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Stephen Brady
Tempest Therapeutics

07 March 2023

Will you introduce Tempest Therapeutics and the company's unique contribution to the field of oncology?

Tempest is a clinical-stage oncology company with a diverse portfolio of four novel molecules in development that range from early research to an ongoing global randomized study in first line liver cancer patients.  We select targets without the limitations of a platform scope or a particular biology bias, and instead proceed where we believe Tempest can truly make a difference. We have come a long way since I joined the company in the fall of 2019, i.e., from one early-stage clinical program to two clinical programs, one of which is in the randomized global study, and two research programs.

Our team is made up of scientists, doctors, and businesspeople who share a passion for working in the field of oncology. The standard of care for several types of cancer has improved, but there are still – unfortunately - many places where we need new cancer drugs. For example, we presented positive data from our lead program, TPST-1120, in patients in cholangiocarcinoma and kidney cancer in oral presentation at the 2022 ASCO Annual Meeting, and our most advanced study is in liver cancer in collaboration with Roche, where we believe there remains a significant opportunity to help patients. Cancer is many different diseases and there is still much to be done, and we are working to bring new and improved solutions that will positively impact the lives of patients.

What innovations are you working on presently, and how are you funding these efforts?

TPST-1120 recently completed a Phase 1 study where we saw clinical benefit in patients, including in kidney cancer and cholangiocarcinoma, and is now in a frontline global randomized trial in liver cancer in collaboration with Roche. We expect the first data from that study this year and are interested because liver cancer was one of the top three cancers of interest when we started the program, given the specifics of the cancer and its interplay with TPST-1120’s target, as well as the argument that TPST-1120 should work well with the mechanisms of Roche’s therapy.

Shifting gears to the earlier programs, we expect to present Phase 1 data on our second clinical program, TPST-1495, this year, and the company has two existing research programs, including one that targets TREX-1 in the STING pathway – a target that remains of interest in the oncology drug development community.


As you know, the pharma/biotech sector soared during the pandemic, but the biotech public equity markets have since become more volatile and raising funds has become more difficult.


Tempest currently retains development and commercialization rights to all programs, so we have the potential optionality to combine business development and the sale of securities to fund the programs.

In what ways did you notice the emphasis on innovation and R&D shifting during the pandemic?

Some companies shifted their focus to developing a COVID-19 vaccine based on their experience with the relevant technology. Tempest, however, remained on strategy and although our labs had to remain open because of ongoing clinical studies, we adjusted to a hybrid work model.

Like many companies, we experienced external factors that affected our business. For example, many of our clinical sites are academic institutions that had shifted their focus to the pandemic. Furthermore, we learned that some cancer patients were hesitant to seek treatment in hospitals for fear of contracting an infection. We pivoted and added some commercial sites, and unlike some companies working with non-life-threatening indications, were fortunate not to experience material enrollment delays for our clinical trials.

What have been the most difficult challenges you have come across on your journey to innovation?

Starting with internal challenges, Tempest is breaking new ground with our programs in our quest to improve cancer patients’ lives, so there is always the possibility of scientific failure. In addition, the labor market had been very tight given the number of new companies, although the recent downsizing trends across the biotech industry should provide a broader available talent pool, which is important to us because culture fit is a high priority for the company. 

Externally, the industry has faced headwinds on the drug pricing front, as seen with the recent passage of the IRA. The law contains counterintuitive provisions with respect to small molecule pricing negotiations with the government. Because they usually become quite cost effective to manufacture, small molecule therapies provide an opportunity for more affordable pricing with the entry of generic competition. We’re hopeful that this “small molecule penalty” will be fixed in the IRA and won’t stifle innovation in small molecule programs, which have made a significant  positive impact on healthcare globally.

What are your top priorities over the next five years?

Our priority is to continue development of our four novel programs, ideally across significant milestones in the near-term. As mentioned, TPST-1120 is poised to leap forward and expand if we receive positive data this year from the ongoing randomized study. We are open to evaluating new programs and targets, but are fortunate to have our hands full now with four programs. We believe that 2023 could be a transformative moment for Tempest, and the next five years could be exciting as the pipeline continues to develop.

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