Normal remedy for a lot of autoimmune illnesses contains medicine that suppress the immune system. Even when this strategy works (and it doesn’t work for everybody), continual immunosuppression places sufferers vulnerable to infections amongst different issues. Nuvig Therapeutics is creating a first-in-class drug that would supply an alternate remedy for autoimmune illnesses and the startup now has $161 million to advance scientific improvement of its lead program.
Nuvig goals to deal with autoimmune illness by tapping right into a built-in mechanism of the physique that tamps down inflammatory pathways. The Menlo Park, California-based firm’s medicine are proteins engineered to bind to kind II Fc receptors, a category of receptors that regulate immune responses. The corporate says the binding of its drug to those receptors results in the growth of regulatory T cells, or Tregs, a kind of immune cell that suppresses immune responses. This strategy additionally downregulates quite a few inflammatory pathways .
Lead Nuvig program NVG-2089 has Section 1 outcomes displaying it was protected and effectively tolerated. Additionally necessary, the outcomes confirmed the drug engaged its goal. In Section 2, Nuvig will take a look at NVG-2089 as a remedy for continual inflammatory demyelinating polyneuropathy (CIDP), a uncommon dysfunction wherein the immune system assaults myelin, the protecting sheath protecting nerve fibers. This illness results in nerve and motor issues in addition to progressively worsening muscle operate.
Normal CIDP remedy contains intravenous immunoglobulin (IVIg), an infusion of antibodies sourced from wholesome donors. This remedy gives a affected person with antibodies that block the inflammatory processes that injury myelin. Immunosuppressants are one other CIDP remedy choice. Not all sufferers reply to those therapies, however there’s already a brand new various. This previous June, the FDA expanded the approval of Argenx drug Vyvgart Hytrulo to incorporate CIDP. This injectable drug, which was initially permitted to deal with generalized myasthenia gravis, is an antibody fragment designed to bind to and block the neonatal Fc receptor (FcRn). Consequently, disease-driving autoantibodies go to a mobile system that degrades proteins.
By means of the primary three quarters of 2024, Argenx reported greater than $1.4 billion in product gross sales, a 77.5% improve over the identical interval in 2023. These figures contains Vyvgart, the unique intravenously infused formulation of the FcRn inhibitor. Argenx has touted its drug’s potential makes use of in a variety of autoimmune indications and the corporate is in varied phases of scientific improvement testing its FcRn-blocker in a number of illnesses. Equally, Nuvig says its drug has the potential to handle many autoimmune indications. However first, the corporate will see how its drug works in CIDP.
Nuvig selected CIDP as a result of it is a sign the place IVIg is the usual of care and there may be nonetheless unmet want for a better-tolerated remedy that isn’t immunosuppressive, co-founder and Chief Scientific Officer Pamela Conley stated in an e mail. She added that her firm’s strategy is distinct from that of the Argenx drug and different FcRn inhibitors. Most autoimmune illnesses, together with CIDP, aren’t totally mediated by the presence of autoantibodies, she defined. Moderately, many of the injury in CIDP is mediated by immune cells that infiltrate the myelin that defend nerve cells.
An FcRn blocker like Argenx’s drug does nothing to scale back the infiltration of immune cells into myelin, Conley stated. Moreover, blocking FcRn results in an as much as 80% discount in general circulating antibodies. Persistent upkeep of those low antibody ranges is immunosuppressive, placing sufferers vulnerable to an infection.
Moderately than being immunosuppressive, Nuvig’s drug is immunomodulatory, Conley stated. The drug gives a broader strategy by down regulating the response of immune cells that drive irritation whereas additionally increasing and activating Tregs, which is analogous to what occurs with IVIg. Conley added that scientific assessments of the Argenx drug confirmed the general response of CIDP sufferers was lower than what has been noticed in CIDP research with IVIg.
“We imagine that the [mechanism of action] of NVG-2089 will result in larger efficacy in CIDP than what was noticed with Vyvgart,” Conley stated.
Nuvig, which is predicated on analysis from The Rockefeller College, emerged from stealth in 2022 backed by a $47 million Sequence A spherical. The brand new Sequence B spherical was co-led by Sanofi Ventures, Blue Owl Healthcare Alternatives (previously Cowen Healthcare Investments), and Norwest Enterprise Companions. Different contributors embrace new traders B Capital, Leaps by Bayer, International BioAccess Fund, LOTTE Holdings, Alexandria Enterprise Investments, and funds managed by abrdn Inc., in addition to earlier traders Novo Holdings, Platanus, Bristol Myers Squibb, Digitalis Ventures, and Mission BioCapital.
Right here’s a recap of different latest biotech financing information:
—Metabolic medicines biotech Antag Therapeutics raised €80 million (about $80.6 million) to enter the clinic with weight problems drug candidate AT-7687, a peptide designed to dam the GIP receptor. The drug is predicated on an endogenous GIP receptor antagonist. The drug is meant to be dosed alongside present or future weight problems medicine, together with those who block the GLP-1 receptor. In comparison with different medicine being developed to dam GIP, Antag says its strategy gives flexibility in dosing that would enhance each efficacy and tolerability. The drug may be utilized by itself as a upkeep remedy.
In assessments in monkeys, Antag stated AT-7687 dosed with a GLP-1 drug produced “best-in-industry weight reduction” together with improved glycemic management and lipid profiles that have been impartial of weight modifications. Antag added that these advantages have been achieved with out gastrointestinal negative effects. The biotech’s pipeline contains drug mixtures for different targets and a follow-on molecule that would supply month-to-month dosing. Versant Ventures led Antag’s Sequence A financing.
—Maze Therapeutics raised $115 million to advance scientific improvement of its two lead packages. MZE829, an oral drug designed to dam a protein referred to as APOL1, is on monitor to Section 2 testing within the uncommon kidney illness focal segmental glomerulosclerosis. MZE782, an oral inhibitor of SCL6A19, is on in Section 1 testing; South San Francisco-based Maze plans to judge it in continual kidney illness and phenylketonuria. Maze’s Sequence D spherical was co-led by Frazier Life Sciences and Deep Monitor Capital.
—Adcendo, a developer of antibody drug conjugates for most cancers, lately obtained FDA clearance to start a Section 1/2 take a look at of ADCE-D01 in sufferers with superior comfortable tissue sarcoma. Now it has $135 million to fund the scientific analysis. ADCE-D01 is designed to focus on uPARAP, a receptor that’s overexpressed in mesenchymal cancers, together with subtypes of soppy tissue sarcoma. Copenhagen-based Adcendo earlier this yr expanded its Sequence A spherical of funding to €98 million (about $102.5 million). The brand new spherical, a Sequence B financing, was led by TCGX.
—Kanglin Biotechnology unveiled $20 million in Sequence A financing to advance to scientific improvement with lead program, KL003, a gene remedy for the uncommon blood illnesses beta thalassemia and sickle cell illness. These illnesses are already addressed by FDA-approved gene therapies from Vertex Prescription drugs and Bluebird Bio. Hangzhou, China-based Kanglin claims its lentiviral vector-based remedy may be greatest in school with shorter time to transfusion independence and engraftment of the genetically modified cells. No investor particulars have been disclosed.
—35Pharma raised $53 million to help scientific improvement of HS135 for pulmonary hypertension and HS235 for cardiometabolic illness and weight problems. Each medicine are fusion proteins designed to dam activins and progress differentiation components (GDFs), proteins related to many illnesses. Frazier Life Sciences led the Sequence C spherical for Montreal-based 35Pharma.
—Startup Valora Therapeutics emerged with $30 million to advance the event of a brand new class of medication it calls antibody lectin chimera, or AbLecs. These engineered antibodies goal the glycol-immune checkpoint, blocking glycans, sugar molecules on the floor of cells, from interacting with lectins. This strategy has potential functions to most cancers and autoimmune illness. Avalon BioVentures co-led the seed spherical of San Diego-based Valora.
—Enveda raised $130 million to help its pipeline of 10 packages and a number of discovery candidates, all from an AI know-how platform that applies machine studying strategies to metabolomics knowledge. In October, the Boulder, Colorado-based firm started a Section 1 research of ENV-294, a possible oral anti-inflammatory drug for atopic dermatitis and different inflammatory issues. Kinnevik and FPV led the Sequence C spherical, which brings the corporate’s funding complete to $360 million.
—TRexBio closed $84 million to advance its lead inner program, TRB-061, by early scientific improvement. The drug is an agonist of the TNFR2 receptor, which is plentiful on regulatory T cells within the pores and skin and intestine. TRB-061 is a possible remedy for atopic dermatitis and ulcerative colitis; a Section 1 research is on monitor to start within the first half of 2025. Delos Capital led TRexBio’s Sequence B financing.
—Wellington Administration and Venrock led the $215 million financing of Metsera, a clinical-stage developer of metabolic dysfunction medicine. The Sequence B spherical comes seven months after Metsera launched backed by $290 million. Essentially the most superior program of the New York-based firm is a long-acting GLP-1 drug administered once-monthly — a key dosing edge over presently obtainable GLP-1 medicine that sufferers should inject as soon as weekly. Metsera expects to report preliminary Section 2 knowledge within the first half of 2025.
—Alentis Therapeutics raised $181.4 million for scientific improvement of two antibody drug conjugates. ALE.P02 is on monitor to start Section 1/2 testing in superior CLDN1-positive squamous strong tumors. ALE.P03 is being readied to enter the clinic in sufferers with CLDN-positive tumors. Alentis final raised cash in 2023, a $103 million Sequence C spherical. Orbimed led the newest spherical, a Sequence D financing, together with co-leads Novo Holdings and Jeito Capital.
—Arda Therapeutics raised $43 million to take a brand new strategy to treating continual illness. Moderately than modulating the exercise of proteins produced by cells that drive illness, San Francisco-based Arda is creating focused biologic medicine that deplete these cells. Andreessen Horowitz led Arda’s Sequence A financing.
—Evommune raised $115 million because the biotech prepares for upcoming knowledge readouts for 2 pores and skin illness medicine. Lead program EVO756 is on anticipated to report knowledge within the first half of 2025 from a Section 2 take a look at in continual inducible urticaria. Section 2 assessments are additionally deliberate for EVO756 in continual spontaneous urticaria and for EVO301 in atopic dermatitis. Knowledge from these assessments are anticipated in 2026. RA Capital Administration and Sectoral Asset Administration led the Palo Alto-based biotech’s Sequence C financing.
—Hint Neuroscience launched with $101 million and a lead program in improvement for amyotrophic lateral sclerosis (ALS). The South San Francisco-based biotech says its antisense oligonucleotide drug restore a protein referred to as UNC13A, which in flip reestablishes wholesome communication between nerves and muscle cells which are affected by neurodegenerative issues. Third Rock Ventures led Hint’s Sequence A financing.
—Axonis Therapeutics has $115 million to help a lead program in improvement for treating epilepsy and ache. The Boston-based firm’s drug candidate, AXN-027, targets KCC2, a chloride transporter within the central nervous system that’s important for inhibitory neurotransmission. It’s the identical goal being pursued by Ovid Therapeutics, which acquired its KCC2-targeting molecules from AstraZeneca. Cormorant Asset Administration and venBio Companions co-led Axonis’s Sequence A financing.
—Blue Earth Therapeutics introduced its presence within the rising radiopharmaceuticals sector with a $76.5 million Sequence A spherical. The Oxford, U.Ok.-based firm will apply the proceeds towards Section 2 assessments of its radioligand therapies that focus on PSMA, the identical protein hit by Novartis radiopharmaceutical Pluvicto. Soleus Capital led the spherical, which was co-led by Sands Capital Administration.
—Archon Biosciences, a Seattle startup from the College of Washington lab of Nobel Prize-winning scientist David Baker, emerged with $20 million and a platform know-how that designs antibodies in a means that controls their construction. These antibody cages, or AbCs, can management how a drug distributes within the physique to doubtlessly supply benefits in security and efficiency. Madrona Ventures led Archon’s seed financing.
—Kivu Bioscience launched with $92 million, revealing antibody drug conjugates and know-how licensed from Lonza subsidiary Synaffix. The startup, named for Lake Kivu in Africa, isn’t disclosing its most cancers targets, however it plans to advance its lead program into Section 1 testing in 2025. Novo Holdings led Kivu’s Sequence A financing.
—Agomab raised $89 million to help ongoing scientific testing of AGMB-129, which is in improvement as a possible remedy for fibrostenosing Crohn’s illness. On this complication of the inflammatory intestine dysfunction, scar tissue (fibrosis) and irritation result in thickening of the bowel. The Antwerp, Belgium-based biotech’s drug is a small molecule designed to dam ALK5, a protein concerned in a signaling pathway related to fibrosis. Agomab’s Sequence D spherical added new traders Sanofi and Invus.
—Pathos AI raised $62 million because it plans to advance to mid-stage scientific improvement. P-500, one among two clinical-stage property the biotech acquired previously yr, is a brain-penetrating small molecule inhibitor of a goal referred to as PRMT5. The Chicago-based firm says it can use its AI-powered know-how to make affected person choice and scientific trial design choices. New Enterprise Associates led Pathos AI’s Sequence C spherical.
—With a lead drug candidate in Section 1/2 testing and a brand new program on its heels, B-cell therapies developer Be Biopharma raised $82 million in Sequence C financing. The Cambridge-based biotech’s know-how engineers B cells to supply therapeutic proteins. Its most superior program, BE-101, is in improvement for treating hemophilia B. The subsequent program is BE-102, a possible remedy for hypophosphatasia, a uncommon inherited dysfunction that results in weak bones and tooth. Be Bio final raised cash in 2022, a $130 million Sequence B spherical.
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