At this rate, 2018 could be a record-breaking year for biotech IPOs. Two more Boston-area companies filed their IPO plans late last week. Neon Therapeutics is developing personalized cancer vaccines, one of which is in Phase 1 clinical testing. Translate Bio is a messenger RNA (mRNA) company that started human testing just last month.
Neon and Translate each set a preliminary $115 million target for their respective IPOs, but that number is likely to change after the companies set their share price. Cambridge, MA-based Neon plans to list on the Nasdaq under the symbol “NTGN.” Translate, headquartered in Lexington, MA, has applied for a Nasdaq listing under the symbol “TBIO.”
Neon’s cancer vaccines are made using the unique mutations that drive a patient’s cancer to grow. Bits of mutated proteins from a patient’s tumors, called neoantigens, are given to the patient as a vaccine, which then instructs the immune system to attack tumors bearing this genetic signature. Neon’s scientific founders, from the Dana-Farber Cancer Institute and the Broad Institute, published a paper in Nature last year reporting initial results from a Phase 1 trial. This study tested a first-generation neoantigen vaccine in six patients with late-stage melanoma who had had their tumors surgically removed. After being treated with the vaccine, the melanoma did not return in four of the patients during a two-year follow-up. In the other two patients, the recurring tumors disappeared after treatment with a checkpoint inhibitor.
A larger Phase 1 trial,— testing Neon’s lead vaccine, NEO-PV-01, in combination with nivolumab (a checkpoint inhibitor) in melanoma, lung and bladder cancer—is ongoing, in collaboration with Bristol-Myers Squibb (NYSE: BMY). In regulatory filings, Neon said there have been no significant safety issues in the first 31 patients treated. Last month, Neon started a second Phase 1 trial of NEO-PV-01 in combination with another checkpoint inhibitor, pembrolizumab, in partnership with Merck (NYSE: MRK). The company plans to start another trial of NEO-PV-01 later this year.
Another Neon program, NEO-PTC-01, is a personalized neoantigen cell therapy composed of T cells that target a patient’s tumors. Neon says it hopes to launch a clinical trial for this in Europe next year.
According to Neon’s regulatory filings, the company has raised $161 million since its launch in 2015. The main stockholders are Third Rock Venture, Access Industries, Fidelity, and Partner Fund Management
Translate Bio is working on mRNA drugs that encode key proteins missing or dysfunctional in disease. Its lead drug candidate, MRT5005, is for cystic fibrosis and began Phase 1/2 clinical testing last month. Its second drug, MRT5201, targets a rare liver disease and should enter the clinic early next year. Translate acquired these programs through a deal with Shire (NASDAQ: SHPG) at the end of 2016, making Shire Translate’s largest stockholder. Other owners include Fidelity, Baupost Group and Atlas Venture. The company got its start in 2011 as RaNA Therapeutics but changed its name last year.
In its regulatory filings, Translate said that the proceeds of the IPO probably will not be enough to allow the company to finish the clinical trial that it just started or the one it hopes to launch next year.