Alltrna Applies Machine Learning to Engineer tRNA Oligonucleotides with Significantly Improved Activity and Demonstrates In Vivo Readthrough of the Two Most Common Premature Termination Codons in Genetic Disease

On May 7, 2024 Alltrna, a Flagship Pioneering company unlocking transfer RNA (tRNA) biology and pioneering tRNA therapeutics to regulate the protein universe and resolve disease, reported the presentation of new data at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 27th Annual Meeting demonstrating that Alltrna’s platform, enabled by machine learning (ML), can optimize sequences and modifications from natural tRNAs to significantly increase in vivo activity to readthrough premature termination codons (PTCs) caused by nonsense mutations (Press release, Alltrna, MAY 7, 2024, https://www.alltrna.com/press/alltrna-applies-machine-learning-to-engineer-trna-oligonucleotides-with-significantly-improved-activity-and-demonstrates-in-vivo-readthrough-of-the-two-most-common-premature-termination-codons-in-genetic-disease [SID1234646024]).

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"Alltrna’s ML-driven platform explores at an unprecedented scale the expansive combinatorial space of tRNA sequences and modifications, which has the potential to generate more engineered tRNA oligonucleotides than atoms in the universe," said Michelle C. Werner, CEO of Alltrna. "The data demonstrate the power of Alltrna’s platform to identify key combinations of tRNA sequences and modifications and precisely design tRNA oligonucleotides with significantly improved in vivo activity. With optimized engineered tRNAs for the two most prevalent premature termination codons, we are advancing preclinical studies for our first Stop Codon Disease indications."

tRNAs are programmable molecules with a diverse biology of sequences and modifications that are key to their structure, function, and stability. There’s the potential for approximately 10^34 tRNA sequences and more than 120 natural and synthetic modifications for each nucleotide. Using ML-powered screens, Alltrna scientists applied high-throughput sequence optimization to increase engineered tRNA activity by ~100-fold. ML-driven modification optimization further increased engineered tRNA activity.

Data were presented for the optimization of engineered tRNA oligonucleotides to address two different PTCs: Arg-TGA and Gln-TAG. Delivered using a liver-directed lipid nanoparticle (LNP), both optimized tRNAs showed robust in vivo activity in two transgenic mouse models. The first carries a human rare disease gene with a PTC mutation, the second carries a reporter gene with a different PTC as a general in vivo model for Stop Codon Disease. Alltrna previously presented in vitro data on the engineered tRNA for Arg-TGA showing that it can readthrough nonsense mutations regardless of gene or location in 25 disease reporter models, 14 different genes, and seven different mutation locations on a single gene.

"These data confirm that the application of high-throughput sequence and ML-driven modification optimization through Alltrna’s unique platform can significantly increase the in vivo activity of engineered tRNAs," said Stephen W. Eichhorn, Ph.D., Head of Computational and Molecular Biology at Alltrna. "We’ve also demonstrated that we can engineer robust tRNA activity for two different premature termination codons, each of which are highly prevalent in Stop Codon Disease."

About Stop Codon Disease

Stop Codon Disease encompasses thousands of rare and common diseases that stem from premature termination codons (PTC) also called nonsense mutations, where the code for an amino acid has been mutated into a premature "stop" codon. This results in a truncated or shortened protein product with no or altered biological activity that causes disease. Approximately 10% of all people with a genetic disease have Stop Codon Disease, representing approximately 30 million people worldwide. Alltrna is engineering tRNA medicines that can read these PTC mutations and deliver the desired amino acid, thereby restoring the production of the full-length protein.

Consolidated Financial Summary (IFRS) Fiscal 2024 First Quarter

On May 7, 2024 Kyowa Hakko Kirin reported its Consolidated Financial Summary (IFRS) Fiscal 2024 First Quarter (Press release, Kyowa Hakko Kirin, MAY 7, 2024, View Source [SID1234645288]).

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Flagship Pioneering Unveils Prologue Medicines to Unlock the Therapeutic Potential of the Viral Proteome

On May 7, 2024 Flagship Pioneering, the bioplatform innovation company, reported Prologue Medicines, a company unlocking the therapeutic potential of the viral proteome for the creation of powerful new medicines (Press release, Prologue Medicines, MAY 7, 2024, View Source [SID1234643565]). Flagship has initially committed $50 million to advance the company’s Decoding Evolutionary Logic of Variant Ensembles (DELVE) Platform and harness its power to develop a pipeline of medicines fora wide range of diseases, with an initial focus in immunological, oncology and metabolic indications.

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"We asked, what if we could expand beyond the functional boundaries of the human proteome by harnessing viral evolution," said Noubar Afeyan, Ph.D., Founder and CEO of Flagship Pioneering and Co-Founder and Chairman of the Strategic Oversight Board of Prologue. "By exploring the viral proteome, we can discover novel proteins with enhanced or completely unique therapeutic properties to develop medicines for optimal patient outcomes."

Prologue is unlocking viral proteome-assisted drug discovery with its novel DELVE Platform. DELVE combines computation and high-throughput biology to continually mine the expanding viral proteome to uncover viral proteins and their unique features and evaluate their potential to modulate human physiology for the treatment of disease. The platform contains the largest known database of viral protein structures layered both with detailed data from known human proteins and annotations of previously uncharacterized viral proteins predicted through Prologue’s proprietary computational frameworks. By applying the learned rules of natural viral evolution, Prologue creates enhanced therapeutic proteins programmed to have properties, some previously unique to viruses, that expand the functional boundaries of human proteins.

"The viral proteome dwarfs the human proteome by orders of magnitude, enabling us to reveal a trove of powerful new proteins that can be used as medicines across nearly any therapeutic area," said Lovisa Afzelius, Ph.D., MBA, Co-Founder and CEO of Prologue and Origination Partner at Flagship Pioneering. "Nature has evolved proteins with unique characteristics across the viral proteome. Advances in machine learning are enabling us to quickly characterize and select those that can precisely regulate human physiology to create powerful new medicines with impeccable precision."

In addition to Afeyan and Afzelius, Prologue is led by Theonie Anastassiadis, Ph.D., Founding President of Prologue and Senior Principal at Flagship Pioneering, and Hozefa Bandukwala, Ph.D., Founding Chief Scientific Officer of Prologue and Science Partner at Flagship Pioneering.

Janux Therapeutics Reports First Quarter 2024 Financial Results and Business Highlights

On May 7, 2024 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms, reported financial results for the first quarter ended March 31, 2024 and provided a business update (Press release, Janux Therapeutics, MAY 7, 2024, View Source [SID1234642882]).

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"We continue to focus on enrollment in the two clinical studies for PSMA-TRACTr JANX007 and EGFR-TRACTr JANX008, and we are pleased with the progress," said David Campbell, Ph.D., President and CEO of Janux. "As we advance our clinical programs and gather additional clinical data, we are also expanding our pipeline so that we can create further value from our technology platforms and, most importantly, accelerate the development of new meaningful therapies for cancer patients."

RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES:


JANX007 continues to enroll in the first-in-human Phase 1 clinical trial in mCRPC (NCT05519449).


JANX008 continues to enroll in the first-in-human Phase 1 clinical trial in advanced or metastatic solid tumors (NCT05783622).

An update on JANX007 data and doses selected for expansion cohorts is anticipated in the second half of 2024. An update on JANX008 data is expected in 2025.

FIRST QUARTER 2024 FINANCIAL RESULTS:


Cash and cash equivalents and short-term investments: As of March 31, 2024, Janux reported cash and cash equivalents and short-term investments of $651.8 million compared to $344.0 million at December 31, 2023.


Research and development expenses: For the quarter ended March 31, 2024, Janux reported research and development expenses of $14.1 million compared to $15.9 million for the comparable period in 2023.


General and administrative expenses: For the quarter ended March 31, 2024, Janux reported general and administrative expenses of $7.3 million compared to $6.5 million for the comparable period in 2023.


Net loss: For the quarter ended March 31, 2024, Janux reported a net loss of $14.8 million compared to $17.5 million for the comparable period in 2023.

Janux’s TRACTr and TRACIr Pipeline

Janux’s first clinical candidate, JANX007, is a TRACTr that targets PSMA and is being investigated in a Phase 1 clinical trial in adult subjects with metastatic castration-resistant prostate cancer (mCRPC). Janux’s second clinical candidate, JANX008, is a TRACTr that targets EGFR and is being studied in a Phase 1 clinical trial for the treatment of multiple solid cancers including colorectal cancer, squamous cell carcinoma of the head and neck, non-small cell lung cancer, and renal cell carcinoma. We are also generating a number of additional TRACTr and TRACIr programs for potential future development, some of which are at development candidate stage or later. We are currently assessing priorities in our preclinical pipeline.

BPGbio Brings Late Clinical Stage Rare Disease and Oncology Assets to US and EU Pharma Partnering Summits

On May 7, 2024 BPGbio, Inc., a leading biology-first AI-powered biopharma that focuses on oncology, neurology, and rare diseases, reported its participation in both the US Pharma Partnering Summit, scheduled for May 14-15, 2024, in San Diego and the EU Pharma Partnering Summit taking place May 22-23, 2024 in Basel, Switzerland (Press release, BPGbio, MAY 7, 2024, View Source [SID1234642825]).

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BPGbio’s executives, including Daniel Elliott, Board Member and Chief Commercial Advisor, plan to share details of the company’s commercial ready assets. Of particular note is progress in advancing BPM31510-IV, their lead drug candidate, which is currently enrolling in Phase 2b trial for glioblastoma multiforme (GBM) and in Phase 2b trial design for pancreatic cancer as well as being studied for a range of other aggressive cancers. BPM31510 acts by targeting the mitochondrial machinery and tumor microenvironment (TME) to create a metabolic shift in cancer cells, leading to cancer cell death. BPM31510 has already received Orphan Drug designations from the U.S. FDA for both GBM and pancreatic cancer. BPGbio is also exploring a late stage trial with BPM31510-IV/oral for primary coenzyme Q10 deficiency, an ultra-rare, potentially life threatening disease that affects the brain, muscles, and kidneys in afflicted patients.

"The clinical trial success of our lead candidate, BPM31510, underscores the value of our biology-first approach and the decade plus we have spent refining our approach to AI-powered drug discovery," said Niven Narain, PhD, CEO of BPGbio. "Our team is looking forward to meeting with potential partners in the biopharma industry who want to join us in bringing our novel therapeutics to patients in need or leveraging our AI-capabilities to support their development activities."

The executives will also provide insights into the company’s growing portfolio of therapeutic targets and candidates, including their novel E2 Degrader Platform, which have been identified through BPGBio’s proprietary AI-powered NAi Interrogative Biology Platform. This platform identifies targets, biomarkers, and drugs and assists the development team through both the development and clinical trial stages. The NAi Platform is now commercially available to pharma, academic, and government organizations. The platform operates a clinically annotated, longitudinal 100,000+ patient/sample biobank, uses domain specific AI models to analyze multi-omics data with the world’s current fastest supercomputer, Frontier, at Oak Ridge National Laboratory (ORNL), making it the only fully integrated high-performance computing (HPC) platform in the biopharmaceutical industry for AI-driven target nomination, discovery, and molecule design.

BPGbio’s therapeutic pipeline also includes drug candidates for epidermolysis bullosa (EB, orphan drug), squamous cell carcinoma (SCC, orphan drug), sarcopenia, solid and liquid tumors, Huntington’s disease (orphan drug) and Parkinson’s disease.

The company’s diagnostic pipeline includes its prostate diagnostic test pstateDx, as well as tests being developed and validated for the detection of Parkinson’s disease (ParkinsonDx), pancreatic cancer (PancDx), breast cancer, and liver disease.