After two decades working in leadership positions at big pharmaceutical companies like AstraZeneca and Novartis, immunologist and emergency physician Volkan Manga wanted to go in a new direction. He realized that as he watched some drugs pass through clinical trials and reach real patients, many more drugs with great potential sat by the wayside. “When you have like 100 plus projects going on, it is difficult to give the intense research focus [needed] to find where each drug fits best,” said Manga. “There's a lot of underexplored science out there.”

In July of 2024, he joined Uniquity Bio as their Chief Medical Officer. Manga said that he was excited to become part of the company because its mission is to fill the exact void he noticed during his time in Big Pharma. Uniquity Bio aims to find promising drug compounds that large companies don’t have enough resources to investigate deeply anymore.

Uniquity Bio focuses on immune-mediated diseases, which Manga noted “almost describes everything. … [The] immune system is involved in pathogenesis of almost all the diseases we have.” Currently, the company’s lead compound is the monoclonal antibody solrikitug, which they acquired from Merck. The drug is now in Phase 2b clinical trials to treat asthma, chronic obstructive pulmonary disease (COPD), and eosinophilic esophagitis (EoE). They plan to develop many other compounds that lie in wait too.

“More companies like us are needed to make the entire continuum of drug discovery, development, and commercialization become much more successful than it is today,” he said.

How would you describe Uniquity Bio’s vision?

The Big Pharma we have today —  the Pfizers, GSKs, Mercks, Roches, Novartises of the world — they're really good, well-oiled commercialization or medical transformation machineries. As good as they are when it comes to post-Phase 3 clinical trials, it's very difficult for them to be great before Phase 3. That’s because they don't have enough manpower and resources to put all their effort behind all the hundreds of different compounds that they have in their portfolios. They need to put well-trained, well-educated scientists behind these drug development projects, which cost a lot and take a lot of time. Simply, they can't shortcut anything, so they can only develop a handful of drugs. This means that a lot of drugs and potential targets wait on the shelf. The drug development community is leaving a lot in the tank when it comes to transforming human health.

That’s where we come in; we are very complimentary to Big Pharma. What Uniquity Bio wants to do is deeply study these underexplored science areas and focus on compounds that the big pharma companies don’t have time for. At Uniquity Bio, I’m working with a fantastic set of drug developers, and we are really giving a compound the attention it deserves to get the best out of it.

How does Uniquity’s financial model allow it to accomplish these goals?

It’s critical to our success that we have an institution like Blackstone Life Sciences partnering with us and supporting our process. We are properly resourced so that we can be scientifically ambitious and transformative, and we scan the scientific landscape to find the best opportunities so that we can really explore which diseases are the best ones to treat with a particular compound. The ideal model is that we prove that drug A is fantastic and will be transformative for disease B. Then, we can hand it over to a large pharma company who can scale it up in Phase 3 trials.

Tell me about your lead compound, solrikitug, the monoclonal antibody that targets thymic stromal lymphopoietin (TSLP). What is TSLP, and why target it?

TSLP is a cytokine that belongs to a family called epithelial alarmins. In hypersensitivity diseases, certain organs that are exposed to the external world — like the lungs, skin, or mucosa — can have exaggerated immune responses to harmless particles (1). TSLP is one of the molecules that signals this epithelial stress and leads to downstream inflammatory responses called type 2 immunity (2). Type 2 immunity is a critical pathological process in many of these diseases, and TSLP is a target for many of them.

In 2017, my colleagues at Uniquity Bio saw the scientific potential of solrikitug when AstraZeneca and Amgen announced the first results of another anti-TSLP monoclonal antibody in asthma. By that time, in various other companies, there were anti-TSLP drugs, and our colleagues reached out to Merck. As far as I know, Merck's interest at the time was more focused toward oncology, so the team there allowed us to take on their anti-TSLP compound and move forward with a respiratory and immunology focused approach.

What is the current status of solrikitug?

We’re testing it in lung diseases, specifically asthma and COPD. We’re also testing it in the gastrointestinal indication EoE. These are very important high unmet need disease areas, especially for COPD and EoE where we rapidly and badly need new and better drugs. Asthma is a bit more established, but especially for moderate-to-severe asthmatics, there’s definitely a need for better versions of the current drugs. We will also be exploring other respiratory diseases and other organ systems where type 2 immunity is indicated.  

We haven't published any data yet. But, we've started three Phase 2b trials for asthma, COPD, and EoE, and we’ve been very successful in progressing those. We're expecting to read out the initial findings later this year and next year for all of these, which hopefully will allow us to move into Phase 3 pivotal testing. We believe that for these initial three indications, the probability of success is pretty high based on the historical data accumulated over the last decade and a half.

Where does Uniquity Bio plan to focus its efforts in the future?

Number one, we need to deliver the indications that we have in our hands. Beyond that, we’re also focused on accelerating our bispecific programs. These are compounds that bind to two targets. We believe that we have a best-in-class anti-TSLP antibody, and we’re building our bispecific drugs based on our solrikitug backbone. We're also carefully selecting different cytokines to target in addition to TSLP. In combination, we see better immunomodulatory and better anti-inflammatory responses, which may result in better disease outcomes. The goal is: How can we move the field forward? How can we transform the outcomes of these diseases in a way that is optimal for patients?

This interview has been condensed and edited for clarity.

References

1. Janeway, C.A. Jr. et al. Hypersensitive diseases in Immunobiology: The Immune System in Health and Disease. 5th edition (Garland Science, 2001). 
2. Lloyd, C.M. & Snelgrove, R.J. Type 2 immunity: Expanding our view. Sci Immunol  3, eaat1604 (2018).