AI-powered drug discovery: update (VII)
✴️ Roivant, ✳️ HiFiBio, 💠 Celsius, 🔷 Accuratar, 🔶 Berg, ⚜️ Black Diamond, 🌀 Herophilus, 👾 Compugen, 🔰 Epivax and ✅ BioAge Labs
“In a very real sense we have two minds, one that thinks and one that feels”.
By Daniel Goleman, Emotional Intelligence: Why It Can Matter More Than IQ
For the previous newsletters of this series of updates specifically on AI drug discovery companies with assets in preclinical and clinical trials 👉
Index for “AI-powered drug discovery: update part VII” 🧵
Roivant
HiFiBio Therapeutics
Celsius Therapeutics now a part of AbbVie
Accutar Biotech
Berg Pharma now part of BPGbio
Black Diamond Therapeutics
Herophilus acquired by Genentech
Compugen
Epivax
BioAge Labs
✴️ Roivant Sciences Ltd
Roivant Science is a drug discovery company focused on completing the development of promising late-stage drug candidates and reducing the time and cost of developing new medicines. Roivant does this by building entrepreneurial biotech and healthcare technology companies with a unique approach to sourcing talent, aligning incentives and deploying the technology. So far, they have the following companies in the Roivant family spanning multiple therapeutic areas, modalities and technologies: Dermavant, Immunovant, Priovanttx, Datavant, VantAI, Psivant, Covanttx, Lokavant, Kinevant and Genevant.
The Roivant Discovery physics-driven drug design platform combines quantum physics, statistical thermodynamics, molecular simulations, AI, ML, a dedicated HPC supercomputing cluster, purpose-built software and in-house laboratory. In fact, they have developed the most accurate force field and conformational modulation simulations in the industry to model the motions of proteins and small molecules that are critical to design drugs that act at the molecular basis of disease.
Roivant Sciences (Basel, Switzerland and London and New York) (NASDAQ:ROIV) was incorporated on April 7, 2014 under the name Valor Biotechnology Ltd and changed its name to Roivant Sciences Ltd on November 5, 2014.
In 2022, Roivant (Dermavant) launched VTAMA® (tapinarof) cream, 1%, for the topical treatment of plaque psoriasis in adults.
Currently, they are working on the following assets:
Dermavant: VTAMA (Tapinarof) for Atopic Dermatitis in Review,
Immunovant: Batoclimab for Myasthenia Gravis in Phase 3,
Immunovant: Batoclimab for Thyroid Eye Disease in Phase 3,
Immunovant: Batoclimab for CIDP in Phase 3,
Immunovant: Batoclimab for Graves' Disease in Phase 3,
On December 20, 2023, Roivant Reports Positive Initial Phase 2 Results for Batoclimab in Graves’ Disease.
Immunovant: IMVT-1402 for Numerous Indications in Phase 1,
Priovant: Brepocitinib for Dermatomyositis in Phase 3,
Priovant: Brepocitinib for Non-Infectious Uveitis in Phase 3,
Priovant: Brepocitinib for Other Indications in Phase 2,
Kinevant: Namilumab for Sarcoidosis in Phase 2.
On December 14, 2023, Roivant announced the completion of the previously announced acquisition by Roche (SIX: RO, ROG; OTCQX: RHHBY) of Telavant, for an upfront payment of approximately $7.1 billion. Telavant holds the rights in the US and Japan to RVT-3101 (Novel TL1A Directed Antibody: RVT-3101), a promising new therapy in development for people suffering from inflammatory bowel disease, including ulcerative colitis and Crohn’s disease.
On August 22, 2024, the Editorial Team of Simply Wall St wrote (editorial-team@simplywallst.com):
✳️ HiFiBio Inc
HiFiBiO Therapeutics (2017) is a clinical-stage global biotech pioneering a unique high-resolution translational solution (DIS®, Drug Intelligence Science) to enhance the probability of success for immunotherapies. DIS combines unique single-cell capabilities with AI/ML approaches using patient samples to discover novel targets, effective antibody drugs and predictive biomarkers (comprehensive data from imaging, sequencing, PK/PD analysis and patient history is collected and analyzed to generate data-driven predictive biomarker hypotheses).
DIS allows for the screening of millions of species agnostic B cells within hours (CelliGo™) and is powered by bioinformatics software (AbSolution™) for data analysis of single B cells. Their ML model guides antibody binding prediction and affinity maturation to enhance efficiency with better outcomes. HiFiBiO Therapeutics is headquartered in Cambridge, MA with additional operations in Paris, France, Hong Kong, Shanghai and Hangzhou, China.
So far, HiFiBiO has gained an unprecedented understanding of immune modulation in human diseases driving a robust clinical pipeline of transformative immunotherapies with:
Three active Phase 1 clinical programs:
The first-in-class TNFR2 agonist monoclonal antibody HFB200301 (NCT05238883), an immune cell agonist with an excellent safety profile and promising clinical activity in monotherapy and in combination with anti-PD-1. They are actively enrolling patients with DIS-selected advanced cancers for treatment with HFB200301 monotherapy or in combination with anti-PD-1 tislelizumab. Identification of biomarkers predictive of response is ongoing.
The next-generation fully human OX40 agonist monoclonal antibody HFB301001 (NCT05229601), a novel fully human IgG1 class OX40 agonist antibody with an optimized pharmacological profile. And
The best-in-class BTLA antagonist monoclonal antibody HFB200603 (NCT05789069), a best-in-class BTLA antagonist monoclonal antibody that has been shown to reverse HVEM-mediated immune suppression. They are actively enrolling patients with DIS-selected advanced cancers for treatment with HFB200603 monotherapy or in combination with anti-PD-1 tislelizumab. Identification of biomarkers predictive of response is ongoing.
Three active preclinical programs targeting key immune cell types involved in immunology and inflammation diseases: HFB200604 (a BTLA agonist monoclonal antibody developed to suppress activated T and B cells), and HFB200902 and HFB101110 both out-Licensed Programs (FribroGen).
The most advanced, HFB200604, is scheduled for IND filing in Q3 2024.
Liang Schweizer, Founder, Chairperson and CEO of HiFiBiO Therapeutics, sits down with Nasdaq Host, Kristina Ayanian, to discuss how the company's single-cell analytics platform is designed to mobilize the human immune system to combat cancer and autoimmune disorders: HiFiBiO Therapeutics: Pioneering Curative Immunotherapies.
HiFiBiO has raised a total of $179.5M.
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💠 Celsius Therapeutics Inc now a part of AbbVie
Celsius Therapeutics located in Cambridge, Massachusetts is a community of scientists, technologists, clinicians and drug hunters leveraging single-cell RNA sequencing, genomic analysis and AI/ML to develop life-changing medicines for cancer and autoimmune disease patients
On June 27, 2024, AbbVie (NYSE: ABBV) announced the acquisition of Celsius Therapeutics, Inc, a privately held biotechnology company pioneering new therapies for patients with inflammatory disease (AbbVie Acquires Celsius Therapeutics).
Celsius' lead investigational asset is CEL383, a potential first-in-class anti-TREM1 antibody that has completed a Phase 1 clinical study for the treatment of IBD (Inflammatory bowel disease). TREM1 (Triggering Receptor Expressed On Myeloid Cells 1) has been identified as a key disease driver gene in IBD, where it is expressed on inflammatory monocytes and neutrophils. In these cell types and others, TREM1 is upstream of multiple known inflammatory pathways and acts as an amplifier of inflammation.
In preclinical assays, CEL383 has been shown to inhibit TREM1 signaling, reducing the levels of multiple inflammatory mediators of high clinical relevance in inflammatory conditions.
Subsequently, a Phase 1 first-in-human, randomized, double-blind, placebo-controlled, single ascending dose study evaluated the safety, tolerability and pharmacokinetics of CEL383 in healthy volunteers (NCT05901883).
Under the terms of the agreement, AbbVie has acquired all Celsius’ equity for $250M in cash, subject to certain customary adjustments.
Apart Celsius Therapeutics, AbbVie also acquired the following TechBio companies:
On May 23, 2024, AbbVie announced also that it had completed the acquisition of Landos Biopharma, Inc (NASDAQ: LABP) that is utilizing its LANCE Advanced AI platform to discover and develop novel oral therapeutics (AbbVie Completes Acquisition of Landos Biopharma). Landos' lead investigational asset is NX-13, a first-in-class, oral NLRX1 agonist (a member of the NOD-like receptor family), which is currently in Phase 2 for the treatment of moderate to severe Ulcerative colitis (NEXUS study, NCT05785715). NLRX1 regulates immunometabolism and inflammation and its activation may address inflammatory bowel disease (pathogenesis.
On January 10, 2023, AbbVie paid $42M upfront to work with the Anima Biotech on small molecule mRNA drugs against three “undruggable” targets in oncology and immunology. Anima Biotech is advancing mRNA Lightning, which is a novel platform for the discovery of selective small molecule mRNA drugs and their mechanisms of action (MoA) (for more about MoA), combining high scale phenotypic screening and AI.
For more about Anima: