Cairn Therapeutics is a pharmaceutical company with a mission to help patients beat cancer. Its team is developing a novel drug for solid tumors and possibly blood-borne cancers that has the potential to revolutionize chemotherapeutic cancer treatments.
The first-in-class DNA binding agent, CT-262 was developed by renowned chemist Dale Boger, Ph.D, a premier researcher on duocarmycin drugs at Scripps Research. CT-262 is a pro-drug that is converted into an active form inside cells. It is a promising breakthrough high-potency cancer treatment with a reduced impact on the immune system and long-lasting action.
“The pre-clinical data on the efficacy of this drug was pretty substantial, with the potential to replace a significant portion of the current chemotherapeutics that are on the market” says Tom Fritz, COO at Cairn Therapeutics, “It would be a shame if this drug was not tested clinically for its true potential in treating human cancers.”
KreaMedica assisted Cairn Therapeutics in preparing the Investigational New Drug (IND) application package for their lead candidate, CT-262. We asked Tom Fritz to share some of the challenges that KreaMedica helped overcome for Cairn Therapeutics.
Navigating the challenges of preclinical development
When Tom Fritz joined Cairn Therapeutics as COO, he was well-equipped to guide the drug development and regulatory submission process, with 30 years of experience and successful completion of numerous major clinical trials. However, no two drugs are the same, and getting CT-262 ready for IND submission came with a set of unexpected challenges.
Challenge #1: Finding the right CRO and overseeing toxicology studies in Canada
Conducting non-clinical toxicology studies in the U.S. comes at a substantial cost.
“We were seeking a more budgetary-friendly option,” says Tom. Cairn Therapeutics discovered a toxicology research lab in Montreal that offered substantial cost savings. However, because the safety studies were taking place during the COVID-19 pandemic, their ability to travel to the site was limited.
KreaMedica became an intermediary between Cairn Therapeutics and the toxicology CRO, helping with the development of study plans, on-site monitoring, guidance and review of reports.
“They quickly assigned a program manager and a scientist with substantial toxicology background and a good understanding of the regulatory requirements,” says Tom. “They were both very competent and did a remarkable job.”
Thanks to KreaMedica’s on-site monitoring, Cairn Therapeutics was able to establish if side effects were due to technical difficulties or the drug itself. Additionally, working with a Canadian service provider through KreaMedica provided a favorable cost structure due to the Canadian SRED tax incentives, which resulted in substantial cost savings for Cairn Therapeutics.
“Thanks to KreaMedica, we were able to execute our toxicology studies on a smaller budget and nimbly in a foreign country, especially when travel was restricted due to the pandemic,” says Tom.
Challenge #2: Establishing the right dosing schedule and thresholds
CT-262 is a pro-drug molecule that goes through a two-step enzymatic activation mechanism in the hypoxic tumor microenvironment, remaining mostly in its inactive form in healthy cells. This drug has a substantial half-life, so once it gets into the cells, it will maintain cytotoxic effects for a fair amount of time. While this provides a significant benefit in terms of the drug’s potency, establishing the maximum tolerable dose presented challenges around the dosing schedule and thresholds.
KreaMedica helped Cairn Therapeutics interface with the toxicology labs to develop the appropriate study protocols and resolve issues that arose due to the drug’s high potency. Through on-site monitoring and in-person discussions with the study director, KreaMedica was able to provide an accurate and objective picture of the status of the studies and work with the obstacles of the product, such as the dosing schedule and formulation.
Challenge #3: Preparing reports for IND submission
In addition to managing the toxicology studies, KreaMedica helped define the requirements of the IND submission package based on Cairn Therapeutics’ molecule and indication, removing studies and methods that were not required in their situation (such as dose formulation analysis).
“They were instrumental in managing the preparation of the study reports, as well as editing and support,” said Tom. “When we got the report, it had been substantially refined and cleaned up, which helped to expedite the process.
“KreaMedica’s assistance in regards to the quality of the data and the reports will most certainly facilitate the [IND submission] and favorable review,” said Tom.
Challenge #4: Project development plan for bridge funding
Since the completion of the IND submission package, Cairn Therapeutics has reached out to KreaMedica for help on a different project. Cairn Therapeutics is developing a next-generation product and soliciting bridging funding during the development cycle. KreaMedica provided expertise in designing the study program for the new generation drug and putting forward a budget with sufficient details to inform investors.
Despite initial challenges, including formulation issues and toxicity concerns, the Cairn Therapeutics team overcame these hurdles with the help of KreaMedica, which provided cost-effective program management and toxicology expertise. The drug is now ready for IND submission, with the potential to revolutionize chemotherapy treatments by offering greater efficacy and safety.
“I don’t really know how we would have completed the project without KreaMedica under all the circumstances,” said Tom, summing up the interaction between Cairn Therapeutics and KreaMedica.
About Tom Fritz
Tom Fritz, COO Cairn Therapeutics: Over 30 years working with companies both as an executive and as a consultant to plan, organize, and manage drug development programs to fruition, and has been directly responsible for the successful completion of numerous major clinical trials. Expertise in pharmaceutical operations management, clinical and regulatory strategy, technical and operational due diligence, as well as operational design and restructuring. Extensive background in both small and large molecule manufacturing and integrated drug development solutions.
About Cairn Therapeutics
Cairn Therapeutics, Inc. is a pharmaceutical company with a mission to help patients beat cancer. Founded in 2016, Cairn is developing its lead candidate, CT-262, a first-in-its-class treatment for solid and hematological tumors. Cairn holds the exclusive worldwide license to CT-262, which was invented at Scripps Research using unique medicinal chemistry to create a highly potent DNA alkylating agent that preferentially activates in cancer cells. In vitro and in vivo animal oncology models have shown CT-262 to produce markedly better efficacy and safety results than current first-line therapies and highlight the potential to replace these compounds in a broad array of cancers.
About KreaMedica
KreaMedica was founded in 2009 with a vision to revolutionize drug development through functional outsourcing. The Montreal-based company has planned, managed and executed over 150 development programs from lead candidate selection through non-clinical safety assessments and early clinical trials by outsourcing to their world-class CRO/CMO network. With a commitment to research, development and quality, KreaMedica has become a trusted “one-stop-shop” drug development partner, offering reliable solutions and cost-saving strategies for their international biotech and pharma clients.