Galecto raises €79M to run late-phase IPF trial

Lungs illustration (Image: Pixabay)
In 2014, Bristol-Myers secured an option to buy Galecto within 60 days of seeing phase 1b data. (Pixabay)

Galecto Biotech has raised €79 million ($90 million) to take its treatment for idiopathic pulmonary fibrosis (IPF) into a phase 2/3 trial. The OrbiMed-Ysios Capital co-led round sets Galecto up to power into late-phase development despite Bristol-Myers Squibb passing up the chance to buy it out.

Galecto’s lead candidate is TD139, a selective inhibitor of galectin-3. When inhaled by IPF patients, TD139 is designed to block galectin-3 and thereby stop the galactoside-binding lectin from triggering a pathway that activates macrophages and myofibroblasts. As these cell types are central to organ fibrosis, Galecto thinks stopping their activation can reduce or prevent such diseases.

New investors OrbiMed and Ysios have stepped up to bankroll Galecto’s pursuit of the idea. The pair were joined in the series C by fellow new backers HBM Healthcare, Bristol-Myers, Maverick Ventures and Seventure Partners, plus existing investors Novo Seeds, M Ventures and Sunstone Capital.

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The financing gives Galecto the means to run a late-phase IPF trial at sites across Europe and the U.S. Galecto brought ex-GlaxoSmithKline VP Richard Marshall, M.D., Ph.D., on board in May to serve as CMO and work on the clinical development program. With Galecto having also agreed on the trial design with the FDA and the U.K.’s MHRA, the series C puts the final piece in place for the push into phase 2/3.

At one stage it looked like Galecto might not need to orchestrate the late-phase program itself. In 2014, Bristol-Myers secured an option to buy Galecto within 60 days of seeing phase 1b data. Galecto completed the study in March 2017, but news of Bristol-Myers’ exercising of its option never arrived. The deal could have netted Galecto up to $444 million.

The phase 1b data paint a limited picture of the effect of TD139. In the small trial, IPF patients who took the two higher doses of TD139 daily for two weeks experienced statistically significant declines in galectin-3 expression on alveolar macrophages, indicating the drug’s target was suppressed. The safety and tolerability data came in clean, too.

The limitations of existing IPF drugs, namely Roche’s Esbriet and Boehringer Ingelheim’s Ofev, mean Galecto is far from the only biotech targeting the indication. FibroGen and Galapagos are respectively moving an infused antibody and oral autotaxin inhibitor into late-phase development, while Roivant recently added an inhaled phase 2 drug to its sprawling roster of programs.

While Galecto’s own move into phase 2/3 is the focus of the financing, the Danish biotech is keeping some money back for its earlier-stage programs. 

“The financing will also enable clinical studies for two additional programs, which are based on galectin modulators optimised for dosing in fibrotic diseases of other organs, such as the liver and eye,” Galecto CEO Hans Schambye, M.D., Ph.D., said in a statement.

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