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.

UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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The 2021 top 100 bio­phar­ma in­vestors: As the pan­dem­ic hit and IPOs boomed, VCs swung in­to ac­tion like nev­er be­fore

The global pandemic may have roiled economies, killed hundreds of thousands and throttled entire industries, but the only effect it had on biopharma venture investing was to help turbocharge the field to giddy new heights.

Below you’ll find the new top 100 venture investors in the industry, ranked by the number of deals they were publicly involved in, as tracked by DealForma chief Chris Dokomajilar. The numbers master then calculated the estimated amount of money they put into each deal — divvying up the cash by the number of players — to indicate how they managed their syndicates.

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Antoine Papiernik, Sofinnova managing director (Business Wire)

Sofinno­va Part­ners stays fo­cused on late-stage deals with a new, $540M crossover fund

One of Europe’s most high-profile biopharma investors is getting $540 million to invest in new crossover deals for late-stage companies.

The Paris-based VC says the fresh Sofinnova Crossover Fund raise positions them as the “largest crossover investor in Europe dedicated to late-stage biopharma and medtech investments.”

They got a leg up in France after winning a special “Tibi” designation from the French government, giving them access to a pool of €6 billion that helped them gain an edge with institutional investors. Since they were founded close to 50 years ago, the venture group has backed more than 500 companies and currently has more than €2 billion under management.

Hal Barron, Endpoints UKBIO19

GSK, Vir's hopes for a Covid-19 an­ti­body fall flat in NIH 'mas­ter pro­to­col' with no ben­e­fit in hos­pi­tal­ized pa­tients

GlaxoSmithKline and Vir Biotechnology were hopeful that one of their partnered antibodies would carve out a win after getting the invite to a major NIH study in hospitalized Covid-19 patients. But just like Eli Lilly, the pair’s drug couldn’t hit the mark, and now they’ll be left to take a hard look at the game plan.

The NIH has shut down enrollment for GSK and Vir’s antibody VIR-7831 in its late-stage ACTIV-3 trial after the drug showed negligible effect in achieving sustained recovery in hospitalized Covid-19 patients, the partners said Wednesday.

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As Brain­Storm con­tin­ues to tout ‘clear sig­nal’ on ALS drug, the FDA of­fers a rare pub­lic slap­down on the da­ta

A little more than a week after BrainStorm acknowledged that regulators at the FDA had informed them that the biotech needed more data before it could expect to gain an approval for its ALS treatment NurOwn — while still touting a “clear signal” of efficacy and not ruling out an application — the agency has decided to clarify the record in a most unusual statement.

The FDA statement amounts to a straight slap own, offering a different set of efficacy numbers from the company’s public presentation last November and ruling out any chance of statistical significance.

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In­tro­duc­ing End­points FDA+, our new pre­mi­um week­ly reg­u­la­to­ry news re­port led by Zachary Bren­nan

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.

Presage teams with Mer­ck on its Phase 0 test­ing; Kem­Pharm AD­HD drug wins ap­proval in chil­dren aged 6 and up

Seattle-based Presage Biosciences, which approaches drug development through its microdosing platform, has some new partnerships and cash to come with them.

Presage closed a $13 million financing round Tuesday, aiming to expand its network of clinical trial sites and advance development of its microdosing injection devices. They also closed partnership deals with Merck and Maverick Therapeutics.

The financing included $7 million from new investors, including the LabCorp Venture Fund, Bristol Myers Squibb, and InHarv Partners. An additional $6 million convertible note from Takeda Ventures will convert to equity.

Eli Lil­ly claims suc­cess in a new JAK in­di­ca­tion: hair loss

Over the last decade, drugmakers have proven JAK inhibitors can treat a smattering of immune-related diseases ranging from rheumatoid arthritis to Covid-19. Now Eli Lilly has pulled out a new one.

Lilly and its biotech partner Incyte announced Wednesday that their JAK inhibitor baricitinib effectively regrew patients’ hair in a Phase III trial for alopecia areata, an autoimmune condition that can cause sudden, severe and patchy hair loss. Lilly didn’t break down the results from the 546-patient trial, but the primary endpoint was improvement on a standard score for alopecia symptoms.

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CEO David Campbell (Janux)

Fresh off $1B+ Mer­ck deal, Janux locks down first pri­vate fundraise for its T cell en­gagers

Janux Therapeutics had kept a relatively low profile since being founded back in 2017 but burst onto the scene late last year when Merck plunked down more than $1 billion in promised milestones for its T cell engagers. Now, less than three months later, the small biotech has clinched its first round of private funding led by some prominent backers.

As it prepares its first programs for INDs, Janux completed a $56 million Series A on Wednesday morning, with Jay Lichter’s Avalon Ventures joining forces with new investors OrbiMed and RA Capital Management to fund the company. Janux will use the cash to primarily advance its T cell engagers targeting PSMA and TROP2, which are expected to hit the clinic in the first and second quarters of 2022, respectively.