Sev­er­al months af­ter strik­ing an al­liance with No­var­tis, TCR ther­a­py-fo­cused TScan Ther­a­peu­tics has reeled in a crossover round that should hold it over for the next two years as it eyes a pub­lic de­but.

The Christoph West­phal port­fo­lio com­pa­ny had been ar­rang­ing the crossover for the last few months, CEO David South­well said. Just be­fore Christ­mas, they nailed down what he called a “re­al­ly blue-chip” syn­di­cate of four new in­vestors, in­clud­ing Black­Rock, RA Cap­i­tal Man­age­ment and two undis­closed funds. They closed on the $100 mil­lion Se­ries C just over a week ago, and wait­ed un­til Mon­day morn­ing to an­nounce it.

“I think it’s like­ly that we’re go­ing to go pub­lic at some point,” South­well told End­points News. But for now, the Se­ries C cash gives them flex­i­bil­i­ty through 2022.

The Har­vard Uni­ver­si­ty spin­out is build­ing a repos­i­to­ry of clin­i­cal­ly-ac­tive TCRs us­ing its high-through­put whole genome dis­cov­ery plat­form. The com­pa­ny had com­pared it to a vend­ing ma­chine or a li­brary of sorts, be­fore fi­nal­ly set­tling on the term “bank,” South­well said.

The process be­gins with T cells from pa­tients’ tu­mors. Re­searchers use the dis­cov­ery plat­form to find out ex­act­ly what tar­gets the T cell is hit­ting, then clin­i­cal­ly val­i­date the TCR to see if it has any off-tar­get ef­fects. When the TCR is val­i­dat­ed, it gets added to the bank. Know­ing a pa­tient’s HLA type and tu­mor tar­get, re­searchers can then take TCRs out of the bank, “grow them up, and put them in­to the pa­tient,”  South­well said.

“Those T cell re­cep­tors are of­ten there in the pa­tient, but the prob­lem is that they’re not there in suf­fi­cient abun­dance to re­al­ly at­tack the tu­mor,” he added.

The ap­proach comes from the lab of Har­vard pro­fes­sor Stephen Elledge, who set out years ago to screen anti­gen-TCR match­es in a faster, more sys­tem­at­ic way. He spent 7 years putting to­geth­er the tech for a plat­form that could run mul­ti­ple TCRs against anti­gen epi­topes and pin­point the ex­act pairs that ap­pear to in­ter­act. Now, what be­gan as 96 plates in Elledge’s lab has trans­formed in­to a com­pa­ny that has raised $180 mil­lion to date and at­tract­ed the likes of No­var­tis.

Back in April, the No­var­tis In­sti­tutes for Bio­Med­ical Re­search put down $30 mil­lion to kick off a new TCR im­muno-on­col­o­gy pro­gram with TScan. The part­ners are work­ing on dis­cov­er­ing tar­gets in a “se­lect sol­id tu­mor in­di­ca­tion,” TScan re­vealed. NI­BR pitched in­to TScan’s Se­ries B round, along­side the phar­ma’s ven­ture fund.

“There’s a lot with this dis­cov­ery plat­form that we can do, that we’re not go­ing to de­vel­op on our own,” South­well said, in­clud­ing Covid-19 work.

Com­ing up in 2021, TScan plans on fil­ing INDs for two liq­uid tu­mor TCR T cell ther­a­pies — TSC-100 and TSC-101. It has an­oth­er three sol­id tu­mor can­di­dates ex­pect­ed to hit the clin­ic in 2022.

While the com­pa­ny cur­rent­ly has 60 staffers, South­well pre­dicts they’ll have well over 100 in the next six to nine months as they build out their man­u­fac­tur­ing and cell pro­cess­ing units.

The feel­ing at TScan? “We’re re­al­ly ex­cit­ed,” South­well said.

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.

The Federal Trade Commission has gotten involved in a patent feud over Supernus’ Parkinson’s drug Apokyn, a case the agency said may have ‘‘significant implications” for patients who rely on the drug.

Sage Chemical won the first generic approval for its Apokyn formulation (also known as apomorphine hydrochloride injection) back in 2022. The non-ergoline dopamine agonist is approved to treat Parkinson’s symptoms during “off episodes,” such as difficulty moving, tremors and intense cramping. However, regulators specified that the approval pertained to the generic drug cartridges only, not the injector pen required for administration.

The White House’s Office of Science and Technology Policy (OSTP) last year sought to find ways to better coordinate large-scale clinical trials in the US — as the UK lead by example during the pandemic — especially for these emergency clinical trials.

The lobbying group PhRMA Tuesday called for more clinical trial diversity in underserved areas, including by making participation less of a burden, and expanding eligibility criteria when appropriate.