AI-powered drug discovery: update (V)
AI-powered drug discovery: update (V)
MetaphysicalCells: A newsletter about Science, Technology and AI Drug Discovery
This newsletter is part of a series of newsletters dedicated to AI-drug discovery progress of drug candidates in preclinical and clinical phases. For the previous newsletters:
“There is no religion better than love, no color better than the color of happiness and no language better than the language of compassion.”
By Abhijit Naskar, Love, God & Neurons: Memoir of a scientist who found himself by getting lost
Index for “AI-powered drug discovery: update part V” 🗃️
1910 Genetics
Seismic Therapeutics
AbCellera
BioXcel
Sinopia Biosciences
RubrYc Therapeutics acquired by iBio
Numedii
Envisagenics
Gritstone Bio
Generate Biomedicines
Biolojic Design
Evaxion Biotech
⚗️ 1910 Genetics Inc
1910 Genetics (2018, US) integrates AI with three proprietary data streams, computational data, wet lab proxy biological data and wet lab biological data, to deliver novel drug candidates and software solutions to leading pharma and tech partners, and advance their internal pipeline for neurological, autoimmune diseases and cancer. They address key challenges of small and large molecule drug discovery with their Input-Transform-Output (ITO™) platform.
In particular, they use atomistic modeling and parallel simulations to generate billions of computational data points, which are purpose built for their SOTA AI models. They leverage their SOTA robotics-driven lab facility to design and scale wet lab ground truth biochemical, cellular and pharmacological in vitro assays for training their AI models (in vitro ADME, in vivo PK, PD, efficacy), and validate the small and large molecule therapeutics they design.
On April 29, 2024, 1910 Genetics announced that it was combining its strengths with Microsoft’s high-performance computing platform, Azure Quantum Elements. The goal of this five-year commercial agreement and go-to-market collaboration is to create an AI-driven drug discovery and development platform that helps R&D teams generate drugs faster and cheaper than has previously been possible.
1910 Genetics is working on non-receptor tyrosine-protein kinase TYK2 (JH2 domain) inhibitors, reported to be useful for the treatment of allergy, cancer, inflammation, autoimmune disease, metabolic diseases, endocrine and neurological disorders.
1910 Genetics has raised a total funding of $29.8M over 3 rounds. They are backed by leading investors including M12 - Microsoft's Venture Fund, Playground Global, Sam Altman, Y Combinator, FoundersX Ventures, Scientia Ventures, and many others
🧬 Seismic Therapeutic Inc
Seismic Therapeutic is a ML Immunology company that was founded in 2020 with the help of Harvard billionaire professor Timothy Springer, Ph.D. and other academic founders, Jo Viney, Ph.D. and Alan Crane, with $101M to start off.
Usually, traditional protein identification and optimization involves inefficient, independent sequential iteration and protracted combination steps. Seismic’s IMPACT platform enables parallelized multi-property optimization by integrating ML with structural biology, protein engineering and translational immunology for the accelerated generation of novel biologics.
The IMPACT platform opens new protein sequence space, allows the simultaneous optimization of multiple drug-like properties, including immunogenicity, and reduces both the number and duration of design/test cycles:
allowing to find previously unexplored sequences and to design proteins with optimal drug-like properties,
allowing to remove B and T cell epitopes from novel biologic drugs to make them invisible to the immune system while retaining fitness and function of these drugs, and
enabling parallelization, thereby removing many cycles of iteration and mutation combinations and shortening the time of each cycle to rapidly identify top candidates.
On January 4, 2024, Integral Molecular, a biotech specializing in antibody discovery against undruggable protein targets, announced that it has entered into an antibody license agreement with Seismic, that will provide an exclusive license to Seismic for a collection of fully humanized, highly specific, preclinical antibodies to add to their platform, library and pipeline of molecules in the immunology space.
On June 04, 2024, Seismic Therapeutic announced that the company will participate in three upcoming scientific conferences, presenting data on Seismic’s emerging pipeline of novel therapeutics to treat rare and prevalent autoimmune diseases. The company’s two lead drug candidates that will be highlighted are:
S-1117, a novel pan-immunoglobulin (Ig) G protease addressing multiple pathogenic mechanisms in autoimmune disease, and
S-4321, a PD-1 agonist Fc gamma receptor IIb selective Dual-cell Bidirectional (DcB) antibody.
Last year Seismic Therapeutic secured $121M (for a total of $222M).
🧪 AbCellera Inc
AbCellera (Vancouver, Canada, 2012) is an AI-powered therapeutic antibody company. With their full-stack AI-powered antibody discovery platform they search, decode and analyze natural immune systems to find antibodies that their partners can develop into drugs that improve health. They combine proprietary repertoire sequencing technologies with functional data from single B cells to annotate immune repertoires and boost the number of candidates and they explore large multidimensional data with Celium™, their proprietary antibody visualization software.
Their first two preclinical programs in their internal pipeline are
ABCL575 (for atopic dermatitis targeting OX40L) and ABCL635 (undisclosed, unknown target), both IND-enabling studies (IND submissions for both ABCL575 and ABCL635 are anticipated in 2025).
In addition, they anticipate that additional development candidates will enter IND-enabling studies in 2024 and 2025. And
T-cell engager (TCE) programs for cancer therapy:
CD3-binding antibodies that consistently generate T-cell engagers with potent tumor-cell killing and low cytokine release across multiple tumor targets, including PSMA, B7-H4 and 5T4.
Costimulatory CD28-binding antibodies that stimulate T cells without superagonist activity. And
Highly specific T-cell engagers for the peptide-MHC target MAGE-A4.
In November 2023, AbCellera signed a multi-year, multi-programme deal with Prelude Therapeutics (NASDAQ: PRLD). On March 12, 2024, AbCellera Announced to Collaborate with Biogen to Discover Therapeutic Antibodies for Neurological Conditions (NASDAQ: BIIB). On May 1, 2024, AbCellera, Viking Global Investors and ArrowMark Partners announced that they have entered into a collaboration to advance new antibody drug programs with an aim to launch multiple asset-based companies. Their first two programs will be in the area of immunology. Under the collaboration, ArrowMark and Viking will lead the initial process of program selection, followed by joint determination of the therapeutic product profile and AbCellera’s initiation of new antibody drug programs. Finally, Empirico, a biotechnology company that combines unmatched expertise in human genetics-driven target discovery with world-class capabilities in siRNA drug discovery, also has a strategic collaboration with AbCellera.
AbCellera (NASDAQ: ABCL) has raised a total of $516M of funding over 11 rounds.
🦠 BioXcel Therapeutics Inc
BioXcel Therapeutics in the US was spun out of BioXcel Corporation in March 2017 to leverage AI and ML for drug re-innovation, and now utilizes AI to find applications for existing approved drugs or clinically validated candidates in immuno-oncology, neuroscience and rare diseases. BioXcel’s leading product is IGALMI™, a sublingual film used to treat agitation associated with schizophrenia or bipolar disorder. It was approved in April 2022 and is currently on the market.
Since BioXcel Therapeutics aims to become the leading AI-enabled neuroscience company, entered a $260M long-term financing agreement with Oaktree Capital Management and Qatar Investment Authority to accelerate growth and to commercially launch IGALMI™, in return for a share of the profits.
On June 25, 2024, BioXcel Therapeutics announced positive topline results from a post-marketing requirement study of IGALMI™ sublingual film that demonstrated no evidence of tachyphylaxis, tolerance, or withdrawal with the 180 mcg dose after seven days of treatment.
On July 16, 2024, BioXcel Therapeutics announced preliminary estimated unaudited net revenue results from sales of IGALMI™ for the second quarter ended June 30, 2024. BioXcel expects unaudited revenue of approximately $1.1M for the three months ended June 30, 2024, representing an increase of approximately 90% quarter over quarter and approximately 141% compared to the same period in 2023.
Moreover,
on February 06, 2024, BioXcel Therapeutics announced the completion of patient enrollment in the safety lead-in portion of the investigator-sponsored Phase 2 trial of BXCL701 in combination with KEYTRUDA® (pembrolizumab by Merck & Co, NYSE: MRK) in previously treated metastatic pancreatic ductal adenocarcinoma (PDAC). BXCL701 (talabostat) is an oral small molecule inhibitor of dipeptidyl peptidases (DPP), primarily DPP8 and DPP9, which triggers inflammasome mediated pyroptosis in macrophages leading to induction of IL-18 and IL-1beta, bridging between innate and adaptive immunity.
on February 12, 2024, BioXcel Therapeutics, Inc. (Nasdaq: BTAI) announced that the FDA has designated as a Fast Track development program the investigation of BXCL701 in combination with a checkpoint inhibitor (CPI) for the treatment of patients with metastatic small cell neuroendocrine prostate cancer (SCNC) with progression on chemotherapy and no evidence of microsatellite instability.
on April 10, 2024, BioXcel announced details regarding the planned design of its upcoming TRANQUILITY In-Care Phase 3 trial to evaluate BXCL501, the company’s investigational proprietary, orally dissolving film formulation of dexmedetomidine, as a potential acute treatment for agitation associated with Alzheimer’s dementia (AAD).
BXCL501 is also being investigated in the Serenity phase 3 trial for schizophrenia.
BXCL501 is BioXcel’s most advanced neuroscience clinical asset. In indications other than those approved by the FDA as IGALMI, BXCL501 is an investigational, proprietary, orally dissolving film formulation of dexmedetomidine, a selective alpha-2 receptor agonist targeting symptoms from stress-related behaviors such as agitation.
BXCL501 has been granted Breakthrough Therapy designation by the FDA for the acute treatment of agitation associated with dementia and Fast Track designation for the acute treatment of agitation associated with schizophrenia, bipolar disorders, and dementia.
Just this month, AI Drugmaker BioXcel Beats Investor Fraud Suit, For Now.
🔬 Sinopia Biosciences Inc
Sinopia Biosciences founded in 2011 in California 🌵 is enabling the promise of data-driven drug discovery (D4) by applying high-throughput multi-omics data, ML and network analyses, and disease models (genome engineered in vitro models and relevant in vivo models). The company is focused on metabolomics.
So far, the vast majority of all omics data used for understanding diseases and therapeutics has been generated by microarray and sequencing technologies for DNA and RNA. Focusing on nucleotides was an obvious choice in the previous two decades however, not measuring other biomolecules at scale limits the ultimate utility of D4.
Accordingly, combining pioneering advances in metabolomics technologies and computational data analysis is now enabling Sinopia to study diseases and compounds at an unprecedented level of biomolecular detail using signals (i.e. metabolites) that most closely relate to cellular functions. These advances in multi-omics data generation and ML analysis led to it's platform LEADSTM (LEarn And DiScover). In the Learn step, the platform combines ML and network analysis of multi-omics data (genes, proteins and the environment) to identify common disease mechanisms. And in the DiScover step, the platform uses high-throughput screening to rapidly screen millions of candidate molecules, and identify and test new targets and compounds.
On April 19, 2023, Sinopia announced that it has selected SB-0110 (a novel proprietary small molecule) after extensive preclinical studies as its lead clinical candidate for Parkinson’s disease and levodopa-induced dyskinesia.
SB-0110 is a novel, proprietary small molecule with a unique mechanism of action. In multiple preclinical rodent and non-human primate studies, SB-0110 has demonstrated a unique and potentially transformative pharmacology for treating both the symptoms of Parkinson’s disease and also the complications of levodopa, (i.e., levodopa-induced dyskinesia). Further, SB-0110 has demonstrated potential for cognitive enhancing effects in non-human primate models of Parkinson’s disease, an area of high unmet need with no approved treatments
On May 30, 2024, Sinopia Biosciences announced that it has been awarded a Small Business Innovation Research (SBIR) grant from the National Institute of General Medical Sciences (NIGMS) to advance its computational drug discovery LEADS™ platform and explore applications in oncology and immunology.
Sinopia Biosciences has raised $14.1M and the co-founders are Aarash Bordbar and Bernhard Palsson.
🧑🔬 RubrYc Therapeutics Inc
iBio, a developer of next-generation biopharmaceuticals, announced that it has closed on the acquisition of all of the assets of RubrYc Therapeutics, Inc (iBio Acquires RubrYc Therapeutics’ AI Drug Discovery Platform and Pipeline), on September 27, 2022, with an upfront payment of $1M in iBio’s common stock to RubrYc investors and eligibility for RubrYc’s investors to receive up to $5M in development milestones over the next five years.
The acquired assets of RubrYc Therapeutics by iBio, Inc (NYSEA:IBIO) (a pioneer of the sustainable FastPharming Manufacturing System) include:
a patented system that uses AI to design 3D models of epitopes to facilitate the creation of better antibody drug candidates. In particular, the RubrYc Discovery Engine uses predictive algorithms to identify and model subdominant and conformational epitopes, enabling the discovery of new antibody treatments for hard-to-target cancers and other diseases.
previously licensed candidates: IBIO-101 (an IL-2 sparing anti-CD25 antibody for depletion of regulatory T cells) and “Target 5”.
IBIO 101 (formerly known as RTX 003) is a targeted anti-CD25 (IL2Rα) monoclonal antibody, and anti-tumor responses have been observed in pre-clinical models of disease using IBIO-101 as a monotherapy, as well as in combination with checkpoint inhibitors. And
new 🆕 therapeutic candidates: three promising immuno-oncology candidates, plus a partnership-ready PD-1 agonist for serious autoimmune diseases, such as systemic lupus erythematosus and multiple sclerosis.
On February 26, 2024, iBio announced that it has entered into an asset purchase agreement with Otsuka Pharmaceutical Co., Ltd., to which Otsuka acquired iBio’s assets related to its early-stage programmed cell death protein 1 (“PD-1” ) agonist program. The transaction closed on February 25, 2024 (iBio Announces Sale of Preclinical PD-1 Agonist Antibody Program to Otsuka).
Latest News 🐋
🐋 Backed by Nvidia and Pfizer, Israeli AI medical startup raises $80m in fresh capital
Tel Aviv-based CytoReason, which uses machine learning to build computational models of human diseases to speed up treatment discoveries, plans to open a US office later this year
🐋 Living Cell Technologies Unveils AI Drug Discovery Platform
Living Cell Technologies Ltd. is set to launch its AlgoraeOS AI platform, which will predict drug combinations for diseases by analyzing vast medical data.
🐋 The Bioptimus team just released H-optimus-0
H-optimus-0 is the world’s largest open-source AI foundation model for pathology that achieves SOTA performances in many important downstream tasks
🐋 OpenAI and Los Alamos National Laboratory announce bioscience research partnership
OpenAI and Los Alamos National Laboratory are developing evaluations to understand how multimodal AI models can be used safely by scientists in laboratory settings
🐋 Singapore's BluMaiden Secures Major Funds for AI Drug Discovery Expansion
Utilizing AI-guided computational genetics and chemistry, BluMaiden aims to explore the extensive chemical space within the human body to develop new medicines.
🐋 Insilico Medicine launches AI assistant for drafting medical research papers
Named DORA, the manuscript helper taps multiple AI and large language models to support the drafting of academic papers and case studies, in addition to applications for grants and patents.
⚗️ Numedii Inc
NuMedii (California US, 2008) uses its Life Sciences Big Data technology to discover and de-risk new indications for existing drugs and to discover and de-risk new molecular entities based on therapeutically relevant biological networks. It partners with pharmaceutical companies for the clinical development and commercialization of its de-risked drug candidates.
NuMedii, announced in January 2020 a new partnership with a drug delivery company to develop new therapeutics for ulcerative colitis. The collaboration will bring together NuMedii’s NM-001 asset for ulcerative colitis and a proprietary delivery technology that enables efficient delivery to the gastrointestinal tract ("NuMedii, Inc. Announces Pharmaceutical Discovery Collaboration For Ulcerative Colitis").
🧬 Envisagenics Inc
Envisagenics (founded in 2014 as a spinout of Cold Spring Harbor Laboratory) has an AI-driven technology, SpliceCore, that is a cloud-based platform experimentally validated to predict drug targets and biomarkers through splicing ✂️ discovery from RNA-sequencing data (in-silico RNA therapeutics discovery platform). According to the company, it ensures higher precision and speed compared to traditional methods. Led by Dr. Adrian Krainer, Envisagenics’ founding scientific team helped in the development of SPINRAZA that became in 2016 the first FDA approved RNA therapeutic to treat Spinal Muscular Atrophy by correcting the disease-causing splicing error.
In their pipeline, the most advanced program is Breast Cancer ASO, in the preclinical phase. On April 25, 2024, Envisagenics announced the publication, in the journal Molecular Systems Biology, of the results evaluating SpliceCore in Triple Negative Breast Cancer (TNBC). The study demonstrated the efficacy of AI/ML for target discovery in TNBC and for identifying functional and verifiable splice-switching oligonucleotides (SSOs) crucial for the development of RNA therapeutics for TNBC (Development and validation of AI/ML derived splice-switching oligonucleotides), targeting NEDD4Le13 that decreased the proliferative and migratory behavior of TNBC cells via downregulation of the TGFβ pathway.
On June 05, 2024, Envisagenics announced a Series B fundraising round with participation from existing investors Third Kind Venture Capital, Empire State Development and Red Cell Partners, and new strategic investor Bristol Myers Squibb (NYSE: BMY).
Envisagenics has raised a total of $52M.
🧪 Gritstone Bio Inc
Gritstone (founded in August 2015 as Gritstone Oncology, Inc and based in Emeryville, California) is developing tumor-specific cancer immunotherapies to fight multiple cancer types. The company has developed its product candidates using two key pillars: 1) a proprietary ML based platform, Gritstone EDGE™, which provides a powerful ability to predict from a routine tumor biopsy the tumor-specific neoantigens, or TSNA, that are presented on a patient’s tumor cells and 2) the ability to develop and manufacture potent immunotherapies utilizing patients’ TSNA to drive the patient’s immune system to attack and destroy tumors.
Unfortunately, Gritstone Bio (Nasdaq: GRTS) announced on April 2, 2024 that its personalized cancer vaccine didn’t induce more responses than standard of care in a trial for colorectal cancer, raising questions about the future of both the program and the company (Gritstone Bio says personalized cancer vaccine falls short in key trial). The cancer vaccine failed to trigger hoped-for changes in circulating tumor DNA (ctDNA), causing the phase 2 trial to miss its primary endpoint.
On July 22, 2024, Levi & Korsinsky, LLP notified investors in Gritstone Bio (NASDAQ: GRTS) of a class action securities lawsuit (Gritstone bio, Inc. Sued for Securities Law Violations - Investors Should Contact Levi & Korsinsky for More Information - GRTS).
On July 24, 2024, Gritstone announced it will host a virtual key opinion leader event on Friday, August 2 at 9:00 AM ET, featuring J. Randolph Hecht, MD, (Professor, UCLA Gastrointestinal Oncology Program) and Howard Brown (CRC Survivor, Patient and Advocate) who will discuss the unmet need and current treatment landscape for patients with metastatic microsatellite stable colorectal cancer (MSS-CRC).
Gritstone management will also highlight the development of Gritstone’s personalized neoantigen vaccine program, GRANITE, as a potential treatment for immunologically “cold” tumors including MSS-CRC. Mature progression-free survival data from a randomized Phase 2 study of GRANITE in frontline MSS-CRC are expected in the third quarter of 2024.
They also have the SLATE program an 'Off the shelf' vaccine program for solid tumors (KRAS-driven tumor types) in phase 2 and a phase 1 HIV Therapeutic vaccine in collaboration with Gilead (NASDAQ: GILD).
👩🔬 Generate Biomedicines Inc
Generate Biomedicines—existing at the intersection of ML, biological engineering and medicine—is using ML algorithms to generate novel sequences for proteins (antibodies, peptides, enzymes, stealth proteins) that have never been seen in nature.
Generate Biomedicines (2018), that is Flagship Pioneering Company, released a diffusion model for protein design called Chroma, that learns patterns in the 3D structures and amino acid sequences of proteins and protein complexes from the Protein Data Bank, and can then synthesize new protein molecules that adhere to specific principles while combining them in novel ways. Chroma is able to generate extremely large proteins and protein complexes (e.g. 30,000+ heavy atoms across 4,000+ residues) in a few minutes on a single commodity GPU.
By harnessing the power of data and ML at Generate they have the following programs in in areas such as:
Oncology: 6 programs in total in preclinical phase, two in collaboration with the University of Texas MD Anderson Cancer Center and two in collaboration with Rosewell Park.
Immunology:
GB-0895 targeting TSLP, in phase 1
On January 4, 2024, Generate announced key advancements across its clinical pipeline and generative AI platform, including its first patient dosed with GB-0895, an anti-TSLP monoclonal antibody for the treatment of mild-to-moderate asthma.
They successfully dosed the first patient with GB-0895 in the UK. And the primary endpoint of the study, which will also be conducted in Germany, aims to evaluate the safety and tolerability of GB-0895 for subcutaneous administration, with the goal of selecting 1–2 doses/regimens to advance in development.
Generation program targeting TL1A, in preclinical
Generation program targeting IL-13, in preclinical
Undisclosed: 6 programs in total in collaboration with Amgen.
On January 4, 2024, Generate announced key advancements across its clinical pipeline and generative AI platform, including an expansion of its collaboration agreement with Amgen (NASDAQ: AMGN).
Amgen has exercised its rights under the collaboration agreement to opt in for a sixth program. This represents the first expansion of the original agreement, and as a result, Amgen will make an undisclosed upfront payment and will pay up to $370M in future milestones and royalties up to low double digits for this new program.
On September 15, 2023, Generate Biomedicines secured $273M to advance its therapeutic portfolio. To date, the company has raised $700M from Flagship Pioneering, Amgen and Nvidia, among others.
🧫 Biolojic Design Ltd
Biolojic Design (Israel, US) is utilizing ML to create superior drugs by programming antibodies to become dynamic functional switches that affect biology in new ways. Biolojic’s AI-designed antibodies provide a precise molecular effect, in the desired micro-environment, at the right time, leading to greater efficacy and lower toxicity, while maintaining impeccable developability, half-life, stability and safety of human antibodies.
In particular, their platform mimics the way the human immune system makes antibodies, allowing them to create personalized smart drugs that act like nanobots in the body. Unlike conventional drugs, which behave the same way everywhere, these programmable antibodies can sense the micro-environment in a specific patient at a specific time and respond dynamically.
For example, AU-007 is the first-ever computationally designed antibody to enter human clinical trials and was designed by Biolojic to precisely bind to pre-defined epitope on interleukin-2 (IL-2) to redirect IL-2 toward cells that express dimeric receptors (T effs, NKs, NKTs), and away from cells that express the trimeric receptor (T regs, vascular endothelium). Thus, AU-007 unlocks the full potential of IL-2 to fight cancer: it starves the cells that protect the tumor and nourishes those cells that kill the tumor.
On April 24, 2024, Biolojic Design announced that Nektar Therapeutics (NASDAQ: NKTR) exercised its license option to develop a program resulting from the companies’ research collaboration initiated in 2021. The research collaboration was established to design and test agonistic antibodies targeting tumor necrosis factor receptor type II (TNFR2), a target implicated in a wide range of autoimmune diseases that has been difficult to drug with conventional medicines.
On June 3, 2024, Biolojic Design Entered into a Multi-Target Drug Discovery Collaboration with Merck KGaA, Darmstadt, Germany. Merck (ETR: MRK) will leverage Biolojic Design’s AI capabilities to create potential best-in-class multi-specific antibodies that uniquely modulate biology, and Biolojic Design will receive a low double-digit million euro upfront payment and is eligible for up to €346M in discovery, development, regulatory and commercial milestones, in addition to royalty payments on net sales.
Biolojic Design has raised about $30M to date.
🦠 Evaxion Biotech A/S
Evaxion Biotech (Denmark, 2008) is a preclinical-clinical AI immunology platform company aiming to develop novel immunotherapies to treat cancer and infectious diseases. PIONEER™ is their proprietary AI-Immunology model for the rapid discovery of patient-specific neoantigens used for personalized cancer immunotherapies. Using proprietary computational AI models developed at Evaxion, PIONEER™ has been developed to select the neoantigens that are most likely to generate a strong T-cell response and anti-tumor effect in each patient. This platform holds the potential for generating one new target every 24 hours.
EDEN is their second AI platform that rapidly identifies novel, highly protective antigens for the use in pathogen-specific prophylactic vaccines against bacteria, and RAVEN is their third proprietary AI platform that brings a unique ML approach to vaccine design and development for viral diseases.
📯 On February 20, 2024, Evaxion Biotech A/S (NASDAQ: EVAX) announced the successful completion of the initial phases of its vaccine collaboration with MSD (Merck Sharp & Dohme, NYSE: MRK, or MSD outside the United States and Canada) for EVX-B3. EVX-B3 (in target discovery) is an AI-designed vaccine candidate against an undisclosed bacterial pathogen. EVX-B3 aims to address a serious global medical issue, targeting a pathogen associated with repeated infections, increasing incidence and often serious medical complications, and for which no vaccines are currently available.
Moreover, always in collaboration with MSD, Evaxion is co-developing EVX-01 (in phase 2 clinical trial), a peptide-based neoantigen cancer therapy intended for the first-line treatment of a variety of metastatic and unresectable melanoma. EVX-01 has shown promising clinical results in, with patients benefiting, and even recovering, after receiving the therapy.
On June 03, 2024, Evaxion Biotech A/S reported data from its ongoing Phase 2 study at the American Society of Clinical Oncology (ASCO) Annual Meeting 2024. The data demonstrated vaccine-induced immune response in metastatic melanoma patients treated with the personalized cancer vaccine, EVX-01, in combination with an anti-PD1 inhibitor. The EVX-01 vaccine targets neoantigens, antigenic sequences derived from cancer mutations, that are displayed on the surface of the cancer cells, allowing the immune system to recognize, attack and eliminate the malignant cells.
On June 17, 2024, Evaxion announced the publication of data from its Phase 1 dose escalation study of its lead personalized cancer vaccine candidate, EVX-01, for metastatic melanoma. The study results, published in the Journal for ImmunoTherapy of Cancer, demonstrated that eight out of 12 patients (67%) experienced objective clinical responses with six partial and two complete responses. Further, EVX-01 immunization did not induce vaccine-related serious adverse events in patients co-administered with anti-PD1 therapy.
Other programs in preclinical phase are:
EVX-03 is an improved, next-generation DNA-based neoantigen cancer immunotherapy, intended for the treatment of advanced solid cancer.
EVX-B1 is a multi-component vaccine, initially developed for the prevention of S. aureus-induced skin and soft tissue infections.
EVX-B2 is a multi-component vaccine against Gonnorhea. And
EVX-V1 is a vaccine against Cytomegalovirus (co-developed with ExpreS2ion Biotechnologies).
In phase 1/2a, they have EVX-02, a DNA-based neoantigen cancer immunotherapy, intended for the adjuvant treatment of patients with advanced resectable melanoma. Despite surgical removal of the tumors and subsequent treatment with checkpoint inhibitors, still, too many patients relapse and eventually succumb to their disease.
Evaxion Biotech has raised a total of $92M.
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This is so epic! Getting hard to keep up with all of this.