From The Editor | September 1, 2020

COVID Pandemic Hastens Search For New Technology And CRO Partner

Ed Miseta

By Ed Miseta, Chief Editor, Clinical Leader
Follow Me On Twitter @EdClinical

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Mateon Therapeutics is a publicly traded company focused on developing drugs for the treatment of rare pediatric cancers. Mateon is the combination of three different companies: It completed a reverse merger with Oncatelic in April 2019. Later that year, in November 2019, the company acquired PointR Data, a technology company with expertise in artificial intelligence (AI). 

The company now has three products in Phase 3 clinical trials, three in Phase 1 and Phase 2, and four in discovery. The treatments are targeting brain and pancreatic cancer, melanoma, and other solid tumors. The company’s product attempts to break down the protective wall surrounding tumors, allowing the body’s immune system to recognize, target, and destroy the tumor cells. The company also recently began developing a lead oncology drug for the treatment of COVID-19.

The Pandemic Forces Change

As the pandemic began to rage, the company was seeking a tool to assist with preclinical development. The crisis meant many patients were suddenly unable to visit clinics.

“We were a company that was in need of a tool to help us get through preclinical and clinical development,” says Saran Saund, chief business officer for Mateon. “We are a company focused on oncology, but the pandemic led us to use our AI tools to examine our pipeline. We hoped to discover if one of our treatments might help patients suffering from the COVID virus. When the pandemic hit, we also needed to change how sites interacted with patients to ensure everyone’s safety.”

Almost overnight the search for a preclinical development tool was suddenly a high priority. Mateon needed a tool that provided scalability, accessibility, and data integration. Site visits had been cut drastically and patient interactions with clinics were suddenly migrating to Zoom. Saund knew he needed a new tool to deal with the developing situation.

Data Is King

Saund believes that data is king in any clinical trial. Regardless of how good the therapy is, an FDA approval depends on clean and reliable data. He states that if the protocol is a Bible, the EDC system is the shelf that holds the Bible. A clinical trial will fail or succeed, depending on how easily the protocol transitions from a document approved by the FDA to a set of screens that allow sponsors to track the data. That data must be gathered, analyzed, and viewed in real time by both the CRO and the sponsor. That typically means a cloud-based solution.

“Researchers can no longer receive a data report once a week,” he states. “It is something that has to be reviewed continuously and something that I can review during meetings. Today, data is pouring in from many different sources. When new data is coming in, researchers need to view the data as a whole, not as separate entities. With many of the systems we looked at, this was a problem. The systems had difficulty integrating data coming in from different sources.”

Scalability was also a huge concern for Saund. Some of Mateon’s oncology trials may involve only 20 patients. Still, as the company grows, he wanted a solution that could also accommodate thousands of patients for trials conducted in other therapeutic areas.

Select The Right Tool

Saran Saund, chief business officer, Mateon Therapeuitcs
Saran Saund, chief business officer, Mateon Therapeuitcs
Mateon spoke to several CROs, soliciting their advice on a technology solution that would meet its needs. Several of them suggested IBM Clinical Development (ICD). When he investigated ICD, he learned IBM was supporting COVID-19 clinical research through an initiative designed to support trial sponsors with promising therapeutic and vaccine candidates. Mateon submitted a proposal and was granted access to the Watson Health ICD platform free of charge for the clinical trial evaluating the potential of Mateon’s lead drug candidate OT-101 in COVID-19 patients. This provided a substantial cost savings to the company.

The CROs recommending ICD to Mateon were some of the top providers in the industry. When ICD popped up on Saund’s radar, he asked IBM for the names of CROs that were using the platform. When he got the list, he noted it contained the names of companies he wanted to work with. That was when he contacted those companies to get their assessment. All recommended the platform, which provided him with a good deal of confidence in the product.

“The feedback I got from CROs validated our decision to work with ICD,” says Saund. “We were told it was one of the top tools in terms of performance. IBM has been around a while and we also learned the company was expanding its footprint in the clinical space. We were told ICD is flexible, scalable, and easy to program. Hearing this from CROs who worked with the tool made us feel comfortable with implementing it. It provided all the tools we needed, including ePRO, data integration, reporting and analytics, quality and compliance, medical coding, endpoint analysis, randomization, and clinical trial supply management.”

“I guess many people view IBM as a large monolithic organization,” he says. “We did not experience that. The platform we installed is flexible and responsive. We are very happy with the performance and the CROs we work with are also happy with the choice we made.

The Search For A CRO Partner

The information Saund gathered on the technology platform also assisted him in the search for a CRO partner, as he hoped to work with a company that was familiar with the IBM solution. After sending out RFPs and conducting bid defense meetings, Mateon opted to partner with one of the large global CROs. Mateon is a small biotech company with less than 50 employees. Still, Saund had no qualms about working with a large CRO.

“The company had an international footprint,” he says. “With the COVID pandemic sweeping the world, we had no idea where the next hotspot would be. We needed a CRO with that international reach and a platform that could be programmed and input internationally. At the same time, we needed the flexibility of a CRO that could address the needs of a small biotech company. We had a long list of qualifications for our CRO partner but having an international footprint and the ability to work with small companies were our major concerns.” 

“Our greatest challenge will be locating the right patients for our study,” notes Saund. “We require patients with mild symptoms of COVID. It is difficult to locate COVID patients who have not been hospitalized. Hospitals will generally not admit patients who have COVID but do not require oxygen or a ventilator. Therefore, we need to find patients who have tested positive and are hospitalized but are not on oxygen. That is a requirement of the protocol and makes recruitment challenging and rigorous. This is an area where we really needed a CRO to step up with a strategy that helps us get there.”

Saund also hopes governments will do what is necessary to provide many treatment options for patients. That means looking at all available data and not placing their focus on pharmaceutical grade drugs. He believes there are traditional medicines that have been honed in India, China, and Africa that have the potential to save lives.

“This is not a virus that will suddenly go away,” he adds. “We may see second and third waves impacting countries. Our search for treatments must be data driven and non-political. I hope our governments will fund many different treatments that have demonstrated efficacy, especially those coming from small biotech companies. These companies bring a lot of knowledge, innovation, creativity, flexibility, and speed to the development process. We need to take available money and spread it out over a vast array of vaccines and therapeutics.”