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NORTH CHICAGO, Ill., May 1, 2025 /PRNewswire/ -- BLR Bio, a biotechnology company in Rosalind Franklin University's Helix 51 incubator, announced new data on its novel therapy for systemic sclerosis and lung fibrosis at the British Society for Rheumatology (BSR) Annual Conference this week in Manchester, UK. BLR Bio CEO and CSO Bruce Riser, a renowned expert in fibrotic diseases, pictured in his lab at Rosalind Franklin University's Helix 51 biomedical incubator. Interstitial Lung Disease (ILD) is a devastating disorder, encompassing a group of chronic lung conditions that affect the tissue between the air sacs in the lungs. ILD conditions can include Idiopathic pulmonary fibrosis (IPF), which can result from systemic sclerosis. The estimated prevalence in the United States is 654,852, according to a February 2024 publication in the journal CHEST. "These patients are in urgent need of a therapy that can halt or reverse this disease without the threat of serious side effects," said BLR Bio CEO and CSO Dr. Bruce Riser. In the new study, presented by Dr. Andrew Leask at the University of Saskatchewan in Canada, BLR 200, the company's lead compound, demonstrated the ability to reduce key disease tissue markers for fibrotic lung disease. Reductions were shown in Ashcroft scores, collagen levels, and both fibronectin-1 (FN-1) and profibrotic CCN4, signaling molecules involved in the development of scar tissue. Dr. Leask is a leading expert in fibrosis and CCN proteins and a long-term collaborator with BLR Bio. "Our data shows the reductions in Ashcroft scores and collagen levels appear to be more pronounced than those seen with other therapies on the market and in development," Dr. Riser said. "Combined with prior observations modeling scleroderma skin fibrosis, BLR-200 has shown the potential to address both skin and lung fibrosis. It appears to be the only drug in development that reduces expression of all three CCN proteins — CCN1, CCN2, CCN4 — that play a crucial role in the activation of fibroblast cells critical for initiating and maintaining fibrosis." Dr. Joseph DiMario, RFU Interim VP for Research, noted that BLR Bio was one of the first tenants of Helix 51. "We are very pleased to see the progress the company is making toward the development of life-changing medicines," he said. About Rosalind Franklin University Rosalind Franklin University of Medicine and Science embodies the spirit of inquiry and excellence modeled by its namesake Dr. Rosalind Franklin, whose Photo 51 was crucial to solving the structure of DNA. Recognized for its research in areas including neuroscience, brain-related diseases, inherited disorders, diabetes, obesity, and gait and balance, RFU encompasses the Chicago Medical School, College of Health Professions, College of Nursing, College of Pharmacy, School of Graduate and Postdoctoral Studies and the Dr. William M. Scholl College of Podiatric Medicine. Learn more at rosalindfranklin.edu. About BLR Bio Learn more at blrbio.com. Office of Marketing and Communications [email protected] SOURCE Rosalind Franklin University of Medicine and Science WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Investment addresses the need for disease-modifying therapies targeting the root causes of fibrosis Funding will support the advancement of CCN family inhibitor TRX-44 into clinical trials for treatment of fibrotic conditions including idiopathic pulmonary fibrosis (IPF) Novo Holdings and HealthCap co-created Tribune in 2020 COPENHAGEN, Denmark, March 26, 2025 /PRNewswire/ -- Novo Holdings today announced its participation in a €23 million Series A round for Tribune Therapeutics ('Tribune'). The round was led by new investor LifeArc Ventures and joined by Novo Holdings, HealthCap, Innovestor's Life Science Fund and Inven2 as well as new Series A investors Industrifonden and Investinor. Tribune Therapeutics was co-founded in 2020 by the Seed Investments team of Novo Holdings and HealthCap Ventures to create broadly applicable disease-modifying therapies for fibrotic diseases by targeting downstream, tissue-agnostic gatekeepers of scar formation and tissue remodelling. Through a Pioneer Innovator Grant, the Novo Nordisk Foundation – whose assets Novo Holdings manages – partially funded scientific discoveries at the Oslo University Hospital by Professor Håvard Attramadal and Ole J. Kaasbøll that led to Tribune's formation. The Pioneer Innovator grant programme is designed to advance science-based discoveries in sustainability and health by funding experiments and activities that push ideas toward proof-of-concept and beyond, in line with Novo Nordisk Foundation's vision of improving people's health and the sustainability of society and the planet. Tribune's lead programme, TRX-44, is currently in development for the treatment of fibrotic conditions including idiopathic pulmonary fibrosis (IPF). TRX-44 prevents scar formation by mimicking the structure and function of CCN5. CCN5 is an endogenous protein that naturally blocks the pro-fibrotic effects of other CCN family members, including CTGF/CCN2 and WISP1/CCN4, on multiple cell types contributing to fibrotic pathology. João Ribas, PhD, Principal of Novo Holdings, said: "Tribune's scientific founders have discovered key insights into the mechanism of action of CCNs, leading to an elegant and powerful approach to harness the biology of CCNs to shut down a key pro-fibrotic pathway. The novel path being advanced by Tribune holds potential for meaningfully impacting the treatment of multiple devastating and often terminal fibrotic indications." Georg Vo Beiske, PharmD, Tribune Chief Executive Officer and HealthCap Venture Partner, said: "Tribune's foundational science has far-reaching therapeutic potential, and Novo Holdings has been a great partner in bringing the company to fruition through its early support and extended network. As we advance toward the clinic, having the backing of such a strong investor group increases our confidence in our innovative approach to treat fibrotic diseases." About Tribune Therapeutics Tribune Therapeutics is a biotechnology company advancing novel medicines to treat fibrosis, regardless of the cause, tissue or diagnosis. The company was founded on groundbreaking structural insights into the CCN family of proteins, key drivers of scar formation that have historically been difficult to comprehensively target. Tribune is advancing multiple programs, including CCN5 mimic TRX-44. For more information, visit or follow us on LinkedIn. About Novo Holdings A/S Novo Holdings is a holding and investment company that is responsible for managing the assets and the wealth of the Novo Nordisk Foundation. The purpose of Novo Holdings is to improve people's health and the sustainability of society and the planet by generating attractive long-term returns on the assets of the Novo Nordisk Foundation. Wholly owned by the Novo Nordisk Foundation, Novo Holdings is the controlling shareholder of Novo Nordisk A/S and Novonesis A/S (Novozymes A/S) and manages an investment portfolio with a long-term return perspective. In addition to managing a broad portfolio of equities, bonds, real estate, infrastructure and private equity assets, Novo Holdings is a world-leading life sciences investor. Through its Seed, Venture, Growth, Asia, Planetary Health and Principal Investments teams, Novo Holdings invests in life science companies at all stages of development. As of year-end 2023, Novo Holdings had total assets of EUR 149 billion. About the Novo Nordisk Foundation Established in Denmark in 1924, the Novo Nordisk Foundation is an enterprise foundation with philanthropic objectives. The vision of the Foundation is to improve people's health and the sustainability of society and the planet. The Foundation's mission is to progress research and innovation in the prevention and treatment of cardiometabolic and infectious diseases as well as to advance knowledge and solutions to support a green transformation of society. SOURCE Novo Holdings WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Pamrevlumab arm of the Precision PromiseSM study in metastatic pancreatic cancer, sponsored and conducted by the Pancreatic Cancer Action Network (PanCAN), did not meet the primary endpoint of overall survival as determined by the protocol pre-specified Bayesian statistical analysis LAPIS study in locally advanced, unresectable pancreatic cancer, sponsored by FibroGen, did not meet the primary endpoint of overall survival Pamrevlumab was generally safe and well tolerated across both studies, with no clinically meaningful difference in overall safety vs. control arms Company to implement immediate and significant cost reduction plan in the U.S. Terminate pamrevlumab research and development (R&D) investment and expeditiously wind down remaining obligations Reduce U.S. workforce by approximately 75% July 30, 2024 -- FibroGen, Inc. (NASDAQ: FGEN) today announced topline results from two late-stage trials evaluating the efficacy and safety of pamrevlumab in patients with pancreatic cancer and a corporate update. The pamrevlumab experimental arm in PanCAN’s Precision Promise Phase 2/3 adaptive platform trial compared treatment with pamrevlumab combined with gemcitabine + nab-paclitaxel to gemcitabine + nab-paclitaxel alone for treatment in first line (1L) and second line (2L) patients with metastatic pancreatic ductal adenocarcinoma (mPDAC). The pamrevlumab arm of the study did not meet the primary endpoint of overall survival as determined by the protocol pre-specified Bayesian statistical analysis. The Phase 3 LAPIS trial compared treatment with pamrevlumab combined with gemcitabine + nab-paclitaxel or FOLFIRINOX to placebo combined with gemcitabine + nab-paclitaxel or FOLFIRINOX for the treatment of locally advanced, unresectable pancreatic cancer (LAPC). The study did not meet the primary endpoint of overall survival. “We are deeply disappointed that the pamrevlumab arm in the Precision Promise trial and the LAPIS trial did not meet the primary endpoint of overall survival,” said Thane Wettig, Chief Executive Officer, FibroGen. “We were hopeful that pamrevlumab could bring meaningful innovation to pancreatic cancer patients in desperate need of new therapies. FibroGen would like to thank the patients, their families and the clinical trial investigators and teams for their dedication to participating in these studies. I would also like to express my deepest gratitude to our FibroGen colleagues who have dedicated so much of their time and energy for the prospect of bringing much needed therapies to some of the most challenging and deadly diseases affecting humanity.” Based upon the results of the late-stage pamrevlumab trials in pancreatic cancer, the Company plans to implement an immediate and significant cost reduction plan in the U.S. The pamrevlumab development program will be terminated and the Company plans to expeditiously wind down any remaining pamrevlumab obligations. As a result of the cost reduction plan, headcount in the U.S. will be reduced by approximately 75%. FibroGen’s collaboration agreement with AstraZeneca for roxadustat in China, where roxadustat is the market leader by brand value share in the chronic kidney disease (CKD) anemia category, as well as FibroGen’s collaboration agreement with Astellas for roxadustat in the E.U., Japan, and other territories, remain in place. Given both 1L and 2L pamrevlumab treatment groups graduated into Stage 2 of PanCAN’s Precision Promise study, the hazard ratio for the primary overall survival (OS) analysis assumed a common hazard ratio to estimate a single treatment effect for both 1L and 2L pamrevlumab patients combined compared to patients treated with gemcitabine + nab-paclitaxel. In addition, the pre-specified Bayesian model utilized a hierarchical model that included the borrowing of data from the mFOLFIRINOX control arm to the gemcitabine + nab-paclitaxel control arm for the primary efficacy analysis. The pre-specified primary efficacy analysis was performed in a modified intention-to-treat (mITT) population that included only subjects who initiated treatment. The mITT population in the pamrevlumab arm was comprised of a total of 102 patients in the 1L treatment group and 111 patients in the 2L treatment group and the gemcitabine + nab-paclitaxel control arm was comprised of a total of 34 patients in the 1L treatment group and 36 patients in the 2L treatment group. Primary OS Analysis as Determined by Pre-Specified Bayesian Statistical Analysis (mITT Population) Bayesian Model Common Hazard Ratio (HR)Posterior ProbabilityMedianMean (SD)95% CIPr(HR Primary Efficacy Analysis1.1701.184 (0.175)(0.882, 1.563)0.13977 LAPIS Efficacy Results The study did not meet the primary endpoint of overall survival (stratified log-rank p-value=0.55). Median overall survival of 17.3 months was observed in the pamrevlumab combined with gemcitabine + nab-paclitaxel or FOLFIRINOX arm compared to median overall survival of 17.9 months in the control arm of placebo combined with gemcitabine + nab-paclitaxel or FOLFIRINOX (HR: 1.08; 95% CI – 0.83 to 1.41). The preliminary safety analyses across both studies indicate that the safety profile of pamrevlumab combined with gemcitabine + nab-paclitaxel or FOLFIRINOX was generally well tolerated with an acceptable safety profile in pancreatic cancer patients. No clinically meaningful differences in treatment emergent adverse events were seen between the treatment arms. PanCAN’s Precision Promise adaptive platform trial (NCT04229004) is a U.S.-based, seamless Phase 2/3 study sponsored by PanCAN that enrolled patients in 24 sites nationwide. The multi-arm study consists of experimental treatment arms and two comparator arms: gemcitabine + nab-paclitaxel and mFOLFIRINOX. The pamrevlumab experimental arm enrolled 102 patients with mPDAC in first line (1L) and 111 patients with mPDAC in second line (2L). Both 1L and 2L patients received pamrevlumab in combination with gemcitabine and nab-paclitaxel. The final analysis was based upon the data collected up to 12 months after the last patient initiated treatment. The LAPIS study is a global Phase 3, randomized, double-blind trial to evaluate the efficacy and safety of neoadjuvant treatment with pamrevlumab or placebo in combination with either gemcitabine + nab-paclitaxel or FOLFIRINOX in the treatment of participants with locally advanced, unresectable pancreatic cancer (LAPC). The study enrolled 284 patients, who were randomized at a 1:1 ratio to receive either pamrevlumab or placebo, in combination with either gemcitabine + nab-paclitaxel or FOLFIRINOX. All patients were dosed up to six cycles of treatment and patients who completed study treatment were evaluated for surgical exploration for possible R0 or R1 resection. Participants who were ineligible for surgical exploration continued to receive treatment as per standard of care (SOC) for each institution. Pamrevlumab is a potential first-in-class anti-CTGF fully human monoclonal antibody being developed by FibroGen to inhibit the activity of connective tissue growth factor (CTGF). Pamrevlumab is in clinical development for the treatment of metastatic pancreatic cancer and locally advanced unresectable pancreatic cancer (LAPC). The U.S. Food and Drug Administration has granted Orphan Drug Designation for the treatment of patients with pancreatic ductal adenocarcinoma (PDAC), and Fast Track designation to pamrevlumab for the treatment of patients with LAPC. Pamrevlumab is an investigational drug and not approved for marketing by any regulatory authority. For information about our pamrevlumab studies please visit www.clinicaltrials.gov. FibroGen, Inc. is a biopharmaceutical company focused on accelerating the development of novel therapies at the frontiers of cancer biology. Roxadustat (爱瑞卓®, EVRENZOTM) is currently approved in China, Europe, Japan, and numerous other countries for the treatment of anemia in chronic kidney disease (CKD) patients on dialysis and not on dialysis. Roxadustat is in clinical development for chemotherapy-induced anemia (CIA) and a Supplemental New Drug Application (sNDA) has been accepted for review by the China Health Authority. FG-3246 (also known as FOR46), a first-in-class antibody-drug conjugate (ADC) targeting CD46 is in development for the treatment of metastatic castration-resistant prostate cancer. This program also includes the development of an associated CD46-targeted PET biomarker. In addition, FibroGen has expanded its research and development portfolio to include two immuno-oncology product candidates for the treatment of solid tumors. For more information, please visit www.fibrogen.com. The content above comes from the network. if any infringement, please contact us to modify.