As Candel Therapeutics gears up for a planned U.S. approval push for its prostate cancer drug later this year, RTW Investments has stepped in with $100 million to bankroll the launch.
The nine-figure fund is conditional on Candel securing FDA approval for the oncolytic virus, called aglatimagene besadenovec or CAN-2409, in intermediate- to high-risk localized prostate cancer. The biotech currently expects to file for approval in the fourth quarter.
In return, RTW will be in line for a tiered single-digit percentage of annual net sales of aglatimagene in the U.S., subject to a cap, according to a Feb. 19 release.
“This non-dilutive strategic financing will support the U.S. launch of aglatimagene besadenovec, assuming FDA approval, and will allow us to further invest in what we believe will be a world class commercial program,” Candel CEO Paul Peter Tak, M.D., Ph.D., said in the release.
“We remain on track to submit the BLA for aglatimagene in Q4 of this year, and we look forward to collaborating with the FDA to pursue an expeditious approval of aglatimagene,” Tak added. “We are thrilled with our RTW partnership, as we seek to provide a new treatment option for patients in the early stages of prostate cancer who are treated with curative intent, a disease that has seen minimal innovation over the past two decades.”
Aglatimagene is administered as an injection into the prostate of an adenovirus encoding an enzyme. Candel saw its stock surge 200% at the end of 2024 as the company unveiled phase 3 data linking the therapy to a 14.5% relative improvement in disease-free survival.
Roderick Wong, M.D., managing partner and chief investment officer at RTW, said the phase 3 readout had “demonstrated the potential of aglatimagene besadenovec in early, localized prostate cancer.”
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“Today’s commitment reflects our confidence in Candel and the strong commercial potential of this therapy,” Wong added in yesterday’s release. “We are proud to partner with the Candel management team and look forward to supporting their efforts to bring this meaningful treatment to patients with localized prostate cancer.”
Candel ended September 2025 with $87 million in the bank, although the company had already been planning to augment this with a loan facility from Trinity Capital that could stretch to $130 million. As well as the deal with RTW, the biotech also announced yesterday that it hopes to raise a further $100 million in a public offering of its common stock, with the proceeds earmarked for ensuring aglatimagene is ready for launch.