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        AI-driven drug development company DR.NOAH BIOTECH has received the green light from the US FDA for its Investigational New Drug (IND) application to proceed with Phase I clinical trials for a new drug combination aimed at treating Amyotrophic Lateral Sclerosis (ALS).
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        The new drug combination, known as NDC-011, was developed using DR.NOAH's AI platform NOAH&rsquo;S ARK, designed to induce anti-inflammation, neuroprotection, neuronal differentiation promotion, and muscle cell protection in ALS patients. It is planned to be tested in a trial conducted on 24 healthy adult participants in a US clinical trial facility, aiming to determine the drug's bioavailability, safety, and tolerability. Phase I of the trial is scheduled to begin in the first half of 2025 and Phase II is expected to commence in 2026.
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        South Korea-based DR.NOAH BIOTECH specializes in developing new drug combinations (NDCs) targeting rare neurological and neuromuscular diseases. The company leverages its proprietary ARK AI-powered platform to accelerate drug discovery and enhance treatment efficacy while minimizing side effects. The company's pipeline includes NDC-011 for ALS and NDC-002 for stroke recovery, among other development programs.
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    <a href="https://www.globenewswire.com/news-release/2024/09/02/2939017/0/en/DR-NOAH-BIOTECH-s-AI-driven-ALS-Medicine-Receives-U-S-FDA-Approval-for-Phase-1-Clinical-Trial-IND.html">
      <b>Press release</b>
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AI Drug Discovery

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 <p>The US FDA has approved an Investigational New Drug (IND) application from drug development company DR.NOAH BIOTECH for a new drug combination, NDC-011, to treat Amyotrophic Lateral Sclerosis (ALS). The drug was developed using the company's AI platform, NOAH’S ARK, and aims to provide anti-inflammation, neuroprotection, neuronal differentiation promotion, and muscle cell protection to ALS patients. The Phase I clinical trial is set to begin in the first half of 2025 with 24 healthy adult participants in a US clinical trial facility, to assess the drug's bioavailability, safety, and tolerability, with Phase II starting the following year.</p>
 <p>Based in South Korea, DR.NOAH BIOTECH specializes in creating new drug combinations (NDCs) for rare neurological and neuromuscular diseases using its proprietary ARK AI-powered platform. This technology allows faster drug discovery and improved treatment effectiveness, while also reducing side effects. Other drugs in the company's developmental stages include NDC-002 for stroke recovery.</p>
 
</div>

US FDA approves DR.NOAH BIOTECH’s IND application for Phase I clinical trials of AI-developed ALS drug

Using real-time data to create dynamic virtual representations of the real world

Digital Twin

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 <p>Slingshot Aerospace, a provider of AI-powered space solutions, has raised USD 30 million in growth capital from Trinity Capital. </p>
 <p>These additional funds are planned to be used to expand operations and support key growth initiatives for the company.</p> 
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Slingshot Aerospace secures USD 30 million in growth capital from Trinity Capital

ANALYST_QUICK_TAKE

PROMINENT_CATEGORY

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 <p>Akselos, a provider of digital twin technology, has launched a new software called Structural Performance Management for FPSO 4.0. The software is designed for Floating Production Storage and Offloading (FPSO) vessels and aims to enhance their operations and longevity.</p>
 <p>The software offers several benefits including a reduction in operating costs, optimal planning for inspections and maintenance, minimal downtime, and faster resolution of structural issues. Utilizing RB-FEA technology, the software produces millimeter-level precision for monitoring structural integrity. It develops a digital twin of the FPSO and has the capability to integrate various data such as inspection, metocean, tank fills, and unloading.</p>
 
</div> <p><b>Analyst QuickTake:<br>
 </b> Akselos has entered partnerships to offer digital twin solutions for FPSOs in the past. Last September, the company partnered with <a href="https:<br>
//sp-edge.com/updates/21998"> Yinson Production and Enauta </a> to deploy Akselos' digital twin technology on the floating vessel Atlanta FPSO in Brazil's Santos Basin.</p>

Akselos introduces software for FPSO monitoring

Clean, congestion-free air travel gets liftoff

Passenger eVTOL Aircraft

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 <p>Vertical Aerospace, a UK-based aerospace and technology company, has completed the first phase of flight testing for its VX4 eVTOL aircraft, though pricing information is yet to be released. The company plans to carry out the next phase of the testing program, which includes thrustborne piloted flights for the prototype, at Cotswold Airport.</p>
 <p>According to the company, pre-orders for up to 1,500 eVTOL aircraft have been placed, valued at approximately USD 6 billion. The orders are from potential customers such as Virgin Atlantic Airways, American Airlines, Japan Airlines, Brazil’s GOL Airlines, and helicopter operator Bristow.</p>
 
</div> <p><b>Analyst QuickTake:<br>
</b> The VX4 prototype was first unveiled in <a href="https:<br>
//sp-edge.com/updates/31652"> July 2024 </a> , with new electric propulsion units that increased the aircraft's power-to-weight ratio by 20% to achieve its target cruise speed of ~240 mph. In <a href="https:<br>
//sp-edge.com/updates/32019"> July 2024 </a> , the company completed VX4's first tethered piloted flight, and in <a href="https:<br>
//sp-edge.com/updates/33502"> September 2024 </a> , Vertical Aerospace partnered with Olsen Actuators and Drives to receive flight control actuation systems for an older VX4 prototype, the VA-1X.</p>

Vertical Aerospace completes first phase of VX4 flight testing

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 <p>Turbine, a company specialising in AI-based biological simulations, has made a significant development in its research partnership with Ono Pharmaceutical. Multiple targets identified through Turbine's Simulated Cell platform, which operates in silico, have been selected by Ono for future development.</p>
 <p>Under the terms of the original agreement, reaching this milestone triggers a payment to Turbine. The company will also provide consultation for Ono during the leading in vitro validation studies of the selected oncology targets at Ono's laboratory facilities. Additional payments could be made to Turbine based on the success of the validation process and ongoing drug development and commercialisation.</p>
 
</div> <p><b>Analyst QuickTake:<br>
</b> The original partnership agreement between Turbine and Ono Pharmaceutical was established in <a href="https:<br>
//www.businesswire.com/news/home/20231024051366/en/Turbine-Establishes-Research-Collaboration-with-Ono-Pharmaceutical-to-Identify-and-Validate-Novel-Oncology-Targets-%C2%A0"> October 2023 </a> to identify and validate novel targets within the oncology domain, a priority area for Ono. Turbine agreed to deploy its Simulated Cell platform for target discovery and to conduct in vitro and in vivo validation of identified targets in return for developmental milestone payments based on the progress of drug development and commercialization by Ono.</p>

Turbine and Ono Pharmaceutical reach developmental milestone in oncology research collaboration

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 <p>Digital biology company BioGeometry has partnered with Sino Biological to enhance protein research and development with their AI protein design and recombinant protein production technologies. A combination of GenAI platform and lab experiments will optimize protein design.</p>
 <p>The use of AI models and experimental data integration will improve efficiency, accuracy and reduce project duration time. This will aid in developments in biopharmaceuticals, disease treatment and sustainable development through expanded protein research.</p>
 <p>BioGeometry, based in China, specializes in AI-driven protein design. Its GenAI platform, GeoBiologics, uses geometric deep learning to model and optimize interactions between antigens and antibodies. The platform aids pharmaceutical companies in creating novel antibodies with AI-powered tools for protein molecule design and structure prediction.&nbsp;</p>
 
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Sino Biological and BioGeometry partner to optimize protein design using GenAI technology

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 <p>Sinopia Biosciences, a biotherapeutics company that utilizes AI, has been granted a Phase II SBIR grant of USD 2.2 million from the National Institute of Dental and Craniofacial Research (NIDCR). This funding will be used to speed up its oral mucositis program through directing the discovery and optimization process. Sinopia Biosciences will make use of its Learn And Discover (LEADS) technology along with AI and ML for the discovery and development of drugs.</p>
 <p>The main focus of Sinopia Biosciences is to develop new therapeutics via its unique computational drug discovery platform, LEADS. This platform makes use of high-throughput multi-omics data combined with AI/ML and network biology to identify and prioritize new drug targets and compounds. Aside from that, the company is also developing its lead clinical candidate, SB-0110, for the treatment of Parkinson's disease and levodopa-induced dyskinesia.</p>

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Sinopia Biosciences raises USD 2.2 million in Phase II SBIR grant funding to accelerate oral mucositis program

Retail investors demanding sophisticated passive investment strategies are looking for an edge.

Retail Trading Infrastructure

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 <p>The online trading platform eToro, based in Israel, has consented to pay a penalty of USD 1.5 million to resolve SEC allegations of functioning as an unregistered broker and clearing agency for certain cryptocurrencies. </p>
 <p>In accordance to the settlement, eToro will restrict its US customers to trade only Bitcoin, Bitcoin Cash, and Ether on its platform. The activities with other cryptocurrencies offered as securities will be stopped. The platform will give its users the go-ahead to sell other cryptocurrencies 180 days post the SEC's order and liquidate any remainders within 187 days, refunding these proceeds to its customers.</p>
 <p>The SEC regards this settlement as a step towards augmenting investor protection and provides a blueprint for other crypto intermediaries to adhere to the existing regulatory frameworks.</p>
 
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eToro settles for USD 1.5 million with SEC over unregistered trading of certain crypto assets

Longevity Tech

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 <p>Amprion has received a USD 100,000 grant from The ALS Network. The company will use these funds to conduct research to understand the cause of sporadic amyotrophic lateral sclerosis (ALS) and to develop potential therapies. This includes supporting necessary clinical and lab research, as well as the development of lab tests to detect other misfolding proteins connected to ALS pathology.</p>
 <p>The company specializes in diagnostic tests for neurodegenerative diseases, identifying misfolded proteins correlated with illnesses such as Parkinson’s disease, Lewy body dementia (LBD), and Alzheimer’s disease with Lewy bodies. Amprion's flagship product, the SAAmplify-ɑSYN Test, uses a seed amplification assay (SAA) method to recognize misfolded proteins before the disease symptoms become apparent. </p>

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Amprion raises USD 100,000 in research grant funding from ALS Network to support ALS research and therapy development

Leveraging personal data for custom-fit diagnosis and treatment

Precision Medicine

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 <p>Amprion has received a USD 100,000 grant from The ALS Network, formerly known as ALS Golden West, to support its global research initiative. The company will use the grant to research the cause of sporadic amyotrophic lateral sclerosis (ALS) and assist the development of potential therapies and lab tests to detect other misfolding proteins tied to ALS pathology.</p>
 
 <p>The company is known for creating diagnostic tests for neurodegenerative diseases. Their tests identify misfolded proteins like alpha-synuclein, related to diseases including Parkinson’s, Lewy body dementia (LBD), and Alzheimer’s disease with Lewy bodies. Amprion's primary product, the SAAmplify-ɑSYN Test, leverages a seed amplification assay (SAA) to detect misfolded proteins before disease symptoms appear.</p>
  
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 <p>Epitopea has obtained a grant worth approximately USD 658,000 from Innovate UK as part of a GBP 12 million Cancer Therapeutics program. This funding will aid Epitopea's investigation into creating therapeutic vaccines and treatments based on T-cell receptors, which target antigens presented distinctively by stromal cells. Using their CryptoMapTM platform, Epitopea plans to extend its RNA immunotherapies range.</p>
 <p>The biotech company, with operations in the UK and Canada, works on creating innovative cancer immunotherapies. Epitopea targets a unique class of tumor-specific antigens (TSAs), termed Cryptigens. Their proprietary platform, CryptoMap, utilizes immunopeptidomics, mass spectrometry, genomics, and bioinformatics to identify conserved TSAs that are expressed arbitrarily. This allows for the development of ready-to-use cancer vaccines and additional immunotherapies.</p>
 
</div>

All Updates

US FDA approves DR.NOAH BIOTECH’s IND application for Phase I clinical trials of AI-developed ALS drug

Slingshot Aerospace secures USD 30 million in growth capital from Trinity Capital

Akselos introduces software for FPSO monitoring

Vertical Aerospace completes first phase of VX4 flight testing

Turbine and Ono Pharmaceutical reach developmental milestone in oncology research collaboration

Sino Biological and BioGeometry partner to optimize protein design using GenAI technology

Sinopia Biosciences raises USD 2.2 million in Phase II SBIR grant funding to accelerate oral mucositis program

eToro settles for USD 1.5 million with SEC over unregistered trading of certain crypto assets

Amprion raises USD 100,000 in research grant funding from ALS Network to support ALS research and therapy development

Amprion raises USD 100,000 in research grant funding from ALS Network to support ALS research and therapy development

Epitopea raises GBP 500,000 in grant funding to develop vaccines and TCR-based therapies

AI Drug Discovery

US FDA approves DR.NOAH BIOTECH’s IND application for Phase I clinical trials of AI-developed ALS drug

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