An­oth­er mega-start­up: Chi­na in­vestors back TCR2's $125M cash round to fu­el a pre­clin­i­cal as­sault on sol­id tu­mors

Gar­ry Men­zel

In yet an­oth­er dis­play of biotech’s bold fundrais­ing en­vi­ron­ment right now, a Cam­bridge, MA-based start­up with a hand­ful of pre­clin­i­cal can­cer drugs in its pipeline has scored a $125 mil­lion mega-round — with all of the cash in the bank.

TCR2 Ther­a­peu­tics tells me they want­ed flex­i­bil­i­ty to pur­sue “mul­ti­ple pro­grams in mul­ti­ple for­mats,” which re­quires a sig­nif­i­cant amount of cash on hand. When peo­ple get hyped about mega-rounds, sober­ing re­al­ists will al­ways point out how mega-rounds are usu­al­ly tranched. That means the cash is gat­ed, and ac­cess to that cash is de­pen­dent on the start­up meet­ing cer­tain mile­stones.

This arrange­ment pro­vides some pro­tec­tion for cau­tious in­vestors, and is com­mon­place con­sid­er­ing this in­dus­try’s fail­ure rate. In­vestors in this case, how­ev­er, ap­pear to have thrown that cau­tion to the wind, bank­ing on TCR2’s abil­i­ty to pro­vide a re­turn one way or an­oth­er.

“All the mon­ey ar­rives in the bank on day one,” said Gar­ry Men­zel, CEO at TCR2.

How did the com­pa­ny get so much cash to play with? In part, they tapped flush in­vestor groups in Chi­na, one com­po­nent of a an in­creas­ing­ly pop­u­lar strate­gic move to fo­cus heav­i­ly in that mar­ket.

“There’s so much ac­tiv­i­ty in Chi­na right now,” Men­zel said. “There’s a tremen­dous amount of clin­i­cal ex­pe­ri­ence, good man­u­fac­tur­ing ca­pa­bil­i­ties, and it’s a big mar­ket.”

The mega-round was co-led by Shang­hai-based 6 Di­men­sions Cap­i­tal and Dal­las-based Cu­ra­tive Ven­tures. A long (long) list of new in­vestors and ex­ist­ing in­vestors joined in, in­clud­ing MPM Cap­i­tal (a ma­jor in­vestor in the on­col­o­gy space). Check out the com­pa­ny’s press re­lease for the full run­down.

Patrick Baeuer­le

What has these in­vestors so jazzed? TCR2 thinks it can lever­age the com­pa­ny’s un­der­stand­ing of the T cell re­cep­tor struc­ture to im­prove on how the body’s can­cer-fight­ing cells re­spond to dis­ease. The hope is to break down bar­ri­ers that have lim­it­ed ef­fi­ca­cy, ex­tend­ing im­muno-on­col­o­gy’s range in­to sol­id tu­mors.

The com­pa­ny was found­ed in 2015 by can­cer im­mu­nol­o­gist Patrick Baeuer­le, man­ag­ing di­rec­tor of MPM Cap­i­tal. You might rec­og­nize Baeuer­le as the for­mer CSO of Mi­cromet, which used an an­ti­body to redi­rect killer T cells to de­stroy tu­mor cells. Am­gen went on to ac­quire Mi­cromet in 2012 in a deal val­ued at $1 bil­lion-plus, bring­ing Baeuer­le on board to Am­gen to con­tin­ue work­ing on Blin­cy­to, an an­ti­body-based leukemia drug.

Now Baeuer­le sits on the board of TCR2, a com­pa­ny that wants to take im­muno-on­col­o­gy far past where CAR-Ts can go.

“There’s a lot of ex­cite­ment around CAR-T, and a lot of com­pa­nies in that space,” Men­zel said. “But CAR-T ran in­to a brick wall with sol­id tu­mors. There’s just been no ac­tiv­i­ty there.”

TCR² takes its name from T cell re­cep­tors (TCR), mol­e­cules on the sur­faces of im­mune cells that rec­og­nize a spe­cif­ic mol­e­c­u­lar tar­get, or anti­gen, and fo­cus an im­mune at­tack on cells with that tar­get. But CAR-T on­ly taps a part of a TCR’s full struc­ture.

“You can think of CAR-T as a piece of the TCR,” Men­zel said. “TCR has six sub­units, and CAR-T is one.”

Al­fon­so Quin­tás Car­dama

TCR² hopes to find a way to em­ploy the full TCR — a goal that com­pa­nies like blue­bird bio, Kite (Gilead), and GSK all have their eye on.  But TCR²’s CMO Al­fon­so Quin­tás Car­dama says the start­up has a game-chang­ing dif­fer­en­tia­tor. “We are ag­nos­tic to HLA. That’s the ad­van­tage of our plat­form over any oth­er TCR plat­form that re­quires spe­cif­ic HLA geno­typ­ing.”

TCR² has four pro­grams in the pipeline, all of which are tar­get­ing can­cers. Its lead in­ves­ti­ga­tion­al drug is called TC-210, a pre­clin­i­cal sol­id tu­mor ther­a­py that tar­gets mesothe­lin, an anti­gen present in sev­er­al types of can­cer. The com­pa­ny is hop­ing that drug can be used against ovar­i­an can­cer, mesothe­lioma, cholan­gio­car­ci­no­ma, and non-small cell lung can­cer (NSCLC).

Its sec­ond pro­gram is ba­si­cal­ly TC-210 with a PD1 switch at­tached, which the com­pa­ny hopes will make the ther­a­py more ef­fec­tive in lung can­cer pa­tients.

Its re­main­ing two pro­grams are still very ear­ly in their de­vel­op­ment, in ei­ther lead op­ti­miza­tion or dis­cov­ery stage. And TCR² isn’t say­ing much about ei­ther pro­gram, ex­cept that one is called Pro­gram X and the oth­er will take on blood can­cers.

Men­zel said the mas­sive Se­ries B round will like­ly take two pro­grams to proof-of-con­cept by 2021 and fi­nance an ex­pan­sion of the plat­form. TCR² plans to dou­ble its staff over the next year — from 30 to rough­ly 60 em­ploy­ees — all of whom will be work­ing out of a brand new fa­cil­i­ty in the heart of Kendall Square.

“You’ll see us grow­ing quite rapid­ly over the next year,” Men­zel says.

With $125 mil­lion in the bank, we wouldn’t ex­pect any less.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Christian Itin, Autolus CEO (UKBIO19)

Au­to­lus tips its hand, bags $220M as CAR-T show­down with Gilead looms

The first batch of pivotal data on Autolus Therapeutics’ CAR-T is in, and execs are ready to plot a path to market.

With an overall remission rate of 70% at the interim analysis featuring 50 patients, the results set the stage for a BLA filing by the end of 2023, said CEO Christian Itin.

Perhaps more importantly — given that Autolus’ drug, obe-cel, is going after an indication that Gilead’s Tecartus is already approved for — the biotech highlighted “encouraging safety data” in the trial, with a low percentage of patients experiencing severe immune responses.

Dipal Doshi, Entrada Therapeutics CEO

Ver­tex just found the next big ‘trans­for­ma­tive’ thing for the pipeline — at a biotech just down the street

Back in the summer of 2019, when I was covering Vertex’s executive chairman Jeff Leiden’s plans for the pipeline, I picked up on a distinct focus on myotonic dystrophy Type I, or DM1 — one of what Leiden called “two diseases (with DMD) we’re interested in and we continue to look for those assets.”

Today, Leiden’s successor at the helm of Vertex, CEO Reshma Kewalramani, is plunking down $250 million in cash to go the extra mile on DM1. The lion’s share of that is for the upfront, with a small reserve for equity in a deal that lines Vertex up with a neighbor in Seaport that has been rather quietly going at both of Vertex’s early disease targets with preclinical assets.

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WIB22: Am­ber Salz­man had few op­tions when her son was di­ag­nosed with a rare ge­net­ic dis­ease. So she cre­at­ed a bet­ter one

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

Amber Salzman’s life changed on a cold, damp day in Paris over tiny plastic cups of lukewarm tea.

She was meeting with Patrick Aubourg, a French neurologist studying adrenoleukodystrophy, or ALD, a rare genetic condition that causes rapid neurological decline in young boys. It’s a sinister disease that often leads to disability or death within just a few years. Salzman’s nephew was diagnosed at just 6 or 7 years old, and died at the age of 12.

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Ahead of ad­comm, FDA rais­es un­cer­tain­ties on ben­e­fit-risk pro­file of Cy­to­ki­net­ic­s' po­ten­tial heart drug

The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet next Tuesday to discuss whether Cytokinetics’ potential heart drug can safely reduce the risk of cardiovascular death and heart failure in patients with symptomatic chronic heart failure with reduced ejection fraction.

The drug, known as omecamtiv mecarbil and in development for more than 15 years, has seen mixed results, with a first Phase III readout from November 2020 hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as key to breaking into the market.

Ab­b­Vie slapped with age dis­crim­i­na­tion law­suit, fol­low­ing oth­er phar­mas

Add AbbVie to the list of pharma companies currently facing age discrimination allegations.

Pennsylvania resident Thomas Hesch filed suit against AbbVie on Wednesday, accusing the company of passing him over for promotions in favor of younger candidates.

Despite 30 years of pharma experience, “Hesch has consistently seen younger, less qualified employees promoted over him,” the complaint states.

Nashville-based CD­MO nets a $65M Se­ries B to ex­pand fa­cil­i­ty and ca­pa­bil­i­ties

Another $65 million is music to the ears of the team at August Bioservices, a contract manufacturer in Nashville.

The company announced the Series B round last week, which will fund equipment in a new building expected to open in 2023, according to CEO Jenn Adams. It was led by Oak HC/FT, the same firm that led August’s Series A round in July 2020.

August Bioservices, a producer of materials such as prefilled syringes, IV bags and vials, was formed back in 2020 after the acquisition of PMI BioPharma Solutions, also based in Nashville. Adams said the goal was to build a business that could “address the scarcity of supply relative to sterile injectable manufacturing based in the US” and provide a broad range of manufacturing services.

Rami Elghandour, Arcellx CEO

Up­dat­ed: Gilead, Ar­cel­lx team up on an­ti-BC­MA CAR-T as biotech touts a 100% re­sponse rate at #ASH22

Gilead and Kite are plunking down big cash to get into the anti-BCMA CAR-T game.

The pair will shell out $225 million in cash upfront and $100 million in equity to Arcellx, Kite announced Friday morning, to develop the biotech’s lead CAR-T program together. Kite will handle commercialization and co-development with Arcellx, and profits in the US will be split 50-50.

Concurrent with the deal, Arcellx revealed its latest cut of data for the program known as CART-ddBCMA, ahead of a full presentation at this weekend’s ASH conference — a 100% response rate among patients getting the therapy. Investors jumped at the dual announcements, sending Arcellx shares $ACLX up more than 25% in Friday’s morning session.

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WIB22: Lead­ing NK cell re­searcher re­flects on roots in Iran, the UK and Texas

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

In a small but widely-cited 11-person study published in NEJM in 2020, seven patients saw signs of their cancer completely go away after getting a new therapy made from natural killer cells. The study was one of the earliest to provide clinical proof that the experimental treatment method had promise.

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