ASCO Launches Mentor Program With Grant to Noted Researcher

Alex A. Adjei, MD, PhD

Professor and Chair, Department of Medicine, Katherine Anne Gioia Chair in Cancer Medicine Senior Vice President, Clinical Research, Roswell Park Cancer Institute, Buffalo, NY

An effort to nurture the drug development skills of young oncologists as they explore a novel targeted agent has gained support from the Conquer Cancer Foundation of the American Society of Clinical Oncology (ASCO).

Alex A. Adjei, MD, PhD, is the recipient of the foundation’s first Drug Development Research Professorship grant, an award that will enable him to mentor researchers engaged in earlyphase studies of CBLB502, a toll-like receptor 5 agonist that appears to promote an immune response in patients with solid tumors without inducing septic shock-like symptoms.

The $500,000 award is supported by Sanofi Oncology, according to Roswell Park Cancer Institute (RPCI), where Adjei leads a drug development program with about 20 new agents under investigation.

Adjei said in an interview with OncologyLive that the grant would enable him to teach his junior colleagues the process of designing and running clinical trials, analyzing results, and working with FDA regulations.

“It’s really how you test a new drug and the science of drug development,” said Adjei. “I’m pretty excited about this.”

Adjei said that although many drugs are being tested, “there are not many young oncologists who are well trained in the science of drug development.”

He noted that it is vital to evaluate drugs correctly in early-phase investigations.

“It’s a very crucial time because you don’t know what the drug is going to do in patients,” he said. “You have to make sure that you test this safely. You don’t cause any harm. You identify all the side effects of that drug and figure out a way of ameliorating these side effects, and, at the same time, pick out the ones that actually have promise, activity in patients, and so on, before it can go to phase II and phase III.

“In this phase I setting, if you don’t do it right, you might kill a lot of good drugs or, on the flip side, there might be drugs that don’t work that are dangerous that you send on to phase II and III trials,” said Adjei. “I think it’s a credit to ASCO in acknowledging and realizing that this is an area where we need a lot of expertise.”

Donald L. Trump, MD, the president and CEO of RPCI, praised ASCO’s choice of Adjei for the inaugural professorship.

“Many physicians become better clinicians because of their research or better researchers because of their clinical practice, but few incorporate these separate functions as fully and effectively as Alex,” Trump said in a press release. “He deeply understands the realities of the drug-development arena—the possibilities and the limitations—and for all these reasons is uniquely qualified to mentor young researchers.”

Specifically, the grant will support Adjei’s work with CBLB502, according to the Conquer Cancer Foundation. Andrei Gudkov, PhD, DSci, senior vice president of Basic Science and chair of the Department of Cell Stress Biology at RPCI, is developing the agent through Cleveland BioLabs, Inc, where he serves as chief scientific officer.

CBLB502 is recombinant protein that acts by mobilizing antitumor immune response and, unlike other toll-like receptors, does not induce a septic shock-like syndrome known as a “cytokine storm,” according to Cleveland BioLabs’ website.

Adjei is the principal investigator in a phase I study evaluating the safety and pharmacokinetic profile of CBLB502 in patients with locally advanced or metastatic solid tumors that cannot be removed through surgery.

The study seeks to enroll 48 patients who would receive CBLB502 subcutaneously daily for five days with two to three cycles of repeated treatment every six to 12 weeks.

Cleveland BioLabs also is exploring CBLB502 as a biodefense agent for the treatment of patients exposed to potentially lethal doses of radiation under the FDA’s Fast Track program.