HONG KONG, June 12, 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. VivaVision Forges Strategic Alliance with Renhe Shanliang, and Intitated Their Domestic Phase III Trial for VVN001 On June 6th, World Eye Health Day, a themed event was held in Shanghai. At this grand occasion, guests witnessed the signing of a joint venture agreement between VivaVision, invested and incubated by Viva BioInnovator (VBI), and Jiangxi Shanliang Pharmaceutical Co., Ltd. The two parties will join forces to build a renowned Chinese brand for contact lens care products. Back on March 16th, VivaVision had announced that the initiation meeting for the domestic Phase III clinical trial of VVN001 eye drops - their independently developed dry eye treatment, a LFA-1 antagonist - was successfully convened in Shanghai, marking the official setting sail of the Phase III clinical trial. QurAlis Grants Lilly Exclusive Global License for QRL-204 CAMBRIDGE, Mass., June 3rd, 2024–QurAlis Corporation ("QurAlis"), invested and incubated by Viva BioInnovator (VBI), recently announced that it has entered into an exclusive license agreement with Eli Lilly and Company ("Lilly") in which QurAlis is granting Lilly global rights to develop and commercialize QRL-204, a potentially best-in-class splice-switching antisense oligonucleotide (ASO) designed to restore UNC13A function in amyotrophic lateral sclerosis (ALS), frontotemporal dementia (FTD), and other neurodegenerative diseases. Under the terms of the agreement, QurAlis granted Lilly an exclusive, worldwide license to develop and commercialize QRL-204 and other UNC13A-targeting compounds in exchange for an upfront payment of $45 million to QurAlis, plus an additional equity investment. QurAlis is also eligible for future milestone payments of up to $577 million and tiered royalties on net sales. Arthrosi Announces Multiple Presentations at the European League Against Rheumatism (EULAR) Congress 2024 SAN DIEGO, May 30th, 2024 /PRNewswire/ -- 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. Recently they announced the acceptance of two presentations, including one poster tour at the European League Against Rheumatism (EULAR) Congress 2024 meeting, being held in Vienna, Austria on June 12-15. Lucy Therapeutics Secures New Funding to Advance New Alzheimer's and Parkinson's Treatments WALTHAM, Mass.--(BUSINESS WIRE)--Lucy Therapeutics, Inc. (LucyTx), incubated and invested by Viva BioInnovator (VBI), announced it has raised $12.5 million in additional funding led by existing investors Engine Ventures and Safar Partners with new participation from Bill Gates, Parkinson's UK, and the Michael J. Fox Foundation, which provided a $2 million non-dilutive grant. The fresh capital brings LucyTx's total funding to date to more than $36 million. The investments will further the company's research programs for Alzheimer's and Parkinson's diseases and continue its development of a novel drug target for Rett syndrome. Technoderma Medicines Initiates Phase 2 Clinical Trial for TDM-180935, a Novel Drug for Atopic Dermatitis/Eczema, and Officially Establishes Presence at Chengdu Tianfu International Bio-Town On April 29th, 2024, Technoderma Medicines Inc., ("Technoderma Medicines"), a clinical-stage biotech company developing innovative drugs that is invested and incubated by Viva BioInnovator (VBI), officially announced the initiation of its Phase 2 clinical trial (NCT 06363461) for TDM-180935, a topical ointment for atopic dermatitis/eczema, with patients beginning treatment. Previously, on April 20th, Thyrologics officially established its presence at the Chengdu Tianfu International Bio-Town. Multipeptide Screening Integrated with Biochips, Unveiling New Strategies of XLEMENT and Healthytide On March 27th, 2024, two leading companies in the biopharmaceutical industry - Hangzhou Healthytide Biotechnology Co., LTD. (hereinafter referred to as "Healthytide") and XLEMENT, which is invested incubated by Viva BioInnovator (VBI), announced a strategic cooperation agreement to jointly advance technological innovation and breakthroughs in the field of peptide drug development. Healthytide brings its single-molecule peptide diversity library to the table, while XLEMENT contributes its innovative and industry-leading biochip technology platform to support the collaboration. 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 . About QurAlis Corporation QurAlis is trailblazing the path to conquering amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases with genetically validated targets with next-generation precision medicines. QurAlis' proprietary platforms and unique biomarkers enable the design and development of drugs that act directly on disease-causing genetic alterations. Founded by an internationally recognized team of neurodegenerative biologists from Harvard Medical School and Harvard University, QurAlis is advancing a deep pipeline of antisense oligonucleotides and small molecule programs including addressing sub-forms of ALS that account for the majority of ALS patients. For more information, please visit or follow us on Twitter @QurAlisCo. About Arthrosi Arthrosi Therapeutics, Inc. was founded in San Diego, CA, in 2018 with a mission to create a revolutionary treatment option to target uric acid levels and reduce joint damage for people living with gout. With its vast therapeutic and treatment knowledge, Arthrosi has accumulated a comprehensive and robust intellectual property portfolio and impressive Phase 1 and Phase 2b data showing industry-leading efficacy rates and superior safety profiles. About Lucy Therapeutics Lucy Therapeutics is a private biotechnology company in Waltham, MA, founded by Amy Ripka, Ph.D., in 2017, dedicated to unraveling the complex and interrelated biological processes driving mitochondrial dysfunction and addressing them to slow and stop the diseases they cause. Sitting at the center of genetics and metabolism, Lucy Therapeutics is leading the change in how we think about mitochondria and the intersecting pathways that play critical roles in human health and disease, particularly those of the central nervous system, including Parkinson's disease and Rett syndrome. For more information, visit lucytherapeutics.com. About Technoderma Medicines Technoderma Medicines, Inc. is a privately held clinical stage biopharmaceutical company. The Company was originally located in Jiaxing Xiuzhou Biomedicine Guoqian Park, China, and recently relocated to Chengdu Biomed Town, Chengdu, Sichuan Province, China. Its current core programs focus on development of innovative therapies for Androgenetic Alopecia, Atopic Dermatitis, Psoriasis and Lupus Erythematosus. Its "first-in-class" small molecule thyromimetic drug candidate TDM-105795 for Androgenetic Alopecia is currently in Phase 2a clinical testing. Technoderma's novel JAK1/TYK2 inhibitor TDM-180935 for Atopic Dermatitis is now in Phase 1 clinical testing. The pipeline targets dermatologic indications. About XLEMENT As an Innovator in the field of biopharmaceutical R&D and health diagnostics, Liangzhun has independently developed and launched the pioneering next-generation ultra-surface plasmon resonance detection "MetaSPR Biochip Technology". SOURCE Viva Biotech Holdings

Phase 2License out/inPhase 3Phase 1Oligonucleotide

03 Jun 2024

·www.prnewswire.com

QurAlis Grants Lilly Exclusive Global License for QRL-204, a Potentially First-in-Class Precision Therapy That Restores UNC13A Function in ALS and FTD

QRL-204 is a splice-switching ASO generated through QurAlis' FlexASO™ Platform; represents Lilly's first program targeting UNC13A in ALS and FTD Parties to also collaborate to leverage QurAlis' ALS and ASO development expertise to advance QRL-204 and next-generation compounds UNC13A is an essential regulator of neurotransmitter release at synapses; mis-splicing is a critical RNA alteration occurring in up to 63 percent of all ALS patients and up to one-third of all FTD cases CAMBRIDGE, Mass., June 3, 2024 /PRNewswire/ -- QurAlis Corporation ("QurAlis") today announced that it has entered into an exclusive license agreement with Eli Lilly and Company ("Lilly") in which QurAlis is granting Lilly global rights to develop and commercialize QRL-204, a potentially best-in-class splice-switching antisense oligonucleotide (ASO) designed to restore UNC13A function in amyotrophic lateral sclerosis (ALS), frontotemporal dementia (FTD), and other neurodegenerative diseases. Under the terms of the agreement, QurAlis granted Lilly an exclusive, worldwide license to develop and commercialize QRL-204 and other UNC13A-targeting compounds in exchange for an upfront payment of $45 million to QurAlis, plus an additional equity investment. QurAlis is also eligible for future milestone payments of up to $577 million and tiered royalties on net sales. The agreement includes a research and development (R&D) collaboration to identify and develop additional candidates targeting UNC13A, leveraging QurAlis' proprietary FlexASO™ Splice Modulator Platform. The QurAlis FlexASO Splice Modulator Platform was developed to generate splice-switching ASOs with improved potency and increased therapeutic index. QurAlis' ASOs correct UNC13A mis-splicing, restore UNC13A protein production and reduce cryptic exons that may contribute to disease progression. "We are determined at Lilly to uncover the next great idea, the next collaboration, the next advancement in technology that will drive us toward meaningful treatments for ALS and FTD patients. It's all for one reason – to make life better for even more people," said Andrew Adams, senior vice president, neurodegeneration research, and director, Lilly Institute for Genetic Medicine. "Genetic precision medicines like QRL-204 that target specific causal components of disease pathology hold great promise for delivering meaningful advances against a range of neurodegenerative diseases like ALS and FTD. We look forward to collaborating with QurAlis to identify and develop additional next-generation candidates targeting UNC13A." "On behalf of the entire team at QurAlis, we are extremely pleased to partner with Lilly, an innovation-led company advancing transformative medicines to help make life better for people around the world," said Kasper Roet, chief executive officer and co-founder of QurAlis. "At QurAlis, we are driven to explore the deepest aspects of human neurology to find the treatments patients urgently need. This partnership enables QRL-204 to rapidly move toward the clinic, while we continue to advance our other lead programs. We look forward to combining our complementary strengths to uncover additional candidates that target UNC13A that have the potential to transform the treatment of neurodegenerative diseases like ALS and FTD and beyond." Amyotrophic lateral sclerosis is a progressive neurodegenerative disease characterized by the loss of neurons in the spinal cord, brainstem, and brain. A defining feature of both sporadic and familial disease is the cytoplasmic mis-localization of TAR DNA Binding Protein-43 (TDP-43). TDP-43 pathology is implicated in 90 percent of ALS cases and approximately 50 percent of FTD cases. UNC13A is an essential regulator of neurotransmitter release at synapses and is one of several pre-mRNAs that becomes mis-spliced due to loss of nuclear TDP-43 in disease. Up to 63 percent of ALS patients and up to one-third of FTD patients carry a single nucleotide polymorphism in the UNC13A gene or show TDP-43 pathology, which greatly exacerbates UNC13A mis-splicing leading to loss of function of the UNC13A protein. Preclinical data recently presented at the AD/PD™ 2024 International Conference on Alzheimer's and Parkinson's Diseases and Related Neurological Disorders showed QurAlis' UNC13A splice-switching ASOs modulate UNC13A splicing and restore normal synaptic activities in ALS and FTD. QurAlis' ASOs prevented cryptic exon inclusion in UNC13A transcripts, increased UNC13A protein levels, and normalized localization of UNC13A protein at the synapse. About QurAlis Corporation At QurAlis, we are neuro pioneers on a quest to cure. We work with a relentless pursuit of knowledge, a precise attention to craft, and an optimistic mindset to discover and develop effective precision medicines that will alter the trajectory of amyotrophic lateral sclerosis (ALS), frontotemporal dementia (FTD), and other neurodegenerative diseases. Founded by an internationally recognized team of neurodegenerative biologists from Harvard Medical School and Harvard University, QurAlis is advancing a pipeline with therapeutic candidates that target specific components of ALS and FTD pathology and defined patient populations based on both disease-causing genetic mutation(s) and clinical biomarkers. For more information, please visit or follow us on X @QurAlisCo or LinkedIn. SOURCE QurAlis

License out/inOligonucleotide

03 Jun 2024

·www.fiercebiotech.com

Lilly gilds neuro pipeline, paying QurAlis $45M for preclinical ALS, dementia prospect

Lilly will work with QurAlis to identify and develop additional therapies targeting UNC13A Eli Lilly is splicing another asset onto its neurodegenerative disease pipeline, paying QurAlis $45 million for rights to a preclinical treatment for amyotrophic lateral sclerosis (ALS) and frontotemporal dementia (FTD). The deal gives Lilly global rights to QRL-204, a splice-switching antisense oligonucleotide (ASO) designed to restore UNC13A function. Researchers linked a variant in UNC13A to ALS and FTD years ago, but it took longer to find a causal link between the gene and diseases. A 2022 paper showed how UNC13A variants exacerbate reduced function of TDP-43, the RNA-binding protein implicated in many ALS and FTD cases. QurAlis designed QRL-204 to modulate UNC13A splicing and restore normal synaptic activities in ALS and FTD. Having shared preclinical evidence that it is on to something in March, the biotech has persuaded Lilly to pay $45 million upfront and up to $577 million in milestones to add the ASO to its pipeline. “Genetic precision medicines like QRL-204 that target specific causal components of disease pathology hold great promise for delivering meaningful advances against a range of neurodegenerative diseases like ALS and FTD,” Andrew Adams, Ph.D., senior vice president, neurodegeneration research at Lilly, said in a statement. While hustling QRL-204 toward the clinic, Lilly will work with QurAlis to identify and develop additional therapies targeting UNC13A. The partners will use a QurAlis platform designed to create splice-switching ASOs with improved potency and increased therapeutic index. UNC13A is implicated in roughly two-thirds of ALS cases and one-third of FTD cases, numbers that have caught the attention of a small band of biotechs. AcuraStem has an ASO against UNC13A in development for ALS and FTD. Maze Therapeutics also discovered an UNC13A ASO but has handed the rights to a new biotech that is yet to exit stealth, according to its pipeline. While Lilly is a new challenger for the UNC13A niche, it is a familiar presence in the broader ALS and FTD spaces. The drugmaker expanded in ALS through its $135 million takeover of Disarm Therapeutics in 2020 and a smaller partnership with Verge Genomics the following year. Lilly added a FTD prospect to its pipeline when it bought Prevail Therapeutics for $880 million and has a stake in Arkuda Therapeutics.

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100 Deals associated with QRL-204

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Indication	Highest Phase	Country/Location	Organization	Date
Amyotrophic Lateral Sclerosis	Preclinical	US	QurAlis Corp.Startup	02 Jun 2023
Amyotrophic Lateral Sclerosis	Preclinical	US	Eli Lilly & Co.	02 Jun 2023
Frontotemporal Dementia	Preclinical	US	Eli Lilly & Co.	02 Jun 2023
Frontotemporal Dementia	Preclinical	US	QurAlis Corp.Startup	02 Jun 2023

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