Follow the Money: Trials for Major Depressive Disorder Therapies, Kidney Disease Treatment, More
By Clinical Research Staff
October 29, 2024 | Seaport Therapeutics plans to advance their therapeutic candidate SPT-300, an oral prodrug of allopregnanolone; Purespring Therapeutics will initiate a clinical trial for IgAN, a common, chronic kidney disease primarily affecting young adults; and more.
$400M: Series A for Next-Gen Obesity Treatments
Kailera Therapeutics announced its launch as a clinical-stage biopharmaceutical company focused on advancing a broad pipeline of next-generation therapies for the treatment of obesity and related conditions. Kailera is developing several clinical-stage injectable and oral therapies that have demonstrated potential as best-in-class treatments for chronic weight management. Their most advanced program, KAI-9531 (in development as HRS9531 in China) is an injectable GLP-1/GIP (glucagon-like peptide-1, glucose-dependent insulinotropic polypeptide) receptor dual agonist that demonstrated compelling results in Phase 2 trials in obesity and type 2 diabetes in China.
$225M: Series B for Enhanced Bioavailability, Reduced Hepatotoxicity
Seaport Therapeutics closed an oversubscribed $225 million Series B financing round. Seaport will use the proceeds to further advance the capabilities of the Glyph technology platform, which has demonstrated clinical proof-of-concept. The Glyph platform is designed to enable and enhance oral bioavailability, avoid first-pass metabolism and reduce liver enzyme elevations or hepatotoxicity and other side effects to advance clinically active drugs that were previously hindered by those limitations. The most advanced therapeutic candidate in the pipeline is SPT-300, an oral prodrug of allopregnanolone that is being advanced into a Phase 2b study for major depressive disorder with or without anxious distress that has the potential to be registration-enabling. Allopregnanolone is an endogenous neurosteroid with clinically validated rapid anti-depressant and anxiolytic activity, and SPT-300 retains this activity in an oral form.
$175M: Series B for Radiopharmaceuticals Advancement
Aktis Oncology has successfully closed an oversubscribed and upsized $175 million Series B financing. Proceeds will be used to further advance the company's differentiated radiopharmaceuticals pipeline, including its first-in-class Nectin-4-targeted miniprotein radioconjugate.
$126.3M: Series C for Radiopharmaceuticals
Alpha-9 Oncology announced an oversubscribed $126.3 million (approx. CA$175 million) Series C financing to support the progression of its pipeline. The proceeds will fund human studies for the clinical stage assets and advancement of discovery stage assets to clinic-ready development candidates. It will also be used to expand R&D capabilities and continued investment in CMC and supply chain. Alpha-9 has a differentiated toolbox of binders, linkers, chelators and radioisotopes—elements that each play an integral role in radiopharmaceutical development.
$120M: Series B for AI Platform for Target-Ligand Interactions
Terray Therapeutics closed a Series B funding of $120 million. The funding will further enhance Terray’s integrated AI platform, tNova, which it uses to power both internal and partnered programs. Terray’s platform has quantitatively measured 5 billion+ target-ligand interactions in the past 3 years–roughly 50X the entirety of all publicly available chemistry data. This dataset is doubling annually. This data advantage enables best-in-class AI capabilities to identify and optimize novel small molecule solutions to the most complex problems. Terray applies this expertise to its own internal pipeline focused on immunological diseases and to additional challenging targets in partnership with Bristol Myers Squibb and Calico.
$115M: Series B for Monoclonal Antibody Inhibitor and Hereditary Pancreatis Treatment
Triveni Bio announced a $115 million Series B to support pipeline expansion. The proceeds will be used to advance second-generation anti-kallikrein 5/7+IL-13 bispecific (TRIV-573) through clinical proof-of-concept. Triveni Bio also plans to submit an Investigational New Drug (IND) application for its lead candidate, TRIV-509, in the first quarter of 2025. TRIV-509 is a monoclonal antibody inhibitor targeting kallikreins 5 and 7 (KLK 5/7) that has demonstrated superior efficacy compared to IL-4R inhibition in multiple preclinical atopic dermatitis models. TRIV-573 combines KLK 5/7 inhibition with a well-established IL-13 mechanism. They will also advance an antibody inhibitor of trypsin 1 and 2 for the treatment of hereditary pancreatitis, a genetic disorder predominantly caused by PRSS1 mutations. Hereditary pancreatitis, which currently has no approved treatments, impacts around 10,000 individuals in the United States.
$105M: Series B for Kidney Disease Clinical Trial Initiation
Purespring Therapeutics raised $105 million (approx. £80 million) in a Series B financing. Purespring is the first company to successfully treat kidney disease models by directly targeting the podocyte, a specialized cell implicated in approximately 60% of renal diseases, through its proprietary adeno-associated viral (AAV) gene therapy platform. Proceeds will be used to support Purespring’s pipeline including the initiation of a Phase I/II clinical trial for IgAN, a common, chronic kidney disease primarily affecting young adults. About one third of IgAN patients will go on to lose their kidney function within five years and require a kidney transplant or dialysis.
$101.5M: Financing for Phase 3 Trial of Metabolic Dysfunction-Associated Steatohepatitis
Inventiva announced immediate financing of $101.5 million (approx. €94.1 million) and up to $375.7 million (approx. €348 million), subject to satisfaction of specified conditions, to advance the completion of the Phase 3 NATiV3 MASH trial and preparation for the potential filing for marketing approval and commercialization of lanifibranor. Currently, there are more than 1,100 patients randomized in the NATiV3 study evaluating lanifibranor for the treatment of noncirrhotic MASH, with completion of enrollment projected in 1H 2025.
$100M: Series D for Sepsis Diagnostic Test
Cytovale raised $100 million in Series D funding led by Sands Capital. Cytovale will use the funding to build upon its early clinical success and accelerate commercial expansion of IntelliSep to more hospital emergency departments (ED) and health systems nationwide. IntelliSep is the first and only U.S. Food and Drug Administration (FDA)-cleared cellular host diagnostic indicated for use in the ED, where over 80% of sepsis cases present. The test, which takes only approximately eight minutes, provides clinicians a first-ever look into the biology that causes sepsis, enabling care teams to quickly and confidently identify the proper diagnosis and deliver appropriate, patient-centered care.
$100M: Series A for Oligonucleotide Medicines for the Kidney
Judo Bio launched with $100 million in initial financing, including seed financing and Series A. Judo Bio has discovered a novel approach to create oligonucleotide medicines targeted to the kidney. The proceeds from the financing will be used to advance the lead ligand-siRNA conjugate to the clinic and to further build the company’s proprietary STRIKE (Selectively Targeting RNA Into KidnEy) platform. Judo Bio’s initial pipeline programs are megalin-STRIKERs that use the megalin receptor family to selectively deliver siRNA therapeutics to the proximal tubule epithelial cells of the kidney. These megalin-STRIKERs are designed to silence mRNA, resulting in reduction of specific solute carrier proteins (SLCs).
$82.4M: Series B for End-Stage Liver Disease Therapy
Resolution Therapeutics raised £63.5 million in Series B financing. The proceeds from the Series B financing will be used to advance Resolution’s lead candidate, RTX001, an autologous, engineered, pro-regenerative macrophage cell therapy specifically designed to deliver transformative outcomes in patients with end-stage liver disease. EMERALD, Resolution’s first-in-human Phase I/II clinical trial, will be conducted in the UK and Spain and is anticipated to initiate patient recruitment in Q4 2024. Additional uses of proceeds include investment in Resolution’s manufacturing platform and expansion of its pipeline into other inflammatory and fibrotic indications, including graft-vs-host disease (GVHD) and lung fibrosis.
$75M: Financing for Protein Expression System
Nuclera completed a $75 million financing round (approx. £57 million). The investment will enable the continued commercialization of Nuclera’s eProtein Discovery benchtop system, particularly in the US and across Europe. Nuclera’s eProtein Discovery system is designed to speed up protein expression and purification in research labs, including those using AI for protein design. The system reduces the time and cost of these processes by automating construct screening, allowing for protein scale-up, and producing milligram amounts of protein in less than 48 hours, compared to the months or years other methods can take.
$68M: Series A for Trial Advancement of Brain-Penetrant SARM1 Inhibitor
Nura Bio announced the closing of more than $140 million in Series A financing. This includes the addition of $68 million to the initial Series A round of $73 million, which was announced in 2020. The financing close comes at a pivotal point with the Phase 1 success of NB-4746, a brain-penetrant SARM1 inhibitor that has been shown to prevent axon degeneration and provide neuroprotection in multiple preclinical models of nerve injury and disease. Nura Bio plans to initiate a Phase 1b/2 trial in a patient population in 2025.
$60M: Series B for Data Collection, AI Development, and Programmable Genetic Medicines
Basecamp Research completed a $60 million Series B financing and entered a multi-year collaboration with the laboratory of Dr. David R. Liu at the Broad Institute of MIT and Harvard. The Basecamp Research and the Liu Lab collaboration anticipates advancing new approaches to programmable genetic medicines that have the potential to transform treatments for a wide range of diseases. The proceeds will go toward scaling the pace and volume of Basecamp Research’s data collection—growing its foundational dataset that already contains 100 times more advanced biological systems than the public databases most-used by pharma researchers. Basecamp Research will also continue to strengthen its AI capabilities, investing heavily in compute and working on a new generation of foundational models to tackle increasingly complex tasks.
$58M: Series A for Custom Genomic Writing Technology
Constructive Bio secured $58 million in the first close of its Series A financing, bringing the total amount raised by the company to date to $75 million. The investment will be used to further develop Constructive Bio’s technology that writes genomes from scratch and creates entirely new biomolecules. Through genome synthesis, Constructive Bio’s technology is able to write entire custom genomes with full control of the genetic sequence and code. By engineering protein translation, it can create and biomanufacture entirely new molecules with novel properties and functions.
$52M: Series B for Methylmalonic Acidemia Clinical Trial
Genespire announced the closing of a $52 million (approx. €46.6 million) Series B financing. The financing will enable the development of GENE202, the company’s lead candidate, up to a Phase I/II clinical trial for the treatment of Methylmalonic Acidemia (MMA), a devastating genetic disorder impairing the metabolism of certain amino acids and fats. GENE202 is a pioneering off-the-shelf gene therapy which harnesses the company’s Immune Shielded Lentiviral Vector (ISLV) platform. ISLVs are designed to be used intravenously, enabling the patient's liver to produce the therapy throughout its lifetime.
$50M: Series B for Small Molecule Therapeutics
858 Therapeutics raised $50 million in Series B financing. 858 Therapeutics plans to use the proceeds to advance its pipeline of small molecule therapeutics. The company’s lead asset, ETX-19477, is a potent and selective inhibitor of the DNA repair protein PARG and is currently being evaluated in patients with advanced solid tumors. Data from the ongoing clinical trial will provide insights for advancing ETX-19477 through clinical development and for understanding the patients who may benefit most from PARG inhibition.
$43M: Series A for Allosteric Small Molecule MutSβ Inhibitor
LoQus23 successfully closed a $43 million (approx. £35 million) Series A financing. The proceeds of the Series A financing will be primarily used to support the pre-clinical development and initial clinical studies of LoQus23's lead program an allosteric small molecule MutSβ inhibitor. MutSβ inhibitors—and the MutSα inhibitors—are part of the company’s small molecule series that are therapeutically relevant in up to 30 triplet repeat diseases, including Huntington's Disease. LoQus23is preparing its lead program to enter the clinic in 2026.
$43M: Series A for Targeted Cell Depletion Therapies
Arda Therapeutics secured $43m in Series A financing to develop targeted cell depletion therapies. The company is focused on eliminating the cells responsible for disease, rather than simply modulating the proteins they produce. Its advanced single-cell-based discovery engine plays a crucial role in detecting the specific pathogenic cells that cause disease and their surface markers with remarkable precision. Arda's technology could potentially treat a range of conditions including fibrotic diseases such as pulmonary fibrosis, and autoimmune and metabolic disorders.
$32.5M: Series B for TCR-Based Immunotherapies
Enara Bio announced the closing of a $32.5 million Series B financing. Enara Bio will use the proceeds to advance its pipeline of TCR-based immunotherapies against novel and differentiated Dark Antigen targets for solid tumors. Dark Antigens are a rich source of novel cancer-specific targets derived from regions of the genome that were historically considered to be ‘dark’ or non-coding, known as the genomic dark matter. While usually silenced in healthy cells, altered cellular processes in cancer cells lead to the transcription of Dark Antigen-encoding sequences and presentation of novel peptide antigens on the surface of tumor cells.
$28.4M: Series A for CAR-T Cell Therapy Clinical Trial Advancement
MarchBio has received a $28.4 million (approx. £21.9 million) Series A financing round. Since its inception, March Bio has rapidly advanced its innovative autologous chimeric antigen receptor T-cell (CAR-T) therapy, MB-105, in development for the treatment of relapsed and refractory CD5 positive T-cell lymphoma. MB-105 is specifically engineered to overcome major hurdles related to T-cell targeting by overcoming T-cell fratricide while maintaining high potency against CD5 positive tumor cells. MB-105 has demonstrated a favorable safety profile and durable remissions in relapsed T-cell lymphoma patients in a Phase 1 clinical trial at Baylor College of Medicine, with plans to begin a Phase 2 clinical trial in early 2025. Proceeds from the financing will support the Phase 2 clinical development of MB-105 to expand on this data with optimized manufacturing processes.
$27M: Funds Awarded for Gen-AI Discovery Platform and Novel Antibiotics
Phare Bio, along with the Collins Lab at the Massachusetts Inistutte of Technology (MIT), announced that they were awarded up to $27 million in funding from the Advanced Research Projects Agency for Health (ARPA-H), part of the U.S. Department of Health and Human Services, to enhance their generative artificial intelligence (AI) discovery platform and produce novel classes of antibiotics. The funding will help Phare Bio and the Collins Lab to: generate millions of new training data points across key drug development parameters (e.g., toxicology, drug metabolism, formulation) to enable more clinical precision in AI-based drug discovery efforts; share their curated datasets in the first open-source database for AI-based antibiotic discovery; leverage their data to incorporate up to 10 new ‘filters’ into Phare Bio’s generative AI drug discovery engine to produce novel and targeted antibiotics against specific bacterial disease indications (e.g. drug-resistant urinary tract infections, pneumonia, and sepsis); and advance 15 novel AI-generated preclinical antibiotic candidates to help replenish the global pipeline of urgently needed antimicrobials.
$26M: Series A for First-In-Class Small Molecule CMTR2 Inhibitor
Alyssum Therapeutics gained an additional $14.5 million to raise a total of $26 million in Series A financing. Alyssum Therapeutics is developing AT-1965, a clinical stage, first in class small molecule CMTR2 inhibitor that converts immunologically cold tumors into hot and recruits a B cell-driven immune response against the tumor. High expression of CMTR2 in tumors is associated with poor prognosis in many tumors, positioning it as a novel target in cancer therapy. The recruitment of B cells has recently been reported to be the best indicator of long-term survival in cancer patients. Earlier this year, Alyssum had announced the dosing of the first patient with AT-1965.
$20M: Seed Funding for Complex Disease Therapies and Tools
Passkey Therapeutics emerged from stealth with $20 million in seed funding. The funding will support Passkey’s development of SMThs (pronounced as “smiths”)—a new class of single-drug therapies designed to modulate rare combinations of proteins that work together—and Locksmith, the company’s proprietary computational and experimental platform for SMTh discovery. Passkey’s Locksmith platform uses advanced computational and experimental tools to analyze extensive human genetic datasets and identify previously undiscovered combinations of proteins—termed “Multilogs”—that work in concert.
$19.3M: Series B for Novel Lymphedema Treatment
Lymphatica Medtech SA raised $19.3 million (approx. €17.9 million) in Series B funding. This investment will accelerate the clinical development and validation of LymphoDrain, an implantable device designed to treat lymphedema, a chronic vascular condition that currently has no cure and affects millions worldwide. First of its kind, LymphoDrain is easy to implant subcutaneously through a minimally invasive technique and it’s intended to provide unprecedent benefits to patients by locally and actively replacing the lymphatic vessels draining function.
$19M: Series A for Blood Test for Autism Diagnosis
MARAbio closed a $19 million Series A financing. MARAbio is a precision immunology company whose mission is to detect, treat and prevent Maternal Autoantibody Related Autism (MARA), a biological subtype of autism caused by the presence of a pattern of distinct autoantibodies in a mother. The company has developed a proprietary blood test for women to accurately determine if they are carriers of the antibodies that cause MARA. The test can be used to diagnose MARA in children as early as birth as well as predict MARA prior to pregnancy. MARAbio is working to develop pre-symptomatic interventions, including therapeutic treatments, which will enable families and physicians to detect and limit the incidence of this subtype of autism.
$17.2M: Seed Financing for Thymus-Based Therapies for Immune-Mediated Diseases
Tolerance Bio announced the closing of its oversubscribed $17.2 million seed financing round. Tolerance Bio is developing an allogeneic, or “off the shelf,” thymus induced pluripotent stem cell (iPSC)-based cell therapy platform as well as pharmacological thymus therapies to address immune-mediated diseases caused by abnormalities in immune tolerance, including cancer, autoimmunity, transplant rejection, infections, immune deficiencies, and allergies. The thymus, an organ in the chest, plays a crucial role in training T lymphocytes (T cells) to defend against threats such as infections and cancers while preventing autoimmunity. The T cell repertoire is developed in the first two years of life, and the thymus then declines with age, increasing the risk of immune diseases and mortality.
$16M: Seed Funding for Cell Simulation AI Platform
Shift Bioscience raised $16 million (approx. £12.5 million) in seed funding. The investment will be used for the continued development of Shift Bioscience’s artificial intelligence (AI) cell simulation platform, for the identification of genes that can safely rejuvenate cells to combat the effects of age-related illnesses. The funding will also support the development of an IP portfolio for the novel rejuvenation genes identified by Shift Bioscience.
$15.3M: Series A for Commercialization of Clinical Diagnostic AI
Mindpeak raised $15.3 million in a Series A funding round. This new investment will enable the company to further expand the commercialization of its pioneering technologies across several geographies. Mindpeak’s AI algorithms were among the first to be deployed for routine clinical diagnostics in both the US and EU. The company’s solutions enable automated histological and immunohistochemical tissue analysis, helping experts make more confident decisions.
$15M: Financing for Next-Gen Tests for Tau Tangle Pathology
C2N Diagnostics received a new $15 million program-related investment from GHR Foundation (GHR) to support the next generation of tests specific to tau tangle pathology. Tau tangles represent an integral component of Alzheimer’s disease pathology and are believed to play an important role in clinical progression of the disease. This next generation of tests offers a potential alternative to invasive, costly, and often inaccessible tau PET tracers. The new tests will focus on a combination of tau-based blood biomarkers, including MTBR-tau, which are important indicators of pathological tau tangles and neurites associated with Alzheimer’s disease. These blood biomarkers may aid in differential diagnosis of clinical Alzheimer’s disease among people with cognitive symptoms, biologically stage the disease, and help inform the development of tau-directed therapeutics by providing insights into tau pathology.
$15M: Financing for Small Molecule Discovery Platform
Booster Therapeutics launched with the support of a $15 million financing. Booster is discovering small molecules through its DGRADX platform, which combines proprietary methods for automated high-throughput screening with advanced structural and computational tools. The company has built an extensive library of activator compounds with therapeutic potential and aims to develop a multi-disease pipeline to address proteinopathies.
$12.9M: Series A for First-In-Class Allogeneic Innate Cell Therapy
LIfT BioSciences successfully raised $12.9 million (approx. £10 million) in the first close of a Series A financing with the second close scheduled for Q1 2025. LIfT is developing an allogeneic innate cell therapy platform called Neutrophil Only Leukocyte Infusion Therapy (N-LIfT) that produces a new type of myeloid cell called Immunomodulatory Alpha Neutrophils (IMANs). IMANs are a type of super enhanced neutrophil with a unique dual mode of action that can kill cancer cells both directly and indirectly, through recruiting the patient’s own immune cells by modulating the tumour microenvironment (commonly known as turning “cold” tumors “hot”). The funds raised will be used to advance the Company’s IMANs into clinical trials through a Phase I Investigator Initiated Trial with Galway University. The objectives of this study will be to demonstrate that IMANs are safe and well tolerated and can successfully recruit other immune cells inside the tumour to improve immune infiltration, a major obstacle in the treatment of cancer. The proceeds will also allow LIfT to further develop its N-LIfT platform to secure partnering and licensing agreements with pharmaceutical companies.
$12M: Series B for Novel Degrader Programs
PhoreMost added $12 million to its Series B financing, bringing the total raised to over $50 million. The additional investment will support the progression of PhoreMost’s pipeline of novel degrader assets. This new investment will enable pipeline progression of PhoreMost’s novel degrader programs in oncology and inflammatory diseases towards preclinical development. Additionally, the funding supports further deployment of the recently launched GlueSEEKER platform2, informing molecular glue design for unprecedented targets, and support the growth of new and existing pharma collaborations.
$10.8M: Series A for Bioinformatics Platform Expansion
Sequentia Biotech closed a $10.8 million (approx. €10 million) Series A. The investment will accelerate Sequentia Biotech’s mission to drive innovation in the field of #omics, the collective characterization and quantification of pools of biological molecules that translate into the structure function and dynamics of an organism(s). The funds will also enable Sequentia Biotech to accelerate the market introduction and expansion of its flagship platform, MICK, and the scale up of its Best-in-Class Bioinformatics Enabling Technologies, driving its ambitious go-to-market strategy. The MICK platform provides state-of-the-art data analysis and interpretation, enabling a deeper exploration of microbiome data and translating it into actionable insights for multiple applications.