NTSR1

HONG KONG, Aug. 6, 2024 /PRNewswire/ -- Even with the ever-changing situation, technological innovation is still the most critical component for biopharmaceutical companies' long-term development. This continuous innovation keeps companies up to date and promotes the evolution of R&D and the success of commercialization. Recently, Viva Biotech's portfolio companies have new updates. Keep reading for more details. Nerio Therapeutics, A Viva Biotech's Portfolio Company, Was Successfully Acquired by Boehringer Ingelheim for $1.3 Billion San Diego, California - On July 29, 2024, Boehringer Ingelheim announced the addition of an innovative preclinical program with the acquisition of Nerio Therapeutics Inc. ("Nerio"), which is invested and incubated by Viva BioInnovator (VBI), for a total of up to USD 1.3 billion. Boehringer Ingelheim aims to develop this program as a potential key centerpiece component for its immuno-oncology portfolio to achieve its goal of improving cancer patient outcomes. Dr. Han Dai, Chief Innovation Officer (CIO) of Viva Biotech and Head of Viva BioInnovator, stated, "Nerio has successfully leveraged the founding team's extensive R&D experience in targeting phosphatases to develop innovative and highly selective PTPN2/N1 phosphatase inhibitors for tumor immunotherapy. This achievement addresses the challenges of selectivity and druggability of phosphatase inhibitors. We are delighted to have invested in and supported Nerio's growth from proof of concept to preclinical research. The acquisition by Boehringer Ingelheim is a strong validation of our investment strategy and the comprehensive post-investment support we provide. With Boehringer Ingelheim's deep expertise in phosphatases and tumor immunotherapy, we anticipate accelerated development of Nerio's pipeline, ultimately delivering greater benefits to patients." Apeiron to Expand Investment in Synthetic Lethality Pipeline After New Phase in Collaboration with Exscientia San Francisco, USA, and Shanghai, China - On July 18, 2924, Apeiron Therapeutics (Apeiron), invested and incubated by Viva BioInnovator (VBI), announced that it has reached an agreement with Exscientia plc (NASDAQ: EXAI), granting Exscientia full control over GTAEXS617 ('617) and all related intellectual property. This asset is currently in the ELUCIDATE Phase 1/2 clinical trial stage. Under the terms of the agreement, Apeiron will receive an upfront payment of $30 million in cash and equity, in addition to receiving single digit royalties if Exscientia or a third party commercializes '617, which could be worth over $100 million in the upcoming years. Full-Life Technologies, SK Biopharmaceuticals Enter Licensing Agreement for Novel Therapeutic Targeting Multiple Solid Tumors Heidelberg, Germany and Seoul, Korea - On July 17, Full-Life Technologies ("Full-Life"), a fully integrated global radiotherapeutics company, announced that it has entered into a license agreement with SK Biopharmaceuticals, a global biotech company, for exclusive worldwide clinical research, development, manufacturing, and commercialization rights to Full-Life's "FL-091" radiopharmaceutical compound targeting neurotensin receptor 1 (NTSR1) positive cancers. This licensing deal worth $571.5 million includes an upfront payment, and development and commercial milestones, separate from royalties. Under the terms of the agreement, SK Biopharmaceuticals will in-license the NTSR1-targeting Radionuclide Drug Conjugate (RDC) program FL-091 - as well as its back-up compounds - aimed at developing and commercializing it as an innovative anti-cancer drug. Arthrosi Announces First Patient Dosed in Pivotal Phase 3 Reduce 2 Trial of Lead Compound AR882, and Announces Multiple Presentations at the European League Against Rheumatism (EULAR) Congress 2024 San Diego - On June 27, 2024, Arthrosi Therapeutics, Inc., invested and incubated by Viva BioInnovator (VBI), is a late-stage biotechnology company developing a potentially best-in-class, highly potent and selective next generation URAT1 inhibitor to reduce serum urate levels, flares and Tophi in patients with gout. They announced that it has dosed the first patient in REDUCE 2, a pivotal Phase 3 clinical trial to evaluate reduction of sUA in gout patients. During the 2024 European Congress of Rheumatology (EULAR) Congress held from June 12 to June 15, groundbreaking clinical trial results for AR882, a global Class 1 new drug jointly developed by Arthrosi and ApicHope (300723.SZ), were prominently presented by Dr. Robert Keenan, Chief Medical Officer of Arthrosi, reported the latest data from this study at the conference (Abstract Number: POS0268). The research showed that in the 6 to 12-month extension study conducted on patients with tophi, AR882 demonstrated good safety and tolerability, significantly reduced serum uric acid (sUA) levels, and exhibited continued dissolution of tophi and crystal volume. AR882 showed more significant efficacy and better safety in treating gout patients, including those with clinically visible and subclinical crystal deposits. VivaVision Biotech Enrolls First Subject in VVN001 Phase III Clinical Trial in China Wenzhou, China - VivaVision Biotech, Inc. (hereinafter referred to as "VivaVision"), an innovative Chinese ophthalmic drug development company incubated and invested by Viva BioInnovator (VBI), has announced that the first subject has been successfully enrolled and dosed in the China Phase III clinical trial of its independently developed innovative drug for dry eye disease treatment - VVN001 eye drops, a new generation LFA-1 antagonist. About Nerio Therapeutics Nerio Therapeutics, Inc. is a drug discovery and development company focused on phosphatases, a notoriously difficult class of potentially high-value therapeutic protein targets. Nerio has developed novel, potent, and highly selective PTPN2/N1 inhibitors with excellent drug-like properties. Nerio's first-in-class PTPN2/N1 inhibitors enhance immune function and sensitize tumors to pro-inflammatory signals, promoting robust anti-tumor activity. Nerio was founded by Avalon Ventures and had additional financial support from a syndicate including Bregua Corporation, Correlation Ventures, Alexandria Venture Investments and Viva BioInnovator. Nerio was developed in the Avalon BioVentures accelerator, benefiting from their resident expertise in early-stage drug development and comprehensive company support. About Apeiron Therapeutics Apeiron is redefining medical discovery, using artificial intelligence to streamline the drug development process—from target selection to clinical trials. With strategic locations in the San Francisco Bay Area and Shanghai, and significant partnerships in Europe, Apeiron integrates talent and cutting-edge technologies spanning multiple regions. We believe that by pushing the frontiers of biomedical innovation and engaging talent globally we can create breakthrough medicines for the highest unmet medical needs. About Full-Life Technologies Full-Life Technologies ("Full-Life") is a fully integrated global radiotherapeutics company with operations in Belgium, Germany, and China. We aim to own the entire value chain for radiopharmaceutical research & development, production & commercialization to deliver clinical impact for patients. The Company endeavors to tackle fundamental challenges affecting radiopharmaceuticals today by pioneering innovative research that will shape the treatments of tomorrow. We are comprised of a team of fast-moving entrepreneurs and seasoned scientists with a proven history of success in the life sciences, alongside radioisotope research and clinical development. For more information, visit Full-Life's website at . About Arthrosi Arthrosi Therapeutics, Inc., headquartered in San Diego, CA, is focused on developing AR882, a potentially best-in-class, highly potent and selective next generation URAT1 inhibitor to reduce serum urate levels, flares and Tophi in patients with gout. Gout remains a large and growing market with ~ 13M patients in the U.S. alone, ~2M of which have tophaceous gout. AR882 has demonstrated encouraging efficacy and safety compared to SOC in Phase 2 studies as well as impressive results in achieving complete resolution of tophi in a Phase 2b study. Arthrosi is currently advancing AR882 in a pivotal phase 3 program. About VivaVision Biotech VivaVision is a clinical stage pharmaceutical company focused on best-in-class and first-in-class therapies for ocular diseases. VivaVision's current pipeline includes VVN001 for treating dry eye syndrome, VVN539 for the treatment for Glaucoma or Ocular Hypertension, and VVN461 for the treatment of non-infectious ocular inflammation of Uveitis. VivaVision is also engaged in discovery and development of novel therapies for the treatment of other anterior and posterior eye diseases. For more info, visit . SOURCE Viva Biotech Holdings

FDA's citations for Hengrui, Sanofi's $437 million expansion in India, and closure of the Singapore biotech Aslan made our news this week. A 10-page Form 483 has detailed the shortfalls at Hengrui Pharma's PD-1 plant behind a recent FDA rejection. Sanofi is investing heavily to expand its global capacity center in India. Singapore biotech Aslan Pharma is winding down. And more. 1. Behind Hengrui's surprise FDA rejection: Scathing Form 483 lists litany of shortfalls at PD-1 drug plant The Form 483 that led to the FDA’s rejection of Jiangsu Hengrui Pharma and Elevar Therapeutics’ PD-1 inhibitor camrelizumab included 10 observations issued to Hengrui’s subsidiary, Suzhou Suncadia Biopharmaceuticals. In addition, the FDA has upgraded a prior eight-observation Form 483 into a warning letter for Hengrui’s small-molecule facility in Lianyungang, China. 2. Sanofi to more than double its workforce at Hyderabad site with $437M expansion: reports Sanofi will invest 400 million euros through the end of the decade to expand its global capacity center in Hyderabad, India. Sanofi plans to grow the site’s workforce to 2,600 people—from 1,000 today—in two years, making it the largest of the company’s four global capacity hubs. The site will grow its digital capabilities, including utilizing artificial intelligence tools. 3. Aslan’s dream of challenging Dupixent dies as cash-strapped biotech winds down Aslan Pharmaceuticals, one of the first Singapore-based biotechs to rise to the global stage, is shutting down. With $18.4 million in cash as of the end of March, the company has decided to file for liquidation and has let go all its staffers. The biotech’s stock price was once worth nearly $390 a piece at its peak in 2018 until its lead program, the pan-HER drug varlitinib, failed. Before the decision to close doors, Aslan received a delisting warning from Nasdaq as its stock price had been trading below the $1 bid price. 4. J&J’s CAR-T partner Legend Biotech reportedly receives buyout offer Legend Biotech reportedly received a takeover bid and has tapped Centerview Partners as a financial adviser, according to StreetInsider. The stock price surged for Legend and its former parent and largest shareholder, GenScript. The report came a few weeks after two House lawmakers had requested an intelligence briefing on GenScript and its related operations, including Legend. 5. SK inks $572M deal for Full-Life prospect, advancing push to become Asia’s radiopharma leader SK Biopharmaceuticals inked a $571.5 million biobucks deal to license an NTSR1-directed radionuclide-drug conjugate candidate, FL-091, from Full-Life Technologies. NTSR1 is overexpressed in colorectal, breast, pancreatic, and head and neck cancers. The Korean company outlined plans a year ago to expand in oncology and identified radiopharmaceuticals as one of the modalities driving the push. Other News of Note: 6. Sotio taps Biocytogen to create bispecific ADCs in $326M deal 7. Aveo spins a silver lining in failed trial of kidney cancer drug Fotivda 8. BeiGene brings on Merck veteran as new CFO (release)

The deal is part of a broader expansion into radiopharmaceuticals. SK Biopharmaceuticals has followed through on its promise to place big bets in a bid to become Asia’s radiopharma leader. The Korean biotech got the ball rolling by striking a $571.5 million biobucks deal to license a drug candidate in development at Full-Life Technologies. Today, SK’s pipeline and portfolio is focused on central nervous system disorders, with the epilepsy drug Xcopri leading the charge. But the biotech is making a concerted effort to branch out. One year ago, SK outlined plans to expand in oncology and identified radiopharmaceuticals as one of the modalities at the heart of the push. SK is joining a who’s who of Big Pharma companies on the hunt for radiopharma deals. The expansion plan led SK to Full-Life, a radiotherapeutics biotech with operations in Belgium, Germany and China. Specifically, SK has plucked the NTSR1-directed radionuclide drug conjugate program FL-091 from Full-Life’s pipeline.  NTSR1 is overexpressed in tumors including colorectal, breast, pancreatic, and head and neck cancers, leading Full-Life to identify the neurotensin receptor as a potential target for a radioligand. The biotech recently published preclinical data on FL-091. The public pipeline of Full-Life, which has a PSMA program in human testing, puts FL-091 on the cusp of clinical development.  SK has secured global rights to take FL-091 forward through a deal worth up to $571.5 million in upfront and milestone payments. Neither party has disclosed the size of the upfront payment. The deal gives SK the right of first negotiation to license other pre-selected Full-Life programs. The deal is part of a broader expansion into radiopharmaceuticals. SK CEO Donghoon Lee used the press release about the deal to tease the unveiling and implementation of radiopharmaceutical business plans later this year. The company put another piece of its oncology strategy in place in 2023 when it bought a 60% stake in Proteovant Therapeutics to add protein degradation capabilities and a cancer R&D center.