PROVIDENCE – There are almost too many good choices facing Denice Spero, Ph.D., the new president and chief business officer at ProThera Biologics, as she seeks to develop new partnerships to advance the company’s platform for its new biologic, Inter-Alpha Inhibitor Proteins, into clinical development.

The biologic is a naturally occurring, broad-spectrum modulator of inflammation.

It has shown strong potential in treating a range of life-threatening inflammatory diseases, such as dengue fever, anthrax, and bacterial sepsis.

In addition, as part of its core technology platform, ProThera is working to develop a series of biomarkers in systemic inflammation from bacterial and viral causes, as well as a diagnostic marker for neonatal sepsis.

“The initial data looks promising,” Spero told ConvergenceRI, in a recent interview, one week into the challenges of her new job, assessing the clinical potential of the biologic as a treatment for diseases. “Interestingly, the data looks great for everything.”

The company’s co-founder and CEO, Dr. Yow-Pin Lim, has compiled an impressive track record in securing nearly $8 million in federal preclinical research grants since the firm was founded in 2001, backed by an initial $100,000 investment by the Slater Technology Fund. The company has received an additional $500,000 in equity investments by Slater since then.

In February, exhibiting confidence in its future, ProThera Biologics moved into a new location, leasing the 4,000 square-foot building at 349 Eddy St., owned by Brown University, for three years. [Previous tenants have included Nabsys and NuLabel.]

As an early stage company on the verge, ProThera is serving as the lead tenant, sub-leasing space to two startups: Ryon Technologies, a Brown University academic lab spinout, which has developed new technology to perform what it calls “unambiguous chemical analysis”; and 3prime Dx, a company being launched by Dr. Samuel Dudley, chief of cardiology at Rhode Island Hospital and The Miriam Hospital, and director of the Cardiovascular Institute.

A story with promise, potential
Spero’s recruitment by ProThera to lead the company’s next stage into clinical development of its products marks the fascinating intersection of two paths within Rhode Island’s emerging innovation ecosystem. It is a story that speaks to the promise and potential of the state’s biomedical industry sector.

Spero has more than two decades of executive management in building scientific organizations. She served as vice president at Boehringer Ingelheim Pharmaceuticals from 1989 to 2007, managing the interface of discovery and development to assess the potential of drugs prior to entering late-stage pre-clinical and clinical development.

In 2007, Spero co-founded and served as president of Developing World Cures, Inc., building a team to develop new drugs for tropical diseases.

In 2009, she was appointed research professor and co-director of the Institute for Immunology and Informatics, or iCubed, at the University of Rhode Island.

In 2013, Spero became vice-president of strategic alliances at NsGene, Inc, a company working on development of implantable technology containing human cells producing therapeutic proteins for the treatment of diseases such as Alzheimer’s and Parkinson’s.

Spero also co-founded and leads a new cluster group, the R.I. BioScience Leaders, which includes some 30 biotech company CEOs in Rhode Island.

Lim co-founded ProThera while working as a biomedical researcher at Lifespan’s Rhode Island Hospital. In the last decade, he has forged relationships with an impressive group of some 15 clinical and academic research scientists who have served as collaborators and advisors.

In 2014, they included: Dr. James Padbury, from Women & Infants Hospital and Brown, working on neonatal sepsis; Dr. Stephen Opal, from Memorial Hospital and Brown Medical School, working on sepsis and biodefense; Dr. Alan Rothman from the University of Rhode Island, working on dengue; Dr. Barbara Stonestreet from Women & Infants and Brown, working on brain injury; and Dr. Louise McCullough from the University of Connecticut, working on stroke.

Moving forward, one of the key strategic partnerships that Spero will help ProThera facilitate is expected to be with a leading player in the blood product industry to ensure the flow of high-quality product supply needed to support clinical development and trials. The biologic Inter-Alpha Inhibitor Proteins is created through a blood fractionation process.

On the cusp of success
Here is the interview with Denice Spero, Ph.D., a week into her new job, as the president and chief business officer at ProThera Biologics.

ConvergenceRI: What kinds of new partnerships do you anticipate being developed with ProThera under your leadership?
SPERO: We’re going to have to get a handle on the manufacturing [of the biologic Inter-Alpha Inhibitor Proteins]. One of the reasons that I’m here on board is to really look closely at the business aspects.

Yow-Pin has done a really wonderful job defining and exploring the biological [properties] of this molecule, and the indication areas in so many different ways. He’s done an incredible job of finding and deciphering the breadth of the molecule.

Now, we’re at an inflection point, ready to move to the next level. It [will require] a lot of shifting to move all of the regulatory parts – and the manufacturing [forward]. We’re going to need to be focused on the development of a clinical plan. I’m here to do that.

The other part is the fund-raising piece; I’ll be working on funding the clinical studies as we go forward.

In terms of collaborations, we have developed a network of very fine academic collaborators and clinicians, thanks to Yow-Pin.

ConvergenceRI: What do you see as the best potential market for clinical development of Inter-Alpha Inhibitor Proteins – as a biomarker or as a biologic for potential treatment?
SPERO: We’re in the process of having those discussions now. There are a number of [options] we can go after.

The decision-making about which we will choose will be based upon unmet medical needs, looking at where there is [the best] chance for IAIP to move forward into [the clinical market], which ones are most advanced.

There is also the rapid care test, a point of care rapid test, [as a biomarker].

It’s an incredible package to have both; it’s not typical to have both [product opportunities].

The rapid care test is very, very interesting. It’s going to allow a physician to discern how severe the inflammation is, when a patient comes in with a high fever.

The rapid test using IAIP as an indicator for a plunging immune response can be very [important for quick, accurate treatment.] We’re in those discussions now.

The challenge is how we’re going to stack up the opportunities, which one goes first, which is first in the pipeline. It’s a true wealth of opportunities here.

ConvergenceRI: Do you think there is a potential tie-in to new research related to how diseases cross the blood-brain barrier as a result of inflammation?
SPERO: That’s a good question. In terms of brain injuries and strokes, we’re very interested in that. As you know, I have bit of a neuroscience background.

We’re looking at whether this molecule crosses the blood-brain barrier. In many diseases, the blood-brain barrier is compromised because of the pathology of the disease.

You can have situations where you are treating something systemically, mediating levels of inflammation in the periphery.

ConvergenceRI: What is the message that you see ProThera’s potential success delivering in regard to the emerging landscape in Rhode Island for the biomedical industry sector?
SPERO: I think the landscape is really very positive. Everywhere I go, I see a lot of very good, sound research that academic investigators have done. Many of them are asking the question: how do I move my company to the next level?

They love the science and they really want to move it forward, and they’ve put a lot of thought into it. I see more and more of that.

ConvergenceRI: How do you see ProThera in that emerging landscape?
SPERO: Yow-Pin [set the scientific foundations] very well. He got nearly $8 million in grants to do the independent biology, and we’re ready to go now. In the indication areas, we don’t have to do more biology. We’re ready to take the next steps. It’s a broad landscape that looks very promising.

ConvergenceRI: What’s your reaction to the proposed new biopark on the former 195 land by CV Properties and Wexford Science & Technology?
SPERO: I see that as a very, very positive development. It’s an affirmation, one that sees the promise of the biosciences sector, and broader, with medical devices and engineering.

For so many startup companies, providing space is essential; [the firms] don’t know where to get lab space. They have to find space somewhere; it’s challenging to build it out by yourself.

If there’s a place where the startup can just go to, it lowers the barriers, allowing them to just focus on the science, and then having the space to expand.

ConvergenceRI: How has the conversation changed? Is there a better recognition of the potential of the sector in Rhode Island?
SPERO: It seems very promising. I think people really get it now. A lot of scientists are verbalizing [about the potential here]. That people think there’s a great opportunity, with broad groups supporting it. There is an energy about this.

[From my new office], I’m looking at the South Street project, the nursing center. That’s another piece to this, an affirmation that this is important for Rhode Island.

ConvergenceRI: How important is collaboration as part of the process of health innovation?
SPERO: I see a lot of collaboration happening here. Using ProThera [as an example], we’re collaborating with Memorial Hospital, with Women & Infants Hospital, with the Brown Medical School, with grants from STAC and the SBIR Innovate Rhode Island program, with URI, with the engineering school at URI. I think that people are connecting.

ConvergenceRI: Will you continue with the leadership role at R.I. BioScience Leaders? Or will the new job be all encompassing?
SPERO: This job is going to be all encompassing, but I will continue with my role at BioScience leaders. I will do both.

With this job, I am committing everything I have; we’re going to make it a success.

But it’s also helping the biotech life sciences sector develop here.

ConvergenceRI: In terms of deal flow, with Slater Technology Fund having recently received some $4.3 million in new funds, do you expect that they will make another equity investment in ProThera?
SPERO: We’re looking at all the options moving forward. I’ve been here for just over a week now. I’m developing a total plan to see how much we’re going to need, and where are we going to get it.

ConvergenceRI: Is the potential biodefense work with anthrax still on the table?
SPERO: It’s still on the table. The initial data looks promising. Interestingly, the data looks great for everything.