Why this Philadelphia cancer therapy developer is taking a clinical testing path less traveled

Philadelphia Business Journal

Philadelphia, PA — October 29, 2019

By John George – Senior Reporter, Philadelphia Business Journal

When tackling the task of testing new drug candidates, startup biotech and pharmaceutical companies typically hire a contract research organization — or CRO — to manage clinical trials.

The advantage of using a CRO, said Context Therapeutics co-founder and CEO Martin Lehr, is they work quickly and allow a company to keep control of their drug studies.

Lehr has decided go a different way with his startup, which he founded in 2016 with Drexel University College of Medicine assistant professor Felix Kim to develop treatments for hormone-responsive cancers.

“I have chosen to flip the typical model and go solely with ISTs (investigator-sponsored trials),” Lehr said. “By the end of the year, we will have five clinical trials in the United States and Europe up and running that will ultimately enroll almost 200 patients.”

Those trials will be evaluating the effectiveness of Apristor, Philadelphia-based Context Therapeutics’ lead new drug candidate, in a variety of cancers.

In investigator sponsored trials, a physician both initiates and conducts the clinical study. The IST model requires that a company transfer a trial's control and execution to the investigator. Lehr, who earlier in his career was part of the founding team at the Philadelphia venture capital firm Osage University Partners, said “venture funds [that back life sciences startups] are reluctant to transfer control of their most valuable asset outside of the company.”

Context Therapeutics CEO Martin Lehr founded the company in 2016.

The advantage for the company is the cost of the clinical trial conducted by an IST is a fraction of the cost of a CRO-run study, Lehr said. Mid-stage CRO managed clinical trials can range from $170,000-to $200,000 per patient for small molecule drugs. Lehr said for cell therapy, the cost is "multiples" of that range.

“Typically what happens is a single researcher who will come to you and say, ‘Hey I love what you're doing and I have 15 patients. Let's [test the company’s new drug candidate] and see if something great happens. ISTs are looked down on because they often involve a single junior faculty member at a single institution and there can be concerns about cherry-picking patients, about their being a bias. The reality is when you work with a small site they are enrolling everyone, so you do end up with a heterogeneous population.”

Lehr noted some well-known drugs — including the rheumatoid arthritis drug Remicade initially developed by Malvern-based Centocor and Pfizer’s fibromyalgia drug Lyrica — started out being tested in investigator-sponsored trials.

Context Therapeutics' first IST is being run by a Memorial Sloan Kettering Cancer Center doctor who is already enrolling patients with advanced gynecological tumors. In September, the company announced a phase-II clinical collaboration with the Sidney Kimmel Cancer Center at Jefferson Health. The study will evaluate whether Apristor when used in combination with estrogen blockers antiestrogen and anastrozole, can enhance outcomes for patients with metastatic endometrial cancer who have certain known hormone receptors and failed multiple prior therapies.

Also in September, Context signed a clinical collaboration deal with SOLTI, a leading collaborative and academic group in Spain, that is looking at Apristor as a potential breast cancer treatment. Last month, the company announced clinical collaboration for an Apristor study with the Wisconsin Oncology Network.

The Jefferson study will be led by the Dr. Saveri Bhattacharya, an assistant professor of medical oncology.

Bhattacharya said she learned about Context Therapeutics and Apristor through her mentor Dr. Russel Schilder, director of the gynecologic medical oncology program at the Kimmel Cancer Center at Jefferson, who knew Lehr. Schilder is a co-investigator for the study.

“We had heard about the company and its compounds and we got in touch with him [about conducting a combination therapy trial],” she said. “The phase-I data they have produce was very compelling to me.”

Bhattacharya said she has written the clinical trial proposal and received approval for it from Context, and is now hopeful for it to approved by Jefferson in the next few months.

Finding an investigators to sponsor a trial, Lehr said, can be a challenge.

“You have to find these intrepid researchers who are typically mid-career and have bought into your idea,” he said. “They want to lead a trial that will help them advance their career. If any of our trials hit, that researcher’s career will head up on a positive trajectory."

Lehr said the best case scenario for an IST is two have two researchers leading trial: One who is a mid-career faculty member who would be the true lead and "a senior person who provides the gravitas.”