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.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Fireside chat between Hal Barron and John Carroll, UKBIO19

It’s time we talked about bio­phar­ma — live in Lon­don next week

Zoom can only go so far. And I think at this stage, we’ve all tested the limits of staying in touch — virtually. So I’m particularly happy now that we’ve revved up the travel machine to point myself to London for the first time in several years.

Whatever events we have lined up, we’ve always built in plenty of opportunities for all of us to get together and talk. For London, live, I plan to be right out front, meeting with and chatting with the small crowd of biopharma people we are hosting on October 12 at Silicon Valley Bank’s London headquarters. And there’s a lengthy mixer at the end I’m most looking forward to, with several networking openings between sessions.

Take­da to pull key hy­poparathy­roidism drug from the mar­ket af­ter years of man­u­fac­tur­ing woes

Takeda on Tuesday morning made an announcement that almost 3,000 people with the rare disease known as hypoparathyroidism were fearing.

Due to unresolved supply issues and manufacturing woes, Takeda said it will cut its losses and discontinue its hypoparathyroidism drug, known as Natpara (parathyroid hormone), halting all manufacturing of the drug by the end of 2024, but the entire inventory will be available until depleted or expired, a company spokesperson said via email.

Pfizer and BioNTech's original Marvel comic book links evolving Covid vaccine science to Avengers' evolving villain-fighting tools.(Source: Pfizer LinkedIn post)

Pfiz­er, BioN­Tech part­ner with Mar­vel for Avengers and Covid-fight­ing com­ic book

Pfizer and BioNTech are collaborating with Marvel to celebrate “everyday” people getting Covid-19 vaccines in a custom comic book.

In the “Everyday Heroes” digital comic book, an evolving Ultron, one of the Avengers’ leading villains, is defeated by Captain America, Ironman and others. The plotline and history of Ultron is explained by a grandfather who is waiting with his family at a clinic for Covid-19 vaccinations.

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FDA+ roundup: Ad­comm date set for Cy­to­ki­net­ics heart drug; New gener­ic drug guid­ance to re­duce fa­cil­i­ty de­lays

The FDA has set Dec. 13 as the day that its Cardiovascular and Renal Drugs Advisory Committee will review Cytokinetics’ potential heart drug, setting up a key vote ahead of a Feb. 28, 2023 PDUFA date.

The drug, known as omecamtiv mecarbil, read out its first Phase III in 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 the key to breaking into the market, failing to significantly differ in reducing cardiovascular death from placebo.

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Af­ter Covid set­back, Val­ne­va lines up $100M for Pfiz­er-al­lied Ly­me dis­ease PhI­II

Valneva has secured €102.9 million (around $99.9 million USD) in a share offering to push forward its Pfizer-partnered Lyme disease vaccine and a jab for chikungunya that awaits an FDA decision.

The French vaccine maker largely snagged the near $100 million from Deep Track Capital and local state-owned Bpifrance, the company said Tuesday night. The capital injection is nearly equal to the amount Pfizer paid to nab equity in the company earlier this summer as part of the duo’s vaccine tie-up.

Valitor CEO Steven Lo (L) and president and CSO Wesley Jackson

A dozen years in the mak­ing, a UC Berke­ley spin­out nabs funds to take on the eye

Largely funded by government grants for the better part of its first decade, a UC Berkeley spinout has secured a new CEO and the funds to take its research into the clinic in early 2024.

The biotech, named by one of the co-founder’s daughters and originally scrapped together with NIH funds in the aftermath of the 2008-09 financial crisis, is also on a mission to upend the treatment of wet age-related macular degeneration, or AMD, with an injectable drug that it claims could be more durable than the “800-pound gorilla” in the room, Genentech’s Lucentis and Regeneron/Bayer’s Eylea.

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Car­olyn Bertozzi (Illustration: Assistant editor Kathy Wong for Endpoints News)

Car­olyn Bertozzi, re­peat biotech founder and launch­er of a field, shares in chem­istry No­bel win

Carolyn Bertozzi, predicted by some to become a Nobel laureate, clinched one of the world’s top awards in the wee hours of Wednesday, winning the Nobel Prize in Chemistry alongside a repeat winner and a Copenhagen researcher.

The Stanford professor, Morten Meldal of University of Copenhagen and 2001-awardee K. Barry Sharpless of Scripps shared the prize equally. The Nobel is sometimes split in quarters and/or halves.