Global Roundup: Genuv Adds AI to Aid Discovery of Alzheimer’s, ALS Therapies

Biopharma and life sciences companies from across the globe provide updates to their pipelines and businesses.

South Korea-based Genuv is bolstering its ATRIVIEW drug discovery platform with Finland-based Aiforia Plc’s AI and Deep Learning technology. The addition of AI means faster drug discovery and faster development of therapeutics aimed at Alzheimer’s disease and amyotrophic lateral sclerosis (ALS).

Genuv’s lead drug candidate, SNR161 has been shown to restore CNS functions in preclinical models of ALS and Alzheimer’s disease. It is now being studied in a Phase I/IIa clinical trial for ALS.

ATRIVIEW is used to screen both existing drugs and new substances for neuroprotective and neurogenerative effects.

“Aiforia is helping Genuv bring the power of deep learning artificial intelligence to our unique ATRIVIEW drug discovery platform,” Sungho Han, founder and chief executive officer of Genuv said in a statement. “The additional speed will enable Genuv and our partners to bring more drug candidates to the clinic more quickly.”

For Finland’s Aiforia, this is the first time its AI platform has been applied to neurodegenerative drug discovery. Korea’s Genuv joins pharma giants Sanofi, Boehringer Ingelheim, AstraZeneca and Bristol Myers Squibb as Aiforia clients.

“We’re excited to help Genuv extend the capabilities of the remarkable ATRIVIEW® platform with the help of our powerful, deep learning technology,” Jukka Tapaninen, CEO of Aiforia said in a statement. “Aiforia brings increased efficiency and precision to medical image.”

Elsewhere around the globe:

Azafaros BV – Netherlands-based Azafaros announced positive data from its first-in-human Phase 1 study with AZ-3102, the company’s lead program in development as a potential treatment for pediatric neurogenetic lysosomal storage disorders. AZ-3102 is an azasugar, orally available, small molecule designed to be a potent and selective inhibitor of two target enzymes involved in glycolipid metabolism by modulating the metabolism of glycosphingolipids. Data from the Phase 1 study with AZ-3102 in healthy volunteers demonstrate its positive safety and tolerability profile and provide the first clinical proof of the compound’s mechanism of action.

ProBioGen – Germany-based ProBioGen forged a multi-product commercial license agreement with AstraZeneca for the company’s GlymaxX technology. AstraZeneca is expected to incorporate the technology. GlymaxX improves target cell killing orchestrated by natural killer cells, enhancing antibody-dependent cell-mediated cytotoxicity (ADCC). GlymaxX also allows using the same modified cell line to produce antibodies of varying levels of fucosylation.

Sequana Medical – Based in Belgium, Sequana has received Medical Device Regulation (MDR) certification from the British Standards Institution for its alfapump system.

Opthea Limited – Australia’s Opthea presented data from a prespecified subgroup analysis of a Phase IIb dose-ranging study of intravitreal OPT-302 in combination with ranibizumab, compared with ranibizumab alone, in participants with neovascular age-related macular degeneration (wet AMD). OPT-302 combination therapy had a safety profile consistent with standard of care anti-VEGF-A monotherapy while demonstrating greater improvements in best-corrected visual acuity (BCVA) and less retinal fluid compared to ranibizumab monotherapy.

Noema Pharma – Switzerland-based Noema announced it will initiate a Phase IIb study of the mGluR5 inhibitor NOE-101 in trigeminal neuralgia (TN) following clearance from the U.S. Food and Drug Administration. The LibraTN trial will evaluate the efficacy and safety of NOE-101 in adults with pain associated with TN. NOE-101 has previously been found to be safe and well tolerated in adult subjects.

AC Immune SA – Also based in Switzerland, AC Immune announced new interim 10-week data from the high-dose cohort of a placebo-controlled Phase Ib/IIa trial evaluating ACI-35.030, a first-in-class phosphorylated-Tau (pTau) vaccine candidate in participants with early Alzheimer’s disease. The interim data shows that the high-dose of ACI-35.030 led to the strong induction of antibodies selective for pTau and its aggregated form, enriched paired helical filaments (ePHF).

Trinity Biotech PLC – Based in Ireland, Trinity received approval for its new HIV screening product, TrinScreen HIV, from the World Health Organization (WHO). TrinScreen HIV is a rapid test providing results in less than 12 minutes from a finger stick drop of blood.

OxDx – University of Oxford spinout OxDx raised £2.6 million (about US$3.53 million) in pre-seed funding for its AI-powered diagnostic technology that can recognize and identify specific species and strains of viruses, bacteria and other pathogens within a sample in seconds. The company intends to develop an ultra-fast analysis platform capable of rapidly scaling for many diseases via simple software updates improving the cost and access to infectious disease diagnostics worldwide. The funding is co-led by IQ Capital and Ahren Innovation Capital with participation from Science Creates Ventures.

OKYO Pharma – Also based in the U.K., OKYO Pharma Limited completed a pre-IND meeting with the FDA regarding the development plans for OK-101 to treat dry eye disease (DED). The regulatory agency provided guidance on a Phase II study based on clinical and nonclinical milestones.

ONK Therapeutics – Ireland’s ONK and Intellia Therapeutics entered into a licensing agreement for natural killer cell therapies. The agreement grants ONK a non-exclusive license to Intellia’s proprietary ex vivo CRISPR/Cas9-based genome editing platform and its lipid nanoparticle (LNP)-based delivery technologies. ONK intends to develop up to five allogeneic NK cell therapies. Intellia will be eligible to receive up to $184 million per product in development and commercial milestone payments, as well as up to mid-single digit royalties on potential future sales.

LianBio – Based in Shanghai, LianBio announced that the National Medical Products Administration granted Breakthrough Therapy Designation in China for mavacamten for the treatment of patients with obstructive hypertrophic cardiomyopathy (oHCM). Breakthrough Therapy Designation was supported by data from the global Phase III EXPLORER-HCM trial of mavacamten in oHCM patients. In the EXPLORER-HCM trial, mavacamten met all primary and secondary endpoints with statistical significance and clinically improved functional status, symptoms, and quality of life.

JCR Pharmaceuticals – At WORLDSymposium, Japan-based JCR Pharmaceuticals highlighted the potential benefits of therapies that rely on J-Brain Cargo®, a proprietary technology developed by JCR Pharmaceuticals, to deliver medicine across the blood-brain barrier. Presentations focused on the long-term safety and efficacy and potential behavioral effects of JR-141 (pabinafusp alfa 10 mL, intravenous drip infusion), the company’s investigational therapy for mucopolysaccharidosis type II (MPS II, or Hunter syndrome). JR-141 is a recombinant iduronate-2-sulfatase enzyme replacement therapy (that was approved in March 2021 in Japan, where it is marketed as IZCARGO® for the treatment of patients with MPS II.

Elypta – Based in Sweden, Elypta initiated the clinical study LEVANTIS-0087A to validate the diagnostic performance of GAGomes – the complete profile of human glycosaminoglycans – as metabolic biomarkers for Multi-Cancer Early Detection (MCED). The study aims to detect any type of cancer in adults who show no symptoms or have any recent history of cancer.

Revive Therapeutics – Canada’s Revive Therapeutics was granted Orphan Drug Designation from the FDA for Bucillamine for the prevention of ischemia–reperfusion injury (IRI) during liver transplantation. Currently, there are no approved treatments available for IRI. Liver ischemia-reperfusion injury is a major complication of liver transplantation and is one of the leading causes for post-surgery hepatic dysfunction.

InflaRx NV – Based in Germany, InflaRx initiated the second dosing cohort of the vilobelimab and PD-1 checkpoint inhibitor, pembrolizumab, combination arm of the Phase II clinical trial in cutaneous squamous cell carcinoma (cSCC). The study is investigating two independent arms: vilobelimab alone and vilobelimab in combination with pembrolizumab. The trial’s main objectives are to assess the safety and antitumor activity of vilobelimab monotherapy and determine the maximum tolerated or recommended dose, safety, and antitumor activity in the combination arm. The trial is expected to enroll a total of approximately 70 patients.

XO Life – Also based in Germany, XO Life raised more than €2 million (about US$2.27 million) to build its patient insights platform for drugs and therapies.

Funding Societies – Singapore’s Funding Societies, Southeast Asia’s largest SME digital financing platform, announced that it has raised US$144 million in an oversubscribed Series C+ equity round. This comes on the back of its US$45 million Series C raised between 2020 and 2021.

Memo Therapeutics – Based in Switzerland, Memo closed an oversubscribed Series B financing round. The company raised 37 million Swiss Francs (approximately US$40.16 million). The round was led by Swisscanto Invest. The proceeds will be used to advance the clinical development of its best- and first-in-class neutralizing antibody, MTX-005, targeting BK virus infection in renal transplant patients.

Centauri Therapeutics – London-based Centauri closed a £24 million (about $32 million) Series A investment round. The funds will support the continued advancement of the company’s antimicrobial resistance (AMR) research and development, using the Alphamer platform to identify and progress novel antibacterial candidates through first-in-human trials for difficult-to-treat infections.