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CALLUNA PHARMA names Mark Gaffney CEO & Board member EXITS Oxular to Regeneron · Vedere Bio to Novartis SERIES A €75M to chase fibrosis & inflammation LEAD CAL101 wrapping Phase 1 RESUME Engineer · Lawyer · Air Force intel · Dealmaker
Calluna Pharma · Oslo / Boston

Mark Gaffney

He doesn't start biotechs. He inherits the hard middle and gets them across the line - twice into the arms of pharma giants, now once more in Oslo.

CEO Board Member Engineer Lawyer Operator
20+Years in Biotech
2Exits to Pharma Giants
€75MCalluna Series A
2Degrees: Eng + Law

An engineer who reads contracts, a lawyer who reads pipelines

In October 2024, a clinical-stage biotech in Oslo went looking for someone to steer its lead drug through the last yards of Phase 1. They picked a man who had already sold two companies out from under their respective problems - and who happens to hold a mechanical engineering degree and a law degree at the same time.

Mark Gaffney runs Calluna Pharma, a company that did not exist three years ago. It was assembled in 2023 from the merger of two Norwegian players in innate immunology, Oxitope Pharma and Arxx Therapeutics, then capitalized with a 75 million euro Series A announced in January 2024. By the time Gaffney took the CEO chair, the science was no longer a pitch deck. The lead candidate, CAL101, was on pace to finish its Phase 1 program that same year. That is the moment he likes - not the blank page, but the point where a real molecule meets a real clinic and somebody has to make the calls.

It has been a rapid and impressive start to our journey as Calluna Pharma following joining forces of Oxitope Pharma and Arxx Therapeutics, two key players in the innate immunology space. - Mark Gaffney

Calluna's whole bet is on the immune system's oldest machinery. Most of biotech spends its energy on the adaptive immune system, the part that learns. Calluna is going after the innate side, the ancient first responders, and the self-reinforcing loops that turn a sensible inflammatory reaction into the slow scarring of fibrosis. The company describes its candidates as targeting "disease amplifying loops" - first-in-class antibodies aimed at quieting the feedback before tissue hardens. It is a contrarian corner of immunology, and Gaffney walked into it at the exact moment it stopped being theoretical.

Penn bolts, Boston torts, and a stint in Air Force intelligence

Start with the strange detail. Before the boardrooms, Gaffney served in U.S. Air Force intelligence. Then he went to the University of Pennsylvania and trained as a mechanical engineer - the discipline of load, tolerance, and failure modes. Then, instead of designing machines, he enrolled at Boston University and came out with a Juris Doctor. Calluna's own bio credits that engineer-plus-lawyer combination for his "analytical problem-solving approach," which is a polite way of saying he tends to take a system apart before he agrees to run it.

That toolkit is unusual in a CEO chair. Engineers think in constraints; lawyers think in obligations and downside. Put them in the same head and you get someone temperamentally suited to the least glamorous, most decisive part of drug development - the corporate development desk, where molecules become deals and deals become exits.

First Job, Roughly

U.S. Air Force intelligence - the analytical foundation before the lab coats and term sheets.

The Engineering

Mechanical engineering at the University of Pennsylvania. Load, tolerance, failure modes.

The Law

Juris Doctor from Boston University. The part that reads the fine print before the handshake.

Two companies in, two pharma giants out

Gaffney's reputation was built on the corporate development bench at Ironwood Pharmaceuticals and then Cyclerion Therapeutics, the kind of roles where you learn how a biotech actually keeps its lights on between trials. But the headline lines on his resume are the two exits.

At Vedere Bio, a company developing next-generation ocular gene therapies, he served first as Chief Business Officer and then as Chief Operating Officer. In late 2020, Novartis acquired it. Then came Oxular Limited, a developer of novel drug-delivery and formulation technology for retinal disorders, where he was CEO. In late 2024, Regeneron acquired that one too. Notably, he didn't fully walk away from Oxular when he took the Calluna job - he stayed on as a strategic advisor and board member, the kind of move that suggests the relationships outlast the transactions.

I am delighted to join the team at such an exciting stage with Calluna's lead candidate, CAL101, completing its Phase 1 program this year, and with the other programs in our pipeline demonstrating such promise. - Mark Gaffney

There is a pattern here, and it is not the founder's pattern. Gaffney is rarely the person who dreams a company into being. He is the person who shows up when the science is promising but the path is murky, builds the operational and financial scaffolding, and finds the door - whether that door is an acquisition or a clinic. Two eye-focused biotechs went to Novartis and Regeneron on his watch. The third, this time aimed at fibrosis and inflammation rather than the retina, is the one he gets to drive from the front seat.

Quieting the loops that turn inflammation into scar tissue

Fibrosis is what happens when the body's repair response forgets to stop. Inflammation flares, the immune system rushes in, and instead of healing cleanly the tissue lays down scar - in lungs, in skin, in organs - until function declines. It is implicated in a long list of serious conditions, and it has been stubbornly hard to drug. Calluna's thesis is that the innate immune system runs self-amplifying loops that keep the fire burning, and that selective antibodies can interrupt them at the source.

Where Calluna aims its antibodies

Illustrative focus across the pipeline thesis - innate immunology & fibrotic disease
Innate immune loopsPrimary
Fibrotic diseaseCore
Inflammatory diseaseCore
First-in-class antibodiesApproach

Gaffney's job is not to invent that biology - the scientific bench at Calluna, led by a chief scientific officer with three decades in immune-mediated and metabolic disease, handles that. His job is the translation layer: turning a robust early pipeline and a single Series A into a company that can actually run the trials, hit the readouts, and decide, with cold engineering honesty, which programs deserve the next round of capital.

An Oslo company, a Boston commute, a heather for a name

Calluna is headquartered at Gaustadalleen 21 in Oslo, in the thick of Norway's research corridor, and backed by a European investor syndicate that includes Forbion, Sarsia, Investinor and others. Gaffney, by contrast, is anchored in the Boston biotech ecosystem - the same orbit as Ironwood, Cyclerion and Vedere. Running a Norwegian company from Massachusetts is its own small statement about how modern biotech actually works: the science can be Nordic, the capital pan-European, and the operator transatlantic.

Even the name fits the temperament. Calluna is the genus of heather - hardy, low plants that thrive in poor, acidic, inhospitable ground where little else will grow. A company chasing some of medicine's most intractable diseases, run by a man who specializes in the unglamorous middle, could hardly have chosen a better botanical mascot.

I look forward to working with Mark Altmeyer, the other members of our Board and the team as we continue to progress Calluna's programs to make treatments for fibrotic and inflammatory diseases a reality. - Mark Gaffney

The readout era

For most of his career, Gaffney's wins were measured in signed deals. At Calluna, the scoreboard changes. The next chapters are clinical - CAL101 moving past Phase 1, the rest of the pipeline proving whether the disease-amplifying-loop thesis holds up in human beings, and the inevitable capital decisions that follow. It is the difference between selling a story and owning the outcome.

He has spent two decades preparing for exactly this kind of moment: a company where the science is real, the money is in the bank, and someone with an engineer's respect for failure modes and a lawyer's respect for downside has to decide what to do next. The heather is planted in hard ground. Now everyone gets to watch whether it takes.