TechBio News 🎩
TechBio News 🎩
MetaphysicalCells: A newsletter about Science, Technology and AI Drug Discovery
“These mysteries about how we evolved should not distract us from the indisputable fact that we did evolve.”
By Jerry A. Coyne, Why Evolution Is True
News 🎳
Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices (May 13, 2024 update)
FDA plans to release AI drug development guidance this year
Merck KGaA taps AI-focused biotech for new ADC pact worth $376M
The Intersection of Chemistry, Robotics and AI in Drug Discovery (BIO 2024)
Syntekabio Makes Waves at Biotech Convention
Profluent’s new platform is like ChatGPT for genetic technology
MilliporeSigma-sponsored white paper on AI drug discovery
QuantumPharm, an AI drug discovery firm, is seeking to raise up to HK$1.13 billion ($145M) from an initial public offering (IPO) in Hong Kong
Quest Diagnostics Completes Acquisition of Select PathAI Diagnostics’ Lab Assets from PathAI, Accelerating Adoption of AI and Digital Pathology to Speed Cancer Diagnosis
FogPharma
FogPharma, spun out of Harvard University by pioneering academic scientist and successful biotech company builder Dr. Gregory Verdine, is a clinical-stage company that developed Helicons™, a novel therapeutic modality. Helicons are designed to combine the cell-permeability and broad tissue distribution of traditional small molecule drugs with the high specificity, broad target accessibility and rapid discovery of monoclonal antibody drugs. But what are these Helicons?
In nature the α-helices in proteins are critically important for mediating interactions with other proteins, and can also endow proteins with unique features, like the ability to embed themselves in cellular membranes. So, at FogPharma they developed the Helicons based on this privileged α-helix and used their innovative discovery engine to discover novel therapeutics against some of the most relevant and historically difficult-to-target disease proteins.
Their discovery platform integrates cutting-edge technologies such as directed evolution, proprietary α-helix conformational hyperstabilization chemistry, highly multiplexed drug optimization technology, analytical and predictive data science including ML and DL, structure-based drug discovery and multiscale manufacturing. By using their tandem discovery platform, FogPharma’s scientists have been able to design, synthesize and evaluate thousands of new Helicons in both biochemical and cell-based assays, progressing early hits into leads in a matter of months, as for example:
FOG-001 is a first-in-class, TCF-blocking β-catenin inhibitor that directly blocks the key oncogenic driver of the Wnt/β-catenin signaling pathway, unlike any previously reported Wnt/β-catenin pathway modulators.
FOG-001 is currently being evaluated in a first-in-human Phase 1/2 clinical trial in patients with Wnt/β-catenin signaling pathway-activated advanced or metastatic solid tumors.
In March 2024, FogPharma Announced a $145M Financing to Support Ongoing Clinical Development of FOG-001 and Accelerate Helicon Peptide Portfolio.
Fog’s ERG program is designed to block or destroy ERG function in ERG-fusion-positive prostate cancers. ETS-related gene or ERG is a member of the E-26 transformation-specific (ETS) family of transcription factors with roles in development that include vasculogenesis, angiogenesis, haematopoiesis and bone development. ERG’s oncogenic potential is well known because of its involvement in Ewing’s sarcoma, leukemia and prostate cancer.
Fog’s Cyclin E1/2 degrader program represents a unique therapeutic mechanism targeting Cyclin E1/2 amplified and overexpressed tumor types, and holds the promise of being a transformational therapy in those patients where Cyclin E is a driver of cancer.
A pan-KRAS inhibitor. And
In May 2024, FogPharma and ARTBIO announced a collaboration to co-develop Helicon-enabled alpha radioligand therapies (HEARTs) for the treatment of multiple types of cancer. The collaboration will leverage Fog’s Helicon platform of tunable stabilized α-helical peptides and ARTBIO’s AlphaDirectTM platform for the development of ARTs using isotope 212Pb (FogPharma and ARTBIO Announce Collaboration to Co-Develop Multiple Helicon™-Enabled Alpha-Particle Radioligand Therapies for the Treatment of Cancer).
FogPharma has raised so far a total of $530.3M in funding over 6 rounds. Their latest round was in March 2024 with the successful closing of a $145M Series E financing round. The financing was led by Nextech Invest with participation from other new investors including RA Capital Management, Rock Springs Capital, General Catalyst, Marshall Wace, Samsara Biocapital, Foresite Capital, Symbiosis, Catalio Capital Management, Sixty Degree Capital and former chairman and CEO of Johnson & Johnson, Alex Gorsky.
Redalpine
Redalpine is a Swiss venture capital firm founded in 2006, that brings together financial investment, operational expertise, and a vast international network to help ambitious entrepreneurs transform their vision into a reality. With over €1bn in assets under management and a disciplined, sector-agnostic investment strategy, the firm has backed some of Europe’s most disruptive companies, including N26, Taxfix, Inkitt, 9fin, Carvolution, Zenjob, vivenu and Umiami. Redalpine has over 95 companies in its portfolio and invests Europe-wide from its offices in Zurich and Berlin. They invest into:
Apoha (UK) is a new kind of machine intelligence biotech offering sensory intelligence, merging groundbreaking brain physics research with the discovery of nonlinear lucassen waves to create an entirely new kind of computer: the liquid brain™. Sensory Intelligence refers to the high-dimensional, instant processing of natural stimuli exhibited by chemical and biological systems using a minimal amount of computing power.
Araris Biotech AG, a spin-off company from the Paul Scherrer Institute and ETH Zurich, is pioneering the development of a novel, proprietary antibody-drug conjugate (ADC)-linker technology. Τheir linker platform enables payload attachment to ‘off-the-shelf’ antibodies in one step without needing to re-engineer or reduce antibodies, resulting in highly homogenous, stable and potent ADC therapies.
On November 8, 2023, Araris announced a collaboration with Taiho Pharmaceutical, under which Araris will use its proprietary linker-conjugation platform to generate novel ADCs against undisclosed targets provided by Taiho Pharmaceutical Co., Ltd., a Japanese R&D-driven specialty pharma company with a focus on oncology.
Memo Therapeutics AG (Switzerland) is a biotech company developing best-in-class therapeutic antibodies with its unique platform technology (throughput and functional screening capabilities) that can capture and bank complete antibody repertoires of individual humans and animals (mining antibodies). In this way they enable fast and cost-efficient discovery of highly relevant therapeutic antibody candidates, and increase the probability of success in subsequent clinical development. By using its immortal cell libraries and unique nano droplet technology, Memo’s identifies and isolates the most potent antibodies based on functionality at an unprecedented rate, including discovering ultra-rare antibodies that competing technologies miss.
On March, 07, 2024, Memo announced that it has successfully raised CHF 20M as part of an extension of its Series C financing, bringing the total amount raised in the funding round to CHF 45M. New investors Ysios Capital and Kurma Partners participated in the extension round, joining existing Series C round investors including Pureos Bioventures, Swisscanto, Vesalius Biocapital, Adjuvant Capital, Verve Ventures, Schroders Capital, GF Group, Fresenius Medical Care Ventures and Red Alpine.
The new funding will be used to bolster the clinical advancement of Memo’s lead asset, AntiBKV (a highly effective and safe neutralizing antibody to treat BK virus infection in kidney transplant recipients), expanding the Phase II trial.
Genialis (US) is an RNA biomarker company empowering biotech companies to get the most out of their data by interpreting data sets in a simple and intuitive way to identify new drug targets or disease biomarkers. Genialis is developing the Genialis ResponderID, a biomarker discovery platform, and the Genialis Expressions software, that enables ML driven biomarker discovery by aggregating consistently analyzed and annotated data. Genialis™ krasID,
is the only biomarker panel both necessary and sufficient to predict tumor response and clinical benefit to KRAS-targeted therapeutics.
The Genialis Expressions software is built on FAIR (findability, accessibility, interoperability and reusability) data management principles, in order to analyze sequencing data across numerous platforms.
Among Genialis’ partners you can find: Roche, Sutter Health, Baylor College of Medicine, Boehringer Ingelheim, HotSpot Therapeutics, Cancer Research Horizons, Debiopharm and Exact Sciences.
On Mar 30, 2023, Genialis raised a $13M Series A funding (for a total of 16M).
On May 31, 2024, the RNA-biomarker company announced a new partnership with the Pancreatic Cancer Action Network (PanCAN) to expand the validation of the Genialis™ krasID biomarker in pancreatic cancer histology. Genialis krasID is a new AI classifier that accurately predicts response and clinical benefit to KRAS inhibitors across preclinical, clinical, and real-world settings.
Tolremo Therapeutics in Switzerland, is combining Tolremo’s add-on compounds with existing cancer drugs and a proprietary screening platform, aiming to ensure that the right patient is treated with the right drug at the right time. Through a unique and novel approach to target identification and medicinal chemistry, they developed compounds capable of specifically blocking a critical mechanism upstream of transcriptional resistance programs without interfering with cancer-unrelated pathways. Their lead candidate TT125-802 is an orally available, selective small molecule inhibitor that blocks the transcription of genes involved in cancer cell resistance to targeted treatment. After a rapid dose escalation as monotherapy, they plan to advance TT125-802 with an innovative clinical development path that focuses on prevention of resistance by combining it with a range of targeted therapies. With their team of experts in medicinal chemistry, bioinformatics and therapeutic development, they aim to deliver a novel therapeutic solution for cancer resistance for a broad range of targeted therapies.
TOLREMO Therapeutics AG has received a total of $39M. Among its investors you can find: BioMedPartners, Pierre Fabre Invest (the investment subsidiary of France's Pierre Fabre Group), Red Alpine and Zürcher Kantonalbank.
Lunaphore is a biotechnology company in Switzerland developing the next-generation spatial biology platform for immuno-oncology research and diagnostics. Its full stack platform, ffex (Fast Fluidic Exchange technology), combines microfluidics, AI, and rapid staining technologies for enhanced precision and efficiency in analyzing tissue samples. This allows for detailed insights into tissue structures, supporting the development of better targeted treatments and aiding pathologists in making informed decisions.
In particular, ffex performs dynamic incubation through pressured-controlled reagent flow rate and direction. The shallow chamber limits vertical diffusion time, accelerating epitope-reagent exchanges. The combination of the shallow chamber and the active flow provides an almost instantaneous reagents exchange called Fast Fluidic Exchange (FFeX™), that allows fast, uniform and reproducible staining across the tissue sample, decreasing the incubation time from several hours to only a few minutes.
They also offer the COMET™’s approach to multiplexing, based on the sequential immunofluorescence (seqIF™) technology, a process involving successive cycles of staining-imaging-elution, without any human intervention.
On March 29, 2024, Nikon and Lunaphore teamed up for spatial biology services. The collaboration aims to provide access to Lunaphore’s COMET platform to biotech, pharma and academic institutions.
On Jan 25, 2024, Bio-Techne Corporation (NASDAQ: TECH) announced that its spatial biology brands, Lunaphore and Advanced Cell Diagnostics (ACD), will launch the first fully automated spatial multiomics workflow with same-section hyperplex detection of RNA and protein biomarkers. This state-of-the-art solution leverages ACD's RNAscope™ HiPlex RNA detection and Lunaphore's universal multiplex sequential immunofluorescence (seqIF™) technology on the COMET™ platform, which performs protein detection with standard, non-conjugated antibodies. The multiomics application will be commercially available in Q2 2024.
Founded in 2014 and headquartered in Tolochenaz, Switzerland, on June 22, 2023 Lunaphore Technologies SA announced it has reached an agreement to be acquired by Bio-Techne Corporation (NASDAQ:TECH), a global life sciences company providing innovative tools and bioactive reagents for the research and clinical diagnostic communities.
Lunaphore has raised a total funding of $82.7M over 8 rounds from 10 investors.
Expressionedits is revolutionizing the genetic toolbox by mastering the design of both existing and synthetic introns, pivotal regulators of gene expression. This innovation ensures the efficient expression of complex therapeutic and industrial proteins across various host cells.
ExpressionEdits
ExpressionEdits is advancing protein expression using AI-driven intronization technology, redefining the status quo of protein expression. Their proprietary platform developed at University of Cambridge improves transgene expression in mammalian systems and has a direct impact on recombinant protein yields and the quality and efficacy of DNA medicines.
In general, many proteins are hard to produce and scale up using conventional methods, and this often leads to insufficient yields for therapeutic applications both in vivo and in vitro. In fact, many scientists have been able to identify proteins that are needed, but haven’t been able to express enough of them. As a solution, ExpressisionEdits is using decades old methods like codon optimization (gene engineering approaches that use synonymous codon changes to increase protein production) and strong viral promoters.
For example introns, once considered "junk DNA", are now recognized as pivotal regulators of gene expression and through intronization, they can enhance gene expression without compromizing the original design. The median intron is over 1500 base pairs, and is often deprioritized for its size by protein producers. However, ExpressionEdits’ introns can be as small as 80 base pairs, allowing them to integrate them into constructs without exceeding size constraints.
Keep in mind that a gene is like a sentence, and the introns are like the spaces between words. Without them a sentence is ...youseehowweirditlookswhenyoudontuseintrons?
In this scenario, if introns are the spacing between words then the Genetic Syntax Engine (the company's AI-driven platform) is the ultimate editor—a computational platform that perfects genetic grammar.
The Genetic Syntax Engine, combines millions of biological data points with ML algorithms to automate the optimization of transgene design. This innovative technology allows ExEd to predict and prioritize crucial transgene properties, and design and introduce artificial introns into recombinant genes (converting cDNA to in-cDNA), thus facilitating the production of therapeutic proteins that were previously difficult to obtain.
On May 29, 2024, RedAlpine announced their co-lead investment in Cambridge-based biotech firm ExpressionEdits, a $13M seed funding round. Octopus Ventures co-led the round, with participation from BlueYard Capital, Wilbe Capital, Acequia Capital, Amino Collective, and Hawktai.
News 🎳
Hoth Therapeutics Inc. has entered into a joint development agreement with Wise Systems International SRL to leverage artificial intelligence utilizing the BioNeMo AI platform of Nvidia
POLYGON, an approach to polypharmacology based on generative reinforcement learning
NVIDIA AI Microservices for Drug Discovery, Digital Health Now Integrated With AWS
Largest genetic database of marine microbes could aid drug discovery
Six ways large language models are changing healthcare
BioStrand, ImmunoPrecise Antibodies’ Subsidiary, Announces Immediate Commercial Offering of Groundbreaking Software with Customizable Interface for AI-Driven Drug Discovery
Third Rock Ventures
Third Rock Ventures is a leading healthcare venture firm focused on advancing disruptive areas of science and medicine. On January 25, 2024, Third Rock Ventures announced that it has expanded its senior team with Seasoned Biotech Executives. Jigar Raythatha has been promoted to partner. Jigar, who joined Third Rock in 2021 as a venture partner, has made significant contributions to the firm’s discovery and company creation activities. In addition, the firm’s venture partner team has been expanded and now includes Mary Lynne Hedley, Ph.D., Steve Paul, M.D., Vyas Ramanan, Ph.D., and Courtney Wallace.
Founded in 2007 and with offices in Boston and San Francisco, the firm invests in biotechnology startups:
Insitro (2018, South San Francisco, California) is a drug discovery company that operates an automated lab equipment running on algorithms that use its own in vitro disease models. In particular, Insitro’s predictive models are grounded in human data (genetic, phenotypic and clinical data) using ML. Moreover, they combine patient-derived induced pluripotent stem cells (iPSCs), genome editing, high content cellular phenotyping and ML to build in vitro models of disease. The outcome is an integrated model of disease spanning in vitro cellular systems and in silico ML models—namely an insitro model that allows them to differentiate between cell states at much finer granularity and predict disease-relevant clinical traits.
So far they have found: 🏓 ML-derived imaging and transcriptional phenotypes in genetic epilepsies; 🏓 have revealed distinct phenotypes from the world’s largest collection of familial, sporadic and isogenically engineered cell lines derived from patients with ALS; 🏓 they have built an ML-native datastore containing significant amounts of multimodal high-content human primary data from a wide variety of solid tumors and discovered un/underexplored pathways that are active in a variety of solid tumors; 🏓 and their ML-driven genetic analysis has enabled the identification of multiple genes with strong human evidence of causality for MASLD that are potentially independent of overall adiposity.
On April 30, 2024, Insitro announced the appointment of Emily Fox, Ph.D., as senior vice president of AI/ML, to oversee those areas as well as data science and computational biology, inclusive of data modalities that span genetics, omics, imaging, clinical data, and molecular design. Dr. Fox, a professor in the Department of Statistics and Department of Computer Science at Stanford University, has made groundbreaking contributions in the application of ML in healthcare.
On April 1, 2024, the company signed a six-year lease extension with Alexandria Real Estate Equities (ARE) for 143,188 square feet at Alexandria’s life sciences center in South San Francisco.
Relay Therapeutics (2016, Cambridge, Massachusetts) offers the Dynamo platform that leverages unparalleled insights into Protein Dynamics and function. They deploy the Dynamo platform in three key phases of Motion-Based Drug Design: 1) to understand how to drug the protein-target of interest, 2) then transition into hit finding and lead generation to identify a chemical starting point, and 3) eventually pass to optimization to obtain a molecule that has the desired characteristics. So far, Relay Therapeutics is advancing three promising therapeutic candidates in early clinical trials:
RLY-4008 designed to be an oral small molecule—a selective inhibitor of FGFR2 frequently altered in certain cancers (Relay Therapeutics Announces Initial RLY-4008 (lirafugratinib) Data Demonstrating Durable Responses Across Multiple FGFR2-Altered Solid Tumors),
RLY-2608 designed to be the first allosteric, pan-mutant (H1047X, E542X and E545X) and isoform-selective PI3Kα inhibitor (Relay Therapeutics Announces Initial Clinical Data Demonstrating that RLY-2608 Selectively Targets Multiple PI3Kα Mutations).
On June 05, 2024, Relay Therapeutics Announces Clinical Trial Collaboration with Pfizer to Evaluate Atirmociclib in Combination with RLY-2608. Initial triplet combination of RLY-2608 + atirmociclib + fulvestrant to be evaluated in patients with PI3Kα-mutated HR+/HER2- metastatic breast cancer; initiation planned by end of 2024.
GDC-1971 (formerly RLY-1971) designed to be an oral small molecule, potent and selective inhibitor of the protein tyrosine phosphatase SHP2 that binds and stabilizes SHP2 in its inactive conformation (into a worldwide license and collaboration agreement with Genentech).
Moreover, on June 6, 2024 Relay Therapeutics, Inc. (Nasdaq: RLAY) announced three new programs from its existing pre-clinical pipeline. The new programs include: two genetic disease programs (for vascular malformations and Fabry disease) and one precision oncology program for a NRAS-specific inhibitor. The new programs announced do not change cash guidance, which is expected to fund operations into the second half of 2026.
Following the biotechnology company's announcement of the three new drug development programs the company received a reiterated Buy rating from TD Cowen. Concurrently, Oppenheimer reduced its price target for Relay to $25 from $33, while maintaining an outperform rating. Despite a delayed timeline for data, Oppenheimer remained positive about Relay Therapeutics' lead drug candidate, RLY-2608, due to its improved selectivity.
MOMA Therapeutics (2020, Cambridge, MA) is on a mission to discover the next generation of precision medicines by targeting the molecular machines that underlie diseases. The current era of disease genetics and whole genome profiling have defined molecular machines as the best intervention points in numerous diseases. Bringing together drug discovery professionals and the tools to enable molecular machine drug discovery by exploiting a key vulnerability inherent to all enzymes in the class: their dependence on well-coordinated, stepwise changes in protein conformation.
On January 04, 2024, MOMA Therapeutics announced a strategic collaboration and licensing agreement with Roche (SIX: RO, ROG; OTCQX: RHHBY). This partnership (for 5 years, $66M in upfront cash with potential milestone payments and royalties exceeding US $2 billion) provides Roche with access to MOMA’s proprietary KnowledgeBase platform.
MOMA’s KnowledgeBase comprises integrated structure-function capabilities, advanced lead-finding technologies and computation-enabled lead optimization. It was built upon the concept that functionally related targets lacking sequence homology still possess three dimensional structural motifs that can be exploited to produce highly impactful therapies.
Kibur Medical (2012, Boston, MA) has engineered an innovative, tumor-implanted, drug-eluting NanoNail™ for simultaneous molecular profiling of tumor response to up to 20 different individual oncology drugs and drug combinations. After retrieval and processing, the resulting multi-omic, spatially registered, single-cell data is analyzed with advanced ML and bioinformatic algorithms to provide a deep, comprehensive understanding of the molecular mechanisms of drug-tumor interaction for each drug or drug combination. Charles River Laboratories International, Inc. (NYSE: CRL) has a strategic partnership with Kibur Medical to offer exclusive access to its implantable microdevice (IMD) for in vivo preclinical oncology studies.
Helicon is an absolute game changer!