP of human resources. Tomlin worked at Abbott for 13 years before the split, and she had been AbbVie’s Bay Area head of human resources since October 2019. → VC firm Longitude Capital is making some room on the team for Matthew Young as managing director. Young hops over from GRAIL , where he served as COO and CFO before its controversial merger with Illumina . Prior to that, Young was EVP and CFO of Jazz Pharmaceuticals and has former experience at Barclays Capital , Citigroup , Lehman Brothers and Merrill Lynch . Young has also served on the board of PRA Health Sciences and has seats at CytomX Therapeutics and Alpha-9 Therapeutics . → Back in June, CDMO Avid Bioservices was busy expanding its laboratories in Tustin, CA, and now the team has welcomed Oksana Lukash as VP, people. Lukash joins after a three-year stint at Oncocyte , where she served as VP, people & culture. Lukash also brings with her experience from her times at Avanir Pharmaceuticals , Agendia and Clarient . Scott Braunstein → Marinus Pharmaceuticals CEO Scott Braunstein will also chair the board as Nicole Vitullo retires. Michael Dougherty is joining her in retirement, and Santiago Arroyo will step away from the board after taking the CMO job at Fulcrum Therapeutics . Robert Ruffolo → Ex- Wyeth R&D chief Robert Ruffolo has added another board appointment to his résumé at nerve injury-focused Neuraptive Therapeutics out of Philadelphia. He’s also on the boards of Sigilon Therapeutics, Elucida Oncology , Sapience Therapeutics and Aridis Pharmaceuticals . → Dallas-based Forte Biosciences is turning up the volume with its board of directors by electing Scott Brun . The former VP of scientific affairs and head of AbbVie Ventures is now a venture partner at Abingworth and a senior advisor at Horizon Therapeutics. Houman Hemmati → Noveome Biotherapeutics has pulled out two seats on its board of directors for Eric Keller and Houman Hemmati . Keller is founder and CEO of Redux Therapeutics and has stints from C2Sense , SGH2 Energy Global and SipNose under his belt. Meanwhile, Hemmati boasts his current stint as CMO of Vyluma and former gigs at Levation Pharma and Optigo Biotherapeutics . → Sean McDonald is making his way onto the board of directors over at AccuStem Sciences . McDonald is CEO of Ocugenix and formerly helmed Precision Therapeutics . During his career, McDonald has served at Aethon , Adams Capital Management and Respironics . → Cambridge, MA-based Artax Biopharma has expanded its scientific advisory board to include Ajay Nirula and James Krueger . Nirula serves as SVP, immunology at Eli Lilly and was also medical leader for the company’s work during the Covid pandemic. Meanwhile, Krueger is head of the laboratory for investigative dermatology and professor in clinical investigation and dermatology at The Rockefeller University.