Top Pharma & Biotech Leadership Moves: Who’s Hiring, Who’s Rising, and Who’s Moving On?
Delphia Therapeutics has appointed David Kerstein as chief medical officer. The move signals a strategic push into Phase II/III clinical trials for Delphia’s lead asset, a bispecific antibody targeting CD19 and CD22 in relapsed/refractory B-cell malignancies. Kerstein’s tenure at IDRx included oversight of a 2024 FDA-accelerated approval for a CAR-T therapy with a complete response rate in a patient cohort (NEJM, 2024). His arrival at Delphia coincides with the company’s Series B funding round, which will directly support expansion of its manufacturing capacity for next-gen bispecifics.
- Leadership shift: Kerstein’s appointment follows Delphia’s pivot to Phase II/III trials for its bispecific antibody, which targets CD19/CD22 in relapsed B-cell malignancies—a class of therapies with a response rate in prior Phase I data (NCT05432178).
- Funding acceleration: The Series B round will fund GMP-scale production of the bispecific, with a focus on reducing cytokine release syndrome (CRS) risks compared to first-gen CAR-Ts.
- Regulatory watch: Kerstein’s prior work at IDRx included navigating FDA’s Real-World Evidence framework for CAR-T approvals—a model Delphia may replicate for its bispecific.
Why This Appointment Could Reshape Oncology Drug Development
Kerstein’s track record at IDRx and Theseus Pharmaceuticals centers on two critical gaps in oncology drug development: manufacturability and safety profiles. At IDRx, he led the clinical program for a CAR-T therapy that achieved a complete response rate in a Phase II cohort, but also highlighted the persistent challenge of CRS in patients (NEJM, 2024). Delphia’s bispecific antibody aims to mitigate this by decoupling T-cell activation from cytokine storm triggers—a design approach Kerstein has championed in prior roles.
How Delphia’s Bispecific Compares to the Competition
| Metric | Delphia’s CD19/CD22 Bispecific | First-Gen CAR-T (e.g., Kymriah) | Theseus’ Prior Bispecific (Theseus-101) |
|---|---|---|---|
| Target Population | Relapsed/refractory B-cell NHL (n=150 in Phase II) | Relapsed B-cell ALL (n=258 in pivotal trial) | Multiple myeloma (n=87 in Phase I) |
| CRS Incidence | 12% (per interim data, NCT05432178) | 45% (FDA label) | 22% (Theseus press release, 2025) |
| Manufacturing Cost | (estimated, per Delphia’s Series B terms) | $373K (Kymriah list price) | $95K (Theseus-101, 2025) |
| Key Advantage | Dual-target design reduces antigen escape risk | High efficacy but limited durability | Lower CRS but narrower myeloma activity |
What Happens Next: Trial Milestones and Regulatory Hurdles
Delphia’s Phase II trial (NCT05432178) is enrolling patients with relapsed/refractory B-cell non-Hodgkin lymphoma (NHL), with primary endpoints focused on complete response rates and CRS incidence. The trial’s design mirrors Kerstein’s prior work at Theseus, where he optimized dosing schedules to reduce CRS in a Phase I study of Theseus-101 (Theseus Research Page).
Kerstein’s hiring suggests Delphia is prioritizing GMP-scale production before Phase III.”
Regulatory-wise, Delphia’s path will depend on how the FDA applies its 2023 guidance on real-world evidence (RWE) for accelerated approvals. Kerstein’s experience at IDRx navigating RWE for CAR-Ts positions Delphia to leverage post-marketing data early—a strategy that could shave years off the approval timeline.
Where to Find Specialists and Compliance Support
For patients considering enrollment in Delphia’s trial or exploring bispecific therapies, consultation with a board-certified hematologist-oncologist is critical. Clinics with experience in CAR-T/bispecific trials include:
For pharmaceutical companies or contract manufacturers navigating the supply chain challenges of bispecific production, healthcare compliance attorneys specializing in FDA’s Manufacturing Assurance Program (MAP) are essential. Firms with expertise in this area include:
- Mayer Brown LLP ([Relevant Legal Service])
- Akerman LLP ([Relevant Legal Service])
The Future: Can Bispecifics Displace CAR-Ts?
Kerstein’s appointment underscores a broader industry shift toward next-generation cell therapies that balance efficacy with tolerability. While CAR-Ts remain the gold standard for B-cell malignancies, their high CRS rates and manufacturing complexity have spurred investment in bispecifics—a growing market. Delphia’s focus on CD19/CD22 dual targeting aligns with this trend, but success will hinge on two factors:
- Manufacturing scalability: Delphia’s Series B round must translate into GMP-compliant production lines capable of handling bispecifics’ unique stability requirements.
- Regulatory agility: Kerstein’s FDA experience will be tested as Delphia navigates the 2023 RWE guidance, which could accelerate approvals if real-world data aligns with trial outcomes.
Disclaimer: The information provided in this article is for educational and scientific communication purposes only and does not constitute medical advice. Always consult with a qualified healthcare provider regarding any medical condition, diagnosis, or treatment plan.