Next-gen T cell play­er TCR2 Ther­a­peu­tics sets stage for $100M-plus IPO as MP­M's Baeuer­le caps pro­lif­ic year

Patrick Baeuer­le

Patrick Baeuer­le has been busy. Right af­ter steer­ing next-gen BiTE com­pa­ny Har­poon Ther­a­peu­tics to­ward an IPO, the MPM part­ner and im­mu­nol­o­gist is shep­herd­ing an­oth­er on­col­o­gy com­pa­ny with pre­clin­i­cal as­sets — TCR2 Ther­a­peu­tics — in­to a pub­lic list­ing. And this time the biotech is look­ing for $100 mil­lion-plus in a mar­ket that’s been on a wild roller coast­er ride.

The im­munother­a­py com­pa­ny is de­vel­op­ing next-gen T-cell drugs for can­cer in an ef­fort to con­front lim­i­ta­tions posed by cur­rent T-cell and CAR-T ther­a­pies in sol­id tu­mors.

Robert Hofmeis­ter

One of the key com­po­nents of the im­mune sys­tem are T cells, which oblit­er­ate can­cer cells by us­ing T cell re­cep­tor (TCR) recog­ni­tion of cell sur­face mark­ers known as anti­gens. When a T cell rec­og­nizes a tu­mor anti­gen via the TCR, it snuffs the ma­lig­nant cell on which it re­sides. Ex­ist­ing T cell ther­a­pies for can­cer, in­clud­ing CAR-T cells and en­gi­neered TCR-T cells, at­tempt to repli­cate this mech­a­nism.

The drug de­vel­op­er’s tech­nol­o­gy — called TRuC-T cells — is de­signed to rec­og­nize and kill can­cer cells by har­ness­ing the TCR sig­nal­ing com­plex, un­like CAR-T for in­stance, which on­ly taps in­to a part of the TCR struc­ture. In con­trast to ex­ist­ing T cell ther­a­pies, the TCR2 tech­nol­o­gy is fash­ioned such that it could be used across pa­tients that ex­press the can­cer sur­face anti­gen ir­re­spec­tive of hu­man leuko­cyte anti­gens (HLA) sub­type, which could po­ten­tial­ly ad­dress a larg­er group of pa­tients.

The com­pa­ny has 5 drugs in its ar­se­nal. Its lead can­di­date — TC-210 — is be­ing de­vel­oped to tar­get mesothe­lin-pos­i­tive sol­id tu­mors. An ap­pli­ca­tion to test the drug in hu­mans was sub­mit­ted in De­cem­ber and the com­pa­ny ex­pects to con­duct a Phase I/II study ear­ly in 2019, and even­tu­al­ly ap­ply for the FDA’s fast track sta­tus. Its sec­ond drug, TC-110, is be­ing eval­u­at­ed for CD19-pos­i­tive B-cell hema­to­log­i­cal ma­lig­nan­cies. An IND is ex­pect­ed to be filed in the sec­ond half of 2019 and the com­pa­ny will al­so seek a fast track des­ig­na­tion for this as­set.  The rest — TC-220, TC-310 and TC-410 — are in ear­li­er stages of pre­clin­i­cal de­vel­op­ment.

Al­fon­so Quin­tás Car­dama

TCRwill have two ex­pe­ri­enced sci­en­tif­ic minds work­ing on their pipeline in the clin­ic: Robert Hofmeis­ter, who de­vel­oped one of the first PD-L1 in­hibitors — Baven­cio — while at EMD Serono, will serve as CSO, while Al­fon­so Quin­tás Car­dama, who was piv­otal in the ap­proval process for one of the two li­censed T cell ther­a­pies for hema­to­log­i­cal ma­lig­nan­cies — No­var­tis’ Kym­ri­ah — will serve as CMO.

The com­pa­ny will be list­ed on the Nas­daq un­der the sym­bol $TCRR, ac­cord­ing to the S-1 post­ed last week. TCRwas found­ed by Baeuer­le, a part­ner at MPM who pre­vi­ous­ly served as CSO at Mi­cromet be­fore it was swal­lowed by Am­gen. Baeuer­le was ush­ered in­to Am­gen — where R&D was then run by Roger Perl­mut­ter — fol­low­ing the buy­out, to help take Mi­cromet’s Blin­cy­to across the fin­ish line.

Mitchell Fin­er

TCR2 al­so worked close­ly with Mitchell Fin­er, an MPM Cap­i­tal ex­ec­u­tive part­ner who has decades of cell ther­a­py man­u­fac­tur­ing ex­pe­ri­ence, in­clud­ing the de­sign of GMP process­es for blue­bird bio and Cell Genesys. Over­all, just un­der half of the 30 com­pa­nies MPM has in­vest­ed in are on­col­o­gy-fo­cused.

So far, TCR2  has raised rough­ly $170 mil­lion from in­vestors, in­clud­ing MPM Cap­i­tal, F2 Ven­tures, Di­men­sions Cap­i­tal, Ar­row­Mark Part­ners, Cathay For­tune Cap­i­tal, Cu­ra­tive Ven­tures, Hill­house Cap­i­tal Group, Mi­rae­As­set Fi­nan­cial Group and Red­mile Group. Pri­or to the IPO, MPM has the biggest hold­ing with a 19.18% stake, and F2 is a run­ner up with a 15.97% stake.

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

President Trump walks past HHS secretary Alex Azar (Getty Images)

Azar falls in line un­der Trump again. Ex­perts say he's re­in­forc­ing a dark sig­nal sent to the FDA

In the latest incident where Alex Azar has steadfastly taken the side of President Donald Trump over that of the FDA, the HHS secretary was noncommittal this morning when asked if he supports the attempt by his subordinates at the FDA to strengthen guidelines for a vaccine EUA.

Appearing on NBC’s Today Show, the HHS secretary muddied the waters, stating that the guidance that matters is the one that is “actually already out there.”

CDC’s Robert Redfield, NIAID’s Anthony Fauci, Admiral Brett Giroir at HHS, and FDA’s Stephen Hahn prepare to testify at a House hearing on June 23 (Getty)

'Ex­treme­ly po­lit­i­cal' — Trump neuters FDA's at­tempt to strength­en vac­cine EUA

Stephen Hahn went before a Senate committee Wednesday and declared he’s fighting. “Every one of the decisions we have reached has been made by career FDA scientists based on science and data, not politics,” he exclaimed, adding that “FDA will not permit any pressure from anyone to change that. I will fight for science.”

A few hours later, he was undermined by President Donald Trump when a reporter asked if he was okay with stricter vaccine guidelines that the FDA was said to be cooking up. “That has to be approved by the White House. We may or may not approve it. That sounds like a political move,” he decided.

On­ly five months af­ter a Se­ries A launch, Taysha goes pub­lic with $157M IPO

As has been the trend in 2020, Taysha Gene Therapies has become the latest biotech to make a quick ascent from a small, privately-funded company to enjoying its very own Nasdaq ticker.

The Dallas-based biotech raised $157 million for its IPO after pricing shares at $20 apiece Thursday, the high-point of its expected range. Initially pegging $100 million in financing, Taysha offered a little less than 8 million shares and will trade under the $TSHA symbol.

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David Berry (Flagship)

Flag­ship's next big tech­no­log­i­cal bet? The cloud

Earlier this month, Flagship announced their big bet on the software half the industry is talking about, launching the AI and machine learning startup. Now, they and a couple other investors are gambling $100 million on a software that much of the public generally thinks of as a cool, IT afterthought: cloud computing.

The idea, says founder and Flagship partner David Berry, is one of scale: The sheer magnitude of biological data that you can store on cloud technology is unprecedented. And that size, when leveraged properly, can allow you to ask questions and form insights that are similarly unprecedented.

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New York governor Andrew Cuomo (AP Images)

An­drew Cuo­mo says New York will un­der­take its own vac­cine re­view process, and wouldn’t rec­om­mend trust­ing the fed­er­al gov­ern­ment

The concerns keep mounting over President Donald Trump’s politicization of the FDA and other federal agencies guiding the development of a safe and effective vaccine. And today, the telegenic New York governor Andrew Cuomo appeared to introduce even more politics into the matter — latest in an ongoing series of incidents that have cast the proudly independent FDA in starkly political terms.

During his daily press conference Cuomo said that the state will review any coronavirus vaccines approved by the federal government, citing a lack of trust of the Trump administration. The announcement comes one day after Trump accused the FDA of making an “extremely political” move in proposing stricter vaccine guidance.

Patrick Enright, Longitude co-founder (Longitude)

As its biotechs hit the pan­dem­ic ex­it, Lon­gi­tude rais­es $585M for new neu­ro, can­cer, ag­ing and or­phan-fo­cused fund

The years have been kind to Longitude Capital. This year, too.

A 2006 spinout of Pequot Capital, its founders started their new firm just four years before the parent company would go under amid insider trading allegations. Their first life sciences fund raised $325 million amid the financial crisis, they added a second for $385 million and then in, 2016, a third for $525 million. In the last few months, the pandemic biotech IPO boom netted several high-value exits from those funds, as Checkmate, Vaxcyte, Inozyme and Poseida all went public.

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Laura Shawver (Silverback Therapeutics)

Fol­low­ing a hefty Se­ries B, Sil­ver­back Ther­a­peu­tics quick­ly pulls in $85M for 'an im­por­tant growth phase'

Months after reeling in a $78 million Series B round, Silverback Therapeutics has hooked an even larger Series C.

The Seattle-based company announced Wednesday that it netted $85 million from a slate of new and previous investors. The quick boost could be a sign that an IPO is on the way.

In an email, Silverback CEO Laura Shawver told me she was “not able to provide any additional comments about Silverback” beyond what was shared in the company’s news release. In the prepared statement, she said the company is at “an important growth phase.”

Covid-19 roundup: Op­er­a­tion Warp Speed's 7th vac­cine is live at­ten­u­at­ed; Small biotech touts big suc­cess where gi­ants have failed

Operation Warp Speed is stacking its vaccine portfolio with a “TBD” new candidate: a live attenuated vaccine that can be administered in a single dose, potentially as an oral formulation rather than an injection.

Sound familiar?

That could be because the unannounced candidate appears to match the profile of an inoculation being developed by Merck, according to Bloomberg, which first reported the development based on a presentation by Moncef Slaoui.

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