A personal loss in the life of BioSapien CEO Khatija Ali inspired her to embark on a completely new career path that just might benefit untold numbers of cancer patients in the future. When her father was diagnosed with colorectal cancer, Ali saw firsthand the ravages of chemotherapy side effects. “It was the worst time in my life,” she said, in an interview with MD+DI, “and I didn’t understand what was going on. I didn’t understand why his hair was falling out. It sparked a curiosity in me.”

That curiosity drove her to leave behind her philosophy studies and apply to medical school, where she researched newer and better drug-delivery systems for chemotherapy.

And so began the idea for BioSapien, the company Ali founded in 2018 to develop a novel approach to delivering chemotherapy directly to tumors. What started as a $10,000 graduation gift from her attending physician increased to $40,000 from a friends and family round of fundraising, to a recently closed $1.8 million last year. Another $15 million is expected to be raised by August this year for clinical trials.

BioSapien’s drug-delivery system is called MediChip. It is a 3D-printed biodegradable mesh that can release any type of cancer drug in a localized manner. “You basically implant the chip on top of a tumor,” Ali said. “And as the chip breaks down, because it's biodegradable, it releases the chemotherapy directly to the site of the tumor without any adverse effects.”

She said that the drug is encapsulated inside the polymer and stays there. As it breaks down, it releases the drug to a very specific site. “So it's a very, very slow release and you can implant it on any solid tumors.

“MediChip is designed with four corners, and those corners can be sutured onto the site of the tumor. The corners are designated as the north, south, east, and west compartments, and each compartment can release the drug at different rates (if desired), because it is a separate polymer, with a unique molecular weight,” Ali said.

And because MediChip is implanted only on the tumor site, and the drug is only being delivered to that specific area, negative side effects typically seen with IV chemotherapy are not present. “In IV chemotherapy, you're putting it through the bloodstream. It's going everywhere,” Ali said. “Your GI cells are sensitive. Your hair follicles are sensitive, hair falls out, [your] stomach gets upset, you get immunity loss.”

These effects have not happened in BioSapien’s animal studies, Ali said. “No weight loss. No hair loss. No problems with the GI. No nausea. No diarrhea. It's as if there is nothing going on, except for tumor reduction, which is exciting,” she said.

The system is intended to be used in patients with Stage 3 localized cancer. “The reason we are targeting those patients is because they are already going in for some form of surgical procedure. The surgeon is already there and they are looking at the tumor and cannot take it out—what we call locally advanced unresectable cancers or residual markings,” Ali explained.

The first population for MediChip is expected to be rectal and anal cancer patients. “In patients with rectal and anal cancer, we are able to noninvasively or minimally invasively insert the MediChip without having to do an open procedure,” Ali said. In such cases, MediChip would be placed through either an endoscopy or colonoscopy. 

BioSapien is on target to complete its IND application by Fall 2022 to start clinical trials in December 2022, with the goal of having the first patient enrolled by the first quarter of 2023.

Ali said that BioSapien has partnered with Memorial Sloan Kettering, Vanderbilt University Medical Center, and the University of California, San Diego Medical Center, and that those are the potential sites for the clinical trials. “We are excited about our collaborations and hope to conduct our first-in-human Phase 1A/2B clinical trial with these Centers of Excellences and their experts” Ali said. “We aim to commercialize by Q4 of 2024.”