One of the standard treatments for idiopathic pulmonary fibrosis is an old drug that offers limited efficacy and a range of side effects. Celea Therapeutics aims to offer advantages over that now generic product, and the company now has $180 million for a pivotal head-to-head clinical trial.
Idiopathic pulmonary fibrosis, or IPF, causes inflammation and scar tissue in the lungs. There is no cure for progressively worsening lung function that eventually becomes fatal. The few available IPF drugs include pirfenidone (brand name Esbriet), an old Roche medicine whose rights were acquired by Legacy Pharma last year. This oral drug works by blocking a key protein associated with fibrosis and inflammation. But the circulation of this small molecule throughout the body leads to systemic side effects.
Celea’s drug, deupirfenidone (formerly LYT-100), is pirfenidone with chemical modifications intended to improve tolerability. In Phase 2b testing, the company reported results showing the potential to stabilize lung function decline over at least 26 weeks as a monotherapy while also maintaining favorable safety and tolerability. Celea added that the initial data from the open-label extension study suggest this effect may be sustained through at least 52 weeks.
The planned Phase 3 study will be a global, double-blind head-to-head study comparing an 825 mg dose of deupirfenidone to an 801 mg dose pirfenidone 801, each taken as a pill three times daily. The main efficacy goal is showing at 52 weeks the change from baseline in absolute forced vital capacity, a measure of how much air can be forcefully be exhaled. Celea expects to begin this study early in the third quarter of this year.
Celea has competition in the race to develop a new and improved version of pirfenidone. Avalyn Pharma’s April IPO raised $300 million to finance clinical development of a pipeline that includes an inhalable version of that drug. Avalyn is also developing an inhalable version of the old Boehringer Ingelheim IPF medication Ofev. Since the drugs of Avalyn and Celea are new versions of older drugs, that could make it easier to secure payer coverage — if they are approved.
Deupirfenidone came from PureTech health, a company that conducts biotechnology research and forms startups around them. Celea formally spun out of PureTech last August, naming former Teva North America executive Sven Dethlefs as its CEO. No financing was disclosed at that time. The new financing announced July 2 includes the participation of RA Capital Management, Leaps by Bayer, and PureTech. The financing also included investment from a U.S.-based healthcare-focused fund and a sovereign wealth fund whose identities were not disclosed.
Here’s a recap of other recent biotech financing activity:
—Beeline Medicines added $126.3 million to its Series A round to support a planned pivotal study of lead drug afimetoran in systemic lupus. Phase 2 data are expected in the second half of this year. The new capital extends the round to $426.3 million.
—Autoimmune disease-focused Oblenio Bio raised $62 million for early clinical development of lead program LBL-051. This drug is a tri-specific T cell engager designed to reset the immune system to treat a range of difficult-to-treat autoimmune disorders. Its targets are BCMA, CD19, and CD3. Pfizer Ventures led Oblenbio’s Series B round.
—Lycia Therapeutics raised $75 million to support clinical development of its cataLYTAC degraders, drugs that degrade extracellular proteins that cause disease. The pipeline includes LCA_0061, which is designed to target immunoglobulin E for food allergy and other allergic diseases, and LCA-0321, which is designed to deplete thyroid-stimulating hormone receptor autoantibodies for Graves’ disease. Lycia’s Series D financing was co-led by Janus Henderson Investors and Balyasny.
—RQ Bio unveiled $115 million to start clinical development of lead program RQB01, long-acting antibody intended to offer full protection from influenza during the full influenza season. The company says this antibody offers a dual mechanism targeting conserved epitopes that are resilient to seasonal variation. RQ expects to bring this drug into the clinic next year. Frazier Life Sciences led RQ’s Series A round.
—Ollin Biosciences raised $330 million to support a global Phase 3 test of OLN324, which it describes as a next-generation VEGF/Ang2 bispecific antibody. This drug is in Phase 3 development for diabetic macular edema and the wet form of age-related macular degeneration. Proceeds will also support OLN102, a novel TSHR/IGF-1R bispecific antibody for thyroid eye disease and Graves’ disease that’s on track to enter the clinic later this year. Ollin’s Series B round was co-led by new investor TCGX and founding investor Arch Venture Partners.
—Osanni Bio closed $190 million in financing to support a pipeline it says spans ophthalmology, cardiology, and more, though no details about its programs were disclosed. Patient Square Capital led Osanni’s Series B round.
—Bionyra Pharma launched with $165 million to support development of a pipeline led by BYN-002, a TL1A-targeting antibody in development for inflammatory bowel disease. While TL1A is also being pursed by companies such as Merck, Roche, and partners Sanofi and Teva Pharmaceuticals, Paris-based Bionyra aims to offer better efficacy and less frequent dosing.
—Retinal diseases drug developer Memento Medicines launched, backed by $93 million. The startup also announced it reached a deal with MabTics Co. and Curacle Co. to license global rights to MMT-205, a bispecific antibody that activates Tie2 and blocks VEGF, two validated targets for retinal and vascular diseases. Phase 1 testing is expected to begin in 2027. MabTics and Curacle received an unspecified upfront payment and equity in Memento; they are also eligible to receive milestone payments tied to the progress of the drug. Memento’s Series A round was co-led by Forbion, RA Capital Management, and Avego BioScience Capital.
—MultiValent Biotherapies raised $27 million to support development of a peptide-like drug conjugate that hits two validated targets to treat prostate cancer. No investors were disclosed for this financing, which the biotech described as the first close of its Series A round.
—Triveni Bio secured $65 million to continue development of a pipeline led by TRIV-509, an antibody drug designed to block kallikreins 5 and 7 to treat atopic dermatitis. Phase 2 data are expected by the end of this year. The biotech is also developing TRIV-573, a bispecific antibody that pairs kallikrein 5 and 7 inhibition with an anti-IL-3 mechanism. Triveni launched in 2023. New investors Ascenta Capital and Janus Henderson Investors co-led its latest financing, a Series C round.
—Cellares added two more investors to its latest financing, bringing the Series D round to $327 million total. The new capital came from a fund managed by Prime Radiant Partners, which invested $50 million, and ARK Invest, which chipped in $20 million. South San Francisco-based Cellares, developer of the Cell Shuttle platform for manufacturing cell therapies, is building a global network of “smart factories” that it claims will be able to produce 10 times more batches than conventional contract manufacturers. Next year could be a big one for Cellares. In addition to commencing commercial operations, the company said it is also preparing for an IPO.
—Vedana Therapeutics launched with $46 million, joining a group of companies developing a new class of antibody drugs for migraine that work by blocking a central nervous system protein called PACAP. The Series A round was co-led by Westlake Village BioPartners and Canaan Partners.
—MultiValent Biotherapies launched with an in-licensed drug for prostate cancer and $27.4 million to support a U.S. clinical trial. The drug, MVB-101, is a bivalent peptide-like drug conjugate designed to target PSMA and folate receptor alpha. No investors were disclosed for this financing, which the startup said is the first close of a Series A round.
—Cour Pharma raised $50 million to continue development of lead program CNP-103. The startup’s drugs employ nanoparticles that encapsulate disease-specific antigens to reprogram inflammatory autoimmune responses to induce immune tolerance. CNP-103 encapsulates four engineered proteins to reprogram the immune response that targets the islet cells in type 1 diabetes; this program is in Phase 2 testing. Earlier investors Lumira Ventures and Roche Venture Fund led COUR’s Series B round. Chicago-based Cour launched in 2024, backed by a $105 million Series A round.
—Ethyreal Bio revealed $101 million in financing as it prepares to enter the clinic with ETHY-001, a monoclonal antibody designed to block activation of the thyroid stimulating hormone receptor (TSHR), which drives Graves’ disease and thyroid eye disease. The Cambridge, Massachusetts-based biotech is developing this drug for subcutaneous administration via an autoinjector. It is made with half-life injection technology to enable less frequent dosing, though Ethyreal has not yet disclosed the dosing interval. The capital is a combination of Series A and B financings.
—Beren Therapeutics revealed $300 million in combined financing as it prepares for the potential launch of adrabetadex, a drug developed for infantile-onset Niemann-Pick disease type C (I-NPC). This drug has a Nov. 17 target date for an FDA regulatory decision.
—SonoThera secured $125 million to bring two programs into the clinic, genetic medicines for Duchenne muscular dystrophy and autosomal dominant polycystic kidney disease. The biotech’s approach uses proprietary ultrasound technology for targeted delivery of DNA and RNA payloads to tissue. Vida Ventures led SonoThera’s Series B round.
—RNA interference drugs developer City Therapeutics raised $99.5 million to support a pipeline led by CITY-FXI, which has started Phase 1 testing in thromboembolic diseases. The company also has encouraging preclinical data for CITY-RBP4, an RNAi therapy for Stargardt disease. The Series B round included the participation of Viking Global Investors and Sofinnova Investments as new investors in the startup. In total, the company said it has raised more than $230 million to date.
—Antibody drug conjugate startup Ona Therapeutics raised $86.6 million to bring its lead program into Phase 1 testing. This ADC targets novel but undisclosed antigens to treat HR-positive, HER2-negative breast cancer. Columbus Venture Partners and Mérieux Equity Partners co-led Ona’s Series B round.
—NewLimit, a startup developing medicines to reverse aging, closed $435 million in financing as it prepares to enter the clinic next year. The company’s describes its first program as a liver reprogramming therapy that reverses the age of liver cells, allowing “livers to heal faster after injury, avoid damage from dietary challenges, and accelerate recovery from alcohol consumption.” Founders Fund led NewLimit’s Series C round.
—Accro Bioscience closed $50 million to fund Phase 2b testing of AC-101, an oral small molecule RIPK2 inhibitor in development for ulcerative colitis. The capital will also support development of other inflammation and immunology drug candidates. OrbiMed led Accro’s Series C round.
—Cytospire Therapeutics now has £61 million (about $83 million) to support a pipeline led by CYT X300, a pan-gamma delta T cell engager in late preclinical development for EGFR-positive solid tumors. These tumors include those from colorectal, head and neck, and non-small cell lung cancers. Cytospire’s Series A round was led by 4BIO Capital.
—Oorja Bio launched with $30 million as it prepares to advance to Phase 2 testing with ORJ-001, an in-licensed antifibrotic drug in development for idiopathic pulmonary fibrosis. ORJ-001 is a subcutaneously administered peptide drug intended to promote alveolar repair and reduce inflammatory signaling. Oorja’s Series A financing came from founding investor Westlake BioPartners.
—Create Medicines secured $122 million to support a pipeline that includes preclinical CRT-402, a next-generation CD19-targeted in vivo CAR T therapy in development to deplete B cells to treat autoimmune disorders. In oncology, Create’s MT-303 has reached early clinical development as a frontline treatment for hepatocellular carcinoma. The Series B round was co-led by earlier investors Newpath Partners, Arch Venture Partners, and Hatteras Venture Partners.
—Cerevance raised $20 million in Series C financing that it said will fund the company into mid-2027, supporting completion of a Phase 3 test of solengepras in Parkinson’s disease. Solengepras is small molecule designed to target the GPR6 receptor to reduce “off” periods, the times when Parkinson’s symptoms return despite medication.
—Isomorphic Labs, a techbio startup that’s a subsidiary of technology conglomerate Alphabet, unveiled $2 billion in new financing but no details about its drugs or disease targets. The investment syndicate is comprised of investment firms that typically back internet and technology-enabled companies. Thrive Capital led Isomorphic’s Series B financing.
—Kanvas Biosciences raised $48 million for clinical testing of KAN-001, a live biotherapeutic designed to target a patient’s gut microbiome to improve response to checkpoint inhibitors, a type of cancer immunotherapy. The Series A round was co-led by earlier investors DCVC and Lions Capital.
Image: Jackie Niam, Getty Images
