Zak Mir talks to Tim McCarthy, CEO of Immupharma, the speciality biopharmaceutical company that discovers and develops peptide-based therapeutics, announcing the filing of a groundbreaking new patent application for its lead asset, P140, the world’s first “Immunormalizer.”

The three discoveries that reset the strategy

• Under-dosing: The team concluded the dose used in the Phase III trial was far too low — roughly 10 to 15 times lower than the dose they now believe is required to achieve the intended biological effect.
• Steroid confounding: Standard-of-care steroids given to patients in the trial suppress the immune system and masked P140’s effect. Future trials will include steroid tapering protocols so the drug’s impact isn’t obscured.
• Patient stratification — “super responders”: For the first time the team identified a patient profile that responds exceptionally well to P140. That diagnostic signature is central to the patent and allows the drug to be matched to the right patients.

What P140 actually does — the Immunormalizer concept

Tim described P140 as an agent that restores immune homeostasis rather than suppressing the immune system. That’s an important distinction:

• Most current therapies try to blunt or suppress immune activity (e.g., steroids or many immunomodulators), which can cause side effects and still leave patients vulnerable.
• P140 appears to "normalize" the immune response — increasing or decreasing components such as B cells toward a healthy balance depending on what the patient needs.
• In practice that means if a patient has excessive B-cell activity, P140 reduces it; if a patient has deficient activity, P140 can boost it — a balancing action not commonly seen in current treatments.

"“We’ve coined the phrase ‘Immunormalizer’ — it brings the immune system back to normal homeostasis rather than simply suppressing it.”"

Safety profile that matters

Across preclinical studies, Phase I/II and the Phase III programme, P140 demonstrated an unusually clean safety record: no serious adverse events and very few side effects. Tim highlighted this as a major reason the team pursued the diagnostic-plus-therapeutic patent: a safe mechanism that can be targeted precisely.

The diagnostic: identifying “Type M” immune disorder patients and super responders

One of the most exciting elements of the patent is the combination of a diagnostic test with the therapeutic. The diagnostic identifies patients with what ImmuPharma calls a “Type M” immune disorder — those who are likely to be super responders to P140.

• This stratification means future clinical trials will enroll patients who have the biomarker profile most likely to benefit, improving the chance of clear, positive outcomes.
• The diagnostic is precise enough that it could identify at-risk patients even before symptoms appear, enabling earlier intervention.
• Tim suggested it could potentially be incorporated into routine health checks, allowing doctors to pick up vulnerability to autoimmune disease much earlier than current practice permits.

"“We can identify those patients that are responding to P140 and identify them as the Type M patients before they’re even getting the disease.”"

Clinical path forward: higher doses, steroid tapering, targeted enrolment

Building on the three discoveries, the next clinical plan is straightforward:

1. Use higher dosing (10–15× what was used previously) to reach therapeutic exposure.
2. Incorporate steroid tapering in trial protocols to avoid immune suppression masking the drug’s effect.
3. Enroll biomarker-positive “Type M” patients (super responders) to maximise the chance of demonstrating efficacy.

These changes address the confounders that affected the earlier trial and are supported by additional preclinical work that underpinned the patent filing.

From lupus to a broad autoimmune opportunity

Although P140’s clinical history has focused on lupus, Tim explained the mechanism is broadly applicable across autoimmune diseases — there are around 50 recognised autoimmune conditions. The key is that within each disease there are subsets of patients who match the Type M profile and may respond to P140.

That opens a large commercial and clinical opportunity: diagnose earlier, treat the right patients, and potentially prevent disease development. Tim compared the potential impact to other recent transformative therapies in adjacent areas — stressing that the market opportunity and patient benefit could be enormous.

Commercial strategy: partners, patents and deals

ImmuPharma’s plan is to partner with larger pharma companies for development and global reach. Tim said discussions with multiple big pharma partners were already underway prior to the patent filing and that the patent has catalysed deeper interest.

• Filing the patent helps validate the science for prospective partners and allows confidential due diligence to proceed.
• Tim expects deals (or multiple deals) to be closed before the end of the year, saying that talks are advanced and partners recognise the uniqueness of this technology.
• Big pharma has been actively seeking assets in autoimmunity; an asset that combines a precise diagnostic with a safe, disease-normalizing therapeutic is particularly attractive.

Where ImmuPharma stands financially

Tim confirmed that cash is not an immediate concern. A recent exercise of warrants brought additional funds into the company, and he expects partner deals to provide substantial commercial funding moving forward. He said the company is comfortably funded into the second half of next year and is focused on closing partnership deals to accelerate development.

How the team feels — the CEO’s perspective

After years of internal restructuring, new leadership, and focused scientific work, Tim was candid about the excitement in the team. On a 1–10 scale he jokingly put himself at an 11, reflecting the belief he and the team have in the uniqueness and transformative potential of P140.

"“I’ve been in this business a long time, and I’ve never been in this position… this is absolutely unique.”"

Key takeaways

• P140 is now positioned as an “Immunormalizer” that restores immune balance rather than suppressing it.
• The newly filed patent covers both a precise diagnostic and the therapeutic use, enabling targeted treatment of “Type M” patients (super responders).
• Past Phase III results are being reinterpreted: dose was too low, steroids confounded outcomes, and patients were not stratified.
• Next clinical steps include higher dosing, steroid tapering, and biomarker-based patient selection.
• ImmuPharma expects partnership discussions to convert into deals before year-end; cash position is secure for now.
• If validated clinically, P140 could be transformative across many autoimmune diseases and could even be used proactively to prevent disease in at-risk individuals.

Final thoughts

The combination of a novel mechanism, a strong safety profile, and a companion diagnostic makes ImmuPharma’s P140 a story worth following. If the team’s scientific conclusions hold up in controlled trials with the new dosing and patient selection strategy, P140 could represent a step-change in how autoimmune diseases are diagnosed and treated.

If you care about developments in autoimmune therapy, keep an eye on partnership announcements and upcoming clinical designs from ImmuPharma — this is one of those rare biotech stories that blends scientific curiosity, hard data re-evaluation, and the potential for genuine patient impact.