With ambitions to enter the clinic in the first half of 2023, Keir Loiacono, esq., aims to double down on BlueSphere’s strengths rather than make any major course corrections.
BlueSphere Bio CEO Keir Loiacono/courtesy of BlueSphere Bio
BlueSphere Bio named a new CEO Tuesday. With ambitions to enter the clinic in the first half of 2023 with its acute myeloid leukemia program, Keir Loiacono, esq., aims to double down on the company’s strengths rather than make any major course corrections.
“We’re in a good spot in terms of our strategic vision,” said Loiacono in an exclusive interview with BioSpace.
In addition to its clinical development targets, BlueSphere is developing its drug discovery technology platform for use by potential partners.
“One of the reasons I came to BlueSphere almost two years ago was that the company has multiple, different ways to drive value,” Loiacono said. Compared to single product companies, this extends its opportunities for success, he noted.
Primarily, “I look at us as a drug development company,” Loiacono said.
A glance at BlueSphere’s pipeline shows two candidates – TCX-101 and TCX-201 The former is being investigated for AML, acute lymphoblastic leukemia (ALL), myelodysplastic syndrome (MDS) and, separately, allogeneic transplantation. TCS-201, still in the discovery phase, is being explored as a therapeutic for solid tumors. The company has a strong cash position that will see it through data generation for at least the initial clinical trial.
Partners Wanted
Underpinning these programs is the discovery technology. “The discovery platform is able not only to discover novel targets for our own clinical development but for other partners, as well,” Loiacono said.
It is divided into two proprietary elements. One, TCXpress isolates, amplifies and clones tumor-infiltrating lymphocytes (TILs), thus forming a T-cell receptor repertoire library. The other, NeoXpress, develops neo-antigen libraries that are specific to certain tumors, which then can be further screened to identify the best lead candidates for particular tumors, either for individual patients or for specific patient populations.
Loiacono said he considers the discovery platform a key asset, not only for BlueSphere’s internal programs but for potential partners.
“Ideally,” he said, “that first partner would be an organization that was interested in discovering novel T-cell receptors or a novel TCR panel to a shared antigen.” Other companies have already expressed interest in leveraging that platform as it continues to develop.
Clinical Target: 1H 2023
Loiacono’s near-term goals are to get the first asset into the clinic in the first half of 2023.
“We’re still working out the details of the first study in patients with AML,” he said. The study is being planned as an open-label trial involving approximately 10 patients and will have dose escalation and safety as primary endpoints.
“It’s important to note that this study also could validate the platform. It (is expected to) demonstrate that the platform is capable of discovering targets that are useful in the clinic.” If that occurs, it will lay the groundwork for additional targets and studies in the future, he said.
In terms of challenges, Loiacono said he sees nothing out of the ordinary for any early-stage cell therapy company. For all, the big challenge is simply, “how do you make a cell therapy product and bring it into the clinic on time and on budget?”
Loiacono is a patent attorney by training. That, coupled with his early experience in the commercial side of the industry as a pharmaceutical sales representative, is an advantage in his new role as CEO.
“I think being a lawyer and having represented a lot of businesses both as outside counsel and as general counsel, I’ve seen a lot,” he said. “When you’re general counsel, you are involved in every aspect of the business, so I really learned how companies work. I also learned how the markets work and did complex financings, which gave me an opportunity. I’ve held or overseen almost every non-technical position in a (biopharma) company.” That breadth of experience has given Loiacono a unique perspective among CEOs.
Additionally, his legal training encouraged him to be results-oriented, he said, and to understand that often, time is of the essence.
“Being a lawyer makes you a really good decision-maker under pressure, but we’re also taught never to make decisions alone...to have people around us who are really strong and whom we value.”
A Natural Fit
Loiacono has that team at BlueSphere Bio. He was chief business officer there before becoming CEO, so already is well-known and respected in the company. “And,” he says, “as chief business officer, I’ve had the opportunity to build a lot of the infrastructure and hire a lot of the people who are here.”
Countless CEOs have pointed out the value of having an exceptional team around them to achieve a company’s goals.
“Having a team led by someone they know and trust and who has had success in the past makes leadership easier,” Loiacono said. Because he has a history with that team, Loiacono knows their strengths and challenges, as well as the inner working of the company. This eliminates the onboarding learning curve those hired from outside typically experience.
Loiacono, as CEO, understands there are dire unmet needs and is committed to making substantial improvements in cancer treatments for patients.
“I think, as drug developers in the cancer space, we have to act with a sense of urgency for our patients,” he said. “My former company used to say, ‘Doing what’s in the best interest of the patient ultimately will be in the best interest of the shareholder.’
“These patients don’t have a lot of time, so you can look at any oncology company and apply that same philosophy. If I can impart anything to the folks who are here, on top of the great work they are doing, it’s to operate with a sense of urgency, as if people are waiting for this. Because they are.”
