Ep. 7 - Heading to Houston: What We’re Looking Forward to at ASN Kidney Week 2025 (with Dr. Pietro Canetta)
Release Date: 11/03/2025
Ep. 7 - Heading to Houston: What We’re Looking Forward to at ASN Kidney Week 2025 (with Dr. Pietro Canetta)
Biotech Matters
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 (p<0.0001)....
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Ep. 6 - B-cells vs. Complement in IgAN: A Look at the Data from Kidney Week 2024 (with Dr. Vlado Perkovic)
Biotech Matters
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...
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Ep. 5 - It’s ASN Kidney Week 2024! Here’s What We’re Excited About (with Dr. Beatrice Goilav)
Biotech Matters
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...
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Ep. 4 - ADC Alchemy: A Post-ASCO Discussion
Biotech Matters
Bluestar Managing Director is back from the ASCO conference in Chicago and joins Principal 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: •...
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Ep.3 What We’re Watching at ASCO 2024
Biotech Matters
As the Bluestar team prepares to head to ASCO 2024 this upcoming weekend, Bluestar Principal Jeff Fineberg sits down with Bluestar Managing Director Erin Olsen to talk about interesting abstracts related to two topics: What are the unmet needs in 1L therapy? The KRAS G12C mutation landscape
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Ep. 2 - Making Sense of the Latest IgAN Trials (with Dr. Pietro Canetta)
Biotech Matters
After attending ASN Kidney Week, Bluestar Principal Jeff Fineberg sits down with Dr. Pietro Canetta to talk all things IgA nephropathy (IgAN). After Dr. Canetta provides a brief summary of his IgAN lecture at Kidney Week, Emerging Therapeutic Options in IgA Nephropathy, the two discuss the Filspari (sparsentan) data presented from both the PROTECT study, in IgAN, the DUPLEX study, in FSGS. From there, Dr. Canetta opines on the value of surrogate endpoints in predicting the three D’s of CKD: death, dialysis, and doubling of serum creatinine (SCr). Dr. Canetta briefly discusses...
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Ep. 1 - What We’re Looking for at ASN Kidney Week 2023: A Conversation with Dr. Beatrice Goilav
Biotech Matters
In the first ever Biotech Matters podcast episode, Principal Jeff Fineberg, PhD, sits down with nephrologist Beatrice Goilav, MD, to talk all things Kidney Week. Dr. Goilav offers her thoughts on an ideal day-by-day itinerary, as well as her hopes for what will be presented at a variety of sessions, including drug trials in IgAN, and new studies of SGLT2 inhibitors. She also offers her perspective on the potential for complement inhibitors in glomerular diseases, and which of these drugs in development she is most interested in. Finally, she makes some recommendations on poster abstracts to...
info_outlineBluestar 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 (p<0.0001). Vera plans to submit the BLA for atacicept in 2025, which may allow for a commercial launch in 2026. And these are just the recent developments in IgAN. Travere Therapeutics, manufacturer of FILSPARI (sparsentan) presented data from their FSGS trial – DUPLEX – at Kidney Week 2023 in Philadelphia. In contrast to the contemporaneous PROTECT study in IgAN, DUPLEX did not meet the primary endpoint. Subsequently, Travere has worked with an FDA advisory committee, reanalyzed the trial data, and announced last month that it has filed a sNDA for approval in FSGS; the PDUFA date is January 13th, 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
Where to learn more:
Glomerular Disease-Focused CME Course
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