David Southwell (L) and Christoph Westphal

Har­vard spin­out kicks off 2021 with a crossover round and sights set on the clin­ic

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.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

No­vo Nordisk re­mains un­der UK scruti­ny as MHRA con­ducts its own re­view in 'in­cred­i­bly rare' case

The UK’s Medicines and Healthcare products Regulatory Agency is now reviewing Novo Nordisk’s marketing violation that resulted in its loss of UK trade group membership last week. Novo Nordisk was suspended on Thursday from the Association of the British Pharmaceutical Industry (ABPI) for two years after an investigation by its regulatory arm found the pharma broke its conduct rules.

MHRA said on Tuesday that its review of the Prescription Medicines Code of Practice Authority (PMCPA) investigation is standard practice. An MHRA spokesperson emphasized in an email to Endpoints News that the situation with Novo Nordisk is “incredibly rare” while also noting ABPI took “swift and proportionate action.”

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Andy Plump, Takeda R&D chief (Jeff Rumans for Endpoints News)

What kind of PhI­Ib da­ta is worth $4B cash? Take­da’s Andy Plump has some thoughts on that

A few months back, when Takeda caused jaws to drop with its eye-watering $4 billion cash upfront for a mid-stage TYK2 drug from Nimbus, it had already taken a deep dive on the solid Phase IIb data Nimbus had assembled from its dose-ranging study in psoriasis.

Now, it’s rolling that data out, eager to demonstrate what inspired the global biopharma to go long in a neighboring, but new, disease arena for the pipeline. And the most avid students of the numbers will likely be at Bristol Myers Squibb, who will have a multi-year head start on pioneering the TYK2 space with Sotyktu (deucravacitinib) as Takeda makes its lunge for best-in-class status.

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FDA warns Proc­ter & Gam­ble over NyQuil la­bel's in­gre­di­ent list­ings

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.

FTC says patent bat­tle over Parkin­son's drug could have 'sig­nif­i­cant im­pli­ca­tion­s' for pa­tients

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.

Growth hor­mone from No­vo Nordisk is in short­age over man­u­fac­tur­ing de­lays

Novo Nordisk’s growth hormone Norditropin is in shortage because of manufacturing delays, according to an FDA site that tracks drug shortages as well as the American Society of Health-System Pharmacists’ shortages list.

The FDA has shortages of the drug listed for its 5, 10, 15 and 30 mg doses, while the pharmacists’ group, also known as ASHP, reported shortages of the same doses, except for the 15 mg version.

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PhRMA calls for more di­verse in­fra­struc­ture up­grades to US emer­gency tri­als frame­work

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.

FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

Ahead of Wednesday’s advisory committee hearing to discuss Biogen’s ALS drug tofersen, the FDA appeared open to approving the drug, newly released briefing documents show.

Citing the need for flexibility in a devastating disease like ALS, regulators signaled a willingness to consider greenlighting tofersen based on its effect on a certain protein associated with ALS despite a failed pivotal trial. The documents come after regulatory flexibility was part of the same rationale the agency expressed when approving an ALS drug last September from Amylyx Pharmaceuticals, indicating the FDA’s openness to approving new treatments for the disease.

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Mar­ket­ingRx roundup: What could a US Tik­Tok ban mean for phar­ma? Pfiz­er, Lil­ly lead phar­ma March Mad­ness ad­ver­tis­ers

Just as pharma marketers finally make moves into TikTok, the threat of a US ban on the social media channel is now looming. Already banned on federal employee phones by an initial Congressional act, more bills and maybe bans are on the way. With rare bipartisan agreement, lawmakers have introduced legislation that would give the US president the power to ban TikTok (although not mentioned by name) and other foreign-owned technology platforms that represent a security threat to the US.

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