Standard treatment for many autoimmune diseases involves using immunosuppressive drugs, which can put patients at risk of infections and other complications. Nuvig Therapeutics is working on a novel drug that could provide an alternative treatment for autoimmune diseases, with $161 million in funding to support the clinical development of its leading program.
Nuvig’s approach involves targeting a natural mechanism in the body that helps to reduce inflammation. Their drugs are engineered proteins that bind to type II Fc receptors, which play a role in regulating immune responses. By binding to these receptors, Nuvig’s drug can increase the production of regulatory T cells (Tregs), which help to suppress immune responses and reduce inflammation.
Their lead program, NVG-2089, has shown promising results in Phase 1 trials, demonstrating safety and efficacy in engaging its target. In Phase 2, Nuvig plans to test NVG-2089 as a treatment for chronic inflammatory demyelinating polyneuropathy (CIDP), a rare autoimmune disorder that affects the nerves.
While the standard treatment for CIDP involves intravenous immunoglobulin (IVIg) or immunosuppressants, Nuvig’s drug offers a new approach that is immunomodulatory rather than immunosuppressive. This means that it can help to reduce inflammation without compromising the immune system’s ability to fight infections.
Nuvig’s unique approach has attracted significant funding and support from investors, and the company is optimistic about the potential of their drug to address a wide range of autoimmune conditions. By focusing on CIDP first, Nuvig aims to demonstrate the efficacy of their drug in a challenging autoimmune disease where current treatments have limitations. ADCE-D01 has been developed to target uPARAP, a receptor that is commonly found in mesenchymal cancers, including certain types of soft tissue sarcoma. Adcendo, based in Copenhagen, recently increased its Series A funding to €98 million (approximately $102.5 million) through a new round of funding, known as Series B, led by TCGX.
Kanglin Biotechnology has announced $20 million in Series A funding to progress its lead program, KL003, a gene therapy for rare blood diseases such as beta thalassemia and sickle cell disease. These diseases are already being treated with FDA-approved gene therapies from Vertex Pharmaceuticals and Bluebird Bio. Kanglin, based in Hangzhou, China, claims that its lentiviral vector-based therapy can be superior with a quicker time to transfusion independence and engraftment of genetically modified cells. Investor details were not disclosed.
35Pharma has raised $53 million to support the clinical development of HS135 for pulmonary hypertension and HS235 for cardiometabolic disease and obesity. These drugs are fusion proteins designed to inhibit activins and growth differentiation factors (GDFs), proteins associated with various diseases. The Series C round was led by Frazier Life Sciences for the Montreal-based 35Pharma.
Valora Therapeutics has emerged with $30 million to advance the development of a new category of drugs known as antibody lectin chimera, or AbLecs. These engineered antibodies target the glycol-immune checkpoint, preventing glycans, which are sugar molecules on the cell surface, from interacting with lectins. This approach has potential applications in cancer and autoimmune diseases. Avalon BioVentures co-led the seed round for Valora, based in San Diego.
Enveda has secured $130 million to support its pipeline of 10 programs and multiple discovery candidates, all stemming from an AI technology platform that utilizes machine learning techniques on metabolomics data. The Boulder, Colorado-based company initiated a Phase 1 study of ENV-294, a potential oral anti-inflammatory drug for atopic dermatitis and other inflammatory disorders in October. Kinnevik and FPV led the Series C round, bringing the total funding for the company to $360 million.
TRexBio has closed $84 million to advance its lead internal program, TRB-061, through early clinical development. This drug is an agonist of the TNFR2 receptor, which is prevalent on regulatory T cells in the skin and gut. TRB-061 shows promise as a treatment for atopic dermatitis and ulcerative colitis, with a Phase 1 study set to commence in the first half of 2025. Delos Capital led TRexBio’s Series B financing.
Wellington Management and Venrock have led the $215 million financing of Metsera, a clinical-stage developer of drugs for metabolic disorders. This Series B round follows the company’s launch with $290 million. The most advanced program from the New York-based company is a long-acting GLP-1 drug administered monthly, providing a dosing advantage over current weekly injections. Metsera anticipates reporting preliminary Phase 2 data in the first half of 2025.
Alentis Therapeutics has raised $181.4 million for the clinical development of two antibody drug conjugates. ALE.P02 is on track for Phase 1/2 testing in advanced CLDN1-positive squamous solid tumors, while ALE.P03 is being prepared for clinical trials in patients with CLDN-positive tumors. Alentis previously raised $103 million in 2023 through a Series C round. The latest round, a Series D financing, was led by Orbimed, with co-leads Novo Holdings and Jeito Capital.
Arda Therapeutics has secured $43 million to take a novel approach to treating chronic diseases. Instead of targeting the activity of disease-driving proteins produced by cells, the San Francisco-based company is developing biologic drugs that deplete these cells. Andreessen Horowitz led Arda’s Series A financing.
Evommune has raised $115 million as it prepares for upcoming data readouts for two drugs targeting skin diseases. The lead program, EVO756, is expected to release data in the first half of 2025 from a Phase 2 trial in chronic inducible urticaria. Phase 2 trials are also planned for EVO756 in chronic spontaneous urticaria and for EVO301 in atopic dermatitis, with data expected in 2026. RA Capital Management and Sectoral Asset Management led the Series C financing for the Palo Alto-based biotech.
Trace Neuroscience has launched with $101 million and a lead program in development for amyotrophic lateral sclerosis (ALS). The South San Francisco-based biotech’s antisense oligonucleotide drug aims to restore a protein called UNC13A, which can help reestablish healthy communication between nerves and muscle cells affected by neurodegenerative disorders. Trace’s Series A financing was led by Third Rock Ventures.
Axonis Therapeutics has secured $115 million to support its lead program targeting epilepsy and pain. The Boston-based company’s drug candidate, AXN-027, focuses on KCC2, a chloride transporter in the central nervous system essential for inhibitory neurotransmission. Cormorant Asset Management and venBio Partners co-led Axonis’s Series A financing.
Blue Earth Therapeutics has announced its entry into the radiopharmaceuticals sector with a $76.5 million Series A round. The Oxford, U.K.-based company will use the funds to conduct Phase 2 trials of its radioligand therapies targeting PSMA, the same protein targeted by Novartis radiopharmaceutical Pluvicto. Soleus Capital led the round, co-led by Sands Capital Management.
Archon Biosciences, a Seattle startup emerging from the University of Washington lab of Nobel Prize-winning scientist David Baker, has raised $20 million. The company has a platform technology that designs antibodies to control their structure, known as antibody cages, or AbCs. These structures can influence how a drug is distributed in the body, potentially offering benefits in safety and effectiveness. Madrona Ventures led Archon’s seed financing.
Kivu Bioscience has launched with $92 million, unveiling antibody drug conjugates and technology licensed from Lonza subsidiary Synaffix. The startup, named after Lake Kivu in Africa, plans to progress its lead program into Phase 1 testing in 2025. Novo Holdings led Kivu’s Series A financing.
Agomab has raised $89 million to support ongoing clinical trials of AGMB-129, a potential treatment for fibrostenosing Crohn’s disease. This complication of the inflammatory gut disorder involves scar tissue and inflammation leading to bowel thickening. Agomab’s drug is a small molecule designed to block ALK5, a protein involved in a signaling pathway associated with fibrosis. The Series D round for the Antwerp, Belgium-based biotech included new investors Sanofi and Invus.
Pathos AI has secured $62 million as it plans to advance to mid-stage clinical development. P-500, uno de los dos activos en etapa clínica que la biotecnología adquirió en el último año, es un inhibidor de molécula pequeña que penetra en el cerebro de un objetivo llamado PRMT5. La compañía con sede en Chicago dice que utilizará su tecnología alimentada por IA para tomar decisiones sobre la selección de pacientes y el diseño de ensayos clínicos. New Enterprise Associates lideró la ronda Serie C de Pathos AI.
—Con un candidato a fármaco líder en pruebas de fase 1/2 y un nuevo programa en sus talones, el desarrollador de terapias de células B Be Biopharma recaudó $82 millones en financiamiento de la Serie C. La biotecnología con sede en Cambridge ingenia células B para producir proteínas terapéuticas. Su programa más avanzado, BE-101, está en desarrollo para tratar la hemofilia B. El siguiente programa es BE-102, un posible tratamiento para la hipofosfatasia, un trastorno hereditario raro que lleva a huesos y dientes débiles. Be Bio recaudó fondos por última vez en 2022, una ronda Serie B de $130 millones.
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