Biotech Matters

Ep. 8 – New Frontiers in FSGS: A Discussion of Recent Data and Developments (with Dr. Howard Trachtman)

In this episode, Bluestar Principal Jeff Fineberg is joined by Dr. Howard Trachtman, a pediatric nephrologist and researcher, who has been a principal investigator on many NIH- and industry-sponsored clinical trials in glomerular diseases, including FSGS. Following a brief recap of the recent history of sparsentan in FSGS, and some recent developments in its hopeful path toward FDA approval, Jeff and Dr. Trachtman define what FSGS really is, before the two of them dive into the long-term efficacy and safety data of sparsentan in FSGS from the DUET and DUPLEX clinical trials. This includes a discussion of the PARASOL working group, and their efforts to find good surrogate endpoints for clinical trials in FSGS. From there, the conversation turns toward treatment response rates and durability of remission as observed in a recent study, and the implications toward finding biomarkers for both better targets, as well as a more personalized approach to FSGS therapy. Finally, Dr. Trachtman shares the results of a recent clinical trial of BI-764198, a TRPC6 inhibitor from Boehringer Ingelheim, in development for FSGS, including the rationale for this target, and what we can conclude from the study results. Chapters * 00:00 - Intro. * 03:40 - What is FSGS? * 07:25 - Can near-term changes in proteinuria quantitatively predict long-term outcomes in FSGS? (DUET and DUPLEX Trials of Sparsentan in FSGS). * 14:00 - The PARASOL Working Group to find surrogate endpoints in FSGS. * 20:40 - Are there certain patient subgroups for whom we can tailor therapy in FSGS? (Treatment response rates and kidney outcomes in FSGS). * 25:20 - Potential for additional diagnostics to predict treatment response. * 28:30 - What is TRPC6, and what is its role in FSGS? * 30:45 - A double-blind RCT of BI-764198, a TRPC6 inhibitor, in FSGS. * 37:40 - Closing thoughts. Article links * Campbell, et al., 2024, Kidney Medicine [https://www.kidneymedicinejournal.org/article/S2590-0595(24)00044-X/fulltext] * Sim, et at., 2025, CJASN [https://journals.lww.com/cjasn/abstract/2026/02000/treatment_response_rates_and_kidney_outcomes_among.14.aspx] * Trachtman, et al., 2026, Lancet [https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)02255-X/abstract]

Ep. 7 - Heading to Houston: What We're Looking Forward to at ASN Kidney Week 2025 (with Dr. Pietro Canetta)

Bluestar is once again heading to ASN Kidney Week, this time in Houston, TX. Since our last episode, Otsuka, the manufacturer of sibeprenlimab, announced that the FDA has granted Priority Review of their BLA application; its PDUFA date is November 28th of this year. Additionally, Vera Therapeutics, the manufacturer of atacicept put out a press release this past summer that the ORIGIN Phase 3 trial met its primary endpoint of reduction in proteinuria (UPCR); participants receiving atacicept achieved a 46% reduction from baseline, and 42% reduction compared to placebo at week 36 (pth, 2026. After the 2023 conference, Dr. Pietro Canetta joined Bluestar Principal Jeff Fineberg on the Biotech Matters podcast to talk about all things IgAN, as well as the two FILSPARI trials and the data presented at the conference. So, it's only fitting that Dr. Canetta is back on the podcast to revisit that conversation, discuss what has happened in the two years since, and tell us what he's most looking forward to at this year's conference. Where to find Dr. Canetta: Columbia University Glomerular Center [https://glomerularcenter.org/] Where to learn more: Columbia CME Courses [https://www.columbiamedicinecme.org/] Glomerular Disease-Focused CME Course [https://www.columbiamedicinecme.org/Attendee/Attendee/EventPage?eId=xx5PzvJbs%2F7BiCKPqB6LDQ%3D%3D] Topics and Timestamps * 00:00 - Intro + recap * 04:00 - Reflection on Filspari in FSGS; implications for UPCR in FSGS and other diseases going forward * 12:40 - DKD: better/newer surrogate endpoints; matching patients to the right Tx * 19:30 - IgAN: the 4-hit model of disease and the role of B cells * 22:45 - Where do B cell-targeting therapies fit in the evolving IgAN Tx Paradigm? * 26:45 - The counter argument to using Bcells early in IgAN treatment * 30:10 - Bcells beyond IgAN: Lupus Nephritis and other glomerular diseases * 33:00 - Different B cell-targeting mechanisms for different glomerular diseases and/or heterogeneous patient populations * 36:45 - A homecoming for complement inhibitor therapies * 42:00 - Other recommended sessions at Kidney Week 2025 * 45:00 - Where to learn more from Dr. Canetta

Ep. 6 - B-cells vs. Complement in IgAN: A Look at the Data from Kidney Week 2024 (with Dr. Vlado Perkovic)

Principal Jeff Fineberg, PhD [https://bluestarbioadvisors.com/team/jeffrey-fineberg#bio] sits down with Vlado Perkovic, MBBS, PhD, to discuss the IgA nephropathy trial data presented at Kidney Week 2024 in San Diego. Jeff begins by asking Dr. Perkovic to talk about why targeting B-cells is an attractive target, and why BAFF/APRIL might prove more promising than CD20. The two then discuss the data with two agents in development for the treatment of IgAN, atacicept (targeting BAFF/APRIL) and sibeprenlimab (targeting APRIL only). The conversation then pivots to the prospect of complement inhibition with FABHALTA® (iptacopan) in IgA nephropathy, including a comparison of the strategy to target certain complement factors/pathways over others in IgAN. Finally, the discussion takes a broader lens to the evolving IgAN treatment landscape, that may include both of these novel therapeutic mechanisms, in addition to recently approved drugs FILSPARI® (sparsentan) and TARPEYO® (budesonide), as well as other CKD therapeutic classes, such as SGLT2 inhibitors and GLP-1 receptor agonists. Vlado Perkovic Bio Vlado Perkovic is the Provost at UNSW Sydney and Scientia Professor at UNSW, and was previously the Dean of the Faculty of Medicine and Health as well as Professorial Fellow at The George Institute, Australia, and a Staff Specialist in Nephrology at the Royal North Shore Hospital. His research focus is clinical trials and epidemiology, in particular, in preventing the progression of kidney disease and its complications. He leads several major international clinical trials with a focus on diabetic kidney disease, IgA nephropathy and CKD more broadly, and has Chaired the Steering Committees of many trials including CREDENCE, FLOW, TESTING, PROTECT, and APPLAUSE, along with several ongoing trials. Dr. Perkovic holds a Doctor of Philosophy from the University of Melbourne and is a Fellow of the Royal Australasian College of Physicians, of the Australian Academy of Health and Medical Sciences, and of the American Society of Nephrology.

Ep. 5 - It's ASN Kidney Week 2024! Here's What We're Excited About (with Dr. Beatrice Goilav)

Principal Jeff Fineberg, PhD [https://bluestarbioadvisors.com/team/jeffrey-fineberg#bio] welcomes back returning guest nephrologist Beatrice Goilav, MD, to discuss the program featured at Kidney Week 2024 in San Diego. Dr. Goilav reflects on what has happened in the field since last year's Kidney Week conference, as well as her hopes for what will be presented at a variety of sessions, including more data in IgA nephropathy, lupus nephritis, and FSGS. She also offers her perspective on the newest advancements with complement inhibitors in glomerular diseases – including approval of FABHALTA® (iptacopan) in IgA nephropathy – as well as recommendations for educational symposia and scientific sessions on the topic. Finally, she and Jeff discuss GLP-1 receptor agonists, and what this class of drug may mean for the management of CKD. Dr. Goilav hangs out on the social network X. Her handle is @BGoilav, and her DM is open to listeners with follow-on questions. For more information about Bluestar BioAdvisors, please visit our website [https://bluestarbioadvisors.com/].

Ep. 4 - ADC Alchemy: A Post-ASCO Discussion

Bluestar Managing Director Erin Olsen [https://bluestarbioadvisors.com/team/erin-olsen#bio] is back from the ASCO conference in Chicago and joins Principal Jeff Fineberg [https://bluestarbioadvisors.com/team/jeffrey-fineberg#bio] on the podcast again, this time to talk about all things antibody drug conjugates (ADCs) in oncology. Given the number and value of deals in this space over the past couple of years, as well as the 170+ ADCs now in clinical development, Jeff asks Erin to take stock of what we've learned about the potential of these molecules, with all their moving parts, and opine on what lies ahead. Over the course of this brief conversation, Erin and Jeff touch on some key questions about ADCs, including: • Are ADCs living up to their promise? (1:48) • What are some lessons learned from Enhertu? (3:20) • What have we learned about TOP1 payloads and TROP2 targeting? (6:10) • Have ADCs delivered on better safety than chemo? (8:40) • What's next for ADCs? (10:50) Bluestar BioAdvisors LLC is a boutique consulting firm comprised of strategic experts in the business of life sciences. We help clients answer key strategic questions about asset value, positioning, and future market potential, serving as an independent, objective advisor through the critical decision-making points of portfolio planning and business development. For more information about us, please visit Bluestar BioAdvisors' [https://bluestarbioadvisors.com] website, Erin's bio [https://bluestarbioadvisors.com/team/erin-olsen#bio], and Jeff's bio [https://bluestarbioadvisors.com/team/jeffrey-fineberg#bio].