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.

Atul Deshpande, Harbour BioMed chief strategy officer & head, US operations (Harbour BioMedO

An­oth­er biotech IPO set-up? Multi­na­tion­al biotech leaps from round to round, scoop­ing up cash at a blis­ter­ing pace

A short four months after announcing a $75 million haul in Series B+ fundraising, the multinational biotech Harbour BioMed pulled in another round of investments and eclipsed the nine-digit mark in the process.

Harbour completed its Series C financing, the company announced Thursday morning, raising $102.8 million and bringing its total investment sum to over $300 million since its founding in late 2016. The biotech plans to use the money to transition early-stage candidates from the discovery phase, fund candidates already in the clinic, and prep late-stage candidates for commercialization.

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Regeneron CEO Leonard Schleifer speaks at a meeting with President Donald Trump, members of the Coronavirus Task Force, and pharmaceutical executives in the Cabinet Room of the White House (AP Photo/Andrew Harnik)

OWS shifts spot­light to drugs to fight Covid-19, hand­ing Re­gen­eron $450M to be­gin large scale man­u­fac­tur­ing in the US

The US government is on a spending spree. And after committing billions to vaccines defense operations are now doling out more of the big bucks through Operation Warp Speed to back a rapid flip of a drug into the market to stop Covid-19 from ravaging patients — possibly inside of 2 months.

The beneficiary this morning is Regeneron, the big biotech engaged in a frenzied race to develop an antibody cocktail called REGN-COV2 that just started a late-stage program to prove its worth in fighting the virus. BARDA and the Department of Defense are awarding Regeneron a $450 million contract to cover bulk delivery of the cocktail starting as early as late summer, with money added for fill/finish and storage activities.

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Ed Engleman (Stanford Blood Center)

Stan­ford star on­col­o­gy sci­en­tist Ed En­gle­man helped cre­ate the im­munother­a­py field. Now he wants to shake up neu­rode­gen­er­a­tion R&D

Over the last generation of drug R&D, Ed Engleman has been a standout scientist.

The Stanford professor co-founded Dendreon and provided the scientific insights needed to develop Provenge into a pioneering — though not particularly marketable — immunotherapy. He’s spurred a slate of startups, assisted by his well-connected perch as a co-founder of Vivo Capital, and took the dendritic cell story into its next chapter at a startup called Bolt.

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Nello Mainolfi (Kymera via YouTube)

Out to re­vive R&D, a resur­gent Sanofi pays $150M cash to part­ner up with a pi­o­neer­ing pro­tein degra­da­tion play­er

Frank Nestle was appointed Sanofi’s global head of immunology and inflammation research therapeutic area just days before dupilumab, the blockbuster-to-be IL-4 antibody, would be accepted for priority review. After four years of consolidating immunology expertise from multiple corners of the Sanofi family and recruiting new talents to build the discovery engine, he’s set eyes on a Phase I-ready program that he believes can grow into a Dupixent-sized franchise.

UP­DAT­ED: Bio­gen shares spike as ex­ecs com­plete a de­layed pitch for their con­tro­ver­sial Alzheimer's drug — the next move be­longs to the FDA

Biogen is stepping out onto the high wire today, reporting that the team working on the controversial Alzheimer’s drug aducanumab has now completed their submission to the FDA. And they want the agency to bless it with a priority review that would cut the agency’s decision-making time to a mere 6 months.

The news drove a 10% spike in Biogen’s stock $BIIB ahead of the bell.

Part of that spike can be attributed to a relief rally. Biogen execs rattled backers and a host of analysts earlier in the year when they unexpectedly delayed their filing to the third quarter. That delay provoked all manner of speculation after CEO Michel Vounatsos and R&D chief Al Sandrock failed to persuade influential observers that the pandemic and other factors had slowed the timeline for filing. Actually making the pitch at least satisfies skeptics that the FDA was not likely pushing back as Biogen was pushing in. From the start, Biogen execs claimed that they were doing everything in cooperation with the FDA, saying that regulators had signaled their interest in reviewing the submission.

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Covid-19 roundup: CDC de­bat­ing who should get first avail­able vac­cines; EU in Gilead talks af­ter US gob­bled first remde­sivir dos­es

The federal government has now spent billions of dollars accelerating the development of a Covid-19 vaccine, and yet they’ve remained hush on who, precisely, would actually get inoculated once the first doses are approved and available. Internally, though, they have been debating it.

The CDC and an advisory committee of outside health experts have been working since April to devise a ranking system that would determine who receives a vaccine and when,  The New York Times reported. The question of who is first in line for inoculation is important because no matter how many doses developers can make or how quickly they can make them, doses will still come out in batches; 300 million inoculations will not appear overnight.

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Francis Collins, NIH director (Sean Zanni/Patrick McMullan via Getty Images)

NIH kicks off Covid-19 vac­cine, mon­o­clon­al an­ti­body re­search net­work

The NIH today announced the kickoff of a national clinical trials network to test vaccines and other treatments that could prevent infection with SARS-CoV-2, the virus that causes infection with Covid-19.

The network has been established by the National Institute of Allergy and Infectious Diseases (NIAID) through the merger of four previously existing clinical trials networks that focused on HIV/AIDS.

Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

A new study points to $6.5B in pub­lic sup­port build­ing the sci­en­tif­ic foun­da­tion of Gilead­'s remde­sivir. Should that be re­flect­ed in the price?

By drug R&D standards, Gilead’s move to repurpose remdesivir for Covid-19 and grab an emergency use authorization was a remarkably easy, low-cost layup that required modest efficacy and a clean safety profile from just a small group of patients.

The drug OK also arrived after Gilead had paid much of the freight on getting it positioned to move fast.

In a study by Fred Ledley, director of the Center for Integration of Science and Industry at Bentley University in Waltham, MA, researchers concluded that the NIH had invested only $46.5 million in the research devoted to the drug ahead of the pandemic, a small sum compared to the more than $1 billion Gilead expected to spend getting it out this year, all on top of what it had already cost in R&D expenses.

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Sin­gu­lar fo­cus on ROR1 earns Velos­Bio $137M to fund PhI ADC and oth­er pro­grams

Years after selling Acerta to AstraZeneca for $7 billion, largely on the promise of its BTK inhibitor, Dave Johnson has once again gathered hefty financial support behind a new cancer target.

Matrix Capital Management and Surveyor Capital are leading a $137 million round for VelosBio, which has recently begun a Phase I study for its lead antibody-drug conjugate targeted against ROR1. Johnson took up the CEO post in October 2018.