VVN-001

VVN461, a non-steroidal dual JAK1/TYK2 immunomodulator, achieves primary endpoint, demonstrating statistical and clinical efficacy compared to vehicle in treating post-operative inflammation following cataract surgery Statistically and clinically meaningful reductions in inflammation and ocular pain observed as early as Day 3 Very favorable safety profile with low adverse event rate in active groups WENZHOU, China and SAN DIEGO, Dec. 3, 2024 /PRNewswire/ -- VivaVision Biotech (VivaVision), a clinical-stage, privately held biotechnology company focused on developing treatments for ocular diseases, today announced positive topline results from its U.S. Phase 2 clinical trial of VVN461-CS-201, a potent non-steroidal dual JAK1/TYK2 immunomodulator for the treatment of post-operative inflammation following cataract surgery. The multicenter, randomized, double-masked, vehicle-controlled study enrolled 91 subjects who underwent routine unilateral cataract extraction by phacoemulsification and lens replacement (CELR). Subjects were randomized into three groups (VVN461 1.0%, VVN461 0.5%, and vehicle) and received four doses daily (QID) for 14 days. VVN461 demonstrated statistical and clinical improvements across all primary and secondary endpoints compared to vehicle. Key findings include: Primary Endpoint: At Day 14, 60.0% (18/30) (1.0%) and 53.3% (16/30) (0.5%) of subjects in the VVN461 groups achieved anterior chamber cell (ACC) Grade 0 compared to 19.4% (6/31) in the vehicle group (p=0.0012 and p=0.0057, respectively.) Secondary Endpoints: Clinically significant reductions in anterior chamber flare (ACF) and subject-reported ocular pain, with therapeutic effects observed as early as Day 3. Exploratory Findings: Over the 14 days of the study, only 4 subjects (combined active groups) out of 61 in the VVN461 groups required rescue medication, compared to 15 out of 30 in the vehicle group, indicating faster and more effective post-operative healing and improved baseline ocular comfort. The adverse event rate with both concentrations of VVN461 was low, with only mild severity, and similar to its vehicle, confirming VVN461's safety profile. "VVN461's Phase 2 results highlight its potential as a safer alternative to corticosteroids for post-operative inflammation," said Jason Bacharach, M.D., Founder and Director of Research at North Bay Eye Associates. "The positive efficacy of VVN461, combined with its excellent safety profile, addresses a critical need for anti-inflammatory therapies with fewer corticosteroid-associated risks." Traditional corticosteroid eye drops, while effective, are associated with adverse effects such as increased intraocular pressure, delayed wound healing, and ocular infections, particularly with long-term use. VVN461 offers a promising alternative, leveraging its targeted, non-steroidal mechanism to minimize these risks while maintaining anti-inflammatory efficacy. "VVN461 represents a meaningful step forward in ophthalmic anti-inflammatory therapy," said Dr. Wang Shen, CEO of VivaVision. "The reductions in inflammation and ocular pain observed as early as Day3, combined with a favorable safety profile, underscore the potential impact of this therapy for patients. These results provide a strong foundation to advance our efforts around a Phase 3 clinical trial of VVN461 in the U.S." VivaVision is also conducting Phase 2 studies for VVN461 in non-infectious anterior uveitis (NIAU) in China. About VivaVision Biotech Founded in 2016, VivaVision Biotech is a clinical-stage pharmaceutical company dedicated to advancing best-in-class and first-in-indication therapies with additional investigational drug candidates for ocular diseases. The company's leading pipeline assets include: VVN461: non-steroidal dual JAK1/TYK2 immunomodulator for post-operative inflammation after cataract surgery and non-infectious anterior uveitis. VVN001: an investigational treatment for dry eye syndrome. VVN1901: a therapy targeting neurotrophic keratitis VVN481: a non-steroidal dual JAK1/TYK2 inhibitor for suprachoroidal delivery targeting treatment of posterior/pan-uveitis In addition to its pipeline, VivaVision is actively engaged in the discovery and development of additional therapies for anterior and posterior segment eye diseases to address unmet patient needs. For more information, please visit . US Media Contact Kellie Shuck, RHMM Inc. Phone: +1 682-553-7283 Email: [email protected] China Media Contact Ruby SUN Phone: +86 181-1619-2461 Email: [email protected] SOURCE VIVAVISION BIOTECH LTD WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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