Flame Biosciences searches for future after Novartis flunks on canakinumab

Flame Biosciences debuted with the idea that its monoclonal antibody that inhibits IL-1ß, a key cytokine in inflammation, would be effective at reducing cancer.

But the Pennsylvania biotech flashed the yellow lights on testing that hypothesis last year because it wanted to see if a Big Pharma could prove it first. Novartis failed – again and again and again. The Swiss giant’s canakinumab got the FDA no-go back in 2018 for cardio risk reduction, but Novartis thought the drug would work in oncology.

It didn’t.

So, after Novartis put out word about a third flop in August of last year, Flame went searching, board member and co-CEO Tim Opler told Endpoints News on Wednesday. Most employees on the clinical team were let go last quarter and the board stepped in to direct the startup, which disclosed a $100 million investment in 2020.

“We expect to announce a transaction this quarter,” Opler said, declining to disclose specifics. He said shareholders are “largely pleased.” Bankrollers include Rock Springs Capital, T. Rowe Price Associates, Cormorant Asset Management, Janus Henderson Investors, Citadel’s Surveyor Capital, Samsara BioCapital and others.

The biotech updated a clinicaltrials.gov entry Wednesday morning, noting they never enrolled patients in a Phase II of FL-101 as neoadjuvant therapy in patients with surgically resectable non-small cell lung cancer.

“Why should we be the ones to spend all this money we raised from shareholders to prove the theory right or wrong?” Opler said. If Novartis’ drug had proved a success, Flame would have jumped in, he said. The fledgling biotech opted to wait on Novartis’ readouts and conserve cash for shareholders instead of spending every last penny like other drug developers, he said.

Opler said the board explored strategic alternatives. “You name it, we looked at it,” he said. The executive is also partner and co-founder of life sciences investment banking firm Torreya.

At the time of the biotech’s fall 2020 unveiling, then-CEO Harlan Weisman, who helped develop Remicade and Stelara, said Flame had come across 10-12 different IL-1 blockers made in academic and industry labs and chose to focus on two: FL-101 and FL-201.

Weisman touted FL-101 as 10 times as potent as canakinumab. Had the antibody actually entered human studies, the first data readout was expected to come out toward the end of last year. He became chief executive at Texas-based TFF Pharmaceuticals last month.

Patricia Martin

Flame was also going to test FL-201. Weisman previously told Endpoints the biotech would investigate that asset in gout, osteoarthritis, cardiovascular disorders and other conditions related to inflammation.

Opler’s co-CEO and board peer is Patricia Martin, who was COO of Eli Lilly’s diabetes unit for most of the 2010s, after serving as diversity chief of the Indianapolis-based Big Pharma, among other roles over two decades. She’s also president and CEO of BioCrossroads, a life sciences incubator in Indiana.

The leadership team included medical chief Cassandra Choe-Juliak (former Affimed VP and head of clinical development), CFO/COO David Barrett (who’s now listed on Flame’s website as “head of transition”) and ex-CSO Ian Anderson (former Janssen SVP for immunology discovery).

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